title: Influence of Muscular Atrophy on Biological and Functional Benefit of Respiratory Rehabilitation in Patients With Chronic Respiratory Failure

acronym: INSPIRE

summary:
The prevalence of chronic respiratory failure (CRF) is increasing worldwide and will become the 3rd cause of death by 2020. At the stage of the disease requiring ventilatory assistance, this relates to 50,000 patients in France, life expectancy is very limited, and quality of life is poor.

CRF led to a reduction in muscle mass, which is found in 35 and 55% of patients, in some to a profound cachexia. A reduced fat free mass (FFM) is a factor associated with a poor tolerance to exercise and an halved survival. The exact causes and mechanisms leading to cachexia are not yet established. Recently, a chronic inflammatory condition has been quoted as a putative cause. This chronic inflammation would involve the molecular mechanisms leading to poor regulation of the balance of synthesis / protein degradation in muscle. A decrease in plasma and muscle amino acids was found among patients with a low FFM.. In addition, a decrease of plasma levels of some anabolic hormones, GH and androgens or IGF-1 has been found that could explain a lack of protein synthesis.

It is now well established that respiratory rehabilitation, including a program of exercise reconditioning, increases tolerance to exercise and improve the quality of life. Besides the classical type of endurance exercises stimulating the cardio-respiratory system, it is suggested to add resistance exercises. Several studies have reported the benefit of this strategy but the link with intracellular molecular pathways has not been described; moreover, it is unknown whether the existence of an initial muscular atrophy influences the gain in muscle strength/mass.

ReferenceCitation: Costes F, Gosker H, Feasson L, Desgeorges M, Kelders M, Castells J, Schols A, Freyssenet D. Impaired exercise training-induced muscle fiber hypertrophy and Akt/mTOR pathway activation in hypoxemic patients with COPD. J Appl Physiol (1985). 2015 Apr 15;118(8):1040-9. doi: 10.1152/japplphysiol.00557.2014. Epub 2015 Feb 19.

name: Service de Physiologie Clinique et de l'Exercice, Pôle NOL, CHU Saint Étienne, France;

name: Laboratoire de Physiologie de l'Exercice, Université de Lyon, Saint Étienne, France; and

family: Costes

full_name: Frédéric Costes

name: NUTRIM School for Nutrition, Toxicology and Metabolism, Department of Respiratory Medicine, Maastricht University Medical Center, Maastricht, The Netherlands

family: Gosker

full_name: Harry Gosker

given: Harry

family: Feasson

full_name: Léonard Feasson

given: Léonard

family: Desgeorges

full_name: Marine Desgeorges

given: Marine

family: Kelders

full_name: Marco Kelders

given: Marco

family: Castells

full_name: Josiane Castells

given: Josiane

family: Schols

full_name: Annemie Schols

given: Annemie

family: Freyssenet

full_name: Damien Freyssenet

given: Damien

journal_name: Journal of Applied Physiology

repository_institution: Maastricht University - Research Publications

publisher: American Physiological Society

publisher_dissemination: American Physiological Society

publisher_group: American Physiological Society

publisher_normalized: American Physiological Society


title: Impact Médico-Economique de la Chirurgie de la cATaracte au Laser Femtoseconde

acronym: FEMCAT

summary: Cataract is the leading cause of blindness worldwide and cataract surgery is the most frequent surgery performed in France. A new technology, the femtosecond laser-assisted cataract surgery, has to be compared with phacoemulsification alone, the conventional cataract surgery, to determine the economic impact of femtosecond laser-assisted process for the French healthcare insurance.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Abraham AG, Condon NG, West Gower E. The new epidemiology of cataract. Ophthalmol Clin North Am. 2006 Dec;19(4):415-25. Review.

ReferenceCitation: Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.

ReferenceCitation: Lamoureux EL, Fenwick E, Pesudovs K, Tan D. The impact of cataract surgery on quality of life. Curr Opin Ophthalmol. 2011 Jan;22(1):19-27. doi: 10.1097/ICU.0b013e3283414284. Review.

ReferenceCitation: Høvding G, Natvik C, Sletteberg O. The refractive error after implantation of a posterior chamber intraocular lens. The accuracy of IOL power calculation in a hospital practice. Acta Ophthalmol (Copenh). 1994 Oct;72(5):612-6.

ReferenceCitation: Norrby S. Sources of error in intraocular lens power calculation. J Cataract Refract Surg. 2008 Mar;34(3):368-76. doi: 10.1016/j.jcrs.2007.10.031.

ReferenceCitation: Norregaard JC, Thoning H, Bernth-Petersen P, Andersen TF, Javitt JC, Anderson GF. Risk of endophthalmitis after cataract extraction: results from the International Cataract Surgery Outcomes study. Br J Ophthalmol. 1997 Feb;81(2):102-6.

ReferenceCitation: Powell SK, Olson RJ. Incidence of retinal detachment after cataract surgery and neodymium: YAG laser capsulotomy. J Cataract Refract Surg. 1995 Mar;21(2):132-5.

ReferenceCitation: Norregaard JC, Thoning H, Andersen TF, Bernth-Petersen P, Javitt JC, Anderson GF. Risk of retinal detachment following cataract extraction: results from the International Cataract Surgery Outcomes Study. Br J Ophthalmol. 1996 Aug;80(8):689-93.

ReferenceCitation: Qatarneh D, Mathew RG, Palmer S, Bunce C, Tuft S. The economic cost of posterior capsule tear at cataract surgery. Br J Ophthalmol. 2012 Jan;96(1):114-7. doi: 10.1136/bjo.2010.200832. Epub 2011 Mar 1.

ReferenceCitation: Chatoux O, Touboul D, Buestel C, Balcou P, Colin J. [Crystalline lens photodisruption using femtosecond laser: experimental study]. J Fr Ophtalmol. 2010 Sep;33(7):472-80. doi: 10.1016/j.jfo.2010.06.008. French.

ReferenceCitation: Friedman NJ, Palanker DV, Schuele G, Andersen D, Marcellino G, Seibel BS, Batlle J, Feliz R, Talamo JH, Blumenkranz MS, Culbertson WW. Femtosecond laser capsulotomy. J Cataract Refract Surg. 2011 Jul;37(7):1189-98. doi: 10.1016/j.jcrs.2011.04.022. Erratum in: J Cataract Refract Surg. 2011 Sep;37(9):1742.

ReferenceCitation: Palanker DV, Blumenkranz MS, Andersen D, Wiltberger M, Marcellino G, Gooding P, Angeley D, Schuele G, Woodley B, Simoneau M, Friedman NJ, Seibel B, Batlle J, Feliz R, Talamo J, Culbertson W. Femtosecond laser-assisted cataract surgery with integrated optical coherence tomography. Sci Transl Med. 2010 Nov 17;2(58):58ra85. doi: 10.1126/scitranslmed.3001305.

ReferenceCitation: Masket S, Sarayba M, Ignacio T, Fram N. Femtosecond laser-assisted cataract incisions: architectural stability and reproducibility. J Cataract Refract Surg. 2010 Jun;36(6):1048-9. doi: 10.1016/j.jcrs.2010.03.027.

ReferenceCitation: Taketani F, Matuura T, Yukawa E, Hara Y. Influence of intraocular lens tilt and decentration on wavefront aberrations. J Cataract Refract Surg. 2004 Oct;30(10):2158-62.

ReferenceCitation: Nagy Z, Takacs A, Filkorn T, Sarayba M. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. J Refract Surg. 2009 Dec;25(12):1053-60. doi: 10.3928/1081597X-20091117-04.

ReferenceType: derived

ReferenceCitation: Schweitzer C, Brezin A, Cochener B, Monnet D, Germain C, Roseng S, Sitta R, Maillard A, Hayes N, Denis P, Pisella PJ, Benard A; FEMCAT study group. Femtosecond laser-assisted versus phacoemulsification cataract surgery (FEMCAT): a multicentre participant-masked randomised superiority and cost-effectiveness trial. Lancet. 2020 Jan 18;395(10219):212-224. doi: 10.1016/S0140-6736(19)32481-X.

family: Schweitzer

full_name: Cedric Schweitzer

given: Cedric

sequence: first

family: Brezin

full_name: Antoine Brezin

given: Antoine

sequence: additional

family: Cochener

full_name: Beatrice Cochener

given: Beatrice

family: Monnet

full_name: Dominique Monnet

given: Dominique

family: Germain

full_name: Christine Germain

given: Christine

family: Roseng

full_name: Stephanie Roseng

given: Stephanie

family: Sitta

full_name: Remi Sitta

given: Remi

family: Maillard

full_name: Aline Maillard

given: Aline

family: Hayes

full_name: Nathalie Hayes

given: Nathalie

family: Denis

full_name: Philippe Denis

given: Philippe

family: Pisella

full_name: Pierre-Jean Pisella

given: Pierre-Jean

family: Benard

full_name: Antoine Benard

family: Albou-Ganem

full_name: Cati Albou-Ganem

given: Cati

family: Arné

full_name: Jean-Louis Arné

given: Jean-Louis

family: Bardet

full_name: Emilie Bardet

given: Emilie

family: Bourreau

full_name: Catherine Bourreau

given: Catherine

family: Chatoux

full_name: Olivier Chatoux

given: Olivier

ReferenceCitation: Schweitzer C, Hayes N, Brezin A, Cochener B, Denis P, Pisella PJ, Benard A; FEMCAT study group. Re: Abell et al.: Cost-effectiveness of femtosecond laser-assisted cataract surgery versus phacoemulsification cataract surgery (Ophthalmology 2014;121:10-6). Ophthalmology. 2014 Oct;121(10):e53-4. doi: 10.1016/j.ophtha.2014.05.025. Epub 2014 Jun 26.

location_facility:
Hospices Civils de Lyon
CHU de Bordeaux
CHU de Tours
Hôpital Cochin
CHU de Brest


title: Study During Pregnancy of miRNAs in Rheumatoid Arthritis or Systemic Lupus Erythematosus

acronym: SPIRALE

summary:
Rheumatoid arthritis (RA) is a systemic disease, which mainly targets joints and results in osteoarticular destruction and serious disability. When clinical symptoms (painful and swollen joints) occur, the innate and adaptive immune responses against self antigens have already been largely amplified. This might explain that even when RA patients are treated very early and aggressively, a remission of the disease can only be obtained in approximately half of them. This proportion of remission under treatment can only be achieved using treat to target strategies involving biologics, such as anti-TNF. Unfortunately, less than 20% of patients remain in remission after treatment discontinuation. Thus, despite the availability of 5 different types of biologics, there are still therapeutic unmet needs. However, a spontaneous, drug-free decrease of disease activity can be observed in a physiological condition, pregnancy. Although most of treatments of RA have to be discontinued during pregnancy, a marked improvement, and sometimes remission, can be observed during pregnancy, with frequent post-partum flares. The situation is the opposite with an increased risk of flares in systemic lupus erythematosus (SLE), a rare systemic autoimmune disease which generally progresses in flares-up and can affect nearly any organ (the skin, joints, kidneys, the brain, the heart, …). The course of the disease remains unpredictable for a given patient, and very few biomarkers are available to help clinicians to identify patients a risk of flares. Thus, safe therapeutic options remain limited, especially in patients with serious complications. A specific concern in SLE is the fact that the disease usually starts in women entering their sexual and reproductive life. Even with a stable condition (i.e : lupus without recent flares and no impaired renal or cardiac function) as it is medically recommended before getting pregnant, up to 40% of SLE patients flare up during pregnancy.

We hypothesize disease-specific and pregnancy-induced epigenetic changes, especially those regarding the pattern and levels of microRNAs, could explain the clinical improvement and the risk of flares in RA and SLE, respectively. A better understanding of the underlying mechanisms could help to identify new biomarkers, notably those predicting flares in SLE, and therapeutic targets, by trying to mimicking or amplifying micro-RNA changes observed in RA and targeting them in SLE.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service de rhumatologie Hôpital de Hautepierre

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Implementation of a Return Home With a Hospitalization at Home or With a Home Health Care Provider From the Services of Oncopneumology, Oncology and Hematology of University Hospital of Strasbourg: Observational, Prospective, Monocentric, Non-interventional Study. Advantages, Disadvantages, Limitations

summary:
Hospitalization at home is booming. It is designed to meet the demands of patients and their families to continue care at home. It partially solves the problem of the lack of places in the "long-term care" structures and allows to respond to a desire of the health policy to reduce the lengths of stay in the hospital. Hospitalization at home is also an alternative in the management of chronic patients. Nevertheless, at the moment a certain number of requests for hospitalization at home remain unsuccessful or their implementation is complicated. In addition, the number of home health care provider has increased significantly in recent years. According to the federation of home health care provider, the number of beneficiaries increased by 1.7% in 4 years. The home health care provider would support 1,200,000 patients per year.

The objective of the study is to analyze the factors participating in Implementation of a return home with a Hospitalization at home or a home health care provider during a return home project constructed with the patient and his / her relatives from the services of Oncology, oncology, hematology of the University Hospital of Strasbourg.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

status_simplified: Unknown


title: Evaluation of Left Ventricular Filling Pressures in Post-operative Cardiac Surgery: Trans-thoracic Ultrasound VS Invasive Pressure of the Left Atrium

acronym: ECHOPOG

summary: As part of cardiac and hemodynamic evaluation of patients, echocardiographic measurements allow indirect evaluation of left ventricular filling pressures (LVFP). These ultrasound parameters, including mitral valve doppler and mitral ring doppler (in particular the E / E 'ratio), are well validated in medical cardiology and in some resuscitation patients. The measurement of filling pressures is an important daily element in the medical management of patients in intensive care, in particular on the hemodynamic and respiratory levels. No studies have evaluated the relevance of these markers in a postoperative context of cardiac surgery. Indeed, the surgery alters the cardiac function, which could modify the values of the echocardiographic parameters and their predictability. Left atrium pressure (LAP) directly reflects LVFP and is measured in cardiac surgical resuscitation by a surgically placed catheter as part of routine institutional care and will serve as gold-standard. To study the clinical significance of these LAP and LVFP values estimated by cardiac ultrasound, we will study their correlation with clinical and ultrasound signs of acute lung edema (ALE).

time_perspective: Retrospective

ipd_sharing: No

location_facility: Service Réanimation chirurgicale cardio-vasculaire - NHC


title: LONG-TERM EFFECTS TOLERANCE AND THE Ulipristal Acetate IN DISEASE Charcot-MARIE-TOOTH TYPE OF 1A

acronym: UPACOMT

summary:
The disease Charcot-Marie-Tooth disease type 1A (CMT1A) is the most common inherited peripheral neuropathy, for which no treatment has proved its effectiveness. It is autosomal dominant, associated with a duplication of the chromosome 17p11.2 region which leads to overexpression of the gene and the protein-peripheral myelin protein-22 (PMP22), a major component of peripheral myelin.

In animals and humans, PMP22 mRNA level of glutathione S-transferase theta 2 and Cathepsin A (markers of oxidative stress), detected in a skin biopsy are markers that may play a role in the prognosis evolution of the disease. Furthermore, several studies have shown that the administration of progesterone increased the expression of PMP22 gene (measured in a skin biopsy) and worsening symptoms. In contrast, anti-progestins reduce the synthesis of PMP22 and improve symptoms in rat CMT1A.

The long-term safety of anti-progesterone was evaluated for mifepristone (RU486) ulipristal acetate and (EllaOne®). Few side effects have been reported including a few cases of endometrial hyperplasia reversible upon discontinuation of treatment. With the RU486, rare cases of adrenal androgen and failure have been observed. However, EllaOne® has low antagonistic action on the glucocorticoid receptor and no action on androgen receptors. The investigators therefore believe that it will be well tolerated in humans and will reduce the synthesis of PMP22 and the action of oxidative stress by improving disability of patients.

status: Terminated

location_facility: Département de Neurologie Centre de Référence des Maladies Neuromusculaires Grand Est (CERNEST) Hôpital de Hautepierre

intervention_type: Drug


title: Electrophysiological Study of the Functioning of Magnocellular Visual Pathway in Regular Cannabis Users

acronym: CAUSA MAP

summary:
This study will evaluate the impact of regular use of cannabis on the spatial sensitivity of magnocellular system (visual event-related potential, visual ERP).

Secondary purposes of this study are to evaluate the impact of regular use of cannabis on the temporal sensitivity of magnocellular system (visual event-related potential), on the dynamics of cortical visual processing during face perception test (visual event-related potential) and on functioning of retinal photopic and scotopic systems (electroretinogram).

The ancillary study is a genetic analysis of a group of candidate genes that aims to identify biomarkers for changes in visual processing. This will allow to distinguish among more homogeneous and specific groups in future studies on larger cannabis user population. This ancillary study concerns all participants subject to their informed consent (facultative study).

design_allocation: Non-Randomized

primary_purpose: Other

ReferenceCitation: Remy I, Schwitzer T, Albuisson É, Schwan R, Krieg J, Bernardin F, Ligier F, Lalanne L, Maillard L, Laprevote V. Impaired P100 among regular cannabis users in response to magnocellular biased visual stimuli. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Sep 11;113:110437. doi: 10.1016/j.pnpbp.2021.110437. [Epub ahead of print]

family: Remy

full_name: Irving Remy

given: Irving

family: Schwitzer

full_name: Thomas Schwitzer

given: Thomas

family: Albuisson

full_name: Éliane Albuisson

given: Éliane

family: Schwan

full_name: Raymund Schwan

given: Raymund

family: Krieg

full_name: Julien Krieg

given: Julien

family: Bernardin

full_name: Florent Bernardin

given: Florent

family: Ligier

full_name: Fabienne Ligier

given: Fabienne

family: Lalanne

full_name: Laurence Lalanne

given: Laurence

full_name: Louis Maillard

given: Louis

family: Laprévote

full_name: Vincent Laprévote

given: Vincent

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Progress in Neuro-Psychopharmacology and Biological Psychiatry

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Central Hospital, Nancy, France

location_facility: Maison des Addictions - CHU de Nancy, Hôpital St Julien


title: Characterization of Molecular Signature Associated With T-cell Dysfunction Observed During Chronic HBV Infection

acronym: VHB-Roche

summary:
Chronic hepatitis B (CHB) infection remains an important public health with more than 240 million people chronically infected despite the existence of an effective vaccine. Cirrhosis and hepatocellular carcinoma (HCC) are major complications of CHB infection and are responsible for more than 600,000 deaths each year. These complications are strongly related to the function of the immune system. Indeed, the persistence of HBV and the progression of liver disease are mainly due to the development of an ineffective immune response to HBV. Therefore, the clinical outcome depends on the complex interaction between HBV replication and adaptive immune responses.

The ultimate goal of antiviral treatments is the elimination of HBsAgHBs and the appearance of anti-HBs antibodies without detectable PCR replication. Current treatments are effective at lowering viral DNA levels, but they are not able to permanently eliminate chronic HBV infection, due to the persistence of cDNA in the nucleus of infected hepatocytes. This therapeutic goal is rarely achieved and new therapeutic approaches are needed. In this sense, Immunotherapy represents a very promising new therapeutic approach that could lead to the cure of chronic HBV infection. Indeed, HBV infection is characterized by a progressive depletion of T lymphocytes which results in a progressive loss of function, associated with a sustained positive regulation of inhibitory control molecules.

Thus, the objective of this study is to define the immune signature and the main control pathways associated with T-cell depletion in patients chronically infected with HBV, by analyzing immune cells isolated from these patients at phenotypic , transcriptional and functional levels

status: Recruiting

primary_purpose: Prevention

intervention_type: Biological

status_simplified: Ongoing


title: Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on the Survival of Hospitalized Elderly Patients With COVID-19: a Randomized, Multicenter, Adaptative Study

acronym: COVID-Aging

summary: In November 2019, Wuhan city in China, became the center of an outbreak of pneumonia due to a novel coronavirus SARS-CoV-2, which disease was named coronavirus disease 2019 (COVID19) in February, 2020. The COVID19 is much more dangerous for people over 60 with a death rate of 3.6% after 60, 8.0% after 70 and 14.8% after 80 -and according to our Italian colleagues over 20% after 90- against 2.3% in the general population. The elderly patients who died most often had multiple comorbidities and in particular: cardiovascular disease (10.5% mortality), diabetes (7.3%), chronic respiratory disease (6.3%) and hypertension (6%). These elderly patients with COVID19 are therefore very fragile and require treatment that fights the virus but is also adapted to their state of health and age. Most of current therapeutic trials worldwide exclude people aged over 75 years, which is precisely the age group affected by COVID19. We therefore propose to carry out a therapeutic trial specific to the elderly with drugs at doses that are bearable for these patients. Using the WHO, clinicaltrial, pubmed and the Chinese CCDC/CHCTR websites to find the better drugs adapted to elderly people, we decided after concertation between infectiologists and geriatricians to do a four arms clinical trial during two weeks twice a day: Hydroxychloroquine 200mg, Telmisartan 40mg, Azithromycin 250mg and standard care. We therefore hypothesize that one or more of these treatments may have a beneficial effect in controlling COVID19, without major and repeated side effects in elderly patients.


title: Hyper-Cardia Study : Hyperoxia and Pulmonary Complications After Cardiac Surgery

acronym: HYPER-CARDIO

summary: The main objective is to demonstrate that hyperoxia in cardiac surgery increase the occurrence of post-operative pulmonary complications


title: Adult-onset Generalized Morphea : A Retrospective Multicenter Study

acronym: MORPHEA

summary: This study aimed to describe the demographical and clinical characteristics of a retrospective cohort of adult-onset GM and to investigate whether these findings differ between patients with an isomorphic and a symmetric pattern of lesion distribution.

location_facility: Service de dermatologie - Hôpital Civil de Strasbourg


title: Topical 0.01% Atropine for the Control of Fast Progressing Myopia

acronym: Myopie-STOP

summary:
Myopia prevalence has dramatically increased worldwide in recent years in the general population and among children. Progressive myopia increases gradually with growth until the age of 20-25 years. At the same time, there is a remarkable increase in the prevalence of severe myopia (more than -6 diopters). Severe myopia is associated with many complications, which can lead to blindness. There is thus an increase in the number of myopic patients in general, and severe myopic patients in particular.

The management of myopia and its complications is therefore a major public health issue.

All the means likely to slow the evolution of myopia (thus to limit the prevalence of strong myopia) must be developed to limit the consequences. 0.01% Atropine seems to be a drug with a great interest to slow down the progression of myopia.

The aim of the present study is to evaluate the efficacy at 1 year of 0.01% atropine (1 drop per day administered for 1 year) on the reduction of fast progressing myopia in children aged 4 to 12, compared to a control group (instillation of a placebo).


title: Evaluation of Patient Analgesia After Bloc Serratus for the Management of Thoracic Trauma

acronym: TraumaThorax

summary:
Thorax traumas are very common in severe traumatology, including road accidents, representing the second most frequent site (after head injury, according to the FIRST study). These thoracic lesions are the cause of many complications (pneumothorax, hemothorax, lung infections, atelectasis).

The national recommendations recommend the use of multi-modal analgesia with the use of regional loco anaesthesia for pain management and prevention of respiratory complications, including infectious complications. The loco-regional anaesthesia of choice is thoracic epidural or paravertebral block, but these techniques are not without risks, and are contraindicated in many situations (severe head trauma, patient under curative anticoagulation, pelvic trauma...).

The anterior Serratus block appears to be a quality localoregional anaesthesia in thoracic surgery, and a few cases in the literature have shown an interest in severe traumatology.

The investigators perform this anterior Serratus block almost systematically in patients with thoracic trauma in the Hautepierre surgical intensive care unit.

location_facility: Service de Réanimation chirurgicale_ Hôpital de Hautepierre


title: Retrospective Observational Study on the Epidemiological Characteristics of Influenza Patients Who Consulted in the Emergency Services of the University Hospitals of Strasbourg From September 2018 to March 2019

acronym: Influenza

summary: Seasonal influenza outbreaks contribute to the saturation of emergency services. Better knowledge of the epidemiology and clinical presentation of this pathology would optimize the organization of emergency reception services and provide better care for patients, disseminate educational elements to the population more appropriate as well as optimal recommendations for health professionals.

study_start_date_type: Anticipated


title: Does the Contact Between the Deep Surface of the Supraspinatus Muscle Tendon and the Posterior Superior Labrum Physiological ?

summary: The possibility of physiological contact between the deep surface of the tendon of the supraspinatus muscle and the labrum and/or posterior superior glenoidal rim during an armed movement of the arm (abduction and external rotation or ABER position) has been described for many years. The physiological hypotheses put forward to explain this contact are first of all that the intrinsic mobility of the scapulohumeral joint is limited by these 2 structures, that an anterior instability or micro-instability induces an abnormal anterior translation when performing an abduction and lateral rotation movement, or finally that there is a decrease in humeral retroversion. When this contact becomes symptomatic, it is called a posterior superior conflict. This pathology is mainly found in throwing athletes or athletes repeating maximum external rotation in the abducted position of the arm. This conflict is also described among some manual workers, and is then observed in an older age group.

location_facility: Service de chirurgie du membre supérieur Hautepierre 2


title: Evaluation of the Interest of 18F-FDG Positron Emission Tomography in the Management of Unexplained Fevers and Inflammatory Syndromes in Elderly Subjects

summary:
Patients aged 75 and over represent a heterogeneous population with fragile subjects who have a higher risk of poor tolerance to many tests and especially who have a risk of major functional loss in the event of hospitalization. It is therefore necessary to adapt our prescriptions and not to impose on these patients an examination that is unnecessary. Or on the contrary, not to do without, out of ignorance, a minimally invasive examination that could be useful to these patients.

In this study, the investigators wish to evaluate the interest of the Pet-Scan in the therapeutic management of these elderly patients

location_facility: Service de Médecine Interne, diabète et maladies métaboliques - Médicale B


title: Evaluation of an Alternative Treatment of Localized Prostate Cancer by Guided MRI Transurtral Ultrasound With 1-year Control of the Absence of Cancer

acronym: MRI-TULSAP

summary:
Primary purpose :

Evaluation of the efficiency and safety of an alternative global prostate treatment in localized prostate cancer.

Primary Objective:

Absence of clinically significant cancer (CSC) on control biopsy at 1-year follow-up.

Secondary Objectives:

Biochemical response
Presence of any CSC on biopsy at 1- and 2-year follow-up
Radical treatment free survival
Adverse events, clinical tolerance
Urinary continence
Erectile function
Quality of life

status: Active, not recruiting

intervention_type: Procedure


title: Epidemiological Study on the Evolution of the Rate and Causes of Mortality in Geriatric SRH in the HUS

summary: In view of the ageing population and the increasing fragility of geriatric patients, it seems interesting to carry out a retrospective epidemiological observational study, on the evolution of the mortality rate and the causes of death in services of suite care and geriatric rehabilitation, in order to apprehend at best the supports, in particular palliative


title: Diffusion Weighted MRI Accuracy in Cholesteatoma Localization

acronym: CHOLEMRI

summary: Magnetic resonance imaging of the middle ear has an increasing place in the therapeutic strategy in otology and especially for cholesteatoma. It is currently performed for complicated cholesteatomas and as part of the follow-up of operated patients to detect a recurrence or a cholesteatoma residue (alternative of choice to "second look" surgery). Some people take CT and MRI fusion to improve the localization of cholesteatoma. Many studies have investigated the diagnostic capabilities of MRI but very few have demonstrate their reliability in location diagnosis. The aim of the study was to propose a topographic reading method of the MRI of the middle ear and to evaluate the performances in the localization of the cholesteatoma in order to adapt the surgical management

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


title: Efficacy Cost Analysis: Retrospective Study on the REMOTEV Study's Ancillary Data

summary: The implications of the medico-economic impact are essential in the choice of first-line therapists. The economic impact is an important criterion to recommend the privileged use of Direct Oral Anticoagulants (AOD) in first intention.

location_facility: Service Des Maladies Vasculaires - Hta - Nhc


title: Thrombin Generation as a New Test for Anticoagulation Management in Patients With ECMO

acronym: ECMOstase

summary: ECMO (Extracorporeal Membrane Oxygenation) is a circulatory assistance device aiming at maintaining or restoring cardiopulmonary circulation. Complications of this device are mainly hemorrhagic, related to coagulopathy induced by the initial pathology or by the device itself, or thrombotic and ischemic. One of the major challenges is therefore the management of a suitable curative anticoagulation, sufficient to limit the activation of hemostasis du to the ECMO, but reasonable to prevent hemorrhagic complications. To date, there is no standardized and validated protocol for the management of anticoagulation of patients under ECMO. The thrombin generation may be a valuable test to manage anticoagulation of patients with ECMO.

location_facility: Service de Réanimation médicale CHU Strasbourg

intervention_type: Diagnostic Test


title: Study Of The Metabolic Parameters Of Uterine Muscle Cells In Cold Ischemia From Hysterectomies Programmed For Benign

summary:
To date, no transplant has allowed pregnancy from a donor in a state of brain death. One of the main reservations lies in the ischemic properties of the uterine graft between the sampling time and the grafting time.

Investigators propose to carry out a prospective monocentric study at the University Hospitals of Strasbourg in 2018/2019: the objective would be to study physiologically the time of ischemia of the uterine muscle The objective is to carry out a preparatory study on healthy uteri to study the ischemic properties of uterine muscle from living markers: study of mitochondrial respiration and free radical production on uterine muscle samples If the markers are reliable, they would then be used to measure the ischemia of whole uteri collected at the end of the multi-organ retrieval process from donors in a state of brain death and stored in tissue survival media.


title: Evaluation of MassArray Platform Versus Illumina Miseq for the Detection of Driver Mutations in Hematological Malignancies

acronym: MAHM

summary:
Detection of somatic mutations in hematological malignancies is now routinely assessed by NGS sequencing. This powerful approach is nevertheless time consuming and its costs represent limitation for its availability. An original approach is now available, using mass spectrometry (MS). In this study the analytical performance of both methods will be compared, using samples that were previously analyzed by NGS.

The goal of the study is to assess whether MS can represent or not a faster and cheaper way to detect key point mutations in patients suffering from hematological malignancies


title: Cricopharyngeal Dysfunction in Adults: Diagnostic and Therapeutic Effects of Cricopharyngeal Botulinum Toxin (Botox) Injection

summary: The objective of the study, after reviewing the recent literature, is to corroborate the thesis of the authors considering the injection of botulinum toxin as a gesture that is both diagnostic and therapeutic in the disorders of the Upper Esophageal Sphincter and reinforce the results already published with a larger series of patients.

location_facility: Service ORL et chirurgie cervico-faciale


title: Preoperative CT Scan Analysis to Predict Perioperative Round Window Visibility Through the Posterior Tympanotoy in Cochlear Implant Surgery

summary:
It is difficult to predict the intraoperative visibility of the round window through the posterior Tympanostomy. In case of non-visualization, the surgeon may have to change operative technique during cochlear implant surgery.

The primary purpose of the study is to define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window. Define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window.

The secondary purpose is to validate the investigator's scanner reading protocol for a prospective study.


title: PREDICTEURS ET IMPACT CLINIQUE DE LA THROMBOSE DU STENT APRES LES THROMBECTOMIES CEREBRALES POUR LES OCCLUSIONS EN TANDEM

acronym: DST-TANDEM

summary: The aim is to describe the rate of delayed stent thrombosis after endovascular management of consecutive tandem lesions, in a patient series with systematic follow-up of stent patency. In addition, Investigatros aim to research baseline patient characteristics that are associated with a higher risk of delayed stent thrombosis and to evaluate the clinical consequences of stent thrombosis

location_facility: Service de Neuroradiologie Interventionnelle


title: Coverage and Future of Children Referred by a Liberal Doctor's Letter to Pediatric Emergency in Strasbourg Teaching Hospital Compared With Children Who Are Coming by Themselves in 2017

summary:
Since 80's, admissions in Emergency medical services increase regularly. Children represents 30% of the patients in Emergency medical Service. Only 20% of admissions are hospitalized and only 3 % need emergency care. Consequences are team's exhaustion, a reduction of healthcare quality, a slowdown in emergency care.

Investigator decided to realize an epidemiologic prospective study in Emergency medical and surgical Pediatric Service in Strasbourg Teaching Hospital to compare coverage of children who are referred by a liberal doctor with children who are coming by themselves matched with age and complaint.

This study will analyze the relevance of complaints and decision-making factors for the liberal doctor to send children in Emergency Medical and Surgical Service. Investigator will talk about the importance of close collaboration between liberal doctor and hospital doctor, as well as patient's information about basic care service on nights and week-ends in order to decrease the number of emergency admission.

location_facility: Service D'Urgences Medico Chirurgicales Pediatriques


title: INTEREST OF INTRAVENOUS INJECTION OF GADOLINIUM IN EXPLORATION INTRA-LABYRINTHINE SCHWANNOMA IN MRI 3 TESLAS

summary: Evaluate the interest of gadolinium for the positive and topographic diagnosis of intra-labyrinthine schwannoma, comparing T1 sequence acquired after gadolinium injection to a sequence of fast imaging type employing steady state acquisition (FIESTA-C)


title: Breast MRI for Neaodjuvant Chemotherapy Response Prediction and Evaluation in Breast Cancer, With Focus on Background Parenchymal Enhancement

summary: The aim of this retrospective study is to evaluate the value of pre-treatment and post-treatment multimodality MRI study, including quantitative evaluation of background parenchymal enhancement, for response prediction and evaluation. This study will include 100 patients treated in a single institution between 2011 and 2016


title: Translation and Validation of the French Version of the Postoperative Quality of Recovery Score QoR-15

summary: After a surgery, the recovery of the previous health status of patients, such as walk, body care, sleep, diet, feeling of comfort, is one of the priorities of the perioperative medicine. The QoR-15 was designed to measure quality of recovery after surgery. It provided a valid, extensive and efficient evaluation of the postoperative quality of recovery. The primary objectives of this study is to translate the original QoR-15 questionnaire into French, and do a full psychometric evaluation of the French version. We will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, orthopedic, […], gynecological surgery, in the University Hospital of Strasbourg. The secondary objectives will be to evaluate the quality of recovery of the patients who undergone surgery at Strasbourg University Hospital, and to evaluate the incidence of postoperative complications occurring within three months postoperatively and a possible association with the QoR-15F.

ReferenceCitation: Demumieux F, Ludes PO, Diemunsch P, Bennett-Guerrero E, Lujic M, Lefebvre F, Noll E. Validation of the translated Quality of Recovery-15 questionnaire in a French-speaking population. Br J Anaesth. 2020 Jun;124(6):761-767. doi: 10.1016/j.bja.2020.03.011. Epub 2020 Apr 15.

family: Demumieux

full_name: François Demumieux

given: François

family: Ludes

full_name: Pierre-Olivier Ludes

given: Pierre-Olivier

family: Diemunsch

full_name: Pierre Diemunsch

given: Pierre

family: Bennett-Guerrero

full_name: Elliott Bennett-Guerrero

given: Elliott

family: Lujic

full_name: Marko Lujic

given: Marko

family: Lefebvre

full_name: François Lefebvre

family: Noll

full_name: Eric Noll

given: Eric

journal_name: British Journal of Anaesthesia

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

location_facility: Service D'Anesthesiologie - Reanimation Chirurgicale


title: Characterization of Phenotypes of Occupational Asthma: Descriptive Study

summary: The general objective of this multicenter, international study is to perform a multivariate descriptive analysis of a large population of well-defined subjects with sensitizer-induced OA ascertained by a positive SIC result in order to provide more information on the characteristics of this condition.

location_facility: Service de pneumologie, d'allergologie et de pathologie de l'environnement


title: Relevance of Mammary MRI in the Preoperative Assessment of Ductal Carcinoma in Situ (DCIS)

summary: Compare the estimate of the lesional size in MRI to that in mammography, taking as a reference the definitive anatomo-pathological size


title: Imaging of Facial Neuritis Using T2-weighted Gradient-echo Fast Imaging Employing Steady State Acquisition After Gadolinium Injection

summary: Improved means of positive diagnosis of facial neuritis, the leading cause of peripheral facial palsy


title: Fast and Accurate Diagnosis of an Oval or Round Window Perilymphatic Fistula on CT and MRI, Without Injection, on 101 Patients With Surgical Confirmation

summary: Our objective is to validate the CT / MRI combination of non-injected rock for the rapid positive diagnosis of perilymphatic fistulas.


title: Epidemiology of Merkel Carcinomas in the Bas-Rhin From 1983 to 2011: General Population Study Based on the Bas-Rhin Cancer Registry

summary: The aim of this work is to study demographic, clinical, management (diagnostic and therapeutic) and survival data concerning patients with Merkel's carcinoma in the Lower Rhine, thus obtaining the first French data.


title: Duration of Stay for Outpatient Surgery After Tension Free Vaginal Tape (TVT) Urologic Surgery : Neuraxial Versus General Anesthesia

summary:
Outpatient midurethral surgery is a frequent surgery. It is performed either under general anesthesia or neuraxial anesthesia. A frequent complication is postoperative urinary retention requiring urinary catheterization, which implies a higher infectious risk.

The investigators compared the complication rate after TVT surgery depending on the type of anesthesia.


title: Characteristics of Positive Lyme PCR Arthritis, Data From CNR Borrelia 2011-2016

acronym: ArthLyme

summary: Lyme disease is due to Borrelia burgdorferi sensu lato and is transmitted by a tick vector of the genus Ixodes. One of the clinical forms of this disease in the disseminated phase is the appearance of arthritis, classically mono or oligo-arthritis in the large joints.


title: Self-confidence Study in Patients With Argus II Artificial Retina

summary: To evaluate whether the use of the Argus II retinal prosthesis improves the confidence and self-esteem of patients with advanced retinopathy pigmentosa


title: Work on the Social Representation of Addiction Among Mental Health Professionals

summary: Our goal is to determine the representations of addiction among caregivers working in the field of mental health. We hypothesize that caregivers, despite their investment in care, have a negative social representation of patients suffering from addictive disorders, which could be related to a lack of training on the pathology and its social repercussions.

time_perspective: Other


title: Spontaneous Haematomas of Psoas Occurring in Intensive Care: Incidence, Patient Characteristics and Treatment, a Retrospective Study

summary: Psoas hematomas are a rare and potentially lethal pathology whose incidence in resuscitation is unknown. The pathophysiology of this pathology is not known to date.


title: Intraoperative Systemic Arterial Hypotension Secondary to Beach Positioning : an Observational Study

acronym: HypoTAShoulder

summary:
This study aims at describing the systemic arterial hypotension secondary to intraoperative beach chair positioning. This is a non-interventional prospective study.

The primary endpoint will be the intraoperative systemic arterial pressure measured at the arm.

The secondary endpoints will include postoperative mortality, intensive care admission, post anesthesia care unit length of stay,


title: Impact of Setting up a Multidisciplinary Consensus Meeting in the Prognosis and Management of Infectious Endocarditis at Strasbourg University Hospital.

summary: New ESC 2015 recommendations with encouragement to set up a Multidisciplinary Consultation Meeting to discuss the medical and surgical management of endocarditis, set up at Strasbourg University Hospital in October 2016: Impact and benefits

location_facility: Service de Maladies Infectieuses et Tropicales


title: Correlation Between Gait Disorders and Neuropsychological Profile in Patients With Alzheimer's Disease and Lewy Body Disease

summary:
The prevalence of neurodegenerative diseases will increase over the next decades driven by ageing population. It seems important to develop reliable, replicable and accessible diagnostic tools.

This is a prospective study whose objective is to study the spatio-temporal parameters of gait in patients with Alzheimer's and Lewy body diseases. 64 patients were included in this study. A comparison of the two pathologies was conducted, followed by an analysis based on four groups (mild, severe Alzheimer's disease, mild, severe Lewy body disease) and a study of the severity of the diseases. To study these parameters, we used the Gaitrite treadmill.

The analysis of spatio-temporal parameters of walking in Alzheimer's disease and Lewy body disease enables to identify discriminating variables between the two pathologies. The probability of suffering from an Alzheimer's disease decreases with the pace increase but increases with variations in length of the step, and with the rotation of the foot. While the probability of suffering from Lewy body disease increases with the pace, variations in the step duration, and the duration of double support.

These results are interesting but do not allow to establish a diagnostic score for these two diseases. The monitoring of the variations of these parameters at individual level would probably be more relevant and would enable to detect dual pathologies.

location_facility: Service de Gériatrie Hôpital de la Robertsau


title: Survival Rates of Atients Wearing a Mobile Unicompartimental Knee Prosthesis for the Past 10 Years

summary:
The unicompartmental knee prosthesis has become a routine procedure. Survival rate of over 90% after 10 years are generally reported. However, complications and reoperation may still occur for many reasons, and some of them may be related to component design: loosening (tibial above), polyethylene wear, knee stiffness, ligamentous instability, etc ... . Therefore, new designs can, at least in theory, improve the results of conventional models.

In this study, the investigators want to compare retrospectively data concerning survival rates of patients wearing unicompartmental knee prosthesis with mobile plate for over 10 years, with the ones published in the literature for conventional fixed-bearing prostheses and mobile-bearing prostheses

location_facility: Centre de Chirurgie Orthopédique et de la Main (CCOM)


title: Genotyping FcɣRs Genes of HIV-1 Patients "Progressor": Correlation With the Changing Profile of the Infection

summary: This non-interventional study aims to determine whether there is a correlation between the Fc receptor polymorphism (FcR) and the course of the disease following HIV infection.

location_facility: Le Trait d'Union - Centre de soins de l'infection par le VIH au NHC


acronym: Sentimetre

summary:
Selective lymphadenectomy Sentinel (LSS). This technique is already well established in breast cancer and melanoma and more recently in vulvar and cervical cancer.

Compared to lymphadenectomy, it has several theoretical advantages:

this is a sensitive technique with a detection rate of> 90% and a false negative rate of <5%.
the anatomopathological techniques used (immunohistochemistry with anti-cytokeratin antibodies, serial sections) are more sensitive than the standard histological analysis of lymphadenectomy, which allows an improvement in the detection of metastases (micro-metastases, isolated tumor cells). In the SENTI-ENDO study, it was possible to detect lymph node metastases in 11% of patients with low-risk endometrial cancer and in 15% of intermediate-risk patients.
it avoids short-term and long-term operative and post-operative morbidity of lymphadenectomy.

Early studies of LSS in endometrial cancer demonstrated superior efficacy of the colorimetric method coupled with the Technetium 99m isotopic method with an overall detection rate of 78% [95% CI: 73-84]. The fluorescent green of indocyanine appears to give better results with an overall detection rate of 94% and a bilateral detection rate of 80%.

It seemed useful to take stock of this technique using this new dye.

location_facility: Service de gynécologie-obstétrique - Hôpital de Hautepierre


title: Preliminary Study: Perceptions of Doctors and Caregivers Confronted With Adult Patients in Advanced or Terminal Stage of a Severe, Progressive and Incurable Pathology in the Services of the Hospitals University of Strasbourg Including Beds Identified Palliative Care

summary:
Hospitals, doctors and caregivers, who take care of increasingly heavy patients, are faced with ever more complex situations, particularly in the case of severe, progressive, and incurable pathologies.

Thanks to their willingness and expertise, these care providers try to guarantee the continuity and quality of care for both patients and patients in a palliative situation. Nevertheless, these same actors testify to the complexity they encounter in the care of patients in advanced or terminal stages, especially since the concept of "palliative care", which was often erroneously reduced during the Any end of life and therefore death, remains a source of questions, contradictions, even resistances.

In this context, how do physicians and caregivers appropriate palliative care? How do they react to the complexity and intensity of certain situations? Do they have specific expectations of help or support in the face of certain difficulties? Are there actions to be carried out and developed to make the aid given to these actors of the palliative approach more efficient?

These are the topics that the HUS palliative care service proposes to explore through a study of physicians and caregivers working in HUS services for adult patients with LISP.


title: Venous Congestion and Acute Renal Failure in Cardiac Surgery Postoperative (COVD)

acronym: COVD

summary:
Acute renal failure (ARF) is a frequent complication in the postoperative cardiac surgery, and is a major risk factor for mortality in this context.

The right ventricular dysfunction post cardiopulmonary bypass (CPB) is also a common complication, close to 100% if one takes into account the transient dysfunction.

A recent study showed that right ventricular dysfunction and the IRA seemed related, rather on the slope of venous congestion. We wish to study this phenomenon more specifically in particular to offer reliable diagnostic markers of venous congestion.

location_facility: Service Réanimation chirurgicale cardio-vasculaire - NHC


title: Tonsillectomy and Primitive IgA Nephropathy in Children: Strasbourg Cohort and Assessment Practices in Inter North East Region

summary: Primitive kidney disease IgA, represented by Berger's disease and rheumatoid purpura nephropathy, are the first cause of kidney failure from chronic glomerulonephritis: changes in 20 years to end-stage renal failure is described in 10 to 30 % of cases in Berger's disease and in 15 to 20% of cases in nephropathy HSP. These two pathological entities share biological and histological characteristics, as well as common pathophysiological mechanisms, particularly the production of abnormally glycosylated IgA1 promoting their proliferation in the mesangium. Tonsils part of Iga abnormal production sites that would be associated with an infectious stimulus, tonsillectomy has been studied as a possible treatment in primitive IgA nephropathy. The benefit of tonsillectomy is controversial: many Japanese studies demonstrate its effectiveness in terms of reduction of proteinuria, improved renal function in the long term regression of histological lesions and reduced risk of relapse following clinical remission whereas European studies do not suggest its effectiveness in treating IgA nephropathy. In this context, the aim of our study is to describe the scope of practice of tonsillectomy in the treatment of primary renal disease in IgA child in the inter East region and describe the short renal become Strasbourg end of the cohort that received this treatment.

location_facility: Service de Pédiatrie 1 Hôpital de Hautepierre


title: BECOME CHILDREN OF HOLDERS Corpus Callosum Agenesis Screened IN PERIOD Antenatal

summary:
The corpus callosum agenesis is an interesting malformation between 0.05% and 1.5% of the general population. This malformation is mostly diagnosed prenatally by ultrasound, usually at 22 weeks of gestation, and the use of prenatal advice is routinely offered to the couple.

Several studies in recent years have helped to define the determinants of prognosis for the unborn child suffers from agenesis of the corpus callosum, whether total or partial. These, mainly retrospective, demonstrated that the isolated nature of the deformity (defined as no other brain malformations and brain extra, absence of abnormal karyotype, maternal poisoning or viral seroconversion when pregnancy) is associated with favorable developments in terms of psychomotor development in 80% of cases Similar results were also found in prospective studies, while the associated nature of the defect seems most heavily encumber the prognosis as other malformation or syndrome associated with agenesis of the corpus callosum Although these recent data have already significantly influence prenatal counseling and outcome of pregnancy, questions about the future of the child carrying a prenatal diagnosis of agenesis of the corpus callosum are still valid.

location_facility: Service de Pediatrie 1 - Hopital de Hautepierre


title: Role of Anti-BK Virus Neutralizing Antibodies (BKV) as a Prognostic Marker for the Development of Nephropathy BK

summary:
BKV nephropathy (BKV) is one of the most frequent complications of kidney transplantation.

In the absence of specific anti-BKV treatment, pre-emptive reduction of immunosuppression is the main strategy that has proven effective in reducing the risk of BKVN. However, it exposes a transplant rejection risk estimated between 4 and 14% according to studies.

Despite the pre-emptive reduction of immunosuppression, a significant number of patients continue to progress towards BKVN suggesting that pre-emptive strategy is late. It's therefore urgent to develop new prognostic markers to identify earlier and more effectively patients with a higher risk of developing BKVN.


title: Feasibility and Safety of Ultrasound Guided Installation Central Subclavian Catheter Through Supraclavicular Way

summary: Our goal is to demonstrate the feasibility of laying uncomplicated ultrasound-guided central subclavian catheter by supraclavicular route in the newborn.

location_facility: Service de réanimation néonatale - HOPITAL DE HAUTEPIERRE


title: OPTIMIZATION OF NUTRITIONAL MANAGEMENT OF PATIENTS WAITING FOR LUNG TRANSPLANT INTO Strasbourg University Hospitals

acronym: nONsTOP

summary:
Undernutrition is the result of energy and protein deficiency and / or catabolic. These phenomena are observed daily in patients awaiting lung transplantation.

After lung transplantation that undernutrition is growing (on average 11% weight loss after the first observations in the continuing care of the University Hospital of Strasbourg). In other words the non-malnourished patients become. Hence the importance to reach every patient awaiting transplant, mainly to patients already malnourished before surgery.

Several studies have shown that early nutritional support has a direct effect on reducing comorbidities and the average length of stay. In the course of care of these patients it is necessary to intensify the dietary management to give them the best chance for early rehabilitation.

The main objective of the study is to evaluate the impact of the use of the SFNEP's nutritional care decision-making tree (Société Francophone Nutrition Clinique et Métabolisme) on the implementation of enteral nutrition by gastrostomy tube in patients awaiting for lung transplantation.

location_facility: Service de pneumologie - Nouvel Hôpital Civil


acronym: PROBA-PD

summary:
Our hypothesis is that the conventional treatment of Behavioral Addiction in Parkinson's disease is often not effective, and that affects the motor aspects (worsening akinéto-rigid syndrome and / or worsening of dyskinesia due to higher levodopa doses to compensate for the drop in behavioral addictions) and non-motor (withdrawal syndrome dopamine agonist) anxiously including apathy.

Our goal is to describe the natural history of Behavioral Addiction under the effect of the evolution of the disease and adapt treatment according to the prior art, through a study of a larger population of patients than in the few published studies.


title: Clinical Signs and Symptoms of Anemia in Patients Over 75 Years

summary: Anemia is a common pathology in geriatrics. According to the World Health Organization it affects 23.9% of subjects over 60 years in the world, and 8% of patients over 60 years in Europe. A prevalence that increases with the age and twice in individuals over 85 years.

location_facility: Service de Médecine Interne, diabète et maladies métaboliques - Médicale B


title: Study of the Impact of Laparoscopic Surgical Management of Endometriosis on Fertility

summary: The aim of the investigators study is to know the results of the endometriosis surgery and particularly to highlight a benefit of this surgery on fertility.


title: Validation of a Noninvasive Navigation System for in Vivo Measurement of the Kinematics of the Knee

summary: The knee prosthesis is a validated treatment for end-stage osteoarthritis, and this intervention usually provides a significant improvement in the quality of life of patients. However, a significant percentage of patients (up 30%) say disappointed with the outcome of the intervention. One hypothesis that could explain these poor results might be poor adaptation of the implants to the patient's anatomy, resulting in a non-physiological kinematics for the patient. Multiple studies try to obtain an individual adaptation of the intervention according to multiple criteria. The measurement of the kinematics of the knee before surgery could participate in this process.


title: Prevalence of Intracranial Arterial Stenosis in Regular Resin of Cannabis Users Compared to Control Subjects: a Preliminary Study of Feasibility

summary: There is an association between intracranial arterial stenosis and ischemic stroke in young adults. The aim of this study is to evaluate the prevalence of intracranial arterial stenosis in asymptomatic regular resin of cannabis users in comparison with control subjects.

primary_purpose: Diagnostic


title: Virulence of Staphylococcus Lugdunensis in Severe Infections

acronym: VISLISI

summary: The main objective is to identify new virulence factors produced by Staphylococcus lugdunensis that can be associated with clinical sign of severe infections and identified symptoms. The methodological approach is based on the comparison between the production of toxins by a given S. lugdunensis isolate classified in patients groups according to the infection clinically defined. Each group will be compared to the presence or not of studied virulence factors. Clinical features associated with toxin activity are not known for S. lugdunensis. This comparative approach is based on the hypotheses that drove to the definition of patient groups and their clinical criteria. However, in the absence of the evident correlation between production of toxins and kind of infection, the statistical evaluation will be completed by a multi-varied analysis. This approach has not been choosen first because of the multiple parameters that undergo during infection that may reveal relationships without true correlation. About the number of included patients in each defined group, if one of them does not reach the expected count, we still might extend inclusions to 3-6 months more. The presence of severe infections without usually defined risk is intriguing. For these last patients, we have planned, after their individual consent to achieve an exome sequencing. The obtained data will be compared to available resources for the human genome. By filtering data through usual protocols, we hope to able to focus onto few genes that evoke specific sensitivity to infections, e.g. severe endocarditis due to S. lugdunensis without defined risk.

primary_purpose: Basic Science

intervention_type: Genetic


title: Pilot Study Prok-Idm: Interest of Dosage of Prokinecitine in Acute Myocardial Infarction

acronym: Prok-Idm

summary: The study aims to investigate the presence of a substance in the blood called prokinecitine, which is released by the heart when a heart attack occurs. Several venous blood samples at the arm are withdrawn at admission, H6, H12, H24, H48 and H72 in order to measure the concentration of this substance in the blood. The usefulness of this new blood marker is going to be determsined to seek if it would be of help to better diagnose or estimate the gravity of heart infarction after a heart attack.


title: Comparative Study of Pathophysiological Mechanisms and Bronchial Response in Occupational Asthma to Wheat Flour and Quaternary Ammonium Compounds During Standardized Bronchial Provocation Tests

summary: Occupational asthma (OA) caused by high molecular weight (HMW) substances have been shown to induce predominantly an eosinophilic inflammation. In contrast, OA caused by low molecular weight (LMW) substances results in a neutrophilic inflammation. In addition, data regarding phenotype of lymphocytes in OA caused by HMW and LMW substances are scarce. The use of a new equipment will allow the realization of specific standardized bronchial challenges (BC) to occupational agents. Thus, we propose to study in more detail the cellular mechanisms involved during BC to HMW and LMW occupational agents in a double-blind placebo controlled study.


title: The Somatic-to-cerebral Oxygen Saturation Gradient as a Non-invasive Index of Anaerobic Threshold in High-risk Cardiac Surgical Patient

summary: In patients undergoing cardiac surgery under cardiopulmonary bypass, some organs like brain and heart are preserved while others (skin, gut and skeletal muscle) are being underperfused. This phenomenon is related to silent peripheral vasoconstriction that is not clinically available but threatens end-organ perfusion and carries the risk of multi-organ failure. By measuring non-invasively the somatic-to-cerebral oxygen saturation gradient, the present study aims at detecting silent peroperative hypoperfusion episodes. The investigators hypothesize that gradient, measured during the surgical procedure, will predict the occurrence of anaerobic metabolism, ascertained by an elevation of blood lactate concentration, measured in intensive care unit.

location_facility: Pôle d'anesthésie réanimation - Nouvel Hôpital Civil

intervention_type: Device


title: Characteristics of Cognitive Decline During Parkinson's Disease in the Elderly

summary: Cognitive disorders in Parkinson's disease (PD) are not as obvious as cognitive disorders in Alzheimer disease and their diagnosis tends to be delayed. If neuropsychological assessment of cognitive decline in Parkinson's disease is well established, the thresholds of cognitive testing corresponding to a dementia are unknown. Recently, new diagnosis criteria of dementia associated with PD have been proposed by the movement disorder society. In this study two groups of patients with idiopathic PD will be separated and compared according to their Mini Mental State Examination (MMSE) score (upper or lower than 26). Included patients will have clinically idiopathic PD, will be over 65 years old and will present cognitive complain. Cognitive and mood disorders as well as motor symptoms will be assessed using validated scales and a neuropsychological assessment dispatched in two visits will be performed . Differences in the distribution of data from the two groups of patients will be assessed in statistically analysis with non parametric tests. The purpose of this study is to determine the most effective tests and their threshold value corresponding to a pathological cognitive decline.

location_facility: Service de Gériatrie, Hôpital de la Robertsau, Hôpitaux Universitaires de Strasbourg


title: Evaluation of the Brain Natriuretic Peptide as a Predictor of Morbidity and Mortality in Cardiac Surgery

summary:
Objective: The purpose of the present study is to assess if perioperative variation of Brain Natriuretic Peptide (BNP) levels is a predictor of mortality and morbidity after cardiac surgery.Material and Methods: 500 consecutive patients will be enrolled prospectively in this study before cardiac surgery under cardiopulmonary bypass. BNP levels will be measured prior to surgery and at postoperative day 1. Variations of BNP levels will be analyzed to determine if it is a predictor of mortality and morbidity after cardiac surgery. This dynamic evaluation will be compared to other tools of risk stratification in cardiac surgery as the EuroScore. All patients will be followed 3 years after the procedure.

Hypothesis: Perioperative BNP variations may be more sensitive than pre- or postoperative BNP levels alone. Furthermore the perioperative homeostasis will be measured to assess its impact on BNP secretion during the perioperative period.

ReferenceCitation: Kindo M, Minh TH, Perrier S, Petit-Eisenmann H, Bentz J, Cristinar M, Ajob G, Collange O, Mazzucotelli JP. Impact of prosthesis-patient mismatch on early haemodynamic status after aortic valve replacement. Interact Cardiovasc Thorac Surg. 2017 Jan;24(1):48-54. doi: 10.1093/icvts/ivw303. Epub 2016 Sep 13.

family: Kindo

full_name: Michel Kindo

given: Michel

family: Minh

full_name: Tam Hoang Minh

given: Tam Hoang

family: Perrier

full_name: Stéphanie Perrier

given: Stéphanie

family: Petit-Eisenmann

full_name: Hélène Petit-Eisenmann

given: Hélène

family: Bentz

full_name: Jonathan Bentz

given: Jonathan

family: Cristinar

full_name: Mircea Cristinar

given: Mircea

family: Ajob

full_name: Gharib Ajob

given: Gharib

family: Collange

full_name: Olivier Collange

given: Olivier

family: Mazzucotelli

full_name: Jean-Philippe Mazzucotelli

given: Jean-Philippe

journal_name: Interactive CardioVascular and Thoracic Surgery

evidence: open (via free pdf)

license_normalized: no license

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Impact of prosthesis–patient mismatch on early haemodynamic status after aortic valve replacement

location_facility: Service de Chirurgie Cardio-Vasculaire au NHC, Hôpitaux Universitaires de Strasbourg


type: Registry Identifier

title: Role of the Subthalamic Nucleus in the Control of Movement: Physiopathology of Akinesia in Parkinson's Disease.

acronym: GB-MOV

summary: This program aims to understand the role of the subthalamic nucleus in the control of the movement in healthy humans and patients with Parkinson's disease, how the STN dysfunction contributes to akinesia and how the STN stimulation improves motor signs in PD patients .

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

location_facility:
CIC-GHPS
Groupe Hospitalier Pitie-Salpêtrière


title: "Evaluation of the Effectiveness of the MDT Method (Mechanical Diagnosis and Therapy) in the Management of Low Back Pain in the Subacute Phase"

acronym: Mc-SubLomb

summary:
The investigators propose to carry out a study evaluating the effectiveness of the MDT method (mechanical diagnosis and therapy) in the subacute phase of common low back pain.

Few studies have specifically evaluated the effectiveness of the MDT method in the subacute phase, a phase that appears to be crucial before the chronicization of low back pain.

The main objective of this study will be to evaluate the pain of patients managed by the MDT method.

The analysis of the main criterion (Visual Analog Scale) will be done using a type individual clinical trial specific: the Single Case Experimental Design or SCED in lines of multiple bases.

This type of study makes it possible to carry out a comparative test on a single subject acting as its own witness in order to obtain an acceptable level of evidence response for that particular patient.

lead_sponsor: Nantes University Hospital

location_facility: Picasso physiotherapy cabinet (5 rue Nina Simone - 44 000 NANTES)


title: Monocentric Study on the Quality of Life Among Adolescents With Attention Deficit/Hyperactivity Disorder

acronym: QuaVAT

summary:
Attention Deficit Hyperactivity Disorder (ADHD) with a overall prevalence of 5.3% is one of the most common neurobehavioral disorders in children. In the foreign literature, many studies bring to light in children and adolescents the negative impact of ADHD on overall quality of life. Some of these studies were able to identify the fact that the higher the age of ADHD children or adolescents, the lower the quality of life. Currently, to our knowledge, only a few European studies have demonstrated the negative impact of ADHD on the quality of life of children and adolescents. In addition, these studies used only questionnaires intended for parents and not for children or adolescents.

During a regular follow-up consultation with their referent child psychiatrist, adolescents accompanied by at least one of their parents will be informed of the modalities of our study. A newsletter will be delivered to parents and one to the adolescent. If neither the adolescent nor the parents is opposed to participate, the child psychiatrist will register the patient on the list of study participants. He will also fill out a medico-social information sheet about the adolescent as to summarize the data in the medical record. At the end of this consultation, in the waiting room, adolescents will answer questionnaires KIDSCREEN-27 and MSPSS; their parents will complete the CBCL questionnaire. These questionnaires will be handed to the secretary who will put them back in the patient's record. The KIDSCREEN-27, MSPSS and CBCL questionnaires as well as the medico-social information sheet will be source documents. The principal investigator or one of the associates investigators will complete the case report form from these source documents. For this purpose the data will be entered anonymously into a data entry software on a computer server secured by the Centre Psychothérapique de Nancy (CPN). Then, anonymous data from the software will be forwarded to Dr. Epstein of the Clinical Investigation Center for statistical analysis. The study will begin when the favourable opinion of the Ethical Research Comittees will be obtained and the study will last one year.

time_perspective: Cross-Sectional

lead_sponsor: Centre Psychothérapique de Nancy

location_facility: Consultation régionale de pédopsychiatrie / Centre Psychothérapique de Nancy

lead_sponsor_type: industriel


type: Other Identifier

title: Essai Clinique Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d'ExérèsE (PERSÉE) appliquée à la Chirurgie Hépatique

acronym: PERSEE

summary: This study aims at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during laparoscopic hepatic masses resection for intra-operative characterisation of hepatic masses and surgical margins assessment.

lead_sponsor: Mauna Kea Technologies


title: Early Valve Surgery Versus Conventional Treatment in Infective Endocarditis Patients With High Risk of Embolism: a Randomized Superiority Clinical Trial

acronym: CHIRURGENDO

summary:
Infective endocarditis (IE) is associated with an overall in-hospital mortality rate of 15-25% and a high incidence of embolic events (20-50%). Leading causes of mortality are heart failure (HF) resulting from valve dysfunction, and stroke caused by vegetation embolization. The rate of symptomatic embolic events occurring after antibiotic initiation is around 15%. Valve surgery benefit has been clearly demonstrated in patients with periannular complications and moderate to severe HF resulting from acute valve regurgitation. The timing of surgery to prevent embolism is critical since the risk of new embolic event is highest during the first weeks of antibiotic treatment.

The primary objective is to compare clinical outcomes of Early Valve Surgery (as soon as possible within 72 hours of randomization) with those of a conventional management based on current guidelines in patients with native left-sided IE and high risk of embolism.

208 patients (104 patients per arm) will be included in a national multicenter (19 centers) prospective randomized open blinded end-point (PROBE) sequential superiority trial.

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Randomized Controlled Pilot Study for Medico-economic Impact Evaluation in Telemedecine Follow-up in Complement of a Mobile Team in Patients With Neurological Disabilities (HANDI@CCESS)

summary: Access to care for people with traumatic or degenerative neurological disabilities is a current public health concern. New technological tools such as telemedicine can bring expertise to the place of life of people while promoting the city-hospital link.

lead_sponsor: Pôle Saint Hélier


title: Specificity of Early Maladaptive Schemas in Functional Movement Disorders

acronym: SCHEMAF

summary:
Functional neurological disorders (FND) are neurological symptoms that cannot be explained by a lesion or related to an identified dysfunction of the central nervous system. FND are under-diagnosed, although common and highly disabling. Childhood trauma events are found in 30% to 80% of FND patients, and are more common in people with functional neurological disorder than in healthy controls and patient controls. Overall, risks factors, perpetuating factors and maintaining factors have been described in FND, although none of the studies have analysed the prevalence of Early Maladaptive Schemas (EMS) in these patients. EMS, as measured with the Young Schema Questionnaire (YSQ), are proposed to underlie a variety of mental health problems, in particular Personality Disorders. We hypothesize that some of these early maladaptive schemas may participate in the psychopathology and severity of FND.

The main outcome of this study is to assess the prevalence of early maladaptive schemas in patients presenting with Functional Movement Disorders in comparison to patients presenting with Parkinson's Disease or Organic Dystonia. The secondary outcomes are to further analyse the underlying relation of these early maladaptive schemas and (i) the severity of the motor symptoms, (ii) anxiety and/or depression, (iii) the occurrence of childhood trauma events in our participants.


title: Pilot Study of the Metabolic Signature of 13C-enriched Wheat Bran Linked to Intestinal Fermentation in Humans: Identification of New Biomarkers

acronym: FITABLE

summary: It is a pilot study, conducting on 6 healthy women and aiming at defining new biomarkers related to wheat bran fermentation. For this, a breakfast, containing 5 biscuits enriched in 13-C wheat bran (which grown under 13-CO2 enriched atmosphere) is given to the subjects, then a following will be realized on 24h with breath, urine, fecal and blood samples. Analysis will be performed on these samples in order to determine potential biomarkers of fibers consumption to evaluate the metabolic effects of this consumption and to refine the relevance of nutritional recommendation regarding fibers for healthy subjects.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes


title: Multimodal Imaging of Hypoxia in Gliomas

acronym: GLIOXYMAGE

summary:
The imaging of cerebral oxygenation is an extremely important tool in understanding the pathophysiology of the tumor and for adaptation of therapies according to hypoxia. Currently, imaging of cerebral oxygenation is mainly performed by the use of Positron Emission Tomography (PET). Thus, the investigators have been able to show that the FMISO radiotracer can reveal tumor hypoxia (HypOnco study, promotor: Caen University Hospital, main investigator: J.S. Guillamo). After injection of the radiotracer, increased uptake is observed in the regions for which the tissue oxygen pressure is less than 10 mmHg (the healthy brain with a tissue oxygen pressure (ptO2) ≈ 40mmHg).

Although PET is a reference methodology, it is not widely practiced mainly because of radioactive sources. Magnetic Resonance Imaging (MRI) would bypass the previously mentioned PET limitations. The investigators have recently shown that a measure of local oxygen saturation could be obtained by MRI.

This methodology has also been implemented at a clinical scale on lower field MRI magnets, but its formal validation in a clinical situation remains to be demonstrated with respect to FMISO.

The major advantage of this methodology is that MRI is already performed in routine practice for patients. Measuring tissue oxygenation with MRI (SatO2-MRI) would not add additional examination for the patient. In addition, MRI is a non-ionizing methodology with a very good spatial resolution compared to PET, this should help to better understand intratumoral heterogeneity. Similarly, in preclinical studies, the investigators have shown in a context of mild hypoxia that SatO2-MRI may be more sensitive than PET.

The investigators propose a study to compare in patients with glial tumors, images obtained by 3 Tesla MRI of SatO2-MRI to the hypoxia maps obtained by FMISO PET. These imaging studies will be confronted with studies carried out in immunohistochemistry on biopsies / resection allowing to reveal and to quantify by image analysis the expression of the factors induced by hypoxia (HIF1, HIF2).

This study should include 20 patients with glioma (15 high-grade patients and 5 low-grade patients) in pre-surgery. The aim is to show that SatO2-MRI is a relevant methodology (in terms of sensitivity, specificity) for assessing intratumoral oxygenation in a context of brain tumors. This fits perfectly into an era of personalized medicine where functional imaging finds its meaning.

lead_sponsor: University Hospital, Caen


title: Enhanced Effectiveness of Combined Eccentric and Concentric Exercise Over Traditional Cardiac Exercise Rehabilitation Program in Patients With Chronic Heart Failure: a Randomized Controlled Study

acronym: REX-HF

summary:
As part of the regular rehabilitation program for chronic heart failure (CHF) patients, the addition of dynamic eccentric endurance (ECC) exercise sessions to the conventional concentric cycling program (CON) would enable greater gains in functional capacity that the CON alone. Furthermore, in the case of severe heart failure, results of conventional exercise rehabilitation remains limited on account of the poor physical fitness and deconditioning. Dynamic ECC has been shown to enhance muscle mass and improve muscle strength in subjects with functional limitations comparable to those in CHF, but to date reports on effects on muscle endurance and overall functional capacity remain scarce or non-existent.

Investigator hypothesize that a combination of these two types of training will allow both an improvement in strength and oxidative muscle capacities. These benefits must be objectified at the level of the walking distance covered in 6 min (6-WT).

ReferenceCitation: Plaquevent-Hostache G, Touron J, Costes F, Perrault H, Clerfond G, Cuenin C, Moisa A, Pereira B, Boiteux MC, Eschalier R, Richard R. Effectiveness of combined eccentric and concentric exercise over traditional cardiac exercise rehabilitation programme in patients with chronic heart failure: protocol for a randomised controlled study. BMJ Open. 2019 Sep 26;9(9):e028749. doi: 10.1136/bmjopen-2018-028749.

family: Plaquevent-Hostache

full_name: Guillaume Plaquevent-Hostache

given: Guillaume

family: Touron

full_name: Julianne Touron

given: Julianne

family: Costes

full_name: Frédéric Costes

given: Frédéric

family: Perrault

full_name: Hélène Perrault

family: Clerfond

full_name: Guillaume Clerfond

family: Cuenin

full_name: Christine Cuenin

given: Christine

family: Moisa

full_name: Andreea Moisa

given: Andreea

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Boiteux

full_name: Marie-Claire Boiteux

given: Marie-Claire

family: Eschalier

full_name: Romain Eschalier

given: Romain

family: Richard

full_name: Ruddy Richard

given: Ruddy

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: University Hospital, Clermont-Ferrand


title: A Single-center, Phase 1 Dose Escalation Study of Trametinib Combined With HDM201 in Patients With RAS/RAF Mutant and TP53 Wild-type Advanced/Metastatic Colorectal Cancer.

acronym: TRAHD

summary:
Recent preclinical studies suggest that combining MEK and MDM2 inhibition synergize to induce apoptosis in RAS/BRAF-mutant and TP53 wild-type CRC models. In vitro, in RKO cell lines (poorly differentiated colon carcinoma cell line resistant to single agent targeting MDM2 and MEK and BRAF inhibition), the MDM2 plus MEK inhibitor combination generated a synergistic increase in apoptotic index. In vivo, in mice harboring human RKO colon tumor xenografts the combination of MDM2 plus MEK inhibition elicited 93% decreases in tumor volume.

This trial is to conduct a single-center, Phase 1 dose escalation study of trametinib combined with HDM201 (a HDM2 inhibitor) in patients with advanced/metastatic RAS/RAF mutant and TP53 wt CRC.

lead_sponsor: Centre Leon Berard


title: Study of Motor Control Mechanisms in DBS-implanted Parkinson's Disease Patients

acronym: PARKMOTEUR

summary: Akinesia is one of the most prominent symptom in Parkinson's Disease (PD) patients. It typically consists in a inability to initiate voluntary movement, and it affects patients' quality of life. This study aims at exploring the influence of Deep Brain Stimulation (DBS) in the quality of motor control, and particularly of voluntary movement initiation, and its neural correlates. They will be evaluated using behavioral and motor tasks together with Transcranial Magnetic Stimulation (TMS) and electrophysiology (EMG and EEG).

lead_sponsor: University Hospital, Grenoble


title: Acute Effects of a Passive Stretching Session on the Mechanical Properties of Medial Gastrocnemius Muscle in Children With Cerebral Palsy

summary: Children with cerebral palsy present early in the childhood altered muscular properties, as soon as structural or stiffness. In the gastrocnemius muscle, altered muscular properties are characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. This study assess efficacy of an acute high intensity and long-time stretching session of plantarflexors muscle on their viscoelasticity properties and maximal dorsiflexion angle gain. Single stretching session is characterized by high intensity and long time (5 minutes).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: A Prospective Single Centre Randomized Interventional Controlled Trial Comparing Patient and Staff Safety During Aorto-iliac Revascularization Procedures Under Automated Fusion Imaging Guidance With Controls

acronym: CYDAR ILIAC

summary:
Endovascular revascularization has revolutionized the field of vascular surgery and has become the first-choice treatment for peripheral arteries occlusive disease. However, the drawback of this technic is the X-ray exposure for both patients and staff and the iodinated contrast injection for the patient.

One way to reduce both radiation and contrast use is to use advanced imaging techniques allowing an overlay of a 3D vascular mask (from a pre-operative CT scan) onto the live X-ray image. This has been proven during endovascular aneurysm repair.

This advanced imaging application is currently available only in the latest expensive hybrid operating rooms, requires additional manoeuvre from the operator throughout the procedure, and may be X-rays and contrast consuming.

This trial will examine the clinical benefits based on patient and staff' radiation exposure during aorto-iliac revascularisation, of a new software imaging guidance, suitable for any theatre including those equipped with mobile C-arm, fully automated and with a radiation free overlay registration process.

location_facility: Nantes University Hospital, Vascular surgery, Institut du Thorax


title: Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease

acronym: PICTURE

summary:
Crohn disease is an inflammatory chronic disease of the bowel the complex physiopathology of which brings in immunological, genetic and environmental factors. At present, the appeal to biotherapics anti-TNFa (infliximab and adalimumab) or anti-IL-12/23 (ustekinumab) in MC represents a major therapeutic progress at the origin of a significant improvement of the symptoms, the healing of the intestinal hurts and the quality of life.

Considering the new immunological targets of these biotherapics, the investigators put the hypothesis that an immunological profile (impulsive person and\or tissular) specific of the patients with one MC is associated with the answer to biotherapics. So, before beginning the treatment the patients expressing strongly the pro-inflammatory cytokine TNFa, would more may be answering machines in anti-TNFa and those with whom the immunological profile is very marked towards the way Th1/Th17 would more may answer favorably the ustekinumab. The identification of immunological profiles capable of predicting before treatment the answer under biotherapics could establish in MC but also in other inflammatory diseases a major step forward to guide the coverage.

status: Not yet recruiting


title: Dynamic Stabilization of the Upper Cervical Spine in a Cohort of Rugby's Players Via Ergometer (Cervistab©)

acronym: Cervistab

summary:
Rugby players are often exposed to destabilisation of the upper cervical spine.This kind of trauma may lead to dramatic injuries, due to lesion of spinal cord.

CerviStab© is a device which evaluate the bio-mechanical and neuromuscular behavior of the upper cervical spine in rugby situation.

The aim of this study, is to evaluate the dynamic stabilization of the upper cervical spine in reaction to unexpected impact.

lead_sponsor: University Hospital, Montpellier


title: Descriptive Observational Study of the Evolution of the Lifestyle Alteration in Patients With Breast Cancer

acronym: SPENCER

summary:
Scientific context: With more than one million cases per year, breast cancer is the most common female cancer. All treatments such as surgery, chemotherapy, radiotherapy or hormone therapy lead to major changes patients' lifestyle. These treatments can lead to a decrease of physical activity due to fatigue and also changes in the diet. Sometimes, chemotherapy induces nutritional aversions and can cause weight gain that is known to increase the risk of recurrence. Cognitive complaints are also frequent, in particular in patients who received chemotherapy and can also lead to quality of life's alteration

Fatigue assessed with prevalence between 70 % and 100 % is usually a part of a series of symptoms including anxiety, depression, pain, sleep disturbance, decreased activity level, nutritional changes and pre-existent comorbidities. These symptoms can lead to an alteration of the quality of life. The chemotherapy involves disturbances at physiological, psychological and social levels and eating disorders leading to changes in eating habits which can lead to weight loss or weight gain. To limit these deleterious changes in lifestyle, increased physical activity, specialized counseling and nutritional monitoring may be recommended.

According to current knowledge there is no prospective study that evaluated different lifestyle changes according to different types of patients and the appearance of the installation of these symptoms during the patient pathway.

Research hypothesis: the study hypothesis is that description of the evolution of the quality of life and, physical, nutritional and cognitive parameters in a population of patients with non-metastatic breast cancer will better characterize these patients in order to propose an appropriate and personalized rehabilitation intervention.The investigators propose this feasibility study consisting of 2 cohorts of patients according to the adjuvant therapy given (+/- chemotherapy) after the primary breast surgery.

intervention_type: Behavioral


title: Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging

acronym: HYPNOTIC

summary: The prostatic biopsies echo-guided are a painful and stressful. The purpose is to test a new medical device created recently, " Hypnos-Pro ", wich uses connected technologies. This connected device is a mask with diodes coupled with an audio headset and a touch pad. This connected mask is an another option to induce an hypnotic state for our patients. the objective is to value hypnotic mask effectiveness, to reduce the level pain and anxiety for the patients who benefit a prostatic biopsies echo-guided with local anesthesia.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Lille


title: Ustekinumab for the Treatment of Relapse of Refractory Giant Cell Arteritis

acronym: ULTRA

summary:
Giant cell arteritis (GCA) is the most common form of vasculitis after age 50. It is a vasculitis affecting the large vessels, in particular the aorta and its collateral vessels, especially those in the external carotid area.

Corticosteroids are the cornerstone of GCA treatment. They are very effective but are generally continued for 18 to 24 months or more since at least 30% of patients with GCA will relapse during their follow-up. Thus, the vast majority of patients treated for GCA have at least one adverse event from corticosteroid therapy, which is the main source of morbidity in these elderly patients.

Reducing the use of corticosteroids, especially during relapses, is therefore a major objective to improve the treatment of patients with GCA. Methotrexate, abatacept and tocilizumab have been shown to be effective during GCA. However, the therapeutic effect of the first two is modest. As for tocilizumab, its use has many limitations: suspensive effect, many contraindications and there are no biological parameters available for reliable monitoring of inflammatory syndrome in these patients.

Recent data have shown the major role of T helper (Th) Th1 and Th17 T cells in the pathophysiology of GCA. Th17 lymphocytes are sensitive to corticosteroid therapy but Th1 persists despite treatment and produces interferon-γ which activates macrophages and smooth muscle cells, leading to remodelling of the vascular wall responsible for ischemic GCA manifestations. Joint targeting of Th17 and Th1 responses is therefore necessary to fully treat the vascular inflammation that exists during GCA. Ustekinumab, which is a monoclonal antibody blocking the subunit common to IL-12 and IL-23 (p40), blocks the Th1 and Th17 responses, and could therefore be an excellent treatment for GCA.

This study aims to evaluate the efficacy of ustekinumab for the treatment of GCA relapses.

Very little data is available on the use of ustekinumab during GCA. Recently, 14 patients with refractory GCA, defined as the occurrence of at least 2 relapses and the inability to reduce the prednisone dose below 10 mg/d, received ustekinumab treatment. No patients relapsed during treatment while the median dose of prednisone was reduced from 20 to 5 mg/d.

Ustekinumab has also been used successfully in a patient with refractory GCA. Under treatment, the patient did not have a new relapse and the dose of prednisone was reduced. In addition, there was a major decrease in the percentages of circulating Th1 and Th17 lymphocytes.

However, to date, no controlled studies have been conducted to confirm the efficacy of ustekinumab during GCA relapses.

This guarantees the originality and innovation of this study.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Impact of a Strategy Based on the Unyvero® Testing System on Appropriate and Targeted Antimicrobial Treatment in Patients With Suspected VAP or HAP Requiring Mechanical Ventilation: a Randomized Controlled Unblinded Trial

acronym: VAPERO

summary: VAPERO is a randomized, unblinded, controlled study to measure the impact of a strategy based on the Unyvero® multiplex PCR test on the adjustment of antimicrobial therapy in patients suspected with ventilator-associated or hospital-acquired pneumonia (VAP/HAP) requiring mechanical ventilation. The gold-standard microbiological diagnostic method for pneumonia in the ICU is still culture-based identification and antimicrobial susceptibility testing (AST) despite being more than a hundred years old, with results turnaround time spanning over several days, exposing patients to potentially inappropriate broad-spectrum antimicrobial therapy. The investigators aim to measure the impact of the Unyvero® testing strategy to improve the percentage of patients with VAP or HAP receiving early targeted antimicrobial therapy compared to standard care.

ReferenceCitation: Kerneis S, Visseaux B, Armand-Lefevre L, Timsit JF. Molecular diagnostic methods for pneumonia: how can they be applied in practice? Curr Opin Infect Dis. 2021 Apr 1;34(2):118-125. doi: 10.1097/QCO.0000000000000713. Review.

family: Kerneis

full_name: Solen Kerneis

given: Solen

family: Visseaux

full_name: Benoit Visseaux

given: Benoit

family: Armand-Lefevre

full_name: Laurence Armand-Lefevre

given: Laurence

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

journal_name: Current Opinion in Infectious Diseases

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health


title: Comparison of McGrath and Macintosh Laryngoscopes for Insertion of a Double Lumen Tube by Residents

acronym: MacGrathDES

summary: The insertion of double lumen tube is difficult even more if it is a resident with no experience. we think that using videolaryngoscopes for novice ones would facilitate insertion of double lumen tube thanks to the visualization on a LCD screen of the laryngeal structure.


title: A Phase II Study to Evaluate the Safety and the Efficacy of a Blinatumomab Based Consolidation and Maintenance in Patients With High-risk B-cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL). GRAALL-QUEST

acronym: GRAALL-QUEST

summary:
The GRAALL-QUEST study is a Phase 2 study nested in the GRAALL-2014/B study (NCT02617004). The GRAALL-QUEST study evaluates the safety and the efficacy of blinatumomab-containing consolidation and maintenance therapy in patients aged 18-59 years old with high-risk B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in first complete hematologic remission after one induction course of standard chemotherapy and no central nervous system (CNS) involvement at diagnosis.

High-risk patients are defined as patients with KMT2A/MLL gene rearrangement, and/or IKZF1 (Ikaros) intra-genic deletion and/or high post-induction Ig-TCR minimal residual disease (MRD) level (≥10-4). In such patients not receiving blinatumomab, 3-year hematologic relapse incidence and relapse-free survival (RFS) are estimated at 60-65% and 50% only, respectively, on the basis of historical results.

A large subset of these high-risk patients (i.e. those with post-induction MRD level ≥10-3 and/or post-consolidation MRD level ≥10-4), but not all, will also be considered as candidates for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in first hematologic remission. The primary objective of the GRAALL-QUEST study is to evaluate the efficacy of adding blinatumomab to consolidation and eventually maintenance therapy in term of Relapse Free Survival (RFS). Secondary objectives are overall survival, comparison of RFS and Overall Survival (OS) in transplanted versus non-transplanted patients, MRD response and safety. Blinatumomab will be given as monthly cycles at the daily dose of 28 microg/d continuous IV infusion, together with 3 triple intra-thecal (IT) chemotherapy injections. The first cycle will start after completion of the first consolidation chemotherapy phase (corresponding to the MRD2 time-point). Patients receiving allo-HSCT will receive successive blinatumomab cycles until allo-HSCT. Patients not receiving allo-HSCT will receive a first blinatumomab cycle (cycle 1) during the second consolidation chemotherapy phase, followed by late intensification, then the third consolidation chemotherapy phase including another blinatumomab cycle (cycle 2) and maintenance chemotherapy including three additional blinatumomab cycles (cycles 3 to 5), for a total of 5 blinatumomab cycles maximum.