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

acronym: COVATRANS

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

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

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


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

acronym: TUMOVASC

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

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

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

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

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

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

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

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

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Les Hôpitaux Universitaires de Strasbourg

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing


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

acronym: UFOGUIDE

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

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

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

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

study_start_date_type: Actual

status: Recruiting

study_type: Interventional

primary_purpose: Device Feasibility

ipd_sharing: No


title: Measurement of Noradrenaline Concentrations Using Different Dilution Methods

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

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

status: Unknown status

location_facility: Strasbourg University Hospitals - Anesthesia-intensive care unit

status_simplified: Unknown


title: Cognitive and Neural Mechanisms of Multidimensional Apathy in Psychiatric Pathologies

acronym: AmSeD

summary:
Apathy is defined by quantitative decrease in goal-directed activity in comparison to the person's previous level of functioning. Apathy is a transnosographic symptom, prevalent in many neurological and psychiatric pathologies (specifically in schizophrenia and depression), and almost half of patients suffer from it. It is an important source of burden, affecting both personal and occupational life. Despite its high prevalence and negative consequences, no pharmacological or non-pharmacological treatments exist, the underlying mechanisms of apathy being poorly understood. The main aim of the present study is to advance in our knowledge of cognitive and neural mechanisms of apathy by using a multidimensional model of apathy, distinguishing three forms: executive, emotional and auto-activation/initiative.

the investigators hypothesize, independently of the pathology (schizophrenia and depression), the existence of different cognitive deficits underlying each of the 3 subforms of apathy. Indeed, according to the predictions of Levy and Dubois' model (2006), executive disorders underlie the cognitive form of apathy. It may be related to lesions of the dorsolateral prefrontal cortex and the cognitive territory of the basal ganglia. Emotional apathy could be due to motivational disorder. Dysfunctions or lesions in the orbital and medial prefrontal cortex and limbic territories of the basal ganglia may underlie this. Finally, the initiative form, may be a mixed form, with both motivational and executive difficulties. Lesions or dysfunctions may affect both the cognitive and limbic territories of the basal ganglia or the anterior cingulate cortex.

design_allocation: Non-Randomized

primary_purpose: Other

location_facility: Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

intervention_type: Other


title: Analysis of the Prevalence of Sensitisation to Plants Containing Gibberellins Using Realistic Skin Prick Tests in a Population of Patients Attending the Montpellier University Hospital.

acronym: GIBBERELLINES

summary:
Gibberellin-related proteins (GRPs) are proteins contained in both pollens and vegetables and are associated with an increased risk of severe food allergy reactions. The best characterized one the only one for which a specific IgE may be dosed in current clinical practice is Pru p 7, an allergen contained in peaches (Prunis persica). Sensitization to GRPs seems to be greater in areas with high exposure to pollens of the Cupressaceae family (as in the Montpellier region in Southern France); a subtype of Cupressaceae pollinosis, characterized by sensitization to Pru p 7 has been shown to be responsible for severe peach allergies.

To date, there has been no real analysis of the prevalence of sensitization to GRPs, or of possible cross-sensitization between plants and foods containing GRPs. Main food containing GRPs with a high level of homology with Pru p 7 include y apples (Malus domestica, 97.3%), sesame (Sesamum indicum, 91.9%), carrots (Daucus carota subsp. Sativus, 88.9%), lemons and oranges (different species, with a homology of 87.3%).

If we consider that sensitization to GRPs could be associated with severe allergic hypersensitivity reactions, it is important to detect the prevalence of sensitization to these allergens and to find sensitization profiles for these patients in order to gain a better understanding of this type of allergy and offer a more appropriate and preventive management to allergic patients. This remains today a major challenge for the allergy community in the Mediterranean region.

This study aims to investigate the rate of sensitization to peach and 5 other allergens containing gibberellins, chosen on the basis of their homology with Pru p 7 (the gibberellin from Prunus persica): carrot, lemon, orange, apple and sesame.

lead_sponsor: University Hospital, Montpellier


title: Cognitive Hyperarousal in Insomnia Disorder

acronym: TIP

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

time_perspective: Retrospective

ReferenceType: derived

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

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

repositories: HAL univOAK

repositories_concat: HAL;univOAK

unpaywall_oa_status: gold

publisher_dissemination: Elsevier

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


title: Non-respiratory Comorbidities Observed in Pulmonary French Transplant Patients With Cystic Fibrosis - Exploratory Study From the French Cohort on 2004-2014.

acronym: MUCO TRANSPLAN

summary:
Pulmonary transplantation is the reference treatment for chronic terminal respiratory failure in patients with cystic fibrosis. These are mainly bi-pulmonary transplants (cardiopulmonary transplants are exceptional). The annual number of pulmonary transplants in France for cystic fibrosis is about 90. In 2013, the transplant involves a total of more than 600 patients with cystic fibrosis. The average age at the time of the transplant is 28.5 years (2013 data, French cystic fibrosis register), compared to 58 years for patients transplanted to all pathologies. Cystic fibrosis accounts for 25% of adult bi-pulmonary grafts. Pediatric transplants are currently very rare.

The median survival after pulmonary transplantation in cystic fibrosis is currently 8.5 years (and 10 years when considering patients surviving 3 months, ie excluding early mortality). Cystic fibrosis is the pathology associated with better survival after pulmonary transplantation given the young age of patients (28.5 years on average).

The non-respiratory comorbidities associated with transplantation, all underlying pathologies combined, and referenced in the Registry of the International Society for Heart and Lung Transplantation (ISHLT) are: hypertension, diabetes, renal insufficiency, Dyslipidemia, cancers. Their frequency increases with the survival time of transplanted patients. Cystic fibrosis is associated with non-respiratory comorbidities, the frequency of which increases with age - diabetes, osteoporosis, renal insufficiency, hepatopathy, neoplastic pathologies - and may become worse after transplantation.

The main objective is to estimate the incidence of non-respiratory co-morbidities after lung transplantation in the cohort of patients with cystic fibrosis grafted in the Rhône-Alpes region.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de médecine interne Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

status_simplified: Completed


title: Evaluation of Pneumococcal Vaccine Coverage

acronym: SAUVAC

summary:
Pneumococcal infections are frequent and serious. Streptococcus pneumoniae is the leading cause of community-acquired pneumonia in adults. In metropolitan France, there are 6000 to 7000 bacteremic pneumococcal infections each year, with a mortality rate of 10 to 30% in adults.

To fight against these bacterial infections, vaccines have been developed. At a time when antibiotic savings and the fight against antimicrobial resistance are major public health issues, vaccination is a first choice option to slow the development of pneumococcal resistance. Thus, after these different actions, the proportions of pneumococci with decreased susceptibility to penicillin G fell from 53 to 22%.

While there is a significant decrease in invasive pneumococcal disease in children since the use of conjugate vaccines (vaccination of up to 94% of children), the rate of invasive Pneumococcal disease in adults has decreased less significantly.

In March 2017, the High Council of Public Health (HCSP) proposed the vaccination of all non-immunocompromised adults at risk and immunocompromised patients.

Awareness-raising among vaccinating physicians seems essential, especially in recent years when the value of vaccination is threatened by speculation about its efficacy and toxicity. However, the investigators know that vaccination aims not only to protect the individual, but also the population, especially children and the elderly and the fragile people.

Thus, in the context of pneumococcal vaccination, identifying one or more profiles of patients at risk in the absence of vaccination could be particularly beneficial. Indeed, if the physician knows about the population at risk of not being vaccinated, it will be better able to identify patients at risk of not being protected against pneumococcus.

lead_sponsor: Fondation Hôpital Saint-Joseph


title: Rapid Diagnosis of COVID-19 by Chemical Analysis of Exhaled Air

acronym: COVIDAIR

summary:
Since the start of 2020, the new SARS-CoV-2 coronavirus is causing a real global health crisis.

In France, nasopharyngeal swabs are used to obtain the sample needed for respiratory infection screening. There are three major difficulties with this type of sampling:

I) It is really unpleasant for the patient because the device has to be pushed into the nostril to reach the nasopharynx. It causes some patients to bleed or even feel uncomfortable.

II) It is not easily accepted by children. III) It is dependent on the availability of swabs. Faced with these difficulties linked to the initial sampling, new methods are being studied to enable a rapid and non-invasive diagnosis of COVID-19 based on the instantaneous identification of metabolites or volatile organic compounds (VOCs).

Due to their sensitivity and the wealth of information that can be provided, the most promising techniques are based on mass spectrometry coupled with a soft ionisation system. For example, on-line exhaled air analysis is capable of detecting a very large number of VOCs. Various tests on metabolites in the exhaled air have already been carried out without being totally conclusive because the existing instruments suffer from various limitations:

I) poor repeatability/accuracy in the chemical characterisation of exhaled air ; II) too high specificity (detection of only part of the emitted compounds); III) too limited sensitivity; IV) and poor adaptation to be deployed in a clinic.

In order to overcome these various limitations, we propose the use of a new generation of mass spectrometer: Vocus PTR-TOF. The Vocus PTR-TOF is a Proton Transfer Mass Spectrometer (PTR-MS) developed for the detection, in real time, of trace VOCs in industrial environments, laboratories or directly in the environment. This new generation of instrument offers the following advantages:

I) unequalled sensitivity :

II) a robust ionisation system not affected by environmental conditions (relative humidity...) ; III) a high mass resolution allowing precise identification of compounds ; IV) a compact and durable architecture allowing deployment in a constrained environment such as hospital, airport… The sensitivity and speed of measurement allow the expiration process to be monitored in real time, bringing an additional dimension to the measurement and the chances of success.

primary_purpose: Diagnostic

location_facility: Centre de prélèvement COVID-19 HCL et Métropole de Lyon

intervention_type: Diagnostic Test


title: Effects of Regular and Consequent Citrus Fruit Consumption on Vascular Protection Specific Role of the Component Phytomicronutrients

acronym: AGRUVASC

summary:
Epidemiological studies definitively show that fruit and vegetable consumption is positive for health and more specifically for cardiovascular diseases (CVD) prevention. In France, among fruits, those which are the most frequently consumed are citrus fruits essentially as juices and more specifically as orange juices. However, their health effects have been poorly studied so far. Citrus fruits contain vitamin C associated with various phytomicronutrients i.e. carotenoids (essentially -cryptoxanthin) and polyphenols. Each fruit contains specific compounds: hesperetin in orange, naringenin in grapefruit, eriodyctiol in lemon. Some scientific studies performed either in vitro or in animal models demonstrated properties of these micronutrients which could contribute to a positive health effect of citrus fruits on vascular protection. However data are still missing.

The main goal of this project is to characterize the effect of orange juice consumption on vascular disease risk factors and to evaluate the specific role of their micronutrient compounds (polyphenols and carotenoids) in this protection. To reach this goal, a randomized "cross-over" clinical study will be performed on volunteers presenting a mild hypercholesterolemia. They will consume for 4 weeks an orange juice or a reconstituted drink similar to the orange juice for its composition in carbohydrates, minerals, vitamin C and folates but without phytomicronutrients. The effect of the juice consumption on the vascular function will be monitored exploring lipid abnormalities in plasma, measuring endothelial vasoreactivity (FMD) (Flow Mediated Dilatation), as well as endothelial dysfunction, thrombosis, inflammation and oxidative stress biomarkers in plasma. Comparison of urinary metabolomes after orange juice consumption or that of the reconstituted drink will lead to the identification of the metabolic pathways modulated by the orange juice micronutrients.

Moreover ELISA tests for the two major flavanones from citrus fruits (hesperetin and naringenin) will be developed. They will be used to determine the plasma levels of these molecules in order to analyze the relation "ingested quantity - bioavailable quantity - physiological effect".

The results obtained in this project will allow clarifying citrus fruit effects, and particularly orange juice, in vascular protection.

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Hertog MG, Feskens EJ, Hollman PC, Katan MB, Kromhout D. Dietary antioxidant flavonoids and risk of coronary heart disease: the Zutphen Elderly Study. Lancet. 1993 Oct 23;342(8878):1007-11. doi: 10.1016/0140-6736(93)92876-u.

ReferenceCitation: Hertog MG, Kromhout D, Aravanis C, Blackburn H, Buzina R, Fidanza F, Giampaoli S, Jansen A, Menotti A, Nedeljkovic S, et al. Flavonoid intake and long-term risk of coronary heart disease and cancer in the seven countries study. Arch Intern Med. 1995 Feb 27;155(4):381-6. Erratum In: Arch Intern Med 1995 Jun 12;155(11):1184.

ReferenceCitation: Knekt P, Jarvinen R, Reunanen A, Maatela J. Flavonoid intake and coronary mortality in Finland: a cohort study. BMJ. 1996 Feb 24;312(7029):478-81. doi: 10.1136/bmj.312.7029.478.

ReferenceCitation: Yochum L, Kushi LH, Meyer K, Folsom AR. Dietary flavonoid intake and risk of cardiovascular disease in postmenopausal women. Am J Epidemiol. 1999 May 15;149(10):943-9. doi: 10.1093/oxfordjournals.aje.a009738. Erratum In: Am J Epidemiol 1999 Aug 15;150(4):432.

ReferenceCitation: Geleijnse JM, Launer LJ, Van der Kuip DA, Hofman A, Witteman JC. Inverse association of tea and flavonoid intakes with incident myocardial infarction: the Rotterdam Study. Am J Clin Nutr. 2002 May;75(5):880-6. doi: 10.1093/ajcn/75.5.880.

ReferenceCitation: Leuzzi U, Caristi C, Panzera V, Licandro G. Flavonoids in pigmented orange juice and second-pressure extracts. J Agric Food Chem. 2000 Nov;48(11):5501-6. doi: 10.1021/jf000538o.

ReferenceCitation: Jung HA, Jung MJ, Kim JY, Chung HY, Choi JS. Inhibitory activity of flavonoids from Prunus davidiana and other flavonoids on total ROS and hydroxyl radical generation. Arch Pharm Res. 2003 Oct;26(10):809-15. doi: 10.1007/BF02980025.

ReferenceCitation: Franke AA, Cooney RV, Henning SM, Custer LJ. Bioavailability and antioxidant effects of orange juice components in humans. J Agric Food Chem. 2005 Jun 29;53(13):5170-8. doi: 10.1021/jf050054y.

ReferenceCitation: Lee DH, Gross MD, Jacobs DR Jr; Cardiovascular Risk Development in Young Adults Study. Association of serum carotenoids and tocopherols with gamma-glutamyltransferase: the Cardiovascular Risk Development in Young Adults (CARDIA) Study. Clin Chem. 2004 Mar;50(3):582-8. doi: 10.1373/clinchem.2003.028852. Epub 2004 Jan 15.

ReferenceCitation: Dwyer JH, Paul-Labrador MJ, Fan J, Shircore AM, Merz CN, Dwyer KM. Progression of carotid intima-media thickness and plasma antioxidants: the Los Angeles Atherosclerosis Study. Arterioscler Thromb Vasc Biol. 2004 Feb;24(2):313-9. doi: 10.1161/01.ATV.0000109955.80818.8a. Epub 2003 Dec 1.

ReferenceCitation: Aneja R, Hake PW, Burroughs TJ, Denenberg AG, Wong HR, Zingarelli B. Epigallocatechin, a green tea polyphenol, attenuates myocardial ischemia reperfusion injury in rats. Mol Med. 2004 Jan-Jun;10(1-6):55-62. doi: 10.2119/2004-00032.aneja.

ReferenceCitation: Hadjadj S, Paul JL, Meyer L, Durlach V, Verges B, Ziegler O, Drouin P, Guerci B. Delayed changes in postprandial lipid in young normolipidemic men after a nocturnal vitamin A oral fat load test. J Nutr. 1999 Sep;129(9):1649-55. doi: 10.1093/jn/129.9.1649.

ReferenceCitation: Constans J, Conri C. Circulating markers of endothelial function in cardiovascular disease. Clin Chim Acta. 2006 Jun;368(1-2):33-47. doi: 10.1016/j.cca.2005.12.030. Epub 2006 Mar 10.

ReferenceCitation: Gorinstein S, Caspi A, Libman I, Lerner HT, Huang D, Leontowicz H, Leontowicz M, Tashma Z, Katrich E, Feng S, Trakhtenberg S. Red grapefruit positively influences serum triglyceride level in patients suffering from coronary atherosclerosis: studies in vitro and in humans. J Agric Food Chem. 2006 Mar 8;54(5):1887-92. doi: 10.1021/jf058171g.

ReferenceCitation: Gorinstein S, Leontowicz H, Leontowicz M, Drzewiecki J, Jastrzebski Z, Tapia MS, Katrich E, Trakhtenberg S. Red Star Ruby (Sunrise) and blond qualities of Jaffa grapefruits and their influence on plasma lipid levels and plasma antioxidant activity in rats fed with cholesterol-containing and cholesterol-free diets. Life Sci. 2005 Sep 23;77(19):2384-97. doi: 10.1016/j.lfs.2004.12.049.

ReferenceCitation: Gorinstein S, Leontowicz H, Leontowicz M, Krzeminski R, Gralak M, Delgado-Licon E, Martinez Ayala AL, Katrich E, Trakhtenberg S. Changes in plasma lipid and antioxidant activity in rats as a result of naringin and red grapefruit supplementation. J Agric Food Chem. 2005 Apr 20;53(8):3223-8. doi: 10.1021/jf058014h.

ReferenceCitation: Constans J, Bennetau-Pelissero C, Martin JF, Rock E, Mazur A, Bedel A, Morand C, Berard AM. Marked antioxidant effect of orange juice intake and its phytomicronutrients in a preliminary randomized cross-over trial on mild hypercholesterolemic men. Clin Nutr. 2015 Dec;34(6):1093-100. doi: 10.1016/j.clnu.2014.12.016. Epub 2014 Dec 26.

oa_host_type: closed

repositories_concat: closed

lead_sponsor: University Hospital, Bordeaux

location_facility: Hopital Saint André - Service de Médecine Interne - Pathologie Vasculaire

intervention_type: Behavioral


title: Immunotherapy by Nivolumab in Neoadjuvant and Adjuvant Setting in Patients With Advanced HCC Treated by Electroporation in Curative Intent: French Multicenter Phase 2 Therapeutic Trial.

acronym: NIVOLEP

summary:
Percutaneous ablation (PA) is the only non-surgical curative treatment of hepatocellular carcinoma (HCC). Due to its excellent tolerance, particularly in patients with portal hypertension or bearing comorbidities, it now represents in France nearly 70% of the first-line curative treatment of "in Milan" tumours. For HCC less than 3 cm, ideal indication for percutaneous ablations, results of monopolar radiofrequency ablation (mRFA), are excellent with only 5% of reported non-tumoral control after a first procedure .

In addition to mRFA the arsenal of ablations has grown considerably with the emergence of new techniques. They allow the expansion of indications for PA, especially in patients with poor prognostic tumors or relatively advanced beyond the Milan criteria . In this setting, multibipolar mode using no touch technique (mbpRFAnt) increases the tumour volume that can be ablated, allowing the removal of large tumors> 5 cm . Furthermore, electroporation (EP) is a new PA technique that does not promote thermoablation but induce tumoral cells apoptosis and is particularly interesting for difficult-to-treat lesions located near vascular or biliary trunks . Inadequate tumour control is then de facto greater in these situations, around 20% at one year.

The idea of optimizing HCC curative treatments using neoadjuvant or adjuvant biotherapy, particularly in patients with advanced tumors in curative intent, is particularly attractive. One trial in adjuvant setting was conducted, the STORM trial, that tested the benefit of sorafenib in curative intent of in Milan HCC. This negative trial included patients with in Milan HCC, with an expected low rate of recurrence with only few patients treated by PA.

In parallel, the development of new molecules for HCC treatment, especially immunotherapy, seems to give promising results in palliative setting . Furthermore, PA procedures and most likely electroporation induce T-cell recruitement that may foster immunomodulation .

Neoadjuvant and adjuvant trials using these new molecules must now be cautiously designed based on the rigorous selection of special populations and therapeutic indications.

This project proposes a Phase 2 trial testing the safety and efficacy of treatment with Nivolumab in neoadjuvant and adjuvant setting in patients with advanced HCC treated by electroporation in curative intent.

status: Active, not recruiting

primary_purpose: Treatment

ReferenceCitation: Sutter O, Calvo J, N'Kontchou G, Nault JC, Ourabia R, Nahon P, Ganne-Carrie N, Bourcier V, Zentar N, Bouhafs F, Sellier N, Diallo A, Seror O. Safety and Efficacy of Irreversible Electroporation for the Treatment of Hepatocellular Carcinoma Not Amenable to Thermal Ablation Techniques: A Retrospective Single-Center Case Series. Radiology. 2017 Sep;284(3):877-886. doi: 10.1148/radiol.2017161413. Epub 2017 Apr 28.

ReferenceCitation: Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, Cai J, Poon RT, Han KH, Tak WY, Lee HC, Song T, Roayaie S, Bolondi L, Lee KS, Makuuchi M, Souza F, Berre MA, Meinhardt G, Llovet JM; STORM investigators. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015 Oct;16(13):1344-54. doi: 10.1016/S1470-2045(15)00198-9. Epub 2015 Sep 8.

ReferenceCitation: El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, Kim TY, Choo SP, Trojan J, Welling TH Rd, Meyer T, Kang YK, Yeo W, Chopra A, Anderson J, Dela Cruz C, Lang L, Neely J, Tang H, Dastani HB, Melero I. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017 Jun 24;389(10088):2492-2502. doi: 10.1016/S0140-6736(17)31046-2. Epub 2017 Apr 20.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

version: acceptedVersion

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

unpaywall_oa_status: green

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Bristol-Myers Squibb

intervention_type: Drug


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

acronym: VIF-DOR

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

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

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


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

acronym: PregWom-Covid

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

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


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

acronym: DOP-RENAL

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


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

acronym: Endo-Metrios

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

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

location_facility: Department of Gynecology - Strasbourg University Hospitals


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

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

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

location_facility: Strasbourg University Hospitals - Otorhino-Laryngology Department


title: Molecular Mechanisms of Tooth Eruption

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

intervention_type: Procedure


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

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

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


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

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

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


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

acronym: GRAAL

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

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

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

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

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

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

sponsor_collaborators:
University Hospital, Strasbourg, France
Etablissement Français du Sang

location_facility: ENT department-Hôpitaux Universitaires de Strasbourg


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

acronym: ScleroBross

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

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


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

acronym: SELF-MCL

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


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

acronym: LidoCovid

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

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

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

license: cc-by

license_normalized: cc-by

repositories:
PubMed Central
univOAK

repositories_concat: PubMed Central;univOAK

repositories_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

publisher_dissemination: Springer-Nature


type: Other Identifier

title: Analysis of Non-vaccination Factors Against Hepatitis B Virus (HBV) in Drug Users Consulting at the Croix-rousse Drug Addict Care Center (Annuaire Centres de Soins, d'Accompagnement et de prévention en Addictologie (CSAPA))

acronym: ANOVAC B

summary:
Hepatitis B is one of the major public health problems in the world. According to World Health Organization (WHO) data, about 2 billion people have been in contact with the hepatitis B virus (HBV), and 257 million have chronic HBV infection.

Although France is a low endemic country, with just over 280,000 people with chronic infection, hepatitis B remains a public health problem due to its morbidity and mortality.

Drug users are a population at risk by their consumption practices (injection or sniffing), but also by other high-risk behaviours, particularly sexual behaviours.

Prevention therefore involves securing consumption practices (sterile and single-use equipment) and protection of sexual intercourse, but also by vaccination (protecting more than 90%).

Since 1982, HAS has recommended to systematically vaccinate drug users. However, according to the Marmottan study published in 2003, immunization coverage among drug addicts was already insufficient in 1999 (45.3%) and decreased again in 2000 and 2001 (15.6 and 21.7%).

This decrease can be explained by the controversy around the potential link, now refuted, between vaccine against HBV and demyelination, which has stopped the mass vaccination campaign launched by the French health authorities in 1995.

A study conducted between 2009 and 2012 on injecting drug users in Alsace, estimated vaccination coverage at 28%.

The hypothesize is that despite the recommendations in a population at high risk of contamination, and a balance of benefits and risks in favor of vaccination, vaccination coverage against the hepatitis B virus remains insufficient among drug users because of poor vaccination acquaintance, and hepatitis B in general, in this population.

Principal objective of this study is to identify non-vaccination factors against hepatitis B virus among drug users consulting at the Croix-Rousse CSAPA.

location_facility: Hôpital de la Croix-Rousse, 103 grande rue de la Croix-Rousse


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

acronym: CarDiab

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

time_perspective: Other

location_facility: Service de Physiologie et d'Explorations Fonctionnelles


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

acronym: PlasmaFaisa

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

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


title: Optical Coherence Tomography Imaging in Systemic Sclerosis

acronym: OCTISS

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

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

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


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

acronym: PRESAGE

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


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

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

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


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

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

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

location_facility: Hôpitaux Universitaires de Strasbourg (Nouvel Hôpital Civil)


title: Sagittal Balance Through Ages

acronym: ESTA

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

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


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

acronym: COBBALT

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

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

primary_purpose: Supportive Care

intervention_type: Genetic


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

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

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


title: Comparison of the Efficacy and Tolerance of Triple Therapy Guided by the PCR Detection of Clarithromycin Resistance WITH Empiric Concomitant Quadruple Therapy for Helicobacter Pylori Infection: a Randomised Multicentre Trial

acronym: Hepysé

summary:
The H pylori infection remains a public health problem. The eradication rate with the first line triple therapy (PPI-amoxicillin-clarithromycin) is insufficient (estimated at 70%) due to the frequency of resistance to clarithromycin, which reaches 21% in France. Until now,European and French consensus recomended tofavor sequential therapy (5 days PPI-amoxicillin and 5 days PPI-clarithromycin-metronidazole) or quadruple bismuth therapy ( 10 days PPI-tetracyclin,-metronidazole- bismuth). Studies in countries with low prevalence of clarithromycin resistance reported eradication rate of 85% with sequential therapy and reported a low impact of clarithromycin resistance on the effectiveness of this treatment. However, recent studies suggest a greater impact of clarithromycin resistance. Recent meta-analysis shows that empiric sequential therapy is less efficacious than concomitant quadruple therapy. Therefore, recent Maastricht V / Florence meeting October 7-8 2015) recommended to abandon sequential therapy and to favor 14 days concomitant therapy in first line in order to reach an eradication rate >90%.

In a multicenter randomized clinical trial (HELICOSTIC 2010-2011 AO ICST 2009), we compared a triple therapy guided by the results of a PCR test that detects resistance to clarithromycin and levofloxacin (HelicoDR ®) to empirical triple therapy (PPI-amoxicillin-clarithromycin). 1384 patients and among them 526 infected patients were enrolled in 10 centers. The results in 415 patients were 73.1% for the empirical treatment versus 85.5% (p <0.001) for the treatment guided by PCR HelicoDR®. This study also demonstrated the limits of the test HelicoDR®: onerous, possibility of contamination, little practical contribution of the determination of resistance to quinolones.

Moreover, it has been shown that triple therapy efficiency could be optimized by increasing duration up to 14 days and increasing dose of PPI to 40mg b.d;.and eradications rates > 90% were reported with susceptible to clarithromycin strains.

Adverse events are less common with optimized triple therapy than with concomitant quadruple therapy.

The main objective is to compare the efficacy of optimized triple therapy guided by the results of a PCR test (eradication rates 90% hypothesized) with quadruple concomitant therapy (eradication rate 90% hypothesized).

The secondary objective is to determine side effects of optimized guided triple therapy as well as the quadruple concomitant therapy in France.

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: HEPYSE

titre: Comparaison de l'efficacité du traitement séquentiel . Guide par la détection de la résistance aux macrolides par PCR et de la quadrithérapie bismuthée au traitement séquentiel classique  de l'infection à  Helicobacter pylori: Essai controlé, multicentrique, randomisé

discipline_principale: gastro-entérologie

nom_porteur: DELCHIER

prenom_porteur: Jean Charles


title: Impact of a Telemonitoring Program on the Rate of Hospitalizations for Worsening of Cardio-respiratory Symptoms in COPD Patients Treated at Home by Long-term Non-invasive Ventilation (NIV): a Randomized Controlled Trial

summary:
COPD is characterized by non-reversible chronic airway obstruction. Its evolution is punctuated by successive exacerbations precipitating the progression of the disease and its co-morbidities. The most severe exacerbations are the source of frequent hospitalizations that strongly affect the patient's quality of life and are associated with increased mortality. The diagnosis of exacerbation is mainly clinical but patients frequently consult their doctor too late which may lead to delays in care. However, the early detection and management of these exacerbations can reduce their impact and in particular avoid hospitalization or shorten their duration.

In France, long term Non-Invasive Ventilation (NIV) is a widely used treatment modality in COPD patients with chronic alveolar hypoventilation who have frequent exacerbations. The investigators have demonstrated in a previous study that the analysis of parameters from software embedded in the NIV device can reliably predict the occurrence of an exacerbation. The investigators hypothesize that the daily transmission via a telemonitoring platform of the ventilation parameters of patients, together with an ad hoc warning system, would reduce the rate of hospitalization for COPD patients treated at home with NIV thanks to the early detection and early treatment of these exacerbations.

The purpose of the study is to compare if a program of telemonitoring using the parameters stored by the NIV impact the rate of hospitalization for worsening of cardiorespiratory symptoms in COPD patients versus standard care over a one year period.

status: Terminated

lead_sponsor: University Hospital, Grenoble

collaborators:
Philips Healthcare
AGIR à Dom

sponsor_collaborators:
University Hospital, Grenoble
Philips Healthcare
AGIR à Dom


title: The CINSARC Genomic Signature as a Predictor of Resectability of High Grade Serous Ovarian Adenocarcinomas

acronym: OVASARC

summary:
The majority of primary cancers of the ovary or peritoneum are represented by high-grade serous adenocarcinomas. These are rare pathologies, the incidence of which is estimated at 7.1 per 100,000, representing approximately 4,500 new cases per year in France (INCA 2017). In the absence of effective screening, nearly 85% of patients have an advanced disease at diagnosis (corresponding to the FIGO III or IVA stage, characterized by diffuse peritoneal involvement). Despite multidisciplinary care, the majority of patients (80%) will recur within a median of 18 to 24 months.

It is therefore necessary to develop new tools, in particular molecular, in order to allow :

to better select patients accessible to full interval surgery
to exclude patients who would not benefit from this surgery in terms of survival

In 2010, Chibon et al. identified, from a cohort of patients with soft tissue sarcoma (STM), a molecular signature (called CINSARC), based on the expression profile of 67 genes involved in mitotic control and chromosomal integrity. The team showed that this transcriptomic signature is an independent prognostic factor in different types of STM, but also a prognostic factor more discriminating than the histological grade (FNCLCC), historical and major prognostic factor of STM.

Being initially made from frozen material and on a DNA biochip (Affymetrix), this signature was unusable outside the field of fundamental research. This is why CINSARC has been gradually optimized, first by the RNA sequencing technique on frozen tissue fixed in formalin (FFPE), and recently on FFPE tissue by the NanoString® technique. This very sensitive and inexpensive technique requires only small amounts of total RNA, making it compatible with use on "routine" diagnostic samples, microbiopsy or surgical biopsy, opening the door to real clinical application. Several clinical studies using this latest CINSARC optimization (called NanoCind®) to determine the treatment of patients with STM will also begin soon.

As a result of this work, necessary in order to more precisely support the potential of CINSARC in this pathology, the investigators hope to be able to assess from the diagnosis the evolutionary potential of the patients, which could make it possible to evaluate therapeutic strategies adapted to the profiles of each subpopulation: the investigators can for example imagine in theory a therapeutic de-escalation for low-risk patients, or else, for very high-risk patients, an intensified strategy.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Claudius Regaud Institut Universitaire du cancer Toulouse Oncopole

lead_sponsor_type: industriel


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

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

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


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

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

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


title: Multi-centre Prospective Cohort of Childhood Leukaemia: Determinants of Health and Quality of Life of the Patients After Treatment for an Acute Leukaemia During Childhood or Adolescence - LEA

summary: Regular advances in cancer treatment have dramatically improved the prognosis of children and adolescents with acute leukemia (AL), raising with a great acuity the problem of the late physical side effects, social integration, quality of life of the patients and their family as well as identification of the determinants of these outcomes. Large nationwide and international cohorts developed in general population (I4C, EPIC ELF…) are restricted to the study of childhood cancers occurrence. In addition, the national registries (French, European) of childhood cancers are designed to evaluate incidence and mortality, but not to produce individual detailed data on the follow-up and outcome of these children. Answering these questions supposes a comprehensive multidisciplinary approach resting on prospective cohorts of cancer survivors, specifically exploring the outcome of these children. These cohorts allow to identify prognostic factors of the health condition and social integration, and to propose adapted strategies of follow-up. The Childhood Cancer Survivor Study (CCSS), which remains the most important study, only concerns the North-American populations and rests on a self-reported follow-up assessment. In France, the LEA study, initiated in 2004 could answer some of these questions, but the representativeness and the size of the population (study initially limited to two areas PACA-Corsica and Lorraine) remain insufficient to study uncommon events. Similar approaches are conducted in Europe trough the broad collaborative Pancare network, to which the LEA program is associated.

primary_purpose: Health Services Research

ReferenceCitation: Oudin C, Berbis J, Bertrand Y, Vercasson C, Thomas F, Chastagner P, Ducassou S, Kanold J, Tabone MD, Paillard C, Poiree M, Plantaz D, Dalle JH, Gandemer V, Thouvenin S, Sirvent N, Saultier P, Beliard S, Leverger G, Baruchel A, Auquier P, Pannier B, Michel G. Prevalence and characteristics of metabolic syndrome in adults from the French childhood leukemia survivors' cohort: a comparison with controls from the French population. Haematologica. 2018 Apr;103(4):645-654. doi: 10.3324/haematol.2017.176123. Epub 2018 Jan 19.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Jean Moulin Lyon 3

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Saultier P, Auquier P, Bertrand Y, Vercasson C, Oudin C, Contet A, Plantaz D, Poiree M, Ducassou S, Kanold J, Tabone MD, Dalle JH, Lutz P, Gandemer V, Sirvent N, Thouvenin S, Berbis J, Chambost H, Baruchel A, Leverger G, Michel G. Metabolic syndrome in long-term survivors of childhood acute leukemia treated without hematopoietic stem cell transplantation: an L.E.A. study. Haematologica. 2016 Dec;101(12):1603-1610. doi: 10.3324/haematol.2016.148908. Epub 2016 Aug 11.

repositories_concat: PubMed Central

ReferenceCitation: Oudin C, Auquier P, Bertrand Y, Chastagner P, Kanold J, Poiree M, Thouvenin S, Ducassou S, Plantaz D, Tabone MD, Dalle JH, Gandemer V, Lutz P, Sirvent A, Villes V, Barlogis V, Baruchel A, Leverger G, Berbis J, Michel G. Late thyroid complications in survivors of childhood acute leukemia. An L.E.A. study. Haematologica. 2016 Jun;101(6):747-56. doi: 10.3324/haematol.2015.140053. Epub 2016 Mar 11.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Biological


title: Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients: a Prospective Randomized Single-blind Trial

acronym: RHEO-PAD

summary:
Peripheral arterial disease (PAD) with limb-threatening ischemia (PAD-LTI) involves both macrocirculation and microcirculation. Macrocirculatory abnormalities are accessible to revascularization techniques (endovascular or surgical) contrary to microcirculatory abnormalities. Conservative treatments have limited efficacy in patients with end-stage renal disease (ESRD). There is no alternative treatment for patients with PAD-LTI in hemodialysis.

Rheopheresis is an apheresis technique specifically designed for the treatment of microcirculatory disorders in which anomalies of rheology are at the center of physiopathology. This double cascade plasma filtration technique reduces plasma viscosity and eliminates inflammation mediators which play an essential role in PAD. This technique has already shown its effectiveness in a randomized trial in dry Age-related macular degeneration (AMD), another pathology of microcirculation. The effectiveness of rheopheresis in PAD-LTI has only been reported in a small number of cases.

This Hypothesis is that the treatment of microcirculation by rheopheresis would improve wound healing of the ischemic lesion and/or reduce major amputation and thus the prognosis of the affected limb of the patient with PAD-LTI in hemodialysis. This objective is to demonstrate the efficacy of rheopheresis, (twelve sessions), to avoid major amputation and reaches complete wound healing of ischemic lesion in the dialysis patient population with PAD-LTI. This study is prospective, Controlled, Parallel, Randomized, Single blind and Multicentric in France (12 French centers).

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

region: Provence-Alpes-Côte d'Azur

nom_etablissement: APHM DIRECTION GENERALE

acronyme: RHEO-PAD

titre: Efficacité et tolérance de la rhéophérèse dans le traitement de l'artérite discale du patient dialysé : une étude prospective randomisée en simple aveugle.

discipline_principale: nephrology

nom_porteur: ROBERT

prenom_porteur: Thomas


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

acronym: MIRE

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

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


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

acronym: PREMAQUICK

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

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

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


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

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

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

location_facility: Service d' Anesthésie Réanimation Chirurgicale


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

acronym: COVID-APE

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

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

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


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

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

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

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health


title: Mobility and Quality of Life in Community Ambulators With Knee Locking Deficiency Using a Microprocessor Controlled Knee Ankle Foot Orthosis and a Stance Control Orthosis: Randomized Crossover Trial

summary: The purpose of this multicentric study is to assess the impact of C-BRACE on mobility, endurance, confidence, participation, satisfaction, psychosocial adjustment and quality of life in community ambulators using a Stance Control Orthosis.

ReferenceCitation: Deems-Dluhy S, Hoppe-Ludwig S, Mummidisetty CK, Semik P, Heinemann AW, Jayaraman A. Microprocessor Controlled Knee Ankle Foot Orthosis (KAFO) vs Stance Control vs Locked KAFO: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Feb;102(2):233-244. doi: 10.1016/j.apmr.2020.08.013. Epub 2020 Sep 22.

ReferenceCitation: Karatzios C, Loiret I, Luthi F, Leger B, Le Carre J, Saubade M, Muff G, Benaim C. Transcultural adaptation and validation of a French version of the Prosthetic Limb Users Survey of Mobility 12-item Short-Form (PLUS-M/FC-12) in active amputees. Ann Phys Rehabil Med. 2019 May;62(3):142-148. doi: 10.1016/j.rehab.2019.02.006. Epub 2019 Apr 6.

ReferenceCitation: Chatman AB, Hyams SP, Neel JM, Binkley JM, Stratford PW, Schomberg A, Stabler M. The Patient-Specific Functional Scale: measurement properties in patients with knee dysfunction. Phys Ther. 1997 Aug;77(8):820-9. doi: 10.1093/ptj/77.8.820.

ReferenceCitation: Demers L, Monette M, Descent M, Jutai J, Wolfson C. The Psychosocial Impact of Assistive Devices Scale (PIADS): translation and preliminary psychometric evaluation of a Canadian-French version. Qual Life Res. 2002 Sep;11(6):583-92. doi: 10.1023/a:1016397412708.

ReferenceCitation: Middleton A, Fritz SL, Lusardi M. Walking speed: the functional vital sign. J Aging Phys Act. 2015 Apr;23(2):314-22. doi: 10.1123/japa.2013-0236. Epub 2014 May 2.

ReferenceCitation: Probsting E, Kannenberg A, Zacharias B. Safety and walking ability of KAFO users with the C-Brace(R) Orthotronic Mobility System, a new microprocessor stance and swing control orthosis. Prosthet Orthot Int. 2017 Feb;41(1):65-77. doi: 10.1177/0309364616637954. Epub 2016 Jul 10.

ReferenceCitation: Schmalz T, Probsting E, Auberger R, Siewert G. A functional comparison of conventional knee-ankle-foot orthoses and a microprocessor-controlled leg orthosis system based on biomechanical parameters. Prosthet Orthot Int. 2016 Apr;40(2):277-86. doi: 10.1177/0309364614546524. Epub 2014 Sep 23.

ReferenceCitation: Filiatrault J, Gauvin L, Fournier M, Parisien M, Robitaille Y, Laforest S, Corriveau H, Richard L. Evidence of the psychometric qualities of a simplified version of the Activities-specific Balance Confidence scale for community-dwelling seniors. Arch Phys Med Rehabil. 2007 May;88(5):664-72. doi: 10.1016/j.apmr.2007.02.003.

ReferenceCitation: Andrade LF, Ludwig K, Goni JMR, Oppe M, de Pouvourville G. A French Value Set for the EQ-5D-5L. Pharmacoeconomics. 2020 Apr;38(4):413-425. doi: 10.1007/s40273-019-00876-4.

lead_sponsor: Otto Bock France SNC

sponsor_collaborators:
Otto Bock France SNC
EVAMED

location_country: Germany France

location_facility:
Katholisches Klinikum Koblenz-Montabaur
Hôpital Raymond-Poincaré
IRR Louis Pierquin
Centre Bouffard Vercelli
CRF Korian Le Mont Veyrier
CRRF Léopold Bellan
Hia Laveran
Pôle de Réadaptation de Cornouaille
LADAPT Thionis
PFH Private Hochschule Göttingen
Centre Hospitalier Dieppe
CRRF La Tourmaline
Centre Jacques Calvé Fondation Hopale
HIA Percy
CRF Salies de Béarn
CRRF La Chataigneraie
IRMA Institut Robert Merle d'Aubigné
Chu Rangueil


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

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

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


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

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


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

acronym: NASH-SPE

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

location_facility: Les Hôpitaux Universitaires de Strasbourg


title: Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions

acronym: ADD-Echo

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

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

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

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

Secondary end points aim to evaluate

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


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

acronym: BKANIG

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

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

region: Grand Est

nom_etablissement: HOPITAUX UNIVERSITAIRES DE STRASBOURG

type_etablissement: CH

acronyme: BKANIG

titre: Intérêt des Immunoglobulines Intraveineuses dans la prévention de l'infection à BK virus chez le greffé rénal en fonction du taux des anticorps neutralisants BKV le jour de la greffe: Etude multicentrique prospective randomisée

discipline_principale: néphrologie

nom_porteur: Fafi-Kremer

prenom_porteur: Samira


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

acronym: INTERSEP

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

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

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

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

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


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

acronym: AZITHROPARO

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

Secondary purpose:

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

appel_a_projets: PHRCI

acronyme: AZITHROPARO

titre: Impact des facteurs cliniques locaux, bactériens et de défense de l'hôte sur le traitement non chirurgical des parodontites chroniques sévères par azithromycine: étude randomisée, en double aveugle versus placebo

discipline_principale: autre

nom_porteur: DAVIDEAU

prenom_porteur: Jean-Luc


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

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

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

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

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

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

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

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


type: Registry Identifier

title: Comparison of Prevention Bacterial Inhalation of Patients on Mechanical Ventilation by Using Endotracheal Tube Balloon Polyvinyl Chloride or Polyurethane

acronym: Top-cuff

summary: A number of techniques have been recommended for the prevention of ventilator acquired pneumonia (VAP). These techniques - such as patient positioning, continuous sub-glottic suction of the secretions, selective decontamination of the digestive tract etc… - aim at prevent the inhalation of oro-pharyngeal contaminated secretions around the cuff of the tracheal tube used for connecting the patient to the machine. Their efficacy has been regularly challenged and they are still unable to suppress totally the occurrence of VAP. The cuff of the tracheal tube used for long-term MV in the ICU is most often a low pressure high volume polyvinyl chloride (PVC) cuff in order to adhere to a large surface of the tracheal wall without inducing ischemic lesions. Recent advances allowed industrial companies to provide us with 1) polyurethane cuffs and 2) cuffs with a conic shape, both potentially offering a better tightness against inhalation at least in VITRO and in animal models. The effect on the reduction of VAP incidence has been suggested by several pilot series. The aim of the present project is to assess the efficacy of four types of cuffs (PVC with a conic or a cylinder shape and polyurethane with a conic or a cylinder shape) to prevent tracheal colonisation. We shall measure both oro-pharyngeal and tracheal colonisation during the hours and days following intubation. This will be done in 600 ICU patients of four university affiliated centres from France and Tunisia divided in 64 cluster randomized groups. The results of this research will confirm (or not) the rationale to perform a larger study designed specifically to address the impact on VAP.

ReferenceCitation: Misset B, Timsit JF, Dumay MF, Garrouste M, Chalfine A, Flouriot I, Goldstein F, Carlet J. A continuous quality-improvement program reduces nosocomial infection rates in the ICU. Intensive Care Med. 2004 Mar;30(3):395-400. doi: 10.1007/s00134-003-2096-1. Epub 2003 Dec 12.

ReferenceCitation: Koenig SM, Truwit JD. Ventilator-associated pneumonia: diagnosis, treatment, and prevention. Clin Microbiol Rev. 2006 Oct;19(4):637-57. doi: 10.1128/CMR.00051-05.

ReferenceCitation: Garrouste-Orgeas M, Chevret S, Arlet G, Marie O, Rouveau M, Popoff N, Schlemmer B. Oropharyngeal or gastric colonization and nosocomial pneumonia in adult intensive care unit patients. A prospective study based on genomic DNA analysis. Am J Respir Crit Care Med. 1997 Nov;156(5):1647-55. doi: 10.1164/ajrccm.156.5.96-04076.

ReferenceCitation: Dullenkopf A, Schmitz A, Frei M, Gerber AC, Weiss M. Air leakage around endotracheal tube cuffs. Eur J Anaesthesiol. 2004 Jun;21(6):448-53. doi: 10.1017/s0265021504006064.

ReferenceCitation: Lucangelo U, Zin WA, Antonaglia V, Petrucci L, Viviani M, Buscema G, Borelli M, Berlot G. Effect of positive expiratory pressure and type of tracheal cuff on the incidence of aspiration in mechanically ventilated patients in an intensive care unit. Crit Care Med. 2008 Feb;36(2):409-13. doi: 10.1097/01.CCM.0000297888.82492.31.

ReferenceCitation: Philippart F, Gaudry S, Quinquis L, Lau N, Ouanes I, Touati S, Nguyen JC, Branger C, Faibis F, Mastouri M, Forceville X, Abroug F, Ricard JD, Grabar S, Misset B; TOP-Cuff Study Group. Randomized intubation with polyurethane or conical cuffs to prevent pneumonia in ventilated patients. Am J Respir Crit Care Med. 2015 Mar 15;191(6):637-45. doi: 10.1164/rccm.201408-1398OC.

publisher_dissemination: American Thoracic Society

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Kimberly-Clark Corporation
Medtronic - MITG


title: Assessment of Nephrotoxicity Associated to Parenchymal Clamping During Partial Nephrectomy Using a Microdialysis Technique: NECPAR Study

acronym: NECPAR

summary:
Surgery plays a central role in kidney cancer management being the only therapy that offers the possibility of healing the patients. Currently, the partial nephrectomy is a standard technique because it meets the principle of nephron sparing surgery. A partial nephrectomy requires a control of the renal blood flow using a clamp, which can be parenchymal or vascular (pedicular). In France, most of the centers use pedicular clamping. It is well established that this technique results in warm ischemia of the entire healthy parenchyma and can lead to permanent kidney damages. Currently, no study evaluated the impact of parenchymal clamping on the healthy parenchyma.

The aim of the investigators study is to evaluate the nephrotoxicity of the healthy parenchyma due to parenchymal clamping during partial nephrectomy. This assessment will be done through a microdialysis technique. The microdialysis probe is directly implanted in the healthy unclamped parenchyma and will allow us to measure in real time, during the surgery, the biological changes related to anaerobic metabolism of renal interstitial space. All those measures will be completed by urinary and plasmatic assessments. Oxidative stress will be assessed using four markers of tubular viability : Interleukin 18 (IL18), Kidney Injury Molecule-1 (KIM-1), Neutrophil Gelatinase-Associated Lipocalin (NGAL) and cystatin C and four parameters of anaerobic metabolism : lactate, pyruvate, glycerol and glucose.

This is a prospective pilot study limited to 10 patients included over 12 months. Depending on the results, it will be further developed by a second study comparing parenchymal with pedicle clamping.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Lung Transplantation for Pleuroparenchymal Fibroelastosis : a French Multicentric Retrospective Study

summary: This retrospective observational study will evaluate the outcomes of lung transplantation for a rare cause of interstitial lung disease called pleuroparenchymal fibroelastosis. Data will be collected from all transplantation center in France.

location_facility:
Marie Lannelongue Hospital
Bichat Claude Bernard Hospital, APHP
Foch Hospital
Hopital Louis Pradel