title: Randomized Phase II Trial Evaluating the Efficiency of Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure

acronym: ANGIOPAS

summary:
The angiodysplasias may be responsible for recurrent gastrointestinal bleeding and in some cases bleeding remaining inaccessible to endoscopic treatment. Several observational studies suggest that treatment with somatostatin analogue would reduce transfusion requirements in patients with recurrent bleeding due to angiodysplasia.

No randomized studies are available. The main objective of this study multicenter, prospective, randomized, was to assess the transfusion requirements in patients with recurrent bleeding due to angiodysplasia treated by a new analogue of somatostatin, Pasireotide, versus placebo.

Patients with recurrent gastrointestinal bleeding related to angiodysplasias, endoscopic treatment failure, with a need transfusion at least 6 red blood cells during the 6 months prior to inclusion could be randomized to receive monthly intramuscular injection of Pasireotide 60 mg or placebo for a period of 6 months. Patients were then followed for an additional 6 months after stopping treatment. A test monthly clinical and laboratory was performed during the six months of treatment then quarterly during the six months of surveillance.

ReferenceCitation: Boley SJ, Sammartano R, Adams A, DiBiase A, Kleinhaus S, Sprayregen S. On the nature and etiology of vascular ectasias of the colon. Degenerative lesions of aging. Gastroenterology. 1977 Apr;72(4 Pt 1):650-60.

ReferenceCitation: Foutch PG, Rex DK, Lieberman DA. Prevalence and natural history of colonic angiodysplasia among healthy asymptomatic people. Am J Gastroenterol. 1995 Apr;90(4):564-7.

ReferenceCitation: Vreeburg EM, Snel P, de Bruijne JW, Bartelsman JF, Rauws EA, Tytgat GN. Acute upper gastrointestinal bleeding in the Amsterdam area: incidence, diagnosis, and clinical outcome. Am J Gastroenterol. 1997 Feb;92(2):236-43.

ReferenceCitation: Ohmiya N, Yano T, Yamamoto H, Arakawa D, Nakamura M, Honda W, Itoh A, Hirooka Y, Niwa Y, Maeda O, Ando T, Yao T, Matsui T, Iida M, Tanaka S, Chiba T, Sakamoto C, Sugano K, Goto H. Diagnosis and treatment of obscure GI bleeding at double balloon endoscopy. Gastrointest Endosc. 2007 Sep;66(3 Suppl):S72-7.

ReferenceCitation: Chalasani N, Cotsonis G, Wilcox CM. Upper gastrointestinal bleeding in patients with chronic renal failure: role of vascular ectasia. Am J Gastroenterol. 1996 Nov;91(11):2329-32.

ReferenceCitation: Bhutani MS, Gupta SC, Markert RJ, Barde CJ, Donese R, Gopalswamy N. A prospective controlled evaluation of endoscopic detection of angiodysplasia and its association with aortic valve disease. Gastrointest Endosc. 1995 Nov;42(5):398-402.

ReferenceCitation: Veyradier A, Balian A, Wolf M, Giraud V, Montembault S, Obert B, Dagher I, Chaput JC, Meyer D, Naveau S. Abnormal von Willebrand factor in bleeding angiodysplasias of the digestive tract. Gastroenterology. 2001 Feb;120(2):346-53.

ReferenceCitation: Pavey DA, Craig PI. Endoscopic therapy for upper-GI vascular ectasias. Gastrointest Endosc. 2004 Feb;59(2):233-8.

ReferenceCitation: Junquera F, Feu F, Papo M, Videla S, Armengol JR, Bordas JM, Saperas E, Piqué JM, Malagelada JR. A multicenter, randomized, clinical trial of hormonal therapy in the prevention of rebleeding from gastrointestinal angiodysplasia. Gastroenterology. 2001 Nov;121(5):1073-9.

ReferenceCitation: Bauditz J, Lochs H, Voderholzer W. Macroscopic appearance of intestinal angiodysplasias under antiangiogenic treatment with thalidomide. Endoscopy. 2006 Oct;38(10):1036-9.

ReferenceCitation: Dabak V, Kuriakose P, Kamboj G, Shurafa M. A pilot study of thalidomide in recurrent GI bleeding due to angiodysplasias. Dig Dis Sci. 2008 Jun;53(6):1632-5.

ReferenceCitation: Kurosaki M, Saegert W, Abe T, Lüdecke DK. Expression of vascular endothelial growth factor in growth hormone-secreting pituitary adenomas: special reference to the octreotide treatment. Neurol Res. 2008 Jun;30(5):518-22.

ReferenceCitation: Ludwig D, Terai S, Brüning A, Stange EF. Long-term haemodynamic effects of octreotide on postprandial splanchnic hyperemia in humans: a placebo-controlled echo-doppler study. Aliment Pharmacol Ther. 1999 Aug;13(8):1119-29.

ReferenceCitation: Szilagyi A, Ghali MP. Pharmacological therapy of vascular malformations of the gastrointestinal tract. Can J Gastroenterol. 2006 Mar;20(3):171-8. Review.

ReferenceCitation: Nardone G, Rocco A, Balzano T, Budillon G. The efficacy of octreotide therapy in chronic bleeding due to vascular abnormalities of the gastrointestinal tract. Aliment Pharmacol Ther. 1999 Nov;13(11):1429-36.

ReferenceCitation: Scaglione G, Pietrini L, Russo F, Franco MR, Sorrentini I. Long-acting octreotide as rescue therapy in chronic bleeding from gastrointestinal angiodysplasia. Aliment Pharmacol Ther. 2007 Sep 15;26(6):935-42.

ReferenceCitation: Brown C, Subramanian V, Wilcox CM, Peter S. Somatostatin analogues in the treatment of recurrent bleeding from gastrointestinal vascular malformations: an overview and systematic review of prospective observational studies. Dig Dis Sci. 2010 Aug;55(8):2129-34. doi: 10.1007/s10620-010-1193-6. Review.

ReferenceCitation: Weckbecker G, Briner U, Lewis I, Bruns C. SOM230: a new somatostatin peptidomimetic with potent inhibitory effects on the growth hormone/insulin-like growth factor-I axis in rats, primates, and dogs. Endocrinology. 2002 Oct;143(10):4123-30.

lead_sponsor: Robert Benamouzig

location_facility: Société Française d'Endoscopie Digestive (SFED)


title: Innovative Treatment for Scarred Vocal Cords by Local Injection of Autologous Stromal Vascular Fraction

summary: Post-operative scarring on vocal cords is responsible for disorders of the vibration of the lining to the original dysphonia can be troublesome for the patient both in his private and professional life. There is no currently codified treatment for this type of situation and no therapeutic antifibrotic has been effective. Cell therapy is a promising new approach.After a liposuction and removing of mature adipocytes (40 to 60%), the remaining cells called stromal vascular fraction (SVF) could be isolated. SVF consists of a heterogeneous cell population including multipotent stem cells similar to mesenchymal stem cells present in bone marrow. The investigators hypothesis is that the trophic and antifibrotic properties of SVF could benefit patients with vocal cords scarring responsible for dysphonia.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Mattei A, Bertrand B, Jouve E, Blaise T, Philandrianos C, Grimaud F, Giraudo L, Aboudou H, Dumoulin C, Arnaud L, Revis J, Galant C, Velier M, Veran J, Dignat-George F, Dessi P, Sabatier F, Magalon J, Giovanni A. Feasibility of First Injection of Autologous Adipose Tissue-Derived Stromal Vascular Fraction in Human Scarred Vocal Folds: A Nonrandomized Controlled Trial. JAMA Otolaryngol Head Neck Surg. 2020 Apr 1;146(4):355-363. doi: 10.1001/jamaoto.2019.4328.

name: Department of Oto-Rhino-Laryngology and Head and Neck Surgery, Assistance Publique–Hôpitaux de Marseille, La Conception University Hospital, Marseille, France

name: Laboratoire Parole et Langage, Centre National de la Recherche Scientifique, Aix Marseille University, Aix-en-Provence, France

family: Mattei

full_name: Alexia Mattei

given: Alexia

sequence: first

name: Department of Plastic and Reconstructive Surgery, Assistance Publique–Hôpitaux de Marseille, La Conception University Hospital, Marseille, France

family: Bertrand

full_name: Baptiste Bertrand

given: Baptiste

sequence: additional

name: Assistance Publique–Hôpitaux de Marseille, Institut National de la Sante et de la Recherche Medicale, Institut de Neurosciences des Systèmes, Service de Pharmacologie Clinique et Pharmacovigilance, Centre d’Investigation Clinique Centre de Pharmacologie Clinique et d’Évaluation Thérapeutique, Aix Marseille University, Marseille, France

family: Jouve

full_name: Elisabeth Jouve

given: Elisabeth

family: Blaise

full_name: Théo Blaise

given: Théo

family: Philandrianos

full_name: Cécile Philandrianos

given: Cécile

name: Cell Therapy Department, Assistance Publique–Hôpitaux de Marseille, Institut National de la Sante et de la Recherche Medicale, La Conception University Hospital, Aix Marseille University, Marseille, France

family: Grimaud

full_name: Fanny Grimaud

given: Fanny

family: Giraudo

full_name: Laurent Giraudo

given: Laurent

family: Aboudou

full_name: Houssein Aboudou

given: Houssein

family: Dumoulin

full_name: Chloé Dumoulin

given: Chloé

family: Arnaud

full_name: Laurent Arnaud

family: Revis

full_name: Joana Revis

given: Joana

family: Galant

full_name: Camille Galant

given: Camille

name: Institut National de la Sante et de la Recherche Medicale and Institut National de la Recherche Agronomique, Aix Marseille University, Centre Recherche en CardioVasculaire et Nutrition, Marseille, France

family: Velier

full_name: Mélanie Velier

given: Mélanie

family: Veran

full_name: Julie Veran

given: Julie

family: Dignat-George

full_name: Françoise Dignat-George

given: Françoise

name: French National Centre for Scientific Research, Centre National de la Recherche Scientifique, Etablissement Français du Sang, Anthropologie bio-culturelle, Droit, Ethique et Santé, Aix Marseille University, Marseille, France

family: Dessi

full_name: Patrick Dessi

given: Patrick

family: Sabatier

full_name: Florence Sabatier

given: Florence

family: Magalon

full_name: Jérémy Magalon

given: Jérémy

family: Giovanni

full_name: Antoine Giovanni

given: Antoine

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JAMA Otolaryngology–Head & Neck Surgery

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

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 - ParisTech

title: Feasibility of First Injection of Autologous Adipose Tissue–Derived Stromal Vascular Fraction in Human Scarred Vocal Folds

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assisitance Publique Hopitaux de Marseille


title: Pharmacokinetic Study of the Amoxicillin / Clavulanic Acid Association to Optimize Dosage Among Obese Adults (PHACO)

acronym: PHACO

summary:
Description of the pharmacokinetic parameters of the amoxicillin / clavulanic acid to healthy voluntary obese after oral and intra venous administration Determination of the pharmacokinetic parameters of amoxicillin / clavulanic acid obtained from plasmatic concentrations of intravenous injection (IV) and oral administrations. The criterion of evaluation allowing to answer our main objective corresponds to the parameters estimated by the pharmacokinetic model of the concentrations obtained from the data IV and by the pharmacokinetic model of the concentrations obtained from the oral data. The following pharmacokinetic parameters will be considered at every obese volunteer's for both molecules (amoxicillin and clavulanic acid) from the concentrations by pharmacokinetic analysis of population.

The main evaluation criteria are PK parameters of amoxicillin / clavulanic:

Cl, systematic plasmatic clearance
Vd, volume of distribution
ASC 0-oo, area under the curve time - concentration
T1/2, half-life time
F, bioavailability after oral administration
Ka, constant of speed of absorption

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Virtual Reality and Relaxation for the Treatment of Generalized Anxiety Disorders: a Comparative Study With Standard Relaxation

acronym: Relax-TAG

summary:
The purpose is threefold: Assess the anxiety reduction, the mood positive effect and the rise of quality of life when using methods of relaxation combined with virtual reality with patients suffering from generalized anxiety disorder in comparison of the effect of traditional relaxation therapy. Observe and evaluate the effect of perceived presence in synthetic environments in the virtual experience of relaxation. Evaluate the therapeutic efficacy of stereoscopy during exposure to relaxing virtual environments for the treatment of generalized anxiety disorder.

It is a comparative, randomized, two groups study (29 in each group):

Relaxation optimized virtual reality
Classical relaxation (without Virtual Reality). The protocol comprised for each groups 7 relaxing sessions (with or without virtual reality epending on the group). Each session lasted for approximately 30 to 35 minutes, including a 5-minute pause between immersive trials, in order to avoid cyber sickness in the virtual reality group.

Expected results: a measurable therapeutic improvement produced by the combination of relaxation and virtual and its additional effect when compared to the traditional treatment.

Measurements of variables and therapeutic effects will be carried out with psychometric measures.

The creation process of the relaxing virtual environments has already been completed. The virtual environments are ready for use.

The apparatus needed and in our possession include:

A laptop for generating virtual environments
A stereoscopic display
Apparatus for physiological measurements

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Unknown


title: Evaluation of Screening for Visual Disorders of the Old Subject in Consultation Memory

acronym: EVAM

summary: Visual disorders are often overlooked in the treatment of cognitive disorders of the elderly. Yet the visual deficit impacts the quality of life, the evolution of the autonomy and psycho-behavioral disorders in cognitive diseases. The main objective of the study is to evaluate the prevalence of visual disorders among elderly patients at consultant outpatient center of Nantes clinical gerontology as part of the consultation geriatric memory. Secondary objectives are to describe ophthalmological diseases detected and taken into the proposed ophthalmic load, to determine if there are associations between eye diseases and cognitive disorders, to estimate the proportion of patients who may have an ophthalmologic evaluation to determine the cognitive profiles and geriatric evaluation and ocular pathological, depending on the assessment of arterial stiffness. The results of this study will build a testing strategy to promote access of older patients with cognitive impairment to vision care.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Nantes University Hospital

intervention_type: Other


title: Non-Invasive Evaluation of Myocardial Stiffness by Elastography Pediatric Cardiology Under

summary:
First, investigators must determine the physiological standards across age classes of myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular stiffness [VD] and left ventricular [LV]). This will be done in groups of children without heart condition, age group (10 children per group, four age groups [0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years]).

Secondly, investigators will evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with cardiomyopathy and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values. The total population of the study will be 120 children (40 healthy, 80 patients).

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: French Cardiology Society

intervention_type: Device


title: Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old): Evaluating the Efficacy of a Nelarabine Based Consolidation and Maintenance in High-risk Patients

summary: The purpose of this study is to evaluate the efficacy of nelarabine-based consolidation and maintenance therapy in term of relapse-free survival (RFS) in high-risk (HR) patients.

status: Recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

status_simplified: Ongoing


title: The Impact of Surgical Outcomes Monitoring Using Control Chart on Surgical Performance: A Cluster Randomized Trial

acronym: SHEWHART

summary: This two arms parallel cluster-randomized trial will evaluate the impact of monitoring surgical outcomes using Shewhart control chart (intervention) on the occurence of major adverse events, among a large sample of French surgical departments. Trends in surgical outcomes before and after the intervention will be compared between arms.

ReferenceCitation: Duclos A, Chollet F, Pascal L, Ormando H, Carty MJ, Polazzi S, Lifante JC; SHEWHART Trial Group. Effect of monitoring surgical outcomes using control charts to reduce major adverse events in patients: cluster randomised trial. BMJ. 2020 Nov 4;371:m3840. doi: 10.1136/bmj.m3840.

family: Duclos

full_name: Antoine Duclos

family: Chollet

full_name: François Chollet

given: François

family: Pascal

full_name: Léa Pascal

given: Léa

family: Ormando

full_name: Hector Ormando

given: Hector

family: Carty

full_name: Matthew J Carty

given: Matthew J

family: Polazzi

full_name: Stéphanie Polazzi

given: Stéphanie

family: Lifante

full_name: Jean-Christophe Lifante

given: Jean-Christophe

journal_name: BMJ

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Hospices Civils de Lyon


type: Registry Identifier

title: Effect of PEEP and Trendelenburg on Ultrasound Size of Internal Jugular and Subclavian Veins: A Cross-over Randomized Controlled Study

acronym: PEEPUS

summary:
There is no recommendation for the management of the positive end-expiratory pressure (PEEP) during setting of a central venous catheter (CVC) in a ventilated patient. Several non-randomized studies have investigated the cross-sectional area (AST) ultrasound minor axis for different pressure levels by evaluating a single vessel every time or by not displaying the right or left side in the evaluation. Another study showed that there could be unpredictable size differences between the 2 subclavian veins.

In ventilated patient, the PEEP, which is intrathoracic, will result in a decrease of venous return and thus possibly a superior vena cava dilation, located outside the pleura, depending on their capacitance. Different pressure levels showed an increase of AST with the increase of intra-thoracic pressure on certain veins, in a heterogeneous and not randomized manner.

The primary purpose of the study is to measure the effect of PEEP (0, 5, 10 or 15 cm H2O) and the patient's position (supine or Trendelenburg strict -15-20 °) on the cross-sectional area of the jugular and subclavian veins.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Evolution of the Metabolic, Cardiovascular, Bone Complications and of the Quality of Life in Cushing's Disease

acronym: COMPLICUSHING

summary: This study aims at investigating the complications of Cushing's disease in "de novo" patients. A series of investigations will assay before treatment and every year thereafter during a 3 years follow-up period the various complications of the disease. These investigations will determine the presence and severity of cardiovascular, metabolic, and bone complications as well as the Quality of Life. Outcome of these complications after treatment, especially after pituitary surgery will be monitored, as well as cortisol levels.


title: Evaluation of the Impact of a Follow-up Phone Call Nurse Device in the Care of Patients With Chemotherapy Treatment, in Their Quality of Life and Medico-economic Analysis of This Follow-up Program Device

acronym: EVAL'COACH

summary: This study evaluate the Impact of a Follow-up Phone Call Nurse Device in the Care of Patients With Chemotherapy Treatment, in their Quality of Life and Medico-economic Analysis of this Follow-up Program Device.

primary_purpose: Health Services Research

lead_sponsor: Institut Claudius Regaud


type: EudraCT Number

title: Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy: a Prospective, Randomized, Double-blind Versus Placebo Study

summary: The sensory innervation of the face depends on the trigeminal (fifth cranial) which is divided into three branches, the mandibular nerve (V3) having motor fibers to the temporal and masseter muscle. The regional anesthesia of the face has grown in recent years for performing certain actions under light general anesthesia or sedation. The mandibular block is a simple and reliable technique but little used. Yet it reduces postoperative pain sagittal osteotomy of the mandibular branch by reducing consumption of opioids and in the oropharynx cancer surgery. Made with ropivacaine, known for its vasoconstrictive action, it also improves the visibility of the operative field during mandibular osteotomies reducing bleeding. Despite a real clinical benefit (ease of implementation, latency and duration of action of the local anesthetic), the V3 block ropivacaine is not evaluated in the maxillofacial surgery.

ReferenceCitation: Bertuit M, Rapido F, Ly H, Vannucci C, Ridolfo J, Molinari N, De Boutray M, Galmiche S, Dadure C, Perrigault PF, Capdevila X, Chanques G. Bilateral mandibular block improves pain relief and morphine consumption in mandibular osteotomies: a prospective, randomized, double-blind, placebo-controlled clinical trial. Reg Anesth Pain Med. 2021 Apr;46(4):322-327. doi: 10.1136/rapm-2020-102417. Epub 2021 Feb 9.

family: Bertuit

full_name: Marina Bertuit

given: Marina

family: Rapido

full_name: Francesca Rapido

given: Francesca

family: Ly

full_name: Habib Ly

given: Habib

family: Vannucci

full_name: Charlotte Vannucci

given: Charlotte

family: Ridolfo

full_name: Jérôme Ridolfo

given: Jérôme

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

family: De Boutray

full_name: Marie De Boutray

given: Marie

family: Galmiche

full_name: Sophie Galmiche

given: Sophie

family: Dadure

full_name: Christophe Dadure

given: Christophe

family: Perrigault

full_name: Pierre-François Perrigault

given: Pierre-François

family: Capdevila

full_name: Xavier Capdevila

given: Xavier

family: Chanques

full_name: Gérald Chanques

given: Gérald

journal_name: Regional Anesthesia & Pain Medicine

lead_sponsor: University Hospital, Montpellier

intervention_type: Procedure


title: Impact of Denosumab in the Prevention of Bone Loss in Non-menopausal Women With Anorexia Nervosa

acronym: DIBLAN

summary:
The drastic reduction of nutritional intake in anorexia nervosa(AN) alters many hormonal factors that regulate the activity of bone cells. This alteration of bone remodeling is characterized by increased bone resorption and decreased bone formation, leading to a marked reduction of bone mineral density, osteoporosis and an increased risk of fracture.

To date, there is a paucity of studies and no consensus on the management of bone loss in patients with AN. The few previous studies were performed with small samples and using short follow-up periods.

Denosumab is a fully human monoclonal antibody that binds with high specificity to human RANKL (6, 7), thereby reducing the number and activity of osteoclasts and therefore decreasing bone resorption that was found increased in patients AN.

Denosumab may transiently protect bone whilst psychonutritional management will induce a weight restoration

status: Terminated

ipd_sharing: No


type: Other Identifier

acronym: EVA

summary:
Aim : To assess the ability of healthy subjects and patients with a severe motor disability to voluntary control their attention

Material and Methods:

Population: healthy subjects, patients with brain injury Electroencephalographic study to research attentional modulation during different kind of stimulation (visual, auditory, tactile)

Sudy 1: passive recording.

Study 2: active recording (instruction of attentional control given to the subject).

Study 3: active recording with a feedback obtained after a processing of the brain activity.


title: Biomechanical and Ultrasonic Assessment of the Achilles Tendon in Vivo (MEDUSAA)

acronym: MEDUSAA

summary:
Among Musculoskeletal disorders (MSD) the rupture of the Achilles tendon is the most common. Up today, the mechanical and elastic properties of the Achilles tendon are still unknown, and that both in healthy subjects in pathology. The viscoelastic properties or dynamic mechanical properties are directly related to the tendon of the health status and its elongation capacity.

The laboratory UMR Inserm U930 - CNRS ERL 3106 in Tours has developed a non-invasive ultrasonic device, named Achillus, which, via an ultrasonic probe, allowing to access the viscoelastic properties of the tendon during the contraction of the sural triceps.

This is what we want to do in this first protocol: in vivo observation of the normal values and variations, looking for changes related to hyper solicitation and finally trying to highlight a tendon fragility parameter for patients who have experienced of a Achilles tendon rupture.

lead_sponsor: University Hospital, Tours


title: Immunoregulation of Periodontal Diseases

summary: Periodontal diseases are a group of diseases that affect 15% of the population and in the absence of treatment causes tooth loss. Periodontal lesions are characterized mainly by strong inflammation and hyper-vascularization. Search in blood cells and inflammatory markers attempts to explain the etiological-pathogenetic mechanisms. Innate immunity can be assessed by qualitative and quantitative analysis of blood phagocytes, natural killer cells, complement, proteins of inflammation and cytokines. Current data from the literature on this subject give contradictory results and the comparison of studies are difficult because the diversity of the populations studied, evaluated cells and the methods used. The aim of the study was to evaluate the innate immunity of patients with periodontal disease and compare it with a group of patients without periodontal disease.

location_facility: Assistance Publique Hopitaux de Marseille


title: Ultrasound Guidance to Alleviate the Pain Associated With Intramuscular Injections of Botulinum Toxin in Spastic Patients

acronym: TOXINECHO

summary: Intramuscular injections of botulinum toxin are currently the best focal treatment of spasticity, with clearly defined indications and role. French and European recommendations focus on the toxin's mode of administration, which must be as precise as possible. The toxin's specific action on motor endplates (blocking the release of acetylcholine) shows the importance of targeted injections within the muscle belly. The pain caused by these injections is due partly the number of injections (up to 30 in a single session), and partly to the use of electrical stimulation guidance. Prevention and alleviation of the pain caused by these injections have become a regulatory obligation since the law of 4 March 2002 relating to the rights of patients and the quality of the health system (" Any person has the right to receive relief from pain, which must, under all circumstances, be prevented, evaluated, taken into account and treated … ").

lead_sponsor: University Hospital, Toulouse


title: Arthrodesis Gleno Humeral Under Arthroscopy in the Sequelae of Plexus Brachial Evaluation of the Technical Feasibility

acronym: DESEP

summary: Arthrodesis shoulder blade/humerus under arthroscopy. Implementation of an external fixative spray at the proximal level in the thorn of the scapula and distal in the diaphysis humerus.

lead_sponsor: University Hospital, Brest


title: Human Fine-motor-skills in Weightlessness: Comparison of a Laboratory and an Everyday-like Context

acronym: FINESKILL

summary:
The human performance during weightlessness was tested in a multiplicity of laboratory experiments during parabolic flights and in space. It is therefore known that human fine motor skills as grasping are affected by the impact of changing gravity levels. However, because everyday life movements differ in several aspects from those done in an experimental lab situation, investigators do not know until know if this kind of movements is altered in the same extend.

Fine motor skills seem to depend on the context in which they are made. Thus, the performance in weightlessness during everyday life could substantially differ from the results given by previous laboratory studies.

This assumption will be tested in the present project, with subjects executing one and the same grasping movement in two different contexts, both in normal gravity conditions and in weightlessness. To that end, the investigators developed a new method which allows comparing the same grasping movements under different conditions.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Caen


title: Creation of a Multimodality Image Database (MRI + Ultrasound) for the Development of a Computer Aided Diagnostic (CAD) System in Patients With Prostate Cancer

acronym: Echo-CAD

summary:
Prostate cancer is currently detected by ultrasound-guided biopsy. Computer-aided diagnostic (CAD) systems based on multiparametric MRI are now capable of detecting most aggressive cancer foci non-invasively, but additional progress is needed for the technique to be accepted in clinical practice. We hypothesize that combining MRI and ultrasound imaging can improve the detection of cancerous tumors. As a first step in this direction, we need to create a database with MR images, 3D ultrasound images, and corresponding histopathology results, in patients treated by radical prostatectomy for prostate cancer. This is the purpose of the present study.

In a later stage (outside the scope of this study), we will be learning how to combine these images to best recognize cancerous tumors, we will use that knowledge to develop a new CAD system, and we will assess the performance of the new CAD. We expect this future system to improve the detection of prostate cancer and to reduce the number of patients requiring biopsy.

location_facility: Hôpital Edouard Herriot - Service Service de radiologie


title: Prognostic Value of Hemodynamic Disturbances of the Central Retinal Artery in Color Doppler Ultrasound in Rhegmatogenous Retinal Detachment

acronym: CRADO-RED

summary:
Retinal detachments correspond to a separation of the neuroepithelium from the pigment epithelium. They can be exudative (sometimes in conjunction with a tumor), tractional, traumatic (postoperative) or rhegmatogenous (in relation to a tear).

Ultrasound, requested when the fundus is difficult to achieve and shows a hyperechoic mobile membrane. It can also measure the hemodynamic parameters of retinal arteries.

A preliminary study showed a correlation between systolic velocity in the central retinal artery and postoperative visual acuity.

The aim of this study is to confirm those preliminary data.

primary_purpose: Other

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmique Adolphe de Rothschild


title: Impact of the Platelet Level During Radiotherapy Associated With Temozolomide in Patients Treated for Glioblastoma

acronym: GLIOPLAK

summary: The purpose of GLIOPLAK is to evaluate the predictive value of a biological test performed in the radio-chemotherapy phase in patients suffering from glioblastoma. The studied parameter is the variation in platelet count during the radio-chemotherapy phase. The main objective is to identify early in Stupp protocol a group of patients having high risk to undergo thrombocytopenia in maintenance phase of temozolomide. With this result an algorithm of platelet monitoring for patients treated with Stupp protocol wil be proposed.

ReferenceCitation: Fontanilles M, Marguet F, Beaussire L, Magne N, Pépin LF, Alexandru C, Tennevet I, Hanzen C, Langlois O, Jardin F, Laquerrière A, Sarafan-Vasseur N, Di Fiore F, Clatot F. Cell-free DNA and circulating TERT promoter mutation for disease monitoring in newly-diagnosed glioblastoma. Acta Neuropathol Commun. 2020 Nov 4;8(1):179. doi: 10.1186/s40478-020-01057-7.

family: Fontanilles

full_name: Maxime Fontanilles

given: Maxime

family: Marguet

full_name: Florent Marguet

given: Florent

family: Beaussire

full_name: Ludivine Beaussire

given: Ludivine

family: Magne

full_name: Nicolas Magne

family: Pépin

full_name: Louis-Ferdinand Pépin

given: Louis-Ferdinand

family: Alexandru

full_name: Cristina Alexandru

given: Cristina

family: Tennevet

full_name: Isabelle Tennevet

given: Isabelle

family: Hanzen

full_name: Chantal Hanzen

given: Chantal

family: Langlois

full_name: Olivier Langlois

given: Olivier

family: Jardin

full_name: Fabrice Jardin

given: Fabrice

family: Laquerrière

full_name: Annie Laquerrière

given: Annie

family: Sarafan-Vasseur

full_name: Nasrin Sarafan-Vasseur

given: Nasrin

family: Di Fiore

full_name: Fréderic Di Fiore

given: Fréderic

family: Clatot

full_name: Florian Clatot

given: Florian

currency_apc_doaj: GBP

journal_name: Acta Neuropathologica Communications

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Henri Becquerel


title: Pre-operative Haemorrhagic Risk Screening, Using a Standardized Questionnaire Before Scheduled Surgeries.

acronym: HEMORISQ

summary:
"This is not a validation study of a questionnaire. This is a multicenter diagnostic study, assessing the sensitivity and specificity of a simple structured questionnaire, to identify patients requiring further haemostatic investigations, in pre-operative patients. This study will also allow for the assessment of the sensitivity and specificity of the routine care strategy.

All patients are recruited during the pre-anaesthesia visit by an anaesthesiologist, in different anaesthetic sectors each day of the week, so that different types of surgery are represented.

Each day (from Monday to Friday), the first 2 eligible patients will be offered to take part in the study.

Routine care strategy is not modified by the study protocol. In addition, the simple structured questionnaire will be completed by the patient with a research assistant after the pre-operative consultation As recommended in diagnostic studies, the gold standard (see secondary endpoint paragraph) will be performed consistently in all patients to avoid verification bias.

The improvement of screening for the need of further investigations by use of the questionnaire compared to routine care will be measured counting how many patients are adequately reclassified with the questionnaire compared to the routine care strategy, regarding the gold standard (using the Net Reclassification Index)."

ipd_sharing: Undecided


title: Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting: The ALPHEUS Study

acronym: ALPHEUS

summary:
The new P2Y12 inhibitors prasugrel (Efient®-Effient®) and ticagrelor (Brilique®-Brilinta®) have shown promising results in the respective TRITON and PLATO trials making of prasugrel and ticagrelor recommended first line treatments for acute coronary syndrome ACS (ESC Guidelines: Class 1 LOE B). These two drugs showed superiority over clopidogrel in ACS patients undergoing percutaneous coronary intervention (PCI), by the dramatic diminution of stent thrombosis, the reduction in death or Myocardial Infarction (MI) as well as the reduction in death in a meta-analysis.

The field of elective PCI (stable patients) has not been studied with these 2 new drugs and clopidogrel remains the standard of care. However, off-label use of prasugrel and ticagrelor is increasing in patients undergoing high risk elective PCI (left main, diabetics, multiple stenting, high risk of stent thrombosis, no clopidogrel pretreatment…) but is not supported by scientific evidence. More than half of PCI patients undergo elective stenting for proven ischemia and/or stable angina, a relatively safe procedure with the use of the latest generation of stents. However complications remain either frequent when considering PCI-related myonecrosis/myocardial injury that have been linked to the prognosis of patients or rare but serious when considering stent thrombosis, Q wave MI or stroke, leaving room for improvement with these two newest drugs.

The investigators propose to perform a multicenter international study in stable patients undergoing elective PCI with a randomization between clopidogrel and ticagrelor. The investigators hypothesize that this study will show superiority of the new P2Y12 inhibitor over clopidogrel in elective PCI on the primary ischemic endpoint (peri-procedural MI and myocardial injury) without significant excess bleeding (BARC definition).

ReferenceCitation: Silvain J, Lattuca B, Beygui F, Rangé G, Motovska Z, Dillinger JG, Boueri Z, Brunel P, Lhermusier T, Pouillot C, Larrieu-Ardilouze E, Boccara F, Labeque JN, Guedeney P, El Kasty M, Laredo M, Dumaine R, Ducrocq G, Collet JP, Cayla G, Blanchart K, Kala P, Vicaut E, Montalescot G; ALPHEUS investigators. Ticagrelor versus clopidogrel in elective percutaneous coronary intervention (ALPHEUS): a randomised, open-label, phase 3b trial. Lancet. 2020 Nov 28;396(10264):1737-1744. doi: 10.1016/S0140-6736(20)32236-4. Epub 2020 Nov 14.

family: Silvain

full_name: Johanne Silvain

given: Johanne

family: Lattuca

full_name: Benoit Lattuca

given: Benoit

family: Beygui

full_name: Farzin Beygui

given: Farzin

family: Rangé

full_name: Grégoire Rangé

given: Grégoire

family: Motovska

full_name: Zuzana Motovska

given: Zuzana

family: Dillinger

full_name: Jean-Guillaume Dillinger

given: Jean-Guillaume

family: Boueri

full_name: Ziad Boueri

given: Ziad

family: Brunel

full_name: Philippe Brunel

given: Philippe

family: Lhermusier

full_name: Thibault Lhermusier

given: Thibault

family: Pouillot

full_name: Christophe Pouillot

given: Christophe

family: Larrieu-Ardilouze

full_name: Elisa Larrieu-Ardilouze

given: Elisa

family: Boccara

full_name: Franck Boccara

given: Franck

family: Labeque

full_name: Jean-Noël Labeque

given: Jean-Noël

family: Guedeney

full_name: Paul Guedeney

given: Paul

family: El Kasty

full_name: Mohamad El Kasty

given: Mohamad

family: Laredo

full_name: Mikael Laredo

given: Mikael

family: Dumaine

full_name: Raphaëlle Dumaine

given: Raphaëlle

family: Ducrocq

full_name: Grégory Ducrocq

given: Grégory

family: Collet

full_name: Jean-Philippe Collet

given: Jean-Philippe

family: Cayla

full_name: Guillaume Cayla

given: Guillaume

family: Blanchart

full_name: Katrien Blanchart

given: Katrien

family: Kala

full_name: Petr Kala

given: Petr

family: Vicaut

full_name: Eric Vicaut

given: Eric

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

ReferenceCitation: Silvain J, Cayla G, Beygui F, Range G, Lattuca B, Collet JP, Dillinger JG, Boueri Z, Brunel P, Pouillot C, Boccara F, Christiaens L, Labeque JN, Lhermusier T, Georges JL, Bellemain-Appaix A, Le Breton H, Hauguel-Moreau M, Saint-Etienne C, Caussin C, Jourda F, Motovska Z, Guedeney P, El Kasty M, Laredo M, Dumaine R, Ducrocq G, Vicaut E, Montalescot G; ALPHEUS study group. Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study. Am Heart J. 2020 Jul;225:27-37. doi: 10.1016/j.ahj.2020.04.017. Epub 2020 Apr 29.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

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

location_facility: Institut de Cardiologie - USIC - Hôpital Pitié-Salpêtrière


title: Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases

summary: The aim of the study is to assess prospectively the impact of radiosurgery on the quality of life in patients with brain metastases.

lead_sponsor: Centre Oscar Lambret


title: Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome

summary: The purpose of this study is to compare the efficacy and safety of T2762 versus Optive® in the treatment of moderate to severe Dry Eye Syndrome.

lead_sponsor: Laboratoires Thea


title: Secretion Induction of Neutrophil Extracellular Traps (NETs)in Inflammatory and Infectious Environment of Mucoviscidose

acronym: MucoNETs

summary:
The study is defined in 3 stages of in vitro assays :

Phase 1 : Secretion of NETs in response to lung disease and their secretion of factors.

This is a transversal study in which we compare :

Producing NETs (DNA and proteases ) by neutrophils purified from sputum and blood of patients
Producing NETs (DNA and proteases ) by purified neutrophils in the blood of patients and blood of control subjects

Phase 2: Mechanisms of activation of NETs secretory pathways . This phase will identify receptors (TLR ) involved in the secretion of NETs and analyze the involvement of dependent transduction pathways calcium and PKC . It will be performed on control blood neutrophils.

Phase 3: Analysis of cell death ( NETose )

This is a transversal study that will analyze :

the mode of cell death of neutrophils purified blood and sputum of patients and control blood neutrophils by flow cytometry and transmission electron microscopy .


title: Prospective, Randomized Study of the Impact of a Education Program for Patients Suffering From Low Back Pain

acronym: TENS

summary:
According to the WHO, therapeutic education is intended to help patients acquire or maintain the skills they need to optimally manage living with a chronic disease. Low back pain is frequent and therapeutic education could be a promising option.

The purpose of the study is to evaluate the impact of a therapeutic education program for patients suffering from low back pain.

lead_sponsor: Hopital Foch


title: Buspirone Treatment of Iatrogenic Dyskinesias in Advanced Parkinson' Disease. Multicenter, International, Placebo-controlled, Randomised, Double Blind Trial

acronym: BUSPARK

summary:
Parkinson's disease (PD) is one of the most common neurodegenerative diseases, with a higher prevalence in the elderly. Levodopa induced dyskinesias (LID) are a major motor complications that impair quality of life for patients with PD. The mechanisms of these dyskinesias remain unclear, but several hypotheses have been put forward: non continuous, pulsatile stimulation of dopaminergic receptors, or alterations of other neurotransmitters within the motor striatum such as glutamate and serotonin.

Few strategies are now available to treat severe LID:

Medications: reduction of dopaminergic treatment, addition of amantadine,
Functional neurosurgery. The purpose of this study is to investigate the efficacy of buspirone in PD patients suffering from dyskinesias. The role of serotonin in the occurrence of LID was recently demonstrated in transplant PD patients and a test double-blind, single dose was achieved. Following administration of 10 mg oral buspirone, a 5HT1A agonist, LID were clearly improved. A antidyskinetic effect of buspirone had already been reported in 1991 and 1994, but identification of buspirone as a serotonin receptor agonist has been reported more recently.

This trial is aimed at (1) validate the serotoninergic hypothesis of hyperkinetic levodopa induced dyskinesias (LID) in Pakinson's disease patients, (2) evaluate, in a phase 3 trial, the motor efficacy of buspirone to improve LID vs placebo, (3) look at a possible dose/effect relationship and (4) check the hypothesis of a better therapeutic ratio using the association of buspirone and amantadine instead than a single drug.

ReferenceCitation: McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. Review.

name: Parkinson’s advocate, Innovation Fixer Ltd, Oxford, UK

family: McFarthing

full_name: Kevin McFarthing

given: Kevin

name: Parkinson’s Disease and Movement Disorders Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

family: Prakash

full_name: Neha Prakash

given: Neha

family: Simuni

full_name: Tanya Simuni

given: Tanya

journal_name: Journal of Parkinson's Disease

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

publisher: IOS Press

publisher_dissemination: IOS Press

publisher_group: IOS Press

publisher_normalized: IOS Press

title: CLINICAL TRIAL HIGHLIGHTS – DYSKINESIA


title: Feasibility of a Video-oculography in Patients With Huntington's Disease VOG-HD Study

acronym: VOG-HD

summary: The purpose of this study is to know the limits of feasibility of a reliable oculomotor record for patient with Huntington's disease.

lead_sponsor: University Hospital, Angers


title: Contribution of CT Venography for Diagnosing Venous Thromboembolism During Postpartum

acronym: CTVENPOSTPART

summary: The purpose of this study is to determine whether systematically performing computed tomography (CT) venography (i.e a CT acquisition of the pelvis and of the lower limbs, during the venous phase of opacification) in addition to thoracic CT angiography in women with suspected postpartum pulmonary embolism (PE) results in a gain in venous thromboembolism detection rate.

ReferenceType: background

ReferenceCitation: Revel MP, Sanchez O, Dechoux S, Couchon S, Frija G, Cazejust J, Chatellier G, Meyer G. Contribution of indirect computed tomographic venography to the diagnosis of postpartum venous thromboembolism. J Thromb Haemost. 2008 Sep;6(9):1478-81. doi: 10.1111/j.1538-7836.2008.03078.x. Epub 2008 Jul 8.


title: Characterization of B Regulatory (Breg) Cells in Healthy Subjects and in Rheumatoid Arthritis (RA)

acronym: Breg

summary:
Recently, it has been shown that B cells could also have regulatory functions through the secretion of interleukin 10 (IL-10). They are called the B regulatory cells (Breg). In the mouse model the most commonly used of rheumatoid arthritis, collagen-induced arthritis (CIA), the transfer Breg helps prevent the development of CIA and cure established arthritis. The investigators have recently shown that Breg were decreased in patients with RA compared to controls and that the rate of Breg was inversely correlated with disease activity and autoantibody. These results thus suggest that the lack of IL-10 secretion by B cells plays an important role in the pathophysiology of RA. Nevertheless, in humans, the Breg remain poorly understood. The main objective of this project is to better characterize the B capable of producing IL-10 both in subjects with RA and controls. Understanding which induces the secretion of IL-10 by B could allow to consider new therapeutic approaches in autoimmune diseases, including in RA.

The investigators therefore aim to identify nutrient transporters, chemokine receptors, genes and surface proteins differentially expressed between Breg and other B cells in patients with RA and in controls.


title: Prospective Pilot Study on the Quantitative Evaluation of Vision Parameters Needed by Virtual Reality Goggle Displays for Subjects With Concentric Visual Field Constriction. AUgmented REality for the Visually Impaired - Part 1

acronym: AUREVI 1

summary:
The main objective of this study is to quantify vision parameters in subjects with concentric visual field constriction, and this in relation to the display on virtual reality goggles. More specifically:

The maximum brightness value for visual comfort (THRESHOLD_MAX)
The minimum value of the perceptible light contrast in low light perceptible (THRESHOLD_MIN)
The speed of light change adaptation in the range [THRESHOLD_MAX-THRESHOLD_MIN] and [THRESHOLD_MIN-THRESHOLD_MAX].

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémea


title: Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy in the Hepato-Gastroenterology Department of the Nîmes University Hospital

acronym: OPTI-PP

summary:
The main objective of this study is to evaluate the impact of the presence of a pharmacy technician in a care unit (Hepato-Gastroenterology Department) on detected medication errors.

This is a before-after study consisting of three sequential phases:

Month 1: one month of observation of what is happening in the department Month 2: one month wash out period Month 3: active participation of a pharmacy technician in the department

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Interrupter Technique and Plethysmography Airway Resistance Measurement: Comparison of These Two Techniques for the Diagnosis of Airway Obstruction Diagnosis and Bronchodilation Response in Children 3 to 6 Years of Age

summary: In preschool aged children, the most suitable techniques to assess airway obstruction is debit interruption technic (Rint) and plethysmographic measure of specific airway resistance (sRaw). Even if Rint is easily and routinely performed, it also includes a component of lung tissue and chest wall resistance as well as respiratory tissue viscoelasticity. sRaw seems to be better for discriminating airway obstruction. These two techniques will be compared in terms of concordance in the diagnosis of pulmonary obstruction and bronchodilator response.

ReferenceCitation: Mauger-Hamel P, Du Boisbaudry C, Léon K, Alavi Z, Giroux-Metges MA. Relationship between baseline and post-bronchodilator interrupter resistance and specific airway resistance in preschool children. Ann Allergy Asthma Immunol. 2020 Apr;124(4):366-372. doi: 10.1016/j.anai.2020.01.003. Epub 2020 Jan 13.

family: Mauger-Hamel

full_name: Pauline Mauger-Hamel

given: Pauline

family: Du Boisbaudry

full_name: Cécile Du Boisbaudry

given: Cécile

family: Léon

full_name: Karelle Léon

given: Karelle

family: Alavi

full_name: Zarrin Alavi

given: Zarrin

family: Giroux-Metges

full_name: Marie-Agnès Giroux-Metges

given: Marie-Agnès

journal_name: Annals of Allergy, Asthma & Immunology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier


title: Interest of the Ultrasound to Evaluate the Quadriceps Muscle Wasting in Critical Ill Patients.

acronym: ECHOSCAN

summary:
Intensive care unit acquired muscle weakness (ICUAW) is a common disease. After 7 days of mechanical ventilation, a quarter of patients develop an ICUAW responsible of a 15-20% of muscle loss. This is a serious pathology associated with high morbidity and mortality.

Clinical diagnosis of ICUAW is difficult and need a patient awoken. CT scan and Magnetic Resonance Imaging (MRI) are considered as "gold standards" to quantify and monitor changes in muscle mass. But these tools are not adapted to ICU patients.

Ultrasound (US) is an easy access tool at the bedside to assess muscle mass and does not expose the patient to additional radiation.

The objective of this study is to evaluate the correlation between US and CT scan to measure quadriceps muscle thickness of ICU patients.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Gastroenteric Anastomosis With Natural Orifice Translumenal Endoscopic Surgery (NOTES) Using the New Fashionned Tissue Apposing Stent Axios® for the Treatment of Antro-pyloric or Duodenal Obstructions : Prospective Evaluation of Feasibility, Efficacy and Tolerance.

summary:
Achieving gastro-jejunal or duodenal anastomosis (GJA ) by exclusive endoscopically is a real goal for many years in the development and research of the transluminal endoscopic surgery (N.O.T.E.S). Endoscopic treatment, including palliative antro duodenal stenosis by metallic stent, although minimally invasive, causes problems in long-term secondary obstruction and migration. Surgical treatment of these strictures is associated with significant morbidity and mortality . The complication rate and severity of post-operative surgery after gastric bypass Roux-en-Y anastomosis or gastroduodenal fistulas remain close to 5% with a mortality of 1%. After 3 years of experimental research on porcine model, our team has developed a procedure of gastro duodenal anastomosis using transgastric endoscopic minimally invasive surgical technique (or NOTES) - LBA UMRT24 CERC laboratory , Aix-Marseille University , Faculty of Medicine North, with the aim to offer a credible alternative to conventional surgery.

Thus the investigators propose to conduct a pilot prospective intervenionnal study. The investigators hypothetized that this technique would reduce morbidity and mortality clinical but also economic consequences of surgery while making it possible to obtain excellent results permeability and long-term functionality. This method uses a new concept of tissue apposition with a fully covered metallic stent to create the anastomosis under endoscopy exclusively. Ten patients with antro duodenal obstructions requiring surgical or endoscopic bypass will be included as part of an interventional biomedical research that will be conducted in one expert center. The duration of the inclusions will be 18 months. Then, the stent will be removed three months after insertion, at the end of the healing process, and each patient will be followed for one year. The primary endpoint will be the assessment of the feasibility of the procedure for gastro duodenal anastomosis using tissue apposition stenting and NOTES in human being. The secondary endpoints will be the clinical efficacy, the long term (1 year) patency of the anastomosis, the procedure duration, adverse events, morbidity and mortality, the quality of life and the length of stay.

In case of failure of the NOTES procedure, the patient will be treated either by surgery or by conventional endoscopy according to the usual techniques without loss of chance. The risk / benefit ratio appears positive and a safety report will be issued after the first 4 inclusions. There will be no supplementary examination in patient follow-up in this study for which a CT iconography and biology are enough. The material used in the context of this work is consistent with the legislation on medical devices and has received CE Mark (tissue apposition fully covered stent Axios ®).

lead_sponsor: Assistance Publique Hopitaux De Marseille


acronym: CAR-DIFF

summary:
An injury of haematosis in post ischemic chronic heart failure limits the clinic tolerance.

There is a correlation between injury of pulmonary diffusing, chronic heart failure intensity and aerobic physic ability evaluated by an heart-rate maximal exercise tolerance test (VO2 max). This injury is a new follow-up parameter of cardiac function for the adult.

The nature of damage (vascular or membrane) can be determined by the measure of double pulmonary diffusing capacity to carbon monoxide (CO) associated to nitric oxide (NO).

Today, in chronic heart failure consecutive to a congenital heart disease, there is no data on evolution of membrane and capillar factors.It is impossible to predict if membrane damage will be the best factor correlated to the VO2max in patients suffering from complex congenital heart disease.

Assessing these parameters could be an comparative evaluation of heart-rate exercise tolerance test with VO2max and an early control of his damage without risks related to heart-rate maximal exercise and independently of age, sex, hemoglobin, type of heart disease.These results would have an early prognostic value that would permit to refine the follow-up and the treatment.

The main objective of this trial is to assess the statistic correlation between the membrane injury of alveolar-capillary diffusing at rest and aerobic physic ability restriction in children and adults suffering from complex congenital heart disease.


title: Toxicity of Perirenal Fat in Overweight or Obese Subjects: A Pathophysiological Link Between Uric Acid Stones and Renal Ammonium Formation

summary:
Patients who are overweight or obese, diabetic or not, share with those who are suffering from uric stones the same way to remove abnormal acidity of the body in urine, ie a kidney ammoniogenesis default. This results in an overly acidic urine pH which is directly pathogenic in people predisposed to develop uric stones because the precipitation of urate soluble uric acid is accelerated in acid medium.

Excess visceral fat, particularly perirenal, this defect may promote formation of renal ammonium. Indeed, the perirenal fat is adjacent to the renal cortex and shares with it a common arterial supply via the plexus Turner. Adipokines and fatty acids of the perirenal fat are predisposed to gain the renal cortex, seat of the ammoniogenesis. In humans the pathogenic role of the perirenal fat is demonstrated in chronic kidney disease and essential hypertension. However, the amount of fat and perirenal that of intra-abdominal fat are positively correlated.

Investigators hypothesis is that the perirenal fat also exert a pathogenic role in uric because of anatomical links between kidney stones and greasy environment and because excess fatty acids reaching the renal cortex decreases ammoniogenesis in an animal model metabolic syndrome.

For the test, the investigators will compare the amount of fat and perirenal renal ability to form ammonium in patients with uric or calcium lithiasis taking into account the amount of intra-abdominal fat.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Transcriptomes Breast, Ovarian and Leukocyte Hereditary Genes Predisposing to Breast and / or Ovarian Cancer

acronym: CASOHAR

summary:
This is a case-control study of molecular diagnostics.

This study requires two steps:

The first part of the study will be conducted on a population of 20 women without breast cancer and, or ovarian family (Healthy Volunteers controls)
The second part of the study will be conducted on a population of 50 patients predisposed to familial breast and, or ovarian cancer compared to 20 controls .

For analysis of leucocytes of the patients, a blood sample collected in a prior study (EXSAL study, ID-RCB 2009-A00833-54) will be used.

lead_sponsor: Centre Francois Baclesse


title: Cognitive Training in Children With Attention Deficit Hyperactivity Disorder (ADHD)

summary:
ADHD is associated with cognitive deficit. Therefore, cognitive training is often proposed as an intervention for ADHD that targets cognitive deficits, with specific exercises through intensive training sessions. This intervention is based on principles of brain plasticity and cerebral functional reorganizations.

Working memory deficits constitute a key impairment in ADHD. That is why, Cogmed working memory training is the most commonly used and studied cognitive training program in clinical practice and research. It is clear from most studies that Cogmed training program increases working memory in ADHD. However, transfer of learning is not demonstrated on: other cognitive functions that are not targeted by the program, on ADHD symptoms, nor on academic achievement.

In addition to this type of intervention multi-factorial program targeting different cognitive function as Presco also exist but have been less studied.

To address these challenges, this study will follow a randomized and controlled design.

The main objective of this study is to examine the impact of cognitive training in comparison with a control waiting-list group among children with ADHD on:

ADHD symptoms,
cognitive functioning,
attentional capacities
academic achievement.

The second objective is to compare two types of cognitive training a unifactorial program Cogmed targeting working memory and a multifactorial Presco focusing on different cognitive functions affected by ADHD.

Long-term effects are examined six months after training. Participants (n=90) will be randomly assigned to the two experimental group (Cogmed or Presco) or to the control group waiting list. Participants will be evaluated three time (time 1) just before the intervention, (time 2) six weeks after the first evaluation, immediately after the intervention and (time 3) six months after the intervention.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: A Cohort Survey of Patients With Metastatic Colorectal Cancer Starting a Chemotherapy in Combination With Avastin®

acronym: CONCERT

summary: This is a longitudinal, multicenter, prospective, pharmacoepidemiological study to evaluate progression free survival (PFS) in a real-life setting in participants with metastatic colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab.

lead_sponsor: Hoffmann-La Roche


title: French Aspirin Study in Essential Thrombocythemia: an Open and Randomized Study

acronym: FAST

summary:
The hypothesis is that efficient prevention of thrombosis with aspirin at diagnosis becomes less useful once patients have achieved a hematologic response (HR) (modified by amendment 1/03/2017) and/or that this benefit is hampered by an increased hemorrhagic risk especially in elderly patients.

Hence, investigator propose a prospective randomized study to assess the benefit / risk ratio of aspirin maintenance in high risk Essential thrombocythemia (ET) patients, in hematological response (modified by amendment 1/03/2017) on Hydroxyurea.

ReferenceCitation: Alvarez-Larrán A, Pereira A, Arellano-Rodrigo E, Hernández-Boluda JC, Cervantes F, Besses C. Cytoreduction plus low-dose aspirin versus cytoreduction alone as primary prophylaxis of thrombosis in patients with high-risk essential thrombocythaemia: an observational study. Br J Haematol. 2013 Jun;161(6):865-71. doi: 10.1111/bjh.12321. Epub 2013 Apr 12.

ReferenceCitation: Barbui T, Barosi G, Birgegard G, Cervantes F, Finazzi G, Griesshammer M, Harrison C, Hasselbalch HC, Hehlmann R, Hoffman R, Kiladjian JJ, Kröger N, Mesa R, McMullin MF, Pardanani A, Passamonti F, Vannucchi AM, Reiter A, Silver RT, Verstovsek S, Tefferi A; European LeukemiaNet. Philadelphia-negative classical myeloproliferative neoplasms: critical concepts and management recommendations from European LeukemiaNet. J Clin Oncol. 2011 Feb 20;29(6):761-70. doi: 10.1200/JCO.2010.31.8436. Epub 2011 Jan 4.

ReferenceCitation: Barosi G, Birgegard G, Finazzi G, Griesshammer M, Harrison C, Hasselbalch HC, Kiladjian JJ, Lengfelder E, McMullin MF, Passamonti F, Reilly JT, Vannucchi AM, Barbui T. Response criteria for essential thrombocythemia and polycythemia vera: result of a European LeukemiaNet consensus conference. Blood. 2009 May 14;113(20):4829-33. doi: 10.1182/blood-2008-09-176818. Epub 2009 Mar 10.

ReferenceCitation: Barosi G, Mesa R, Finazzi G, Harrison C, Kiladjian JJ, Lengfelder E, McMullin MF, Passamonti F, Vannucchi AM, Besses C, Gisslinger H, Samuelsson J, Verstovsek S, Hoffman R, Pardanani A, Cervantes F, Tefferi A, Barbui T. Revised response criteria for polycythemia vera and essential thrombocythemia: an ELN and IWG-MRT consensus project. Blood. 2013 Jun 6;121(23):4778-81. doi: 10.1182/blood-2013-01-478891. Epub 2013 Apr 16.

ReferenceCitation: Barosi G, Birgegard G, Finazzi G, Griesshammer M, Harrison C, Hasselbalch H, Kiladijan JJ, Lengfelder E, Mesa R, Mc Mullin MF, Passamonti F, Reilly JT, Vannucchi AM, Barbui T. A unified definition of clinical resistance and intolerance to hydroxycarbamide in polycythaemia vera and primary myelofibrosis: results of a European LeukemiaNet (ELN) consensus process. Br J Haematol. 2010 Mar;148(6):961-3. doi: 10.1111/j.1365-2141.2009.08019.x. Epub 2009 Nov 23. Review.


title: Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis : Controlled Clinical Trial With Efficacy Assessment

summary:
Systemic sclerosis (SSc) is an auto-immune orphan disease mainly characterized by an alteration of the microvascular network, and by cutaneous and visceral fibrosis. Hands are frequently affected, as a consequence of ischemic phenomena and cutaneous fibrosis.

. The injection of adipose autologous tissue is a common practice in plastic surgery, and has been known for over a century. Adipose tissue, originally used to increase volume, is also characterized by trophic properties associated to stromal vascular fraction (SVF), which contain multipotent stem cells, capable of tissue repair. Interestingly, some SVF cells can be angiogenic and anti-inflammatory, which could improve damage seen with SSc.

A prior study (the SCLERADEC protocol: ClinicalTrials.gov NCT01813279) has already allowed the safety and tolerance at 6 months of the subcutaneous injection of SVF in the fingers of twelve patients to be proven.

The encouraging results have encouraged us to propose a trial which would bear on a higher number of patients and include a control group.

ReferenceCitation: Daumas A, Magalon J, Jouve E, Casanova D, Philandrianos C, Abellan Lopez M, Mallet S, Veran J, Auquit-Auckbur I, Farge D, Levesque H, Benhamou Y, Arnaud L, Giraudo L, Dumoulin C, Giverne C, Boyer O, Giuliani A, Bourgarel V, Harlé JR, Schleinitz N, Brunet J, Pers YM, Ferreira R, Cras A, Bocara D, Larghero J, Château J, Hot A, Dignat-George F, Magalon G, Sabatier F, Granel B. Adipose tissue-derived stromal vascular fraction for treating hands of patients with systemic sclerosis: a multicentre randomized trial. Rheumatology (Oxford). 2021 Jul 23. pii: keab584. doi: 10.1093/rheumatology/keab584. [Epub ahead of print]

name: Internal Medicine Department, Assistance Publique Hôpitaux de Marseille (AP-HM), MARSEILLE, FRANCE

name: Vascular Research Center Marseille, INSERM, INRA, Aix-Marseille University, MARSEILLE, FRANCE

family: Daumas

full_name: Aurélie Daumas

given: Aurélie

name: Culture and Cell Therapy Laboratory, INSERM CIC BT 1409, Assistance Publique Hôpitaux de Marseille (AP-HM), Aix-Marseille University, MARSEILLE, FRANCE

family: Magalon

full_name: Jérémy Magalon

given: Jérémy

name: Pharmacometry CIC- CPCET, Clinical Pharmacology and Pharmacovigilance Department, Assistance Publique Hôpitaux de Marseille (AP-HM), MARSEILLE, FRANCE

family: Jouve

full_name: Elisabeth Jouve

given: Elisabeth

name: Plastic Surgery Department, Assistance Publique Hôpitaux de Marseille (AP-HM), MARSEILLE, FRANCE

family: Casanova

full_name: Dominique Casanova

given: Dominique

family: Philandrianos

full_name: Cécile Philandrianos

family: Abellan Lopez

full_name: Maxime Abellan Lopez

given: Maxime

name: Department of Dermatology, Assistance Publique Hôpitaux de Marseille (AP-HM), MARSEILLE, FRANCE

family: Mallet

full_name: Stéphanie Mallet

given: Stéphanie

family: Veran

full_name: Julie Veran

given: Julie

name: Normandie Univ, UNIROUEN, INSERM, U1234, Rouen University Hospital, Department of Plastic, reconstructive and hand surgery, ROUEN, FRANCE

family: Auquit-Auckbur

full_name: Isabelle Auquit-Auckbur

given: Isabelle

name: Assistance Publique-Hôpitaux de Paris, Saint-Louis Hospital, Autoimmune and Vascular Disease Unit, Internal Medicine (UF04), Center of reference for rare systemic autoimmune diseases (FAI2R); Université de Paris, PARIS, EA, 3518, FRANCE

name: Department of Medicine, McGill University, Montreal, QC, CANADA

family: Farge

full_name: Dominique Farge

name: Department of Internal Medicine, Normandie Univ, UNIROUEN, INSERM U1096 EnVI, Rouen University Hospital, ROUEN, FRANCE

family: Levesque

full_name: Hervé Levesque

given: Hervé

family: Benhamou

full_name: Ygal Benhamou

given: Ygal

family: Arnaud

full_name: Laurent Arnaud

given: Laurent

family: Giraudo

full_name: Laurent Giraudo

family: Dumoulin

full_name: Chloé Dumoulin

given: Chloé

name: Normandie Univ, UNIROUEN, INSERM, U1234, Rouen University Hospital, Department of Immunology and Biotherapy, ROUEN, FRANCE

family: Giverne

full_name: Camille Giverne

given: Camille

family: Boyer

full_name: Olivier Boyer

given: Olivier

name: Health research department, Assistance Publique Hôpitaux de Marseille (AP-HM), MARSEILLE, FRANCE

family: Giuliani

full_name: Alexandra Giuliani

given: Alexandra

name: Cancer Research Center of Marseille (CRCM), INSERM UMR1068, CNRS UMR7258, Aix-Marseille University, MARSEILLE, France

family: Bourgarel

full_name: Véronique Bourgarel

given: Véronique

family: Harlé

full_name: Jean-Robert Harlé

given: Jean-Robert

family: Schleinitz

full_name: Nicolas Schleinitz

given: Nicolas

family: Brunet

full_name: Julie Brunet

name: Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, Department of Rheumatology, Lapeyronie University Hospital, MONTPELLIER, France

name: IRMB, University of Montpellier, INSERM U1183, CHU Montpellier, MONTPELLIER, France

family: Pers

full_name: Yves-Marie Pers

given: Yves-Marie

name: Assistance Publique—Hôpitaux de Paris, Hôpital Saint-Louis, Unité de Thérapie Cellulaire, PARIS, France

name: INSERM U976 et CIC de Biothérapies CBT501, Université de Paris, PARIS, France

name: Department of Plastic, Reconstructive, and Esthetic Surgery, Saint Louis Hospital, Paris; Paris Diderot University, Sorbonne, Paris, France

name: INSERM UMR1140 et CIC de Biothérapies CBT501, Université de Paris, PARIS, France

name: Department of Hand Surgery ICMMS, Medipole Hospital Lyon Villeurbanne; Department of plastic, reconstructive and aesthetic surgery, Hospital Jean Mermoz Lyon; CRIOac Lyon, Regional Reference center for the management of complex bone and joint infection, Hospices Civils de Lyon, LYON, France

name: Service de Médecine Interne, Hôpital Edouard Herriot, LYON, F-69003, France

name: Hematology and Vascular Biology Laboratory, Assistance Publique Hôpitaux de Marseille (AP-HM), Aix-Marseille University, FRANCE


title: Assessing the Impact of Clown Therapy in a Palliative Care Unit: A Prospective, Descriptive Study

acronym: OUPS

summary: The main objective of this study was to assess changes in the quality of life of patients in a Palliative Care Unit via the symptoms by the Edmonton Symptom Assessment System (ESAS) before and one hour after the passage of a clown therapist .

primary_purpose: Supportive Care


title: Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment (Prednisone 5 Milligram Per Day) in Quiescent Systemic Lupus

acronym: CORTICOLUP

summary: Systemic Lupus (SLE) is a chronic disease for which long term treatments are warranted. The aim of this study was to study the possibility of corticosteroids interruption in patients with quiescent SLE treated since at least one year with 5 milligrams of predonisone per day.

ReferenceCitation: Mathian A, Pha M, Haroche J, Cohen-Aubart F, Hié M, Pineton de Chambrun M, Boutin THD, Miyara M, Gorochov G, Yssel H, Cherin P, Devilliers H, Amoura Z. Withdrawal of low-dose prednisone in SLE patients with a clinically quiescent disease for more than 1 year: a randomised clinical trial. Ann Rheum Dis. 2020 Mar;79(3):339-346. doi: 10.1136/annrheumdis-2019-216303. Epub 2019 Dec 18.

family: Mathian

full_name: Alexis Mathian

given: Alexis

family: Pha

full_name: Micheline Pha

given: Micheline

family: Haroche

full_name: Julien Haroche

given: Julien

family: Cohen-Aubart

full_name: Fleur Cohen-Aubart

given: Fleur

family: Hié

full_name: Miguel Hié

given: Miguel

family: Pineton de Chambrun

full_name: Marc Pineton de Chambrun

given: Marc

family: Boutin

full_name: Thi Huong Du Boutin

given: Thi Huong Du

family: Miyara

full_name: Makoto Miyara

given: Makoto

family: Gorochov

full_name: Guy Gorochov

given: Guy

family: Yssel

full_name: Hans Yssel

given: Hans

family: Cherin

full_name: Patrick Cherin

given: Patrick

family: Devilliers

full_name: Hervé Devilliers

family: Amoura

full_name: Zahir Amoura

given: Zahir

journal_name: Annals of the Rheumatic Diseases

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: Groupe Hospitalier Pitié Salpêtrière, Service de médecine Interne 2, Institut e3m


title: Clinical and Medico-economic Evaluation of Radiofrequency Ablation Versus Oesophagectomy in the Treatment of High Grade Dysplasia in Barrett's Oesophagus

acronym: HARMONI

summary:
First intent treatment for superficial circular esophageal neoplasm is surgical resection. Endoscopic mucosal resection is not recommended due to the high rate of subsequent esophageal stenosis (higher than 80%).

Surgical limits are related to a high level of morbidity due, in particular, to respiratory complications or infections that require prolonged hospitalisations, and by significant rate of mortality (from 2 to 5 %). As an alternative to the surgical treatment, an innovative technique to remove esophageal circular preneoplastic and neoplastic lesions has been developed: it consists to ablate the mucosa by means of a balloon of a fixed diameter which incorporates approximately 100 electrodes on its surface that emit radiofrequency waves (HALO® Radiofrequency Ablation Technology System). By varying the strength and the duration of the electrical impulses, it is possible to obtain a homogenous and controlled destruction of the tissue of the whole mucosa, leaving no remaining pre-neoplastic or neoplastic elements underneath. The technique will be used for high grade glandular epithelial neoplasia, Vienna 4-1 or 4-2, developed on a mucosa at risk, i.e. the Barrett's oesophagus, occupying more than half of the circumference of the esophagus and that requires surgical treatment. The expected benefit for the patient is linked to the reduced invasiveness of the technique in comparison to the surgery

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon, Hépatogastroentérologie, Pavillon H, Hôpital Edouard Herriot


title: Quantification of Cerebral Blood Flow by Arterial Spin Labeling in the Screening and Monitoring of Vasospasm in Subarachnoid Haemorrhage

acronym: ASL-HSA

summary: A technique of MRI infusion -l'Arterial Spin Labeling-, non-invasive and non-irradiating, repeatable over time, appears promising in the field. This sequence allows for routine, generate perfusion maps relating to the entire brain volume


title: Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis

summary: In patients with asymptomatic aortic stenosis (AS), the prognostic value of reduced left ventricular (LV) ejection fraction is well known. Consequently, there is class I indication for surgery in these patients when LV ejection fraction <50%. However, there is growing evidences suggesting that subclinical LV dysfunction, and more particularly longitudinal myocardial dysfunction, may be a powerful early predictor of outcome, even when LV ejection is still preserved. In asymptomatic AS patients with LV ejection fraction >50%, a reduced LV global longitudinal strain, as assessed using speckle tracking imaging with transthoracic echocardiography, may be an accurate marker to identify early subclinical LV dysfunction and thus, to improve the risk stratification, the management and the timing of surgery. Several mono-centric observational small studies recently reported results emphasizing the role of LV global longitudinal strain in AS patients. Therefore, a meta-analysis may be conducted and may provide meaningful data. The investigators hypothesized that LV global longitudinal strain is a determinant of outcome in asymptomatic patients with AS and preserved LV ejection fraction.

time_perspective: Retrospective

lead_sponsor: European Association of Cardiovascular Imaging


title: Identification of Early Semantic Markers of Alzheimer's Disease by Using Eye Tracking in Reading Neutral and Predictable Sentences

acronym: ADAL

summary: The objective of this study is to identify early and accurate semantics markers of Alzheimer's disease (AD) by using two types of methods. First, the investigator will evaluate semantic processing of patients with AD or related disorders which will be compared to age matched controls by taking neuropsychological tests. Then, the investigator will analyze the effect of contextual word predictability on eye movements in reading sentences with the help of the same participants by using an eye tracker. Both of these methods will be used twice with a time interval of 6 months.


title: Immunization Anti HLA in the Liver Transplant Recipients (DSATH)

acronym: DSATH

summary:
Anti HLA alloimmunization against the donor evaluated by the detection of anti-donor specific antibodies (DSA) is an underestimated factor in liver transplantation and may contribute to dysfunction and graft loss , especially among candidates for retransplantation, that have major immunization.

This study will analyzed immunization markers at the time of liver retransplantation and systematically in patients follow-up. This will allow to characterize the histological lesions due to humoral immunization, to establish further investigations and to adapt early immunosuppressive therapy.

location_facility: Unité Médicale de Transplantation Hépatique In Service d'Hépato-Gastro-Entérologie


title: Multicenter Randomized Double-blind Study Comparing the Efficacy and Safety of Rituximab in Combination With Corticosteroids to Corticosteroids Plus Placebo in the Treatment of Non-infectious Active Mixed Cryoglobulinemia Vasculitis

acronym: ESBAM

summary: Multicenter randomized double-blind study comparing the efficacy and safety of rituximab in combination with corticosteroids to corticosteroids plus placebo in the treatment of non-infectious active mixed cryoglobulinemia vasculitis.


title: Effect in the Short and Medium Term of Different Techniques of Tactile Stimulations on Neurological Development in a Population of Very Preterm Infants

summary:
Premature birth deprives infants of sensory stimulation. Tactile stimulation such as massage pressure with kinesthetic movement significantly increases the weight, bone density and shorten the duration of stay of premature babies who benefits.

Studies using vegetable oils show an increase in the effect on weight gain by cutaneous absorption. The mechanism is probably vagal (stimulation of baroreceptors and skin mechanoreceptors) since it is found in children stimulated an increase in the vagal activity, acceleration of gastric emptying and an increase in the secretion of insulin and IGF1.

Few studies have evaluated the effects of massage on the medium-term neurological development in preterm infants and the effect of the essential oils in the effectiveness of touching the short and medium term massage.

The aim of the investigators study is to evaluate the neurological development in the short and medium term in premature newborns and biological effects of massage with essential use of vegetable oil.

Methodology and possible collaborations This is a monocentric, randomized, controlled, in a neonatal intensive care unit. It concerns 60 children born between 26 and 30 weeks of amenorrhea. Each child receives massage randomized with or without oil ISIO 4. The treatment is administered 10 minutes twice a day for 10 consecutive days watching for signs of intolerance. The quality of the spontaneous motility between 12 and 20 weeks of age corrected is used as the first neurological assessment criterion.

The questionnaire (ASQ) Bricker and Squires (translated into French by Martha Bonin et al.) is used to 6, 12, 24 months corrected age and completed by the parents as a second neurological endpoint.

A lipid chromatography is performed at the beginning and at the end of the massage time and at the deliverance from NICU for comparing the profile of children's fatty acids.

Expected results Show that there is an improvement in the neurological development in children who received massage with vegetable oil ISIO 4. Show that there is a skin absorption of essential fatty acids that can substitute for a known major deficiency in premature even in infants fed breast milk.


title: In Vivo Endomicroscopic Description of Pulmonary Microcirculation in Systemic Sclerosis and Emphysema Patients

acronym: MiPECSE

summary:
Systemic sclerosis (SSc) is a generalized disorder of connective tissue, arterioles and microvessels, characterized by the occurrence of fibrosis and vascular obliteration phenomena. The alterations in lung microvessels are found in pulmonary involvement of scleroderma, which are the most serious complications of the disease.

In pulmonary emphysema, there are also changes in pulmonary microvasculature, which are involved in the onset and development of the disease.

The confocal endomicroscopy is an endoscopic technique which can be performed during a bronchoscopy. This technique makes it possible to observe in real time the most distal pulmonary elements at the microscopic scale. After injection of fluorescein, then the technique of observing the pulmonary microvasculature, in vivo and in situ.

The characterization of microvascular lesions in these two pathologies could improve understanding of their mechanisms and ultimately improve the early management of patients.

lead_sponsor: University Hospital, Rouen


title: Predicted Level of General Anaesthesia in Hip Fracture Surgery

acronym: NAPfem

summary: The purpose of this study is to evaluate if prediction of general anaesthesia level by the Smartpilot® View device can improve the quality of anaesthesia in patients undergoing hip fracture surgery.

ReferenceType: result

ReferenceCitation: Leblanc D, Conté M, Masson G, Richard F, Jeanneteau A, Bouhours G, Chrétien JM, Rony L, Rineau E, Lasocki S. SmartPilot® view-guided anaesthesia improves postoperative outcomes in hip fracture surgery: a randomized blinded controlled study. Br J Anaesth. 2017 Nov 1;119(5):1022-1029. doi: 10.1093/bja/aex317.

family: Leblanc

full_name: D. Leblanc

given: D.

family: Conté

full_name: M. Conté

given: M.

family: Masson

full_name: G. Masson

given: G.

family: Richard

full_name: F. Richard

given: F.

family: Jeanneteau

full_name: A. Jeanneteau

given: A.

family: Bouhours

full_name: G. Bouhours

family: Chrétien

full_name: J.M. Chrétien

family: Rony

full_name: L. Rony

given: L.

family: Rineau

full_name: E. Rineau

given: E.

family: Lasocki

full_name: S. Lasocki

given: S.

journal_name: British Journal of Anaesthesia

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific


title: Consequences of DNA Repair and Telomere Defects on the Function of the Immune System: Application to CVID and Immune Deficiencies With Dysmorphic Syndromes

acronym: IMMUNEREP

summary:
The molecular mechanisms participating in the various aspects of the DNA Damage Response (DDR) are absolutely essential to maintain the genome dynamics essential to all living organisms. The most commonly studied consequence of faulty DDR is genome instability participating in cancer onset. In the present proposal, we wish to explore another aspect of DDR, not relevant to cancer, which is its absolute requirement at several key steps of the development, maturation, and function of the immune system.

The most "spectacular" consequences of faulty DNA repair processes with respect to the immuno-hematopoietic tissue are the complete block of B and T lymphocytes maturation owing to defective DNA joining phase during V(D)J recombination resulting in patients with Severe Combined Immune Deficiency (SCID).

The objectives of this study are to increase our knowledge on the role of the various DNA repair processes in the development, the maintenance, and the function of the immune system and thus, to better understand why and how dysfunctions of these DNA repair processes result in human severe conditions such as CVID, LOCID or other manifestations of immune disorders such as autoimmunity.

The explorations of DNA repair mechanisms in the patients will allow us to establish the genetic diagnosis in some patients with until now undefined molecular diagnosis. This is of immediate importance for the patients and their families, as it not only contributes to a better understanding of the patients' condition, but also allows providing genetic counseling for the families.


title: Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs

acronym: VIRIDAE

summary: A recent study has shown that certain drug allergies were actually related to an immune system against certain viruses. The aim of the study is to evaluate, in patients taking antiepileptic drugs, if this treatment induces proliferation of these viruses and secondarily an immune response that would promote the development of a rash. In particular, will be studied whether these drugs can induce virus reactivation "dormant" in the immune system. This study will not affect the usual follow-up proposed by investigators, with the exception of some additional blood samples.


title: Premature Labour Screening by Cervical Ultrasound for Asymptomatic Pregnant Women in the PACA Region. Various Treatment Strategies : 1. Progesterone 200mg (Vaginal Way) 2. Pessary 3. Vaginal Stitching 4. Rest

acronym: Echo-col

summary:
State of the question and research objective: International trials have shown that ultrasound measurement of the cervix identifies a population at high risk of preterm delivery. In case of short neck several types of treatments can be recommended: progesterone, the establishment of a strapping or pessary. These three treatments reduce the risk of preterm delivery. There is no French study.

The objective of this study is to reduce prematurity in the PACA region Monaco-Corsica by introducing a routine ultrasound screening strategy asymptomatic short necks.

Population concerned: All patients with active singleton pregnancy between 16 and 26 SA SA are eligible to ultrasound of the cervix.

Primary endpoint: delivery rate before 37 weeks.
Criteria secondary judgments rate of deliveries before 37 weeks, neonatal mortality morbidity.

Expected result: a prematurity of 50%


acronym: ALINEA

location_facility: Hospices Civils de Lyon / Hopital de la Croix Rousse

source: euctr

title: Phase II Study Evaluating the Efficacy of Aflibercept for the Treatment of Inflammatory Choroidal Neovascularization (CNV) in Young Patients.

summary:
Inflammatory choroidal neovascularization (InCNV) is the third cause of CNV after myopia and Age-related Macular Degeneration (AMD). InCNV is a rare but severe disease and its treatment should not be delayed.

InCNV is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor) therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently indicated in AMD. Case reports suggest that such patients would not need as many injections as in AMD.

ALINEA is an open-label, single arm, prospective, multicenter, phase II study. The main objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment with aflibercept on the visual acuity of patients affected by InCNV. A specific dosage regimen is designed to achieve maximum efficiency. The patients are followed on a monthly basis until 52 weeks. The first injection is mandatory. The other ones are injected only in case of active InCNV.


title: Comparative Evaluation of Two Techniques for the Treatment of Per-operative Bacteriological Samples Associated With Osteo-articular Sepsis: Grinding (Ultra Turrax) Versus Standard Methods

acronym: IOAP Turrax

summary: The main objective of this study was to compare the diagnostic capability (sensitivity and specificity) of standard bacteriological analysis made from one or other of the two sampling processing techniques and perioperative management of samples : the Ultra Turrax method that uses grinding versus the standard method.

intervention_type: Biological


title: Validation of the French Version of the London Chest Activity of Daily Living Scale (LCADL) and the Dyspnea-12 Questionnaire

acronym: LCADL

summary: The main objective of this study is to develop and to validate a French version of the London Chest Activity of Daily Living (LCADL) and the Dyspnea 12 and to determine the reliability of this version for the evaluation of the dyspnea in the Activity of Daily Living in COPD patients (stages severe and very severe).

lead_sponsor: University Hospital, Brest


title: Exploration du système Des Neurones-miroirs Par Enregistrement EEG du Rythme mu Chez l'Enfant Atteint de lésion cérébrale unilatérale Lors d'Action, d'Observation et d'Imagination d'Action du Membre supérieur. " Action-Observation-EEG "

acronym: AOE

summary: To study the reactivity of the mu rhythm during action and action-observation by EEG in children with unilateral cerebral injury.


title: Curative Potential of Liver Transplantation in Patients With Definitively Unresectable Colorectal Liver Metastases (CLM) Treated by Chemotherapy: a Prospective Multicentric Randomized Trial

acronym: TRANSMET

summary: This is a multicentric randomized parallel group open trial comparing 5-year survival of chemotherapy followed by LT (Group LT+C) versus chemotherapy alone (Group C) in patients with confirmed unresectable liver-only metastases, well controlled by chemotherapy (no progression) and extensively explored by modern imaging techniques. The primary objective of the trial is to validate in a large multicentric cohort of selected patients the possibility to obtain at least 50% 5-years survival with LT combined to chemotherapy compared to around 10% with chemotherapy alone.

status: Active, not recruiting


title: Phase IA/IB of Metronomic Chemotherapy Based on Adaptative Bio-mathematical Model of Oral Vinorelbine in Patients With Non Small Cell Lung Cancer or Malignant Pleural Mesothelioma

acronym: NVB Metro

summary:
Background: Metronomic oral Vinorelbine has efficacy in metastatic NSCLC and malignant Pleural Mesothelioma, but all the studies published thus far were based upon a variety of empirical and possibly suboptimal schedules, with inconsistent results. Mathematical modeling showed by simulation that a new metronomic protocol could lead to a better safety and efficacy profile.

Design: This phase Ia/Ib trial was designed to confirm safety (phase Ia) and evaluate efficacy (phase Ib) of a new metronomic oral vinorelbine schedule. Patient with metastatic NSCLC or malignant Pleural Mesothelioma, after failure of standard treatments, ECOG 0-2 and an adequate organ functions, will be eligible. Our mathematical PK-PD model suggested an alternative weekly D1, D2 and D4 innovative schedule (named Vinorelbine Theoretical Protocol) with a dynamic intake of 60, 30 and 60 mg, respectively. Trial recruitment is two-staged as 12 patients are planned to participate in the phase Ia, to confirm safety and consolidate the calibration of the average parameters of the model. Depending the phase Ia result, and after favorable decision of a consultative committee, the extension phase (phase Ib) will be an efficacy study and will include a number of 20 patients receiving the Optimal Vinorelbine Theoretical Protocol. The primary endpoint is the tolerance (assessed by CTC v4.0) for the phase Ia and the objective response according to RECIST 1.1 for the phase Ib.

An ancillary study on circulating angiogenesis biomarkers will be a subproject of the trial.

Discussion: this ongoing trial is the first to prospectively test a mathematical optimized schedule in metronomic chemotherapy. As such, this trial can be considered as a proof-of-concept study demonstrating the feasibility to run a computational-driven protocol to ensure an optimal efficacy/toxicity balance in patients with cancer.

ReferenceCitation: Barlesi F, Imbs DC, Tomasini P, Greillier L, Galloux M, Testot-Ferry A, Garcia M, Elharrar X, Pelletier A, André N, Mascaux C, Lacarelle B, Cheikh RE, Serre R, Ciccolini J, Barbolosi D. Mathematical modeling for Phase I cancer trials: A study of metronomic vinorelbine for advanced non-small cell lung cancer (NSCLC) and mesothelioma patients. Oncotarget. 2017 Jul 18;8(29):47161-47166. doi: 10.18632/oncotarget.17562.

name: Aix Marseille University, APHM, Marseille Early Phases Cancer Trials Center CLIP, Marseille, France

name: Aix Marseille University, SMARTc Unit, INSERM U911, Marseille, France

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Imbs

full_name: Diane-Charlotte Imbs

given: Diane-Charlotte

family: Tomasini

full_name: Pascale Tomasini

given: Pascale

family: Greillier

full_name: Laurent Greillier

given: Laurent

family: Galloux

full_name: Melissa Galloux

given: Melissa

family: Testot-Ferry

full_name: Albane Testot-Ferry

given: Albane

name: Aix Marseille University, APHM, Department of Pharmacology, Marseille, France

family: Garcia

full_name: Mélanie Garcia

given: Mélanie

family: Elharrar

full_name: Xavier Elharrar

given: Xavier

family: Pelletier

full_name: Annick Pelletier

given: Annick

name: Aix Marseille University, APHM, Department of Pediatric Hematology and Oncology, Marseille, France

family: André

full_name: Nicolas André

given: Nicolas

family: Mascaux

full_name: Céline Mascaux

given: Céline

family: Lacarelle

full_name: Bruno Lacarelle

given: Bruno

family: Cheikh

full_name: Raouf El Cheikh

given: Raouf El

family: Serre

full_name: Raphaël Serre

given: Raphaël

family: Ciccolini

full_name: Joseph Ciccolini

given: Joseph

family: Barbolosi

full_name: Dominique Barbolosi

given: Dominique

journal_name: Oncotarget

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Impact Journals, LLC

publisher_dissemination: Impact Journals, LLC

location_facility: Assistance Publique des Hôpitaux de Marseille (CEPCM)


title: How to Act on the Mobility Restriction Linked to Senior's Phobia of Falling

acronym: PACTE

summary: This project aims to determine the respective impacts of two routine care regarding phobic of falling seniors on the mobility restriction. The investigators used a monocentric, randomized and controlled research according to two parallel groups : physical activity, home assessment and modification (rehabilitation group) versus physical activity, home assessment and modification with cognitive behavioral therapy (CBT) (rehabilitation and CBT group). The investigators will assess the efficacy of usual care (rehabilitation group) and the supplementary benefit of CBT (rehabilitation and CBT group) with the Life Space Assessment.


title: Psychoeducational Programme for Patients With Parkinson's Disease Undergoing Subthalamic Deep Brain Stimulation

acronym: PSYCHE

summary: Bilateral subthalamic deep-brain stimulation is a well-established therapeutic option to improve motor signs and reduce dopaminergic treatment and related motor complications in patients with severe forms of Parkinson's disease (PD). However, psychological disorders and socio-familial maladjustment are less clearly improved with subthalamic stimulation with an aggravation of the social adjustment described in about 1/3 of cases, with work disruption, divorce or familial conflict. The caregivers have also been reported to present negative well-being after surgery with an aggravation of the quality of life. In the present study, the investigators evaluate the effects of a perioperative psychoeducational programme to avoid postoperative socio-familial maladjustment in PD patients candidate for subthalamic stimulation, and their caregivers, in a randomized controlled study.


title: Recherche et Mesure d'Anomalies précoces de la Marche au Cours Des Troubles du Comportement en Sommeil Paradoxal Idiopathiques

summary:
Many people with idiopathic rapid eye movement (REM) sleep behavior disorder (RBD) have an underlying synucleinopathy, the most common of which are Parkinson's disease (PD) and Lewy body disease. Identifying additional abnormal clinical features may help in identifying those at greater risk of evolving to a more severe syndrome. Because gait disorders are common in the synucleinopathies, early abnormalities in gait in those with RBD could help in identifying those at increased risk of developing overt parkinsonism and/or cognitive impairment.

The investigators aim to identify subtle gait abnormalities in idiopathic RBD and to identify sensitive and early biomarkers:

to detect subtle gait disorders in pre-symptomatic stage of synucleinopathy and
to track their evolution in the parallel with the disease progression.

Main objective: In comparison with age and gender matched-controls, to identify in patients with RBD a larger reduction of gait velocity (and other abnormalities of spatio-temporal characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task).

Secondary objective:

In comparison with age and gender matched-PD patients, to identify in patients with RBD a smaller reduction of gait velocity (and other abnormalities of spatio-temporal characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task).
In patients with RBD to identify correlations between the spatio-temporal characteristics modifications of gait between a single (gait) and a dual-task (gait+cognitive task) and the percentage of REM without atonia - the dopamine transporter (DAT) density using FP-CIT single-photon emission computed tomography; the reduction of the olfactory discrimination and thresholds.
In patients with RBD to track the spatio-temporal characteristics evolution of gait over time (every 6 months for 2 years)

lead_sponsor: University Hospital, Montpellier