title: Randomized Assay Evaluating the Risk/Benefit of Early Versus Late Resumption of Anticoagulation in Patients With Major, Non-trauma Related Hemorrhage Occurring While on Anticoagulant Treatment for a High Risk of Thrombosis.

acronym: RATHER

summary:
In patients with a high thromboembolic risk, withdrawing anticoagulant treatment is recommended in some situations, including when major hæmorrhage occurs. But withdrawing treatment can be risky. In patients on a curative dose of anticoagulant medicine, treatment withdrawal heightens the risk of thromboembolic events occurring, with potentially major consequences. For instance, mechanical valve thrombosis is fatal in 15% of patients. Resumption of anticoagulation is therefore critical in patients at high risk for thromboembolic events.

However, in these patients having presented major hæmorrhage, resumption of anticoagulation heightens the risk of hæmorrhage recurrence. This risk is even higher when the original hæmorrhage was not accessible via surgical, endoscopic or endoluminal hemostasis.

As far as investigators know, there is no data in the literature to rely on when the major hæmorrhage is not accessible via hemostatic intervention and the risk of thrombosis is high. When confronted with patients who need anticoagulation but have a high risk of hæmorrhage recurrence, the question of when treatment should be resumed has not been resolved. This is why investigators propose to conduct a randomised comparative study to evaluate two treatment strategies - early resumption (H48 to H72) versus late resumption (H120 to H144) of anticoagulation.

MAIN OBJECTIVE: The main objective of the present study is to evaluate in terms of bleeding risk, thrombosis risk and mortality at one month, the effect of early vs. late resumption of anticoagulation in patients having presented with serious hæmorrhage while on curative-dose anticoagulants and facing a high thromboembolic risk.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service d'Urgences et de Réanimation Medicale, CHU de Saint-Etienne


title: Effectiveness of Silodosin in Medical Expulsive Therapy for Ureteral Pelvic Stone From 4 to 10 mm.

acronym: SiloMET

summary:
In the diagnosis of renal colic gallstone , in addition to clinical and biological factors, it is a key : medical imaging. Currently , the French recommendations require at least a couple of Abdomen radiography Without Preparation lying face (ASP ) associated with abdominal ultrasound . "The abdominopelvic CT scan without injection of contrast is the examination of choice.

Current recommendations in the management of gallstone colic simply based on the joint use of analgesics , anti inflammatory drugs and control of water intake .

The mechanism of analgesic action of this treatment is a decrease in the pressure in the cavities by decrease in diuresis and inflammation treatment of ureteral permitting passage of urine . )

The expulsive medical therapy remains under evaluation. The French Association of Urology does not recommend at this time for lack of evidence deemed sufficient.

For foreign companies Urology (EAU , AUA) , the use of calcium channel blockers or alpha blockers in the treatment of symptomatic lower ureteral stones (4 to 10mm ) is recommended (grade 1A) . However, there are less formal studies of their effectiveness .

Investigators wish to demonstrate the effectiveness of alpha in medical expulsive therapy for pelvic stones 4 to 10mm .

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
Centre hospitalier départemental Vendée
CH Loire Vendée Océan

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


title: Bicentric, Open and Pilot Study Evaluating the Efficiency and the Tolerance of the Photodynamic Therapy in the Treatment of Epidermal Dysplasia for Patients Affected by Hereditary Dystrophic Epidermolysis Bullosa

summary:
The hereditary dystrophic epidermolysis bullosa are genodermatosis responsible of a poor adhesion of the epidermis to the dermis pulling a large mucocutaneous fragility and recurrent spontaneous or posttraumatic bullous detachment. They are caused by mutations in the COL7A1 gene encoding for the collagen VII.

No curative treatment is avaible. The main cause of patients death is the development of squamous cell carcinoma, sometimes multiple and paticularly aggressive in repeated healing part. The photodynamic therapy (PDT) is one of technical reference of multiple actinic keratoses lesions for adults, which are also pre-epithelioma lesions. The PDT is well tolerated even by the elderly and requires only a single session.

The main objective of this study is to determine the efficiency of the photodynamic therapy in the treatment of epidermic dysplasies for patients affected by dystrophic epidermolysis bullosa (DEB). The secondary objectives are to evaluate the tolerance of this treatment in terms of pain and healing, and to evaluate the contribution of confocal microscopy in the diagnosis of epidermal dysplasia for patients affected by hereditary dystrophic epidermolysis bullosa. The main evaluation criterion is the cutaneous biopsy before and after (M2) a PDT session of an epidermal dysplasia area. The secondary criteria are the evaluation of the pain during the PDT session and the healing of the cutaneous lesion at M0, M2 and M4 (lesion area and healing time) and correlation histology / MC. Each patient with a suspicious lesion will be biopsied. In case of agreement for this protocol, there will be 1 PDT session followed by a consultation of control at 2 and 4 months after the end of treatment.

status: Withdrawn

study_completion_date_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Nice University Hospital
Saint Louis Hospital

intervention_type: Procedure


title: Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation

summary:
Study is intended to evaluate the one-year safety and clinical status of patients treated for symptomatic uterine fibroids with the VizAblate Intrauterine-ultrasound guided radio frequency (RF) ablation system. Particular attention will be directed to recording safety outcomes including incidence of uterine cavity synechiae. In addition, information on quality of life will be collected.

Overall study duration (first patient enrolled through last patient exit) will be comprised of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment, and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an individual patient, once enrolled, will be approximately 1 month for baseline observations and treatment scheduling, and 12 months for follow up after treatment for a total duration of approximately 13 months.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Gynesonics

location_facility: Le Centre Hospitalier Regional et Universitaire de Tours - Hôpital Bretonneau

location_facility: Assistance Publique Hôpitaux de Paris - Hôpital Bicêtre

intervention_type: Device

lead_sponsor_type: industriel


title: Validation of a New TSH Test for Early Screening of Hypothyroidism

summary:
The aim of this research project, which is realised with the partnership of the enterprise Siamed'Xpress (Marseille), is to validate a new TSH diagnostic test in vitro, to allow an earlier screening of hypothyroidism. A serum bank will be conserved in the "Centre de Biologie Sud" ("Groupement Hospitalier Lyon Sud").

The serum samples will be assayed locally for the usual medical support to patients and after they will be sent to Siamed'Xpress (Marseille), where they will be assayed with the new diagnostic test. The results obtained from the two techniques will be compared.

The validation of this new TSH test represents a major advancement, since it could bring in the future to a therapeutic index which will allow clinicians to treat earlier asymptomatic patients with subclinical hypothyroidism.

study_start_date_type: Actual

status: Completed

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: Hospices Civils de Lyon

location_facility:
Centre Hospitalier de Chambéry
Centre Hospitalier Lyon Sud

intervention_type: Other

status_simplified: Completed


title: Influence of Hyperoxia and Hypergravity on Pulmonary Ventilation and Perfusion

summary: The primary aim of this project is to get further knowledge on the effects of + Gz accelerations and hyperoxia on lung ventilation in humans. The secondary aim is to study lung perfusion and cardiovascular function in these conditions.

primary_purpose: Basic Science

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Armed Forces Biomedical Research Institute

location_facility: Department of Nuclear Medicine, Val-de-Grâce hospital


title: Neuropsychomotor Functions in Children With Autism Spectrum Disorder

summary: The aim of the study is to describe the feasibility of the passation of the assessment battery of psychomotor functions tests (NP-MOT) in children aged 4 to 11 years with a diagnosis of autism spectrum disorder: number and type of evaluable events, number and type of tests with a deficit compared to the standard results.

status: Unknown status

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Lasserre E, Vaivre-Douret L, Abadie V. Psychomotor and cognitive impairments of children with CHARGE syndrome: common and variable features. Child Neuropsychol. 2013 Sep;19(5):449-65. doi: 10.1080/09297049.2012.690372. Epub 2012 Jun 14.

lead_sponsor: Centre Hospitalier Esquirol

location_facility:
Centre de Ressources Autisme Limousin
Centre Hospitalier esquirol

intervention_type: Behavioral


title: Impact of Manual Lymphatic Drainage on Postoperative Edema of the Face and the Neck After Orthognathic Surgery.Open-label Multicenter Randomized Controlled Trial

acronym: DLMOF

summary:
Orthognathic surgery aims to standardize position of the maxilla and the mandible and therefore chewing, breathing, phonation and swallowing functions. In postoperative, several physical and functional consequences are observed in patients: transient edema of the face, maxillo-mandibular blocking (causing difficulties to eat and occasional weight loss), pain and sensory disturbances (labial or/and chin paresthesias).

Achieving sessions of manual lymphatic drainage by physiotherapist may allow faster decrease of postoperative edema, improved postoperative comfort and mental well-being.

The main objective of this study is to evaluate the efficacy of sessions of manual lymphatic drainage to reduce postoperative edema.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Tours

location_facility:
UH Tours
UH Montpellier


summary: Colorectal cancer (CRC) is the third of the most common cancers and the second leading cause of cancer death in western countries. CRC is diagnosed at metastatic stage in approximately 35% of cases, while about 20% to 50% of patients diagnosed at earlier stage (stage II and III) will develop distant metastasis subsequently. Treatment efficacy is usually evaluated by computer tomography (CT) scan with RECIST criteria and dosage of carcinoembryonic antigen (CEA) and carbohydrate antigen (CA) 19-9, which were performed every two weeks during the chemotherapy. The management of treatment for metastatic CRC need the development of early biomarkers to evaluate the efficacy in order to avoid unnecessary toxicity in case of early chemotherapy resistance. In this prospective study, the investigators will compare the monitoring of circulating tumor DNA with the results of CT scan according the RECIST criteria and the blood level of CEA and CA 19-9. The investigators carried out a microfluidic digital polymerase-chain-reaction (PCR) assay to measure the specific somatic genomic alterations in plasma to identify the circulating tumor DNA.

ReferenceType: derived

ReferenceCitation: Unseld M, Belic J, Pierer K, Zhou Q, Moser T, Bauer R, Piringer G, Gerger A, Siebenhüner A, Speicher M, Heitzer E, Prager GW. A higher ctDNA fraction decreases survival in regorafenib-treated metastatic colorectal cancer patients. Results from the regorafenib's liquid biopsy translational biomarker phase II pilot study. Int J Cancer. 2021 Mar 15;148(6):1452-1461. doi: 10.1002/ijc.33303. Epub 2020 Oct 16.

name: Department of Medicine I, Division of Palliative Medicine Medical University of Vienna  Vienna Austria

family: Unseld

full_name: Matthias Unseld

given: Matthias

sequence: first

name: Institute of Human Genetics, Diagnostic and Research Center for Molecular BioMedicine Medical University of Graz  Graz Austria

family: Belic

full_name: Jelena Belic

given: Jelena

sequence: additional

name: Christian Doppler Laboratory for Liquid Biopsies for Early Detection of Cancer  Graz Austria

family: Pierer

full_name: Kerstin Pierer

given: Kerstin

family: Zhou

full_name: Qing Zhou

given: Qing

family: Moser

full_name: Tina Moser

given: Tina

name: Center for Pathobiochemistry and Genetics Institute of Medical Chemistry, Medical University of Vienna  Vienna Austria

family: Bauer

full_name: Raimund Bauer

given: Raimund

name: Klinikum Wels‐Grieskirchen  Wels Austria

family: Piringer

full_name: Gudrun Piringer

given: Gudrun

name: Department of Internal Medicine, Division of Oncology Medical University of Graz  Austria

family: Gerger

full_name: Armin Gerger

given: Armin

name: Clinic for Medical Oncology University Hospital Zurich  Zurich Switzerland

family: Siebenhüner

full_name: Alexander Siebenhüner

given: Alexander

family: Speicher

full_name: Michael Speicher

given: Michael

family: Heitzer

full_name: Ellen Heitzer

given: Ellen

name: Department of Medicine I, Division of Oncology Medical University of Vienna  Vienna Austria

family: Prager

full_name: Gerald W. Prager

given: Gerald W.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: International Journal of Cancer

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: A higher ctDNA fraction decreases survival in regorafenib‐treated metastatic colorectal cancer patients. Results from the regorafenib's liquid biopsy translational biomarker phase II pilot study

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
HEGP
Hopital Européen Georges Pompidou


title: Pharmacokinetics of an Aminoglycoside in Hemodialysis Patients.

acronym: DIAMS

summary:
Aminoglycosides are widely used for the treatment of Gram-negative bacilli and Staphylococcus aureus infections because of their effectiveness and low cost. Nevertheless, many aspects of their optimal use in hemodialysis patients remain unsolved and little is known about their pharmacokinetics in this context. The current practice for prescribing aminoglycosides to these particular patients consists in giving after each hemodialysis session about half the dose usually given to patients with normal renal function.

However, theoretical considerations and emerging clinical data suggest that this may not be the most beneficial dosing regimen as efficient peak concentrations are often not attained and the occurrence of ototoxicity and nephrotoxicity is still frequent.

primary_purpose: Other

ReferenceType: result

ReferenceCitation: Franck B, Monchaud C, Saint-Marcoux F, Rérolle JP, Allard J, Allot V, Marquet P, Essig M, Woillard JB. Population pharmacokinetics of gentamicin in haemodialysis patients: modelling, simulations and recommendations. Eur J Clin Pharmacol. 2020 Jul;76(7):947-955. doi: 10.1007/s00228-020-02867-3. Epub 2020 May 1.

family: Franck

full_name: Bénédicte Franck

given: Bénédicte

family: Monchaud

full_name: Caroline Monchaud

given: Caroline

family: Saint-Marcoux

full_name: Franck Saint-Marcoux

given: Franck

family: Rérolle

full_name: Jean-Philippe Rérolle

given: Jean-Philippe

family: Allard

full_name: Julien Allard

given: Julien

family: Allot

full_name: Vincent Allot

given: Vincent

family: Marquet

full_name: Pierre Marquet

given: Pierre

family: Essig

full_name: Marie Essig

given: Marie

family: Woillard

full_name: Jean-Baptiste Woillard

given: Jean-Baptiste

journal_name: European Journal of Clinical Pharmacology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Limoges

location_facility: CHU LIMOGES - Laboratoire de Pharmacologie


title: A Prospective, Multicentre, Uncontrolled, Phase Ib/II Study of LY2780301 in Combination With Weekly Paclitaxel in HER2-negative Metastatic or Locally Advanced Breast Cancer in Patients With and Without PI3/AKT/S6 Pathway Activation. - TAKTIC-IPC 2012-008

acronym: TAKTIC

summary:
The overall rationale of this study evaluating tolerance and efficacy of LY2780301 in combination with paclitaxel in HER2-negative, inoperable locally advanced or metastatic breast cancer (MBC) is based on :

the medical need in this population with either hormonal-resistant or unsensitive and/or rapidly progressive disease
the preclinical evidences for involvement of PI3K/AKT pathway in tumor progression and drug resistance, including taxanes as well as its potential reversion by AKT inhibition
the high level of frequency of PI3K/AKT activation in HER2-negative MBC
the in vitro and in vivo preclinical activity of LY2780301, and its synergistic combination with various anticancer agents, including taxanes
the favourable profile of tolerance of LY2780301 in phase I trial

Weekly paclitaxel is conventionally administered at 80 mg/m²/week and is a standard treatment in breast cancer (BC) As described above, LY2780301 500 mg once daily has been established as the RP2D in phase I single agent trial.

Evidence of pharmacodynamic activity was noted at 400-500 mg QD. Conservatively, the first dose level to be explored will be LY2780301 400 mg QD and paclitaxel 70 mg/m²/week.

ReferenceCitation: Vicier C, Sfumato P, Isambert N, Dalenc F, Robert M, Levy C, Rezai K, Provansal M, Adélaïde J, Garnier S, Guille A, Carbuccia N, Popovici C, Charafe-Jauffret E, Chaffanet M, Birnbaum D, Pakradouni J, Bertucci F, Boher JM, Sabatier R, Gonçalves A. TAKTIC: A prospective, multicentre, uncontrolled, phase IB/II study of LY2780301, a p70S6K/AKT inhibitor, in combination with weekly paclitaxel in HER2-negative advanced breast cancer patients. Eur J Cancer. 2021 Nov 12;159:205-214. doi: 10.1016/j.ejca.2021.09.040. [Epub ahead of print]

family: Vicier

full_name: Cecile Vicier

given: Cecile

family: Sfumato

full_name: Patrick Sfumato

given: Patrick

family: Isambert

full_name: Nicolas Isambert

given: Nicolas

family: Dalenc

full_name: Florence Dalenc

given: Florence

family: Robert

full_name: Marie Robert

family: Levy

full_name: Christelle Levy

given: Christelle

family: Rezai

full_name: Keyvan Rezai

given: Keyvan

family: Provansal

full_name: Magali Provansal

given: Magali

family: Adélaïde

full_name: José Adélaïde

given: José

family: Garnier

full_name: Séverine Garnier

given: Séverine

family: Guille

full_name: Arnaud Guille

given: Arnaud

family: Carbuccia

full_name: Nadine Carbuccia

given: Nadine

family: Popovici

full_name: Cornel Popovici

given: Cornel

family: Charafe-Jauffret

full_name: Emmanuelle Charafe-Jauffret

given: Emmanuelle

family: Chaffanet

full_name: Max Chaffanet

given: Max

family: Birnbaum

full_name: Daniel Birnbaum

given: Daniel

family: Pakradouni

full_name: Jihane Pakradouni

given: Jihane

family: Bertucci

full_name: François Bertucci

given: François

family: Boher

full_name: Jean M. Boher

given: Jean M.

family: Sabatier

full_name: Renaud Sabatier

given: Renaud

family: Gonçalves

full_name: Anthony Gonçalves

given: Anthony

bso_classification: Chemistry

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

location_facility:
Institut Paoli-Calmettes
Centre Geroges François Leclerd


title: Endoscopic Injection of Botulinum Toxin in Patients With Hypercontractile Esophageal Motility Disorders: a Prospective, Randomized, Double-blind, Controlled Study

acronym: TIBOH

summary: This study aims to evaluate the efficacy and the safety of endoscopic injection of 100 IU of botulinum toxin (BTX) in the distal esophagus in patients with symptoms related to hypercontractile esophageal motility disorders.

ReferenceCitation: Mion F, Marjoux S, Subtil F, Pioche M, Rivory J, Roman S, Zerbib F. Botulinum toxin for the treatment of hypercontractile esophagus: Results of a double-blind randomized sham-controlled study. Neurogastroenterol Motil. 2019 May;31(5):e13587. doi: 10.1111/nmo.13587. Epub 2019 Apr 11.

name: Hospices Civils de Lyon, Hospital E. Herriot Digestive Physiology Lyon France

name: Physiology Department Université de Lyon Lyon France

family: Mion

full_name: François Mion

family: Marjoux

full_name: Sophie Marjoux

given: Sophie

name: Biostatistics Department Hospices Civils de Lyon, Hospital E. Herriot Lyon France

family: Subtil

full_name: Fabien Subtil

given: Fabien

name: Gastroenterology Hospices Civils de Lyon, Hospital E. Herriot Lyon France

family: Pioche

full_name: Mathieu Pioche

given: Mathieu

family: Rivory

full_name: Jerome Rivory

given: Jerome

family: Roman

full_name: Sabine Roman

given: Sabine

name: CHU Bordeaux, Gastroenterology Université de Bordeaux Bordeaux France

family: Zerbib

full_name: Frank Zerbib

given: Frank

journal_name: Neurogastroenterology & Motility

title: Botulinum toxin for the treatment of hypercontractile esophagus: Results of a double‐blind randomized sham‐controlled study

location_facility: Service d'Hépato-Gastro-Entérologie et Oncologie Digestive- Hôpital Haut Lévêque - CHU de Bordeaux

location_facility: Service d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot Pavillon H 5 - Hospices Civils de Lyon


title: Study of the Effectiveness of Maintenance rTMS Sessions for 6 Months Versus Placebo in Subjects With Fibromyalgia Responders to 3 Week-rTMS Treatment

summary: Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with fibromyalgia may maintain the clinical improvement.

ReferenceCitation: Ciobanu C, Girard M, Marin B, Labrunie A, Malauzat D. rTMS for pharmacoresistant major depression in the clinical setting of a psychiatric hospital: effectiveness and effects of age. J Affect Disord. 2013 Sep 5;150(2):677-81. doi: 10.1016/j.jad.2013.03.024. Epub 2013 May 11.

location_facility:
Centre Hospitalier Universitaire
Centre Hospitalier Esquirol


title: Validation of Metrological Properties of Questionnaire of Quality of Life LYMPHOQOL

acronym: LYMPHOQOL

summary: The constitutional lymphœdema is a rare disease with an annual incidence before the age of 20 years considered at 1,15/100 000. This chronic, incurable disease without hiring directly the prognosis for survival, alter the body image imposing a "visible" deformity and of which the treatment which aims at reducing and at stabilizing the physical deformation is binding and expensive. The lymphœdema is a crippling disease of the child. As such, it rings on the everyday life of the child and on the family environment. This question is all the more important, that all the studies show that the success of the treatment bases on the compliance in the concentration and in the care of hygiene. The parameters of the success of these treatments at the child are not known.

ReferenceCitation: Quéré I, Stasi E, Mestre S, Roessler J, Roccatello D, Moffatt C. International Camps for Children with Lymphedema and Lymphatic Anomalies: When Education Links with Psychosocial Research. Lymphat Res Biol. 2021 Feb;19(1):36-40. doi: 10.1089/lrb.2020.0095.

name: Centre de Référence Lymphoedèmes et Malformations Lymphatiques Rares, Département de Médecine Vasculaire, LERN Lymphatic Education and Research Network Center of Excellence, CHU Montpellier, Université de Montpellier, Montpellier, France.

family: Quéré

full_name: Isabelle Quéré

given: Isabelle

name: Center of Research of Immunopathology and Rare Diseases—CMID—Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, Turin, Italy.

family: Stasi

full_name: Elodi Stasi

given: Elodi

family: Mestre

full_name: Sandrine Mestre

given: Sandrine

name: Oncology, Department of Pediatrics, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.

family: Roessler

full_name: Jochen Roessler

given: Jochen

family: Roccatello

full_name: Dario Roccatello

given: Dario

name: School of Social Sciences, Nottingham Trent University, Nottingham, United Kingdom.

family: Moffatt

full_name: Christine Moffatt

given: Christine

journal_name: Lymphatic Research and Biology

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

lead_sponsor: University Hospital, Montpellier


title: Feasibility Study: Physical Activity Program Associated Wtih Nutrition Therapeutic Education in Head and Neck Cancer Population Treating by Chemotherapy With or Without Radiotherapy.

acronym: APANVADS

summary: The purpose of this study is to examine the feasibility of resistance training and physical functioning associated with nutrition therapeutic education in head and neck cancer patients, during their treatment (chemotherapy with or without radiotherapy).

primary_purpose: Prevention

location_facility: CHU LIMOGES - Explorations Fonctionnelles Respiratoires


type: Registry Identifier

title: Benefit of Flow Magnetic Resonance Imaging in the Management of Normal Pressure Hydrocephalus

acronym: HydroFlux

summary: Normal pressure hydrocephalus diagnosis based on quantitative study of cerebro-spinal fluid and blood flow by phase contrast magnetic resonance imaging.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Amiens
CHU Lille


type: Other Identifier

title: Comparison and Reproducibility of Pelvic Area Extension Measurements for Four Types of Lumbopelvic Balance Using Three Different Methods: Clinical Observation Versus Photography Versus the EOS Imaging System

acronym: CRESPEOS

summary: The main objective of this study is to describe for the first time the expansion reserve of the pelvic area (measurements using the EOS system) for each of the four morphotypes (Roussouly classification) commonly found in a population of healthy volunteers.

time_perspective: Cross-Sectional

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


type: EudraCT Number

title: Evaluation of Hypoxia by PET With 18-FluoroMisonidazole During Radiation Therapy of Prostate Cancer

acronym: HYPOXProstat

summary:
With functional imaging development, it becomes possible to increase radiation dose to radioresistant areas (located inside tumor volume) using radiotherapy dose-painting. This strategy is particularly suitable for prostate cancer where tumor hypoxia plays a major role in the resistance of these tumors to radiation.

In order to develop intratumoral hypoxia targeting by radiotherapy dose-painting areas, we should characterize changes in hypoxia before treatment and during radiotherapy.

If hypoxia does not change during radiotherapy, radiotherapy dose-painting strategy by an "integrated" boost is performed.
If hypoxia varied (increasing or incomplete regression), a "final" boost strategy of radiotherapy dose-painting(IMRT, stereotactic brachytherapy or high dose rate) after a first fractionated IMRT could be considered.

This study should show that PET imaging with fluoromisonidazole (18F-MISO) is an available tool to physicians in assessing tumor hypoxia.

ReferenceCitation: Rasey JS, Koh WJ, Evans ML, Peterson LM, Lewellen TK, Graham MM, Krohn KA. Quantifying regional hypoxia in human tumors with positron emission tomography of [18F]fluoromisonidazole: a pretherapy study of 37 patients. Int J Radiat Oncol Biol Phys. 1996 Sep 1;36(2):417-28.

ReferenceCitation: Bentzen SM. Theragnostic imaging for radiation oncology: dose-painting by numbers. Lancet Oncol. 2005 Feb;6(2):112-7.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
CHU Poitiers
ICO Rene Gauducheau


title: Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) for Ulcerative Colitis and Crohn's Disease

acronym: F-IBDQ

summary: The purpose of the study is to develop a validated French version of the IBDQ in a cohort of patients suffering from Inflammatory bowel diseases, namely Crohn's disease and Ulcerative Colitis.

lead_sponsor: Rennes University Hospital

location_facility: Service des Maladies de l'Appareil Digestif, Hôpital de Pontchaillou, 2 rue Henri Le Guilloux


title: Subthalamic Nuclei (STN) Local Field Potentials to Investigate Motor Control During REM Sleep Behaviour Disorder (TCSP) Secondary to Idiopathic Parkinsons Disease (PD)

acronym: RevesParkNST

summary: To compare the electrical activity of SubThalamic Nuclei (STN), by mean of local field potentials recordings, during the phasic behaviours of RBD with the electrical activity recorded at this level during the execution of voluntary movements during the "off" and the "on" phases in patients with RBD secondary to PD.

ReferenceCitation: AASM (2005). International classification of sleep disorders, 2nd ed.: Diagnostic and coding manual. Westchester, IL, American Academy of Sleep Medicine.

ReferenceCitation: Benarroch EE. Subthalamic nucleus and its connections: Anatomic substrate for the network effects of deep brain stimulation. Neurology. 2008 May 20;70(21):1991-5. doi: 10.1212/01.wnl.0000313022.39329.65. Review.

ReferenceCitation: Boeve BF, Silber MH, Saper CB, Ferman TJ, Dickson DW, Parisi JE, Benarroch EE, Ahlskog JE, Smith GE, Caselli RC, Tippman-Peikert M, Olson EJ, Lin SC, Young T, Wszolek Z, Schenck CH, Mahowald MW, Castillo PR, Del Tredici K, Braak H. Pathophysiology of REM sleep behaviour disorder and relevance to neurodegenerative disease. Brain. 2007 Nov;130(Pt 11):2770-88. Epub 2007 Apr 5. Review.

ReferenceCitation: Brown P, Williams D. Basal ganglia local field potential activity: character and functional significance in the human. Clin Neurophysiol. 2005 Nov;116(11):2510-9. Epub 2005 Jul 18. Review.

ReferenceCitation: Buot, A., M. L. Welter, et al. (2012).

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lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital of Purpan
University Hospital of Rangueil


title: A Pilot Study Evaluating the Maintenance of Viral Suppression After 24 Weeks of Therapeutic Interruption in Chronically HIV-1 Infected Patients With a Low Circulating HIV-DNA Reservoir

acronym: ULTRASTOP

summary:
During the ERAMUNE-01 and -02 studies, the HIV-DNA quantification in the PBMCs (Peripheral Blood Mononuclear Cells) showed showed that some patients had a very low or undetectable reservoir.

Recent studies showed that a low reservoir is associated to a spontaneous virologic control in three specific categories of patients:

"Elite Controllers": these rare patients are able to spontaneously maintain an HIV-RNA viral load below 50 copies/mL and elevated CD4 counts without any treatment. These patients belong to the B27/B57 haplotypes associated to a reduced risk of HIV contamination but these haplotypes are very rare in the global population (0,3 %)
"Visconti" patients: early-treated patients, during the primo-infection stage. After 3 to 5 years of treatment, these patients are able to maintain an undetectable HIV-RNA viral load.
"Salto" patients: these patients are treated a bit later compared to the Visconti cohort, when their CD4 count was above 350 cells/mm3 and their HIV-RNA viral load below 50 000 copies/mL. The follow-up of these patients showed the same capacity of control of the HIV infection for at least 2 years following treatment interruption.

Taking into account these 3 categories of patients which common characteristics is a low reservoir, our objective is to answer the 2 following questions:

Is it possible to discontinue the treatment in chronically-infected patients with a "normal" immune system and with an undetectable HIV-DNA reservoir?
Is a low viral reservoir predictive of a treatment-free remission of the HIV infection in chronically-infected patients?

The main objective of the proof-of-concept ERAMUNE-03 trial is to evaluate the proportion of patients in success (i.e. able to maintain a virologic and an immunologic control of the infection) after treatment discontinuation, failure is defined as:

An HIV-RNA viral load > 400 copies/mL on 2 consecutive tests starting from Week 4
Or CD4 count < 400 cells/mm3 on 2 consecutive measures starting from Week 4
Or the onset of an AIDS-related event

lead_sponsor: Objectif Recherche Vaccins SIDA

location_facility:
Hospital Pitié-Salpêtrière
University Hospital of Bicêtre


title: Study of the Capacity of the MRI Spectroscopy to Define the Tumor Area Enriched in Glioblastoma Stem Cells. Proof of Concept Study

acronym: STEMRI

summary:
This is a prospective biomedical study of interventional type which includes 16 patients on 52 months (24 months of inclusion and 28 months of follow up).

This pilot study, combining a metabolic imaging approach (Proton Magnetic Resonance Spectroscopy = 1HMRSI) and a biological one, will be performed in patients harbouring a Glioblastoma (GBM)to determine whether MRI markers of aggressiveness (CNI2) are associated with specific biological patterns as regards to GBMSC (GBM contains tumor stem cell).

In the first part of the study, patients with radiological criteria of GBM amenable to surgical resection will be included ; pre-operative multimodal MRI scans will be done and all data acquired (including H1MRS and DTI data) will be integrated in the image-guided surgical device (ie neuronavigation system) to be used intraoperatively. During tumor resection, tissue samples will be individualized, based on their multimodal imaging characteristics and sent to the radiobiology laboratory INSERM for biological analysis.

After surgery, patient will be treated by the standard radio-chemotherapy stupp protocol and will be followed according to standard practices; multimodal MRI will be performed every 2 months during the first year and then every 3 months until progression.

ReferenceCitation: Pinto G, Saenz-de-Santa-Maria I, Chastagner P, Perthame E, Delmas C, Toulas C, Moyal-Jonathan-Cohen E, Brou C, Zurzolo C. Patient-derived glioblastoma stem cells transfer mitochondria through tunneling nanotubes in tumor organoids. Biochem J. 2021 Jan 15;478(1):21-39. doi: 10.1042/BCJ20200710.

name: Unité de Trafic Membranaire et Pathogenèse, Institut Pasteur, UMR3691 CNRS, 28 rue du Docteur Roux, F-75015 Paris, France

name: Sorbonne Université, ED394 — Physiologie, Physiopathologie et Thérapeutique, F-75005 Paris, France

family: Pinto

full_name: Giulia Pinto

given: Giulia

family: Saenz-de-Santa-Maria

full_name: Inés Saenz-de-Santa-Maria

given: Inés

family: Chastagner

full_name: Patricia Chastagner

given: Patricia

name: Hub de Bioinformatique et Biostatistique — Département Biologie Computationnelle, Institut Pasteur, USR 3756 CNRS, F-75015 Paris, France

family: Perthame

full_name: Emeline Perthame

given: Emeline

name: Cancer Research Center of Toulouse (CRCT), Institut National de la Santé et de la Recherche Médicale (INSERM), UMR 1037, Institut Claudius Regaud, Université Toulouse III Paul Sabatier, Toulouse F-31000, France

family: Delmas

full_name: Caroline Delmas

given: Caroline

family: Toulas

full_name: Christine Toulas

family: Moyal-Jonathan-Cohen

full_name: Elizabeth Moyal-Jonathan-Cohen

given: Elizabeth

family: Brou

full_name: Christel Brou

given: Christel

family: Zurzolo

full_name: Chiara Zurzolo

given: Chiara

journal_name: Biochemical Journal

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

repository_normalized: HAL

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

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

repository_institution: Cold Spring Harbor Laboratory - bioRxiv

repository_normalized: bioRxiv

version: submittedVersion

repositories:
HAL
PubMed Central
bioRxiv

publisher: Portland Press Ltd.

publisher_dissemination: Portland Press

publisher_group: Portland Press

publisher_normalized: Portland Press

lead_sponsor: Institut Claudius Regaud

location_facility:
Institut Claudius REGAUD
CHU Rangueil


title: Phase II Multicenter Trial Evaluating First Line Carboplatin, 5-Fluorouracil and Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer, Aged 70 and Over, Ranked as Fit (no Frailty) by Geriatric Assessment

acronym: ELANFIT

summary: The aim of the trial is to evaluate the clinical benefit (efficacy, safety, preservation of autonomy) of cetuximab-carboplatin-5FU combination as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma in patients over 70 years without frailty (after geriatric assessment).

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_facility:
Hôpital de la Dracénie
Institut Gustave Roussy


title: Maintenance Treatment of Non Segmental Vitiligo With Tacrolimus Ointment 0.1% Versus Control, Randomized and Double Blind Study

summary:
Tacrolimus ointment 0.1% has shown promising results for treating vitiligo in many prospective studies. Prospective randomized studies versus placebo are required to confirm the hypothesis that maintenance treatment with two applications of tacrolimus ointment 0.1% per week can reduce relapses of non-segmental vitiligo lesions.

Main objective To assess the efficacy of maintenance therapy with topical tacrolimus vs placebo in the prevention of depigmentation in patients with vitiligo who responded to treatment.

Secondary objectives

Evaluate the efficacy of maintenance therapy with tacrolimus vs topical placebo to decrease the intensity of depigmentation in patients with vitiligo who responded to treatment.
To study the occurrence of possible adverse effects.

Length of the study Inclusion: 12 months Treatment: 6 months Follow-up: 6 months Total length of the study: 18 months

Intervention Multicentric prospective interventional randomized comparative study versus placebo.

Visit V0: Selection Information of the patient, control of inclusion and non inclusion criteria.
Visit V1: Control of inclusion and non inclusion criteria, patients signed informed consent. An initial clinical evaluation and photographs in direct sunlight and UV. Topical treatment (tacrolimus or placebo) will be delivered to the patient by the hospital pharmacy and should be applied twice per week (3 or 4 days apart) for 24 weeks.
Visit V2:

The patient will be reviewed after the end of treatment (24 weeks after the visit V1) for final evaluation. A clinical assessment will be made and photographs in the same way as the inclusion. Adverse reactions during treatment will be collected by the investigator (they will be noted as and when the patient in a notebook that will be presented at baseline).

The percentage of depigmentation will be evaluated in a blinded treatment of photographs by two reviewers. In case of disagreement, the opinion of a third appraiser will be required.

- End of study: After the end of the study patients will be supported via the usual care recommended for their condition.

Evaluation criteria

primary endpoint

---Percentage of patients at 24 weeks without depigmentation (depigmentation score = 0). A score of depigmentation from 0 to 2 will be used. A blind treatment evaluation of direct light and UV photographs will be made by two independent observers (dermatologists) between inclusion and after 24 weeks of treatment.

secondary endpoints

---- The efficiency to reduce the intensity of relapses will be evaluated using the score of depigmentation (rate of patients with a score of 0 or 1 in each group) and the VASI score (Appendix 4).

The frequency, severity and time of occurrence of adverse events are reported. Side effects are classified into grades according to WHO criteria.

Number of subject Considering that depigmentation occurs in more than 40% of patients during the 24 weeks of maintenance treatment and hoped that the proactive treatment will reduce the rate of depigmentation of 10%, a population of 26 patients per group will be necessary (taking into account 10% of patients lost to follow). The total number of patients to be included in the study will be 52.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Bordeaux
CHU de Nice - Hôpital de l'Archet


title: Pilot Study Evaluating the Efficacy and Safety of Metformin in Melanoma

summary: In western countries, melanoma represents a major mistake of public health by its frequency, lethality and the increasing of incidence. Surgery can cure melanoma diagnosed very early. In other cases, it exists a risk of recurrence of lymph node and visceral. At the stage of visceral metastases, the prognosis of melanoma is catastrophic, with a median survival of 6 months. Indeed, the reference chemotherapy by dacarbazine induces a very limited response rate of 10-20%, the ipilimumab which has been authorized in the second intention, has a response rate of 10%, and other available treatments don't have a superior efficiency. Metformin is an oral antidiabetic of biguanides family which acts by inducing the activation of AMPK, a molecule which is inactivated in many cancers including the melanoma. In agreement with these data, several preclinical studies suggested that metformin has antineoplastic activity. In the case of melanoma, a study published recently has showed that metformin inhibits proliferation of melanoma cells in vitro and we confirmed for our part these results in our laboratory (INSERM U895).

location_facility:
MORTIER Laurent
Bahadoran


title: Analysis of Different Circulating Immune Cells in Patients With Recurrent Glioblastoma or Mixed Anaplasic Glioma Treated With Bevacizumab and Search for a Link With Response to Treatment

acronym: AVA-CELL

summary:
Bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), is an antiangiogenic treatment currently proposed to recurrent high grade glioma patients. Unfortunately some patients fail to respond to this treatment and finding biological factors allowing the discrimination between potential responders and non responders would be very helpful. As the immune system plays a key role in angiogenesis induction and maintenance in cancer, it could serve as a surrogate marker of angiogenesis in cancer patients.

The purpose of this study is to determine the influence of bevacizumab treatment on circulating immune cells in high grade glioma patients and to search for a link between the variation of these cells and the response to treatment.

lead_sponsor: Center Eugene Marquis

location_facility:
Center Eugene Marquis
Hôpital Avicenne


title: An Open-Label Study to Evaluate the Efficacy, Safety and Tolerability of Ribavirin Monotherapy Followed by Combined Treatment With Ribavirin and Hydroxychloroquine in Patients Infected With Hepatitis C

summary: Proof-of Concept, Open-Label, Two-Stage Study without Direct Individual Benefit The proposed study design consists of two treatment periods and one treatment arm. Treatment Period 1 involves the administration of RBV monotherapy for a period of 8 weeks and Treatment Period 2 involves administration of up to 16 weeks combination therapy with RBV plus HCQ.

lead_sponsor: BioLineRx, Ltd.

location_facility:
Hospital St. Joseph
Cochin Hospital


title: Olive Oil Polyphenols, Vitamin D and Docosahexaenoic Acid (DHA) Synergistic Effects on Locomotor Function

summary:
The present project hypothesizes that the potential protective effect of olive oil relies on its polyphenols profile (quality and quantity) and that it may be synergistic to other food components. Among the nutrients that may be of interest for bone and muscle tissues, unsaturated fatty acids and vitamins are the most described.

Consequently, based on the promising available preliminary data, the present project aims to investigate the possible preventive effect of olive oil polyphenols and eventually the synergistic effects of fatty acids and vitamin D on bone, muscle and adipose tissue, in order to prevent any locomotor dysfunction.

Volunteers will be supplemented during 9 months. The primary and secondary outcome measures will be performed at baseline, 3 and 9 months.

lead_sponsor: Lesieur

location_facility: Centre de Recherche en Nutrition Humaine

intervention_type: Dietary Supplement


title: VARITI-5 : Study of Variations of Serum ITIH5 in Women During the Genital Life and in Pathological Situations.

summary:
The five proteins of the ITI (Inter-α-trypsin inhibitor) family, are essential components of the extracellular matrix, the dynamics of which they participate in the processes of cellular differentiation and proliferation. I. The ITIH1, ITIH2, ITIH3 and ITIH4 genes seem to be overwhelmingly expressed in the liver, this organ secreting then the corresponding proteins in the general circulation. The only data on ITIH5 indicate that this gene is poorly expressed in the liver and that the major source of its expression is the placenta. In the context of genetic studies on the syndrome of Mayer-Rokitansky-Küster-Hauser (congenital aplasia of the uterus and vagina), the investigators have shown the involvement of ITIH5 and implemented validation experiments of this gene in mice. The investigators have shown that the production of ITIH5 by the uterus varies greatly depending on the physiological state of this organ, especially during pregnancy and the estrous cycle. The investigators also found that most of the production ITIH5 was located in the uterus. Therefore, the serum dosage of ITIH5 could be used clinically as a new biological marker specific to the uterus. This non-invasive biological marker could thus assist in the diagnosis and the understanding of uterine pathologies. ITIH5 rate being correlated to endometrial proliferation, its dosage could be an early and non-invasive marker of endometriosis. The peak of production of ITIH5 by the uterus at the time of embryo implantation window indicates that the assay could provide a better assessment of endometrial receptivity to embryo. It then could be a hand tool of diagnosis in some cases of early repeated miscarriages, and secondly, a prognostic tool for embryo implantation in the context of in vitro fertilization.

The investigators conducted an initial feasibility study on the serum dosage of ITIH5, which was approved by the ethics committee of the University Hospital of Rennes. This first step has been validated. Now, the project is to perform a quantitative analysis of ITIH5 and to correlate clinical and biological data of relevant pathological and physiological situations. This project was the subject of a national and international patents of which the University Hospital of Rennes is promoter.

location_facility: Rennes University Hospital - Hôpital Sud


title: Executive Dysfunction in Restless Legs Syndrome: Determination of Clinical Correlates and Outcome After Therapeutic Management

summary:
Restless leg syndrome (RLS) is a common neurological disorder whose diagnosis is only clinical. The efficacy of dopaminergic agents in improvement of sensorimotor symptoms advance the hypothesis that altered dopaminergic transmission is at the origin of this condition. RLS usually leads to a sleep fragmentation, which induces sometimes severe insomnia most often associated, in clinical practice, to a cognitive complaint (attentional in nature). Executive functions in which dopaminergic transmission is heavily involved refer to a set of complex functions. At least three of them should be considered during their evaluation (ie flexibility, inhibition, and the updating of working memory). These functions are among the targets of the alteration of the quality and quantity of sleep. The few studies that have focused on the study of the integrity of executive functions in RLS have discordant results. The lack of control of key variables in the assessment of executive functioning (ie intellectual performance, depressive symptomatology, generalized slowing in information processing) and the lack of reference in the theoretical approach in executive functions are certainly the two main reasons. Moreover, the question of polysomnographic correlates and the reversibility of these cognitive abnormalities after pharmacological management of RLS remains unanswered today.

The main objective of this study is to compare the executive performance of untreated RLS patients with a group of matched controls.

status: Recruiting

location_facility:
UH Nîmes
UH Montpellier

status_simplified: Ongoing


acronym: RECOGNITA

summary:
The Attention Deficit Disorder with or without Hyperactivity (ADHD) is one of the most frequently found disorder in children. It is characterized by a triad of symptoms involving attention deficit, hyperactivity and impulsivity and having an impact on the functioning of the subject especially in terms of learning.

Currently, main interventions to treat ADHD in children are stimulant medication or supportive psychotherapy. Data from recent studies highlight the use of stimulant drugs (amphetamine derivatives such as methylphenidate) to treat the core symptoms of ADHD children. These drugs are generally effective but their nature (psychostimulants) and adverse effects they cause (appetite suppression, sleep disturbances, headaches, motor tics, abdominal pain, irritability, nausea and fatigue) encourage the development of new therapeutic approaches. The use of supportive psychotherapy alone would have limited effect on symptoms of children with ADHD. Our aim is to test the use a cognitive remediation program using a virtual classroom in children suffering from ADHD.

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Bordeaux
Centre Hospitalier Charles Perrens


title: Detection of the Emergence of RAS (Rat Sarcoma Viral Oncogene Homolog) Mutations in Circulating DNA (Deoxyribonucleic Acid) in Patients With Metastatic Colorectal Cancer During Treatment With Anti-EGFR (Epidermal Growth Factor Receptor) Therapy

acronym: EmutRAS

summary:
The analysis of circulating DNA (Deoxyribonucleic acid) to identify potential resistance mechanisms during anti-EGFR (epidermal growth factor receptor) treatment is of great interest, as evidenced by the recent journal published by Corcoran in the prestigious New England Journal of Medicine.

EmutRAS is one of the first studies that will specifically and prospectively evaluate the RAS mutational switch and its impact on the efficiency of the 1st line processing.

ipd_sharing: No

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle


title: Effect of Intradialytic Physical ACTIvity in Addition to a NUTritional Support on Protein Energy Wasting and Physical Functioning in Chronic Hemodialysis Patients ("ACTINUT" Study), Multicenter, Randomized, Controlled Open Label Trial Study Multicenter, Prospective, Randomized Study

acronym: ACTINUT

summary:
Sedentary behavior and protein-energy wasting (PEW) are well known risk factors of adverse outcome and low quality of life in chronic renal failure patients treated by dialysis. Treatment strategies of PEW by different types of nutritional support (as dietary counseling, oral nutritional supplements or intradialytic parenteral nutrition) have limited efficacy. Physical activity has been shown to have numerous positive impacts in pathologic conditions associated to end stage renal disease.

Concomitant prescription of physical activity and nutritional support might mutually enhance the anabolic effects of these interventions and improve the rate of remission of PEW.

The aim of this study is to analyze the effect of a programmed, progressive endurance training performed during the dialysis session on a cycle ergometer under the supervision of a qualified trainer, on protein energy wasting and physical functioning of chronic hemodialysis patients.

ReferenceCitation: Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5:CD012616. doi: 10.1002/14651858.CD012616.pub2.

name: Integrated Renal Service; Eastern Health; Box Hill Australia

family: Mah

full_name: Jia Yee Mah

given: Jia Yee

family: Choy

full_name: Suet Wan Choy

given: Suet Wan

name: Eastern Health Clinical School; Monash University; Box Hill Australia

family: Roberts

full_name: Matthew A Roberts

given: Matthew A

name: Department of Dietetics/Renal; Eastern Health; Box Hill Australia

family: Desai

full_name: Anne Marie Desai

given: Anne Marie

family: Corken

full_name: Melissa Corken

given: Melissa

name: Department of Epidemiology and Preventive Medicine; Monash University; Clayton Australia

family: Gwini

full_name: Stella M Gwini

given: Stella M

family: McMahon

full_name: Lawrence P McMahon

given: Lawrence P

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

ReferenceCitation: Magnard J, Deschamps T, Cornu C, Paris A, Hristea D. Effects of a six-month intradialytic physical ACTIvity program and adequate NUTritional support on protein-energy wasting, physical functioning and quality of life in chronic hemodialysis patients: ACTINUT study protocol for a randomised controlled trial. BMC Nephrol. 2013 Nov 26;14:259. doi: 10.1186/1471-2369-14-259.

family: Magnard

full_name: Justine Magnard

given: Justine

family: Deschamps

full_name: Thibault Deschamps

given: Thibault

family: Cornu

full_name: Christophe Cornu

given: Christophe

family: Paris

full_name: Anne Paris

given: Anne

family: Hristea

full_name: Dan Hristea

given: Dan

currency_apc_doaj: GBP

journal_name: BMC Nephrology

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

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

location_facility:
ECHO center ( confluent site )
ECHO CENTER( St-Jacques)


title: Multicenter, Prospective Study, on the Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on: - Healthy and Pathological Periodontium - The Level of Expression of Some Markers of Inflammation and Periodontal Pathogenic Bacteria in Periodontal Sulci and Periodontal Pockets

acronym: ParoPAR

summary:
Rheumatoid arthritis and periodontitis are two inflammatory diseases that share many pathophysiological similarities as some inflammatory mediators like TNF-alpha, IL-1, Il-6, Il-17, Il-12 et Il-17, RANK-L, or OPG The most severe or progressive forms of rheumatoid arthritis require in 10-30% of cases, the use of biotherapies such as anti-TNF-alpha, anti CD-20 and anti-lL-6. All these treatments results in, among other things, an increased risk of infection, both viral and bacterial.

These new biotherapies could have an impact on periodontal status

either by favouring sub gingival colonization of root surfaces by periodontal pathogenic bacteria and initiate periodontitis or exacerbate pre-existing periodontitis,
or a positive modulation of the host response by inhibiting bone resorption of the alveolar process.

To date, very few studies have been conducted on this subject which is really a translational research, involving several medical specialties.

lead_sponsor: Nantes University Hospital

location_facility:
Nantes University Hospital
Brest University Hospital


title: Assessment of Attentional and Executive Disorders in Multiple Sclerosis Using Techniques of Virtual Reality

acronym: SEPREV

summary: Since many years cognitive disorders are a main topic of clinical research in Multiple Sclerosis (MS) as there could be observed early on in the disease and could induce with time in patients significant socio-professional burden. Today assessment of cognitive dysfunction in MS is still based on traditional pencil-paper task tests which are not able to give a true representation of functional burden observed in patients in real life situations. The development of new tools close to these "life situations", i.e. more ecological, are needed to better assess and take in charge cognitive impairment in MS patients. One way to reach this goal is Virtual Reality (VR). VR offers a new human-computer interface paradigm that simulates a realistic 3D environment where the user become immersed and interacts with it. These last ten years VR has known a rapid development in the health domain and has been applied with success to motor rehabilitation, psychiatry and neuropsychology. In this last domain, virtual environment (VE) reproducing activities of daily living have been used to evaluate executive and memory functions as well as attentional or visuospatial processes. Among main VE developed, driving assessment system, navigation skills, cooking behaviors, virtual supermarket have shown better sensitivity to detect functional consequences of cognitive impairment in various neurological and psychiatric disorders than traditional evaluations. In Caen University Hospital, investigators used VE driving system and developed the use of the Virtual Action Planning in a supermarket (VAP-S ; Klinger et al 2004) where a user move to select and buy groceries and other things inside an interactive virtual supermarket using a shopping cart. In a preliminary study investigators have used this virtual interactive tool to evaluate executive functioning in small group of Parkinson's disease and MS patients. Analysis of initial data shows the feasibility of the VAP-S for use with these two kinds of diseases. According to these results investigators planned a new study in Relapsing-Remitting(RR)- MS patients where they compare the use of VE (driving system and the VAP-S) to traditional attentional and executive evaluation for estimate their respective sensitivity to detect cognitive/functional impairment in MS patients. Investigators hope to shown that VR will demonstrate its interest to assess cognitive functions in MS and to develop cognitive rehabilitation.

lead_sponsor: University Hospital, Caen

location_facility: Department of Neurologie, Caen Hospital University

location_facility: Inserm Unit 1075 Comete, Caen Hospital University


title: Speckle Tracking Assessment of Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage and Impact on Neurologic Outcome (SPLASH)

acronym: SPLASH

summary: Cardiac dysfunction can occur in aneurysmal subarachnoid haemorrhage and might impact patient's neurologic outcome Condition Aneurysmal subarachnoid haemorrhage World Neurosurgeon Federation Score ≥ III

ReferenceCitation: Hofmeijer J, Kappelle LJ, Algra A, Amelink GJ, van Gijn J, van der Worp HB; HAMLET investigators. Surgical decompression for space-occupying cerebral infarction (the Hemicraniectomy After Middle Cerebral Artery infarction with Life-threatening Edema Trial [HAMLET]): a multicentre, open, randomised trial. Lancet Neurol. 2009 Apr;8(4):326-33. doi: 10.1016/S1474-4422(09)70047-X. Epub 2009 Mar 5.


title: Intracranial Hypertension Detection Using Optic Nerve Sheath Diameter Measurement in Children

acronym: DENO

summary:
Intracranial hypertension (ICH) is a mortality risk factor in severe traumatic brain injury (TBI), in purulent meningitis, in hepatic encephalopathy and in Reye's syndrome. It is also a risk factor for severe neurologic sequelae in survivors. Intracranial pressure (ICP) monitoring is likely to guide therapeutics, and certain research on adults or on children, suggest that IH therapeutic approach, for instance for bacterial meningitis, would improve the prognosis. Two monitoring techniques are currently recommended. They are reference methods for ICP measure :

monitoring with intraventricular catheter,
intra-parenchymal monitoring using optical fiber catheter. Non invasive methods have been suggested, including ultrasound measurement of optic nerve sheath diameter (ONSD) which is the most interesting one. The ONSD measured ultrasonically is correlated with ICP level in adults with severe TBI. A diameter over 5,9 mm predicts ICH within the first 24 hours. In children, ONSD average values have been worked out, and an ONSD increase is found in children suffering from hydrocephalus with IH and in children with TBI. ICH precocious detection is fundamental in children sensitive to ICH because their cerebral development is not finished yet. Difficulties met for ICP monitoring implementation in infants and its invasive nature are often disliked by clinicians. A non-invasive exam is then essential to allow a better care of children with ICH in intensive care unit.

lead_sponsor: Hospices Civils de Lyon

location_facility: Pediatric Critical Care Unit, Hôpital Femme Mère Enfant ,Hospices Civils de Lyon

location_facility: Pediatric Critical Care Unit, CHU La Tronche


title: Study of the Impact of Bronchial Colonization With Fungi in the Occurrence of Late Ventilator Acquired Pneumonia

acronym: CBF et PAVMt

summary: Ventilator acquired pneumonia (VAP) are severe nosocomial infections. On the other side, bronchial fungi colonization is commonly observed in ICU; therefore, the investigators propose to study the role of bronchial fungi colonization on the occurrence of VAP taking into account the immune status of the patient and the antibiotic and antifungal treatments he has received.

ReferenceCitation: Timsit JF, Schwebel C, Styfalova L, Cornet M, Poirier P, Forrestier C, Ruckly S, Jacob MC, Souweine B. Impact of bronchial colonization with Candida spp. on the risk of bacterial ventilator-associated pneumonia in the ICU: the FUNGIBACT prospective cohort study. Intensive Care Med. 2019 Jun;45(6):834-843. doi: 10.1007/s00134-019-05622-0. Epub 2019 Apr 24.

family: Timsit

full_name: Jean-Francois Timsit

given: Jean-Francois

family: Schwebel

full_name: Carole Schwebel

given: Carole

family: Styfalova

full_name: Lenka Styfalova

given: Lenka

family: Cornet

full_name: Muriel Cornet

given: Muriel

family: Poirier

full_name: Philippe Poirier

given: Philippe

family: Forrestier

full_name: Christiane Forrestier

given: Christiane

family: Ruckly

full_name: Stéphane Ruckly

given: Stéphane

family: Jacob

full_name: Marie-Christine Jacob

given: Marie-Christine

family: Souweine

full_name: Bertrand Souweine

given: Bertrand

journal_name: Intensive Care Medicine

oa_host_type: publisher

evidence: open (via free pdf)

lead_sponsor: University Hospital, Grenoble

location_facility: Hospital University Clermont Ferrand Gabriel Montpied


title: Determination of the Prognostic and Predictive Value of the New Marker HE4 in Metastatic Ovarian Cancer Monitoring

acronym: Meta-Four

summary: HE4 is a new marker that could improve the detection of ovarian cancer. The HE4 assay may have an advantage over the CA-125 assay in that it is less frequently positive in patients with non malignant disease. Since the evaluation of HE4 for detection and diagnosis of ovarian cancer is well known, the behaviour of the marker during chemotherapy and follow-up period after treatment in metastatic ovarian cancer should be studied. It could be used in patient with non CA-125 secretary tumors. Prognosis and predictive value of HE4 should be compared with information provided by CA-125. The kinetics of HE4 values after treatment should be also analysed to determine the role that HE4 could play in the detection of recurrences during the follow-up of metastatic patients.

location_facility:
Institut Bergonié
CRLC Val d'Aurelle-Paul Lamarque


title: Study of Role of Mononuclear Cells of Maternal Peripheric Blood in Human Myometrial Primar Cell Lines Differentiation Toward a Contratyl Phenotype: Influence of Preconceptional Obesity

acronym: ObeDi

summary: The purpose of this study is to improve the understanding of cellular mecanism involved in delivery disorders in obese women, first by characterizing the hyperplasia phenomenon of myometrail cells induced by inflammatory stimulation (Il-1B), then by studying the role of blood mononuclear cells, of leptine and of obese women sera to interfere with the transition of myometrial cells toward hyperplasia phenotype.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
Clinique Sainte Marthe
Maternité du CHU de Dijon


title: Impact of Burden of Comorbidities on Health Related Quality of Life Six Months After Transcatheter Aortic Valve Implantation in Patients Aged 75 Years and Older.

acronym: TAVIQUAL

summary: The aim of the study is to determine whether the burden of comorbidities measured by CIRS-G (Cumulative Illness Rate Scale) is associated with a non-amelioration of the health related quality of life measured by questionnaire called "SF-36", six months after a transcatheter aortic valve replacement in older patients. During the comprehensive geriatric assessment realized before the valve implantation, the following data are recorded and their impact of the health related quality of life will also be analysed: comorbidity, age, depression, functional status, the cognitive impairment and malnutrition.

primary_purpose: Health Services Research

location_facility:
Nantes Universitary Hospital
Angers Universitary Hospital


title: Laser SPEckle Contrast Imaging Interest in dEtection of Cutaneous Microvascular Dysfunction in Systemic Sclerosis.

acronym: SPECIES

summary: The aim of the study is to determine if postocclusive hyperemia of palmar and dorsal face of the hand with Laser speckle contrast imaging discriminate between patients with systemic sclerosis, subjects with primary Raynaud's phenomenon and healthy subjects.

ReferenceCitation: Gaillard-Bigot F, Roustit M, Blaise S, Gabin M, Cracowski C, Seinturier C, Imbert B, Carpentier P, Cracowski JL. Abnormal amplitude and kinetics of digital postocclusive reactive hyperemia in systemic sclerosis. Microvasc Res. 2014 Jul;94:90-5. doi: 10.1016/j.mvr.2014.05.007. Epub 2014 Jun 2.

family: Gaillard-Bigot

full_name: F. Gaillard-Bigot

given: F.

family: Roustit

full_name: M. Roustit

given: M.

family: Blaise

full_name: S. Blaise

given: S.

family: Gabin

full_name: M. Gabin

family: Cracowski

full_name: C. Cracowski

given: C.

family: Seinturier

full_name: C. Seinturier

family: Imbert

full_name: B. Imbert

given: B.

family: Carpentier

full_name: P. Carpentier

given: P.

full_name: J.L. Cracowski

journal_name: Microvascular Research

publisher_normalized: Elsevier

location_facility:
Clinical Research Center
Vascular Medical Unit


title: A Randomized Study Evaluating the Efficacy of the Synthetic Adhesive Solution Ifabond, in Reducing Seroma Formation Post Surgery in Breast Cancer Patients, When Used in Partial Mastectomy With or Without Axillary Lymph Node Dissection

acronym: Ifabond

summary: A randomized prospective simple-blind interventional study evaluating the efficacy of the synthetic adhesive solution "Ifabond", in patients undergoing breast cancer surgery. The main objective of this study is to determine if the application of Ifabond, in addition to the conventional method of breast surgery, reduces the postoperative seroma formation. The secondary objective is to assess quality of life immediately after surgery, and the need for needle aspiration of the axilla, when using Ifabond.

lead_sponsor: Michel Conte, M.D.

location_facility: Centre de Chirurgie Gynecologique Et Des Maladies Du Sein


title: Evaluation of the System NEXFIN for Continuous and Non-invasive Measure of the Blood Pressure During Cesarean Delivery Practised Under Spinal Anesthesia

acronym: NEXFIN-CESAR

summary: Hypotension after spinal anesthesia for cesarean delivery occurs frequently. Oscillometric measurement gives intermittent informations. Nexfin, a continuous noninvasive device, could help to detect hypotension.

ReferenceCitation: Bobet M, Joachim J, Gayat E, Bonnet A, Sievert K, Barnichon C, Fischler M, Le Guen M. Blood pressure measurement during cesarean delivery: Evaluation of a beat-to-beat noninvasive device (NexfinTM). Medicine (Baltimore). 2021 Jun 4;100(22):e26129. doi: 10.1097/MD.0000000000026129.

family: Bobet

full_name: Mathieu Bobet

given: Mathieu

family: Joachim

full_name: Jona Joachim

given: Jona

family: Gayat

full_name: Etienne Gayat

given: Etienne

family: Bonnet

full_name: Agnès Bonnet

given: Agnès

family: Sievert

full_name: Kerstin Sievert

given: Kerstin

family: Barnichon

full_name: Carole Barnichon

family: Fischler

full_name: Marc Fischler

given: Marc

family: Le Guen

full_name: Morgan Le Guen

given: Morgan

currency_apc_doaj: USD

journal_name: Medicine

license: cc-by-nc

license_normalized: cc-by-nc

evidence: open (via page says license)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Hopital Foch

location_facility:
Hopital Foch
Institut Hospitalier Franco-Britannique


title: Prospective Randomized Study Comparing the Results of Digital Rectal Examination in the Supine and Lateral Decubitus

acronym: RIFIONA

summary:
Digital rectal examination is an act clinically performed daily by physicians and surgeons. It remains the key diagnostic test and directs the therapeutic management of cancer of the lower and middle rectum. It can be done in two main positions: lateral decubitus, and supine.

However, no randomized study in colorectal surgery is not interested in evaluating the best position to perform a full rectal exam.

ReferenceCitation: Sabbagh C, Mauvais F, Vecten A, Ainseba N, Cosse C, Diouf M, Regimbeau JM. What is the best position for analyzing the lower and middle rectum and sphincter function in a digital rectal examination? a randomized, controlled study in men. Dig Liver Dis. 2014 Dec;46(12):1082-5. doi: 10.1016/j.dld.2014.08.045. Epub 2014 Sep 22.

family: Sabbagh

full_name: Charles Sabbagh

given: Charles

family: Mauvais

full_name: François Mauvais

given: François

family: Vecten

full_name: Amaury Vecten

given: Amaury

family: Ainseba

full_name: Najib Ainseba

given: Najib

family: Cosse

full_name: Cyril Cosse

given: Cyril

family: Diouf

full_name: Momar Diouf

given: Momar

family: Regimbeau

full_name: Jean-Marc Regimbeau

given: Jean-Marc

journal_name: Digestive and Liver Disease

title: What is the best position for analyzing the lower and middle rectum and sphincter function in a digital rectal examination? A randomized, controlled study in men

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
Beauvais General Hospital
Amiens Universitary Hospital


title: Filling Pressures of the Left Ventricle in Patients With Significant Aortic Stenosis: Study of Echocardiographic Parameters Compared to Invasive Evaluation

acronym: PRESSEVAL

summary:
Left valvular heart disease has become one of the most common heart disease in Western countries. This disease evolve over many years and are characterized by a long phase where the patient is "asymptomatic".

it is characterized by discomfort LV filling may worsen and lead typically to a pressure increase of LV pressure and the left atrium (LA) (1). The onset of symptoms is unpredictable and may occur at the stage of diastolic or systolic dysfunction.

Ventricular dysfunction may be insidious, the goal is to detect early dysfunction, knowing that it is often very difficult to know if the patient is actually symptomatic. The onset of symptoms sign an intolerance to the increase in LV filling pressures and LA , causing pulmonary hypertension .

Therefore, the study of the level of LV and LA filling pressures , if possible by a noninvasive method, would identify patients apparently asymptomatic even though their condition is advanced.

Pressures filling pressures can be explored by two methods:

cardiac catheterization, which is a direct and invasive measurement method
echocardiography, which is an indirect measurement method which has the advantage of being non-invasive The goal of this research is to compare the two methods.

lead_sponsor: University Hospital, Limoges


title: Pilot Study for the Development of a Non-invasive Diagnostic Score to Differentiate Between Essential Thrombocythemia, Premyelofibrosis and Myelofibrosis

acronym: BioScoreSMP

summary: Prospective study for the development of a non-invasive score for differentiating prefibrotic myelofibrosis from essential thrombocytosis and overt myelofibrosis.

ipd_sharing: Yes

ipd_sharing_description: Data of study protocol, Statiscal analysis plan and the infromed consent form will be made available after the study completion

lead_sponsor: University Hospital, Angers

location_facility:
Chu Angers
CHRU de Brest - Hôpital Morvan

intervention_type: Diagnostic Test


title: Interest of Ultrasonography in Electroneuromyography: Single-blind Randomised Controlled Clinical Trial

acronym: US ENMG

summary: Echo-nerve tracking during an electroneuromyographic (ENMG) examination by identifying the optimal stimulation site would reduce the stimulation intensities delivered to the patient and thus improve the tolerance of this examination.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU Nîmes
Nîmes University Hospital


title: Polymorphisms and Efficiency of Caffeine on Performances During Total Sleep Deprivation un Healthy Subject. Multicentric, Versus Placebo, Randomised, Cross Over, Double Blind Study

acronym: PERCAF

summary: In this multicentric controlled study, we aims to evaluate effect of caffeine on mental performances during a sleep deprivation protocol. Genetic polymorphisms are considered as a covariable.

ReferenceCitation: Erblang M, Drogou C, Gomez-Merino D, Rabat A, Guillard M, Beers PV, Quiquempoix M, Boland A, Deleuze JF, Olaso R, Derbois C, Prost M, Dorey R, Léger D, Thomas C, Chennaoui M, Sauvet F. Genetics and Cognitive Vulnerability to Sleep Deprivation in Healthy Subjects: Interaction of ADORA2A, TNF-α and COMT Polymorphisms. Life (Basel). 2021 Oct 19;11(10). pii: 1110. doi: 10.3390/life11101110.

family: Erblang

full_name: Mégane Erblang

given: Mégane

family: Drogou

full_name: Catherine Drogou

given: Catherine

family: Gomez-Merino

full_name: Danielle Gomez-Merino

given: Danielle

family: Rabat

full_name: Arnaud Rabat

given: Arnaud

family: Guillard

full_name: Mathias Guillard

given: Mathias

family: Beers

full_name: Pascal Van Beers

given: Pascal Van

family: Quiquempoix

full_name: Michael Quiquempoix

given: Michael

family: Boland

full_name: Anne Boland

given: Anne

family: Deleuze

full_name: Jean François Deleuze

given: Jean François

family: Olaso

full_name: Robert Olaso

given: Robert

family: Derbois

full_name: Céline Derbois

given: Céline

family: Prost

full_name: Maxime Prost

given: Maxime

family: Dorey

full_name: Rodolphe Dorey

given: Rodolphe

family: Léger

full_name: Damien Léger

given: Damien

family: Thomas

full_name: Claire Thomas

given: Claire

family: Chennaoui

full_name: Mounir Chennaoui

given: Mounir

family: Sauvet

full_name: Fabien Sauvet

given: Fabien

currency_apc_doaj: CHF

journal_name: Life

publisher: MDPI AG

publisher_dissemination: MDPI

publisher_group: MDPI

publisher_normalized: MDPI

ReferenceCitation: Erblang M, Sauvet F, Drogou C, Quiquempoix M, Van Beers P, Guillard M, Rabat A, Trignol A, Bourrilhon C, Erkel MC, Léger D, Thomas C, Gomez-Merino D, Chennaoui M. Genetic Determinants of Neurobehavioral Responses to Caffeine Administration during Sleep Deprivation: A Randomized, Cross Over Study (NCT03859882). Genes (Basel). 2021 Apr 10;12(4). pii: 555. doi: 10.3390/genes12040555.

lead_sponsor: Institut de Recherche Biomedicale des Armees

location_facility: Institut de recherche biomedical des armées


title: Chronic Fatigue Etiology in Intensive Care Unit Survivors: the Role of Neuromuscular Function

acronym: FatPostRéa

summary:
Chronic fatigue is the most common and debilitating symptom in intensive care unit (ICU) survivors. Indeed, it has been widely reported that patients who stayed in ICU for prolonged periods report a feeling of tiredness for months to years after ICU discharge. This chronic fatigue affects their quality of life by decreasing their capacity to perform simple tasks of daily life.

The aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in this feeling of chronic fatigue. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology will allow to optimize rehabilitation treatments to decrease the apparition/persistence of chronic fatigue and in fine improve life quality.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Hôpital privé de la Loire
Chu Saint-Etienne


title: A Randomized, Partial Blind, 3 Parallel Groups Study of the Pharmacodynamic Profile of SAR236553 (REGN727) Administered as Multiple Subcutaneous Doses, Either Alone or on Top of Ezetimibe or Fenofibrate Administered as Multiple Oral Doses in Healthy Subjects

summary:
Primary Objective:

To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol (LDL-C).

Secondary Objectives:

To assess the pharmacodynamic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate, based on other lipid parameters.
To assess the pharmacokinetic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate.

ReferenceCitation: Rey J, Poitiers F, Paehler T, Brunet A, DiCioccio AT, Cannon CP, Surks HK, Pinquier JL, Hanotin C, Sasiela WJ. Relationship Between Low-Density Lipoprotein Cholesterol, Free Proprotein Convertase Subtilisin/Kexin Type 9, and Alirocumab Levels After Different Lipid-Lowering Strategies. J Am Heart Assoc. 2016 Jun 10;5(6). pii: e003323. doi: 10.1161/JAHA.116.003323.

family: Rey

full_name: Jacques Rey

given: Jacques

family: Poitiers

full_name: Franck Poitiers

given: Franck

family: Paehler

full_name: Tobias Paehler

given: Tobias

family: Brunet

full_name: Aurélie Brunet

given: Aurélie

name: Regeneron Pharmaceuticals, Inc, Tarrytown, NY

family: DiCioccio

full_name: A. Thomas DiCioccio

given: A. Thomas

name: Harvard Clinical Research Institute, Boston, MA

family: Cannon

full_name: Christopher P. Cannon

given: Christopher P.

family: Surks

full_name: Howard K. Surks

given: Howard K.

family: Pinquier

full_name: Jean‐Louis Pinquier

given: Jean‐Louis

family: Hanotin

full_name: Corinne Hanotin

given: Corinne

family: Sasiela

full_name: William J. Sasiela

given: William J.

journal_name: Journal of the American Heart Association

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

evidence: oa repository (semantic scholar lookup)

title: Relationship Between Low‐Density Lipoprotein Cholesterol, Free Proprotein Convertase Subtilisin/Kexin Type 9, and Alirocumab Levels After Different Lipid‐Lowering Strategies

lead_sponsor: Sanofi

location_facility:
Investigational Site Number 250001
Investigational Site Number 250002


title: 18-FDG Tumour Metabolism Changes in PDL1 Superior to 50% Stage III/IV Non Small Cell Lung Cancer During First Line Treatment With Pembrolizumab

summary: The aim of this study is to describe the early dynamics of 18-FDG uptake in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response at 3 months.

lead_sponsor: Centre Henri Becquerel

location_facility:
Centre Henri Becquerel
CHU


title: Interest of TARC Serum Marker for Follow-up of Patients With Allergic Broncho-Pulmonary Aspergillosis (ABPA), Excluding Cystic Fibrosis

summary:
The main objective of this study is to determine if a doubling of serum TARC (compared to baseline) is associated with the occurrence of exacerbations of ABPA.

The secondary objectives of the study are :

To investigate if induced sputum eosinophils count (compared to baseline) is associated with the occurrence of exacerbations.
To examine if the exhaled NO (compared to a baseline) is associated with the occurrence of exacerbations.
To investigate if activation of circulating T cells (compared to a baseline) is associated with the occurrence of exacerbations.
To examine if the rate of specific Asp f IgG measured by ELISA (compared to a baseline) is associated with the occurrence of exacerbations.
To determine if the variation of one of the markers above, TARC or Asp f specific IgE measured at baseline, may be associated with the radiological stage of the disease (ABPA-S, ABPA-CB, ABPA-ORF).
To investigate if there is a link between fungal exposure at home (visually assessed by the contamination level and the proportion of positive samples for Asp. f) and the frequency of exacerbations.
To establish if some of the clinical, functional or biological data studied are associated with the frequency of exacerbations.

location_facility:
Nantes University Hospital
CHU Le Mans


title: Can Ventilatory Response at Rest Predict Ventilatory Efficacy and Exercise Tolerance in Patients With a Univentricular Congenital Heart Disease?

summary:
The aim is to evaluate the correlation between the respiratory control to hypercapnia at rest and the VE/VCO2 slope measured during cardiopulmonary exercise testing.

The hypothesis is that patient with univentricular congenital heart disease have a increasing of respiratory drive like chronic heart failure. This increasing of respiratory drive could participate in the increasing of VE/VCO2 slope measured during cardiopulmonary exercise testing and in the genese of central apnea index during the sleep.

lead_sponsor: University Hospital, Montpellier

location_facility: Arnaud de Villeneuve - University Hospital Pediatric and Congenital Cardiology Department Regional Reference Center - M3C


title: Prospective Study for 24-months of Physical Training Introduced in Lifestyle of Patients With Facioscapulohumeral Dystrophy : Tolerance, Sustainability and Efficiency of Unsupervised Training Program.

summary: It is now accepted that physical activity is not deleterious in myopathies, including muscular dystrophies. In patients suffering from facioscapulohumeral dystrophy (FSHD), aerobic training has been reported to be associated with physiological and functional positive effects without alteration in quality of life. Van der Kooi et al. (2005) and Cup et al. (2007) studies suggest that the combination of endurance and strength trainings is even more relevant. However, only a few controlled and randomized studies have been conducted on this topic and the impact of such training programs on skeletal muscle regenerative capacities has not been addressed yet. Moreover, due to the fact that training programs are mainly performed on short-term supervised periods, there is a lack of knowledge regarding long-term effects, patient's autonomy and whether or not practice of regular exercise can be maintained in patient's daily life. Also, only a few experiments report an integrative view of potential benefits of such programs on functional, biological and quality of life.

location_facility:
CHU de Saint-Etienne
CHU de Grenbole


title: Conformity With European Recommendations Concerning the Nutritional Care of the Cancerous Patients Benefiting From a Treatment by Chemotherapy Impact on the Nutritional State and the Quality of Life

summary:
The prevalence of malnutrition in cancerous patients varies between 50% and 80%. It is variable in function: the location and the extension of the tumor, of the general state , of age, of the socio-economic class and the pain. The health consequences of a malnutrition are very important: aggravation of the state of health, complications of treatment, hospitalization, alteration of the quality of life and decrease the survival, and the treatment response.

Nutrition being very important in patients, there are recommendations for the nutritional care of these patients, formulated by the European Society for Clinical Nutrition and Metabolism. The investigators do not know to what extent these recommendations are respected in practice and their influence on the nutritional status and the quality of life of patients.

The investigators therefore propose to assess the conformity of the nutritional care patients in clinical practice in relation to the European recommendations and in a second time to assess the influence of this compliance or non-compliance on the nutritional status clinical and biological of cancerous patients under chemotherapy, on their quality of life, on their response to treatment and on their survival.

The investigators will try to identify factors that may be linked to the non-compliance such as the characteristics of the cancer disease, socio-demographic characteristics of the subject and the factors related to the structure in which it is supported.

ReferenceCitation: Salas S, Mercier S, Moheng B, Olivet S, Garcia ME, Hamon S, Sibertin-Blanc C, Duffaud F, Auquier P, Baumstarck K. Nutritional status and quality of life of cancer patients needing exclusive chemotherapy: a longitudinal study. Health Qual Life Outcomes. 2017 Apr 27;15(1):85. doi: 10.1186/s12955-017-0660-6.

family: Salas

full_name: Sebastien Salas

given: Sebastien

family: Mercier

full_name: Sophie Mercier

given: Sophie

family: Moheng

full_name: Benjamin Moheng

given: Benjamin

family: Olivet

full_name: Sandrine Olivet

given: Sandrine

family: Garcia

full_name: Marie-Eve Garcia

given: Marie-Eve

family: Hamon

full_name: Sophie Hamon

family: Sibertin-Blanc

full_name: Camille Sibertin-Blanc

given: Camille

family: Duffaud

full_name: Florence Duffaud

given: Florence

family: Auquier

full_name: Pascal Auquier

given: Pascal

family: Baumstarck

full_name: Karine Baumstarck

given: Karine

journal_name: Health and Quality of Life Outcomes

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


acronym: PIVKIV

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

source: euctr

title: Comparing the Efficacy of Intravenous Paracetamol and Ketoprofen When Treating Renal Colic in Emergency Situations: a Randomized, Bi-centric, Double-blind Controlled Trial

summary: The main objective of this study was to demonstrate the non-inferiority of intravenous paracetamol relative to intravenous ketoprofen when treating renal colic in an emergency ward. Efficacy is measured by the change in verbal numeric scale (vns) for pain at 30 minutes.


title: Immune Damage and Vaccination in COPD Patients

acronym: ALTIBPCO

summary: Better understanding of the specificities of the vaccine response in patients with COPD

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
CHI Créteil
CHU Henri-Mondor


title: Evaluation of Nexfin During Induction of General Anesthesia and in Intensive Care During a Passive Legs Raising Test

summary:
The purpose of this study is to compare the non invasive measurement of arterial pressure (Nexfin monitor)with the invasive measurement of arterial pressure (radial artery catheter)

during induction of general anesthesia,
during a leg raising test in the Intensive Care Unit

ReferenceCitation: Weiss E, Gayat E, Dumans-Nizard V, Le Guen M, Fischler M. Use of the Nexfin™ device to detect acute arterial pressure variations during anaesthesia induction. Br J Anaesth. 2014 Jul;113(1):52-60. doi: 10.1093/bja/aeu055. Epub 2014 Apr 25.

family: Weiss

full_name: E. Weiss

given: E.

family: Gayat

full_name: E. Gayat

family: Dumans-Nizard

full_name: V. Dumans-Nizard

given: V.

family: Le Guen

full_name: M. Le Guen

given: M.

family: Fischler

full_name: M. Fischler

journal_name: British Journal of Anaesthesia

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

location_facility:
Hopital Foch
Institut Mutualiste Montsouris


title: Fibrosis a New Pathological Actor in Adipose Tissue

acronym: fibrota

summary:
Adipose tissue (AT) has specific alterations in obesity in particular increased fibrosis amount compared to lean subjects. Fibrosis amount measured by immunohistochemistry on adipose biopsies appears to to predict weight loss response after a bariatric surgery. Non invasive tools to measure fibrosis needs to be validated. The investigators primary aim is to validate a new device able to measure adipose tissue stiffness.

Thus the investigators plan to compare the stiffness results obtained with the device to the quantification of fibrosis using immuno-chemistry in massively obese patient's candidates to a bariatric surgery.

ReferenceCitation: Rouault C, Marcelin G, Adriouch S, Rose C, Genser L, Ambrosini M, Bichet JC, Zhang Y, Marquet F, Aron-Wisnewsky J, Poitou C, André S, Dérumeaux G, Guerre-Millo M, Clément K. Senescence-associated β-galactosidase in subcutaneous adipose tissue associates with altered glycaemic status and truncal fat in severe obesity. Diabetologia. 2021 Jan;64(1):240-254. doi: 10.1007/s00125-020-05307-0. Epub 2020 Oct 30.

family: Rouault

full_name: Christine Rouault

given: Christine

family: Marcelin

full_name: Geneviève Marcelin

given: Geneviève

family: Adriouch

full_name: Solia Adriouch

given: Solia

family: Rose

full_name: Cindy Rose

given: Cindy

family: Genser

full_name: Laurent Genser

given: Laurent

family: Ambrosini

full_name: Marc Ambrosini

given: Marc

family: Bichet

full_name: Jean-Christophe Bichet

given: Jean-Christophe

family: Zhang

full_name: Yanyan Zhang

given: Yanyan

family: Marquet

full_name: Florian Marquet

given: Florian

family: Aron-Wisnewsky

full_name: Judith Aron-Wisnewsky

given: Judith

family: Poitou

full_name: Christine Poitou

family: André

full_name: Sébastien André

given: Sébastien

family: Dérumeaux

full_name: Geneviève Dérumeaux

family: Guerre-Millo

full_name: Michèle Guerre-Millo

given: Michèle

family: Clément

full_name: Karine Clément

journal_name: Diabetologia

ReferenceCitation: Bel Lassen P, Charlotte F, Liu Y, Bedossa P, Le Naour G, Tordjman J, Poitou C, Bouillot JL, Genser L, Zucker JD, Sokolovska N, Aron-Wisnewsky J, Clément K. The FAT Score, a Fibrosis Score of Adipose Tissue: Predicting Weight-Loss Outcome After Gastric Bypass. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2443-2453. doi: 10.1210/jc.2017-00138.

family: Bel Lassen

full_name: Pierre Bel Lassen

given: Pierre

family: Charlotte

full_name: Frederic Charlotte

given: Frederic

family: Liu

full_name: Yuejun Liu

given: Yuejun

family: Bedossa

full_name: Pierre Bedossa

journal_name: The Journal of Clinical Endocrinology & Metabolism

ReferenceCitation: Liu Y, Aron-Wisnewsky J, Marcelin G, Genser L, Le Naour G, Torcivia A, Bauvois B, Bouchet S, Pelloux V, Sasso M, Miette V, Tordjman J, Clément K. Accumulation and Changes in Composition of Collagens in Subcutaneous Adipose Tissue After Bariatric Surgery. J Clin Endocrinol Metab. 2016 Jan;101(1):293-304. doi: 10.1210/jc.2015-3348. Epub 2015 Nov 19.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

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

ReferenceCitation: Verger EO, Aron-Wisnewsky J, Dao MC, Kayser BD, Oppert JM, Bouillot JL, Torcivia A, Clément K. Micronutrient and Protein Deficiencies After Gastric Bypass and Sleeve Gastrectomy: a 1-year Follow-up. Obes Surg. 2016 Apr;26(4):785-96. doi: 10.1007/s11695-015-1803-7.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

location_facility: Service de nutrition du Pr Basdevant -Pitié salpêtrière/ Institut Cardiometabolism and nutrition

location_facility: Service de Chirurgie générale et digestive et d'oncologie du Pr Nordlinger -Ambroise Paré