title: Evaluation of Performance Diagnosis of Hemodynamic Parameters of Preload Dependence in ARDS Patients During Prone Position

acronym: PRD-ARDS-PP

summary: Preload dependence assessment is difficult during prone position, and to date, no hemodynamic parameters have been validated to rationalize fluid loading in that position. This study aims to validate several hemodynamic parameters, using continuous cardiac output by pulse contour analysis and transpulmonary thermodilution.

ReferenceCitation: Yonis H, Bitker L, Aublanc M, Perinel Ragey S, Riad Z, Lissonde F, Louf-Durier A, Debord S, Gobert F, Tapponnier R, Guerin C, Richard JC. Change in cardiac output during Trendelenburg maneuver is a reliable predictor of fluid responsiveness in patients with acute respiratory distress syndrome in the prone position under protective ventilation. Crit Care. 2017 Dec 5;21(1):295. doi: 10.1186/s13054-017-1881-0.

lead_sponsor: Hospices Civils de Lyon


study_start_date_type: Actual

acronym: ANGIOCATH

intervention_type: Drug

lead_sponsor: Nantes University Hospital

summary:
Hypertensive leg ulcer, also called Martorell ulcer, represents 1 to 15% of leg ulcers in hospital. These ulcers are painful, long to heal, and hospitalization is sometimes necessary for analgesia and debridement of necrotic tissue. Strong opioids are often required, and are responsible of many side effects. Martorell ulcer arises predominantly in women over 60 years of age, with history of vascular disease, and therefore with a higher risk of adverse event. Pain is also part of the physiopathology, inducing a vasospasm which increases ulcer extension and ischemia.

This is why pain management is one of the main challenge in treatments of these ulcers.

Continuous nerve block of lower limbs are often used during per and postoperative orthopaedic surgery. Few adverse events and rare serious adverse events related to local anesthesic are reported (respectively <1% and <1/1000), and few adverse events related to catheter are reported (<1%). Its benefits have been proved on post-operative pain management and reeducation.

The aim of this study is to assess analgesia provided by continuous sciatic nerve block, in patients with hypertensive leg ulcer, during hospitalization.

Thirty patients will be enrolled on a 3-years period. They will receive a continuous sciatic nerve block with ropivacaïne 0,2%, during 7 days.

Pain intensity will be assessed by 4 datas : numerating rating scale (NRS) at rest, during wound care, maximal and mean. These datas will be collected over two 3-days period : the first 3 days of hospitalization, in which pain treatment will be prescribed depending on pain intensity of the patient ; and the first 3 days of ropivacaïne treatment.

The main evaluation criteria will be at least a 50% decrease of one of the pain NRS when receiving ropivacaïne.

Time to healing, microcirculation evolution measured by Transcutaneous Oxygen Pressure (TcPO2), and quality of life of patients will be collected over a 6 months follow-up.

status: Completed

title: Monocentric Prospective Study, in Order to Assess Analgesia Provided by Continuous Sciatic Nerve Block, in Patients With Hypertensive Leg Ulcer.

primary_purpose: Treatment

source: euctr

enrollment_type: Actual

study_completion_date_type: Actual

study_type: Interventional

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Analysis of Host Genetic Factors in the Occurrence of Anemia and on the Virological Response to a Peg-interferon/Ribavirin Therapy in HIV-HCV Co-infected Patients

summary:
The treatment of HCV (hepatitis C virus) infection has made significant progress over the past decade with the therapy combining pegylated interferon (Peg-IFN) to ribavirin (RBV). The cure of HCV infection which consists to obtain a sustained virological response (SVR) (undetectable HCV RNA 24 weeks after end of treatment) is reached in more than 50% of patients infected with HCV. However, this rate is much lower, around 30 to 40% in HIV-HCV co-infected patients and sometimes can be less than 20% for patients infected with HCV genotype 1. Haemolytic anemia is a dose-limiting adverse effect which occurs frequently under RBV therapy. RBV-induced anemia represents the main cause of treatment discontinuation or dose reduction of RBV, thus limiting the chances of achieving a SVR. RBV has a large inter-individual pharmacokinetic variability and a relationship between the occurrence of anemia and RBV concentration was clearly demonstrated. However, other factors, including genetic factors, could be predictive of hematotoxicity and/or a better efficiency. In particular, IL-28B polymorphism analysis, in patients infected with HCV genotype 1, before starting antiviral therapy could predict the response to treatment (positive predictive value). The genetic polymorphism of inosine triphosphate pyrophosphatase (ITPA) is also strongly associated to a protective effect towards the RBV-induced-anemia. But most of these data are issued from studies performed in a Japanese HCV mono-infected population treated with Peg-IFN-RBV therapy for which there is no other causal variant that the rs1127354. Only few studies are reported in the literature in caucasian HIV-HCV co-infected patients. Moreover, data on RBV plasma exposure are very scarce in all these studies showing an impact of the ITPA polymorphism on the occurrence of anemia. In addition, others polymorphisms of SCL29A1/A2 and SCL28A2/A3 coding for RBV transporters, ENT (equilibrative nucleoside transporter) et CNT (concentrative nucleoside transporter) would be associated to either rapid virological response or anemia in HCV infected patients treated by Peg-IFN plus RBV. No study considering both polymorphisms of ITPA, IL-28B, SCL29A1/A2 and SCL28A2/A3 genes and RBV plasma exposure data has so far been conducted in HIV-HCV co-infected patients.

Thus, it would be interesting in a first time to assess the impact of the ITPA polymorphism on both the RBV plasma exposure and the protective effect towards RBV-induced anemia in HIV-HCV co-infected patients. This study could be helpful to the literature for possible further RBV dose adjustments according to ITPA activity.

Then, it would be relevant to further complete these data by assessing other genetic polymorphisms as IL-28B, SCL29A1/A2 and SCL28A2/A3 and thus evaluate the overall pharmacogenetic relationships towards RBV-induced anaemia and/or virological response to a Peg-IFN/RBV therapy.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Genetic


title: "Narcisse & Echo : Self-consciousness and the Inter-subjective Body"

acronym: Narcisse

summary: The purpose of this study is to demonstrate that bodily self-consciousness is subjectively and inter-subjectively constituted and that some dimensions of the bodily self-consciousness are impaired in Anorexia nervosa.

design_allocation: Non-Randomized

lead_sponsor: Centre Hospitalier St Anne

sponsor_collaborators:
Centre Hospitalier St Anne
The Volkswagen Foundation

intervention_type: Other


title: Phase I-II Trial of Gemcitabine Plus Nab-paclitaxel (GemBrax) Followed by Folfirinox as First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma.

acronym: GABRINOX

summary:
Based on conventional chemotherapy approach, data have indicated that the Folfirinox regimen is more effective and tolerate than the treatment by Gemcitabine alone in patients with metastatic pancreatic adenocarcinoma. A recent study combining gemcitabine and nab paclitaxel improve the objective response rate.

Primary objective of this study is to identify the maximun tolerated dose and the recommended phase II dose of first line treatment combining gemcitabine plus nab-paclitaxel followed by folfirinox in metastatic pancreatic adenocarcinoma.

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

location_facility: Institut regional du Cancer - Val d Aurelle

lead_sponsor_type: industriel


title: Evolution of Gastric Volume Measured by Gastric Tomodensitometry With Gas After Gastric Bypass Surgery or Sleeve Gastrectomy. Research for a Correlation With Weight Evolution : Pilot Study.

acronym: VOLUSCAN

summary:
The Gastric bypass (GBP) is actually one of the most performed bariatric procedures worldwide. Short term results report 67% of mean Excess Weight Loss (EWL) at 2 years, and 58% EWL at 5 years. Sleeve gastrectomy (SG) which is a restrictive procedure has gained in popularity because of its technical simplicity and its efficiency (60% EWL at 1 year and 48% over 4 years). However, failures are observed because of insufficient weight loss or early weight regain. Several hypotheses have been proposed to explain these failures, such as the size of the gastric pouch that could be correlated to weight evolution.

Purpose of the study Taking the hypothesis that a progressive dilatation of the gastric pouch is one of the main factors of weight loss failure after GBP or SG due to the loss of its restrictive function, the aim of our study is to measure these gastric volumes using gastric tomodensitometry with gas, a new reliable,precise and 3 dimension radiological technique. The investigators will try to identify a positive correlation between gastric dilatation and weight regain.

Methods This is a 2 year interventional, prospective, monocentric study with longitudinal follow-up. Forty-five obese patients (BMI>40kg/m²) eligible for primary GBP (n=25) or SG (n=20) will be included. Gastric volumes will be measured by gastric tomodensitometry with gas at 3 and 12 month after surgery. In the GBP group, the investigators will measure the gastric pouch volume, the candy cane Roux limb volume, the neostomach volume (= gastric pouch+candy cane Roux limb) and the gastro-jejunal anastomosis diameter. In the SG group, the investigators will measure the volume of the gastric tube, of the non resectedantrum, of the whole residual stomach and the gastric tube diameter at the middle of the small curvature. Volume variations between 3 and 12 months will be compared to the EWL and to clinical and metabolic data (HbA1c, Insulinemia, HOMA index, liver steatosis). A 30% dilatation of the neostomach at 12 months will be considered as significant. Reinhold's criteria will be used to define surgical failure: EWL<50% at 12 months. Weight regain will be considered as significant if the weight reached at 12 months is higher than the minimum weight obtained. Gastric volume variation, EWL and BMI evolution between the 3rd and the 12th month will be analysed in the whole population and in each group (GBP and SG) with a Wilcoxon test.

Expected benefits If the investigators valid the hypothesis that the dilatation of the neostomach is an essential factor in weight regain after GBP and SG, the benefit for the patient will be dual: 1/ validate the prognostic value of gastric volumetry by gastric tomodensitometry with gas in order to explain weight regain, and in order to use it as a standard. 2/ the identification of specific risk factors related to the surgical procedure could result in surgical technique improvements as well as a better adaptation of revisional procedures, in order to improve treatment of recurrent obesity.

primary_purpose: Diagnostic

ReferenceType: result

ReferenceCitation: Robert M, Pechoux A, Marion D, Laville M, Gouillat C, Disse E. Relevance of Roux-en-Y gastric bypass volumetry using 3-dimensional gastric computed tomography with gas to predict weight loss at 1 year. Surg Obes Relat Dis. 2015 Jan-Feb;11(1):26-31. doi: 10.1016/j.soard.2014.05.014. Epub 2014 May 23.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

location_facility: Hospices Civils de Lyon- hôpital Edouard Herriot- service de Chirurgie Digestive

intervention_type: Device


title: Cutaneous Microcirculation and Diabetic Foot

summary: 15% of diabetics have a diabetic foot (DF) in their lives associated with a risk of amputation and mortality two times greater than that of a diabetic population without DF. Predicting the occurrence of an DF is limited and only the occurrence of a diabetic wound up involved assessment and treatment. Our team is behind the discovery of the Pressure-Induced Vasodilation (PIV) first observed in healthy subjects after local application of a gradual pressure on the skin leading to cutaneous vasodilation at the application of pressure. This gain in blood flow delays the onset of ischemia. However the involvement of PIV in the DF, which is also a pressure-induced skin lesion, remains to be demonstrated in diabetic subjects. The main objective of this study is to show that PIV, a functional examination of the cutaneous microcirculation we developed, is altered in the presence of DF, taking into account the influence of age and neuropathy.

design_allocation: Randomized

primary_purpose: Basic Science

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud


title: Prospective Randomised Double-blind Study to Compare Ropivacaine 10mg/mL Alone Versus Ropivacaine 10mg/mL Associated With Clonidine 1µg/kg for Peribulbar Anesthesia in Posterior Eye Surgery

acronym: CRAPO

summary:
This is a study conducted in 60 patients, randomly assigned to one of two groups of 30: the first will receive ropivacaine alone and the second will receive the association ropivacaine/clonidine.

The aim of the study is to prove that the association of Clonidine with Ropivacaine is more effective than ropivacaine alone for locoregional anaesthesia of the eye for retinal surgery.

The principal interest of this association of drugs is that it procures faster and longer anaesthesia of the eye with less ropivacaine (therefore fewer injections). This provides greater comfort to the patient during and after the intervention.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Clinical and Molecular Characterisation of Orofaciodigital Syndromes and Other Clinical Phenotypes Secondary to Mutations in the OFD1 Gene

summary:
The aim of this multicentre study will be to better describe the clinical characteristics and the etiological bases of patients with OFD syndrome by identifying new genes involved in OFD syndrome. These results will make it possible, from patients who have been clearly identified from a clinical, cytogenetic and molecular point of view, to determine a study strategy in such patients. The data obtained will be used to guide clinical geneticists in genetic counselling for patients and their families.

Identification of the molecular bases of the different OFD syndromes will make it possible to determine whether or not they belong to the group of ciliopathies like type I OFD and to understand their physiopathological bases.

This study will also make it possible to better characterise the phenotype of boys with syndromic mental retardation related to the OFD1 gene and thus to define the clinical criteria of the study of this gene in boys with mental retardation.

The complete absence of knowledge concerning the genetic bases of OFD syndromes, apart from type I, the presence of a large collection of samples from patients with OFD syndrome at Dijon CHU, the recognition of the diagnostic laboratory for syndromic OFD at the international level as well as the technical platform and expertise in molecular cytogenetic methods including CGH-array and molecular genetics (sequencing, quantitative PCR, fragment analysis) at the Cytogenetics and Molecular Biology laboratories at Dijon CHU justify the implementation of such a study in 2010.

status: Unknown status

study_type: Observational

enrollment_type: Anticipated

intervention_type: Biological

status_simplified: Unknown


title: Citrate Versus Heparin for the Lock of Non-tunneled Hemodialysis Catheters in Patients Hospitalised in ICU = Multicentre, Controlled, Randomised Superiority Trial

acronym: VERROU-REA

summary:
After obtaining written informed consent and inclusion, patients will be randomised into 2 groups for the type of dialysis catheter lock:

The first group will have a citrate lock
The second group will have a heparin lock Patients will be stratified according to the centre and type of Renal Replacement Therapy (RRT) continuous or intermittent.

The daily surveillance of patients will not be different from the usual surveillance of patients on Renal Replacement Therapy.

The hemodialysis catheters used will be specific Renal Replacement Therapy catheters.

The decision to withdraw the catheter will be made by the investigator and based on clinical criteria (complications related to the catheter, termination of Renal Replacement Therapy…)

ReferenceType: derived

ReferenceCitation: Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: publishedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Quenot JP, Helms J, Bourredjem A, Dargent A, Meziani F, Badie J, Blasco G, Piton G, Capellier G, Mezher C, Rebibou JM, Nadji A, Crepin T, Barbar SD, Fleck C, Cransac A, Boulin M, Binquet C, Soudry-Faure A, Bruyere R; VERROU-REA Trial Investigators and the CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). Trisodium citrate 4% versus heparin as a catheter lock for non-tunneled hemodialysis catheters in critically ill patients: a multicenter, randomized clinical trial. Ann Intensive Care. 2019 Jul 1;9(1):75. doi: 10.1186/s13613-019-0553-4.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Bruyere R, Soudry-Faure A, Capellier G, Binquet C, Nadji A, Torner S, Blasco G, Yannaraki M, Barbar SD, Quenot JP. Comparison of heparin to citrate as a catheter locking solution for non-tunneled central venous hemodialysis catheters in patients requiring renal replacement therapy for acute renal failure (VERROU-REA study): study protocol for a randomized controlled trial. Trials. 2014 Nov 19;15:449. doi: 10.1186/1745-6215-15-449.

publisher_dissemination: Springer


title: Prospective Study on the Influence of Psychosocial Variables (Stress, Type A Behaviour Pattern, Quality of Life of the Diabetic) on Glycemic Balance in Patients With Type 1 and 2 Diabetes.

acronym: DPP

summary: This study is based on the analysis of psychological and social questionnaires filled in by diabetic patients whose glycemic balance will be assessed by measuring blood levels of glycated haemoglobin. The aim is to compare glycemic balance by measuring HbA1c in diabetic patients (type 1 and 2) according to whether they have a Type A or B psychosomatic profile evaluated by the Bortner self-questionnaire.

time_perspective: Prospective


title: Early Rehabilitation Program is Feasible and Safe in ICU in Liver Transplanted Patients

summary:
Liver transplantation is the last surgical treatment for patients with acute or chronic liver disease. Transplantation therapies technics are in constant evolution. It allows an increasing survivals rates and time to come back to daily activities. The postoperative treatment after abdominal surgery as Liver Transplantation (LT) is usually performed in Intensive Care Unit (ICU).This postoperative phase is one of the most important steps regarding the involvement of the rehabilitation of the patient (Rongies 2005). Physical abilities transplantation are likely to be important in the postoperative. It appears that pre-transplant subjects have a weakened muscle potential, they will increase it significantly in the months after transplantation with a rehabilitation program adapted (Beyer 1999). Length of stay in ICU depends on surgery complications. Inactivity induced by sedation and ICU length of stay are major factor for increasing complications as respiratory disorders and muscle weakness. Several studies have reported feasibility and safety an early mobility program in ICU, especially regarding the length of stay decrease (Bailey 2007; Morris 2008; Schweickret 2009, Needham 2010; Bourdin 2010) These early mobility programs encompass muscle strength assessment, passive range of motion, active mobility, sitting on the edge of bed, standing and walking, which would be related to the primary disease of LT (Rongies 2008). The assessment of the strength for ICU patient is feasible and reproducible with the Medical Research Council score (MRC score). The MRC score consists in an assessment of three muscle groups of upper and lower limbs. Sitting positions and verticalization are included in programs begun as soon as possible after surgery evaluation of the response level to verbal stimulation and physical abilities (Gosselink 2011). The skills of the physiotherapist are established in legal texts making him a key in the assessment and management of these patients on musculoskeletal and respiratory domains.

The purpose of this study is to validate data feasibility and tolerance. Another aim is also to assess the length of stay in ICU, of early mobility and physical program, started in the postoperative period in a population of patients with liver transplantation, during their stay in ICU of Prof. Albanese. Thus, we decided to carry out a parallel study, open, randomized monocentric comparing two groups of patient liver transplanted. The control group will receive the standard treatment used in the ICU and the experimental group will receive a protocol of early mobilization according to data from recent literature on the subject. The study is scheduled to last over one year and included patients will receive physical therapy on five days a week with a frequency of one to several times per day depending on the clinical requirements or conditions of the study.

study_completion_date_type: Anticipated

primary_purpose: Supportive Care

ReferenceCitation: Maffei P, Wiramus S, Bensoussan L, Bienvenu L, Haddad E, Morange S, Fathallah M, Hardwigsen J, Viton JM, Le Treut YP, Albanese J, Gregoire E. Intensive Early Rehabilitation in the Intensive Care Unit for Liver Transplant Recipients: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Aug;98(8):1518-1525. doi: 10.1016/j.apmr.2017.01.028. Epub 2017 Mar 6.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille


title: Dysfunctions and Plasticity Mechanisms of Motor System Assessed by Cortico-cortical and Cortico-muscular Coherence Analysis in Amyotrophic Lateral Sclerosis

summary:
Amyotrophic lateral sclerosis (ALS) is characterized clinically by abnormalities of both upper motor neurons (UMN) and lower motor neurons (LMN). The presence of UMN signs is not always easy to establish. The only technique used in routine to assess the corticospinal dysfunctions is based on transcranial magnetic stimulation (TMS). However, this technique is largely dependent on LMN state and is based on artificial motor cortex activation.

The main objective of our study project is to evaluate a new method assessing functional changes in motor system in ALS patients. By using cortico-muscular and cortico-cortical coherences, it could be possible to show modifications in both cortico-muscular relationship and in cortical activity coordination which could be related to clinical state in ALS patients. We notably expect a decrease in cortico-muscular coherence in ALS patients. Furthermore, these analyses could provide new insights in motor system plasticity phenomena. We expect a partial covering of voluntary motor command by cortical areas adjacent to primary motor cortex. Lastly, the hypothesis that an increased proportion of voluntary motor control may be assumed by ipsilateral corticospinal tract could be tested by coherence analyses.

Coherence analysis might be a useful method to detect corticospinal tract dysfunctions. This method has the advantage to be painless and not to use artificial stimulations as it is used in TMS.

status: Suspended

intervention_type: Procedure


summary:
R-CHOP with doxorubicin is the standard first line treatment of high grade non-Hodgkin's lymphoma. In order to avoid central venous system insertion and reduce hospitalization time in elderly patients, we developed an oral chemotherapy treatment: " OROCIEP"trial.

Nineteen patients were enrolled and 127 chemotherapy cycles were available for toxicities. The estimated two-years overall survival was 74%. The main haematological toxicity was neutropenia.

This study is still ongoing to confirm recommended dose of oral anthracycline.

ReferenceCitation: Guidez S, Lacotte-Thierry L, Tomowiak C, Princet I, Dreyfus B, Olivier G, Fleck E, Corby A, Motard C, Barrier J, Machet A, Le Du K, Debiais-Delpech C, Chabin M, Leleu X, Guilhot J, Delwail V. Oral CHOP-like chemotherapy in 60-80 years-old patients with diffuse large B-cell lymphoma. Br J Haematol. 2019 Sep;186(6):e175-e178. doi: 10.1111/bjh.16056. Epub 2019 Jul 15. No abstract available.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

unpaywall_oa_status: hybrid

lead_sponsor: Poitiers University Hospital


title: In Vivo TICE (TransIntestinal Cholesterol Excretion) Measurement in Bile Duct Diverted Patients

acronym: in vivoTICE

summary: So far, the liver has been the main target for cholesterol elimination. However, several recent studies performed in mice have described a new route of cholesterol excretion, the Trans-Intestinal Cholesterol Excretion or TICE. TICE allows direct elimination of plasma cholesterol in the feces directly via the intestine. Until now, only indirect evidence suggests that TICE is also active in humans, the goal of this proof of concept study is to provide the first proof of its existence in humans by using stable isotopes in patients with bile duct diversion.

ReferenceCitation: Moreau F, Blanchard C, Perret C, Flet L, Douane F, Frampas E, Mirallie E, Croyal M, Aguesse A, Krempf M, Prieur X, Pichelin M, Cariou B, Le May C. In vivo evidence for transintestinal cholesterol efflux in patients with complete common bile duct obstruction. J Clin Lipidol. 2019 Jan-Feb;13(1):213-217.e1. doi: 10.1016/j.jacl.2018.09.010. Epub 2018 Sep 21.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

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

repository_normalized: HAL

version: submittedVersion

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

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories_concat: HAL


type: Other Grant/Funding Number

title: Multicentre Evaluation of a New Laboratory Approach for the Diagnosis of Constitutional Functional Disorders of Platelets

summary: The primary purpose of the study is to evaluate a standardized method of screening for platelet signalling defects in patients with constitutional disorders of platelet function of unknown origin. We hypothesize that such defects are under-diagnosed in patients, due to heavy workup and requirement of relatively large blood sample by conventional biochemical methods. We propose to analyse kinase signalling downstream platelet membrane receptors using multiplex flow cytometry quantification and fluorescent platelet barcoding.

lead_sponsor: University Hospital, Toulouse


title: Causative Diagnosis on Prosthetic Joint Infections: Establishment of a Comprehensive Diagnostic Strategy

summary:
On joint orthopaedic hardware infections are one of the most frequently encountered complications in orthopaedic surgery. However 6% of the cultures remain sterile, etiological diagnosis cannot be established despite obvious signs of infection. As part of this research project, we have developed a new strategy diagnosis including directly the use of PCR to reduce the number of negative results. This should have a major therapeutic impact in terms of timeliness and specificity of antibiotic.

Primary:

Evaluate the effectiveness of the new diagnostic strategy on etiological identification of prosthesis infections.

Hypothesis:

Minimum 6 percent increase in the number of patients with an etiological diagnosis of infection on prosthesis.


title: FREnch Survey on Heart Failure

acronym: FRESH

summary:
Heart failure is the most common heart disease with increasing incidence due to the aging of the population is improving the initial prognosis of various conditions that lead to more or less progressive heart failure.

Heart failure is of great variety of clinical and pathophysiological forms necessitating the creation of quality records to clarify each of these forms.

Many types of cardiomyopathies exist, some of which are infrequent but with specific care.

At the French level, few data exist. In addition, the therapeutic management changes regularly.

New European recommendations (endorsed by the French Society of Cardiology = FSC) were published in May 2012. Many therapeutic approaches are being evaluated. The course of care and how to take non-drug load (network monitoring, rehabilitation ...) have become important issues that have hardly been analyzed by existing records.

This also leads to better define the different forms of this disease, their natural history and methods of management applied in real life. The register of FSC follows the registry of the European Society of Cardiology (ESC)"Heart Failure (HF) Long Term" (CCTIRS No. 11.355bis) with inclusions will be completed in November 2012. This new study aims to generate more accurate data on a number of points and be more representative for a wider selection of patients, the French level.

ReferenceType: background

ReferenceCitation: Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the diagnosis and treatment of acute and chronic heart failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur J Heart Fail. 2008 Oct;10(10):933-89. doi: 10.1016/j.ejheart.2008.08.005. Epub 2008 Sep 16. No abstract available. Erratum In: Eur J Heart Fail. 2009 Jan;11(1):110. Eur J Heart Fail. 2010 Apr;12(4):416. Dosage error in article text.

ReferenceCitation: Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW; American College of Cardiology Foundation; American Heart Association. 2009 Focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines Developed in Collaboration With the International Society for Heart and Lung Transplantation. J Am Coll Cardiol. 2009 Apr 14;53(15):e1-e90. doi: 10.1016/j.jacc.2008.11.013. No abstract available. Erratum In: J Am Coll Cardiol. 2009 Dec 15;54(25):2464.

ReferenceCitation: Heart Failure Society of America; Lindenfeld J, Albert NM, Boehmer JP, Collins SP, Ezekowitz JA, Givertz MM, Katz SD, Klapholz M, Moser DK, Rogers JG, Starling RC, Stevenson WG, Tang WH, Teerlink JR, Walsh MN. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail. 2010 Jun;16(6):e1-194. doi: 10.1016/j.cardfail.2010.04.004.

ReferenceCitation: Gheorghiade M, Zannad F, Sopko G, Klein L, Pina IL, Konstam MA, Massie BM, Roland E, Targum S, Collins SP, Filippatos G, Tavazzi L; International Working Group on Acute Heart Failure Syndromes. Acute heart failure syndromes: current state and framework for future research. Circulation. 2005 Dec 20;112(25):3958-68. doi: 10.1161/CIRCULATIONAHA.105.590091. No abstract available.

ReferenceCitation: Nieminen MS, Bohm M, Cowie MR, Drexler H, Filippatos GS, Jondeau G, Hasin Y, Lopez-Sendon J, Mebazaa A, Metra M, Rhodes A, Swedberg K, Priori SG, Garcia MA, Blanc JJ, Budaj A, Cowie MR, Dean V, Deckers J, Burgos EF, Lekakis J, Lindahl B, Mazzotta G, Morais J, Oto A, Smiseth OA, Garcia MA, Dickstein K, Albuquerque A, Conthe P, Crespo-Leiro M, Ferrari R, Follath F, Gavazzi A, Janssens U, Komajda M, Morais J, Moreno R, Singer M, Singh S, Tendera M, Thygesen K; ESC Committe for Practice Guideline (CPG). Executive summary of the guidelines on the diagnosis and treatment of acute heart failure: the Task Force on Acute Heart Failure of the European Society of Cardiology. Eur Heart J. 2005 Feb;26(4):384-416. doi: 10.1093/eurheartj/ehi044. Epub 2005 Jan 28. No abstract available.

ReferenceCitation: Tavazzi L, Maggioni AP, Lucci D, Cacciatore G, Ansalone G, Oliva F, Porcu M; Italian survey on Acute Heart Failure Investigators. Nationwide survey on acute heart failure in cardiology ward services in Italy. Eur Heart J. 2006 May;27(10):1207-15. doi: 10.1093/eurheartj/ehi845. Epub 2006 Apr 7.

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lead_sponsor: French Cardiology Society


title: Recurrent Prostate Cancer After Irradiation Treated With Brachytherapy Remedial: Phase 2 Study

acronym: CAPRICUR

summary:
After a curative treatment by radiotherapy for localized prostate cancer, between 20% and 50% of patients may have a biological relapse as a progressive re -rise of PSA. After prostate brachytherapy with low flow, this rate is between 2% and 6%. Depending on risk factors initially present, some patients will have a micro metastatic disease at the time of re-rise, but others will have a true local recurrence purely intra-prostate. Local recurrence after radiotherapy is associated with a high incidence of distant metastatic relapse and poor overall survival. For these reasons, the possibility of offering a local treatment for this selected population of patients can have a major therapeutic interest and allow changing a situation often considered palliative to the possibility of a second curative treatment.

Currently, there is no consensus regarding the optimal management of patients with purely local recurrence after prostate irradiation at first intention. When an external radiotherapy or brachytherapy is performed as first choice in a patient with prostate cancer, several remedial treatments have been proposed, with controversial results the decision-making for clinicians and for difficult patients. These main therapeutic options remedial (surgery, cryotherapy and brachytherapy) have the potential for complications such as rectal injury, impotence or incontinence Brachytherapy is a new salvage treatment being evaluated in the United States (Phase II study of the Radiation Therapy Oncology Group No. 0526). Several retrospective trials have shown very encouraging results in terms of acute toxicity and biochemical control in the short term. Thus, a team from Mount Sinai in New York recently published for the first time 10 years retrospective results with this approach. In their experience after treatment failures with external beam radiotherapy or brachytherapy, a dose of 122 Gy was delivered over 90% of the prostate gland. Doing this they observed biochemical control rates and survival specific of 54 % and 96 %, respectively at 10 years, with an hormone treatment associated (median 6 months) in 84 % of cases. Four patients had grade 3 toxicity or higher (11%). To reduce the rate of late toxicities the team from the University Of California San Francisco (UCSF), tested focal brachytherapy guided by functional MRI (MRI spectroscopy) to re-treat local recurrence after initial brachytherapy as monotherapy or boost. By delivering 144 Gy on recidivism objectified on MRI, the authors observed that a minimal dose of 37Gy covered 90 % of the prostate gland to treat the risk of microscopic disease. Doing this, the rate of observed toxicities and biochemical control appeared encouraging, with a median follow-up of 2 years, since no grade 3 toxicity was observed and 74% of patients achieved a PSA nadir <0.5 ng / mL without associated hormone. In case of external radiation or brachytherapy, several attempts proposed to associate an injection of hyaluronic acid gel to the prostate - rectum interface to spare healthy tissue irradiated and thus reduce the rate of radiation proctitis. The feasibility of implementing this gel has been demonstrated in patients with non- irradiated tissues. No inherent toxicity of the injection of hyaluronic acid gel has been described after prostate brachytherapy first line. The feasibility of this injection remains unproven to date on patients previously irradiated externally or by brachytherapy. We hypothesize that the risk of radiation proctitis and fistulas front prostate could be reduced using this technique in this indication.

We propose to carry out a French prospective multicenter phase II trial combining brachytherapy remedial with an injection of hyaluronic acid after surgery to reduce the risk of radiation proctitis and / or recto -urinary fistula in a patient population hyper- selected with a high probability of isolated local recurrence.

lead_sponsor: Centre Georges Francois Leclerc

intervention_type: Radiation


title: Critically Ill Patient's Capacity

acronym: Capacity

summary: How to determine the decision-making capacity of critically-ill patients remain unclear. The investigator study the differences between standardised evaluation and subjective medical evaluation.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Clermont-Ferrand


acronym: NEPHA

summary: Myeloablative allogeneic hematopoetic stem cell transplantation (AHSCT) are prone to frequent secondary malnutrition to metabolic and digestive troubles due to conditioning regimen, treatments (antibiotics, immunosuppressive therapy…) and graft complications (graft versus host disease). In the absence of appropriate nutritional support, myeloablative conditioning lead to a rapid serious denutrition. But, it is known as negative independent prognostic factor of overall survival of patients who presented malignant hemopathy treated by high-dose chemotherapy or AHSCT. Furthermore, it increases hospitalisation delay and decreases quality of life. In AHSCT with myeloablative conditioning, introduction of nutritional support is recommended. However, type of nutritional support remains not clearly defined. Parenteral nutrition is user but favour infections and secondary effects potentially decrease by intravenous glutamine. Few previous studies with low number of patients, mainly retrospective or combining allo-and auto HSCT had shown feasibility, acceptable tolerance and low cost of enteral nutrition (EN). A recent prospective no-randomized study in 45 adults patients who had undergone AHSCT with myeloablative conditioning find a significant decrease of day-100 mortality (5% vs 30%), of infection mortality, of median duration of parenteral nutrition (PN) and prevalence of GvH (Graft versus Host Disease) grade III-IV in EN (enteral nutrition) group. These results had to be confirmed by a randomized study. As EN is 4 to 5 more cheaply than PN, besides mortality/morbidity stakes for the patient, this study could have potential economic interest.

ReferenceCitation: Lemal R, Cabrespine A, Pereira B, Combal C, Ravinet A, Hermet E, Bay JO, Bouteloup C. Could enteral nutrition improve the outcome of patients with haematological malignancies undergoing allogeneic haematopoietic stem cell transplantation? A study protocol for a randomized controlled trial (the NEPHA study). Trials. 2015 Apr 7;16:136. doi: 10.1186/s13063-015-0663-8.

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

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

collaborators: Societe Francaise de Greffe de Moelle et de Therapie Cellulaire

collaborators: Société Francophone Nutrition Clinique et Métabolisme


title: Effectiveness and Cost-effectiveness Analysis of a Telemonitoring Program on Lifestyle for People With Type 2 Diabetes at Home. Study Based on a Health Network in Diabetology.

summary: Severity of diabetes is related to the development of disabling and costly complications (12.9 billion euros in 2007). The French High Health Authority recommends a therapeutic education on lifestyle and dietary rules in first-line treatment of Type 2 Diabetes Mellitus. Despite these recommendations, patients often have difficulties to implement dietary recommendations every day. The objective of EDUC@DOM is to help people with diabetes to improve lifestyle and equilibrium of glycaemia in order to avoid or delay chronic complications of diabetes. Our main goal is to assess effectiveness of our telemonitoring program in type 2 patients' care compared to a usual care of diabetes, on the glycaemia of the patients. It is expected that our program leads to a better monitoring of health status, a greater adherence to medical and non-medical prescriptions, an empowerment of the patient, and as a consequence, a more efficient health care consumption.

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ReferenceCitation: Siddiqui O, Hung HM, O'Neill R. MMRM vs. LOCF: a comprehensive comparison based on simulation study and 25 NDA datasets. J Biopharm Stat. 2009;19(2):227-46. doi: 10.1080/10543400802609797.

ReferenceCitation: Freudenheim JL, Johnson NE, Wardrop RL. Misclassification of nutrient intake of individuals and groups using one-, two-, three-, and seven-day food records. Am J Epidemiol. 1987 Oct;126(4):703-13. doi: 10.1093/oxfordjournals.aje.a114710.

ReferenceCitation: Turnin MC, Gourdy P, Martini J, Buisson JC, Chauchard MC, Delaunay J, Schirr-Bonnans S, Taoui S, Poncet MF, Cosma V, Lablanche S, Coustols-Valat M, Chaillous L, Thivolet C, Sanz C, Penfornis A, Lepage B, Colineaux H, Mounie M, Costa N, Molinier L, Hanaire H; Educ@dom Study Group. Impact of a Remote Monitoring Programme Including Lifestyle Education Software in Type 2 Diabetes: Results of the Educ@dom Randomised Multicentre Study. Diabetes Ther. 2021 Jul;12(7):2059-2075. doi: 10.1007/s13300-021-01095-x. Epub 2021 Jun 23.

ReferenceCitation: Mounie M, Costa N, Gourdy P, Latorre C, Schirr-Bonnans S, Lagarrigue JM, Roussel H, Martini J, Buisson JC, Chauchard MC, Delaunay J, Taoui S, Poncet MF, Cosma V, Lablanche S, Coustols-Valat M, Chaillous L, Thivolet C, Sanz C, Penfornis A, Lepage B, Colineaux H, Hanaire H, Molinier L, Turnin MC; Educ@dom Study Group. Cost-Effectiveness Evaluation of a Remote Monitoring Programme Including Lifestyle Education Software in Type 2 Diabetes: Results of the Educ@dom Study. Diabetes Ther. 2022 Apr;13(4):693-708. doi: 10.1007/s13300-022-01207-1. Epub 2022 Feb 8. Erratum In: Diabetes Ther. 2022 Mar 22;:

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

repository_institution: Conservatoire national des arts et métiers - HAL CNAM

repositories_institution: Conservatoire national des arts et métiers - HAL CNAM

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

location_facility: University Hospitals of Toulouse (Rangueil and Salies-Du-Salat)


title: Comparison of the Ultra-low-dose Veo Algorithm With the Gold Standard Filtered Back Projection for Detecting Pulmonary Asbestos-related Conditions

summary:
Asbestos fibers were intensively used throughout the 20th century and remain prevalent in developing countries. However, asbestos exposure induces a variety of benign and malignant pleural and lung diseases. The most common asbestos-induced neoplasm is lung cancer. Moreover, thin-section computed tomography (CT) is more sensitive than a chest x-ray for detecting early asbestos-related conditions. Increased exposure to radiation underpins the consequences of cancer induction. However, reducing CT doses increases image noise from the filtered back projection (FBP) reconstruction. Strategies to reduce radiation exposure include the use of iterative reconstruction algorithms. A new algorithm called VeoTM (General Electric Healthcare, Milwaukee, MI, USA) decreases the image noise up to 70% compared with the gold standard FBP model. Moreover, Veo improves spatial resolution with excellent detection of low and high contrast objects from a CT Dose Index (CTDIvol) equal to 0.3 mGy.

The objective of the present study is to compare Veo with the gold standard FBP for detecting pulmonary asbestos-related conditions among workers previously exposed to asbestos. Comparisons included radiation delivered and image quality.

ReferenceCitation: Tekath M, Dutheil F, Bellini R, Roche A, Pereira B, Naughton G, Chamoux A, Michel JL. Comparison of the ultra-low-dose Veo algorithm with the gold standard filtered back projection for detecting pulmonary asbestos-related conditions: a clinical observational study. BMJ Open. 2014 May 30;4(5):e004980. doi: 10.1136/bmjopen-2014-004980.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

publisher_dissemination: British Medical Journal


title: A Single-center, Double-blind, Randomized, Placebo-controlled, Single-ascending Oral Dose and Food Interaction Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-281959 / ACT-246475 in Healthy Male Subjects

summary: Study Part I is a single-ascending dose study. Healthy male subjects to be included in the study and randomized in 6 dose groups, Groups A-F (8 subjects per group). Of the 8 subjects per group, 6 subjects receive the investigational drug and 2 subjects receive matching placebo. Study Part II is a 3-period, crossover, single dose study. Nine healthy male subjects to be enrolled in one group (Group G). Each subject to receive 2 different formulations of the prodrug and one formulation of the active drug in a randomized sequence.

lead_sponsor: Idorsia Pharmaceuticals Ltd.


title: Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis

summary:
Rheumatoid arthritis (RA) is one of the most common inflammatory diseases in the general population and many cardiovascular diseases (valvular, myocardial, pericardial, coronary disease, stroke, heart failure etc.) have already been described in this disease. Large epidemiological studies have also demonstrated a higher degree of severity of atherosclerotic vascular disease in RA patients, to such a degree that several authors have highlighted the fact that, in the final analysis, the prognosis of RA is rather determined by the severity of atherosclerotic lesions.

By reducing RA-related systemic inflammation, it can therefore be hypothesized that 24 weeks of anti-TNF therapy would improve arterial endothelial function and large artery stiffness.

The proposed study will assess the effects of adalimumab therapy on these parameters. A group of 26 RA patients will be recruited from a rheumatologists association of the French PACA region (CONCERTO association). This study will be non invasive and will comprise:

in vivo study of endothelial function by measuring the post-ischaemic dilatation by 2D ultrasound;
study of large artery stiffness by pulse wave velocity determined by aplannation tonometry;
study of central pulse pressure;
evaluation of atherosclerosis-related parameters such as intima-media thickness.

The results obtained should provide a better understanding of the mechanisms involved in RA-related vascular disease and the effects of anti-TNF therapy.

In view of the high prevalence of RA, this study could potentially interest the medical community as a whole and could be largely diffused.


type: EudraCT Number

title: Acute Severe Traumatic Pain in the ED : Can we Improve Time to Pain-relief With a Single Dose of Intranasal Sufentanil Given at Triage ? A Randomized Double-blinded Placebo Controlled Study (InSPEED Study)

acronym: InSPEED

summary:
Non-invasive and simple, intranasal (IN) route of administration seems promising for pain management in the Emergency Department (ED), especially when used precociously by triage nurse to rapidly deliver the first opioid dose to severely painful patients.

This randomized double-blind placebo-controlled study will focus on severe traumatic pain experienced by adults admitted in our ED.

We hypothesized that, in addition to traditional morphine titration, a single dose of IN sufentanil given at triage would significantly increase the proportion of patients relieved 30 minutes after their ED admission.

Time to discharge, proportion of side effects and satisfaction rates will also be recorded.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Phase 1 Evaluation of the Influence of Settings of Word Prediction Software (Phase 1)and the Efficiency of Rehabilitation Programm (Phase 2)to Text Input Speed for People With Spinal Cord Injury

acronym: Smartwrite

summary:
Computers now play an important role in the lives of most individuals.Access to computers is crucial for people with disabilities and may improve their quality of life. The use of computers can facilitate mainstreaming at school, for example, and the Internet may provide a valuable means of communication. However, the use of computers requires a certain degree of motor ability. People with motor disabilities frequently experience difficulties using a standard keyboard and standard pointing input systems such as a mouse. Many solutions exist to facilitate computer access, depending on the person's specific impairments and the purpose for which the computer is used. The most common solution relies on the use of a virtual keyboard which is directly displayed on the computer screen. The selection of the desired key on the virtual keyboard can be handled by a large variety of input devices, from a microgravity mouse to single switch devices supplemented by a process of dynamic scanning of the keyboard.Although such assistive devices render computers accessible to people with disabilities, the actual inputting of text can be very slow. A method to increase text input speed is to display words which are predicted from the letters previously typed. Word prediction reduces the number of necessary key strokes by avoiding having to type the whole word. The effect on text input speed is, however uncertain and results in the literature are inconclusive. Indeed, word prediction software provide a enhancement of cognitive load which decrease text input speed.The reduction of cognitive load could therefore be based in part on the optimization settings of the software and / or achievement of a rehabilitation program.Our hypothesis are for people with spinal cord injury : i) optimization settings word prediction software and ii) a rehabilitation program could improve the text input speed.The investigators propose to study the influence of settings word prediction software on text input speed and the influence of a rehabilitation program provided by a therapist, focused on word prediction software to help integrate them. The aim is to increase the performance of people with spinal cord injury and their satisfaction.

The first phase of this research is to select the word prediction software and configuration that provides the best user support.The second phase corresponds to the objective of evaluating the efficiency of a rehabilitation program .

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Laparoscopic Gynecologic Surgery With Robotic Assistance System Kymerax® : Pilot Study

summary:
Laparoscopic robotic surgery (LSM) seems to increase quality of surgery. Diffusion of LSM is limited by cots of the only available system today. Kymerax® is a cheaper new system of LSM.

Aim : To evaluate feasibility of laparoscopy with Kymerax® system in different laparoscopic procedures in gynecology.

Material and methods : Observational study. Inclusion criteria were : patient requiring laparoscopic procedure in gynecology who give informed consent. The investigators evaluate procedures routinely performed by laparoscopy in gynecology.

Hypothesis : Procedures performed routinely in gynecology were feasible with Kymerax® system.


title: Therapeutic Option for Hepatitis B and C: a French Cohort

acronym: HEPATHER

summary:
The cohort will integrate clinical, genetic, pharmacogenomics, environmental, biomarkers and behavioral data in a large number of patients and will be a leading equipment for crossdisciplinary and translational research on hepatitis.
The cohort will be the main support for estimating the relative effects of treatments and for further cost-effectiveness studies on the management and treatment options in chronic HCV (Hepatitis C Virus)and HBV (Hepatitis B virus)infections.

status: Active, not recruiting

ReferenceCitation: Sotty J, Bablon P, Lekbaby B, Augustin J, Girier-Dufournier M, Langlois L, Dorival C, Carrat F, Pol S, Fontaine H, Sarica N, Neuveut C, Housset C, Kremdsorf D, Schnuriger A, Soussan P. Diversity of the nucleic acid forms of circulating HBV in chronically infected patients and its impact on viral cycle. Hepatol Int. 2022 Dec;16(6):1259-1272. doi: 10.1007/s12072-022-10389-6. Epub 2022 Aug 4.

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

ReferenceCitation: Barre T, Carrat F, Ramier C, Fontaine H, Di Beo V, Bureau M, Dorival C, Larrey D, Delarocque-Astagneau E, Mathurin P, Marcellin F, Petrov-Sanchez V, Cagnot C, Carrieri P, Pol S, Protopopescu C; ANRS/AFEF Hepather study group. Cannabis use as a factor of lower corpulence in hepatitis C-infected patients: results from the ANRS CO22 Hepather cohort. J Cannabis Res. 2022 Jun 11;4(1):31. doi: 10.1186/s42238-022-00138-9.

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

repository_normalized: univOAK

repositories:
HAL
PubMed Central
univOAK

repositories_concat: HAL;PubMed Central;univOAK

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

ReferenceCitation: Pageaux GP, Nzinga CL, Ganne N, Samuel D, Dorival C, Zoulim F, Cagnot C, Decaens T, Thabut D, Asselah T, Mathurin P, Habersetzer F, Bronowicki JP, Guyader D, Rosa I, Leroy V, Chazouilleres O, de Ledinghen V, Bourliere M, Causse X, Cales P, Metivier S, Loustaud-Ratti V, Riachi G, Alric L, Gelu-Simeon M, Minello A, Gournay J, Geist C, Tran A, Abergel A, Portal I, d'Alteroche L, Raffi F, Fontaine H, Carrat F, Pol S; French ANRS CO22 Hepather Cohort. Clinical outcomes after treatment with direct antiviral agents: beyond the virological response in patients with previous HCV-related decompensated cirrhosis. BMC Infect Dis. 2022 Jan 27;22(1):94. doi: 10.1186/s12879-022-07076-0.

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

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

repositories:
HAL
PubMed Central
Research Square
univOAK

ReferenceCitation: Poynard T, Lacombe JM, Deckmyn O, Peta V, Akhavan S, de Ledinghen V, Zoulim F, Samuel D, Mathurin P, Ratziu V, Thabut D, Housset C, Fontaine H, Pol S, Carrat F. External validation of LCR1-LCR2, a multivariable HCC risk calculator, in patients with chronic HCV. JHEP Rep. 2021 Apr 24;3(4):100298. doi: 10.1016/j.jhepr.2021.100298. eCollection 2021 Aug.

ReferenceCitation: Barre T, Ramier C, Di Beo V, Carrat F, Fontaine H, Marcellin F, Carrieri P, Pol S, Protopopescu C; ANRS/AFEF Hepather study group. Liver fibrosis and all-cause mortality in chronic HCV-infected diabetic patients: A paradoxical association? (ANRS CO22 HEPATHER). Liver Int. 2021 Jul;41(7):1694-1698. doi: 10.1111/liv.14949. Epub 2021 May 28. No abstract available.

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

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

ReferenceCitation: Chalouni M, Pol S, Sogni P, Fontaine H, Lacombe K, Marc-Lacombe J, Esterle L, Dorival C, Bourliere M, Bani-Sadr F, de Ledinghen V, Zucman D, Larrey D, Salmon D, Carrat F, Wittkop L; ANRS CO13 HEPAVIH and ANRS CO22 HEPATHER cohort study groups. Increased mortality in HIV/HCV-coinfected compared to HCV-monoinfected patients in the DAA era due to non-liver-related death. J Hepatol. 2021 Jan;74(1):37-47. doi: 10.1016/j.jhep.2020.08.008. Epub 2020 Aug 14.

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

ReferenceCitation: Laurain A, Metivier S, Haour G, Larrey D, Dorival C, Hezode C, Zoulim F, Marcellin P, Bourliere M, Zarski JP, Thabut D, Alric L, Ganne-Carrie N, Cales P, Bronowicki JP, Riachi G, Geist C, Causse X, Abergel A, Chazouilleres O, Mathurin P, Guyader D, Samuel D, Tran A, Loustaud-Ratti V, Petrov-Sanchez V, Diallo A, Luzivika-Nzinga C, Fontaine H, Carrat F, Pol S; ANRS/AFEF HEPATHER study group. Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohort. BMC Infect Dis. 2019 Apr 2;19(1):300. doi: 10.1186/s12879-019-3923-5.

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

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

ReferenceCitation: Carrat F, Fontaine H, Dorival C, Simony M, Diallo A, Hezode C, De Ledinghen V, Larrey D, Haour G, Bronowicki JP, Zoulim F, Asselah T, Marcellin P, Thabut D, Leroy V, Tran A, Habersetzer F, Samuel D, Guyader D, Chazouilleres O, Mathurin P, Metivier S, Alric L, Riachi G, Gournay J, Abergel A, Cales P, Ganne N, Loustaud-Ratti V, D'Alteroche L, Causse X, Geist C, Minello A, Rosa I, Gelu-Simeon M, Portal I, Raffi F, Bourliere M, Pol S; French ANRS CO22 Hepather cohort. Clinical outcomes in patients with chronic hepatitis C after direct-acting antiviral treatment: a prospective cohort study. Lancet. 2019 Apr 6;393(10179):1453-1464. doi: 10.1016/S0140-6736(18)32111-1. Epub 2019 Feb 11.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

ReferenceCitation: Pol S, Bourliere M, Lucier S, Hezode C, Dorival C, Larrey D, Bronowicki JP, Ledinghen VD, Zoulim F, Tran A, Metivier S, Zarski JP, Samuel D, Guyader D, Marcellin P, Minello A, Alric L, Thabut D, Chazouilleres O, Riachi G, Bourcier V, Mathurin P, Loustaud-Ratti V, D'Alteroche L, Fouchard-Hubert I, Habersetzer F, Causse X, Geist C, Rosa I, Gournay J, Saillard E, Billaud E, Petrov-Sanchez V, Diallo A, Fontaine H, Carrat F; ANRS/AFEF HEPATHER study group. Safety and efficacy of daclatasvir-sofosbuvir in HCV genotype 1-mono-infected patients. J Hepatol. 2017 Jan;66(1):39-47. doi: 10.1016/j.jhep.2016.08.021. Epub 2016 Sep 10.

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

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Bristol-Myers Squibb
Gilead Sciences
Janssen-Cilag Ltd.
Merck Sharp & Dohme LLC
Roche Pharma AG


title: Frequency and Functional Impact of the c.32A>T Genetic Polymorphism of TLR7 in Women Infected With HIV-1 : the ANRS EP53 Study

acronym: X LIBRIS

summary:
Short title :

X-linked biological response to HIV sensing: the ANRS EP 53 study.

Main outcome :

To demonstrate that HIV-infected women carry the TLR7 c.32A>T SNP at a higher frequency than uninfected women, arguing in favor of a role of impaired production of IFN-alpha by pDCs in the risk of becoming infected by HIV-1.

Secondary outcome :

To directly demonstrate at a single cell level that the TLR7 c.32A>T SNP is responsible for a reduce production of IFN-alpha by pDCs after activation of TLR7 by HIV-1 RNA.

Short abstract (public dissemination) :

Male and female display some differences in how their immune system responds to pathogens. This could be related to hormonal or genetic factors located on the X chromosome. This project aims at characterizing X-linked factors that can influence the innate immune response to HIV-1.

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Comparison of Two Rehabilitation Programs to Improve Walking in Community-dwelling People After Stroke

acronym: ANANTA

summary: This study is designed to determine if adding daily weighted braces on the unaffected ankle may benefit to patient who have returned home compare to a placebo intervention (ankle brace without weight).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: Département d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Paris

intervention_type: Behavioral


lead_sponsor: UNICANCER

summary: The objective of this study is to assess the effect of neoadjuvant cabazitaxel and pelvic radiotherapy in combination with androgen deprivation therapy (ADT)-radiotherapy on clinical progression-free survival in patients with high-risk localized prostate cancer (with a stringent selection of patients with at least 2 high-risk features), in a 2 by 2 factorial trial.

sponsor_collaborators: UNICANCER Sanofi

title: A Randomized Phase III, Factorial Design, of Cabazitaxel and Pelvic Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse

status_simplified: Ongoing


title: Effectiveness and Satisfaction-adaptability of a Novel Concept for a Manual Toothbrush Broscyl®: Randomised Clinical Trial in Children, Adults and Elderly People

acronym: BROSCYL

summary: The aim is to determine the efficacy and the satisfaction/adaptability of the manual Broscyl® toothbrush as compared with a standard " soft " manual toothbrush ADA (American Dental Association) reference using the modified Stillman brushing technique, in children, adults and elderly persons, after 3 months of daily use.


title: Screening for Chromosomal Microarrangements by CGH-array in Developmental Anomalies of the Skin Suggestive of Mosaicism. National Multicentre Descriptive Study.

acronym: MOSAÏQUE

summary:
The principal result expected is the discovery of inframicroscopic chromosomal rearrangements in regions of the genome not yet known to be involved, or mutations in known candidate genes;

The identification of such a mosaic rearrangement in an affected infant would lead to improved genetic counselling. Indeed, as this mosaicism is a consequence of a genetic event occurring at an early stage of embryogenesis, it would be possible to confirm the sporadic nature of the observed disorder and therefore to predict a very low or even negligible risk of recurrence for the couple concerned. For the affected infant, the risk for his/her own offspring will be assessed according to the nature of the genetic anomaly discovered. For medical practice, investigators hope that this study will lead to a clearer definition of the screening modalities for mosaicism in the disorders concerned. In particular, they hope to determine whether or not it is possible to dispense with a skin biopsy, which is more invasive than a blood sample.

ReferenceCitation: Sorlin A, Maruani A, Aubriot-Lorton MH, Kuentz P, Duffourd Y, Teysseire S, Carmignac V, St-Onge J, Chevarin M, Jouan T, Thauvin-Robinet C, Thevenon J, Faivre L, Riviere JB, Vabres P. Mosaicism for a KITLG Mutation in Linear and Whorled Nevoid Hypermelanosis. J Invest Dermatol. 2017 Jul;137(7):1575-1578. doi: 10.1016/j.jid.2017.01.035. Epub 2017 Feb 28. No abstract available.

oa_host_type: publisher


title: ROLE OF PHOSPHOLIPID TRANSFER PROTEINS (PLTP) ON ENDOTOXEMIA CAUSED BY BUCCAL INFLAMMATION

acronym: TOXIB

summary: This is a transversal double-centre study. Patients will be recruited from outpatient consultations. They will have buccal inflammation caused by periodontal disease (frequent oral infections, mostly with GRAM (-) bacteria). Three groups of 80 patients, corresponding to slight, moderate and severe periodontal disease, will be formed according to the results of radiological and clinical examinations.


title: Study of the Effect of a Cognitive Task on Static Balance in Depressive Elderly Subjects According to the Double Task Principle

acronym: DOUBLE TACHE

summary: This study could contribute to understanding the aggravation of balance disorders and the increased risk of falling in depressive people. It could, among other things, shed light on the impact of treatments with antidepressants on balance in treated depressive patients. Finally, it could contribute to improving the sensory-motor management of patients with a depressive syndrome.


title: Optimization of PEEP for Alveolar Recruitment in ARDS

acronym: OPERA

summary: Actual setting of PEEP in ARDS is based on tables linked to FiO2, or respiratory system plateau pressure (e.g EXPRESS Study) or set regarding esophageal pressure mesurement and transpulmonary pressure calculation. Opera study should confirm if a setting approach based on esophageal pressure is helpfull for any ARDS patient in ICU without deleterious side-effect.

lead_sponsor: Hopital of Melun

sponsor_collaborators:
Hopital of Melun
Melun Hospital Intensive Care Unit


title: Cognitive Processes Study in Obese Women With and Without Eating Disorders : Research of Electro-physiological Similarity With Addiction

summary:
The P300 is one of the cognitive wave of the Event-Related Potential (ERP) that is used to investigate the cognitive process. The P300 component are accepted as electro-physiological markers of neuropsychiatric disorders like alcoholism or drug addiction.

Recent scientific data suggest that eating disorders, leading to weight gain and obesity, will be similar of those of drug addiction: it is the incentive sensitization theory that implicates the dopaminergic reward system.

The aim of this cross-sectional study is to investigate the alteration of P300 auditory ERP in obese women with eating disorders in comparison with obese and lean women without eating disorders.

lead_sponsor: Hospices Civils de Lyon

location_facility: CRNH Rhône-Alpes /CENS Centre Européen pour la Nutrition et la Santé Centre Hospitalier Lyon Sud - Pavillon médical 165, chemin du Grand Revoyet


title: Prospective Randomized Controlled Trial to Evaluate the Efficacy and Safety of an Equimolar Mixture of Oxygen and Nitrous Oxide in External Cephalic Version (ECV) in Singleton Pregnancy in Breech Presentation at Term

acronym: MEOREV

summary:
The variety of breech presentation at term is about 3-4% of all births. Our study aims to assess the value of using an equimolar mixture of oxygen and nitrous oxide. Indeed, in some patients algic or relaxed, the success rate seems more important.

It's a single blind prospective randomized controlled study, comparing success rate of ECV after an equimolar mixture of oxygen and nitrous oxide or placebo (medical air).

We need to include 150 patients (75 in each arm), for a period of 2 years. After ECV, we will give the patient a satisfaction questionnaire. We compare the success rate of ECV as primary outcome.

ReferenceCitation: Dochez V, Esbelin J, Misbert E, Arthuis C, Drouard A, Badon V, Fenet O, Thubert T, Winer N. Effectiveness of nitrous oxide in external cephalic version on success rate: A randomized controlled trial. Acta Obstet Gynecol Scand. 2020 Mar;99(3):391-398. doi: 10.1111/aogs.13753. Epub 2019 Nov 18.

evidence: open (via free article)

unpaywall_oa_status: bronze

lead_sponsor: Nantes University Hospital


title: Study of the Racecadotril Linearity After Single Administrations of 10, 30 and 60 mg of a New Racecadotril Formulation (Suspension) by Oral Route and Evaluation of the Comparative Bioavailability of This New Formulation Versus the Sachet Formulation (Granules) After a 60 mg Single Oral Administration in Healthy Male Volunteers

summary:
To investigate the Racecadotril pharmacokinetic linearity after single oral administration of 10, 30 and 60 mg as a suspension.

To evaluate the comparative bioavailability of the new Racecadotril formulation (suspension) versus the reference sachet formulation (granules)

lead_sponsor: Bioprojet


title: Evaluation of the Impact of a Coordinated Regional Organization to Secure Patient's Care Treated by Oral Antineoplastic Agents

acronym: CHIMORAL

summary: The purpose is to estimate evolution of patients treated by oral neoplastic agents, in term of early or unforeseen recourse to the hospital for adverse events.

ipd_sharing: Undecided

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
oncorif


title: OPMED STUDY: Multidisciplinary Program "Optimization of Drug Prescription" : Impact on the Quality of Drug Prescription in Hospitalized Elderly Patients

acronym: OPMED

summary:
Drug prescription is a fundamental component of care for the elderly. Even if drugs are a chance for the older patient, because of changes in pharmacological, pharmacokinetic and pharmacodynamic parameters related with age and acute/or chronic pathologies, the risks associated with drug prescription, particularly those associated with potentially inappropriate medication (PIM), are increased in the elderly.

We suppose that many of hospitalized elderly have at least one prescribed medication without valid indication. Conversely, many diseases are currently undertreated in elderly patients: e.g. medicines used to treat heart failure and osteoporosis are underused in 20 to 70% of patients. Moreover, PMI prescription is associated with an increased of morbidity, mortality, risk of drug-related adverse events, utilization of health care system, care costs and impairment of quality of life. Thus, optimization of drug prescription is a major concern for improvement of the quality and safety of care in elderly.

The investigators' hypothesis is that a multidisciplinary program entitled "Optimisation de la Prescription MEDicamenteuse" ("Optimization of drug prescribing") focused on drug prescription optimization including a physician training to the specificity of the drug prescription in the elderly and a checklist allowing an adapted and standardized pharmaceutical analysis is effective in reducing PIM in elderly patients hospitalized in short-term medical and geriatric care departments.

location_facility: Hospices Civils de Lyon - Hôpital Edouard Herriot


title: Is There a Correlation Between the Pulmonary Artery Pressure and the Acceleration of the Flow in the Pulmonary Artery Evaluated by Transesophageal Echocardiography (TOE) ?

summary:
The measure of the pulmonary artery pressure (PAP) is a very useful index in intensive care to estimate right ventricular after load. The reference technique for this measure is the right catheterism which is an invasive technique. It is possible to estimate the pulmonary artery pressure by using transthoracic echocardiography (TTE) which allows, using the continuous Doppler, the measure of maximum speed of tricuspid regurgitation (TRvmax). The measure of the TRvmax can however be difficult for intensive care patients with little echogenicity or impossible for those having no tricuspid leak. The evaluation of the tricuspid regurgitation is also particularly difficult using TOE. To avoid these drawbacks, one can use the analysis of the pulmonary ejection in the pulmonary artery (PAAT) with TOE. However, the data of the literature are controversial on this method and it was not validated in mechanically ventilated intensive care patients.

The aim of this work is to compare three methods of measure of the PAP: the measure TRVMAX (by means of the tricuspid leak) by transthoracic echocardiography, the measure of the TAAP by transesophageal ultrasound and the direct measure of the pulmonary pressures by right catheterization, in ventilated patients already monitored with a catheter in the right cavities for usual indications in intensive care (ARDS, shock). We shall analyze then the correlation between the TRVmax, the TAAP and the pressures measured by the right catheterism which serves as reference technique.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: EFFECT OF SMOKING ON MUCUS HYPERSECRETION MECHANISMS IN ASTHMA AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE

summary:
Asthma and COPD are characterized by an accelerated decline in lung function associated with incompletely reversible airflow obstruction. This could be the result of lung structural changes and inflammation. Tissue repairing mechanisms may result in a restitution ad integrum of bronchial epithelium. But in most cases, especially in COPD and severe asthma, the "remodeling" is characterized by mucus cells hyperplasia, overproduction of mucus, and physicochemical, biological and immunological changes. Clinically, this mucus overproduction is reported by patients as the clinical symptom called "chronic bronchitis". Generally, it develops at a bronchiolar level where it is responsible for the progression of these diseases. There is a paradox, because the intrinsic properties of mucus seem rather beneficial so fighting against it may not be really wise at long-term. Especially its defensive effect against microbial agents which remains poorly explained. Currently, no treatment aims to reduce the production of mucus and mechanisms leading to such an overproduction are poorly understood in severe asthma and COPD. The identification of new targets to treat this overproduction of mucus in COPD is therefore of major interest.

In view of current knowledge, inflammatory mediators and signal transduction leading to increased mucin production and increased number of goblet cells are probably IL-9, IL-13, IL -1ß and TNF-α involving calcium-sensitive chloride channels. Intracellular signaling pathways seem to be based on STAT-6, FOXA2, SPDEF, EGFR and / or COX-2

primary_purpose: Other


title: Effets de la Nutrition entérale spécifique RealDiet®Renal (NES) Chez Des Patients Insuffisants rénaux hémodialysés dénutris : efficacité, tolérance, qualité de Vie.

acronym: AL-EN-PHED

summary: The objective of this unblinded study is to assess the nutritional effects of a 12 weeks administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as the impact on the patients' quality of life.

status: Withdrawn

lead_sponsor: Lactalis

sponsor_collaborators: Lactalis Clinact

intervention_type: Dietary Supplement


summary: The purpose of this study is to compare the pharmacodynamic activity of LEO 90100 with Dermovate® cream, Dovobet® ointment, betamethasone dipropionate in LEO90100 vehicle, Synalar® ointment and LEO 90100 vehicle using a human skin blanching test.

ReferenceCitation: Queille-Roussel C, Bang B, Clonier F, Lacour JP. Phase I evaluation of the vasoconstrictor potential of an innovative fixed combination calcipotriene plus betamethasone dipropionate aerosol foam versus other corticosteroid psoriasis treatments. J Am Acad Dermatol. 2015:72 Suppl 1;AB243 (P915).

lead_sponsor: LEO Pharma

location_facility: CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie


title: Does Body Position Influence Pressure Recording by High-resolution Manometry ?

summary:
The anorectal manometry is the gold standard in the evaluation of anorectal function.

Several techniques are currently used (balloons, perfused catheters) and are always performed in the supine position.

Few studies have reported the evaluation of sphincter function in the upright position, whereas symptoms of fecal incontinence occur in this position.

Recently developed, high-resolution manometry, thanks to its many mechanical sensors, allows topographic analysis and evaluation of anorectal function more acurate. In addition, the rigid nature of the probe should allow stability measures / recording, which is not possible with probes perfused catheters example.

We therefore propose to compare anal sphincter pressure in supine and standing, measured in high-resolution manometry.


title: Work of Breathing in Nasal CPAP Versus High Flow Nasal Prong in Infants With Severe Acute Bronchiolitis

summary: Nasal continuous positive airway pressure (nCPAP), widely used in neonatal intensive care is also more and more used in infants with severe acute bronchiolitis. There is no evidence that nCPAP improves outcome, but several studies showed that it reduces work of breathing (WOB), improves gas exchange and decreases intubation rate. High flow nasal prong (HFNP) therapy, also used in neonatal units, has recently been suggested for bronchiolitis management. This technique allows warmed and moist gas administration protecting nasal mucosa, and preventing variations of inspired gas FiO2. HFNP also creates a continuous positive pressure, reducing WOB, and seems much more comfortable and better tolerated by babies than nCPAP. There are no studies comparing both techniques for bronchiolitis management. The main objective of this study is to compare WOB with nCPAP and HFNP therapy in infants with severe bronchiolitis in pediatric intensive care unit. Secondary purpose is to compare efficacy and tolerance of both techniques. We propose to lead an open, single center, crossover randomized study. Each patient will receive the two treatments. Three consecutive periods will be studied: first one (minimum 2 hours), with the first technique CPAP or HFNP according to randomization (treatment 1); second period (2 hours) with the second technique (treatment 2); Third period (6 hours) with the second technique. The primary endpoint will be the comparison of WOB (estimated by the calculation of the transdiaphragmatic pressure-time product) at the end of the two firsts periods. Efficacy and tolerance of each technique will be evaluated and compared by compared measuring respiratory rate, heart rate, FiO2, SpO2, transcutaneous PCO2, modified Wood score, and EDIN score during the third period. Nine subjects by groups are required.


title: A Prospective Study on the Feasibility of Pedicle Screw Placement in the Lumbar Level With a New Robotic-assisted System

acronym: ARASS

summary: The main objective of the study is to evaluate the feasibility of using the robotic assisted device ROSA™ for pedicle screws placement. This device is currently used in cranial neurosurgery but its applications can be extended to other fields, such as spinal surgery. In the future, the use of ROSA™ in pedicle screw placement could increase the accuracy and safety of surgery for the patient.

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
Medtech S.A.S