title: Evaluation of Locomotor Activity Before and After Total Hip Replacement in Patients With Hip Osteoarthritis. Use of Ganglion and Neural Network Techniques to Identify Objective Criteria for the Success of Arthroplasty

summary:
The investigators believe that the application of non-linear methods of analysis using the ganglion and neural network technique will make it possible to analyse all of the complex data obtained in patients with hip osteoarthritis before and then after total hip replacement, and should allow us to identify a combination of objective variables to classify the surgery as " successful " or " unsuccessful ".

To this end, the study will take place as follows:

Step 1: Screening, and inclusion. Step 2: Evaluation of the hip osteoarthritis and analysis of locomotor activity Step 3: Total hip replacement Step 4: Clinical evaluation of locomotor activity carried out between 6 months and 1 year after the THR Step 5: Data analysis

ReferenceCitation: Moissenet F, Naaim A, Ornetti P, Bourredjem A, Binquet C, Morisset C, Gouteron A, Maillefert JF, Laroche D. Is the Pelvis-Thorax Coordination a Valuable Outcome Instrument to Assess Patients With Hip Osteoarthritis? Front Bioeng Biotechnol. 2020 Jan 23;7:457. doi: 10.3389/fbioe.2019.00457. eCollection 2019.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

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

repository_institution: University of Geneva - Archive ouverte UNIGE

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

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

repositories:
HAL
PubMed Central
unige.ch

repositories_concat: HAL;PubMed Central;unige.ch

publisher_dissemination: Frontiers


title: TMSFOS: Preliminary Study to Investigate the Effect of rTMS and SSRI Antidepressants on Leukocyte Expression of the C-FOS and DUSP1 Genes in Patients Treated for Depression

acronym: TMSFOS

summary:
Low frequency rTMS (repetitive Transcranial Magnetic Stimulation) for the treatment of patients with depression, is responsible for a decrease in the expression of the C-FOS and DUSP1 genes in peripheral blood leukocytes. The decrease in C-FOS expression could be explained by the inhibiting effect of low-frequency rTMS (in contrast, high-frequency rTMS causes activation of the cerebral cortex) [Rossi, 2009]. This genetic effect could correlate with the antidepressant effect [Hausmann, 2000].

According to this hypothesis, the genetic effect related to medical antidepressant treatments deserves to be studied because we could observe:

either a decrease in the expression of the C-FOS and DUSP1 genes related to the antidepressant effect of the medical antidepressant treatment,
or an increase in the expression of the C-FOS and DUSP1 genes related to cerebral activation due to the medical antidepressant treatment.

In summary, we wish to determine the validity of this hypothesis by comparing the genetic effect of rTMS with that of medical antidepressants to know if:

this genetic effect is specific to rTMS or common rTMS and medical antidepressants
this effect correlates with the clinical improvement induced by rTMS and by medical antidepressants
this early modification in the C-FOS and DUSP1 genes may be predictor of the therapeutic response to rTMS and antidepressants (early decrease in gene expression)
the absence of any decrease or increase in C-FOS and /or DUSP1 expression is a predictor of therapeutic resistance to rTMS and/or medical antidepressants.

status: Unknown status

study_type: Interventional

design_allocation: Randomized

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


title: STUDY OF FACTORS FAVORING THE ONSET OF NOVO ATRIAL FIBRILLATION IN THE IMMEDIATE AFTERMATH OF CORONARY ARTERY BYPASS SURGERY

summary:
Before la surgery:

Transthoracic cardiac echography will be done systematically, to measure among other things the size of the left atrium.

During surgery:

Surgery under extracorporeal circulation: tissue samples will be harvested from the right atrium (one before clamping of the aorta (T0= pre-ischemia sample), immediately before declamping of the aorta (T1= post-ischemia sample).

Surgery without extracorporeal circulation: tissue samples from the right atrium before CABG (T0) and a second sample after CABG (T1).

In parallel with the harvesting of cardiac tissue, blood samples will be taken at different times (H0, H3, H24) to correlate tissue data with systemic data. These will be taken by the anesthetists.

After the surgery:

Holter ECG will be set up for 7 days of continuous recording. Each patient will fill in an observation notebook. The biological samples will be analysed immediately and the biological data obtained will be recorded in the observation notebook.

status: Completed

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

intervention_type: Other

status_simplified: Completed


title: Evaluation of a Hybrid Prototype Strategy (Electrostimulation of Lower Limb Muscles Associated With Voluntary Strengthening of the Upper Limbs) in Reconditioning to Effort in Patients With Chronic Paraplegia.

summary:
This single-centre study was carried out in collaboration with the Cardiovascular Research Laboratory of Harvard University (Boston, USA). This preliminary study does not include a control group.

The aim of this study was to investigate the effect of a hybrid reconditioning programme (electrostimulation of the lower limb muscles associated with voluntary strengthening of the upper limbs) on a specially developed rowing machine in patients presenting stabilized paraplegia of a traumatic origin. This study will bear on the increase in maximal aerobic capacity (VO2max) between the start and end of the 9-month reconditioning programme.

study_start_date_type: Actual


title: Interest of Preoperative Immunonutrition in Liver Resection for Cancer

acronym: PROPILS

summary: To study the efficacy of preoperative immunonutrition in reducing postoperative morbidity after liver resection for cancer.

study_completion_date_type: Actual

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Ciacio O, Voron T, Pittau G, Lewin M, Vibert E, Adam R, Sa Cunha A, Cherqui D, Schielke A, Soubrane O, Scatton O, Salloum C, Azoulay D, Benoist S, Goyer P, Vaillant JC, Hannoun L, Boleslawski E, Agostini H, Samuel D, Castaing D. Interest of preoperative immunonutrition in liver resection for cancer: study protocol of the PROPILS trial, a multicenter randomized controlled phase IV trial. BMC Cancer. 2014 Dec 18;14:980. doi: 10.1186/1471-2407-14-980.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Nestlé Foundation

location_facility: AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire

intervention_type: Dietary Supplement


title: Non Invasive Assessment of Liver Fibrosis in Children: Evaluation of Diagnostic Performances of ShearWave Elastography (SWE) and Fibrotest®/ Fibromax® by Comparison With Fibrosis Score on Liver Biopsy

acronym: SHEARWAVE

summary: The purpose of this study is to determine if SWE and Fibrotest®/ Fibromax®, alone or associated, are effective methods to assess liver fibrosis in children.

primary_purpose: Diagnostic

intervention_type: Procedure


type: Other Identifier

title: Evaluating the Impact of Chest Physiotherapy Technique Increasing Inspiratory Flow on Weaning From Non Invasive Ventilation (KVNI) Pilot Study

acronym: KVNI

summary:
The main objective is to show by a randomised controled therapeutic trial comparing in two parallel open arms ( 50 infants x 2 = 100 infants) that the technique IIF decreases the duration of non invasive respiratory support in the group treated by chest physiotherapy as compared to the control group. The secondary objectives are to evaluate the duration of oxygen dependence, the duration of hospitalisation and the proportional advent of bronchopulmonary dysplasia.

These study will be conducted in patients less than 32 weeks post menstrual age, eutrophic, treated by non invasive respiratory support after weaning off from mechanical endotracheal ventilation benefitting form a social security system and for whom the appropriate parental authority are non opposed.

primary_purpose: Supportive Care

ipd_sharing: No


title: Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis

acronym: SAMIRA

summary: Use of brain natriuretic peptide to evaluate the cardiac function in the course of meningococcal septic shock or severe sepsis.

intervention_type: Biological


title: Unknown Cause of Acute Liver Failure: Determination of Early Mortality Predictive Factors

acronym: HASIPRO

summary: The purpose of the study is to evaluate the outcome and to determine predictive factors of patients admitted in a context of acute liver failure without identified cause.


title: Lower Extremity Peripheral Arterial Disease and Exercise Ischemia: Walking Capacity Variability, Pain Evolution and Pathophysiological Responses. The CLASH Study.

acronym: CLASH

summary:
Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease. Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues demand due to the narrowing of the arteries. An aggravation of the arterial lesions in LEPAD patients induces a worsening of patients' symptoms and a severe limitation of their walking capacity, contributing to an impairment of their quality of life. Despite maintaining a sufficient walking activity is essential for these patients, LEPAD patients lower their physical activity, which worsen the disease and potentially contribute to increase the risk of cardiovascular events and deaths.

In a recent study in LEPAD patients, we showed, from a one hour GPS recording, a high variability of the patients' walking capacity (i.e., walking distances between two stops induced by lower limbs pain). Results suggested that in most patients previous stop duration before each walk was a predictor parameter of this walking variability. Whether there is an optimal or minimal recovery time influencing the walking capacity in LEPAD patients has never been studied.

This study is a prospective, cross-sectional study in exercise pathophysiology.

The main goal is to determine, following a walk that induces ischemia, the influence of the recovery duration on the subsequent walking performance in LEPAD patients.

Secondary goals are :

To determine the nature of the relationship between the recovery duration and subsequent walking performance.
To study the relationship between exercise ischemia, pain evolution and previous recovery duration.
To determine whether the experimental procedure influence the determination of an optimal of minimal recovery duration.
To study the influence of recovery duration on walking capacity from community-based measurement.

ReferenceType: result

ReferenceCitation: de Mullenheim PY, Chaudru S, Mahe G, Prioux J, Le Faucheur A. Clinical Interest of Ambulatory Assessment of Physical Activity and Walking Capacity in Peripheral Artery Disease. Scand J Med Sci Sports. 2016 Jul;26(7):716-30. doi: 10.1111/sms.12512. Epub 2015 Jul 15.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

ReferenceCitation: Chaudru S, Jehannin P, de Mullenheim PY, Klein H, Jaquinandi V, Mahe G, Le Faucheur A. Using wearable monitors to assess daily walking limitations induced by ischemic pain in peripheral artery disease. Scand J Med Sci Sports. 2019 Nov;29(11):1813-1826. doi: 10.1111/sms.13511. Epub 2019 Jul 31.

oa_host_type: repository

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

repository_normalized: HAL

version: submittedVersion

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

repositories_concat: HAL

unpaywall_oa_status: green

ReferenceCitation: Donnou C, Chaudru S, Stivalet O, Paul E, Charasson M, Selli JM, Mauger C, Chapron A, Le Faucheur A, Jaquinandi V, Mahe G. How to become proficient in performance of the resting ankle-brachial index: Results of the first randomized controlled trial. Vasc Med. 2018 Apr;23(2):109-113. doi: 10.1177/1358863X17740993. Epub 2017 Nov 10.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: SAGE Publications

ReferenceCitation: de Mullenheim PY, Rouviere L, Emily M, Chaudru S, Kaladji A, Mahe G, Le Faucheur A. "Should I stay or should I go now?" Recovery time effect on walking capacity in symptomatic peripheral artery disease. J Appl Physiol (1985). 2021 Jul 1;131(1):207-219. doi: 10.1152/japplphysiol.00441.2020. Epub 2021 May 13.

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

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

publisher_dissemination: American Physiological Society

lead_sponsor: Rennes University Hospital


title: Assessment of the the ETView Double-lumen Tube

summary: The double tube ETView is particularly innovative as it includes an integrated optical fiber to visualize the carena. This study aims to verify if if its use avoids the requirement of a fibreoptic bronchoscopy.

status: Terminated

lead_sponsor: Hopital Foch


title: Evaluation of the Interest of a Nurse-implemented Sedation Protocol for the Reduction of the Duration of Mechanical Ventilation Complication Associated With Extended Sedation in Pediatric Intensive Care Unit.

acronym: PEDIASED

summary:
Mechanical ventilation is a common procedure used in pediatric intensive care units (ICU). Its use requires almost always the establishment of a sedation. Sedation is a generic term for all procedures, pharmacological or not, ensuring physical and psychological comfort and the safety of patient admitted in intensive care units.

An inadequate sedation, insufficient or excessive, has common side effects, as increase of the duration of mechanical ventilation and of hospital-acquired infections (in particular, ventilator associated pneumonia), of hemodynamic disorders, of extubation failure or accidental extubation, of withdrawal syndrome, and of post-traumatic stress disorder (PTSD). All these complications increase mechanical ventilation time and ICU length of stay. Several studies in adult's population have shown that the implementation of a sedation algorithm allowed to decrease the incidence of these complications.

We hypothetized that the duration of mechanical ventilation would be reduced by a nurse-implemented sedative management protocol.

lead_sponsor: Nantes University Hospital


title: Phase I, Open-label, Safety, Tolerability and Preliminary Efficacy Study of Tremelimumab in Combination With Gefitinib in EGFR Mutant NSCLC Patients

acronym: GEFTREM

summary:
This is an open-label phase 1, safety, PK, and preliminary efficacy study of oral Gefitinib and IV Tremelimumab in previously treated NSCLC patients who have documented evidence of an activating mutation in the EGFR gene and have failed treatment with an EGFR inhibitor such as Erlotinib or Gefitinib. The primary objective of this phase I, is to determine the safety and tolerability of oral Gefitinib in combination with escalating doses of Tremelimumab and to establish a recommended phase 2 dose. Secondary objectives include evaluation of, pharmacokinetics, immunogenicity, antitumor activity of Gefitinib and Tremelimumab combination. The exploratory objectives are to evaluate biomarkers that may correlate with activity or prospectively identify patients likely to respond to Tremelimumab and Gefitinib.

The biological rationale for such a study is that even though the disease is progressing it is likely that EGFR sensitive clones, although diminished under the pressure from the EGFR TKI, are still present. Therefore, withdrawing the inhibitory pressure of the EGFR TKI can potentially allow regrowth of the EGFR sensitive cells. On the other hand, the proliferation of EGFR resistant clones needs to be suppressed by another therapeutic approach. Until today no association of chemotherapy and TKI EGFR has demonstrated clinical benefit. Moreover, patients may have received chemotherapy and the likelihood of chemosensitivity is very low. So, the association of Gefitinib with immune checkpoint blockade is very attractive and may result in clinical benefit in NSCLC with EGFRmut.

ReferenceCitation: Riudavets M, Naigeon M, Texier M, Dorta M, Barlesi F, Mazieres J, Varga A, Cassard L, Boselli L, Grivel J, NgoCamus M, Lacroix L, Mezquita L, Besse B, Chaput N, Planchard D. Gefitinib plus tremelimumab combination in refractory non-small cell lung cancer patients harbouring EGFR mutations: The GEFTREM phase I trial. Lung Cancer. 2022 Apr;166:255-264. doi: 10.1016/j.lungcan.2021.11.018. Epub 2021 Dec 3.

publisher_dissemination: Elsevier

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

intervention_type: Drug


title: Phase I/II Open-label Randomized Multicenter Trial to Assess Immunogenicity and Safety of 4 Prime-boost Combinations of HIV Vaccine Candidates (MVA HIV-B/ LIPO-5; LIPO-5/MVA HIV-B; GTU®-MultiHIV B / LIPO-5; GTU®-MultiHIV B/MVA HIV-B) in Healthy Volunteers at Low Risk of HIV Infection

summary: The development of a safe and effective HIV-1 vaccine strategy would probably be the best solution for the ultimate control of the worldwide AIDS pandemic. Heterologous prime-boost immunisations are today considered promising HIV prophylactic vaccine strategies. It is thus relevant to pursue the development of different candidate vaccines in prime-boost vaccine strategies to identify the most promising prime-boost combinations and to integrate scientific inquiry into trial protocols from the beginning to maximize learning opportunities.

primary_purpose: Prevention

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Service d'Immunologie Clinique 51, avenue du Marechal de Lattre de Tassigny


title: Pathophysiology of Non Motor Signs and Compensatory Mechanisms in Parkinson's Disease: Role of the Serotoninergic and Dopaminergic Lesions Studied by PET

acronym: CompensationPD

summary: Parkinson's disease is characterized by a large number of non motor, especially neuropsychiatric, signs. Their pathophysiology is complex but the role of dopaminergic and serotoninergic systems dysfunction is suggested by several studies. In addition, the serotoninergic system is involved in the pathophysiology of dyskinesias. Very few studies have analyzed the abnormalities of these two neurotransmission systems at disease onset, in de novo PD patients. Furthermore, the parallel evolution of the degeneration of the dopaminergic and serotoninergic systems with disease progression remains unknown. Thus the present study aims at determining, by using PET and 11C-PE2I and 11C-DASB the respective role of the serotoninergic and dopaminergic systems dysfunction in motor and non motor manifestations in PD, at different evolution stages.

primary_purpose: Basic Science

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon, Hopital Neurologique Pierre Wertheimer


title: Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not.

summary:
Purpose:

Assessment of ultrasound MASEI index in axial spondyloarthritis and in healthy subjects, athletes or not
Comparison of the ultrasound semiology of enthesitis in the 3 populations
Comparison of the MASEI scores in the 3 populations

design_allocation: Non-Randomized

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Clinico-biological Correlation of Severe Asthma in Children

summary:
Asthma is the most common chronic respiratory disorder in children. Despite significant advances in understanding of asthma, available therapies fail to alter the natural history and progression of the disease. Airway epithelial cells are continuously exposed to and injured by environmental irritants, such as viruses and pollutants, and as such are ideally situated to orchestrate airway function in response to these stimuli.

Severe or difficult-to-treat asthma in children is a complicated disorder characterized by ongoing symptoms and persistent airway inflammation and oxidant stress despite corticosteroid treatment. Although severe asthma is likely a heterogeneous disorder, affected children similar clinical features, including gas trapping, bronchial hyperresponsiveness, and aeroallergen sensitization. However, the molecular and cellular pattern of inflammation in children with severe asthma are not uniform : some investigators have found increased eosinophils and TH2 derived cytokines, others have noted noneosinophilic patterns with neutrophil activation.

Given the heterogeneity of the inflammatory response in children with severe asthma, additional methods to distinguish severe asthma are needed.

study_completion_date_type: Anticipated

sponsor_collaborators: Assistance Publique Hopitaux De Marseille


title: Implementation of Innovative Techniques in Routine Diagnosis of Childhood Acute Leukemia: Analysis of Genome and Transcriptome by Micro-array

summary:
Acute leukemias are a heterogeneous group of malignancies characterized by the abnormal proliferation of a cell clone in the bone marrow, having as origin lymphocytic or myeloid lineage. The repertoire of mutations that determine the leukemic transformation, complex and variable depending on the tumor type and progression of the disease, combined in the same cell of balanced and unbalanced chromosomal aberrations, point mutations and epigenetic abnormalities.

The project presented here is part of a comprehensive approach to diagnosis of hematologic malignancies of children. Using comparative genomic hybridization on microarray (or array- CGH) and transcriptome analysis by microarray, two innovative techniques for a comprehensive analysis of the genome and transcriptome , offer new perspectives identifying molecular defects . These techniques provide new elements in the identification of acute leukemia at diagnosis may identify new prognostic factors to optimize the care of patients.

This project involves both the Department of Medical Genetics (Prof. N. LEVY ) regarding the identification of genomic abnormalities associated with childhood leukemia , the Laboratory of Hematology of the Hospital de la Timone ( Prof. Pierre Morange ) in terms of the phenotypic characterization of tumor cells, and the Onco - Hematology Pediatric Department (Prof. Michel Gerard ) which provides diagnosis, treatment , monitoring and the bone marrow of children with hematologic malignancies . The following project is mainly focused on the identification of genomic abnormalities (deletions and duplications) and abnormalities in gene expression to identify a genetic profile ensuring a better classification within the different groups risk .

The project we propose is centered on the identification of genomic abnormalities , changing the number of copies of certain regions of the genome or determining loss of heterozygosity , and the identification of changes in the level of gene expression by using two analytical techniques, comparative genomic hybridization on microarray (or array- CGH) and expression studies with microarrays . The data generated will , for the identification of " molecular signatures " , the classification of patients according to prognosis , variations in treatment response and survival.

The originality of this project lies in the use of these new tools in the diagnosis of hematological malignancies in children. This pilot study will be conducted with commercial Affymetrix , will develop the chips ' processing' , dedicated , enriched probes corresponding to genes involved in leukemogenesis , with high discriminatory power in identifying these signatures.

The data published in the specialized literature from the study of large series of patients show that microarrays provide important information for the diagnosis and therapeutic management of patients. It is for this reason that in the end we hope to integrate these analyzes in routine diagnosis to complement other analyzes ( phenotyping , identification of fusion genes and sequencing) in order to further characterize the abnormal cells leukemia and establish an " identity card of leukemia .

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Genetic


title: Persistent Platelet Reactivity in Acute Coronary Syndrome

summary: Study of persistent platelet reactivity during acute coronary syndrome. Patients are included at admission to the hospital. Platelet aggregation is evaluated by platelet function testing after blood sampling during hospitalization. No changes in treatment is planned.

lead_sponsor: Hopital Lariboisière

location_facility: Department of Cardiology - Lariboisiere Hospital


title: Randomized Study Evaluating the Influence of the Strategy Intraoperative Anesthetic (Desflurane Versus Propofol) on Cognitive and Psychomotor Functions in Output Post Interventional Room Monitoring

acronym: Cognides

summary:
The recovery of cognitive and psychomotor functions is best performed under anesthesia after desflurane when propofol in that obtaining a Aldrete score> 8/10 output of the allowing SSPI.

The principal objective is to compare the cognitive and psychomotor status of patients recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane) using three tests (Stroop test, Digit Symbol Substitution task and a test of verbal memory (visual verbal learning test) made SSPI.


title: Usefulness of Narrow-band Imaging to Estimate the Superficial Spread of Squamous Cell Carcinomas in Oropharynx, Hypopharynx and Larynx

summary: The aim of this study is to prospectively determine if the use of NBI endoscopy modifies the superficial extension of these tumors.

ReferenceCitation: Chabrillac E, Espinasse G, Lepage B, Uro-Coste E, Dupret-Bories A, De Bonnecaze G, Vergez S. Contribution of narrow band imaging in delineation of laryngopharyngeal superficial cancer spread: a prospective study. Eur Arch Otorhinolaryngol. 2021 May;278(5):1491-1497. doi: 10.1007/s00405-020-06499-2. Epub 2021 Jan 5.

publisher_dissemination: Springer-Nature

lead_sponsor: University Hospital, Toulouse


title: Effect of Apelin on Insulin Sensitivity: Proof of Concept in Healthy Volunteers

acronym: APELINS

summary:
The (PYR1)-apelin-13 is an endogenous peptide discovered relatively recently (1998). The apelin and its receptor, which is named apj, are expressed in many tissues including sensitive to the action of insulin, such as skeletal muscle, adipose tissue and heart tissue.

Recent work by the team of Prof. P.Valet (INSERM U1048, Toulouse) opened a new field of investigation, demonstrating for the first time in mouse models that apelin exerts a glucose-regulating in vivo action. The investigators propose a translational clinical research project whose goal is to provide the proof of concept of the favorable influence of apelin on insulin sensitivity in humans.

ReferenceCitation: Gourdy P, Cazals L, Thalamas C, Sommet A, Calvas F, Galitzky M, Vinel C, Dray C, Hanaire H, Castan-Laurell I, Valet P. Apelin administration improves insulin sensitivity in overweight men during hyperinsulinaemic-euglycaemic clamp. Diabetes Obes Metab. 2018 Jan;20(1):157-164. doi: 10.1111/dom.13055. Epub 2017 Aug 10.


title: Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2

summary: The investigators propose to conduct a comparative pilot cognitive and psychiatric profiles of 10 patients Facio-Scapulo-Humeral Dystrophy (= FHSD) type 1 and 10 patients with type 2 FSHD study. For this, the investigators relied on observational components: FSHD2 patients appear more often present with psychiatric comorbidities and seem to have lower cognitive performance compared to FSHD1 patients. This was confirmed by a preliminary study on a small sample population of patients. It seems to exist mainly executive dysfunction associated with attention disorders in patients FSHD2. Moreover, their performance in IQ tests would be low in relation to their socio-educational and compared with patients FSHD1 level.

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Behavioral


title: Prospective Study of Late Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.

acronym: RESPPEDHEM

summary: Hematopoietic stem cell transplantation (HSCT) is used to treat an expanding array of malignant and non-malignant disorders. This is a prospective multicenter study, in pediatric allo-BMT recipients to analyze the spectrum of noninfectious pulmonary complications (PC), to evaluate the prevalence and course of PFT abnormalities before and after transplant, and to detect risk factor for PC.

primary_purpose: Screening


acronym: SEDULC

summary: The purpose of this study is to determine whether consumption of carbonated drinks containing sweeteners affect insulin sensitivity.

primary_purpose: Other

ReferenceCitation: Bonnet F, Tavenard A, Esvan M, Laviolle B, Viltard M, Lepicard EM, Laine F. Consumption of a Carbonated Beverage with High-Intensity Sweeteners Has No Effect on Insulin Sensitivity and Secretion in Nondiabetic Adults. J Nutr. 2018 Aug 1;148(8):1293-1299. doi: 10.1093/jn/nxy100.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

lead_sponsor: Institute For European Expertise in Physiology

location_facility: Unit of Clinical Investigation,Centre Hospitalo-Universitaire de Rennes

lead_sponsor_type: industriel


title: Determination of the Effective Individual Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis

acronym: Etaplus

summary: The purpose of this study is to determine the optimal dosage of etanercept in patients treated for idiopathic juvenile arthritis


title: Effect of Three Therapeutic Strategies on the Restriction of the Participation of Patients With a Chronic Back Pain : Multidisciplinary is it the Key Component ?

acronym: PLURICLEF

summary: Effect of three therapeutics strategies on the restriction of the participation of patients with a chronic back pain : multidisciplinary is it the key component ?

ReferenceType: background

ReferenceCitation: Bontoux L, Roquelaure Y, Billabert C, Dubus V, Sancho PO, Colin D, Brami L, Moisan S, Fanello S, Penneau-Fontbonne D, Richard I. [Prospective study of the outcome at one year of patients with chronic low back pain in a program of intensive functional restoration and ergonomic intervention. Factors predicting their return to work]. Ann Readapt Med Phys. 2004 Oct;47(8):563-72. doi: 10.1016/j.annrmp.2004.03.006. French.

ReferenceCitation: Leclerc A, Chastang JF, Ozguler A, Ravaud JF. Chronic back problems among persons 30 to 64 years old in France. Spine (Phila Pa 1976). 2006 Feb 15;31(4):479-84. doi: 10.1097/01.brs.0000199939.53256.e0.

ReferenceCitation: Leggett S, Mooney V, Matheson LN, Nelson B, Dreisinger T, Van Zytveld J, Vie L. Restorative exercise for clinical low back pain. A prospective two-center study with 1-year follow-up. Spine (Phila Pa 1976). 1999 May 1;24(9):889-98. doi: 10.1097/00007632-199905010-00010.

ReferenceCitation: Jousset N, Fanello S, Bontoux L, Dubus V, Billabert C, Vielle B, Roquelaure Y, Penneau-Fontbonne D, Richard I. Effects of functional restoration versus 3 hours per week physical therapy: a randomized controlled study. Spine (Phila Pa 1976). 2004 Mar 1;29(5):487-93; discussion 494. doi: 10.1097/01.brs.0000102320.35490.43.

ReferenceCitation: Biering-Sorensen F. Physical measurements as risk indicators for low-back trouble over a one-year period. Spine (Phila Pa 1976). 1984 Mar;9(2):106-19. doi: 10.1097/00007632-198403000-00002.

ReferenceCitation: Ronzi Y, Roche-Leboucher G, Begue C, Dubus V, Bontoux L, Roquelaure Y, Richard I, Petit A. Efficiency of three treatment strategies on occupational and quality of life impairments for chronic low back pain patients: is the multidisciplinary approach the key feature to success? Clin Rehabil. 2017 Oct;31(10):1364-1373. doi: 10.1177/0269215517691086. Epub 2017 Feb 13.

ReferenceCitation: Petit A, Roche-Leboucher G, Bontoux L, Dubus V, Ronzi Y, Roquelaure Y, Richard I. Effectiveness of three treatment strategies on occupational limitations and quality of life for patients with non-specific chronic low back pain: Is a multidisciplinary approach the key feature to success: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2014 Apr 16;15:131. doi: 10.1186/1471-2474-15-131.

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

lead_sponsor: University Hospital, Angers

location_facility: University Hospital of Angers, laboratory epidemiology, ergonomics and occupational health


title: Evaluation de l'intérêt de l'électrostimulation Intra-vaginale à Domicile Par Rapport à Une Prise en Charge Habituelle Dans la Prise en Charge de Patientes Incontinentes Ayant bénéficié d'Une rééducation périnéale

summary: The aim of this study is to assess the benefit of GYNEFFIK®, a perineal electro-stimulator, during this home-care phase. Women with stress urinary incontinence (UI) or with mixed UI (composed predominantly of stress UI), that responded to physiotherapy were included in this study in two parallel groups. The groups followed a self-reeducation program, with or without GYNEFFIK® electro-stimulation sessions. The comparison of the two groups was based on the rate of women for whom the benefit of the initial perineal reeducation was maintained.

lead_sponsor: Effik


title: Search for Biological Markers of Orosensory Perception of Fatty Acids in Healthy Subjects and Possible Modifications in Patients With Type 2 Diabetes and in Obese Non-diabetic Patients.

summary:
Animal studies have shown that stimulation of the lingual lipid-receptor, CD 36, is accompanied by the rapid secretion of hormones in the digestive tract (incretines). We aim to determine in healthy humans whether the orosensory perception of fatty acids is followed by a modification in plasma levels of digestive tract hormones (cholecystokinin, GIP, GLP-1, secretin, pancreatic peptide, peptide YY, insulin) and metabolic markers from adipose tissue (leptin, ghrelin, adiponectin).

We also aim to determine whether the hormonal response induced by orosensory stimulation by lipids is modified:

in patients with type 2 diabetes
in obese non-diabetic patients We expect to show an increase in biological markers biological, and more particularly in certain digestive hormones such as Pancreatic polypeptide, GIP, GLP-1…after stimulation of the lingual lipid receptor, CD36. We will also determine whether or not this response is modified in patients with type 2 diabetes and in obese non-diabetic patients.

We also wish to measure the subjects' gustatory detection threshold for a fatty acid (linoleic acid), and to determine whether there is a relationship between the orosensory perception threshold for linoleic acid and the physiological status of the subjects. In order to achieve this, the thresholds for healthy subjects will be compared with thresholds for obese and diabetic subjects. Expected results: the threshold of detection for linoleic acid in healthy subjects will be lower than that in obese or diabetic patients.

ReferenceCitation: Besnard P, Christensen JE, Bernard A, Simoneau-Robin I, Collet X, Verges B, Burcelin R. Identification of an oral microbiota signature associated with an impaired orosensory perception of lipids in insulin-resistant patients. Acta Diabetol. 2020 Dec;57(12):1445-1451. doi: 10.1007/s00592-020-01567-9. Epub 2020 Jul 16.

oa_colors: green hybrid

ReferenceCitation: Chevrot M, Passilly-Degrace P, Ancel D, Bernard A, Enderli G, Gomes M, Robin I, Issanchou S, Verges B, Nicklaus S, Besnard P. Obesity interferes with the orosensory detection of long-chain fatty acids in humans. Am J Clin Nutr. 2014 May;99(5):975-83. doi: 10.3945/ajcn.113.077198. Epub 2014 Feb 12.


title: LIDA-B: Treatment of Cirrhosis-related Hepatocellular Carcinoma With the Intrahepatic Arterial Injection of an Emulsion of Lipiodol and Idarubicin (Zavedos®): Phase I Study

summary:
Unresectable, non-metastatic cirrhosis-related hepatocellular carcinoma (HCC) has a poor prognosis as there are no recommended curative treatments. Chemoembolisation is the most widely used treatment in these patients, but this technique can prove to be toxic. intrahepatic arterial chemotherapy with lipiodol and idarubicin could be an effective therapeutic approach, without deteriorating liver function.

The rationale for this treatment can be resumed as follows:

HCC are vascularised via the hepatic artery system
The IHA perfusion of anthracyclines leads to high elimination via the liver with low systemic concentrations
The absence of embolisation reduces toxicity
the toxiciity profile of idarubicin is well known and the drug is widely used for the IV treatment of leukemia
idarubicin is the most cytotoxic drug for tumor cell lines.
The in vitro cytotoxicity of idarubicin is 100% at low concentrations
Lipiodol can stay in contact with tumor tissue for several weeks after injection and act as a vector for the drug
The idarubicin-lipiodol is more stable than lipidol emulsions usually given by intraarterial injection
The emulsion is more stable with idarubicin than with other anticancer molecules
Sequential inclusion in accordance with the "continual reassessment method" makes it possible to increase inclusions at a target toxicity level while reducing inclusions at doses that are too low or too toxic The aim of the treatment is to improve survival.


title: Study of the Impact of the Regular Consumption of Polyphenol-rich Grape Juice on the Biological Parameters of Oxidative Stress and on Endothelial Function in Healthy Subjects: a Prospective Randomised Double-blind Study

acronym: Fijus Raisol

summary:
Many epidemiological and clinical studies have suggested the negative effect of oxidative stress ( = attack of cell components by free radicals) on the cardiovascular risk, notably in patients with metabolic syndrome, insulin resistance, diabetes or obesity and smokers.

Polyphenols, notably those present in red grapes, have a certain antioxidant effect. Dietary supplementation with polyphenols in high-risk patients could diminish the harmful consequences of oxidative stress.

The aim of this study is to show that the daily consumption of grape juice rich in polyphenols " R@isol ", has a positive impact on the oxidation/antioxidation balance in healthy volunteers.


title: Comparative Study of Physiological and Cerebrovascular Reactivity in Depression, at the Three Phases of Emotion

acronym: EMPHILINE

summary: The main objective is to compare the physiological reactivity (heart and respiratory rates, galvanic skin response, cerebral perfusion, and startle) in the three phases of emotion between depressive subjects, subjects remitted from depression and control subjects.

lead_sponsor: University Hospital, Tours


title: Phase I / II Study of Sequential High-dose Chemotherapy With Stem Cell Support in Children Younger Than 5 Years of Age With High-risk Medulloblastoma

acronym: HR MB-5

summary:
The trial includes i) the evaluation of the efficacy of a treatment strategy, designed as a phase II trial, and ii) a dose-finding part.

The Phase II trial is an open label, non-randomized, multicentre trial without control group. A Bayesian approach will be used to analyse the EFS, assuming a cure model. We will use three prior distributions of the EFS; (1) an enthusiastic prior distribution, (2) a pessimistic prior distribution, and (3) a non-informative prior distribution. As the patient outcomes in the trial will be recorded, the subsequent distribution of the outcome probability under experimental treatment will be computed by applying Bayes' theorem, which yields an estimated EFS probability with a 95% credibility interval (measure of Bayesian precision). Two interim analyses are planned to monitor the efficacy data (early stopping rules for futility or inefficacy).

The final analysis of efficacy will be made on an intention to treat basis, including all recruited patients, 3 years after recruitment of the last patient.

Due to the uncertainty on the dose of cyclophosphamide that can be given in combination with Busilvex for the last chemotherapy course in patients in complete response after intensification chemotherapy treatment, a dose-finding subtrial will be performed to address this issue (Phase I part). The dose escalation of cyclophosphamide will be performed using the Continual Reassessment Method in a Bayesian framework.

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris


type: Registry Identifier

title: Phase III: Comparison of the Efficacy and Safety of T2762 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome

summary: Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome

lead_sponsor: Laboratoires Thea


title: Prospective Study on Oncologic Cerebral Imagery Contribution by 18F-FDOPA Position Emission Tomography (PET) in a Multidisciplinary Meeting Therapeutic Proposal When Caring for Patients Diagnosed Primary or Secondary Cerebral Tumors

acronym: IMOTEP

summary:
In standard care for patients diagnosed with a primary or secondary (metastasis) cerebral tumor, there is currently complex clinical situations in which the clinic and Magnetic Resonance Imagery (MRI) do not allow for the medical team to arrive at a conclusive diagnosis. The therapeutic proposition requires then a delay in additional follow-up of at least 3 months in order to clarify the situation, with a potential delay in diagnosis and therefore therapeutic care. The contribution of cerebral molecular imagery could allow for new additional information to be brought in or to increase the confidence index in the diagnosis in order to comfort the therapeutic collective attitude proposed in the multidisciplinary meeting (MM).

3.4-dihydroxy-6-18F-fluoro-L-phenylalanine (18F-FD0PA), dopamine precursor amino-acid, Position Emission Tomography (PET), allows for the studying in vivo of the proteic transmembrane transport in gliomatous tissue; active transport happens through a sodic-independent canal, increased in malicious transformations, and in which kinetics can give an indication regarding the development of the primary tumor.

In MRIs, tumor tissue growth after injecting the contrast product translates to a rupture in the Blood-Brain Barrier (BBB), while tumor extraction from the radiopharmaceutical is independent of the state of integrity of the BBB and whose only function is metabolic tissue activity. This method of imagery thus appears as a promising contribution to conventional imagery.

Furthermore, different to 18F-FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose), similar to the largely used glucose in oncologic molecular imagery, exploration of harmful glioma in 18F-FDOPA, is not compromised by background noise activity, and is almost useless in a healthy cerebral cortex, with the exception of striatal physiological fixation used as a level of reference. The best performances in terms of positive and negative predictive value were defined in the literature with a tumor/striatum threshold of 1.

According to the latest and current European recommendations, turning to PET when caring for high-level gliomas patients can be proposed in the evaluation of therapeutic responses. However, very few studies have evaluated the in-practice current clinical contributions of PET and put it into perspective with classic clinical radiological data.

lead_sponsor: Centre Antoine Lacassagne


title: Measurement of Assisted Vital Capacity to Appreciate the Level of Recruitment in Neuromuscular Diseases

acronym: CVassist

summary: Respiratory failure is the most common cause of death in neuromuscular diseases. The aim of this research is to evaluate the thoracopulmonary recruitment by comparison of inspiratory vital capacity (VC ins)and inspiratory/expiratory vital capacity (VC ins-ex) with the vital capacity (VC) according to pathology and severity of pulmonary damage of patients with neuromuscular diseases. The methodology consists in realize VC by support of inspiratory/expiratory pressures, while the patient is passive and realizing a maximal inspiratory/expiratory effort simultaneously, with the aid of mechanical insufflation/exsufflation device (Cough Assist®). The evaluation will last for 30 minutes and the non-inclusion criteria are those for an insufflation. The study hypothesis is that long term insufflation/exsufflation device use could improve thoracopulmonary mobility.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Prospective Monocentric Study on the Efficacy of Lidocain Spray for Patient Comfort During Nasogastric Tube Insertion in Enteral Nutrition: the Xylonut Trial

acronym: Xylonut

summary:
Enteral nutrition is the treatment of choice for malnourish patient. Nasogastric tube (NGT) is although a common act. Unfortunately, this procedure can be painful. Also, many patients will need many NGT re-insertion. Therefore, the investigators need to increase the acceptability of this procedure by increasing comfort during NGT passage. Professionals guidelines of HAS (recommendations professionnelles de bonne pratiques de soins) and SFNEP (Société Française de Nutrition Clinique et Métabolisme) talk about the possibility of using local anesthesic without ordering their use. However, NGT tube insertion is often put without pre-medication in the face of an accumulating body of evidence indicating that local anesthetic prior NGT insertion decrease discomfort of the procedure. On the other hand, these studies have been done in the emergency room with NGT of a bigger gauge and for many reasons except enteral nutrition.

The investigators primary objective of this prospective monocentric study is to evaluate the efficacy (patient comfort) of lidocaine 5 % spray versus placebo (physiologic serum) before NGT insertion in patient needing enteral nutrition, using visual analogue scale. Secondary objectives are to evaluate nurse and patient satisfaction using questionnaires, facility of NGT insertion using Likert scale, numbers of try, time of procedure, complications like tracheal insertion and success of the insertion using thorax x-ray.

The study will be held in CHU Nice at nutrition unit support. After signed consentment, patients will be separate in two groups : group A (lidocaïne spray 5 %) and group B (physiologic serum). There will be 2 spray in nostril and 2 in orophagyngeal cavity 2 minutes before NGT insertion, which will be done by a competent nurse. Vital signs will be noted at the beginning of the procedure and 10 minutes after. At the end, the nurse and the patient will have to answer a questionnaire. Pain will be grade using visual analogue scale immediately after the procedure. Demographic data and complications will be note by the investigator. Finally, thorax X-ray will be done at the end of the procedure. There will be 34 patients by group. If the investigators find a benefit, this can change their practice and guidelines.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: The Prognostic Value of Cervical Elastography for Identifying Patients at Risk for Preterm Delivery

acronym: ElastoMAP

summary: The hypothesis tested is that the physical changes associated with cervical ripening result in a detectable decrease in rigidity. The main objective of this study is therefore to determine whether the measured elastographic rigidity of cervical tissues in addition to cervix size can be used to predict delivery within the next 48 hours (creation of a prognostic score).

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Benefit of Prophylactic Embolization of the Splenic Salvage in Trauma Patients at High Risk of Splenectomy.

acronym: Splash

summary: The main objective is to show that splenic embolization improves salvage rate at one month in a population of hemostatically stable closed splenic trauma patients with a high risk of splenectomy

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ReferenceCitation: Liu PP, Lee WC, Cheng YF, Hsieh PM, Hsieh YM, Tan BL, Chen FC, Huang TC, Tung CC. Use of splenic artery embolization as an adjunct to nonsurgical management of blunt splenic injury. J Trauma. 2004 Apr;56(4):768-72; discussion 773. doi: 10.1097/01.ta.0000129646.14777.ff.

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ReferenceCitation: Ekeh AP, McCarthy MC, Woods RJ, Haley E. Complications arising from splenic embolization after blunt splenic trauma. Am J Surg. 2005 Mar;189(3):335-9. doi: 10.1016/j.amjsurg.2004.11.033.

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ReferenceCitation: Shih HC, Wang CY, Wen YS, Wu JK, Huang MS, Huang CI, Lee CH. Spleen artery embolization aggravates endotoxin hyporesponse of peripheral blood mononuclear cells in patients with spleen injury. J Trauma. 2010 Mar;68(3):532-7. doi: 10.1097/TA.0b013e3181a7bfaa.

ReferenceCitation: Tominaga GT, Simon FJ Jr, Dandan IS, Schaffer KB, Kraus JF, Kan M, Carlson SR, Moreland S 3rd, Nelson T, Schultz P, Eastman AB. Immunologic function after splenic embolization, is there a difference? J Trauma. 2009 Aug;67(2):289-95. doi: 10.1097/TA.0b013e3181a5e7e2.

ReferenceCitation: Arvieux C, Frandon J, Tidadini F, Monnin-Bares V, Foote A, Dubuisson V, Lermite E, David JS, Douane F, Tresallet C, Lemoine MC, Rodiere M, Bouzat P, Bosson JL, Vilotitch A, Barbois S, Thony F; Splenic Arterial Embolization to Avoid Splenectomy (SPLASH) Study Group. Effect of Prophylactic Embolization on Patients With Blunt Trauma at High Risk of Splenectomy: A Randomized Clinical Trial. JAMA Surg. 2020 Dec 1;155(12):1102-1111. doi: 10.1001/jamasurg.2020.3672.

publisher_dissemination: American Medical Association

ipd_sharing: Undecided

lead_sponsor: University Hospital, Grenoble


title: Circulating Endotoxemia After Liver Resection for Hepatocellular Carcinoma in Liver Disease - Influence of Preoperative Administration of Probiotics

acronym: LIPROCES

summary:
Surgical resection is one of the curative treatment modalities for HCC. Limits are postoperative septic and liver functional complications related to an increase in bacterial translocation and systemic endotoxemia. Bacterial translocation is a passage of bacteria and bacterial degradation products from the intestine to the portal circulation. The endotoxemia secondary to bacterial translocation, stimulates endothelial production of nitric oxide (NO). NO is also a potent inducer of membrane instability, responsible for an increase in the permeability of the vascular endothelium and intestinal mucosa, possibly contributing to a worsening of bacterial translocation.

Probiotics are live microorganisms which when administered in adequate amounts, provide a health benefit on the host ((Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria - Cordoba Argentina October 2001). Data from experimental and clinical literature show a significant effect of probiotics on the improvement of liver function and a decrease in infectious complications in patients with chronic liver disease. The proposed study would evaluate the effect preventive and therapeutic in a population of surgical patients, in whom the intestinal portal and hepatic inflammation promotes postoperative complications.

ReferenceCitation: Roussel E, Brasse-Lagnel C, Tuech JJ, Montialoux H, Papet E, Tortajada P, Bekri S, Schwarz L. Influence of Probiotics Administration Before Liver Resection in Patients with Liver Disease: A Randomized Controlled Trial. World J Surg. 2022 Mar;46(3):656-665. doi: 10.1007/s00268-021-06388-7. Epub 2021 Nov 26. Erratum In: World J Surg. 2021 Dec 15;:

lead_sponsor: University Hospital, Rouen


title: Effects of Chair Sitting Exercise Intervention on Weaning From Mechanical Ventilation and Mortality of Critically Ill Patients With Acute Respiratory Failure: a Randomised Controlled Trial.

acronym: RehabVent

summary:
The occurrence of an acute respiratory failure necessitates mostly admission to ICU and mechanical ventilation (MV). Rapid and safe discontinuation of MV should be the objective for the majority of patients. Many reasons may contribute to weaning, extubation failure and prolongation of MV. Critical illness myopathy, induced by immobilisation and prolonged MV, may represent a main factor and early rehabilitation may reverse these conditions and improve the success of weaning from MV.The objective of this study is to evaluate the effect of an early chair sitting (while the patient is awake but still mechanically ventilated) on weaning from mechanical ventilation and ICU mortality.

Methods: Chronic respiratory failure patients with an acute decompensation and requiring MV for more than 48 hours will be randomized to 2 groups at the initiation of weaning schedule: the studied group (20 patients): chair-sitting group will be transferred from bed to arm chair for at least 1 hour and once a day; the control group will stay in bed until extubation. Ventilator free days, extubation failure, nosocomial infections, ICU mortality, ICU length of stay are assessed and compared between groups. Expected results: Early chair sitting would decrease MV duration, number of extubation failure, nosocomial infections and ICU mortality. Feasibility and safety of this intervention will also be evaluated and also the related work load.

ReferenceCitation: Canaud B, Formet C, Raynal N, Amigues L, Klouche K, Leray-Moragues H, Beraud JJ. Vascular access for extracorporeal renal replacement therapy in the intensive care unit. Contrib Nephrol. 2004;144:291-307. doi: 10.1159/000078897. No abstract available.

lead_sponsor: University Hospital, Montpellier

location_facility: Lapeyronie University Hospital, Intensive Care Department


title: Efficacy and Safety of Rebel Reliever Brace in Medial Femorotibial Knee Osteoarthritis. Phase 3, Multicenters, Randomised and Controlled Study With 2 Parallel Groups.

acronym: ROTOR

summary: The purpose of the study is to evaluate the superiority of Rebel Reliever® knee brace + standard treatment versus standard treatment alone in terms of last 24-hour pain relief after 6 weeks. in patients with medial knee osteoarthritis.

lead_sponsor: Thuasne


title: Study of Placental Transfer of Tenofovir and Its Factors of Variability Using the Human Placental Perfusion Model

acronym: TDF-PTP

summary: The purposes of this study are to determine whether transporters expression levels and drug interaction between TDF and FTC could contribute to modulate the placental transfer of this drug or. To test this hypothesis, an ex vivo model known as "the perfused ex vivo cotyledon model" allows to reproduce the conditions of the third trimester of pregnancy

ReferenceCitation: Hirt D, Urien S, Ekouevi DK, Rey E, Arrive E, Blanche S, Amani-Bosse C, Nerrienet E, Gray G, Kone M, Leang SK, McIntyre J, Dabis F, Treluyer JM; ANRS 12109. Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS 12109). Clin Pharmacol Ther. 2009 Feb;85(2):182-9. doi: 10.1038/clpt.2008.201. Epub 2008 Nov 5.

ReferenceCitation: Vinot C, Gavard L, Treluyer JM, Manceau S, Courbon E, Scherrmann JM, Decleves X, Duro D, Peytavin G, Mandelbrot L, Giraud C. Placental transfer of maraviroc in an ex vivo human cotyledon perfusion model and influence of ABC transporter expression. Antimicrob Agents Chemother. 2013 Mar;57(3):1415-20. doi: 10.1128/AAC.01821-12. Epub 2013 Jan 7.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


acronym: DEBITC

summary: Severe traumatic brain injury with increased intracranial pressure can lead to decreased cerebral blood flow. Low cerebral blood flow is responsible for secondary lesions, leading to bad prognosis. It is not yet established whether increasing cardiac output in these patients can lead to an increase in cerebral blood flow, although there are some arguments in favor of this hypothesis. The aim of this study is to demonstrate that increasing cardiac output will improve cerebral blood flow in patients with severe traumatic injury and high cerebral pressure.


title: A Phase Ib, Open-label, Dose Escalation Study of the Safety, Tolerability and Efficacy of LY2780301 (a p70/AKT Inhibitor) in Combination With Gemcitabine in Patients With Advanced or Metastatic Cancer

acronym: INPAKT

summary: In the First-in-Human, JWAA trial, the LY2780301 displayed a favourable safety profile, a high pharmacokinetic exposure and the ability to decrease pS6. LY2780301 has shown synergistic activity in combination with targeted agents or chemotherapy including gemcitabine. We propose herein to combine LY2780301 with gemcitabine and to treat different tumor types with molecular alterations. This may validate the anti-tumor activity of the LY2780301 and it will increase our knowledge regarding molecular predictors of its efficacy.

ReferenceCitation: Angevin E, Cassier PA, Italiano A, Goncalves A, Gazzah A, Terret C, Toulmonde M, Gravis G, Varga A, Parlavecchio C, Paci A, Poinsignon V, Soria JC, Drubay D, Hollebecque A. Safety, tolerability and antitumour activity of LY2780301 (p70S6K/AKT inhibitor) in combination with gemcitabine in molecularly selected patients with advanced or metastatic cancer: a phase IB dose escalation study. Eur J Cancer. 2017 Sep;83:194-202. doi: 10.1016/j.ejca.2017.06.036. Epub 2017 Jul 24.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Exercise Stress MRI to Evaluate Aortic Function (Compliance, Distensibility, Pulse Wave Velocity) and Left Ventricular Function : Validation in Healthy Volunteers and in Selected Patients. A Pilot Study.

summary:
Detecting abnormalities in the left ventricular mechanical and hemodynamic response to the stress of exercise may offer early diagnostic indicators in patients suffering from valvular disease such as mitral regurgitation. Ultrasound-based imaging methods have been gaining importance in providing prognosis among those patients. However, decreased signal to noise ratio in the images and increased motion-related artifacts during exercise stress echocardiography have been reported, with a lack of reproducibility of results and a the limitation of its availability only in reference centers. In our laboratory, we are able to perform supine bicycle exercise MRI (1.5 T) using the Lode ergometer mounted on the far end of the patient table, previously described in healthy volunteers.

The first aim of our study is to demonstrate the safety and the feasibility of our MRI protocol in selected patients with asymptomatic severe organic mitral regurgitation, to assess left ventricular volumes and function, and regurgitant volume in comparison to exercise cardiac echography.

Besides, few recent studies sustain the relevance of novel markers of central aortic function (compliance, distensibility and pulse wave velocity) assessed by noninvasive MRI to explore vascular aging. In monogenic connective tissue diseases, altered arterial stiffness is the premature signature of the disease in asymptomatic patients. Noninvasive evaluation of aortic stiffness would be useful for risk assessment and preventive follow-up strategies in young asymptomatic relatives of subjects with aortic inherited diseases, such as syndromic and non-syndromic familial forms of thoracic aortic aneurysm and /or dissection. Furthermore, this technique should be able to evaluate the effect of drugs on aortic stiffness change in trials, before and after drug therapy, more relevant than the classic change in aortic diameter measurement.

The second aim of our study is 1) to provide the sensibility of our MRI protocol to estimate local and regional heterogeneity in aortic functional parameters (distensibility, compliance and PWV) 2) to evaluate the predictive value of these regional aortic parameters assessed by MRI to diagnose and to stratify the aortopathy related to presymptomatic Marfan patients and to bicuspid aortic valve in young adults, in comparison to carotids-femoral pulse wave velocity estimation by applanation tonometry.

lead_sponsor: Assistance Publique Hopitaux De Marseille


summary: The aim of this study is to demonstrate and quantify the micro architecture and micro vascular changes within skeletal muscles after marathon using 3T MRI (diffusion tensor and arterial spin labeling). Apparent diffusion coefficient, fractional anisotropy and flow parameters will be registered before and after the long-distance run on the lower leg. Axial T1 and axial SPAIR sequences will also be applied at the same time.Stress ox and inflammatory markers will be collected in blood and urine samples and compare with both MRI and Near-infrared spectroscopy (NIRS).


title: Positioning of the Tibial Cut in Unicompartmental Medial Knee Replacement by Using Patient Specific Cutting Guides.

acronym: PSI-PUC

summary:
Unicompartmental knee replacements are performed to treat osteoarthritis or osteonecrosis of the knee especially when it affects only the medial femoro-tibial compartment. To place the prosthesis, bone removal is necessary. The orientations of the bony cuts directly influence the position of the different elements of the prosthesis and the limb alignment. It is known that good positioning of the prosthesis is the key of a good survival of the implants. To guide the blade of the saw, cutting guides are used. The position of these guides gives the final position of the cuts. At present, two main techniques are used to position the guides: the conventional one, not very costly but not very accurate, and the navigated procedure, which is more accurate but also more expensive and more invasive. Since few years, patient specific cutting guides are used in total knee replacement with encouraging results and more recently in uni compartmental knee replacement with no scientific proof of efficiency.

This study aims to validate the procedure of patient specific cutting guides.

lead_sponsor: Rennes University Hospital


acronym: ZOMAXEPT

summary: The study is performed to collect long-term data on the treatment adherence and patient's acceptability when Zomacton®10 mg is administered with the Zomajet® Vision X device in patients with a growth hormone deficiency or Turner's syndrome.

lead_sponsor: Ferring Pharmaceuticals


title: Population Pharmacokinetics of Levofloxacin in Intensive Care Patients With Severe Community-acquired Pneumonia.

acronym: LEVO-PHARM

summary: The aim of this study is 1. to describe levofloxacin pharmacokinetics in ICU patients suffering from pneumonia with taking into account physio-pathological parameters. 2. to verify clinical and bacteriological efficiency and to know if the peak/Minimum Inhibitory Concentration (MIC) ratio > 5 and Area Under Curve (AUC) /Minimum Inhibitory Concentration(MIC) ratio > 125. No therapeutic drug monitoring will be performed in this study.

lead_sponsor: University Hospital, Toulouse


title: A Phase 1, Randomized, Observer Blinded, Placebo Controlled, Single Center, Dose Escalation Study to Evaluate the Safety and Immunogenicity of 3 Vaccinations With Shigella Sonnei Vaccine (1790GAHB) Administered Intramuscularly in Healthy Adults.

summary:
This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of 5 sequentially escalating dosages of a candidate vaccine against Shigella sonnei (1790GAHB vaccine) administered by intramuscular route in healthy adults (18 to 45 years of age at enrollment). The safety profile of the 1790GAHB vaccine is evaluated in comparison to that of placebo (GAHB-Placebo), constituted by an aluminum hydroxide suspension having the same concentration as study vaccine formulations. A total of 50 eligible subjects will be assigned to one of five sequential cohorts of 10 subjects each.

Within each cohort, in an observer-blind fashion, subjects will be randomized to receive three vaccinations, four weeks apart, of either 1790GAHB vaccine (at five antigen concentrations) or GAHB placebo. A Data Safety Monitoring Board will be in place to receive a summary of all safety data obtained during one week follow-up post-first vaccination with the lower dose. Based on evaluation of the safety data, the Data Safety Monitoring Board will make a recommendation, as to whether the next cohort should be vaccinated with higher antigen concentration or not.

Expected duration of the study for an individual subject is 9 months. Each subject will be followed-up for 6 months after the 3rd vaccination.

ReferenceCitation: Micoli F, Rossi O, Conti V, Launay O, Scire AS, Aruta MG, Nakakana UN, Marchetti E, Rappuoli R, Saul A, Martin LB, Necchi F, Podda A. Antibodies Elicited by the Shigella sonnei GMMA Vaccine in Adults Trigger Complement-Mediated Serum Bactericidal Activity: Results From a Phase 1 Dose Escalation Trial Followed by a Booster Extension. Front Immunol. 2021 May 4;12:671325. doi: 10.3389/fimmu.2021.671325. eCollection 2021.

ReferenceCitation: Launay O, Lewis DJM, Anemona A, Loulergue P, Leahy J, Scire AS, Maugard A, Marchetti E, Zancan S, Huo Z, Rondini S, Marhaba R, Finco O, Martin LB, Auerbach J, Cohen D, Saul A, Gerke C, Podda A. Safety Profile and Immunologic Responses of a Novel Vaccine Against Shigella sonnei Administered Intramuscularly, Intradermally and Intranasally: Results From Two Parallel Randomized Phase 1 Clinical Studies in Healthy Adult Volunteers in Europe. EBioMedicine. 2017 Aug;22:164-172. doi: 10.1016/j.ebiom.2017.07.013. Epub 2017 Jul 15.

ReferenceCitation: Muturi-Kioi V, Lewis D, Launay O, Leroux-Roels G, Anemona A, Loulergue P, Bodinham CL, Aerssens A, Groth N, Saul A, Podda A. Neutropenia as an Adverse Event following Vaccination: Results from Randomized Clinical Trials in Healthy Adults and Systematic Review. PLoS One. 2016 Aug 4;11(8):e0157385. doi: 10.1371/journal.pone.0157385. eCollection 2016.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Illinois at Chicago - INDIGO

evidence: oa repository (semantic scholar lookup)

publisher_dissemination: Public Library of Science

lead_sponsor: GSK Vaccines Institute For Global Health S.r.l.

location_facility: Centre d'Investigation Clinique en Vaccinologie Cochin-Pasteur (CIC1417)


summary:
Primary objective:

The primary objective is to demonstrate the superiority of Monoprost® versus Lumigan® 0.01% and Lumigan® 0.03% Unit Dose in term of safety with respect to the assessment of conjunctival hyperaemia in the worse eye at Day 84.

The conjunctival hyperaemia will be scored using the MacMonnies photographic scale (0 to 5).

title: Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01% and Lumigan® 0.03% Unit Dose, in Patients With Primary Open Angle Glaucoma or Ocular Hypertension, Stabilized by Lumigan® 0.01% With Ocular Surface Intolerance

type: EudraCT Number

source: euctr


title: REGENERATING AGENT (OTR4120) AND BACTERIAL KERATITIS : A RANDOMISED TRIAL

acronym: CACICOL

summary: The purpose of this study is to evaluate efficiency of CACICOL20 for bacterial keratitis. It is a double blinded comparison of epithelial defect in two groups of patients randomized between CACICOL20 and physiological salt solution.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Thrombectomy Under Reopro Versus Alteplase and Neurologic Deficit Outcome Trial

acronym: TURANDOT

summary: Intravenous (IV) Alteplase (rt-PA) is the gold standard for brain infarction within 4 h 30 of symptoms onset. Efficacy of this therapy is limited in the setting of large artery occlusions. For middle cerebral artery occlusions (MCA)or internal carotid artery occlusions (ICA), recanalization rates will drop as low as 10%. This element is critical as prognosis is linked to recanalization. Arterial re-occlusions are frequent and may reach 30%, which limits IV thrombolysis efficacy.With the endovascular approach, recanalization rates may reach 90% with last generation devices. A recent meta-analysis has shown that the best candidates for thrombectomy are MCA occlusions. In the coronary literature, endovascular therapy efficacy is increased in association with antiplatelets such as abciximab. The aim of the study was to assess the feasibility of thrombectomy associated with abciximab on revascularisation (TICI score), as well as safety (symptomatic intracranial bleeding), in order to design a clinical trial versus the gold standard for acute ischemic stroke revascularization strategies using IV rt-PA.This is a controlled, pilot study, evaluating feasibility and safety of thrombectomy with abciximab versus IV rt-PA in acute ischemic stroke patients within 4h30 of symptoms onset.

lead_sponsor: SOS Attaque Cérébrale


title: Cerebrospinal Fluid Proteome in Hydrocephalus

acronym: PROLIPHYC

summary: PROLIPHYC is a collaborative prospective study that aims at discovering deep cerebrospinal fluid (CSF) proteome with a new clinically-compatible proteomics strategy, in a cohort of 100 patients suspected of neurodegenerative diseases and/or normal pressure hydrocephalus.

ReferenceCitation: Bech-Azeddine R, Hogh P, Juhler M, Gjerris F, Waldemar G. Idiopathic normal-pressure hydrocephalus: clinical comorbidity correlated with cerebral biopsy findings and outcome of cerebrospinal fluid shunting. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):157-61. doi: 10.1136/jnnp.2006.095117. Epub 2006 Sep 29.


title: Pain During Chest Tube Withdrawal: Evaluation Using Pan Monitor in Patients With or Without Epidural Anesthesia

acronym: Pain Drain

summary:
Pain evaluation remains a clinical problem. Pain Monitor allows pain evaluation using the measurement of skin conductance.

Withdrawal of chest tube can be painful and the purpose of the study was to compare auto-evaluation of pain (visual analogic scale) and the index measured by the Pain Monitor.

lead_sponsor: Hopital Foch


title: Evaluation of Accuvein in Obese Patients

acronym: AVO

summary: The objective of this study is to evaluate the effectiveness of Accuvein to facilitate placement of peripheral intravenous catheters in obese patients. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator), decreases the time to effective cannulation, and decreases the patient's perception of the pain.


title: Evaluation du Niveau d'activité Physique Quotidien, Chez Des Patientes Porteuses d'un Cancer du Sein en période Post thérapeutique

acronym: APQ

summary:
Many studies have demonstrated the beneficial effects of Adapted Physical Activity (APA) in different cancer types.

It therefore seems necessary to assess spontaneous Physical Activity in order to integrate it to the overall calculation of physical activity in clinical practice.

To assess the AP, two types of methods are validated : the subjective method using a questionnaries and objective method using a pedometer , accelerometer or measures calorimetry .

Subjective method shows , good acceptability by patients and low cost but can sometimes lead to poor estimation of the level of activity.

Objective methods obviously increase the accuracy of assessments but are more difficult to use for epidemiological studies , less accepted by the patient and more expensive.

In this study the investigators will measure the spontaneous Daily Physical Activity by both methods andd evaluate the correclation.

lead_sponsor: University Hospital, Limoges


title: A Cohort of Patients With Cystinosis : Compliance to Cysteamine and Neurological Complications

acronym: Crystobs

summary:
Preventing late onset of Cystinosis such as neurological complications and improving compliance to cysteamine treatment remain major challenges in management of subjects with cystinosis.

This study is designed to describe the relationship between compliance of patients with cystinosis treated with cysteamine and treatment efficacy and to understand the pathophysiologic mechanism of neurological disorders. Is cysteamine crossing the blood brain barrier? What is the impact of cystine accumulation in Cerebro Spinal Fluid and Central Nervous System? Our Primary objective is to study the relationship between compliance of patients treated with cysteamine and the WBC cystine level.

Secondary, the study will assess relationship between compliance to cysteamine and its neurological consequences.

The expected duration of the study is 48 months. The enrolment period is 24 months and the study participation of each subject is 24 months. Eligible participants are male and female (age > 4 years) with confirmed diagnosis of cystinosis and receiving any oral cysteamine treatment: Cystagon or RP103.

The compliance under cysteamine is measured using electronic devices, accountability of study treatment, and information in patients' diary. Specific memory and visuoperceptual tests are performed at the beginning and at the end of patients'participation. Nuclear Magnetic Resonance spectroscopy is used to detect possible sites of cystine accumulation in the CNS and their relationship with compliance to cysteamine treatment. NMRS is also used to establish a relationship with the neuropsychological status of the subject.

To describe absorption, distribution and elimination of cysteamine, and its metabolic pathways, and to determine the concentration effect and dose effect relationship, blood samples are performed at each study visit. A lumbar puncture is also proposed to participants to verify if cysteamine is crossing the blood brain barrier. New tools are used to compare metabonomic networks in patients with cystinosis and their controls.

lead_sponsor: Hospices Civils de Lyon


title: Evaluation of the Internal Rotation Deficit of the Glenohumeral Joint in Advanced-level Handball Players Occurring Over One Training Season

acronym: GIRDH

summary: The main objective of this study is to estimate the incidence and prevalence of Internal Rotation Deficit (IRD) defined by a measure of IRD 2 (Internal Rotation Deficit in position 2) strictly greater than 20 ° in a population of advanced-level handball players over a training season.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Evaluation of Therapeutic Management in ESBL-infected Patients or Carriers by Providing and Sharing a Free Tool - the "ESBL toolKIT" and Interventional Study of a Prospective Cohort of HIV+ Patients Searching for Possible Sexual Transmission Factors in ESBL (Extended-spectrum ß-lacatamase-producing Bacteria) Carriers

acronym: Calires

summary:
Bacterial resistance to antibiotics is a major public health problem. The epidemiology of enteric bacteria including E. coli is changing rapidly with the global spread of a resistance mechanism type beta-lactamase extended spectrum (ESBL), responsible for resistance to almost all penicillins and cephalosporins. The resistance is up to 75% for Quinolones, 67% for Cotrimoxazole and 30-50% for Aminoglycosides.

The main phenomena causing this problem are:

The selection pressure by antibiotics, in their use in humans or animals
The hand transmission via the digestive reservoir (faeces)
Easy spread of resistance mechanism in Enterobacteriaceae due to transferable genetic support (plasmid)

In this context, we decided to implement a cross-border study to improve and accelerate the management, diagnosis and treatment of patients with ESBL in close collaboration between medical and paramedical staff in hospitals, laboratories and private medical offices.

The objective of this study is to standardize diagnostic and therapeutic measures allowing a better and rapid treatment of patients and thus prevent the appearence of ESBL bacteria in the PACA region and Liguria by providing a tool : The "Kit ESBL".

The " ESBL ToolKIT" (also translated into Italian) includes:

Information on epidemiological data
A checklist edited for extra-hospital use (private practitioners, health care units other than hospitals)
A checklist edited for hospital use
A leaflet BMR for the patient explaining the problematic as well as hygiene measures
Therapeutical protocols for hospital use and extra hospital use
An sample letter for the attending physician

The objective of this prospective multicenter cohort study is to evaluate the use of this kit, and to measure its impact on:

The prescription of appropriate antibiotics
The measures taken to prevent man to man transmission
The quality of information provided to the patient

In this context we are also performing a multicentre prospective interventional cohort of HIV+ patients searching for possible sexual transmission factors in ESBL (extended-spectrum ß-lacatamase-producing bacteria) carriers.

We will also try to determine if other sexually transmitted infections associated (syphilis, gonorrhea and chlamydia) are contributing factors to ESBL carriage.

So far there is no data documented on ESBL-carriage in a population of HIV-positive patients.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Transient Global Amnesia (TGA) Exploratory Study of the Default Mode Network in Resting State Functional MRI (fMRI) During the Acute Phase

acronym: ICTUS

summary:
The transient global amnesia, in which the memory disorder is massive, transient and pure, offers a unique model for exploring episodic memory. Topographic MRI can reveal a focal and selective lesion located on the CA1 region of the hippocampus better visible between 48h and 72h after onset of the episode.

There is therefore a real dissociation between structural lesions witch are minimal or non-existent and the massive memory disorder. This suggests that functional impairment goes far beyond the structural damage in this condition. To our knowledge, no study has been performed to identify this functional impairment using resting state fMRI.

Thus, investigators wish to study the neural networks involved in memory impairment during the acute phase of transient global amnesia using resting state imaging. This technique appears to be modern and adapted to these patients population. Investigators hypothesize that despite limited structural lesions, a large functional network is impaired compared to that observed in a group of healthy subjects. investigators believe that the alteration of the functional network will explain the depth of memory impairment observed.

The main aim of this study will be to identify functional impairment in the patient group vs. control group during the acute phase of transient global amnesia (TGA) using resting state imaging.

Patients potentially eligible will be informed during their arrival to the emergency unit. If the patient is eligible and would like to participate, information will be given. For the patients willing to participate, inclusion and exclusion criteria will be verified. Two imaging exams (topographic MRI and resting state fMRI) and neuropsychological assessment will be performed during three visits.


title: Evaluation of a Clinico-biological Predictive Score of Enterocolitis and Enteropathy of the Preterm Neonates. Usefulness of the Rapid Assay of the Faecal Calprotectin.

acronym: CALPROPREMA

summary: This study aims to evaluate a clinico-biological predictive score, associating the faecal calprotectin, for the diagnosis of enterocolitis and enteropathy of the preterm neonates.

ReferenceCitation: Campeotto F, Elie C, Rousseau C, Giuseppi A, Hachem T, Gobalakichenane P, Le Touzey M, de Stefano M, Butel MJ, Kapel N. Faecal calprotectin and gut microbiota do not predict enteropathy in very preterm infants. Acta Paediatr. 2021 Jan;110(1):109-116. doi: 10.1111/apa.15354. Epub 2020 Sep 1.

license: cc-by-nc

license_normalized: cc-by-nc

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


title: Randomized Short-term Pre-surgical Study to Assess the Effects of PD 0332991 in Early Breast Cancer Patients

acronym: POP

summary: This is a Phase II study trying to identify whether short term treatment with PD0332991 yields anti-proliferative response -defined by a low level of Ki67 expression (IHC) at surgery- or induces senescence as determined by SABG expression (IHC) in tumors from patients with early breast cancer non-candidates for neoadjuvant hormonotherapy or chemotherapy, as compared to no treatment.

ReferenceCitation: Turner NC, Liu Y, Zhu Z, Loi S, Colleoni M, Loibl S, DeMichele A, Harbeck N, Andre F, Bayar MA, Michiels S, Zhang Z, Giorgetti C, Arnedos M, Huang Bartlett C, Cristofanilli M. Cyclin E1 Expression and Palbociclib Efficacy in Previously Treated Hormone Receptor-Positive Metastatic Breast Cancer. J Clin Oncol. 2019 May 10;37(14):1169-1178. doi: 10.1200/JCO.18.00925. Epub 2019 Feb 26. Erratum In: J Clin Oncol. 2019 Nov 1;37(31):2956.

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: PubMed Central;University of Melbourne - Minerva Access

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Arnedos M, Bayar MA, Cheaib B, Scott V, Bouakka I, Valent A, Adam J, Leroux-Kozal V, Marty V, Rapinat A, Mazouni C, Sarfati B, Bieche I, Balleyguier C, Gentien D, Delaloge S, Lacroix-Triki M, Michiels S, Andre F. Modulation of Rb phosphorylation and antiproliferative response to palbociclib: the preoperative-palbociclib (POP) randomized clinical trial. Ann Oncol. 2018 Aug 1;29(8):1755-1762. doi: 10.1093/annonc/mdy202.


title: Health Related Quality of Life in Children With Food Allergy: Comparison to Healthy Children and Children With Other Chronic Diseases

summary:
The number of studies concerning health related quality of life (HRQL) in children with food allergy is very limited.

Only one study to date has compared HRQL of a group of children with food allergy to data published on general population and other chronic diseases. This study concluded to lowest HRQL scores in food allergic children compared to type 1 diabetes mellitus with important impact on scores concerning social activities.


title: Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology

acronym: MINIRAD

summary:
Interventional Neuroradiology replaces surgery. This technology requires various exposition to X rays : number of X rays photographs, radioscopy, distance between patient and detector, speed of acquisition of X-rays photographs, high tension and intensity.

The manipulator must find the right balance between quality of photographs and dose delivered to the patient (optimization).

Children are particularly exposed to these risks of irradiation (sensitivity to X-rays and long life expectancy with risks. So, it is fundamental to optimize the dose delivered during the procedures.

The investigators propose to analyse a study comparing two protocols of optimization of doses. The investigators' hypothesis is that the protocol experimented in this trial allows less radiation of the children, compared to the usual protocol.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmique Adolphe de Rothschild


title: Prospective Randomized Comparative Study of the Effectiveness of Suprascapular Nerve Block in Arthroscopic Shoulder Surgery

summary: Most arthroscopic surgeries of the shoulder are currently performed as an outpatient. The postoperative analgesia should be optimal. General anesthesia allows for any arthroscopic surgery but does not provide a satisfactory postoperative analgesia . The locoregional anesthesia is recommended and includes several techniques: the interscalene nerve block, the suprascapular nerve block, intra-articular injection of local anesthetic and subacromial infiltration. The interscalene nerve block is currently the gold standard for anesthesia and postoperative analgesia for arthroscopic shoulder surgery with a success rate above 80% . However it must be carried out by teams experienced in the locoregional anesthesia because it is operator -dependent. The suprascapular nerve block is a simple technique that can be performed by the surgeon after surgery , effective in arthroscopic shoulder surgery , less invasive than the interscalene nerve block and exposing the patient to fewer complications. However, his interest was not assessed in the repair of tendons of the rotator cuff. The main hypothesis of this study is that the suprascapular nerve block is as effective as the interscalene nerve block in the prevention of early postoperative pain after arthroscopic repair of the infra and / or the supraspinatus rotator cuff tendons, without increasing the analgesic consumption while reducing the risk of complications related to regional anesthesia.

lead_sponsor: Hospital Ambroise Paré Paris


title: Development of Endothelial Biomarkers for Use in Cohort Studies. Comparison With Reference Biomarkers.

acronym: NUTREND

summary: The main objective is to develop and validate new endothelial function markers discriminating and reproducible by assessing the ability to reveal changes in endothelial function in response to positive and negative nutritional stimuli.


title: Phase 3 : Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis on Adult Face

acronym: Disease

summary: Seborrheic dermatitis is a chronic inflammatory dermatological disease, evolving by relapses, affecting mainly the face and scalp. It would be important to have a maintenance treatment for severe forms of seborrheic dermatitis witch is both effective and relatively well tolerated to reduce the frequency of relapses, prolong remissions obtained after attack treatment and reduce the use of topical steroids.

lead_sponsor: University Hospital, Rouen