title: Correlation Between HLA-E Overexpression by Tumor Cells and the Biology of Tumor-infiltrating Lymphocytes Depending on the Microsatellite Status in Colorectal Cancer.

acronym: HLA-E CCR

summary: Accumulating evidences suggest that colorectal cancer (CRC) progression is not solely determined by the genetic abnormalities of the tumor cells but also by the host response. Indeed, recent studies in CRC have associated improved survival with a high number of tumor-infiltrating (TIL) memory and cytotoxic T lymphocytes, suggesting a link between tumor progression and in situ T cell response. Gene expression profiling studies have clearly isolated a well-known subgroup of CRC characterized by microsatellite instability (MSI) CRC, associated with a strong immune response signature involving both Th1/cytotoxic and immune evasion pathways. Moreover, the investigators have previously shown that HLA-E/β2m is overexpressed by tumor cells in roughly 20% of CRC and is associated with a worse prognosis, most likely due to NK and T effector cell functions upon engagement with the inhibitory NK receptor CD94/NKG2A. However, our recent results on an enlarger cohort of patients suggest that if this observation holds true for MSS CRC, HLA-E over-expression is inversely associated with a good prognosis in MSI CRC. Thus, the phenotype and function of TIL, depending on the MSI/MSS status of CRC have to be precised. The investigators hypothesized that in MSI CRC, known to express a high number of MSI-H related frameshift peptides which represent a pool of tumor specific antigens, HLA-E could present peptides to TCR of non conventional CD8+ HLA-E-restricted alpha-betaT cells (also expressing CD94), then inducing a strong antitumor cytolytic activity. Therefore, the aim of this project is to determine the exact phenotype, function and specificity of the CD94+ TIL in CRC, depending on both the HLA-E and the MSI/MSS status of tumor cells. These results could impact the clinical practice as anti-NKG2A monoclonal antibodies or frameshift peptide based immunotherapy that could be promising new therapeutic options in CRC patients.

sponsor_collaborators:
Nantes University Hospital
U892 INSERM Team 3


title: Can Point of Care Chest Ultrasound Predicts Pulmonary Complications After Major Surgery?

acronym: POCUSR

summary: This study is done to estimate prevalence of the main detectable lung and cardiovascular complications by an ultrasound realized in room of post-interventional supervision at the patients whose duration of general anesthesia is superior at one hour after a surgery to risk

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Hospital Nord

location_facility: Departement anesthesie reanimation hopital nord

lead_sponsor_type: academique

status_simplified: Unknown


title: Prevalence of Obstructive Sleep Apnea Syndrom in Patients With Lymphedema, Admitted for Intensive Decongestive Physiotherapy

acronym: LYMPHOS

summary: Rehabilitation results in a decrease of the perimeters of the limb with lymphedema by a decrease in the amount of liquid of the affected limb, with movement of the intracellular liquid towards the trunk and the neck then into the jugular-subclavian confluence, the superior vena cava and right atrium without modification of extracellular fluid. No study have evaluated the prevalence of sleep apnea syndrome in this population and the effect of this treatment on sleep apnea syndrome.

study_start_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Roux C, Villemur B, Giovannoni B, Koeyemelk L, Mendelson M, Benmerad M, Joyeux-Faure M, Tamisier R, Pepin JL. Prevalence of obstructive sleep apnea syndrome in patients with lymphedema referred for complete decongestive therapy. J Vasc Surg Venous Lymphat Disord. 2020 Jan;8(1):137-142. doi: 10.1016/j.jvsv.2019.07.007. Epub 2019 Oct 18.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via crossref license, author manuscript)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

evidence: open (author manuscript)

license_normalized: no license

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

version: publishedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

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

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

repositories_concat: HAL

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: University Hospital, Grenoble

intervention_type: Other


type: Other Identifier

title: Diffusion Tensor Imaging and Tractography for Cranial Nerves. Interest in Skull Base Surgery and Anatomy

acronym: CN Tracto

summary:
Introduction: The skull base tumors surgery remains a challenge since numerous cranial nerves or vessels closely surround them. Recently, diffusion tensor imaging has developed with the tractography following white fibers and visualizing functional tracts. Cranial nerves tractography could allow predicting their displacement by skull base tumors that may help the surgeon to spare them along the surgery.

Methods: Preoperative cerebral MRI was performed on patients who presented with skull base tumors. A 3 tesla MRI machine was used to acquire DTI sequence with specific parameters: 32 directions, slice thickness 2 mm, echo time 86 ms, repetition time 12000 ms, matrix 128x128, b-value 1000 s.mm-1. An anatomic sequence hyperT2 was overlaid as reference. Distortion was corrected by topup and eddy functions from FSL. Cranial nerves fibers were probabilistically tracked with Mrtrix3. Cranial nerves were selected according to their location around the tumor. The "radiological" expected position of the cranial nerve was compared to its "operative" real position.

status: Recruiting

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Neurologie B, Hôpital Neurologique, HCL

intervention_type: Procedure

status_simplified: Ongoing


title: High-Flow Nasal Cannula Oxygen Therapy (HFNC) Alone or Associated With Noninvasive Ventilation (NIV) for Immunocompromised Patients Admitted to Intensive Care Unit for Acute Respiratory Failure : FLORALI-Immunodéprimés

acronym: FLORALI-IM

summary:
Acute respiratory failure is the leading cause of ICU admission of immunocompromized patients. In this subgroup of patients, the need for intubation and invasive mechanical ventilation occurs in about 50% of cases and is associated with very a high mortality rate, reaching 70% of cases. Therefore, noninvasive oxygenation strategies have been developed to avoid intubation.

More than 15 years ago, 2 trials have suggested that NIV could decrease intubation and mortality rates of immunocompromized patients as compared to standard oxygen through a mask. However these results have not been confirmed in a recent large trial.

HFNC is a recent and well-tolerated oxygenation technique. In a recent trial, HFNC alone could decrease mortality and intubation rates in patients with ARF as compared to NIV. Similar findings have been reported in a post-hoc analysis on immunocompromized patients excluding those with profound neutropenia. Likewise in a retrospective monocentric cohort of immunocompromized patients, we reported better outcomes with HFNC than with NIV.

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Coudroy R, Frat JP, Ehrmann S, Pene F, Terzi N, Decavele M, Prat G, Garret C, Contou D, Bourenne J, Gacouin A, Girault C, Dellamonica J, Malacrino D, Labro G, Quenot JP, Herbland A, Jochmans S, Devaquet J, Benzekri D, Vivier E, Nseir S, Colin G, Thevenin D, Grasselli G, Assefi M, Guerin C, Bougon D, Lherm T, Kouatchet A, Ragot S, Thille AW; REVA Network. High-flow nasal oxygen therapy alone or with non-invasive ventilation in immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure: the randomised multicentre controlled FLORALI-IM protocol. BMJ Open. 2019 Aug 10;9(8):e029798. doi: 10.1136/bmjopen-2019-029798.

ReferenceCitation: Coudroy R, Frat JP, Ehrmann S, Pene F, Decavele M, Terzi N, Prat G, Garret C, Contou D, Gacouin A, Bourenne J, Girault C, Vinsonneau C, Dellamonica J, Labro G, Jochmans S, Herbland A, Quenot JP, Devaquet J, Benzekri D, Vivier E, Nseir S, Colin G, Thevenin D, Grasselli G, Bougon D, Assefi M, Guerin C, Lherm T, Kouatchet A, Ragot S, Thille AW; FLORALI-IM study group and the REVA Research Network. High-flow nasal oxygen alone or alternating with non-invasive ventilation in critically ill immunocompromised patients with acute respiratory failure: a randomised controlled trial. Lancet Respir Med. 2022 Jul;10(7):641-649. doi: 10.1016/S2213-2600(22)00096-0. Epub 2022 Mar 21.

oa_host_type: publisher

repositories_concat: closed

ipd_sharing: Undecided

lead_sponsor: Poitiers University Hospital

intervention_type: Device

status_simplified: Completed

appel_a_projets: PHRCI

region: Nouvelle-Aquitaine

nom_etablissement: CENTRE HOSP. UNIVERSITAIRE DE POITIERS

type_etablissement: CHUR

acronyme: FLORALI-IM

titre: Comparaison de l'oxygénothérapie nasale à haut débit à la ventilation non invasive dans l'insuffisance respiratoire aiguë des patients immunodéprimés.

discipline_principale: autre

nom_porteur: COUDROY

prenom_porteur: Rémi


title: Descriptive Study for the Management of Joint Pain Associated With Osteoarthritis of the Knee: Association of Extracts of Curcuma Longa, Boswellia Serrata and Porphyra Umbilicalis.

summary: The aim of the study is to evaluate at 3 months the effect of a supplementation with extracts of Curcuma longa, Boswellia serrata and Porphyra umbilicalis on the acceptability of pain for patients suffering from gonarthritic pain.

lead_sponsor: PiLeJe

location_facility: Pileje Network of medical practitioners in private offices

intervention_type: Dietary Supplement

lead_sponsor_type: industriel


type: Registry Identifier

title: Imaging Multiparametric/Multimodality (Magnetic Resonance Imaging Combined With Positron Emission Tomography) for Lungcancer

acronym: IRMomics

summary:
To build an imaging biobank of 200 patients with lungcancer, including pathologic and molecular characteristics of the tumor (mutational status, circulating DeoxyriboNucleic Acid (DNA) from serum biobank…), staging of the cancer (according to the new 2016 Tumor Node Metastasis (TNM) status, the table that classify non-small cell lungcancer) and follow-up informations (Response to first-line treatment (Response Evaluation Criteria in Solid Tumors (RECIST)), disease-free survival, 1-3 years survival).
To propose a simple severity scoring system based on tumor features such as size, doubling time (if available), location, amount of enhancement and necrosis. Such approach has been proposed for glioma evaluation (Visually Accessible Rembrandt Images (VASARI)) but is not available for the lung. The objective is to do better than the Tumor Node Metastasis (TNM) staging.
To develop and evaluate an IntraVoxel Incoherent Motion (IVIM) protocol for lungcancer evaluation.

primary_purpose: Other

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
General Electric


title: Oxidation Rates of the Different Substrates During Exercise in Children and Adolescents With Juvenile Idiopathic Arthritis. Case-control Study and Cases Treated / Cases Not Treated With Anti-TNFα

acronym: OSE-JIA

summary:
During exercise, energy comes mainly from carbohydrates and lipids. The relative contribution of lipids and glucose as energy substrates to exercise depends on the parameters of the exercise (duration, intensity and level of training) and the physiological conditions of the subject.

Inflammatory diseases such as juvenile idiopathic arthritis (JIA) are treated, for the most severe forms, by biotherapies. These treatments target certain pro-inflammatory cytokines including TNFα. In adults with rheumatoid arthritis several studies have shown that treatment with anti-TNFα increases insulin sensitivity. There is no data on the oxidation of energy substrates during exercise in children and adolescents with AJI, nor on the impact of anti-TNFα treatments on the oxidation of energetic substrates in children.

Investigators hypothesize that, compared to healthy children, children with JIA should exhibit altered oxidation of energy substrates at rest and submaximal physical exercise due to physical deconditioning and inflammation. In addition, those treated with anti-TNFα should have an oxidation profile of energy substrates at exercise different from that of patients not treated with anti-TNFα. Investigators also hypothesize that anti-TNFα treatments modify the contribution of energy chains (aerobic, anaerobic and anaerobic alactic) during the exercise.

design_allocation: Non-Randomized

ReferenceCitation: Rochette E, Bourdier P, Pereira B, Dore E, Birat A, Ratel S, Echaubard S, Duche P, Merlin E. TNF blockade contributes to restore lipid oxidation during exercise in children with juvenile idiopathic arthritis. Pediatr Rheumatol Online J. 2019 Jul 22;17(1):47. doi: 10.1186/s12969-019-0354-1.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: University Hospital, Clermont-Ferrand


title: Translation and Cultural Adaptation of the Arthritis Self-Efficacy Scale

acronym: ASES

summary:
Questionnaires are often irreplaceable tools of collection of information in research and in the clinical practice. Coupled with other measures, they can be simple complementary tools, but questionnaires are sometimes the only way to collect data, such as self-service efficacy.

The objective of this study is a validation of the French translation of the ASES. To guarantee the comparability between the original version and the translated version, the translation of a questionnaire supposes two essential stages: a literal translation and an adaptation to the cultural context, to the habits of life and to the idioms of the target population. This new version will afterward be validated with patient's troop.

collaborators:
Clermont Communauté
Innovatherm

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Clermont Communauté
Innovatherm


title: Evaluation of a New Sequencing Strategy in Autoinflammatory Diseases Diagnostic Value and Therapeutic Orientation

acronym: BIOSAID

summary:
Main objective: To compare the efficacy of a new strategy of Next Generation Sequencing (NGS) versus a classical Sanger strategy, for the diagnosis of patients referred to the laboratory for suspected systemic autoinflammatory diseases (SAID).

Secondary objectives:

Compare after 6 months the impact of these strategies on the establishment of an effective treatment SAID following genetic result.
Compare the distribution of different forms of SAID found with each genetic diagnostic strategies (NGS vs classic method).

status: Terminated

ReferenceCitation: Rama M, Mura T, Kone-Paut I, Boursier G, Aouinti S, Touitou I, Sarrabay G. Is gene panel sequencing more efficient than clinical-based gene sequencing to diagnose autoinflammatory diseases? A randomized study. Clin Exp Immunol. 2021 Jan;203(1):105-114. doi: 10.1111/cei.13511. Epub 2020 Sep 29.

evidence: open (via free article)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

lead_sponsor: University Hospital, Montpellier


title: Effectiveness of the NephroCheck™ to Predict Postoperative Acute Kidney Injury in Patients Undergoing a Transcatheter Aortic Valve Implantation

acronym: AKI-TAVI

summary:
Postoperative acute renal failure is a frequent complication after a Transcatheter Aortic Valve Implantation (TAVI). The current practice cannot predict Acute Kidney Injuries (AKI) early enough to prevent an organic dysfunction triggering, consequently, cortical tubular necrosis.

Several recent studies in cardiac surgery have shown that sonographic criteria, the Renal Resistive Index (IRR), and a urinary biomarker, the NephroCheck™, could predict AKI promptly. These markers, sonographic and biologic, have both the advantage to be non-invasive and easy to perform. Each marker seems to have sensitivity and specificity to predict AKI promptly after cardiac surgery. Therefore, the IRR and the NephroCheck™ test could become essential tests to guide clinicians in determining rapidly whether a patient will develop AKI after a TAVI procedure. However, so far, no study has tested the NephroCheck™ in patients undergoing TAVI.

Therefore, the aim of this prospective observational study will be first to determine the effectiveness of the NephroCheck™ to predict AKI at an early stage after a TAVI procedure. The secondary outcome will be to compare the NephroCheck™ with the RRI in predicting at an earlier stage than the traditional method an AKI.

lead_sponsor: University Hospital, Bordeaux

location_facility: BORDEAUX UNIVERSITY HOSPITAL - Haut Lévêque


title: Identification of Predictive Epigenetic Biomarkers of Lung Disease Severity in Cystic Fibrosis

acronym: MethylBiomark

summary: The general aims of this project are (i) to identify predictive epigenetic biomarkers of lung disease severity in Cystic Fibrosis, (ii) to characterize a non-invasive cellular model, spontaneous sputum, for the analysis of these epigenetic biomarkers, (iii) to analyze the variations in DNA methylation for a same patient over time.

primary_purpose: Prevention


title: Assessment of Sensory Disorders Associated With Peripheral Neuropathy Induced by Bortezomib: Prospective Comparative Study

acronym: SENSIB

summary:
Chemotherapy-induced peripheral neuropathies (CIPN) remain a problem in oncology because no "gold standard" treatment exists to prevent or treat the CIPN. Therefore, oncologists reduce or stop the chemotherapy doses to limit degradation of the quality of life of patients with CIPN. Bortezomib is relatively understudied while neurotoxicity remains a limiting factor for treatment. Since 2012, the FDA and the EMA validated by the administration of bortezomib subcutaneously (SC) instead of intravenous (IV) in order to limit neurotoxicity.

However, a retrospective study reported that the prevalence of neuropathy induced by bortezomib after SC administration remains high and equivalent to IV route. No studies have quantitatively and qualitatively evaluated the sensory disorders in peripheral neuropathies induced by bortezomib after SC administration. On the other hand, the QLQ-CIPN20 questionnaire (EORTC) evaluating the intensity of sensory, motor and autonomic disorders associated with CIPN has never been tested in this population. The objective of this study is twofold: (i) psychophysical evaluation of neuropathic disorders by studying the thermal and vibratory detection thresholds and thermal nociceptive thresholds and (ii) quantitative and qualitative assessment of neuropathic disorders by the QLQ-CIPN20 and related comorbidities in a population of neuropathic patients treated with bortezomib (n = 15), compared to control patients treated with bortezomib but non-neuropathic (n = 45).

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Laboratoires Takeda


title: A Study to Evaluate the Performance and Safety of CBL-101 Versus Vismed® Multi Eye Drops in the Management of Dry Eye

summary: The primary objectives of this investigation are to show that the performance of CBL-101 Eye Drops is non-inferior to that of Vismed® Multi eye drops in subjects with moderate to severe keratoconjunctivitis sicca after 28 days, and to assess the safety of CBL-101 Eye Drops during a 90-day period with treatment administered 3 to 6 times per day.

ReferenceCitation: Labetoulle M, Mortemousque B; CBL-101 Study Group. Performance and Safety of a Sodium Hyaluronate Tear Substitute with Polyethylene Glycol in Dry Eye Disease: A Multicenter, Investigator-Masked, Randomized, Noninferiority Trial. J Ocul Pharmacol Ther. 2022 Nov;38(9):607-616. doi: 10.1089/jop.2022.0048. Epub 2022 Oct 21.

oa_colors: green hybrid

evidence: open (via page says license)

publisher_dissemination: Mary Ann Liebert Inc

lead_sponsor: Laboratoire Chauvin


title: Diagnostic Performance of Echocardiography Performed by Emergency Physicians After a Basic Training

acronym: ECHOBEDSIDE

summary: After a basic training to echocardiography, emergency physicians will have to answer simple clinical questions about circulatory failure mechanisms. The objective of the study is to assess the agreement between these answers and those of the expert physician in patients admitted in the emergency department with a circulatory failure due to sepsis or not. Emergency physicians will volunteer to take part in a basic training on echocardiography. The training will include 4 hours of theory, 2 hours of interactive clinical cases and 6 hours of tutored practice at patients' bedside (10 to 15 examinations). The objective of the practice sessions will be to learn the technical grounds of transthoracic echocardiography (TTE), the different views and to identify the anatomical structures. The second part of the study will start after the training. Each eligible patient will be successively assessed by two investigators: one emergency physician recently trained and the expert physician. The echocardiography will be performed as soon as possible in the emergency department before or after the initiation of treatment without delaying it. The order of hemodynamic assessments will be random depending on the availability of the investigators; both assessments will however be performed within 30 minutes. Each investigator will independently read the echocardiography in real time at patients' bedside. They will then answer a limited list of standardized questions using two-choice answers or predefined choices. Finally investigators will choose a therapeutic proposition among a predefined list based on the answers. Only the results of the echocardiography performed by the expert physician will be used in patient management.

lead_sponsor: University Hospital, Limoges

sponsor_collaborators:
University Hospital, Limoges
University Hospital, Tours


title: Pilot Study on Patients With Mild to Moderate Form of Alzheimer's Disease and Healthy Volunteers: Characterization of Intra-subject Variability and Chronobiological Variations of ADDIA Biomarkers.

summary: The present single center clinical chronobiological study on 24 subjects (12 patients with mild to moderate form of Alzheimer's disease and 12 Healthy subjects) aims at characterizing the ADDIA biomarkers: a) blood cell-based biomarkers measured by flow cytometry using proprietary probes specific of two targeted biomarkers, beta-Amyloid (Aβ) peptide and a kinase, and b) circulating biomarkers in peripheral body fluids. The biomarkers will be analyzed on samples taken at different time points of the day, including under fasting and non-fasting conditions and at two periods: day 1 and day 14.

lead_sponsor: Amoneta Diagnostics SAS


title: Single-centre, Observational Study, Concerning Blood-lipid Biomarkers of the Response to Treatment With Biotine, Prescribed in the Context of a Nominative TAU (Temporary Authorized Use) in Patients With an Inactive Progressive Form of Multiple Sclerosis (MS).

acronym: BIOMARBIOT

summary:
Biotine is proposed by neurologists to patients with a progressive form of Multiple sclerosis (MS) in the context of a nominative temporary authorization for use (TAU) as a disease-modifying treatment for their MS. A recent study showed that with this treatment, more patients experienced an improvement after one year in comparison with patients given a placebo.

The objective of this study is to identify blood biomarkers to determine good responders as early as possible. In addition, the blood parameters studied will make it possible to better understand the mechanisms of action, that have a beneficial effect on multiple sclerosis.

The management of patients will not be modified: same number of consultations (at the prescription, at 3 months, at 12 months), same clinical examination, and the same number of blood samples (at the prescription, at 3 months, and at 12 months).

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Diagnostic Agreement of Electrophysiological Audiovestibular Examinations With Magnetic Resonance Imaging (MRI) of the Inner Ear in Revealing Endolymphatic Hydrops (EH) in Patients With Certain or Probable Meniere's Disease (MD)

acronym: MRI Meniere

summary:
The aim of this study is to compare 3 methods for the diagnosis of endolymphatic hydrops (EH) in patients with Meniere's disease: MRI 3 Tesla (to visualise EH directly), and functional explorations, namely electrocochleography and dephasing of acoustic distortion products (which are modified by the EH).

The research hypothesis is that the examinations will show agreement in the diagnosis of EH, and that the results obtained (quantitative values) will vary in the same direction over time and during flares of MD.

intervention_type: Diagnostic Test


title: Comparison of Stroke Volume Variation During Alveolar Recruitment With Stepwise Increase in Positive End Expiratory Pressure and Continuous Positive Airway Pressure (30cmH2O During 30 Seconds) in Anesthetised Patients

acronym: Hemorecrut

summary: During general anaesthesia, pulmonary atelectasis has been shown to occur in 85 to 90% of patient. Pulmonary atelectasis increases occurrence of postoperative pulmonary complication including pneumoniae. Pulmonary atelectasis can be prevented or reversed by alveolar recruitment manoeuvres (ARM). Two methods for ARMs have been described. A sustained continuous positive airway pressure (CPAP) or a stepwise increase in PEEP.The transient increase in intrathoracic pressure during ARMs decreases venous return and increases pulmonary vascular resistance. This result in a decrease in right and left ventricular stroke volume (SV). Finally, the deleterious hemodynamic effects of ARMs may be exacerbated by hypovolemia, heart failure, and in patients with chronic treatment wich impedes cardiovascular responses to hypovolemia. At our best knowledge, there is no study which compared the hemodynamic effects of ARM using sustained CPAP or stepwise increase in PEEP. Consequently, the present study was designed to examine the hemodynamic effects of 2 ARM methods in anesthetized patients.

lead_sponsor: University Hospital, Caen


title: Anatobreast : First Step to Virtual Breast Cancer Localization

acronym: Anatobreast

summary:
Radioisotopic and wire localizations suffer from several limitations. These techniques add another procedure prior to surgery, can be uncomfortable and entail additional cost.

The aim is to develop a novel technique of breast tumor localization using preoperative magnetic resonance imaging (MRI) and breast optical scanning.

Patients with diagnosis of breast cancer who have had a preoperative MRI and 3D optical scans are included.

Optical scanning is done preoperatively and intraoperatively after tumor localization was marked on the breast using radioisotopic technique.

The MRI is then adjusted with the intraoperative optical scan to match the breast position at the time of surgery.

The investigators evaluate the efficiency for localization of breast lesion of the novel technique by comparison with radiosiotopic technique.

time_perspective: Retrospective

ipd_sharing_description: NC

sponsor_collaborators:
University Hospital, Montpellier
AnatoScope Montpellier


title: ANALYSIS OF HEALTH DATA COLLECTED SYSTEMATICALLY BY THREE HOSPITALS FOR THE VALIDATION OF THE CHAPTER "ALLERGY AND HYPERSENSITIVITY" IN THE FUTURE VERSION 11 OF THE WORLD HEALTH ORGANIZATION (WHO) INTERNATIONAL CLASSIFICATION OF DISEASES (CIM)

summary:
Allergic diseases, including allergic asthma, allergic rhinitis and anaphylaxis are not properly classified in current classifications of diseases. We here propose a project based on the evaluation of medical records of hospital databases of patients suffering for allergic and hypersensitivity conditions coded with the current and a new coming version of the international classification of diseases, no patient or intervention will be analysed.

We here propose a study to update and reach quality assurance of the classification of allergic and hypersensitivity conditions in international classification systems. The Allergic and hypersensitivity conditions section has indeed been recently built into the new ICD-11 framework and we aim to reach its quality assurance by evaluating medical records of French hospital databases. All the consecutive cases related to allergic and hypersensitivity conditions registered in the last 1 year will be selected and blind-coded by two independent coders based on the online English versions of the ICD-10 (2015 version) and ICD-11 Beta draft. The generated data will support the intra and inter-variability testing, survey among end-users and economic-impact evaluation. The economic impact of the transition from ICD-10 to ICD-11 will be analysed based on average estimated cost per day of each principal diagnosis and the effect of the classification change will be quantified by the cost variance of inter or intra diagnosis of ICD-10 and ICD-11. For the bridge procedure based on the alignment of the allergic and hypersensitivity conditions described into the ICD-10 (and ICD-10 CM US adaptation) framework to the ICD-11 beta phase, we propose the mapping and cross-linking terms methods. Meanwhile, we will start updating the allergic and hypersensitivity procedures by influencing the International Classification of Health Intervention (ICHI).

sponsor_collaborators:
University Hospital, Montpellier
AstraZeneca


title: Neurostimulation-enhanced Behavioral Remediation of Social Cognition in Schizophrenia

acronym: NSOCOG

summary: Social cognition concerns the understanding of how people think about others and how that, in turn, influences our behavior, feelings, and social interactions. schizophrenia social-cognitive impairment is profound (effect size D>1.2), medication resistant and critically limits functional well-being . Social cognition involves complex patterns of coordinated activity within numerous cortical and subcortical networks, making it a difficult target for clinical neuroscience investigation. Yet, prior research demonstrates that sensory-perceptual dysfunction in schizophrenia can upwardly generalize into higher-order social-cognitive impairment making perception a tractable and fruitful approach for studying social cognition in schizophrenia. Here, the investigators explore how distortions in perception of temporal coincidence can contribute to the aberrant inferences of physical causation and social agency.

study_start_date_type: Anticipated

status: Withdrawn

primary_purpose: Basic Science

lead_sponsor: Hôpital le Vinatier


title: Neurovascular Cutaneous Response to Pressure and Risk of Diabetic Foot Ulcer in Patients With Type 2 Diabetes

acronym: PIV & MPP

summary: Diabetic foot ulcer (DFU) is a worldwide burden in the management of patients with diabetes. Peripheral neuropathy has a key role in the physiopathology of DFU. Others factors as skin vulnerability to plantar pressure, glycation of skin protein, articular rigidity, vascular component and abnormal foot plantar pressure are also important to take into account. The aim of the study is to assess prospectively different factors involved in DFU pathogenesis notably the neurovascular response to non noxious pressure.

primary_purpose: Screening

location_facility: service d'endocrinologie, Centre Hospitalier Lyon Sud


title: Identification of Epigenetic Risk Factors for Ischemic Complication During the TAVR Procedure in the Elderly

acronym: METHYSTROKE

summary:
Over the past ten years, the number of endovascular procedures has increased by 5% per year in Europe with the development of interventional cardiology, such as percutaneous coronary angioplasty, aortic valve replacements (TAVR), and vascular endoprosthesis.

The neurological lesions detected on cerebral MRI caused by these endovascular procedures are frequent with an incidence of about 30-70%. These events, although subclinical, have an impact on morbidity and mortality and especially on long-term cognitive decline.

TAVR is the reference treatment for symptomatic elderly patients with stenosis of the aortic valve, considered by a multidisciplinary "Heart Team" as at high surgical risk due to comorbidities, age and high perioperative risk scores ( Euroscore 2 and STS scores). Despite the net clinical benefit, an increase of silent neurological events was detected on post-procedural cerebral MRI with an incidence of approximately 70%.

The epigenetic involvement in the occurrence of ischemic cerebral lesions is still largely unknown. Epigenetic mechanisms, such as DNA methylation, can be associated with aging processes and modulate the risk of developing cerebrovascular pathologies. They are likely to provide new biomarkers that predict the risk of brain damage.

Hypomethylation of leukocyte DNA is directly related to atherosclerosis in humans. This hypomethylation of DNA would represent an easily measurable marker reflecting the presence and progression of atherosclerosis. Because atherosclerotic lesions often precede the clinical manifestation of ischemic cardiovascular disease, such as ischemic heart disease and stroke, DNA hypomethylation could be used to identify individuals at risk for cerebrovascular events.

The investigator hypothesize that hypomethylation of leukocyte DNA can predict the risk of developing new ischemic brain lesions especially after a TAVI procedure.

ReferenceCitation: Ghanem A, Kocurek J, Sinning JM, Wagner M, Becker BV, Vogel M, Schroder T, Wolfsgruber S, Vasa-Nicotera M, Hammerstingl C, Schwab JO, Thomas D, Werner N, Grube E, Nickenig G, Muller A. Cognitive trajectory after transcatheter aortic valve implantation. Circ Cardiovasc Interv. 2013 Dec;6(6):615-24. doi: 10.1161/CIRCINTERVENTIONS.112.000429. Epub 2013 Oct 15.

ReferenceCitation: Kahlert P, Knipp SC, Schlamann M, Thielmann M, Al-Rashid F, Weber M, Johansson U, Wendt D, Jakob HG, Forsting M, Sack S, Erbel R, Eggebrecht H. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation. 2010 Feb 23;121(7):870-8. doi: 10.1161/CIRCULATIONAHA.109.855866.

ReferenceCitation: Bjornsson HT, Sigurdsson MI, Fallin MD, Irizarry RA, Aspelund T, Cui H, Yu W, Rongione MA, Ekstrom TJ, Harris TB, Launer LJ, Eiriksdottir G, Leppert MF, Sapienza C, Gudnason V, Feinberg AP. Intra-individual change over time in DNA methylation with familial clustering. JAMA. 2008 Jun 25;299(24):2877-83. doi: 10.1001/jama.299.24.2877.

ReferenceCitation: Baccarelli A, Wright R, Bollati V, Litonjua A, Zanobetti A, Tarantini L, Sparrow D, Vokonas P, Schwartz J. Ischemic heart disease and stroke in relation to blood DNA methylation. Epidemiology. 2010 Nov;21(6):819-28. doi: 10.1097/EDE.0b013e3181f20457.

ReferenceCitation: Van Belle E, Juthier F, Susen S, Vincentelli A, Iung B, Dallongeville J, Eltchaninoff H, Laskar M, Leprince P, Lievre M, Banfi C, Auffray JL, Delhaye C, Donzeau-Gouge P, Chevreul K, Fajadet J, Leguerrier A, Prat A, Gilard M, Teiger E; FRANCE 2 Investigators. Postprocedural aortic regurgitation in balloon-expandable and self-expandable transcatheter aortic valve replacement procedures: analysis of predictors and impact on long-term mortality: insights from the FRANCE2 Registry. Circulation. 2014 Apr 1;129(13):1415-27. doi: 10.1161/CIRCULATIONAHA.113.002677. Epub 2014 Feb 24.

ReferenceCitation: Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrie D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012 May 3;366(18):1705-15. doi: 10.1056/NEJMoa1114705.

ReferenceCitation: Van Belle E, Debry N, Vincent F, Kuchcinski G, Cordonnier C, Rauch A, Robin E, Lassalle F, Pontana F, Delhaye C, Schurtz G, JeanPierre E, Rousse N, Casari C, Spillemaeker H, Porouchani S, Pamart T, Denimal T, Neiger X, Verdier B, Puy L, Cosenza A, Juthier F, Richardson M, Bretzner M, Dallongeville J, Labreuche J, Mazighi M, Dupont-Prado A, Staels B, Lenting PJ, Susen S. Cerebral Microbleeds During Transcatheter Aortic Valve Replacement: A Prospective Magnetic Resonance Imaging Cohort. Circulation. 2022 Aug 2;146(5):383-397. doi: 10.1161/CIRCULATIONAHA.121.057145. Epub 2022 Jun 20.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: University Hospital, Lille

region: Hauts-de-France

nom_etablissement: CHR LILLE

type_etablissement: CH

acronyme: METHYSTROKE

titre: Identification de marqueurs de risque épigénétiques des complications ischémiques de la personne âgée au cours de la procédure TAVI

nom_porteur: DEBRY

prenom_porteur: Nicolas


title: Development of a Multimodal Approach to Assess Stroke Persons Daily Life Activities and Development of a New Tool to Evaluate the Impact of Functional Activites on Quality of Life

summary: The aim of the study consists in enriching knowledge of health professionals, on the functional difficulties encountered by hemiplegic patients outside the hospital, in particular on hobbies, going out with friends or family, work, daily life and the personal projects. Another objective is to evaluate the diversity of the attitudes and representations of the patients about their body damage. Lastly, the study seeks to develop a new grid of evaluation of the quality of life of the patients, which determines more fields of the existence significantly impacted by the hemiparesy, from the point of view of the patients. It is a question of improving the therapeutic care of the patients and to determine if various therapeutic approaches (occupational, pharmacological, surgical) have an impact on these various fields. The study will be based on qualitative data (interviews) and quantitative (questionnaires).

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Evaluation of Intensity and Consequences of Neuropathic Disorders Induced by Oxaliplatin in Patients After Chemotherapy: Observational and Cross-sectional Study

acronym: PREVOX

summary:
This project will evaluate the neurotoxic effects of oxaliplatin. Oxaliplatin is considered the most neurotoxic chemotherapy, and at the origin of peripheral neuropathies. These neuropathies remain a problem in oncology because currently no prevention strategy has proved effective and only duloxetine seems to have a therapeutic benefit in improving symptoms. In the case of oxaliplatin, neuropathy forced oncologists to reduce the dose or to stop the chemotherapy, potentially degrading the oncological prognosis.

Objective of this study will be to assess, on a large number of patients (n> 500) who completed adjuvant chemotherapy (FOLFOX), the intensity of neuropathic disorders out of 5 years after the end of chemotherapy. Furthermore, this study should enable an assessment of the relationship between the intensity of neuropathy and comorbidities, such as anxiety and depression and health related quality of life of patients.

time_perspective: Cross-Sectional

ReferenceCitation: Selvy M, Pereira B, Kerckhove N, Gonneau C, Feydel G, Petorin C, Vimal-Baguet A, Melnikov S, Kullab S, Hebbar M, Bouche O, Slimano F, Bourgeois V, Lebrun-Ly V, Thuillier F, Mazard T, Tavan D, Benmammar KE, Monange B, Ramdani M, Pere-Verge D, Huet-Penz F, Bedjaoui A, Genty F, Leyronnas C, Busserolles J, Trevis S, Pinon V, Pezet D, Balayssac D. Long-Term Prevalence of Sensory Chemotherapy-Induced Peripheral Neuropathy for 5 Years after Adjuvant FOLFOX Chemotherapy to Treat Colorectal Cancer: A Multicenter Cross-Sectional Study. J Clin Med. 2020 Jul 27;9(8):2400. doi: 10.3390/jcm9082400.

intervention_type: Drug


title: Psychological Evaluation According Colonic Colonization by Escherichia Coli of Patients After Colorectal Surgery

acronym: MicrobioPSY

summary: The purpose of this study is to determine whether the presence of pathogenic Escherichia coli in colon is associated with psychiatric disorders.


title: A Phase I/II Study Evaluating the Safety and Clinical Activity of Anti-PDL1 (Durvalumab [MEDI4736]) + Anti CTLA-4 (Tremelimumab) Antibodies Administrated in Combination With Stereotactic Body Radiotherapy (SBRT) in Patients With Metastatic Squamous Cell Carcinoma of Head and Neck, Lung, Oesophageus, Cervix, Vagina,Vulva or Anus

acronym: ABIMMUNE

summary: The study is an open label, multicentric, Phase I/II trial aiming to evaluate the safety, the clinical activity and abscopal anti-tumor effects of a therapeutic strategy associating Durvalumab in conjunction with SBRT or Durvalumab + Tremelimumab in conjunction with SBRT in patients with metastatic squamous cell carcinoma of head and neck, lung, or esophagus.

status: Active, not recruiting

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Prospective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET)

acronym: THETE

summary:
There is no prospective study published on the Essential Thrombocythemia and the correlation between this specific disease, its complications and the biological variations observed.

The aim of this study is to demonstrate a correlation between biological tests of haemostasis, as Multiplate analyser and thromboelastometry (ROTEM) and the occurrence of clinical complications, thrombosis and/or haemorrhage, in order to determine if this biological tests could be biological prognostic factors

intervention_type: Biological


title: Study of the Prognosis of Infectious Endocarditis (EPEI): Prospective and Retrospective Follow-up of a Cohort of Patients Hospitalized for Infectious Endocarditis

acronym: EPEI

summary:
Infectious endocarditis (IE) is the localization and proliferation of blood-borne germs in the endocardium. It remains a complicated disease to manage due to its low incidence, diagnostic difficulties, the change in epidemiology in recent decades and high mortality rates. The annual incidence is estimated at 3-10 cases per 100,000 people.

The epidemiology of AR has changed significantly in recent years due to new risk factors. Indeed, the frequency of rheumatic heart disease, which was the first predisposing factor, decreased markedly in the industrialized countries, replaced by new predisposing factors: the presence of valvular prostheses or intracardiac materials (the risk of AR is multiplied by 50 Compared with the general population), hemodialysis, nosocomial infections, immunosuppression, increased use of injectable treatments and, above all, an aging population with an increase in degenerative diseases such as aortic stenosis and l Mitral insufficiency.

The diagnosis of IA is based on DUKE criteria. But the clinical presentation is sometimes atypical especially in case of infection on prosthesis where the diagnosis is based mainly on the results of the blood cultures and the ultrasound data.

The lesions visualized in ultrasound are: vegetations, abscesses, pseudo-aneurysms and fistulas constituting the degenerated abscess evolution, the perforation of the cusps of the native valve or the bioprosthesis giving rise to a jet of Eccentric regurgitation.

The evolution of endocarditis and its prognosis vary according to many factors: the type of germ responsible, the precocity of the diagnosis, the existence of a complication, the site of occurrence. These complications of endocarditis are frequent, sometimes revealing. EI is complicated by heart failure, atrioventricular conduction disorders, peri-vascular abscesses, embolic, neurological, renal and septic complications. Despite improvements in diagnosis and therapeutic methods, diagnosis is sometimes difficult, management remains very complicated and morbidity and mortality remain high. Studies are still needed to study the prognosis and to determine the predictive factors for hospital mortality and long-term mortality.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Can Urinary Concentrations of TIMP2 and IGFBP7 be Used to Predict Early Acute Renal Failure Following Cardiac Arrest?

acronym: ACR-CHECK

summary:
Transient renal insufficiency is frequently observed in the course of cardiovascular arrest. Although elevation of creatinine is reversible in a large majority of cases, severe renal insufficiency is sometimes observed and is associated with a dark prognosis. Any intervention that may limit the worsening of renal function may have an impact on patient mortality. There is currently no validated pharmacological treatment to limit the progression of ARI or to accelerate its recovery. A major challenge then concerns the detection of the reversible character of renal damage.

Renal biomarkers have been little studied in the prediction of severe ARI and mortality after cardiac arrest. The combination of TIMP2 (tissue inhibitor of metalloproteinase) and insulin-like growth factor binding protein (IGFBP7) in urine showed good diagnostic performance in the early detection of the risk of developing acute renal failure within 12 hours. Measured in the urine, the excretion of these two markers specifically reflects renal tubular lesions. Moreover, their rate seems to be strongly correlated with the severity of the tubular lesions.

Thus, it can be reasonably assumed that their very early dosing in post-cardiac arrest could detect the presence and severity of renal tubular lesions. A threshold to be defined would discriminate patients at risk of developing an ARI within 48 hours post ACR and to distinguish between severe transient and severe persistent lesions beyond 72 hours.

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


title: Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer on Removal of Small and Middle Size Molecules, Inflammatory Parameters and Oxidative Stress. An Open Cross Over Randomized Study

acronym: THERANOVA

summary:
The aim of this study is to evaluate the removal of midle molecules and inflammatory cytokines with the Theranova-500 ™ dialyzer (medium cut-off membrane, Baxter®) versus a high flux dialyzer Elisio-21H ™ (High-flux membrane, Nipro®) in chronic hemodialysis.

Evaluation of nutritional parameters, inflamatory parameters and oxidative stress will also be carried out.

Finally, the investigators will compare hepcidin levels and the erythropoietin resistance index between the two groups.

sponsor_collaborators:
Poitiers University Hospital
Baxter Healthcare Corporation


title: Role of General Practionners in Management of Women With BRCA1/2 Mutation

summary:
The aim of this study is to determine general practitionners' role in management of women with BRCA1/2 mutation.

This study will be conduct between April 2017 and December 2017 at Montpellier University Hospital on women followed-up in the department of genetics and their general practitionners (GP). Patients and their GP will be called by the investigators and questionnaire will be given to them. Questionnaire includes questions for patients and their GP. The primary endpoint was to determine the rate of GP having sufficient knowledge of the adequate management of patients with BRCA1 / 2 mutation. Adequate knowledge includes : systematic search for a family history of cancer, knowing criteria required to refer women in oncogenetic department, and the ability to respond to patients' questions. Secondary endpoint was to determine women' opinion on their GP : whether or not well managed for their BRCA 1 / 2 mutation.

intervention_type: Behavioral


title: Effect of Continuous Intravenous Lidocaine on Early Rehabilitation in Bariatric Surgery. A Randomized Double Blind Controlled Study

acronym: XYLOBAR

summary:
Although peroperative intravenous lidocaine has been shown to be useful in early recovery after colorectal surgery, its beneficial effect on the specific population of obese patients scheduled for bariatric surgery remained unknown.

Investigators hypothesized that peroperative intravenous lidocaine could decrease postoperative opioid consumption and improve postoperative recovery


title: Identification of Transient Receptor Potential (TRP) Channels as New Potential Therapeutic Targets in Primary and Secondary Raynaud's Phenomenon.

acronym: TRP

summary: The investigators seek to perform a comparative transcriptome analysis of TRP channels residing in the skin between primary and scleroderma secondary Raynaud's phenomenon and healthy subjects.

ReferenceCitation: Herrick AL. Pathogenesis of Raynaud's phenomenon. Rheumatology (Oxford). 2005 May;44(5):587-96. doi: 10.1093/rheumatology/keh552. Epub 2005 Mar 1.

ReferenceCitation: Maricq HR, Carpentier PH, Weinrich MC, Keil JE, Franco A, Drouet P, Poncot OC, Maines MV. Geographic variation in the prevalence of Raynaud's phenomenon: Charleston, SC, USA, vs Tarentaise, Savoie, France. J Rheumatol. 1993 Jan;20(1):70-6.

ReferenceCitation: Chifflot H, Fautrel B, Sordet C, Chatelus E, Sibilia J. Incidence and prevalence of systemic sclerosis: a systematic literature review. Semin Arthritis Rheum. 2008 Feb;37(4):223-35. doi: 10.1016/j.semarthrit.2007.05.003. Epub 2007 Aug 9.

ReferenceCitation: Gabrielli A, Avvedimento EV, Krieg T. Scleroderma. N Engl J Med. 2009 May 7;360(19):1989-2003. doi: 10.1056/NEJMra0806188. No abstract available.

ReferenceCitation: van den Hoogen F, Khanna D, Fransen J, Johnson SR, Baron M, Tyndall A, Matucci-Cerinic M, Naden RP, Medsger TA Jr, Carreira PE, Riemekasten G, Clements PJ, Denton CP, Distler O, Allanore Y, Furst DE, Gabrielli A, Mayes MD, van Laar JM, Seibold JR, Czirjak L, Steen VD, Inanc M, Kowal-Bielecka O, Muller-Ladner U, Valentini G, Veale DJ, Vonk MC, Walker UA, Chung L, Collier DH, Ellen Csuka M, Fessler BJ, Guiducci S, Herrick A, Hsu VM, Jimenez S, Kahaleh B, Merkel PA, Sierakowski S, Silver RM, Simms RW, Varga J, Pope JE. 2013 classification criteria for systemic sclerosis: an American college of rheumatology/European league against rheumatism collaborative initiative. Ann Rheum Dis. 2013 Nov;72(11):1747-55. doi: 10.1136/annrheumdis-2013-204424.

ReferenceCitation: Steen V, Denton CP, Pope JE, Matucci-Cerinic M. Digital ulcers: overt vascular disease in systemic sclerosis. Rheumatology (Oxford). 2009 Jun;48 Suppl 3:iii19-24. doi: 10.1093/rheumatology/kep105.

ReferenceCitation: Hachulla E, Clerson P, Launay D, Lambert M, Morell-Dubois S, Queyrel V, Hatron PY. Natural history of ischemic digital ulcers in systemic sclerosis: single-center retrospective longitudinal study. J Rheumatol. 2007 Dec;34(12):2423-30. Epub 2007 Nov 1.

ReferenceCitation: Thompson AE, Shea B, Welch V, Fenlon D, Pope JE. Calcium-channel blockers for Raynaud's phenomenon in systemic sclerosis. Arthritis Rheum. 2001 Aug;44(8):1841-7. doi: 10.1002/1529-0131(200108)44:83.0.CO;2-8.

ReferenceCitation: Roustit M, Blaise S, Allanore Y, Carpentier PH, Caglayan E, Cracowski JL. Phosphodiesterase-5 inhibitors for the treatment of secondary Raynaud's phenomenon: systematic review and meta-analysis of randomised trials. Ann Rheum Dis. 2013 Oct;72(10):1696-9. doi: 10.1136/annrheumdis-2012-202836. Epub 2013 Feb 20.

ReferenceCitation: Scorza R, Caronni M, Mascagni B, Berruti V, Bazzi S, Micallef E, Arpaia G, Sardina M, Origgi L, Vanoli M. Effects of long-term cyclic iloprost therapy in systemic sclerosis with Raynaud's phenomenon. A randomized, controlled study. Clin Exp Rheumatol. 2001 Sep-Oct;19(5):503-8.

ReferenceCitation: Herrick AL. Vascular function in systemic sclerosis. Curr Opin Rheumatol. 2000 Nov;12(6):527-33. doi: 10.1097/00002281-200011000-00009.

ReferenceCitation: Cooke JP, Marshall JM. Mechanisms of Raynaud's disease. Vasc Med. 2005 Nov;10(4):293-307. doi: 10.1191/1358863x05vm639ra.

ReferenceCitation: Toth BI, Olah A, Szollosi AG, Biro T. TRP channels in the skin. Br J Pharmacol. 2014 May;171(10):2568-81. doi: 10.1111/bph.12569.

ReferenceCitation: Moran MM, McAlexander MA, Biro T, Szallasi A. Transient receptor potential channels as therapeutic targets. Nat Rev Drug Discov. 2011 Aug 1;10(8):601-20. doi: 10.1038/nrd3456.

ReferenceCitation: Wong BJ, Fieger SM. Transient receptor potential vanilloid type-1 (TRPV-1) channels contribute to cutaneous thermal hyperaemia in humans. J Physiol. 2010 Nov 1;588(Pt 21):4317-26. doi: 10.1113/jphysiol.2010.195511.

ReferenceCitation: Zholos A. Pharmacology of transient receptor potential melastatin channels in the vasculature. Br J Pharmacol. 2010 Apr;159(8):1559-71. doi: 10.1111/j.1476-5381.2010.00649.x. Epub 2010 Mar 5.

ReferenceCitation: Wilkins BW. Bring on the heat: transient receptor potential vanilloid type-1 (TRPV-1) channels as a sensory link for local thermal hyperaemia. J Physiol. 2010 Nov 1;588(Pt 21):4065. doi: 10.1113/jphysiol.2010.199703. No abstract available.

ReferenceCitation: Szabo A, Czirjak L, Sandor Z, Helyes Z, Laszlo T, Elekes K, Czompoly T, Starr A, Brain S, Szolcsanyi J, Pinter E. Investigation of sensory neurogenic components in a bleomycin-induced scleroderma model using transient receptor potential vanilloid 1 receptor- and calcitonin gene-related peptide-knockout mice. Arthritis Rheum. 2008 Jan;58(1):292-301. doi: 10.1002/art.23168.

ReferenceCitation: Roustit M, Millet C, Blaise S, Dufournet B, Cracowski JL. Excellent reproducibility of laser speckle contrast imaging to assess skin microvascular reactivity. Microvasc Res. 2010 Dec;80(3):505-11. doi: 10.1016/j.mvr.2010.05.012. Epub 2010 Jun 9.

ReferenceCitation: Fava A, Wung PK, Wigley FM, Hummers LK, Daya NR, Ghazarian SR, Boin F. Efficacy of Rho kinase inhibitor fasudil in secondary Raynaud's phenomenon. Arthritis Care Res (Hoboken). 2012 Jun;64(6):925-9. doi: 10.1002/acr.21622. Epub 2012 Jan 24.

ReferenceCitation: Roustit M, Cracowski JL. Assessment of endothelial and neurovascular function in human skin microcirculation. Trends Pharmacol Sci. 2013 Jul;34(7):373-84. doi: 10.1016/j.tips.2013.05.007. Epub 2013 Jun 21.

ReferenceCitation: Pauling JD, Shipley JA, Raper S, Watson ML, Ward SG, Harris ND, McHugh NJ. Comparison of infrared thermography and laser speckle contrast imaging for the dynamic assessment of digital microvascular function. Microvasc Res. 2012 Mar;83(2):162-7. doi: 10.1016/j.mvr.2011.06.012. Epub 2011 Jul 1.

ReferenceCitation: Daly SM, Leahy MJ. 'Go with the flow ': a review of methods and advancements in blood flow imaging. J Biophotonics. 2013 Mar;6(3):217-55. doi: 10.1002/jbio.201200071. Epub 2012 Jun 18.

ReferenceCitation: Johnson CD, Melanaphy D, Purse A, Stokesberry SA, Dickson P, Zholos AV. Transient receptor potential melastatin 8 channel involvement in the regulation of vascular tone. Am J Physiol Heart Circ Physiol. 2009 Jun;296(6):H1868-77. doi: 10.1152/ajpheart.01112.2008. Epub 2009 Apr 10.

ReferenceCitation: Thompson AE, Pope JE. Calcium channel blockers for primary Raynaud's phenomenon: a meta-analysis. Rheumatology (Oxford). 2005 Feb;44(2):145-50. doi: 10.1093/rheumatology/keh390. Epub 2004 Nov 16.

lead_sponsor: University Hospital, Grenoble


title: Urinary Tract Infections in Kidney Transplant Recipients : an Observational Cohort

acronym: URIKIT

summary: The purpose of this study is to better estimate the prevalence of urinary tract infections (UTI) in kidney transplant (KIT) recipients, and especially multidrug resistant (MDR) bacteria. KIT recipients have a higher risk of UTI over the 6 first months following the transplantation. Urine culture was done in a city lab or at hospital. Current data on bacteriuria and candiduria lead mostly to hospital data that are incomplete..

ipd_sharing_description: No plan will be sharing with others researchers

lead_sponsor: Poitiers University Hospital

sponsor_collaborators:
Poitiers University Hospital
Merck Sharp & Dohme LLC


title: Effect of Voluntary Neck Extension in the Occurrence of an Increase in the Pulsatility Index of Right Internal Carotid Artery in the Amateur Diver, Performing an Apnoea of Two Minutes or More: a Prospective, Monocentric, Open Interventional Study

acronym: APNECK

summary: The aim of this study is to demonstrate the effect of the voluntary neck extension in the occurrence of an increase in the pulsatility index of the right internal carotid artery in the amateur diver, realizing an apnea of two minutes or more.

lead_sponsor: Nantes University Hospital


title: Early Detection and Treatment of Respiratory Sleep Disorders in Children With Down Syndrome

summary: Interventional, comparative, open label, single-center study to demonstrate that an early (from 6 months of age) and systematic (every 6 months) screening of Obstructive Sleep Apnea (OSA) by polysomnography (PSG) in children with Down Syndrome during the first 3 years of life is associated with an improved neurocognitive development at the age of 3 years.

ReferenceCitation: Lal C, White DR, Joseph JE, van Bakergem K, LaRosa A. Sleep-disordered breathing in Down syndrome. Chest. 2015 Feb;147(2):570-579. doi: 10.1378/chest.14-0266.

ReferenceCitation: Bertrand P, Navarro H, Caussade S, Holmgren N, Sanchez I. Airway anomalies in children with Down syndrome: endoscopic findings. Pediatr Pulmonol. 2003 Aug;36(2):137-41. doi: 10.1002/ppul.10332.

ReferenceCitation: Fricke BL, Donnelly LF, Shott SR, Kalra M, Poe SA, Chini BA, Amin RS. Comparison of lingual tonsil size as depicted on MR imaging between children with obstructive sleep apnea despite previous tonsillectomy and adenoidectomy and normal controls. Pediatr Radiol. 2006 Jun;36(6):518-23. doi: 10.1007/s00247-006-0149-7. Epub 2006 Apr 5.

ReferenceCitation: Shires CB, Anold SL, Schoumacher RA, Dehoff GW, Donepudi SK, Stocks RM. Body mass index as an indicator of obstructive sleep apnea in pediatric Down syndrome. Int J Pediatr Otorhinolaryngol. 2010 Jul;74(7):768-72. doi: 10.1016/j.ijporl.2010.03.050. Epub 2010 May 7.

ReferenceCitation: Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Ward SD, Sheldon SH, Shiffman RN, Lehmann C, Spruyt K; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):e714-55. doi: 10.1542/peds.2012-1672. Epub 2012 Aug 27.

ReferenceCitation: Breslin J, Spano G, Bootzin R, Anand P, Nadel L, Edgin J. Obstructive sleep apnea syndrome and cognition in Down syndrome. Dev Med Child Neurol. 2014 Jul;56(7):657-64. doi: 10.1111/dmcn.12376. Epub 2014 Jan 29.

ReferenceCitation: Bull MJ; Committee on Genetics. Health supervision for children with Down syndrome. Pediatrics. 2011 Aug;128(2):393-406. doi: 10.1542/peds.2011-1605. Epub 2011 Jul 25. Erratum In: Pediatrics. 2011 Dec;128(6):1212.

ReferenceCitation: Ellis JM, Tan HK, Gilbert RE, Muller DP, Henley W, Moy R, Pumphrey R, Ani C, Davies S, Edwards V, Green H, Salt A, Logan S. Supplementation with antioxidants and folinic acid for children with Down's syndrome: randomised controlled trial. BMJ. 2008 Mar 15;336(7644):594-7. doi: 10.1136/bmj.39465.544028.AE. Epub 2008 Feb 21.

lead_sponsor: Institut Jerome Lejeune

sponsor_collaborators:
Institut Jerome Lejeune
Hôpital Necker-Enfants Malades


title: Personalized Therapy of Cystic Fibrosis: Set-up of Response Markers

acronym: BIO-CFTR

summary: The purpose of this study is to determine which biological marker, or association of biological markers, best predict clinical response of cystic fibrosis patients to CFTR modulators.

ReferenceCitation: Ramsey BW, Davies J, McElvaney NG, Tullis E, Bell SC, Drevinek P, Griese M, McKone EF, Wainwright CE, Konstan MW, Moss R, Ratjen F, Sermet-Gaudelus I, Rowe SM, Dong Q, Rodriguez S, Yen K, Ordonez C, Elborn JS; VX08-770-102 Study Group. A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. N Engl J Med. 2011 Nov 3;365(18):1663-72. doi: 10.1056/NEJMoa1105185.

ReferenceCitation: Graeber SY, Hug MJ, Sommerburg O, Hirtz S, Hentschel J, Heinzmann A, Dopfer C, Schulz A, Mainz JG, Tummler B, Mall MA. Intestinal Current Measurements Detect Activation of Mutant CFTR in Patients with Cystic Fibrosis with the G551D Mutation Treated with Ivacaftor. Am J Respir Crit Care Med. 2015 Nov 15;192(10):1252-5. doi: 10.1164/rccm.201507-1271LE. No abstract available.

ReferenceCitation: Quittner A, Suthoff E, Rendas-Baum R, Bayliss MS, Sermet-Gaudelus I, Castiglione B, Vera-Llonch M. Effect of ivacaftor treatment in patients with cystic fibrosis and the G551D-CFTR mutation: patient-reported outcomes in the STRIVE randomized, controlled trial. Health Qual Life Outcomes. 2015 Jul 2;13:93. doi: 10.1186/s12955-015-0293-6.

ReferenceCitation: De Boeck K, Munck A, Walker S, Faro A, Hiatt P, Gilmartin G, Higgins M. Efficacy and safety of ivacaftor in patients with cystic fibrosis and a non-G551D gating mutation. J Cyst Fibros. 2014 Dec;13(6):674-80. doi: 10.1016/j.jcf.2014.09.005. Epub 2014 Sep 26.

ReferenceCitation: Boyle MP, Bell SC, Konstan MW, McColley SA, Rowe SM, Rietschel E, Huang X, Waltz D, Patel NR, Rodman D; VX09-809-102 study group. A CFTR corrector (lumacaftor) and a CFTR potentiator (ivacaftor) for treatment of patients with cystic fibrosis who have a phe508del CFTR mutation: a phase 2 randomised controlled trial. Lancet Respir Med. 2014 Jul;2(7):527-38. doi: 10.1016/S2213-2600(14)70132-8. Epub 2014 Jun 24.

oa_host_type: closed

ReferenceCitation: Wainwright CE, Elborn JS, Ramsey BW, Marigowda G, Huang X, Cipolli M, Colombo C, Davies JC, De Boeck K, Flume PA, Konstan MW, McColley SA, McCoy K, McKone EF, Munck A, Ratjen F, Rowe SM, Waltz D, Boyle MP; TRAFFIC Study Group; TRANSPORT Study Group. Lumacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del CFTR. N Engl J Med. 2015 Jul 16;373(3):220-31. doi: 10.1056/NEJMoa1409547. Epub 2015 May 17.

repository_institution: Imperial College London - Spiral

repositories_concat: PubMed Central;spiral.imperial.ac.uk

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: De Boeck K, Kent L, Davies J, Derichs N, Amaral M, Rowe SM, Middleton P, de Jonge H, Bronsveld I, Wilschanski M, Melotti P, Danner-Boucher I, Boerner S, Fajac I, Southern K, de Nooijer RA, Bot A, de Rijke Y, de Wachter E, Leal T, Vermeulen F, Hug MJ, Rault G, Nguyen-Khoa T, Barreto C, Proesmans M, Sermet-Gaudelus I; European Cystic Fibrosis Society Clinical Trial Network Standardisation Committee. CFTR biomarkers: time for promotion to surrogate end-point. Eur Respir J. 2013 Jan;41(1):203-16. doi: 10.1183/09031936.00057512. Epub 2012 Aug 9.

ReferenceCitation: Dekkers JF, Wiegerinck CL, de Jonge HR, Bronsveld I, Janssens HM, de Winter-de Groot KM, Brandsma AM, de Jong NW, Bijvelds MJ, Scholte BJ, Nieuwenhuis EE, van den Brink S, Clevers H, van der Ent CK, Middendorp S, Beekman JM. A functional CFTR assay using primary cystic fibrosis intestinal organoids. Nat Med. 2013 Jul;19(7):939-45. doi: 10.1038/nm.3201. Epub 2013 Jun 2.

ReferenceCitation: Pranke I, Hatton A, Masson A, Flament T, Le Bourgeois M, Chedevergne F, Bailly C, Urbach V, Hinzpeter A, Edelman A, Sermet-Gaudelus I. Might Brushed Nasal Cells Be a Surrogate for CFTR Modulator Clinical Response? Am J Respir Crit Care Med. 2019 Jan 1;199(1):123-126. doi: 10.1164/rccm.201808-1436LE. No abstract available.

publisher_dissemination: American Thoracic Society

lead_sponsor: Hôpital Necker-Enfants Malades

sponsor_collaborators:
Hôpital Necker-Enfants Malades
Association Mucoviscidose-ABCF2
Vaincre la Mucoviscidose


title: Registry on the EXperience of Extracorporeal CO2 Removal in Intensive Care Units

acronym: REXECOR

summary:
Investigators will aim to conduct an observational study in order to assess very thoroughly all patients implanted by Extracorporeal carbon dioxide removal (ECCO2R) in 10 critical care units of Paris and its surburb (APHP, Assistance Publique des hôpitaux de Paris).

Secondary objectives will be:

to assess efficacy and safety of ECCO2R,
to compare the data issue from the registry to others studies assessing the same population and to other centers and
to compare the different ECCOR devices in terms of efficacy and adverse events.

ReferenceCitation: Augy JL, Aissaoui N, Richard C, Maury E, Fartoukh M, Mekontso-Dessap A, Paulet R, Anguel N, Blayau C, Cohen Y, Chiche JD, Gaudry S, Voicu S, Demoule A, Combes A, Megarbane B, Charpentier E, Haghighat S, Panczer M, Diehl JL. A 2-year multicenter, observational, prospective, cohort study on extracorporeal CO2 removal in a large metropolis area. J Intensive Care. 2019 Aug 20;7:45. doi: 10.1186/s40560-019-0399-8. eCollection 2019.

lead_sponsor: Rexecor


title: Correlation in Retinal Nerve Fiber Layer Thickness in Uveitis and Healthy Eyes Using Scanning Laser Polarimetry and Optical Coherence Tomography

acronym: Real

summary:
The aim of this study is to evaluate the correlation of retinal nerve fiber layer (RNFL) thickness measured using spectral domain optical coherence tomography (SD-OCT) and scanning laser polarimetry (SLP) in uveitic eyes compared to healthy eyes.

A descriptive, observational, prospective, consecutive, cross-sectional, controlled, mono-center case series was conducted from May to October 2015. Clinical characteristics, best-corrected visual acuity, intra-ocular pressure, RNFL thickness measurement with SD-OCT and SLP using GDx variable corneal compensation (GDx VCC) were performed for each patient. An evaluation of anterior chamber inflammation with laser flare cell meter was also carried out. Correlations between SD-OCT and GDx VCC RNFL measurement were evaluated by linear regression analysis.

lead_sponsor: Hospices Civils de Lyon


title: Effect of Positioning on Ultrasound Examination of the Gastric Antrum

summary: The aim of this prospective study was to assess the effect of patient positioning on the ultrasound assessment of gastric contents.

lead_sponsor: Hôpital Edouard Herriot


title: The Enzymatic Activity of Lymphocyte Dihydropyrimidine Dehydrogenase DPD in the Blood as a Predictive and Prognostic Factor in Patients With Digestive Cancer in the First or Second Metastatic Line

acronym: DPD DIG

summary: An observational study of a prospective, analytical, monocentric cohort which does not modify the patient care because the phenotyping of the dihydropyrimidine déshydrogénase DPD (lymphocyte activity) is already carried out in routine hospital. The analysis will be based on clinical, radiological and biological criteria.

lead_sponsor: Centre Antoine Lacassagne


title: Simultaneous Assessments of Serotonin and Kynurenine Pathways Parameters in Patients Shortly (Less Than 4 Hours and a Half) After the Onset of a Cerebral Infarction

summary:
Single-center, prospective, descriptive and biomedical research with controls, without health product.

Depression is the second risk factor for stroke as tobacco smoking following hypertension. Peripheral abnormalities in serotonin parameters were described in depression and tobacco smoking. The investigators hypothesized dysregulations in pathways of serotonin (5-HT), which has notably complex vasomotor effects and of kynurenine which could have cognitive dysfunction effects.

The aim of this study is to evaluate simultaneously the involvement of serotonin and kynurenine pathways parameters in patients suffering from a cerebral infarction shortly after the onset (less than 4 hours and a half), within a 2 days follow-up (Day 1 and Day 2) and 3 months after the cerebral infarction.

lead_sponsor: Versailles Hospital


title: Comparison Between Pre-operative Prescription Delivered During Anesthesia Consultation or Post-operative Prescription: a Randomized Prospective Trial

acronym: AMBUPRESS

summary: This study evaluates the comparison of the incidence of postoperative home pain after ambulatory surgery with general anesthesia between a group with pre-surgical prescription delivered during anesthesia preoperative clinic and a group with postoperative prescription.

ReferenceCitation: Selim J, Djerada Z, Chaventre C, Clavier T, Dureuil B, Besnier E, Compere V. Preoperative analgesic instruction and prescription reduces early home pain after outpatient surgery: a randomized controlled trial. Can J Anaesth. 2022 Aug;69(8):1033-1041. doi: 10.1007/s12630-021-02023-0. Epub 2021 May 13.

evidence: open (via free pdf)

lead_sponsor: University Hospital, Rouen


title: Feasibility Study of an Adapted Physical Activity (APA) for Breast Cancer Patients Treated by Neoadjuvant Chemotherapy and Targeted Therapy Against HER2

summary: The purpose of this study is to assess the feasibility of a home-based adapted physical activity during neoadjuvant chemotherapy for HER2+ breast cancer.

primary_purpose: Supportive Care

ReferenceCitation: Ginzac A, Bernadach M, Molnar I, Duclos M, Thivat E, Durando X. Adapted Physical Activity for Breast Cancer Patients Treated with Neoadjuvant Chemotherapy and Trastuzumab Against HER2 (APACAN2): A Protocol for a Feasibility Study. Front Oncol. 2021 Dec 13;11:744609. doi: 10.3389/fonc.2021.744609. eCollection 2021.

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

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

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

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

publisher_dissemination: Frontiers

lead_sponsor: Centre Jean Perrin


title: Prospective Study of Natural Killer Cells in Patients With Metastatic Prostate Cancer: Relationship With Survival and Response Time to Castration

acronym: NKPROSTATE

summary: Prospective research of Natural Killer cells as predictive biomarkers to stratify patients likely to have longer response time to castration.

ReferenceCitation: Pasero C, Gravis G, Granjeaud S, Guerin M, Thomassin-Piana J, Rocchi P, Salem N, Walz J, Moretta A, Olive D. Highly effective NK cells are associated with good prognosis in patients with metastatic prostate cancer. Oncotarget. 2015 Jun 10;6(16):14360-73. doi: 10.18632/oncotarget.3965.

ReferenceCitation: Gannon PO, Poisson AO, Delvoye N, Lapointe R, Mes-Masson AM, Saad F. Characterization of the intra-prostatic immune cell infiltration in androgen-deprived prostate cancer patients. J Immunol Methods. 2009 Aug 31;348(1-2):9-17. doi: 10.1016/j.jim.2009.06.004. Epub 2009 Jun 22.

ReferenceCitation: Mamessier E, Sylvain A, Thibult ML, Houvenaeghel G, Jacquemier J, Castellano R, Goncalves A, Andre P, Romagne F, Thibault G, Viens P, Birnbaum D, Bertucci F, Moretta A, Olive D. Human breast cancer cells enhance self tolerance by promoting evasion from NK cell antitumor immunity. J Clin Invest. 2011 Sep;121(9):3609-22. doi: 10.1172/JCI45816. Epub 2011 Aug 15.

lead_sponsor: Institut Paoli-Calmettes


type: EudraCT Number

title: Assessment of Fetal and Maternal Sufentanil Pharmacokinetics After Intra-amniotic Injection

summary:
The fetus may be exposed during pregnancy to nociceptive stimuli because of fetal pathology (e.g., malformation) or a diagnostic or therapeutic procedure.

To date, there is very little data and no consensus on fetal analgesia. The aim of the investigators study is to evaluate the pharmacokinetics of Sufentanil after intra amniotic injection.

lead_sponsor: University Hospital, Lille


title: Prospective Randomized Trial Comparing TRIPLE Site ventriculAr Stimulation Versus Conventional Pacing in CRT canDidates: TRIPLEAD Trial

acronym: TRIPLEAD

summary:
Cardiac resynchronization therapy (CRT) is a recommended treatment for selected patients with symptomatic heart failure (HF). Although most treated patients show a benefit from CRT, a lack of response is observed for about 25-30% of them whatever the response criteria used either based on the clinical status (NYHA class, Packer clinical composite score) or on ventricular remodeling parameters assessed by echography (Left ventricle end of systole volume). This rate has remained remarkably stable since the therapy started and has motivated many studies to better understand the underlying physiopathology and the CRT action mechanisms.

Among the various research axes to improve CRT response and responders rate, increasing the number of pacing sites in an attempt to better homogenize the cardiac mechanical activity has been evaluated. A configuration with two RV leads and one LV lead was tested acutely in three studies. In all cases, it demonstrated a significant improvement of cardiac performance whether assessed by echographic parameters or LV dp/dt measurements. Additionally feasibility of this approach for long term CRT delivery was demonstrated during a previous study. First results with triple-site ventricular stimulation are encouraging and its clinical efficacy should now be tested on a larger population in order to conclude on its interest for CRT candidates.


title: An Open Label Non-randomized Phase II Study Exploring "Chemo-free " Treatment Association With Idelalisib + Obinutuzumab in Patient With Relapsed/Refractory Waldenstrom's Macroglobulinemia

summary: Prospective national multicenter open label phase II Remodel WM3 trial

ReferenceCitation: Tomowiak C, Poulain S, Herbaux C, Perrot A, Mahe B, Morel P, Aurran T, Tournilhac O, Lepretre S, Assaad S, Villemagne B, Casasnovas O, Nollet D, Roos-Weil D, Chevret S, Leblond V. Obinutuzumab and idelalisib in symptomatic patients with relapsed/refractory Waldenstrom macroglobulinemia. Blood Adv. 2021 May 11;5(9):2438-2446. doi: 10.1182/bloodadvances.2020003895.

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

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

publisher_dissemination: American Society of Hematology

ipd_sharing: Yes

ipd_sharing_description: E CRF

lead_sponsor: French Innovative Leukemia Organisation


title: Binge Drinking And Addiction : Case-Control Study in Hospital

acronym: BACH

summary:
Case Control Study :

Objective:

Frequent Binge drinking during 18-25 years is a risk factor of alcohol addiction in adulthood (25-40 years) Hypothesis: 25% of frequent binge drinking, OR = 2, power 80%, alpha risk : 5% 126 Cases aged 25 to 40 years: alcohol addict patients recruited in Addiction Unit in Rouen University Hospital 126 controls aged 25 to 40 years: non alcohol addict recruited by the Clinical investigation center in Rouen University Hospital An anonymous self-questionnaire was completed Binge Drinking during 18-25 years was retrospectively evaluated Confusion biais was also recorded

ReferenceCitation: Tavolacci MP, Berthon Q, Cerasuolo D, Dechelotte P, Ladner J, Baguet A. Does binge drinking between the age of 18 and 25 years predict alcohol dependence in adulthood? A retrospective case-control study in France. BMJ Open. 2019 May 5;9(5):e026375. doi: 10.1136/bmjopen-2018-026375.

publisher_dissemination: British Medical Journal

lead_sponsor: Marie-Pierre TAVOLACCI


title: Non Invasive Assessment of Morphological and Functional Retinal Patterns in Reversible Cerebral Vasoconstriction Syndrome Using Transorbital Echotomography Doppler, Retinography and Retinal Vessel Analyser

summary:
Reversible cerebral vasoconstriction syndrome (RCVS) is a clinico radiological entity characterized by severe headaches (associated or not with neurological complications) during one to 3 weeks, associated with a characteristic 'string and beads' appearance on cerebral arteries, which resolves spontaneously in 3 months. The pathway is unknown. At early stage of the disease (at the first medical consultation) cerebral arterial abnormalities which are necessary for diagnosis are identified in only 20% of patients (brain magnetic resonance imagery (MRI) ,CT scan angiography), appearing with a delay on 2th or 3rd week after the first severe headache..

Retinal artery network is considered to be a window on brain microvasculature by sharing the same embryologic origin and physiopathology. A retinal arteriolar examination at early stage of RCVS could provide non invasively early clue to confirm diagnosis by identifying anatomical change and /or functional abnormalities at the microvascular level, whereas large cerebral artery abnormalities are still normal.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Physiological department, Lariboisière hospital


title: Musitox® Project: Consumption of Psychoactive Substances at Music Festivals in Aquitaine

acronym: Musitox®

summary: Poisoning by psychoactive substances is increasingly common in Europe and can be responsible for deaths. These substances, also called "festive drugs", circulate among other places in festive gatherings (night clubs, concerts, free music, feria, etc.). The main objective of this study is to determine the molecules that circulate in festive events in Aquitaine, in order to implement prevention actions by looking at whether the circulating substances vary with the style of event.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Regional Health Agency New Aquitaine


summary: The main objective is to highlight, by functional imaging (MRI) dysfunctional brain regions associated with vulnerability to suicidal behavior.

lead_sponsor: University Hospital, Montpellier


title: Postoperative Pain in Neonates After Abdominal Surgery Using Ultrasound Guided Quadratus Lumborum Block Performed at the Beginning of the Procedure

summary: Postoperative pain scores and analgesic requirements will be evaluated in neonates after abdominal surgery, with regional quadratus lumborum block performed at the beginning of the procedure.

lead_sponsor: Hôpital Armand Trousseau


title: Resectable Pancreatic Adenocarcinoma Neo-Adjuvant FOLF(IRIN)OX-based CHEmotherapy - A Multicenter, Randomised Phase II Trial (PANACHE01-PRODIGE48 Study)

summary:
In patients with resectable pancreatic duct adenocarcinoma (PDAC), curative surgery followed by adjuvant chemotherapy is currently the standard of care. However, the long-term results are still poor, with median disease-free and overall survival of 14 months and 23 months. The corresponding 5-year overall survival rate is 20%.

Chemotherapy before surgery (neoadjuvant chemotherapy) allows identification of patients with rapidly progressive metastatic disease at time of preoperative restaging (surgery is then avoided in these patients), and may increase the rate of free margin resection (R0) and reduce the risk of local recurrence.

Even though single-agent gemcitabine and 5-FU have been validated in adjuvant and metastatic settings, the objective response was low (at around 10%), whereas combination chemotherapy exceeds a response rate of 30% in advanced disease. In metastatic PDAC, palliative FOLFIRINOX chemotherapy has been demonstrated to be effective (in terms of response rates and progression-free survival) and well tolerated. Interestingly, the response rate is increased by using more than two chemotherapeutic agents in advanced pancreatic cancer, justifying the use of an alternative neoadjuvant FOLFOX-based chemotherapy arm.

PANACHE-01 is an open, non-comparative, randomised, multicentre Phase II study designed to assess the safety and efficacy of two modes of neo-adjuvant chemotherapy (FOLFIRINOX & FOLFOX) relative to the current reference treatment (surgery and then adjuvant chemotherapy) for resectable PDAC.

Patients with immediately resectable PDAC (definition based on the NCCN's (American National Comprehensive Cancer Network 2014) latest guidelines) will be randomised to either pancreatectomy and adjuvant chemotherapy or 4 cycles of neoadjuvant chemotherapy with either FOLFOX or FOLFIRINOX. The patients in the neoadjuvant chemotherapy arms will receive postoperative chemotherapy for 4 months (8 cycles).

ReferenceCitation: Schwarz L, Vernerey D, Bachet JB, Tuech JJ, Portales F, Michel P, Cunha AS. Resectable pancreatic adenocarcinoma neo-adjuvant FOLF(IRIN)OX-based chemotherapy - a multicenter, non-comparative, randomized, phase II trial (PANACHE01-PRODIGE48 study). BMC Cancer. 2018 Jul 24;18(1):762. doi: 10.1186/s12885-018-4663-4. Erratum In: BMC Cancer. 2020 Mar 3;20(1):168.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

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

collaborators: Federation Francophone de Cancerologie Digestive

collaborators: Federation of Research in Surgery (FRENCH)

collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group

appel_a_projets: PHRCK

region: Normandie

nom_etablissement: CHU ROUEN

titre: CHimiothérapie NeoAdjuvante par FOLF(IRIN)OX pour Adénocarcinome Pancréatique résécable - Essai de phase II multicentrique randomisé.

discipline_principale: oncologie digestive  / digestive oncology

nom_porteur: SCHWARZ

prenom_porteur: Lilian


title: Prospective Efficacy and Tolerance Data Collection in 34 to 36 Weeks Preterm Neonates Treated by High Flow Nasal Cannula for Respiratory Distress Syndrom

acronym: PRIMAIR

summary:
The main objective of the study is to gather preliminary data on the effectiveness of High Flow Nasal canula (HFNC), provided since the delivery room, for ventilatory support in newborns of 34-36 weeks with moderate respiratory distress syndrome (RDS).

The secondary objective is to evaluate the safety of HFNC in this indication.


title: Effect of Choice on Food Pleasure Using fMRI

acronym: PLEASIN

summary: Previous studies have suggested that consumers who can choose what to eat could find food more pleasant, and consume more of that food, than when in absence of choice. However cognitive mechanisms that could explain the effect of choice have not been investigated. The study consists in a fMRI experiment intended to observe the effect of the presence of choice on brain activity following consumption of a fruit-flavored drink, compared to the brain activity when the same drink is consumed without choice. It is suggested that consumers will appreciate drinks they chose better, and that the activity in gustatory and reward regions will change accordingly to changes in declared food pleasure.

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: UMR 914 PNCA - AgroParisTech, INRA, Université Paris-Saclay

collaborators: UR370 QuaPA AgroRésonance - INRA Saint-Génès-Champanelle


title: BANCO Study: Behavioral Addictions and Related NeuroCOgnitive Aspects: A Monocentric, Prospective, Controlled, Open-label Study of a Sample of Patients With Gambling Disorder

acronym: BANCO

summary: The prevalence of people suffering from gambling disorder is relatively high, and the impact on this disorder the individual and those around him is considerable. The etiopathogenic model of gambling disorder is multifactorial, involving various risk and vulnerability factors, involved in the initiation and maintenance of the disorder. Among these factors, neurocognitive alterations associated with the disorder has recently aroused interest among researchers. In this study, the investigators propose to explore the neurocognitive impairments of patients suffering from gambling disorder compared to a control group, in order to identify alterations that could be the target of cognitive remediation programs. Gambling disorder provides a unique opportunity to study the specific neurocognitive impairments of the addictive process because it is not biased by the neurotoxic effect of substances as it is the case in substance use disorders.

ReferenceCitation: Hurel E, Grall-Bronnec M, Thiabaud E, Saillard A, Hardouin JB, Challet-Bouju G. A Case-Control Study on Behavioral Addictions and Neurocognition: Description of the BANCO and BANCO2 Protocols. Neuropsychiatr Dis Treat. 2021 Jul 20;17:2369-2386. doi: 10.2147/NDT.S292490. eCollection 2021.

publisher_dissemination: Informa

lead_sponsor: Nantes University Hospital


title: Neoadjuvant Chemotherapy Response Assessment by Combined PET-MRI in Borderline and Locally Advanced Pancreatic Adenocarcinoma. PACMI (Pancreatic AdenoCarcinoma Multimodality Imaging)

acronym: PACMI

summary: The aim of this study was to assess the diagnostic accuracy of PET-MRI to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: PACMI

titre: TEP/IRM dans l'évaluation de la réponse au traitement néoadjuvant de l'adénocarcinome pancréatique borderline ou localement avancé

nom_porteur: WAGNER

prenom_porteur: Mathilde


title: Cerebral Bases of Multisensory Perception of the Body and Its Action Space

summary: To accurately control body movements to interact with objects, our brain needs representations of the body and the nearby space. The broader aim of this research project is to study the behavioural and physiological mechanisms involved in the constitution of these representations, to identify their neural bases, in order to better understand the dysfunctions in the context of neurological or developmental disorders.


title: " Effect of Affordance of Objects on the Memory: Study in Transcranial Magnetic Stimulation " (SIMULANG-TMS)

acronym: SIMULANG-TMS

summary: The purpose of this study is determine the involvement of motor system in the memory of manipulable objects. The idea is to stimulate the ventral premotor cortex with transcranial magnetic stimulation to see whether this stimulation will affect memory of manipulable objects.

lead_sponsor: Centre Hospitalier St Anne

sponsor_collaborators:
Centre Hospitalier St Anne
University of Paris 5 - Rene Descartes

location_facility: Centre de Recherche Clinique (CRC) - CHSA


title: Assessment of Optical Spectroscopy's Diagnosis Accuracy When Non-invasively and Automatically Classifying Skin Lesions in One of the Following Histological Classes: Healthy, Actinic Keratosis, in Situ Carcinoma and Invasive Carcinoma.

acronym: SPECTROLIVE

summary:
Actinic keratosis are of utmost medical and economical interest because of their high prevalence (20 % of 60 year-old people and older in the Northern hemisphere) and their important cosmetic impact as such actinic keratosis mostly appear on photo-exposed skin sites. The surgeon in charge of such lesions' removal (i) some actinic keratosis adjoining carcinoma to be resected therefore causing the problem of functional areas damaging (eyelids, lips, etc.) or (ii) numerous actinic keratosis localized away from carcinoma (photo-carcinogenesis field) faces the issue of clinical evaluation of such lesions: which ones will spontaneously regress (it is supposed to be the case for 20 % of such lesions);which ones will remain and which ones will develop into invasive carcinomas ?

A non-invasive, non-traumatic, automated and real-time help for the clinical diagnosis orientation of such skin lesions could help improving diagnosis accuracy of the medical practitioner's visual inspection:

In terms of sensitivity in order to potentially decrease the number of actinic keratosis evolving towards invasive carcinoma,
In terms of specificity in order to potentially decrease useless resections and reduce resection margins and therefore reduce scars surface.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Motor Unit Recruitment Study With Fatigue Testing: 9 Months Following up After Anterior Cruciate Ligament Surgery.

acronym: WEAKNESS

summary:
An assessment of the effect of surgical anterior cruciate ligament (ACL) on thigh muscles is critical to the improvement of knee rehabilitation and preservation. However, if a large number of studies had rated surgical technics, giving high results level for ACL reconstruction (ACLR), muscle recovery is still conditioning functional success. Furthermore there is no consensus about criteria in return to sport.

The aim of this exploratory study is to quantify the mechanisms of neuromuscular adaptation of muscle thigh after ACL surgery.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Clermont-Tonnerre


title: Analytic and Functional Evaluation After Surgical Treatment Using an Original Arthroscopic Trillat Technique in Patients With Chronic Anterior Shoulder Instability

acronym: TRILLARTHRO

summary:
The shoulder is the most mobile joint in the body, and the most exposed to the risk of dislocation notably anterior. Chronic instability of the shoulder is frequent after dislocation, and principally affects people who are young and active. It can have major functional repercussions, leading to restricted participation in professional or sports activities, even in everyday life activities.

Surgical stabilisation is the reference treatment for chronic anterior shoulder instability, and has given good results. There are numerous surgical techniques available; the orthopaedists at Dijon CHU now practice the Bristow-Trillat technique under arthroscopy, following many years of reflexion and adaptation.

Rehabilitation following the surgery is essential, notably to recover muscle strength in the shoulder rotator cuff after surgery, which correlates directly with dynamic stability of the joint. At the moment, we do not know the objective evolution of muscle strength after the Trillat arthroscopic technique.

The isokinetic evaluation of muscle strength in the rotator cuff has been validated and is reproducible. It gives objective and reliable values for muscle strength, thus making it possible to guide and to optimise rehabilitation protocols done by patients under the supervision of a physiotherapist, and to estimate time to the return to physical, professional or sports activities, without risk.

time_perspective: Other

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: The Right Ventricle in Chronic Pressure Overload: Identifying Novel Molecular Targets for Functional Imaging

acronym: MVD

summary: Chronically elevated pulmonary pressures do not immediately result in right ventricular failure. During the initial period of exposure, the RV adapts to the increased afterload by altering its metabolism and morphology so as to meet the increased work requirement. Several, interconnected adaptive mechanisms have been proposed, including myocyte hypertrophy, a switch in the primary fuel used for ATP generation, increased angiogenesis, and decreased production of mitochondrial reactive oxygen species. While adaptation is initially successful in many cases, it is temporary, and after an uncertain period of time, the ventricle begins to fail. This transition from a compensated to decompensated state is difficult to predict clinically, and patients with different etiologies of CPOS progress to overt RV failure over significantly different time periods. This variability hinders the implementation of treatments that are tailored to a specific disease stage.

lead_sponsor: Centre Chirurgical Marie Lannelongue


summary:
The main objectives of the prolonged resuscitation paralysis are usually adaptation to mechanical ventilation, lower insufflation pressures and cough suppression.

The use of monitoring during the prolonged neuromuscular blockade is the subject of recommendations. Its interest is subject to a recommendation grade B and its use in prevention of overdose is associated with a recommendation of Grade C.

However, many practitioners continue to objectify the depth of neuromuscular blockade and reversal by simple clinical evaluation. This is a subjective estimate of the depth of neuromuscular block.

Resuscitation in several pharmacokinetic parameters are taken into account. First, the drug distribution volume is usually increased in the Intensive Care patient and requires an increase in initial doses to obtain the same pharmacological effect.

Then, unlike a short-term administration, the administration of neuromuscular blocking agents on days causes diffusion in peripheral compartments. Their diffusion coefficients are slower which contributes to the increase of the elimination period after interruption of the administration of curare. There is therefore a risk of residual paralysis.

Secondarily, the curare needs can be influenced by thermoregulation, water and electrolyte disorders and acid-base, administration of certain drugs, the inter- and intra-individual variability and tachyphylaxis (form tolerance of particularly rapid installation during a few close administration, linked to the proliferation of cholinergic receptors).

The value of monitoring neuromuscular blockade in intensive care is the prevention of overdose and in finding the lowest effective dose.

lead_sponsor: Poitiers University Hospital


title: Involvement of Plasmatic Factors in the Peripheral Muscle Dysfunction of COPD Patients - In Vitro Study

summary: Chronic Obstructive Pulmonary Patients is a defined by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. It is associated with an atrophy of the skeletal muscle that impairs the patient's prognosis. The biological mechanisms of this muscle atrophy have not been elucidated, and the "spill-over theory" has recently emerged. Indeed, in COPD patients, the pulmonary inflammation is associated with a systemic low-grade inflammation, and the increased pro-inflamatory molelcules in the blood - which constitute the cellular micro-environement of the muscle fibre - could activate the mechanisms of the cell atrophy.


title: Determination of Factors Influencing the Physical Condition of Obese Patients Following Bariatric Surgery. Randomized Controlled Trial

acronym: CaPaCITy

summary: The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation.


title: Phenomenological Approach of Epilepsy in Patients With Epilepsy and Their Relatives for Risk Prevention

summary:
Rationale : Persons with epilepsy have a greater risk of incurring accidental injury and a higher mortality risk than the general population.

The main objective of the study is to understand life experience of the disease or risks associated with epilepsy in patients with epilepsy, relatives of patients and bereaved families.

Study design: Qualitative study (study based on interviews) Population: Three groups will be interviewed: bereaved families, patients with epilepsy and relatives of patient. Bereaved family: relatives who contact the French sentinel network "Réseau Sentinelle Mortalité Epilepsie" (RSME) notifying an epilepsy-related death (regardless the cause of the death and the timeframe between death and interview). Patients with epilepsy: patients having a secure diagnostic of epilepsy from 15 years old to 65 years old. Relatives of patients with epilepsy: spouse/husband or parents invited by a patient with epilepsy to participate to the interview who consent to participate.

Method: Semi structured in-depth interviews will be conducted by an experienced qualitative psychologist in face to face, at home, at the hospital or at any other place (depending on the choice of the participants). The interview topic guide will be centered on participants'personal experience. Interviews will be digitally recorded and will be transcribed by a secretary.

The results of this study will be integrated in educational therapeutic programs regarding prevention of risks related to epilepsy.

sponsor_collaborators:
University Hospital, Montpellier
Université Montpellier


title: Causes of Death in Follicular Lymphoma: a Single Center Retrospective Analysis

summary: Background.Although the life expectancy of patients with FL has recently increased, notably since the introduction of rituximab in combination with chemotherapy, little is known regarding the precise causes of patients death. Patients and methods'. This study describes the different causes of death in FL patients among followed since 2000 at Lyon University Hospital, centre Léon Bérard and Mayo Clinic. The causes of death will be classified as related to lymphoma progression, treatment-related toxicity (including TRM and secondary myelodysplastic syndrome/acute myeloid leukemia), secondary neoplasias, or other.

lead_sponsor: Hospices Civils de Lyon


lead_sponsor: Hybrigenics Corporation

summary: To assess the efficacy of inecalcitol in combination with imatinib in CML patients with molecular residual disease on imatinib monotherapy.

title: Phase 2 Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study

source: euctr