title: Prevalence Study of the Etiologies of Pregnancy Anemias

acronym: PREGAN

summary: Anemia during pregnancy occurs in 41% of women. The most common etiology is iron deficiency, but studies to determine prevalence of other causes of anemia in pregnancy are still lacking. However, anemia in pregnancy lead to adverse pregnancy outcomes and increase risk of maternal and fœtal morbidity and mortality. Specific management of anemia is so needed.

lead_sponsor: University Hospital, Brest


title: Observational Study on Intrafamilial Oppositional Defiant Disorder (IODD) in Children and Adolescents

acronym: TOPi

summary:
Oppositional Defiant Disorder (ODD) is defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) as: "A pattern of angry/irritable mood, argumentative/defiant behavior, or vindictiveness lasting at least 6 months exhibited during interaction with at least one individual who is not a sibling." "The disturbance in behavior is associated with distress in the individual or others in his or her immediate social context (e.g., family, peer group, work colleagues), or it impacts negatively on social, educational, occupational, or other important areas of functioning." Children with "classic" oppositional defiant disorder, except for mild forms, show symptoms in several settings (at home, at school, with peers).

In this study, the investigators will consider the specifics of children presenting "intrafamilial" oppositional defiant disorder (IODD). These children's symptoms are confined to only one setting: the home. Therefore, the aim of this study will be to characterize children with intrafamilial oppositional defiant disorder. The investigators want to understand the differences between IODD and classical forms of ODD in terms of psychiatric comorbidities, medical histories and cognitive abilities. They also investigate what clinicians currently do to help these families.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Multiple Breath Nitrogen Washout in Healthy Volunteers

acronym: HV-LCI

summary: This study is designed to establish reference values of multiple breath nitrogen washout indexes in an healthy population of volunteers (from childhood to adulthood)

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Basic Science

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

intervention_type: Procedure

status_simplified: Unknown


title: Allocation of Physician Time in Anesthesiology Practice

summary:
The evolution of the health care system in Western countries has increased the scope of the tasks assigned to doctors in their daily lives. The burden of administrative tasks and the use of IT tools reduce the time spent with the patient. Indeed, in a very recent work published in the Annals of Internal Medicine, Sinsky et al. showed that in 4 different specialties (general medicine, internal medicine, cardiology and orthopaedics) for every hour spent in front of a patient, each physician spent two hours on tasks in the absence of the patient1. This distribution of time was found in the Wenger et al. study in 36 internal medicine interns, since a ratio of 1:3 between the working time spent in the presence of the patient (1.7 hours) and that spent in front of a computer (5.2 hours) was noted2.

The reduction in the clinical time devoted directly to the patient is a major source of dissatisfaction for physicians, which can even extend to burnout3. Moreover, it has been shown that the importance of computer tasks in everyday life is correlated with the occurrence of burnout4. Finally, beyond these clinical times directly or indirectly linked to patient care, the time spent on other tasks (administrative, travel time between different sites,...) appears to be significant (20% in Sinsky et al.)1.

The anesthesiologist faces the same constraints as other specialties, but no work has been specifically concerned with the distribution of time spent on the different tasks. Compared to other specialties, anesthesiologist is also regularly confronted with specific organisational tasks within the operating room that could reduce the time spent directly with patients.

The objective of this work is to determine the division of the different tasks in a anesthesiologist's work day by analysing the time spent directly with the patient but also that allocated to his or her care outside of his or her presence, as well as that devoted to organizational or administrative tasks.

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: University Hospital, Rouen


title: SLEEP APNEA SYNDROME AND TRISOMY 21 : Exploration of the Predictive Factors in the Population With Trisomy 21

summary:
The obstructive sleep apnea syndrome (OSAS) is frequently reported in subjects with trisomy 21. The consequences of this syndrome are expressed in various disorders such as cognitive and cardiovascular alterations. It is also reported a premature exhaustion with the achievement of various professional or recreational activities, as well as an increase in the frequency of daytime sleepiness. In trisomy 21, there are factors that are systematically associated with obstructive apnea. The identification of these factors would make it possible to diagnose OSAS earlier, under-diagnosed in the population with trisomy 21 even though these OSAS are associated with increased cardiovascular risks.

The aim of this study is to identify the predictive factors associated with sleep apnea in the trisomy population in order to propose early detection.

OSAS treatment in a young adult with Down syndrome could reduce physical fatigue apparition during various activities, reduce daytime sleepiness, and have a positive impact on physical fitness, and therefore more broadly on health.

ReferenceType: background

ReferenceCitation: Leti T, Guinot M, Favre-Juvin A, Bricout VA. Difference of catecholamine responses to exercise in men with trisomy 21, with or without chronotropic incompetence. Physiol Behav. 2015 Apr 1;142:97-103. doi: 10.1016/j.physbeh.2015.02.007. Epub 2015 Feb 4.

ReferenceCitation: Bricout VA, Guinot M, Faure P, Flore P, Eberhard Y, Garnier P, Juvin AF. Are hormonal responses to exercise in young men with Down's syndrome related to reduced endurance performance? J Neuroendocrinol. 2008 May;20(5):558-65. doi: 10.1111/j.1365-2826.2008.01695.x. Epub 2008 Mar 15.

ReferenceCitation: Flore P, Bricout VA, van Biesen D, Guinot M, Laporte F, Pepin JL, Eberhard Y, Favre-Juvin A, Wuyam B, van de Vliet P, Faure P. Oxidative stress and metabolism at rest and during exercise in persons with Down syndrome. Eur J Cardiovasc Prev Rehabil. 2008 Feb;15(1):35-42. doi: 10.1097/HJR.0b013e3282f2bff3.

lead_sponsor: University Hospital, Grenoble

intervention_type: Diagnostic Test


title: Study of Transcutaneous Exercise Oxymetry, reLationship to LActates Increase in Claudication

acronym: STELLA

summary:
To our knowledge, the measurement of the transcutaneous oxygen pressure during walking is the only continuous method that estimates the importance of ischemia, bilaterally and segment of limb by segment of limb. The determination of the lactates concentration, with micro method from earlobe sampling, is very widely validated in physiology and exercise physiopathology; and it is widely used, by laboratories, for exercise investigation in athletes. We use it in routine to evaluate the presence of functional limitation during tcpO2 tests on a treadmill.

The present study hypothesises a significant relationship between lactatemia variation (difference between lactatemia after 3 minutes of recovery from walking and the value at rest) and tcpO2 "decrease from rest of oxygen pressure (DROP) values for patients with peripheral artery disease (PAD).

lead_sponsor: University Hospital, Angers


title: Pilot Study on the Influence of the Integration of Natural Images, According to Various Esthetic Approaches, in the Waiting Rooms of Imaging on the Anxiety Felt by the Patients

acronym: VERTIM

summary: VERTIM study aims to evaluate the influence of different environments of imaging waiting rooms on the anxiety felt by patients before MRI or CT scans. For this, four environments (neutral/standard; and nature "green", "sea", and "zen") will be set up in MRI and CT waiting rooms.

lead_sponsor: University Hospital, Bordeaux


title: Diagnostic Value of MRI for Allergic Broncho-Pulmonary Aspergilloses

acronym: ABPA-MR

summary: The aim of the study is to compare the concordance between chest computerized tomography-scan (CTscan) and Magnetic resonance Imaging (MRI) for the description of the abnormalities seen in Allergic BronchoPulmonary Aspergillosis (ABPA).

design_allocation: Non-Randomized

primary_purpose: Diagnostic

intervention_type: Device


title: Evaluation of Technical and Predictive Value of the Basophil Activation Test for Food Allergy Diagnosis in Children

summary:
Background: The need for an oral food challenge (OFC) surrogate is growing in line with the continuous increase in the prevalence and severity of paediatric food allergy. The basophil activation test (BAT) has recently been reported as a promising tool for predicting the outcome of OFC in children.

Objective: We make the hypothesis that BAT might improve the sensitivity of food allergy diagnosis and spare part of current OFC in paediatric patients attending allergy departments in Marseille APHM University hospitals.

Methods: BAT will be performed in parallel with OFC in 100 paediatric patients receiving OFC during a diagnostic or follow-up procedure.

Expected results: Good concordance of BAT and OFC results leading to potential OFC replacement by BAT in at least 50% of the study population

study_start_date_type: Anticipated

ReferenceType: derived

ReferenceCitation: Arif-Lusson R, Agabriel C, Carsin A, Cabon I, Senechal H, Poncet P, Vitte J, Busnel JM. Streamlining basophil activation testing to enable assay miniaturization and automation of sample preparation. J Immunol Methods. 2020 Jun-Jul;481-482:112793. doi: 10.1016/j.jim.2020.112793. Epub 2020 May 6.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Post-Market Clinical-Follow-Up Study of Suprasorb® C Collagen Wound Dressing

acronym: Suprasorb®C

summary: Post-Market Clinical-Follow-Up Study of Suprasorb® C collagen wound dressing

lead_sponsor: Lohmann & Rauscher

lead_sponsor_type: industriel


title: Comparison of the 20-gauge Procore® and 22-gauge Acquire® Needles for Endoscopic Ultrasound-guided Fine Needle Biopsy (EUS-FNB) of Solid Pancreatic or Peripancreatic Masses: an Observational Study.

acronym: Mousquetaires

summary: This observational study compared quality of histological sampling of pancreatic EUS-FNB with the 20-gauge Procore® and 22-gauge Acquire® needles. In total, 68 patients were recruited. Histological diagnosis was achieved and a histological core biopsy was obtained in 82% of patients (28/34) in the 20-gauge Procore® group and 97% of patients (33/34) in the 22-gauge Acquire® group (P=0.1). Core biopsy specimens obtained were significantly longer with the 22-gauge Acquire® needle with a mean cumulative length of tissue core biopsies per needle pass of 4,33±3,46mm vs. 7,9±4,35mm for the 20-gauge Procore® (P<0,01). Reproducibility of this simple histological criterion was validated in intra and inter-observer.

lead_sponsor: Société Française d'Endoscopie Digestive


title: Study of the Reproducibility of Laser Measurement in the Detection of Digital

acronym: REPROLASER

summary:
At the digital level, the diagnosis of obstructive arteriopathy is very difficult in the absence of ulcer or of true ischemic signs, and the arteriography, which is an examination to inject an intra-arterial contrast agent, is the reference measure.

The measure by "Laser Doppler" uses a monochromatic light (laser) to measure the concentration as well as the speed of travel of red blood cells in the skin and deduct the cutaneous blood flow.

The great advantage of this technique is that it is non-invasive, inexpensive and can be performed during a consultation. The patient can therefore be briefly informed of the benign (functional) or organic origin of his disorders.

status: Terminated

ReferenceCitation: Omarjee L, Metairie A, Tueguem Moyo T, Pabic EL, Jego P, Lescoat A, Mahe G. Performance of finger systolic blood pressure measurement to detect digital occlusive arterial disease in systemic sclerosis. Rheumatology (Oxford). 2022 Mar 2;61(3):1115-1122. doi: 10.1093/rheumatology/keab497.

publisher_dissemination: Oxford University Press

ipd_sharing_description: It is indicated in the consent of the patient that his data may be transferred to other searchers in France or abroad in the future

lead_sponsor: Rennes University Hospital

location_facility: CHU Rennes _ Service de radiologie et imagerie médicale


title: Recording Food Consumption in Patients Hospitalised in a Geriatric Centre

acronym: PESALI

summary:
The objective of the study is to measure the quantities of food consumed at each meal by a representative part of the population of patients hospitalised in each department of the Champmaillot Geriatric Centre.

To do so, the quantity eaten will be quantified by weighing the amounts served and subtracting the weight of the left-overs. These measurements will allow us to provide more appropriate meals in the second step.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: DIAGNOSIS and FORENSIC MANAGEMENT OF PSYCHOLOGICAL TRAUMA IN PATIENTS INVOLVED IN THE TERRORIST ATTACK IN NICE ON THE 14TH JULY 2016

acronym: PSYCHIC

summary:
Psychological trauma is a major public health concern that affects numerous patients who have experienced traumatic events.

The objective of our research was to improve the diagnosis and management of persons experiencing such events.

We will seek to determine factors brought into play in the construction of psychological trauma and the best way to identify them so as to implement the optimal management of patients and ensure recognition of this condition.

In addition, in the context of our activity as expert witnesses, we will study the methods used to assess and quantify psychological trauma.

In this respect, a medical appointment will be made by a nurse of the Forensic Medicine Department of Dijon CHU. During this consultation, a self-report questionnaire will be completed by the patient alone to evaluate the level of acute stress followed by a psychiatric consultation and completion of the IES-R questionnaire with the doctor to identify symptoms of psychological trauma.


title: Round-trip Survey or Urine Bag: Evaluation of Pain in Urinary Collections in Pediatric Emergencies in Children Who Have Not Acquired Cleanliness (SONDAPU)

acronym: SONDAPU

summary: Observational study.


title: Multicenter Cohort Study on Duchenne Muscular Dystrophy Cardiomyopathy

acronym: DMD-HS

summary:
Retrospective cohort study including patients with genetically proven Duchenne muscular dystrophy, diagnosed from January 1993 to March 2020.

Inclusion of the data relative to genetic diagnosis, clinical characteristics at baseline, cardiac and respiratory workup, medical treatments (ACE inhibitors, steroids), surgical procedures, and occurrence during follow-up of cardiac, respiratory and fatal events.

Objectives are to describe long-term natural history of the disease, vital prognosis, genotype-phenotype correlations, effect of treatments.

ReferenceCitation: Porcher R, Desguerre I, Amthor H, Chabrol B, Audic F, Rivier F, Isapof A, Tiffreau V, Campana-Salort E, Leturcq F, Tuffery-Giraud S, Ben Yaou R, Annane D, Amedro P, Barnerias C, Becane HM, Behin A, Bonnet D, Bassez G, Cossee M, de La Villeon G, Delcourte C, Fayssoil A, Fontaine B, Godart F, Guillaumont S, Jaillette E, Laforet P, Leonard-Louis S, Lofaso F, Mayer M, Morales RJ, Meune C, Orlikowski D, Ovaert C, Prigent H, Saadi M, Sochala M, Tard C, Vaksmann G, Walther-Louvier U, Eymard B, Stojkovic T, Ravaud P, Duboc D, Wahbi K. Association between prophylactic angiotensin-converting enzyme inhibitors and overall survival in Duchenne muscular dystrophy-analysis of registry data. Eur Heart J. 2021 May 21;42(20):1976-1984. doi: 10.1093/eurheartj/ehab054.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

version: submittedVersion

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

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

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

repositories_concat: HAL

unpaywall_oa_status: bronze

lead_sponsor: Hôpital Cochin

collaborators: Association Monégasque contre les Myopathies

location_facility: Cochin Reference Center for Neuromuscular Diseases


title: Clinical and Paraclinical Characteristics of the Systemic Scleroderma Cohort According to the Criteria ACR 2013 and the History of Professional Exposure or of Agricultural Environment

acronym: PRESSY

summary: The aim of the study is to compare the exposure to environmental and professional toxics by patients with systemic scleroderma and by patients not achieved by this pathology.

time_perspective: Other


title: Immunological and Bacteriological Approaches to the Development of Postoperative Mediastinitis With Staphylococcus Aureus

acronym: MEDIASTAPH

summary: Cardiac surgery with extracorporeal circulation (ECC) yields a deep immune system dysfunction that exposes patients to postoperative infectious complications. Among these, post-operative mediastinitis with Staphylococcus aureus (SA) generates significant morbidity and mortality. Two radically different approaches have been proposed in recent years to reduce the incidence of this complication. A first approach has attempted, without real success, to decrease postoperative immunosuppression. The second, more efficient, consisted of screening and preoperatively treating patients colonized with SA. However, although its incidence has decreased, postoperative mediastinitis remains a terrible nosocomial infection. The authors believe that a thorough analysis of the immunological changes induced by cardiac surgery will initiate active therapeutics to reduce the post-operative immunosuppression phase, thereby decreasing the risk of nosocomial infections. In addition, a study of the interactions between the operated (host) and staphylococcus aureus (pathogenic) immune systems will provide a better understanding of the mechanisms that expose patients to this bacterium.


title: Collaborative Self-Management Support in Chronic Conditions: a Qualitative Study of Patients', Caregivers' and Health Care Professionals' Views and Experiences of Integrated Care in Asthma, Breast Cancer and Stroke

acronym: CoSMaS-ql

summary:
The management of chronic conditions is a challenge for health systems worldwide, particularly in the context of an aging population, and requires urgent improvement of health services. Integrated care and patient empowerment represent promising solutions: offering tailored self-management support in a collaborative framework led to good results in several clinical contexts. Yet, large scale implementation remains a challenge. An important limitation of existing solutions is a lack of utilization of behavioural and communication theory for identifying the dynamics of pluridisciplinary collaboration and the interactive effects of the activities performed by several actors involved in self-management support in a given chronic condition. A second limitation is not involving all relevant actors in the development of health service improvement solutions, which leads to limited programme adoption and sustainability in routine care.

This study is part of a project that proposes to address these limitations and develop and interdisciplinary model of collaborative care in the self-management of chronic conditions (CoSMaS) that adopts a community-based participative approach. CoSMaS-ql is a qualitative study that will consist of semi-structured interviews with several types of stakeholders: patients, caregivers, and health care professionals of different specialties (e.g. general practitioners, nurses, specialist consultants, pharmacists). The main objective of the study is to explore the experiences and of patients, caregivers, and HCPs on how self-management support is currently delivered in asthma, cancer and stroke (content, communication, organisation of care), their needs related to self-management support provision, and envisaged solutions for improving current practice. Three different chronic conditions will be targeted: asthma, breast cancer and stroke. The qualitative data will be analysed via grounded-theory and template analysis. It will inform the development of a theoretical model of collaborative self-management support in chronic conditions. It will also result in three profiles describing 'real' versus 'ideal' care processes, which will represent needs assessment stages for future health services improvement interventions in the three conditions.

location_facility: EA 7425 HESPER - Health Services and Performance Research, Université Claude Bernard Lyon 1


title: Incidence and Risk Factor of Adverse Drug Events Detected at Emergency Department Visit

acronym: ADEsED

summary:
Emergency departments (EDs) are a crucial element of the health care systems at interface between hospital and communities. The goals of the ED are to make an initial diagnosis and deliver urgent and critical care 24 hour per day and 365 days a year. Also, many Adverse Drug Events (ADEs) are not identified by emergency physicians. ADEs are injuries resulting from a drug related medical intervention. Their detection, documentation and reporting are essential for adequate medical care and knowledge of risk/benefit profiles of medication throughout their lifecycle. However, a number of studies indicate that in clinical practice the under-reporting of ADEs is a pervasive and widespread problem. The main reasons for under-reporting were difficulty in determining the cause of the ADE, lack of time, poor integration of ADE-reporting systems and uncertainty about reporting procedures. Successful treatment of ADEs depends on the ability of physicians to attribute ADEs to a medication. Some studies have reported that pharmacists but also student pharmacists were one of the best health care providers to establish medication history. Consequently, the aims of our study were to assess prevalence and characteristics of ADEs identified in an emergency department and to identify factors associated with ADEs in ED patients.

This prospective observational study is conducted at the ED of a tertiary care hospital (University hospital of Montpellier). This department supports 80 000 patients every years. Patient were not included if they were less than 18 years old, present acute psychological disturbance or they did not agree to participate at this study.

For each patient included, a pharmaceutical team conducted: medication reconciliation process to establish medication history and a structured interviews to determine self-reported adherence and self-medication. ADEs were attributed to a medication by the treating senior emergency physician: directly during patient consultation or after being alerted by the pharmaceutical team.

ReferenceCitation: Lohan L, Marin G, Faucanie M, Laureau M, Macioce V, Perier D, Pinzani V, Giraud I, Castet-Nicolas A, Jalabert A, Villiet M, Sebbane M, Breuker C. Impact of medication characteristics and adverse drug events on hospital admission after an emergency department visit: Prospective cohort study. Int J Clin Pract. 2021 Jul;75(7):e14224. doi: 10.1111/ijcp.14224. Epub 2021 Apr 23.

oa_host_type: repository

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

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

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

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Laureau M, Vuillot O, Gourhant V, Perier D, Pinzani V, Lohan L, Faucanie M, Macioce V, Marin G, Giraud I, Jalabert A, Villiet M, Castet-Nicolas A, Sebbane M, Breuker C. Adverse Drug Events Detected by Clinical Pharmacists in an Emergency Department: A Prospective Monocentric Observational Study. J Patient Saf. 2021 Dec 1;17(8):e1040-e1049. doi: 10.1097/PTS.0000000000000679.

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

publisher_dissemination: Wolters Kluwer Health


title: Evaluation of the Psychological Consequences of Complicated Childbirth

acronym: ESPT Obst

summary: Prospective, non-interventional, monocentric, case-control study

location_facility: Hospital-University Psychiatry Center for Children and Adolescents


title: OSS-IRM: Optimization of MRI Sequences in Healthy Volunteers

acronym: OSS-IRM

summary:
Using MRI, many technical parameters can be changed to optimize the diagnostic quality of the examination. The study is interventionnal because healthy volunteers are not supposed to have an MRI exam.

The primary objective of this study is to optimize the imaging protocols and to validate the choice of the technical parameters in healthy volunteers.

The quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools.

primary_purpose: Other


title: Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed Pilot Study

acronym: OSTEO

summary: Staying confined in the bed is frequent at the end of life. The cancer patients can also experiment this situation, and consequences are painful, with pain increasing with the time. This pain are related to the joints stiffing , muscles mass decreasing, and tendons retractions . The non pharmacological approach associated with the conventional treatments can be interesting to assess in this frails patients.

primary_purpose: Supportive Care


title: Deficits of Strength of the Rotator Muscles of the Shoulder in Children With Sequelae of Obstetric Brachial Palsy.

acronym: ROTPOPB

summary: The purpose of this retrospective work is to study the consequences of obstetrical brachial plexus paralysis on the rotator muscles of the shoulder. First of all, the investigators want to study the reproducibility of the isometric contraction forces of the rotator muscles of the shoulder thanks to an isokinetic dynamometer. The investigatorsthen want to compare the measurements obtained from the paralyzed side compared to the healthy side. The preoperative MRI performed will be studied in search of amyotrophy. These data will be compared with those of the isokinetic assessment to identify children requiring muscle transfer of reinforcement of the external rotator muscles.


title: Étude de l'Effet de la Combinaison néoprène et de l'équipement Individuel de Flottaison Sur la Fonction Respiratoire de Repos et Les capacités à l'Effort Chez Les véliplanchistes : étude WINDSURF

acronym: WINDSURF

summary: The purpose of this study is to investigate the effect of wearing both neoprene suit and life jacket on respiratory capacities at rest and cardiopulmonary capacities during exercise in windsurfers.

design_allocation: Randomized


title: Prognostic Factors in Refractory Cardiac Arrest Treated With Extracorporeal Life Support at Dijon CHU

acronym: Pro-ACR

summary:
Through this retrospective observational study (over 4 years; period analysed: 1st January 2011 to 31st December 2014), we looked for prognostic factors associated with better survival in refractory cardiac arrest by:

assessing the overall survival rate
evaluating the frequency of intra et extra-hospital events and by comparing these with the survival rate
studying no flow, low flow, rhythm at initial management, troponinemia, lactatemia and blood pH in the different groups.


title: Physiological Upper Eyelid Laxity

acronym: LAX

summary:
This is a prospective, single-center study in normal subjects aged 20 to 89 years.

The objective was to describe upper eyelid laxity by age group (20/29 years old, 30/39 years old, 40/49 years old, 50/59 years old, 60/69 years old, 70/79 years old and 80/89 years old) measured with the method of McNab and studying it according to her customary side of sleep. In addition, we evaluated a method for measuring tarsal laxity.

primary_purpose: Screening

lead_sponsor: Poitiers University Hospital


title: Companion Protocol for the ¹³C-Methacetin Breath Test Using the BreathID® MCS System for Conatus Phase 2 Study of Emricasan, an Oral Caspase Inhibitor, Under Protocol IDN-6556-14 (NCT02960204)

summary: To validate the ability of the Methacetin Breath Test (MBT) to detect clinically significant portal hypertension (CSPH)/severe portal hypertension (SPH) defined as hepatic venous pressure gradient (HVPG) ≥ 10 mmHg and HVPG ≥ 12 mmHg respectively, in patients with non-alcoholic steatohepatitis (NASH) during the course of treatment with Conatus's investigational product emricasan/placebo.

lead_sponsor: Meridian Bioscience, Inc.

sponsor_collaborators:
Meridian Bioscience, Inc.
Conatus Pharmaceuticals

intervention_type: Drug


type: Other Identifier

title: Evaluation Study of Fear of Cancer Recurrence: Detection, Measure and Risk Factors in Lymphoma Survivorship

acronym: PResEnCE

summary: Cancer survivorship has become an important aspect of oncology research due to the risk of physical and psychosocial complications. These latter concerns 50 % of patients. So, the aim of this research is to measure frequency and intensity of one of these issues: the fear of cancer recurrence (FCR) in the lymphoma survivorship beginning, at M0.

primary_purpose: Prevention

ReferenceCitation: Barboza Solis C, Kelly-Irving M, Fantin R, Darnaudery M, Torrisani J, Lang T, Delpierre C. Adverse childhood experiences and physiological wear-and-tear in midlife: Findings from the 1958 British birth cohort. Proc Natl Acad Sci U S A. 2015 Feb 17;112(7):E738-46. doi: 10.1073/pnas.1417325112. Epub 2015 Feb 2.

ReferenceCitation: Bertuccio P, Bosetti C, Malvezzi M, Levi F, Chatenoud L, Negri E, La Vecchia C. Trends in mortality from leukemia in Europe: an update to 2009 and a projection to 2012. Int J Cancer. 2013 Jan 15;132(2):427-36. doi: 10.1002/ijc.27624. Epub 2012 May 29.

ReferenceCitation: Compaci G, Rueter M, Lamy S, Oberic L, Recher C, Lapeyre-Mestre M, Laurent G, Despas F. Ambulatory Medical Assistance--After Cancer (AMA-AC): A model for an early trajectory survivorship survey of lymphoma patients treated with anthracycline-based chemotherapy. BMC Cancer. 2015 Oct 24;15:781. doi: 10.1186/s12885-015-1815-7.

ReferenceCitation: Koch L, Bertram H, Eberle A, Holleczek B, Schmid-Hopfner S, Waldmann A, Zeissig SR, Brenner H, Arndt V. Fear of recurrence in long-term breast cancer survivors-still an issue. Results on prevalence, determinants, and the association with quality of life and depression from the cancer survivorship--a multi-regional population-based study. Psychooncology. 2014 May;23(5):547-54. doi: 10.1002/pon.3452. Epub 2013 Nov 30.

ReferenceCitation: McGinty HL, Small BJ, Laronga C, Jacobsen PB. Predictors and patterns of fear of cancer recurrence in breast cancer survivors. Health Psychol. 2016 Jan;35(1):1-9. doi: 10.1037/hea0000238. Epub 2015 Jun 1.

ReferenceCitation: Mehnert A, Koch U, Sundermann C, Dinkel A. Predictors of fear of recurrence in patients one year after cancer rehabilitation: a prospective study. Acta Oncol. 2013 Aug;52(6):1102-9. doi: 10.3109/0284186X.2013.765063. Epub 2013 Feb 5.

ReferenceCitation: Simard S, Savard J, Ivers H. Fear of cancer recurrence: specific profiles and nature of intrusive thoughts. J Cancer Surviv. 2010 Dec;4(4):361-71. doi: 10.1007/s11764-010-0136-8. Epub 2010 Jul 10.

ReferenceCitation: Simard S, Thewes B, Humphris G, Dixon M, Hayden C, Mireskandari S, Ozakinci G. Fear of cancer recurrence in adult cancer survivors: a systematic review of quantitative studies. J Cancer Surviv. 2013 Sep;7(3):300-22. doi: 10.1007/s11764-013-0272-z. Epub 2013 Mar 10.

ReferenceCitation: Simard S, Savard J. Fear of Cancer Recurrence Inventory: development and initial validation of a multidimensional measure of fear of cancer recurrence. Support Care Cancer. 2009 Mar;17(3):241-51. doi: 10.1007/s00520-008-0444-y. Epub 2008 Apr 15.

ReferenceCitation: Spector DJ, Noonan D, Mayer DK, Benecha H, Zimmerman S, Smith SK. Are lifestyle behavioral factors associated with health-related quality of life in long-term survivors of non-Hodgkin lymphoma? Cancer. 2015 Sep 15;121(18):3343-51. doi: 10.1002/cncr.29490. Epub 2015 Jun 2.

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
Fondation de l'Avenir

location_facility: Institut Universitaire du Cancer de Toulouse CHU de Toulouse


title: Overall Functional Evaluation After Amputation of the Lower Limb; Locomotion, Energy Efficiency and Strategies to Adapt to the Prosthesis

acronym: PROTEOR

summary:
It appears necessary to confront the reality of the contribution of technological progress in the creation of prostheses with the specific features of lower limb amputees. These contributions must be clearly identified in their different functional dimensions. This justifies a quantitative approach to the locomotor abilities of these patients, with regard to bioenergy parameters (consumption of oxygen while walking) and motor biomechanical parameters (quantified analysis of movement), so as to measure the real impact of the proposed prosthesis technology, as a complement to classical qualitative approaches.

In this context, Dijon CHU, thanks to its Technological Investigation Platform (PIT, CIC 1432), and the company PROTEOR established a research partnership aiming to:

Refine the indications for the prescription of new products, by ensuring that they correspond to the profiles of the patients concerned and their true needs,
Study the underlying adaptive mechanisms, and establish new recommendations for their use, depending on the profiles of the users,
And ultimately, better evaluate, in a more rigorous and systematic manner, the prostheses available on the market.

The research protocol presented in this document aims to provide a framework for part of the explorations that will be conducted in the context of this partnership. Lower-limb amputees who will be evaluated in this research will wear these prostheses (foot and/or knee prostheses), which bear the CE logo, and thus present all of the safety and performance conditions required for their use by these patients (prostheses destined for usual prescriptions), the objective of the study was not to evaluate the prostheses as such, but to explore and quantify the impact of these prostheses and their eventual modifications on the locomotor abilities of the patients concerned.

The investigations will be conducted using non-invasive evaluation tools available on the PIT platform, with no modification in the usual management of these voluntary patients.

status: Recruiting

status_simplified: Ongoing


title: Impact of Daily Videoconference Updates in Neonatal Intensive Care Unit on Parental Stress of Preterm Infants : a Pilot Study

summary: The aim of the study is to test the effect of daily videoconference updates between parents of preterm newborns and health care providers which also offer them the possibility of seeing their child on the parental stress in a neonatal intensive care unit (NICU).


title: Comparison of Hematopoietic Stem Cell Activity in Adipose Tissue From Type 2 Diabetic Patients and Healthy Volunteers: Proof of Concept Study. White Adipose Tissue and Type 2 Diabetes Onset: WAT2DO

summary: Based on solid preclinical results in mice and preliminary data in humans, this study aims to provide the proof of concept of the crucial role of the hematopoietic process occurring in human adipose tissue in the initiation of the inflammatory process at the origin of insulin resistance and type 2 diabetes (T2D). The main objective is to compare the number of pro-inflammatory macrophages derived from human adipose tissue hematopoietic stem cells (HSC) according to their origin, type 2 diabetes subjects or healthy volunteers.

ReferenceCitation: Casteilla L, Planat-Benard V, Laharrague P, Cousin B. Adipose-derived stromal cells: Their identity and uses in clinical trials, an update. World J Stem Cells. 2011 Apr 26;3(4):25-33. doi: 10.4252/wjsc.v3.i4.25.

ReferenceCitation: Bour S, Caspar-Bauguil S, Iffiu-Soltesz Z, Nibbelink M, Cousin B, Miiluniemi M, Salmi M, Stolen C, Jalkanen S, Casteilla L, Penicaud L, Valet P, Carpene C. Semicarbazide-sensitive amine oxidase/vascular adhesion protein-1 deficiency reduces leukocyte infiltration into adipose tissue and favors fat deposition. Am J Pathol. 2009 Mar;174(3):1075-83. doi: 10.2353/ajpath.2009.080612. Epub 2009 Feb 13.

ReferenceCitation: Brooks-Worrell B, Narla R, Palmer JP. Biomarkers and immune-modulating therapies for type 2 diabetes. Trends Immunol. 2012 Nov;33(11):546-53. doi: 10.1016/j.it.2012.07.002. Epub 2012 Aug 14.

ReferenceCitation: Cancello R, Clement K. Is obesity an inflammatory illness? Role of low-grade inflammation and macrophage infiltration in human white adipose tissue. BJOG. 2006 Oct;113(10):1141-7. doi: 10.1111/j.1471-0528.2006.01004.x. Epub 2006 Aug 10.

ReferenceCitation: Caspar-Bauguil S, Cousin B, Bour S, Casteilla L, Penicaud L, Carpene C. Adipose tissue lymphocytes: types and roles. J Physiol Biochem. 2009 Dec;65(4):423-36. doi: 10.1007/BF03185938. Erratum In: J Physiol Biochem. 2011 Sep;67(3):497. Castiella, L [corrected to Casteilla, L].

ReferenceCitation: Cousin B, Andre M, Arnaud E, Penicaud L, Casteilla L. Reconstitution of lethally irradiated mice by cells isolated from adipose tissue. Biochem Biophys Res Commun. 2003 Feb 21;301(4):1016-22. doi: 10.1016/s0006-291x(03)00061-5.

ReferenceCitation: Dalmas E, Tordjman J, Guerre-Millo M, Clement K. [Adipose tissue, a new playground for immune cells]. Med Sci (Paris). 2011 Nov;27(11):993-9. doi: 10.1051/medsci/20112711016. Epub 2011 Nov 30. French.

ReferenceCitation: Han J, Koh YJ, Moon HR, Ryoo HG, Cho CH, Kim I, Koh GY. Adipose tissue is an extramedullary reservoir for functional hematopoietic stem and progenitor cells. Blood. 2010 Feb 4;115(5):957-64. doi: 10.1182/blood-2009-05-219923. Epub 2009 Nov 6.

ReferenceCitation: Nagareddy PR, Murphy AJ, Stirzaker RA, Hu Y, Yu S, Miller RG, Ramkhelawon B, Distel E, Westerterp M, Huang LS, Schmidt AM, Orchard TJ, Fisher EA, Tall AR, Goldberg IJ. Hyperglycemia promotes myelopoiesis and impairs the resolution of atherosclerosis. Cell Metab. 2013 May 7;17(5):695-708. doi: 10.1016/j.cmet.2013.04.001.

ReferenceCitation: Nikolajczyk BS, Jagannathan-Bogdan M, Denis GV. The outliers become a stampede as immunometabolism reaches a tipping point. Immunol Rev. 2012 Sep;249(1):253-75. doi: 10.1111/j.1600-065X.2012.01142.x.

ReferenceCitation: Poglio S, De Toni-Costes F, Arnaud E, Laharrague P, Espinosa E, Casteilla L, Cousin B. Adipose tissue as a dedicated reservoir of functional mast cell progenitors. Stem Cells. 2010 Nov;28(11):2065-72. doi: 10.1002/stem.523.

ReferenceCitation: Poglio S, De Toni F, Lewandowski D, Minot A, Arnaud E, Barroca V, Laharrague P, Casteilla L, Cousin B. In situ production of innate immune cells in murine white adipose tissue. Blood. 2012 Dec 13;120(25):4952-62. doi: 10.1182/blood-2012-01-406959. Epub 2012 Oct 15.

ReferenceCitation: Prunet-Marcassus B, Cousin B, Caton D, Andre M, Penicaud L, Casteilla L. From heterogeneity to plasticity in adipose tissues: site-specific differences. Exp Cell Res. 2006 Apr 1;312(6):727-36. doi: 10.1016/j.yexcr.2005.11.021. Epub 2005 Dec 28.

ReferenceCitation: Richardson VR, Smith KA, Carter AM. Adipose tissue inflammation: feeding the development of type 2 diabetes mellitus. Immunobiology. 2013 Dec;218(12):1497-504. doi: 10.1016/j.imbio.2013.05.002. Epub 2013 May 16.

ReferenceCitation: Shapiro H, Lutaty A, Ariel A. Macrophages, meta-inflammation, and immuno-metabolism. ScientificWorldJournal. 2011;11:2509-29. doi: 10.1100/2011/397971. Epub 2011 Dec 28.

ReferenceCitation: Spinetti G, Cordella D, Fortunato O, Sangalli E, Losa S, Gotti A, Carnelli F, Rosa F, Riboldi S, Sessa F, Avolio E, Beltrami AP, Emanueli C, Madeddu P. Global remodeling of the vascular stem cell niche in bone marrow of diabetic patients: implication of the microRNA-155/FOXO3a signaling pathway. Circ Res. 2013 Feb 1;112(3):510-22. doi: 10.1161/CIRCRESAHA.112.300598. Epub 2012 Dec 18.

ReferenceCitation: Weisberg SP, McCann D, Desai M, Rosenbaum M, Leibel RL, Ferrante AW Jr. Obesity is associated with macrophage accumulation in adipose tissue. J Clin Invest. 2003 Dec;112(12):1796-808. doi: 10.1172/JCI19246.

ReferenceCitation: Xu H, Barnes GT, Yang Q, Tan G, Yang D, Chou CJ, Sole J, Nichols A, Ross JS, Tartaglia LA, Chen H. Chronic inflammation in fat plays a crucial role in the development of obesity-related insulin resistance. J Clin Invest. 2003 Dec;112(12):1821-30. doi: 10.1172/JCI19451.

ReferenceCitation: Ito R, Takahashi T, Katano I, Ito M. Current advances in humanized mouse models. Cell Mol Immunol. 2012 May;9(3):208-14. doi: 10.1038/cmi.2012.2. Epub 2012 Feb 13.


title: Project A3sc - An Atlas of Airways at a Single Cell Level

acronym: AAAsc

summary:
The increasing incidence of chronic respiratory diseases is a public health problem affecting hundreds of thousands of people around the world, including children. Directly exposed to atmospheric aerocontaminants (pollution, allergens), the respiratory tracts represent a complex ecosystem that involves different cells that develop complex interactions with the surrounding connective tissue but also with their rich immune environment and with the microbiota. Although a pathophysiological continuum is postulated between the nasal and bronchial airways in certain diseases, such as allergic diseases, we have identified broad gradients in gene expression between nasal and bronchial samples. This is why cellular variability throughout the respiratory tree needs to be studied in detail.

The sequencing of RNAs specifically present in a particular cell, and its comparison with neighboring cells, allows us to document precise cellular contributions and intercellular relationships. Our project will establish protocols to stabilize airway swabs by brushing and/or biopsy, under conditions that will then allow the analysis of gene expression profiles at the single cell level (single cell RNA sequencing).

The development of the "single cell" stabilisation and analysis protocol will first be carried out on primary respiratory epithelium cultures and then extended to respiratory specimens taken from healthy volunteers. Through sampling at several levels of the respiratory tree, variations in expression along the tracheobronchial axis will be fully documented. Finally, the interaction between the epithelial compartment and the immunological compartment will be studied by analyzing gene expression on a single cell in different physiopathological contexts.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: COMPARISON OF MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE AND CONVENTIONAL OPHTHALMOLOGICAL CONSULTATION

acronym: TELERETINODIAB

summary: The aim of this study is to evaluate the monitoring of moderate diabetic retinopathy by tele-expertise

ReferenceCitation: Schulze-Dobold C, Erginay A, Robert N, Chabouis A, Massin P. Ophdiat((R)): five-year experience of a telemedical screening programme for diabetic retinopathy in Paris and the surrounding area. Diabetes Metab. 2012 Nov;38(5):450-7. doi: 10.1016/j.diabet.2012.05.003. Epub 2012 Jul 4.

ReferenceCitation: Chabouis A, Berdugo M, Meas T, Erginay A, Laloi-Michelin M, Jouis V, Guillausseau PJ, M'bemba J, Chaine G, Slama G, Cohen R, Reach G, Marre M, Chanson P, Vicaut E, Massin P. Benefits of Ophdiat, a telemedical network to screen for diabetic retinopathy: a retrospective study in five reference hospital centres. Diabetes Metab. 2009 Jun;35(3):228-32. doi: 10.1016/j.diabet.2008.12.001. Epub 2009 Apr 5.

ReferenceCitation: Erginay A, Chabouis A, Viens-Bitker C, Robert N, Lecleire-Collet A, Massin P. OPHDIAT: quality-assurance programme plan and performance of the network. Diabetes Metab. 2008 Jun;34(3):235-42. doi: 10.1016/j.diabet.2008.01.004.

lead_sponsor: Centre Hospitalier Sud Francilien

appel_a_projets: PREPS

region: Île-de-France

nom_etablissement: CENTRE HOSPITALIER SUD FRANCILIEN

type_etablissement: CH

acronyme: TELERETINODIAB

titre: Comparaison du suivi des rétinopathies diabétiques modérées par télé expertise et par consultation ophtalmologique conventionnelle.

discipline_principale: endocrinologie / diabétologie / métabolisme et nutrition

nom_porteur: PENFORNIS

prenom_porteur: Alfred


title: Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump. The CLOSE Study

acronym: CLOSE

summary: This study aims at describing the glucose level by automated glucose sensors and correlating it with insulin delivery and meals over 14 days in insulin-requiring T2D patients living in real-life conditions.

lead_sponsor: Air Liquide Santé International

location_facility: CHU de Caen, Service Endocrinologie, Diabétologie


title: Identification de Nouveaux Marqueurs Pronostiques Des Cancers du Sein

acronym: PROBREAST

summary: Candidate markers have been identified thanks to an original approach developed by our research team aiming at detecting ectopic gene expression using public pan-genomic breast cancer data. The same approach had already been used and validated in lung tumors, leukemias and lymphomas. The main objective of the present research is to use tumor samples from patients in a retrospective and prospective cohort to test and validate the relevance of these prognostic markers in breast cancer.

ReferenceCitation: Wang J, Mi JQ, Debernardi A, Vitte AL, Emadali A, Meyer JA, Charmpi K, Ycart B, Callanan MB, Carroll WL, Khochbin S, Rousseaux S. A six gene expression signature defines aggressive subtypes and predicts outcome in childhood and adult acute lymphoblastic leukemia. Oncotarget. 2015 Jun 30;6(18):16527-42. doi: 10.18632/oncotarget.4113.

ReferenceCitation: Le Bescont A, Vitte AL, Debernardi A, Curtet S, Buchou T, Vayr J, de Reynies A, Ito A, Guardiola P, Brambilla C, Yoshida M, Brambilla E, Rousseaux S, Khochbin S. Receptor-Independent Ectopic Activity of Prolactin Predicts Aggressive Lung Tumors and Indicates HDACi-Based Therapeutic Strategies. Antioxid Redox Signal. 2015 Jul 1;23(1):1-14. doi: 10.1089/ars.2013.5581. Epub 2014 Mar 6.

ReferenceCitation: Emadali A, Rousseaux S, Bruder-Costa J, Rome C, Duley S, Hamaidia S, Betton P, Debernardi A, Leroux D, Bernay B, Kieffer-Jaquinod S, Combes F, Ferri E, McKenna CE, Petosa C, Bruley C, Garin J, Ferro M, Gressin R, Callanan MB, Khochbin S. Identification of a novel BET bromodomain inhibitor-sensitive, gene regulatory circuit that controls Rituximab response and tumour growth in aggressive lymphoid cancers. EMBO Mol Med. 2013 Aug;5(8):1180-95. doi: 10.1002/emmm.201202034. Epub 2013 Jul 4.

ReferenceCitation: Rousseaux S, Debernardi A, Jacquiau B, Vitte AL, Vesin A, Nagy-Mignotte H, Moro-Sibilot D, Brichon PY, Lantuejoul S, Hainaut P, Laffaire J, de Reynies A, Beer DG, Timsit JF, Brambilla C, Brambilla E, Khochbin S. Ectopic activation of germline and placental genes identifies aggressive metastasis-prone lung cancers. Sci Transl Med. 2013 May 22;5(186):186ra66. doi: 10.1126/scitranslmed.3005723.

ReferenceCitation: Reynoird N, Schwartz BE, Delvecchio M, Sadoul K, Meyers D, Mukherjee C, Caron C, Kimura H, Rousseaux S, Cole PA, Panne D, French CA, Khochbin S. Oncogenesis by sequestration of CBP/p300 in transcriptionally inactive hyperacetylated chromatin domains. EMBO J. 2010 Sep 1;29(17):2943-52. doi: 10.1038/emboj.2010.176. Epub 2010 Jul 30.


title: Identification of Biomarkers of Attention Deficit Disorder With or Without Hyperactivity (ADHD) by a Metabolomic Approach in Children

acronym: METHADA

summary: Attention-deficit with or without hyperactivity disorder (ADHD) is a real health public concern. No easy-use diagnosis tool are available. Metabolomic approaches has brought very usefull data in others neurological diseases like amyotrophic lateral sclerosis or autism spectrum disorder, as we had shown in previous studies. Targeting on neurotransmitter pathways involving in ADHD, metabolomic screening could help to enhance our diagnosis power to better help numerus of children. We propose to study the phenylalanine and the tyrosine pathways with a multimodal metabolomic approach, in easy-available biological fluid (blood and urine), in child or adolescent suspected of ADHD. Our objectives are: 1- to determine a specific metabolomic signature of ADHD 2- to compare the diagnostic value of this metabolomic signature with the reference methodology for ADHD diagnosis, as now practiced in our reference center for learning troubles.

lead_sponsor: University Hospital, Tours


title: Effect of Neflamapimod (VX-745) on Brain Inflammation Using Positron Emission Tomography (PET) Scan in Alzheimer's Disease (AD) Patients

acronym: VIP

summary:
For this project, neflamapimod and placebo will be provided free of charge by the EIP company (www.eippharma.com). Neflamapimod is currently tested in 2 clinical trials in AD, one in Europe (The Netherlands) and one in the USA (clinical trials.gov/VX-745). The company commenced in May 2015 dosing in two phase 2a clinical studies in patients with Early AD: one in the Netherlands that is focused on PET amyloid imaging as the primary biomarker of drug effect, and one in the US (California) that is focused on Cerebrospinal fluid (CSF) evaluation to determine CSF drug concentrations and effects on inflammatory markers and disease biomarkers. Pharmacokinetic evaluation in these patients has demonstrated blood drug concentration levels in the predicted therapeutic range; and importantly, the data from the US study demonstrate that the drug achieves target drug concentrations in CSF, thus confirming the drug robustly enters the brain in humans.

The present project offers us a unique chance to test this promising drug in AD patients. The aim of the study is to focus on PET neuroinflammation imaging as the primary biomarker of this drug effect. The chosen biomarker for imaging neuroinflammation in patients is [1 8F]-DPA714.

primary_purpose: Treatment

ReferenceCitation: Tormahlen NM, Martorelli M, Kuhn A, Maier F, Guezguez J, Burnet M, Albrecht W, Laufer SA, Koch P. Design and Synthesis of Highly Selective Brain Penetrant p38alpha Mitogen-Activated Protein Kinase Inhibitors. J Med Chem. 2022 Jan 27;65(2):1225-1242. doi: 10.1021/acs.jmedchem.0c01773. Epub 2021 May 11.

publisher_dissemination: American Chemical Society

sponsor_collaborators:
University Hospital, Toulouse
Fondation Plan Alzheimer


title: Influence of Pancreatic Adenocarcinoma Excision Surgery on Peripheral and Portal Circulating Tumor DNA: Prospective Exploratory Pilot Study.

acronym: ICAPAC

summary: Pancreatic cancer represents the fourth cause of death by cancer in western countries. The only curative treatment is surgery but this one is possible only in 10 to 15 % of cases. To date, there are few biomarkers in circulating blood as prognostic or diagnostic markers in pancreatic cancer. The purpose of this study is to determine if the pancreatic tumor mobilization during its resection impacts the quantity of circulating tumor DNA in peripheral and portal blood.


title: Impact of Hyperoxemia on Incidence of Ventilator-associated Pneumonia

acronym: SOH-VAP

summary:
The aim of this prospective cohort single-center observational study is to determine the impact of hyperoxemia on ventilator-associated pneumonia (VAP) occurrence.

SpO2 will be continuously recorded in order to determine the percentage of time spent with hyperoxemia.
Patients with VAP will be prospectively identified.
Patient characteristics and risk factors for VAP will be prospectively collected.
Oxidant stress will be prospectively investigated in study patients: glutathion peroxidase (GPX), plasmatic superoxyde dismutase (SOD), total plasmatic antioxidant status (SAT) and urinary 8-isoprostanes will be performed at ICU admission, once a week, and at VAP occurrence.

Patients with VAP will be compared with those with no VAP

lead_sponsor: University Hospital, Lille


title: Pilot Evaluation of PCR Multiplex Tests for a Rapid Diagnosis of Bone Infections in Diabetic Foot

acronym: RAPDIAGOS

summary: Bone samples from infected diabetic feet will be collected and tests will be performed for the diagnosis of causative bacteria. Samples will be processed by PCR multiplex tests and usual cultures for identification of causative bacteria and sensitivity to antibiotics. Results obtained by the two methods will be compared in terms of quickness and similarity of germ identification. Usual care strategy will not be modified since results of PCR multiplex tests will not be transmitted to the physicians before the results of usual cultures.

lead_sponsor: University Hospital, Montpellier


title: Observational Prospective Comparative Study Before and After Spinal Surgery for Scoliosis With Pelvic Fixation in Patients

acronym: FBPM

summary: The purpose of this study is to determine the effect of double end spinal instrumentation from the upper thoracic to the pelvis with sacro-iliac ﬁxation on the gait of ambulating patients with pelvic obliquity 6 month after surgery.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Comparison of the Duration of Motor Block After Spinal Anesthesia for Planned Cesarean Sections: Hyperbaric Prilocaïne Versus Hyperbaric Bupivacaine

acronym: Césarcaïne

summary: The planned cesarean section is an intervention with a standard operating time of less than 40 minutes in trained teams. Hyperbaric Bupivacaine is the local anesthetic (LA) reference for these operations. But the duration of its motor block is generally greater than 3 hours. The purpose of this study is to show a reduction in motor block time with hyperbaric Prilocaine by at least 30 minutes, which would allow mothers and their children to return to the maternity ward earlier and thus improve the circulation of patients within the maternity's PACU.

ReferenceCitation: Chapron K, Sleth JC, Capdevila X, Bringuier S, Dadure C. Hyperbaric prilocaine vs. hyperbaric bupivacaine for spinal anaesthesia in women undergoing elective caesarean section: a comparative randomised double-blind study. Anaesthesia. 2021 Jun;76(6):777-784. doi: 10.1111/anae.15342. Epub 2021 Jan 11.

sponsor_collaborators:
University Hospital, Montpellier
Hopital Saint Roch


title: Study of the Links Between Perception of Temporal Order Judgment and Causality in Schizophrenic Spectrum Disorders

acronym: TOCAS

summary: People with schizophrenia show disturbances in the perception of time. Among these alterations are the perturbations of the temporal order judgment. They are characterized by the fact that, as opposed to the general population, people with schizophrenia require a longer time interval between two successive stimuli to estimate which of the two events appeared first. If these alterations are now well documented, their consequences remain little explored. Among these consequences could however appear distortions of the judgment of causality (likely to underlie certain delusional interpretations) as well as a distressing experience of loss of the continuity of the lived experience (that could contribute to the alterations basic of self-awareness).

lead_sponsor: Hôpital le Vinatier


title: Comparison in Confocal Microscopy and Optical Coherence Tomography of Postoperative Morphological Changes of Keratoconus Treated by Cross-linking of Collagen in Accelerated Procedure and in Iontophoresis Procedure

acronym: CLACICONE

summary: A monocentric, parallel-arm, prospective, randomized therapeutic trial that compares the efficacy of two curative keratoconus treatment techniques by cross-linking collagen (accelerated conventional technique or iontophoresis). The primary endpoint will be the depth of the demarcation line measured by confocal microscopy and OCT at 1 month. This line represents the limit depth between treated and untreated stroma.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Prospective, Randomized Study Aiming to Assess the Benefit of Autohypnosis Learning in the Care of Patients Treated by Adjuvant Chemotherapy for Colorectal or Breast Cancer.

summary:
Therapeutical hypnosis is proven to be an effective medical support to chemotherapy: it was shown that it can reduce the pain, anxiety, fatigue felt by the patient.

Yet, hypnosis requires the presence of an hypnotherapist, which is why auto-hypnosis could be an efficient alternative to handle the side effects of chemotherapy.

In this study, colorectal cancer and breast cancer patients are either taught auto-hypnosis or are taken in standard care for their chemotherapy.

The life quality score (QLQC30) assessed during and after chemotherapies will determine if auto-hypnosis is a good medical support in chemotherapies' adverse effects management.

The proven benefices of auto-hypnosis in the handling of the side effects of chemotherapies could improve the quality of life of cancer affected patients.

ReferenceCitation: Faivre J, Grosclaude P, Launoy G, Arveux P, Raverdy N, Menegoz F, Pienkowski P, Schaffer P, Daures JP, De Vathaire F. [Digestive cancers in France. Geographic distribution and estimation of national incidence]. Gastroenterol Clin Biol. 1997;21(3):174-80. French.

ReferenceCitation: Edge SB, Compton CC. The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual and the future of TNM. Ann Surg Oncol. 2010 Jun;17(6):1471-4. doi: 10.1245/s10434-010-0985-4.

ReferenceCitation: Gunderson LL, Jessup JM, Sargent DJ, Greene FL, Stewart AK. Revised TN categorization for colon cancer based on national survival outcomes data. J Clin Oncol. 2010 Jan 10;28(2):264-71. doi: 10.1200/JCO.2009.24.0952. Epub 2009 Nov 30.

ReferenceCitation: Sargent DJ, Marsoni S, Monges G, Thibodeau SN, Labianca R, Hamilton SR, French AJ, Kabat B, Foster NR, Torri V, Ribic C, Grothey A, Moore M, Zaniboni A, Seitz JF, Sinicrope F, Gallinger S. Defective mismatch repair as a predictive marker for lack of efficacy of fluorouracil-based adjuvant therapy in colon cancer. J Clin Oncol. 2010 Jul 10;28(20):3219-26. doi: 10.1200/JCO.2009.27.1825. Epub 2010 May 24. Erratum In: J Clin Oncol. 2010 Oct 20;28(30):4664.

ReferenceCitation: Moertel CG, Fleming TR, Macdonald JS, Haller DG, Laurie JA, Goodman PJ, Ungerleider JS, Emerson WA, Tormey DC, Glick JH, et al. Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma. N Engl J Med. 1990 Feb 8;322(6):352-8. doi: 10.1056/NEJM199002083220602.

ReferenceCitation: Zaniboni A, Labianca R, Marsoni S, Torri V, Mosconi P, Grilli R, Apolone G, Cifani S, Tinazzi A. GIVIO-SITAC 01: A randomized trial of adjuvant 5-fluorouracil and folinic acid administered to patients with colon carcinoma--long term results and evaluation of the indicators of health-related quality of life. Gruppo Italiano Valutazione Interventi in Oncologia. Studio Italiano Terapia Adiuvante Colon. Cancer. 1998 Jun 1;82(11):2135-44. doi: 10.1002/(sici)1097-0142(19980601)82:113.0.co;2-u.

ReferenceCitation: Efficacy of adjuvant fluorouracil and folinic acid in colon cancer. International Multicentre Pooled Analysis of Colon Cancer Trials (IMPACT) investigators. Lancet. 1995 Apr 15;345(8955):939-44.

ReferenceCitation: Haller DG, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Gilberg F, Rittweger K, Schmoll HJ. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol. 2011 Apr 10;29(11):1465-71. doi: 10.1200/JCO.2010.33.6297. Epub 2011 Mar 7.

ReferenceCitation: Schmoll HJ, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Hoersch S, Rittweger K, Haller DG. Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer: Final Results of the NO16968 Randomized Controlled Phase III Trial. J Clin Oncol. 2015 Nov 10;33(32):3733-40. doi: 10.1200/JCO.2015.60.9107. Epub 2015 Aug 31.

oa_host_type: publisher

evidence: open (via free pdf)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Andre T, Boni C, Navarro M, Tabernero J, Hickish T, Topham C, Bonetti A, Clingan P, Bridgewater J, Rivera F, de Gramont A. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol. 2009 Jul 1;27(19):3109-16. doi: 10.1200/JCO.2008.20.6771. Epub 2009 May 18.

ReferenceCitation: Schmoll HJ, Twelves C, Sun W, O'Connell MJ, Cartwright T, McKenna E, Saif M, Lee S, Yothers G, Haller D. Effect of adjuvant capecitabine or fluorouracil, with or without oxaliplatin, on survival outcomes in stage III colon cancer and the effect of oxaliplatin on post-relapse survival: a pooled analysis of individual patient data from four randomised controlled trials. Lancet Oncol. 2014 Dec;15(13):1481-1492. doi: 10.1016/S1470-2045(14)70486-3. Epub 2014 Nov 12.

ReferenceCitation: Association of Breast Surgery at Baso 2009. Surgical guidelines for the management of breast cancer. Eur J Surg Oncol. 2009;35 Suppl 1:1-22. doi: 10.1016/j.ejso.2009.01.008. Epub 2009 Mar 18. No abstract available.

ReferenceCitation: Hammond ME. ASCO-CAP guidelines for breast predictive factor testing: an update. Appl Immunohistochem Mol Morphol. 2011 Dec;19(6):499-500. doi: 10.1097/PAI.0b013e31822a8eac.

ReferenceCitation: Harbeck N, Sotlar K, Wuerstlein R, Doisneau-Sixou S. Molecular and protein markers for clinical decision making in breast cancer: today and tomorrow. Cancer Treat Rev. 2014 Apr;40(3):434-44. doi: 10.1016/j.ctrv.2013.09.014. Epub 2013 Sep 29.

ReferenceCitation: Wazir U, Mokbel K. Emerging gene-based prognostic tools in early breast cancer: First steps to personalised medicine. World J Clin Oncol. 2014 Dec 10;5(5):795-9. doi: 10.5306/wjco.v5.i5.795.

ReferenceCitation: Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Peto R, Davies C, Godwin J, Gray R, Pan HC, Clarke M, Cutter D, Darby S, McGale P, Taylor C, Wang YC, Bergh J, Di Leo A, Albain K, Swain S, Piccart M, Pritchard K. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet. 2012 Feb 4;379(9814):432-44. doi: 10.1016/S0140-6736(11)61625-5. Epub 2011 Dec 5.

ReferenceCitation: Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0.

ReferenceCitation: Senkus E, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rutgers E, Zackrisson S, Cardoso F; ESMO Guidelines Committee. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015 Sep;26 Suppl 5:v8-30. doi: 10.1093/annonc/mdv298. No abstract available.

ReferenceCitation: Gianni L, Dafni U, Gelber RD, Azambuja E, Muehlbauer S, Goldhirsch A, Untch M, Smith I, Baselga J, Jackisch C, Cameron D, Mano M, Pedrini JL, Veronesi A, Mendiola C, Pluzanska A, Semiglazov V, Vrdoljak E, Eckart MJ, Shen Z, Skiadopoulos G, Procter M, Pritchard KI, Piccart-Gebhart MJ, Bell R; Herceptin Adjuvant (HERA) Trial Study Team. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol. 2011 Mar;12(3):236-44. doi: 10.1016/S1470-2045(11)70033-X. Epub 2011 Feb 25.

ReferenceCitation: Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, Mackey J, Glaspy J, Chan A, Pawlicki M, Pinter T, Valero V, Liu MC, Sauter G, von Minckwitz G, Visco F, Bee V, Buyse M, Bendahmane B, Tabah-Fisch I, Lindsay MA, Riva A, Crown J; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011 Oct 6;365(14):1273-83. doi: 10.1056/NEJMoa0910383.

ReferenceCitation: Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, de Azambuja E, Procter M, Suter TM, Jackisch C, Cameron D, Weber HA, Heinzmann D, Dal Lago L, McFadden E, Dowsett M, Untch M, Gianni L, Bell R, Kohne CH, Vindevoghel A, Andersson M, Brunt AM, Otero-Reyes D, Song S, Smith I, Leyland-Jones B, Baselga J; Herceptin Adjuvant (HERA) Trial Study Team. 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial. Lancet. 2013 Sep 21;382(9897):1021-8. doi: 10.1016/S0140-6736(13)61094-6. Epub 2013 Jul 18.

ReferenceCitation: Pivot X, Romieu G, Debled M, Pierga JY, Kerbrat P, Bachelot T, Lortholary A, Espie M, Fumoleau P, Serin D, Jacquin JP, Jouannaud C, Rios M, Abadie-Lacourtoisie S, Tubiana-Mathieu N, Cany L, Catala S, Khayat D, Pauporte I, Kramar A; PHARE trial investigators. 6 months versus 12 months of adjuvant trastuzumab for patients with HER2-positive early breast cancer (PHARE): a randomised phase 3 trial. Lancet Oncol. 2013 Jul;14(8):741-8. doi: 10.1016/S1470-2045(13)70225-0. Epub 2013 Jun 11.

ReferenceCitation: Rodary C, Leplege A, Hill C. [Evaluation of the quality of life in clinical research in cancerology]. Bull Cancer. 1998 Feb;85(2):140-8. French.

ReferenceCitation: Osoba D. What has been learned from measuring health-related quality of life in clinical oncology. Eur J Cancer. 1999 Oct;35(11):1565-70. doi: 10.1016/s0959-8049(99)00192-6.

ReferenceCitation: de Haes J, Curran D, Young T, Bottomley A, Flechtner H, Aaronson N, Blazeby J, Bjordal K, Brandberg Y, Greimel E, Maher J, Sprangers M, Cull A. Quality of life evaluation in oncological clinical trials - the EORTC model. The EORTC Quality of Life Study Group. Eur J Cancer. 2000 May;36(7):821-5. doi: 10.1016/s0959-8049(00)00007-1.

ReferenceCitation: Moinpour CM. Do quality of life assessments make a difference in the evaluation of cancer treatments? Control Clin Trials. 1997 Aug;18(4):311-7. doi: 10.1016/s0197-2456(97)00054-8.

ReferenceCitation: Trask PC, Hsu MA, McQuellon R. Other paradigms: health-related quality of life as a measure in cancer treatment: its importance and relevance. Cancer J. 2009 Sep-Oct;15(5):435-40. doi: 10.1097/PPO.0b013e3181b9c5b9.

ReferenceCitation: Johnson JR, Temple R. Food and Drug Administration requirements for approval of new anticancer drugs. Cancer Treat Rep. 1985 Oct;69(10):1155-9.

ReferenceCitation: Gotay CC, Kawamoto CT, Bottomley A, Efficace F. The prognostic significance of patient-reported outcomes in cancer clinical trials. J Clin Oncol. 2008 Mar 10;26(8):1355-63. doi: 10.1200/JCO.2007.13.3439. Epub 2008 Jan 28.

ReferenceCitation: Osoba D. Translating the science of patient-reported outcomes assessment into clinical practice. J Natl Cancer Inst Monogr. 2007;(37):5-11. doi: 10.1093/jncimonographs/lgm002.

ReferenceCitation: Montazeri A. Quality of life data as prognostic indicators of survival in cancer patients: an overview of the literature from 1982 to 2008. Health Qual Life Outcomes. 2009 Dec 23;7:102. doi: 10.1186/1477-7525-7-102.

ReferenceCitation: Quinten C, Coens C, Mauer M, Comte S, Sprangers MA, Cleeland C, Osoba D, Bjordal K, Bottomley A; EORTC Clinical Groups. Baseline quality of life as a prognostic indicator of survival: a meta-analysis of individual patient data from EORTC clinical trials. Lancet Oncol. 2009 Sep;10(9):865-71. doi: 10.1016/S1470-2045(09)70200-1. Epub 2009 Aug 18.

ReferenceCitation: Braun DP, Gupta D, Grutsch JF, Staren ED. Can changes in health related quality of life scores predict survival in stages III and IV colorectal cancer? Health Qual Life Outcomes. 2011 Aug 3;9:62. doi: 10.1186/1477-7525-9-62.

ReferenceCitation: Earlam S, Glover C, Fordy C, Burke D, Allen-Mersh TG. Relation between tumor size, quality of life, and survival in patients with colorectal liver metastases. J Clin Oncol. 1996 Jan;14(1):171-5. doi: 10.1200/JCO.1996.14.1.171.

ReferenceCitation: Lis CG, Gupta D, Granick J, Grutsch JF. Can patient satisfaction with quality of life predict survival in advanced colorectal cancer? Support Care Cancer. 2006 Nov;14(11):1104-10. doi: 10.1007/s00520-006-0100-3. Epub 2006 Jul 4.

ReferenceCitation: McKernan M, McMillan DC, Anderson JR, Angerson WJ, Stuart RC. The relationship between quality of life (EORTC QLQ-C30) and survival in patients with gastro-oesophageal cancer. Br J Cancer. 2008 Mar 11;98(5):888-93. doi: 10.1038/sj.bjc.6604248. Epub 2008 Feb 12.

ReferenceCitation: Efficace F, Bottomley A, Coens C, Van Steen K, Conroy T, Schoffski P, Schmoll H, Van Cutsem E, Kohne CH. Does a patient's self-reported health-related quality of life predict survival beyond key biomedical data in advanced colorectal cancer? Eur J Cancer. 2006 Jan;42(1):42-9. doi: 10.1016/j.ejca.2005.07.025. Epub 2005 Nov 18. Erratum In: Eur J Cancer. 2007 Feb;43(3):633.

ReferenceCitation: Grande GE, Farquhar MC, Barclay SI, Todd CJ. Quality of life measures (EORTC QLQ-C30 and SF-36) as predictors of survival in palliative colorectal and lung cancer patients. Palliat Support Care. 2009 Sep;7(3):289-97. doi: 10.1017/S1478951509990216. Erratum In: Palliat Support Care. 2009 Dec;7(4):533.

ReferenceCitation: Maisey NR, Norman A, Watson M, Allen MJ, Hill ME, Cunningham D. Baseline quality of life predicts survival in patients with advanced colorectal cancer. Eur J Cancer. 2002 Jul;38(10):1351-7. doi: 10.1016/s0959-8049(02)00098-9.

ReferenceCitation: Montgomery GH, Schnur JB, Kravits K. Hypnosis for cancer care: over 200 years young. CA Cancer J Clin. 2013 Jan;63(1):31-44. doi: 10.3322/caac.21165. Epub 2012 Nov 20.

ReferenceCitation: Lang EV, Berbaum KS, Faintuch S, Hatsiopoulou O, Halsey N, Li X, Berbaum ML, Laser E, Baum J. Adjunctive self-hypnotic relaxation for outpatient medical procedures: a prospective randomized trial with women undergoing large core breast biopsy. Pain. 2006 Dec 15;126(1-3):155-64. doi: 10.1016/j.pain.2006.06.035. Epub 2006 Sep 7.

ReferenceCitation: Montgomery GH, Weltz CR, Seltz M, Bovbjerg DH. Brief presurgery hypnosis reduces distress and pain in excisional breast biopsy patients. Int J Clin Exp Hypn. 2002 Jan;50(1):17-32. doi: 10.1080/00207140208410088.

ReferenceCitation: Schnur JB, Bovbjerg DH, David D, Tatrow K, Goldfarb AB, Silverstein JH, Weltz CR, Montgomery GH. Hypnosis decreases presurgical distress in excisional breast biopsy patients. Anesth Analg. 2008 Feb;106(2):440-4, table of contents. doi: 10.1213/ane.0b013e31815edb13.

ReferenceCitation: Liossi C, White P, Hatira P. A randomized clinical trial of a brief hypnosis intervention to control venepuncture-related pain of paediatric cancer patients. Pain. 2009 Apr;142(3):255-263. doi: 10.1016/j.pain.2009.01.017. Epub 2009 Feb 23.

ReferenceCitation: Montgomery GH, Bovbjerg DH, Schnur JB, David D, Goldfarb A, Weltz CR, Schechter C, Graff-Zivin J, Tatrow K, Price DD, Silverstein JH. A randomized clinical trial of a brief hypnosis intervention to control side effects in breast surgery patients. J Natl Cancer Inst. 2007 Sep 5;99(17):1304-12. doi: 10.1093/jnci/djm106. Epub 2007 Aug 28.

ReferenceCitation: Kamen C, Tejani MA, Chandwani K, Janelsins M, Peoples AR, Roscoe JA, Morrow GR. Anticipatory nausea and vomiting due to chemotherapy. Eur J Pharmacol. 2014 Jan 5;722:172-9. doi: 10.1016/j.ejphar.2013.09.071. Epub 2013 Oct 21.

ReferenceCitation: Redd WH, Montgomery GH, DuHamel KN. Behavioral intervention for cancer treatment side effects. J Natl Cancer Inst. 2001 Jun 6;93(11):810-23. doi: 10.1093/jnci/93.11.810.

ReferenceCitation: Montgomery GH, David D, Kangas M, Green S, Sucala M, Bovbjerg DH, Hallquist MN, Schnur JB. Randomized controlled trial of a cognitive-behavioral therapy plus hypnosis intervention to control fatigue in patients undergoing radiotherapy for breast cancer. J Clin Oncol. 2014 Feb 20;32(6):557-63. doi: 10.1200/JCO.2013.49.3437. Epub 2014 Jan 13.

ReferenceCitation: Montgomery GH, Kangas M, David D, Hallquist MN, Green S, Bovbjerg DH, Schnur JB. Fatigue during breast cancer radiotherapy: an initial randomized study of cognitive-behavioral therapy plus hypnosis. Health Psychol. 2009 May;28(3):317-22. doi: 10.1037/a0013582.

ReferenceCitation: Gregoire C, Bragard I, Jerusalem G, Etienne AM, Coucke P, Dupuis G, Lanctot D, Faymonville ME. Group interventions to reduce emotional distress and fatigue in breast cancer patients: a 9-month follow-up pragmatic trial. Br J Cancer. 2017 Nov 7;117(10):1442-1449. doi: 10.1038/bjc.2017.326. Epub 2017 Sep 19.

ReferenceCitation: Bedard G, Zeng L, Zhang L, Lauzon N, Holden L, Tsao M, Danjoux C, Barnes E, Sahgal A, Poon M, Chow E. Minimal important differences in the EORTC QLQ-C30 in patients with advanced cancer. Asia Pac J Clin Oncol. 2014 Jun;10(2):109-17. doi: 10.1111/ajco.12070. Epub 2013 Apr 1.

ReferenceCitation: Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998 Jan;16(1):139-44. doi: 10.1200/JCO.1998.16.1.139.

ReferenceCitation: Zelen M. Randomized consent designs for clinical trials: an update. Stat Med. 1990 Jun;9(6):645-56. doi: 10.1002/sim.4780090611.

lead_sponsor: Groupe Hospitalier Mutualiste de Grenoble

collaborators:
TIMC-IMAG
AG2R La Mondiale
GEFLUC
Espoir Isère Cancer

location_facility: Groupe hospitalier Mutualiste de Grenoble


title: Impact of a Nocturnal Pressure Controlled Ventilation on Mechanical Ventilation Weaning Duration in Patients With Chronic Obstructive Respiratory Diseases REVENTIL 2

acronym: REVENTIL 2

summary:
The weaning of mechanical ventilation is difficult period. This period is particularly difficult for patient with obstructive chronic respiratory disease and a long mechanical ventilation is associated with an increased risk of infectious complication, cardiac dysfunction, muscular weakness or barotromatism. No guideline is available on the ventilator mode to use during the night. In weaning period, some studies have demonstrated that nocturnal control ventilation during the weaning period improved the quality and the quantity of sleep. The hypothesis is that use of nocturnal controlled mechanical ventilation could decrease the weaning period duration and the ventilation weaning failure because of a sleep improvement.

The main objective is to compare mechanical ventilation weaning period duration according to the nocturnal ventilator mode (pressure controlled ventilation versus pressure support ventilation) in patients with an obstructive respiratory disease. A secondary objective is to evaluate the rate of weaning failure after the first extubation according to the nocturnal ventilator mode and to evaluate the sleep during the weaning period according to the nocturnal ventilator mode.

status: Withdrawn

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Decrease in Sympathetic Tone in OSA Patients: Is CPAP More Effective Than APAP ?

acronym: APAP-CPAP

summary: The present study aims to compare muscle sympathetic neural activity by microneurography after one month treatment of fixed versus auto-adjusting CPAP treatment and its impact on arterial blood pressure

ReferenceCitation: Pepin JL, Tamisier R, Baguet JP, Lepaulle B, Arbib F, Arnol N, Timsit JF, Levy P. Fixed-pressure CPAP versus auto-adjusting CPAP: comparison of efficacy on blood pressure in obstructive sleep apnoea, a randomised clinical trial. Thorax. 2016 Aug;71(8):726-33. doi: 10.1136/thoraxjnl-2015-207700. Epub 2016 Apr 18.

publisher_dissemination: British Medical Journal

ReferenceCitation: Treptow E, Pepin JL, Bailly S, Levy P, Bosc C, Destors M, Woehrle H, Tamisier R. Reduction in sympathetic tone in patients with obstructive sleep apnoea: is fixed CPAP more effective than APAP? A randomised, parallel trial protocol. BMJ Open. 2019 Apr 4;9(4):e024253. doi: 10.1136/bmjopen-2018-024253.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

lead_sponsor: University Hospital, Grenoble

collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.


title: Small and Steatotic Hepatocellular Carcinoma : a Distinctive Radiological Variant With Improved Outcome After Percutenous Ablation

summary:
Percutaneous thermoablation in an effective local curative treatment in patients with cirrhosis and HCC smaller than 3 cm in diameter (BCLC 0-A).

Around 30% of HCC patients referred for percutaneous ablation were regarded as non-feasible because of a difficult-at risk location or undetectable nodules.

We used percutaneous thermoablation to treat HCC on high risk locations (subcapsular or liver dome) with or without lipiodol marked (for undetectable HCC).

No clinical study has been published so far to compare percutaneous thermoablation of HCC on liver dome CT guided with artificial pneumothorax and lipiodol marked, and percutaneous thermoablation of HCC guided by ultrasonography (non subcapsular, distent form diaphragm).

This retrospective study evaluate the overall survival, the local tumor progression or distant liver progression after percutaneous ablation for HCC and determine prognostic factors.


title: Peripheral Intravenous Cannulation in Children With Difficult Vein Access : Randomized Study Comparing Accuvein®400 Versus Standard Care

acronym: AVEn

summary:
Peripheral intravenous cannulation is one of the most common procedures performed in children admitted to hospital. It is a painful and anxiety-provoking gesture for children with possible memorization of the pain even more present for patients with chronic pathology. Nevertheless, this care is essential to administer the treatments.

The cannulation is usually set up by the observation and touching of the veins by the nurse. However, this technique is often insufficient in young children and especially infants because they have a higher thickness adipose tissue. Their veins are of small caliber, hardly visible and palpable which increases the probability of a failure of the insertion of the catheter at the first attempt.

In the literature, different techniques are mentioned to promote the visualization of veins and thus the insertion of cannulation. The AccuVein®400 (AV400) system uses an infrared laser beam to project the image of superficial veins to the skin. In adults, AV400 has been shown to improve the success rate of insertion cannulation when venous capital is precarious. The question now arises as to whether this tool could be of interest to children who are particularly difficult to assist cannulation, especially the youngest of them.

Investigator hypothesize that AV400 could bring a benefit to the placement of cannulation, in the child with a venous capital difficult to catheterize and thus increase the success of the cannulation at the first attempt.


type: Registry Identifier

title: Contribution of a Virtual Reality Program in the Treatment of Dysmorphophobia for Adolescent Female With Anorexia Nervosa

acronym: TERV-TCA

summary:
Anorexia nervosa is an eating disorder that begins frequently in adolescence between the ages of 13 and 19, which affects girls with a sex ratio of 10:1, and the prevalence for females varies from 0,3% to 0,9%.

The current therapeutic arsenal has a limited success in the treatment of anorexia nervosa with a long-term mortality rate and a 12-month relapse rate of up to 10% and 40%, respectively.

One of the most difficult symptoms to treat is a body dysmorphic disorder, also called dysmorphophobia, the persistence of this symptom is a major negative prognostic factor.

The main treatment of dysmorphophobia is currently cognitive behavioral therapy (CBT). In most protocols, the technique of progressive exposure face to the mirror is used with low efficiency. Adapted physical activity has recently been proposed in the literature as a tool to improve body perception.

Face of complex management of this major symptom that is dysmorphophobia, some offer to use virtual reality.

It is in this context that the study proposes to study the contribution of virtual reality in the treatment of the body dysmorphic disorder of adolescent patients hospitalized for anorexia nervosa in the department of Child and Adolescent Psychiatry Salvator Hospital in Marseille.

It will be compare the importance and the evolution of the dysmorphophobia between two groups of teenagers hospitalized in Space Arthur for anorexia nervosa: an experimental group receiving the treatment with the contribution of the virtual reality, and a control group receiving the reference treatment of dysmorphophobia used in our unit.

It will be recruit 30 adolescent females with anorexia nervosa according to the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM)-5. The subjects will be divided into 2 groups of 15 teenagers, according to a randomization list, a group with a classic protocol, a group with virtual reality. The subjects with virtual reality will have 5 exposure sessions where they will be able to model their body in view in 1st person and 3rd person, via an Oculus Rift. It will be compare the following parameters: the different scores related to dysmorphophobia according to different questionnaires, the self-evaluation of the Body Mass Index (BMI), in order to observe the evolution of the symptom, then the anxiety relative to the exposure of a BMI higher in order to work the fear of getting fat, the choice of the most pleasant BMI, to evaluate skinny body addiction.

At the end of the study, we hope to highlight the effectiveness of virtual reality to fight against dysmorphophobia, in order to have a better estimate of its body aspect, and to impact the evolution towards the cure in anorexia nervosa in teenage girls. In addition to increasing our knowledge, this could allow to consider new strategies in the management of anorexia nervosa, and why not democratize more virtual reality with adolescents followed in child and adolescent psychiatry.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: A Retro-Prospective Observational Study of Ibrutinib Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice

acronym: FIRE

summary: The purpose of this study is to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy for chronic lymphocytic leukemia (CLL) and mantle-cell lymphoma (MCL).

ReferenceCitation: Dartigeas C, Slama B, Doyle M, Tapprich C, Albrecht C, Dupuis S, Wapenaar R, Schmidt-Hieber C, Leblond V. FIRE Study: Real-World Effectiveness and Safety of Ibrutinib in Clinical Practice in Patients with CLL and MCL. Clin Hematol Int. 2022 Sep;4(3):65-74. doi: 10.1007/s44228-022-00015-5. Epub 2022 Sep 14.

oa_colors: green diamond

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

publisher_dissemination: SAABRON PRESS

lead_sponsor: Janssen-Cilag Ltd.


title: Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder

acronym: NC-TCSP-IRMf

summary:
Up to 50% of Narcolepsy-cataplexy (NC) patients suffer from REM sleep behavior disorder (RBD), a parasomnia.

A strong link was found between RBD and impulse control disorders (ICD) in Parkinson disease (PD) patients. ICD are thought to be related to a dysfunction of meso-cortico-limbic pathways which belong to the so called ''reward system''.

A recent study in IRMf shows that RBD is associated with impaired reward system.

A strong link was found between these two disorders and therefore we believe that RBD is associated with impaired reward system in NC

The main objective of this study is to evaluate differences in brain activation between NC patients with and without RBD.

The investigators hypothesize that NC patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD.

sponsor_collaborators:
University Hospital, Clermont-Ferrand
CH MONTLUCON
Jacques Lacarin Hospital Center


title: A Very Early Standing Study in Elderly Stroke

acronym: AVESSES

summary:
Functional recovery is one of the main issues in the management of stroke and there are various ways in rehabilitation to promote this recovery.

Verticalization is a technique whose benefits have been widely demonstrated, particularly in neurology. Although commonly used in the rehabilitation of stroke, evidence is still lacking as to its impact in this specific care.

Verticalization is underutilized in two situations: in the hyper acute phase as well as in elderly and very deficient patients. It has, however, been shown that the precocity of the treatment allows a better functional recovery. Similarly, the re-education of the elderly is also debated since it has long been mentioned that age was a factor of poor prognosis, the objectives are sometimes underestimated. However, several studies have shown that with the same rehabilitation, elderly patients recover as much as younger patients. The differences found are at least in part due to "less rehabilitation" of older stroke patients.

The different existing data lead us to the hypothesis that the verticalization of the elderly hemiplegic patient in acute phase would allow a better functional recovery.

ReferenceCitation: Allison R, Dennett R. Pilot randomized controlled trial to assess the impact of additional supported standing practice on functional ability post stroke. Clin Rehabil. 2007 Jul;21(7):614-9. doi: 10.1177/0269215507077364.

ReferenceCitation: Bagg S, Pombo AP, Hopman W. Effect of age on functional outcomes after stroke rehabilitation. Stroke. 2002 Jan;33(1):179-85. doi: 10.1161/hs0102.101224.

ReferenceCitation: Bagley P, Hudson M, Forster A, Smith J, Young J. A randomized trial evaluation of the Oswestry Standing Frame for patients after stroke. Clin Rehabil. 2005 Jun;19(4):354-64. doi: 10.1191/0269215505cr874oa.

ReferenceCitation: Benaim C, Perennou DA, Villy J, Rousseaux M, Pelissier JY. Validation of a standardized assessment of postural control in stroke patients: the Postural Assessment Scale for Stroke Patients (PASS). Stroke. 1999 Sep;30(9):1862-8. doi: 10.1161/01.str.30.9.1862.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Impact of Anti-HLA Donor-specific Antibodies in ABO-incompatible Kidney Transplantation

summary: It was previously suggested an improvement of graft survival in ABO/HLA incompatible kidney transplantation (KT) compared with HLA (human leukocyte antigen) incompatible transplantation. Here, the investigators would analyse clinical, biological and histological results of ABO/HLA incompatible kidney transplant recipients, comparing with ABO or HLA compatible kidney transplantation.


title: Acceptability of High-flow Nasal Oxygen to Relieve Dyspnea in Palliative Care: Pilot Study

acronym: OXYPALL

summary:
In palliative care, the relief of the dyspnea is necessary. Medications for the reduction of dyspnea have side effects. High-flow nasal cannula oxygen therapy (HFNC) is a new way to deliver oxygen. Investigators hypothesize that HNFC is an acceptable technic for the patient with dyspnea in palliative care.

A pilot study with 30 patients will be conducted. Acceptability of HNFC will be studied by the time of use by patients of the HNFC during one week. The effectiveness of HNFC in relieving dyspnea will be studied using Borg scale.


title: Comparative Study of Molecular Markers in Cutaneous Inflammation Between Psoriatic Lesional Skin and Healthy Non-lesional Skin

acronym: EMIP

summary: The project topic consists on re-conciliating the fine tuners of the gene expression "microRNAs" and the immunopathogenic occasions responsible for skin disorders in context of skin infection and inflammation such as psoriasis. The skin is a network of effector cells and molecular mediators that constitute a highly sophisticated "Skin Immune System (SIS) described by Jan D Bos in 1986. The cutaneous homeostasis maintenance is dependent on the cross talk between several immune sentinels present in the different compartments of the skin as well as the interplay between innate and adaptive immune responses. The whole is under the control of gene regulation. However, cutaneous homeostasis disruption occurs when the SIS safe framework erroneously sends aggravation signals due to gene regulation disbalance via inflammatory cellular and molecular mediators into the site of infection causing chronic inflammation characterized by thick red irritated skin lesions. The latter was showed to have a characteristic microRNA (regulators of gene expression) signature.

ReferenceCitation: Nestle FO, Di Meglio P, Qin JZ, Nickoloff BJ. Skin immune sentinels in health and disease. Nat Rev Immunol. 2009 Oct;9(10):679-91. doi: 10.1038/nri2622. Epub 2009 Sep 18.

ReferenceCitation: Finlay AY. Current severe psoriasis and the rule of tens. Br J Dermatol. 2005 May;152(5):861-7. doi: 10.1111/j.1365-2133.2005.06502.x.

ReferenceCitation: Sobhan MR, Farshchian M, Hoseinzadeh A, Ghasemibasir HR, Solgi G. Serum Levels of IL-10 and IL-22 Cytokines in Patients with Psoriasis. Iran J Immunol. 2016 Dec;13(4):317-323.

ReferenceCitation: Carrascosa JM, Toro Montecinos M, Ballesca F, Teniente Serra A, Martinez Caceres E, Ferrandiz C. Correlation between trough serum levels of adalimumab and absolute PASI score in a series of patients with psoriasis. J Dermatolog Treat. 2018 Mar;29(2):140-144. doi: 10.1080/09546634.2017.1341619. Epub 2017 Jul 6.

ReferenceCitation: Duhen T, Geiger R, Jarrossay D, Lanzavecchia A, Sallusto F. Production of interleukin 22 but not interleukin 17 by a subset of human skin-homing memory T cells. Nat Immunol. 2009 Aug;10(8):857-63. doi: 10.1038/ni.1767. Epub 2009 Jul 5.


title: Lyon and Rhône Alpes Auvergne Registry of Congestive Heart Failure

acronym: LOOP-HF

summary:
This is a prospective cohort study of patients with Heart Failure with an eighteen-month follow-up aimed to collect all demographic, clinical, biological and para-clinical data to study population characteristics, assess prognosis markers and occurrence of HF treatment side effects.

Congestive Heart failure is a frequent pathology and its prevalence increases with age. Its prognosis stays pejorative despite years of major therapeutical progress. In recent trials, all-cause mortality rates at 1-year reach up to 20% and 50% at 5 years.

Medical care of congestive heart failure is based on precise international recommendations. The association of Beta-Blockers, renin-angiotensin system blockers, mineralocorticoid receptor antagonists, represent the basis of the pharmacological treatment.

Cardiac resynchronization treatment and implantable cardioverter-defibrillator are additional efficient treatments that reduce events in appropriately selected patients.

Despite these improvements, the prognostic of congestive heart failure in registers is worse than those observed in randomized trials. This can be explained by differences in congestive heart failure patient populations and/or by a less rigorous medical care where treatments are not optimized.

The evaluation of medical care in congestive heart failure is today of utmost importance.

Integrating new pharmacological molecules, medical devices and the application of new recommendations have major interest for documentation and practical changes.

The main objective of this cohort will be to evaluate the evolution of the 12-month quality of life score of a HF patient and the characteristics and treatments associated with it.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hôpital Louis Pradel, Centre d'Investigation Clinique


title: Developpemment of a Score to Assess Risk of Medication Errors in Internal Medecin Unit

acronym: SCOREME

summary: Transfers between interfaces of care are recognized as a source of medication discrepancies, medication errors (MEs) and potentially adverse drug events. ME are very common at hospital and may have important clinical and economic consequences. The lack and loss of medication information and communication between health professionals at points of care transition may often lead to ME. According to the literature, up to two thirds of medication histories contain at least one error. Some studies have compared pharmaceutical team with physician or nurse on the detection of UMD or ME and have reported that pharmacists were one of the best health care providers to establish medication history. To improve medication safety and decrease MEs rate, several institutions have recommended to develop medication reconciliation at all transition points such as admission, transfer and discharge. Medication reconciliation is the process that compares a patient's medication order to all medications that the patient has been taking and should take at admission, transfer and discharge of hospitalization. Medication reconciliation programs led by pharmacists are effective to reduce medications discrepancies. However, studies evaluating the efficacy of medication reconciliation program are very heterogeneous in terms of populations, definitions and methodology. Thus, proportion of ME differs enormously between studies, ranging from under 10% to over 60% at admission of hospitalization. Elderly patients with their numerous comorbidities associated with polypharmacy, such as patients of internal medecin unit, are at high risk of ME and at risk of safety issues. However, medication reconciliation process is very time consuming with an average of 30 minutes by patient. Thereby, review of all inpatients within 24 hours of admissions is very difficult or impossible. Targeting "high-risk situation" and "high-risk patient" are crucial to detect ME before causing harm. Therefore, evaluating the risk of MEs and their potential consequences in specific population of internal medicine unit using a validated medication reconciliation process seems of utmost importance for internal medicine specialist clinical practice and the decrease of ME rate. Consequently, the aim of our study was to (i) evaluate the prevalence of ME in an internal medicine unit at admission of hospitalization, (ii) determine the type of medication involved and the potential clinical impact of ME and (iii) identify factors associated with a risk of ME and serious ME.

ReferenceCitation: Audurier Y, Roubille C, Manna F, Zerkowski L, Faucanie M, Macioce V, Castet-Nicolas A, Jalabert A, Villiet M, Fesler P, Lohan-Descamps L, Breuker C. Development and validation of a score to assess risk of medication errors detected during medication reconciliation process at admission in internal medicine unit: SCOREM study. Int J Clin Pract. 2021 Feb;75(2):e13663. doi: 10.1111/ijcp.13663. Epub 2020 Dec 14.

evidence: oa journal (via publisher name)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

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

publisher_dissemination: Hindawi


title: Study of Platelets Sialylation by Flow Cytometry for the Differential Diagnosis of Immunologic and Constitutive Thrombocytopenia: Diagnostic and Prognostic Interest.

acronym: SYMPATHIC

summary:
Idiopathic thrombocytopenic purpura (ITP) is the most frequent auto-immune cytopenia. There is no specific biological marker and the diagnosis often results from the exclusion of other differential diagnoses, notably inherited thrombocytopenia.

Recent studies have reported an original platelet destruction mechanism in ITP, by antibody-mediated desialylation of membrane proteins. The detection of platelet sialylation can be readily achieved using flow cytometry. This could provide a new biomarker of ITP, useful to ascertain a diagnosis of ITP and guide towards proper patient management.

ReferenceCitation: Li J, van der Wal DE, Zhu G, Xu M, Yougbare I, Ma L, Vadasz B, Carrim N, Grozovsky R, Ruan M, Zhu L, Zeng Q, Tao L, Zhai ZM, Peng J, Hou M, Leytin V, Freedman J, Hoffmeister KM, Ni H. Desialylation is a mechanism of Fc-independent platelet clearance and a therapeutic target in immune thrombocytopenia. Nat Commun. 2015 Jul 17;6:7737. doi: 10.1038/ncomms8737.

ReferenceCitation: Sorensen AL, Rumjantseva V, Nayeb-Hashemi S, Clausen H, Hartwig JH, Wandall HH, Hoffmeister KM. Role of sialic acid for platelet life span: exposure of beta-galactose results in the rapid clearance of platelets from the circulation by asialoglycoprotein receptor-expressing liver macrophages and hepatocytes. Blood. 2009 Aug 20;114(8):1645-54. doi: 10.1182/blood-2009-01-199414. Epub 2009 Jun 11.

lead_sponsor: Nantes University Hospital