lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronym: iPROGRESS

location_facility: service de médecine nucléaire-Hôpital Bichat

source: euctr

title: 68Ga-DOTATATE PET-CTA Imaging for the Early Detection of Progressing Coronary Atherosclerosis

summary:
68Ga-DOTATATE is a PET radiotracer with high affinity and selectivity for somatostatin receptor 2 (SSTR 2) and is approved clinically for the evaluation of patients with neuroendocrine tumors. The SSTR2 receptor is also highly expressed at the surface of human macrophages and lymphocytes. In comparison to FDG, 68Ga-DOTATATE presents the advantage of fast clearance from tissues, which are not expressing somatostatin receptors, in particular muscular and myocardial tissues, and the level of blood glucose does not influence its uptake.

Accumulation of 68Ga-DOTATATE has already been detected in coronary and carotid plaques and is associated with the number of activated macrophages present in plaques obtained after carotid endarterectomy. In a recent study, Tarkin et al. confirmed the preferential uptake of 68Ga-DOTATATE by macrophages in atherosclerotic plaques. In addition, the intensity of 68Ga-DOTATATE was higher in culprit lesions in the carotid and coronary arteries than in stable lesions. The evaluation of 68Ga-DOTATATE uptake in coronary arteries was also strongly facilitated in comparison to FDG thanks to the absence of spillover signal from the myocardium.

AAA has developed a new kit that has markedly simplified the synthesis of 68Ga-DOTATATE and has obtained in the US marketing authorization for the kit (Netspot; kit for the preparation of Gallium-68-DOTATATE injection for intravenous use) on June 1st 2016 (NDA 208547) for evaluation of patients with neuro-endocrine tumors. The Netspot kit will be used in this study for the detection of progressing coronary atherosclerosis.


title: Diagnostic Performance of Exome Sequencing in Autism Spectrum Disorders

acronym: REDIA

summary: Evaluation of the diagnostic performance of exome sequencing in a prospective series of patients with autism spectrum disorders (ASD).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: University Hospital, Rouen

lead_sponsor_type: academique

status_simplified: Ongoing


title: Pre-hospital Optimization of Triage of Stroke Suspicions: Bringing an Embedded Visio Conference Device

acronym: OPTIC-AVC

summary: Interventionnal Study to investigate the accuracy of our clinical based algorithm performed by using a visioconference device to assess the eligibility of acute recanalisation treatment (intraveinous thrombolysis (IVT) and/or mechanical thrombectomie (TM). Clinical identification of type of treatment is needed is pre-hospital triage of these patients.

status: Unknown status

study_type: Interventional

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Bordeaux

intervention_type: Procedure

status_simplified: Unknown


title: Permanent Cerebral Oxymetry Monitoring for Early Diagnosis and Treatment of Delayed Vasospasm After Subarachnoid Hemorrhage

acronym: COMOVA

summary:
Transcranial Doppler ultrasound (TCD) monitoring and CT-scanner perfusion are useful but imperfect tools to identify vasospasm and allow intervention to avoid infarction.

Permanent monitoring of cerebral tissue oximetry (rSO2) by NIRS, a noninvasive method could allow better vasospasm detection.

This study will evaluate diagnostic accuracy of cerebral oxymetry (NIRS) -by rSO2 measurement - in order to detect vasospasm in patient with severe subarachnoid hemorrhage compare to standard monitoring tools.

intervention_type: Device


type: Other Identifier

title: Effect of the Quality of Dietary Proteins on the Sleep Young Elite Athletes and the Obese Adolescent

acronym: Protmorpheus

summary:
Adolescence is characterized by major transitions in sleep and circadian rhythm. This rapid pivotal period increases the risks of sleep debt and poor sleep quality, leading to pronounced diurnal fatigue and drowsiness . Some adolescent's populations are more vulnerable than others to poor sleep. Obesity and elite sports involvement are two factors that have been distinctly associated with disturbed sleep. Several studies show that obesity was associated with a decrease in sleep efficiency and increased arousals . On the other hand, recent studies point out that sleep problem is widespread in young athletes which substantially increase the risks of injury, burnout and concussions .

Despite the importance of sleep in holistic development, physical (i.e. recovery, metabolism, muscle growth, weight control), cognitive (i.e. learning, memory, decision-making, Vigilance) and athletic performances (Fullagar et al., 2015).

A wide range of recent papers emphasize that some nutrients take part in the regulation of internal clock and sleep quality. The effect of tryptophan (Trp) on sleep was lifted on the basis of the serotonergic hypothesis. Serotonin (5-HT) is synthesized from Trp circulating in the brain following two-step procedure in raphe neurons. Serotonin, in turn, is a precursor of melatonin and both molecules contribute to the regulation of sleep-wake behaviors. However, Trp is an essential amino acid, which means that it cannot be synthesized by the organism, and must exclusively be provided via degradation of proteins from the diet. The passage of tryptophan to the brain is assured through carrier disposed at the blood-brain barrier level. However, carrier transport depends on other competitive amino acids (LNAAs: leucine, isoleucine, valine, phenylalanine, and tyrosine). Therefore, increased brain uptake of tryptophan does not depend only on Trp concentrations but rather on the blood Trp / LNAA ratio.

PROTMORPHEUS trial, was designed to examine how supplementation with proteins of different Trp/LNAA ratio affect sleep on adolescents (obese, athletes) with mild sleep disturbances.

design_allocation: Randomized

primary_purpose: Prevention

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Dietary Supplement


title: Validation of a French-version of the Leeds Food Preference Questionnaire in Normal Weight and Patients With Obesity

acronym: LFPQ-F

summary:
While Food reward is an important component of the appetite control to consider, there is actually no tool that has been developed in French to perform its evaluation.

The Leeds Food Preference Questionnaire (LFPQ) is a validated and recognized tool to assess food reward, being however developed for British populations.

The aim of this work is to validate a French version of the LFPQ among lean and obese adults.

primary_purpose: Treatment

intervention_type: Behavioral


title: Pulmonary and Ventilatory Effects of Trigger Modulation in Intubated ICU Patients Spontaneously Breathing With Pressure Support Ventilation. A Physiopathology Exploratory Study.

acronym: Trigger

summary: Pressure support ventilation allows intubated ICU patients to breathe spontaneously. Among specific settings, the adjustment of the trigger value (or threshold for triggering the ventilator) has not been explored to date. The trigger threshold corresponds to the sensitivity of the ventilator to detect patient's inspiratory effort and then deliver the predefined pressure support to inflate the lungs and deliver a tidal volume. The purpose of this study is to explore the influence of trigger level on pulmonary and ventilatory physio (-patho)logical parameters in spontaneously breathing ICU patients.

location_facility: Service de Réanimation Adultes et Soins Continus

intervention_type: Other


title: Satietogenic Effect of Liquid Versus Solid Meals in Healthy Adults

acronym: FEED

summary: The aim of the present study is to compare the nutritional compensation between iso-caloric meals of various textures (liquid vs solid) in health young adults.

study_start_date_type: Anticipated


title: Evaluation of Non-Small Cell Lung Cancer Patients' Oxygen Uptake On-kinetics at Cycle-ergometer During Prehabilitation

acronym: Preo-Kinetics

summary:
In developed countries cancer has become the second leading cause of death after cardiovascular disease. The lung is a particularly exposed organ since broncho-pulmonary cancers rank second in terms of incidence, and the first rank in terms of mortality of all cancers listed in like reported in United States.

Lung resection surgery is currently the recommended curative treatment for the early stages of non-small cell lung cancer (NSCLC). Despite this preferred indication, some patients can not be eligible for surgery because of their cardiovascular or respiratory comorbidities or their impaired functional capacity.

Thus, the evaluation of aerobic capacity through cardiopulmonary exercise testing (CPET) of patients estimated at risk of postoperative complication is now recommended to estimate the level of predictive risk associated. The American Thoracic Society and the European Respiratory Socitety agree on thresholds of <10 and> 20 ml/kg/min of maximum oxygen uptake (VO2peak) respectively determining a high or low postoperative risk, between these two thresholds risk is considered moderate.

Aerobic capacity is traditionally expressed in terms of maximum oxygen uptake (VO2max or VO2peak) evaluated during an incremental CPET. In patients with significant respiratory impairment, these tests are often limited by ventilation and sub-maximally on the metabolic or cardiac parameters. However, the analysis of the VO2 kinetic during a constant-intensity test of moderate intensity is also a relevant way of measuring aerobic conditioning. Indeed, the time constant (τ) of phase II of VO2 kinetics (VO2τ) is a marker that closely reflects the adjustment of oxidative metabolism in skeletal muscle. Analysis of the kinetic parameters of the cardio-respiratory response to exercise has been shown to be reproducible and training-sensitive in patients with chronic obstructive pulmonary disease (COPD). The value of VO2τ was also reported to be strongly correlated with markers of severity and prognosis in COPD patients. Previous work has shown that exercise training can improve the speed of the VO2 kinetic response in COPD patients as well as in healthy subjects.

To date, no study to our knowledge has evaluated the kinetics of the cardiorespiratory response during moderate intensity constant-load test in patients with NSCLC. In this context, this work aims to evaluate the applicability of this measure as well as its evolution during a preoperative exercise training program in patients with NSCLC.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: ADIR Association

lead_sponsor_type: industriel

status_simplified: Completed


title: Incentive Spirometry and Pain in the Decompensation of Sickle Cell Disease: Impact on the Length of Stay. Prospective Observational Study

acronym: SPIDO

summary:
In this prospective observational study among sickle cell children aged 7 to 17 years, who face many experience of pain, pain will be assessed during incentive spirometry sessions. Then a relation between, inspiratory volume, pain and the length of hospital stay will be identified .

Currently, there is no scientific data regarding the correlation between acute pain during vaso-occlusive crisis, incentive spirometry and the impact on length of hospital stay. In fact, physiotherapist experience's in the pediatric department suggests that the pain expressed by the child is not always correlated with inspiratory capacity.

The absence of pain is one of the reasons for hospital discharge after decompensation in patients with sickle cell disease. However, no scientific study has linked incentive spirometry, pain and length of hospital stay.

Investigator assume that these children underestimate the real pain and its impact on breathing pattern, and presume that the maximal inspiratory volume during spirometry sessions will be a better reflect of pain than standard pain scale.

The aim of this study is to show that inspiratory volume would be a better indicator of discharge from hospitalization than actual pain scales.

ReferenceType: result

ReferenceCitation: Bellet PS, Kalinyak KA, Shukla R, Gelfand MJ, Rucknagel DL. Incentive spirometry to prevent acute pulmonary complications in sickle cell diseases. N Engl J Med. 1995 Sep 14;333(11):699-703.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Development and Evaluation of the Effectiveness of Rehabilitation Tools for Neurovisual Disorders in Patients With Posterior Cortical Atrophy (PCA)

acronym: REEDUC-ACP

summary:
Posterior cortical atrophy (PCA) is manifested by neuro-visual disorders that alter the spatial location of objects, their manipulation and/or recognition. Its etiology is most often neurodegenerative, with a major impact on the autonomy and mood of patients and their families. Few studies have focused on non-medication management of these disorders.

The present study thus has a double objective: the development of a complete tool to work on the recognition, localization and/or manipulation of objects; and the evaluation of the effectiveness of this type of management.

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Institut Claude Pompidou - Centre Mémoire de Ressources et de Recherche du CHU de Nice


title: Identification of Decision Making Processes in Food, Risky and Steal Situations in Bulimia Nervosa

acronym: FaciB

summary: This trial is a set of four independent experiments involving for each of them functional and structural MRI data acquisition. They aim at investigating decision making mechanisms in bulimia nervosa when participants have to make food or monetary choices under specific conditions that mimic binge eating episodes or kleptomania which are two major symptoms of bulimia nervosa. All experiments are cross sectional studies. Each experiment is subdivided into two parts: a first part without any MRI data acquisition and during which all the tasks are performed. This part aims at making sure that a behavioral effect is observed before starting MRI data acquisition. The second part aims at investigating the neural correlates observed in the first part and additionally, at reproducing the behavioral effects observed in the first part. Therefore the first part may be regarded as an independent study as compared to the second part.

status: Terminated

design_allocation: Non-Randomized

primary_purpose: Basic Science

lead_sponsor: Hôpital le Vinatier


title: Influence of Screen Sizes on Responses to Visual Analog Scales of Stress

acronym: SIVAStress

summary: Visual analog scales (VAS) are one of the most common tools used in questionnaires. VAS are validated for pain and stress for example on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100). Nowadays, most VAS are used on questionnaires on internet. However, the influence of screen sizes on responses to visual analog scales were never studied.

time_perspective: Cross-Sectional


title: Optimization of Transfusion Use and Interest of the Correction of Iron Deficiencies in Cardiac Surgery Under Extracorporeal Circulation (ECC)

acronym: PBMc

summary:
Preoperative anemia is associated with an important increase in transfusions of red blood cells (RBC) compared to a non-anemic patient in cardiac and non cardiac surgery. Furthermore transfusion is also an independent factor of morbi-mortality with notably an increase in the infectious risk, immunological, an increase of the risk of cardiac decompensation, respiratory decompensation Transfusion Related Acute Lung Injury (TRALI) or Transfusion Associated Cardiac Overload (TACO), and an increase in mortality of 16%.

Management of perioperative transfusion is therefore a public health issue. Since 2010, the World Health Organization (WHO) has been promoting a systematic approach to implement blood management programs for the patient to optimize the use of resources and promote quality and safety of care.

Improving the relevance of transfusion in cardiac surgery could be achieved by optimizing the management of patients around 2 axis:

A:non-drug intervention : Review of Practices to Improve the Management of Perioperative RBC Transfusion

B:drug intervention : Systematic correction of pre- and postoperative iron, vitamin deficiencies and anemia

The aim of this program is to improve the relevance of transfusion in cardiac surgery and to limit the morbidity and mortality induced by transfusion. This program is part of a global project of pre, per and postoperative management of the patient undergoing cardiac surgery programmed under extracorporeal circulation (ECC). It requires a multidisciplinary approach between cardiologists, anesthesiologists and intensivists, perfusionists, cardiac surgeons and paramedical teams to optimize the management of the patient.

ReferenceType: derived

ReferenceCitation: Charbonneau H, Pasquié M, Berthoumieu P, Savy N, Autones G, Anglès O, Berthelot AL, Croute-Bayle M, Decramer I, Duterque D, Gabiache Y, Julien V, Mallet L, M'rini M, Quedreux JF, Richard B, Sidobre L, Taillefer L, Soula P, Garcia O, Abouliatim I, Vahdat O, Bousquet M, Ferradou JM, Jansou Y, Brunel P, Breil C, Mayeur N. Patient blood management in elective bypass cardiac surgery: A 2-step single-centre interventional trial to analyse the impact of an educational programme and erythropoiesis stimulation on red blood cell transfusion. Contemp Clin Trials Commun. 2020 Jul 15;19:100617. doi: 10.1016/j.conctc.2020.100617. eCollection 2020 Sep.

family: Charbonneau

full_name: Hélène Charbonneau

given: Hélène

sequence: first

family: Pasquié

full_name: Marie Pasquié

given: Marie

sequence: additional

family: Berthoumieu

full_name: Pierre Berthoumieu

given: Pierre

family: Savy

full_name: Nicolas Savy

given: Nicolas

family: Autones

full_name: Gérard Autones

given: Gérard

family: Anglès

full_name: Olivier Anglès

given: Olivier

family: Berthelot

full_name: Anne Laure Berthelot

given: Anne Laure

family: Croute-Bayle

full_name: Madeleine Croute-Bayle

given: Madeleine

family: Decramer

full_name: Isabelle Decramer

given: Isabelle

family: Duterque

full_name: David Duterque

given: David

family: Gabiache

full_name: Yannick Gabiache

given: Yannick

family: Julien

full_name: Valérie Julien

given: Valérie

family: Mallet

full_name: Laurent Mallet

given: Laurent

family: M'rini

full_name: Mimoun M'rini

given: Mimoun

family: Quedreux

full_name: Jean François Quedreux

given: Jean François

family: Richard

full_name: Benoit Richard

given: Benoit

family: Sidobre

full_name: Laurent Sidobre

family: Taillefer

full_name: Laurence Taillefer

given: Laurence

family: Soula

full_name: Philippe Soula

given: Philippe

family: Garcia

full_name: Olivier Garcia

family: Abouliatim

full_name: Issam Abouliatim

given: Issam

family: Vahdat

full_name: Olivier Vahdat

family: Bousquet

full_name: Marc Bousquet

given: Marc

journal_name: Contemporary Clinical Trials Communications


title: Pilot Study to Predict Falls With Motor Imagery

acronym: FallMI

summary:
At Departmental Hospital Centre, a primary and secondary screening program for osteoporosis was set up in 2014 in the medical services (excluding oncology), gynaecology, outpatient surgery and orthopaedics. Patients who consulted outpatients in the emergency room were not taken into account due to the 24-hour opening hours. The objective of this program was to identify all patients at risk of osteoporosis; i. e. not only patients with a recent or previous fracture history, but also patients with osteoporosis risk factors without a history of fracture to date. This is in order to propose a prevention strategy to referring physicians and thus reduce the risk of fractures. The handover of the Timed Up and Go designed and physically carried out was added in July 2017 to the management of patients as part of this screening.

During this screening, patients are asked to perform 2 realized Timed Up and Go (rTUG), followed by 2 imagined Timed Up and Go (iTUG).

The interest in preventing falls in osteoporotic patients leads investigators to propose this evaluation as part of this "osteoporosis" screening. The investigators will offer patients benefiting from osteoporosis screening as part of the process already in place at Departmental Hospital Centre to participate in the FallMi study. If agreement is reached, the patient's treating physician will be contacted to collect data on the occurrence of falls in these patients. After a request by mail, an email will be sent to the attending physicians of each patient at 6 months, then one year after the completion of the TUG. This email will ask physicians about the presence of a fall that has occurred since the TUGs were performed, as well as the severity of this possible fall.

Investigators objective is to evaluate rTUG and iTUG as predictive factors of a fall with moderate to fatal consequences.

Investigators hypothesize that a lower isochrony between rTUG and iTUG is predictive of a risk of falling.

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Departemental Vendee

intervention_type: Diagnostic Test


title: Evaluation of Vaginal Self-sampling Diagnostic Performances to Identify Genital Infections : A Large, Cross-sectional, Non-inferiority Trial

summary: Screening for genital infection (GI), sexually transmitted infection (STI) and asymptomatic carriage of group B streptococcus (GBS) in pregnant women is a common reason for medical appointments. Conventional testing is performed by using vaginal and/or cervical classic sampling (VCS). Vaginal self-sampling (VSS) has progressively emerged as an alternative to VCS for STI agent screening. The use of vaginal self-sampling (VSS) could facilitate follow-ups and potentially help in the prevention of gynaecological disorders.

ReferenceCitation: Hobbs MM, van der Pol B, Totten P, Gaydos CA, Wald A, Warren T, Winer RL, Cook RL, Deal CD, Rogers ME, Schachter J, Holmes KK, Martin DH. From the NIH: proceedings of a workshop on the importance of self-obtained vaginal specimens for detection of sexually transmitted infections. Sex Transm Dis. 2008 Jan;35(1):8-13.

ReferenceCitation: Lunny C, Taylor D, Hoang L, Wong T, Gilbert M, Lester R, Krajden M, Ogilvie G. Self-Collected versus Clinician-Collected Sampling for Chlamydia and Gonorrhea Screening: A Systemic Review and Meta-Analysis. PLoS One. 2015 Jul 13;10(7):e0132776. doi: 10.1371/journal.pone.0132776. eCollection 2015. Review.

family: Lunny

full_name: Carole Lunny

given: Carole

family: Taylor

full_name: Darlene Taylor

given: Darlene

family: Hoang

full_name: Linda Hoang

given: Linda

family: Wong

full_name: Tom Wong

given: Tom

family: Gilbert

full_name: Mark Gilbert

given: Mark

family: Lester

full_name: Richard Lester

given: Richard

family: Krajden

full_name: Mel Krajden

given: Mel

family: Ogilvie

full_name: Gina Ogilvie

given: Gina

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: PLOS ONE

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: Monash University - Monash University Research Portal

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

lead_sponsor: Hôpital Européen Marseille


title: Interest of Tumor Replicates in Avian Embryo to Model Therapeutic Effects of BRAF Inhibitors/MEK Inhibitors (BRAFi/MEKi) in BRAF Mutated Melanoma

acronym: MELANOPREDICT

summary: This is an interventional mono-centric study in patients with BRAF mutated metastatic melanoma treated with BRAF/MEK inhibitors. The aim of the study is to test the grafting of patient tumoral cells in avian embryo and develop a predictive in vivo model for patient treatment response.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Dermatologie, Centre hospitalier Lyon Sud, HCL


title: Quality of Life and Breast Cancer in Older Women

acronym: SEINIOR

summary:
Background :

Breast cancer is a disease that occurs primarily in elderly women: 54057 of breast cancer occurred on women in 2008, 15.2% were between 75 and 84 years and 5.4% were over 85 years. Elderly women cancers care exposes to several problems: the opportunity for screening, knowing that mammography is not recommended after 75 years old, and the level of treatment depending on the background and the existence of weaknesses. It should determine whether patients are in adequate physiological condition to tolerate classical and "complete" treatment or conversely in a precarious state with advanced fragility, justifying only lightened and adapted symptomatic treatment.

Purpose :

The purpose of this research theme is to assess the quality of life of elderly patients who underwent mastectomy for breast cancer. The objectives are:

Assess the determinants of acceptance and / or rejection of mastectomy based on personal background (level of fragility, self-image) and linked to cancer
Assess the quality of life, 6 months later, of women who underwent or not mastectomy, and appreciate the determinants

Abstract :

The total mastectomy allow, oncologically, a more valid treatment than a lumpectomy, in many cases of women suffering from a breast cancer, but its relevance and acceptability are poorly known. Some think that an elderly woman, postmenopausal, is less concerned with her aesthetics and feminine attributes, which would allow her to accept easily the mastectomy.

The research hypothesis is that the acceptability of mastectomy is not good in elderly women

ipd_sharing_description:
Participants completed a questionnaire that included the test sociodemographic characteristics and a number of standardized validated instruments translated in French language designed to assess for quality of life and psychological profile.

Participants will undergo blood test, electrocardiogram, blood pressure monitoring, geriatric standard evaluation.

lead_sponsor: Central Hospital Saint Quentin


title: Exploration of the Mechanisms of Vulnerability of Anorexia Nervosa at an Early Age : Study of the Cognitive Treatment of Food Stimuli and Body Image

acronym: AMDP

summary: In order to explore the cognitive treatment of patients with early onset anorexia nervosa (AM) in front of images of silhouettes and food, we will use the eye-tracking method. While we hypothesize a judgment disorder in these patients, the exploration of implicit cognitive treatment without desirability bias is essential. Eye-tracking is a method of recording the eye path that provides qualitative and quantitative information on the visual exploration of subjects. The visual pathway depends on how the subject's attention is directed to a given stimulus, but also on certain cognitive traits (e.g., excessive attention to details) or symptoms (e.g., avoidance of caloric food images or attraction to thin images). It is therefore a non-invasive exploration tool, which provides information on how patients look at food images and silhouettes. This project will describe the cognitive treatment of dietary stimuli and body image in young patients with early onset AM. It could identify a biomarker of AM in the pediatric population and improve the diagnosis of the disease. A better diagnosis of AM in patients under 15 years of age is essential and will improve medical care and develop personalized medicine.

primary_purpose: Other


title: Spatial and Dynamic Characterization of Brain Activity for Language and Posture (Verticality) During Normal Aging. Magnetoencephalography (MEG) Study (MEG-AGING)

acronym: MEG-AGING

summary:
Depending on the point of view, different definitions of aging have been proposed. Thus, at the biological level, aging corresponds to a natural physiological process that leads to the progressive degeneration of cells and the slowing down of the vital functions of a living organism. More generally, aging is a multifactorial and multidimensional process that occurs at the cognitive, social, biological or psychological level.

The primary objective of this study is to evaluate the balance between activation (Task-Positive Network : TPN-Language, L, TPN-Verticality, V) and rest (Task-Negative Network : TNN) activity during normal aging, in two domains (language and posturo-spatial perception of verticality).

ReferenceType: background

ReferenceCitation: Hoyau E, Roux-Sibilon A, Boudiaf N, Pichat C, Cousin E, Krainik A, Jaillard A, Peyrin C, Baciu M. Aging modulates fronto-temporal cortical interactions during lexical production. A dynamic causal modeling study. Brain Lang. 2018 Sep;184:11-19. doi: 10.1016/j.bandl.2018.06.003. Epub 2018 Jun 15.

ReferenceCitation: Baciu M, Boudiaf N, Cousin E, Perrone-Bertolotti M, Pichat C, Fournet N, Chainay H, Lamalle L, Krainik A. Functional MRI evidence for the decline of word retrieval and generation during normal aging. Age (Dordr). 2016 Feb;38(1):3. doi: 10.1007/s11357-015-9857-y. Epub 2015 Dec 28.

ReferenceCitation: Boudiaf N, Laboissière R, Cousin É, Fournet N, Krainik A, Baciu M. Behavioral evidence for a differential modulation of semantic processing and lexical production by aging: a full linear mixed-effects modeling approach. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2018 Jan;25(1):1-22. doi: 10.1080/13825585.2016.1257100. Epub 2016 Nov 24.

lead_sponsor: University Hospital, Grenoble


title: Développement de Nouveaux Biomarqueurs en Imagerie Par résonance magnétique Pour Les études Longitudinales Dans l'Angiopathie CADASIL

summary:
CADASIL (Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy) is an cerebral microangiopathy secondary to mutations in the NOTCH3 gene located on chromosome 19. This disease is the most frequent of the hereditary vascular leukoencephalopathies.

CADASIL begins between the ages of 20 and 40 with the appearance of hyper-signs of brain white matter visible on T2 sequences in magnetic resonance imaging (MRI). Before the age of 30, patients are most often asymptomatic. The disease is then responsible for different neurological manifestations:

Migraine attacks with aura occur on average in one in three patients, most often at the beginning of the course of the disease, sometimes even before the appearance of MRI abnormalities;
Transient ischemic strokes or strokes associated with small cerebral infarcts occur most frequently after the age of 50-60 years in more than two out of three patients;
Mood disorders are reported by one in three patients in the same age group;
Cognitive disorders that affect executive functions, especially after the age of 60, until the stage of severe dementia associated with walking disorders are observed during the course of the disease.

To date, there is no treatment whose efficacy has been proven in CADASIL. Various studies have shown that the accumulation of the most destructive brain tissue lesions at the subcortical level was closely correlated in CADASIL with the clinical severity of patients (motor and cognitive disability). It is now possible to measure microstructural changes in brain tissue in diffusion imaging during the course of the disease, even before significant clinical changes are detected.

ipd_sharing: Undecided


title: Sub-study of the NEURODOC Project (Electrophysiological Evaluation of Consciousness in Patients With Disorders of Consciousness During Standard Care Procedures): Neurophysiological Evaluation of a Routine Care Open Label tDCS Session

acronym: Neurodoc

summary:
Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some Minimally Conscious State (MCS) patients, and in some Vegetative State (VS) patients.

However the mechanisms by which tDCS improves consciousness are poorly understood and the electrophysiological effects of such a stimulation have never been studied in disorders of consciousness patients.

In this study, the investigators will use detailed clinical examinations and electrophysiological assessments (quantitative high-density EEG and event-related potentials) to assess the effect of a open-label single session of left dorsolateral prefrontal cortex tDCS stimulation administered as routine care.

ReferenceCitation: Angelakis E, Liouta E, Andreadis N, Korfias S, Ktonas P, Stranjalis G, Sakas DE. Transcranial direct current stimulation effects in disorders of consciousness. Arch Phys Med Rehabil. 2014 Feb;95(2):283-9. doi: 10.1016/j.apmr.2013.09.002. Epub 2013 Sep 11.

ReferenceCitation: Thibaut A, Bruno MA, Ledoux D, Demertzi A, Laureys S. tDCS in patients with disorders of consciousness: sham-controlled randomized double-blind study. Neurology. 2014 Apr 1;82(13):1112-8. doi: 10.1212/WNL.0000000000000260. Epub 2014 Feb 26.

ReferenceCitation: Thibaut A, Wannez S, Donneau AF, Chatelle C, Gosseries O, Bruno MA, Laureys S. Controlled clinical trial of repeated prefrontal tDCS in patients with chronic minimally conscious state. Brain Inj. 2017;31(4):466-474. doi: 10.1080/02699052.2016.1274776. Epub 2017 Mar 10.

ReferenceCitation: Martens G, Lejeune N, O'Brien AT, Fregni F, Martial C, Wannez S, Laureys S, Thibaut A. Randomized controlled trial of home-based 4-week tDCS in chronic minimally conscious state. Brain Stimul. 2018 Sep - Oct;11(5):982-990. doi: 10.1016/j.brs.2018.04.021. Epub 2018 May 2.

ReferenceCitation: Giacino JT, Kalmar K. Diagnostic and prognostic guidelines for the vegetative and minimally conscious states. Neuropsychol Rehabil. 2005 Jul-Sep;15(3-4):166-74.

ReferenceCitation: Sitt JD, King JR, El Karoui I, Rohaut B, Faugeras F, Gramfort A, Cohen L, Sigman M, Dehaene S, Naccache L. Large scale screening of neural signatures of consciousness in patients in a vegetative or minimally conscious state. Brain. 2014 Aug;137(Pt 8):2258-70. doi: 10.1093/brain/awu141. Epub 2014 Jun 11.

ReferenceCitation: Engemann DA, Raimondo F, King JR, Rohaut B, Louppe G, Faugeras F, Annen J, Cassol H, Gosseries O, Fernandez-Slezak D, Laureys S, Naccache L, Dehaene S, Sitt JD. Robust EEG-based cross-site and cross-protocol classification of states of consciousness. Brain. 2018 Nov 1;141(11):3179-3192. doi: 10.1093/brain/awy251.

ReferenceCitation: Bekinschtein TA, Dehaene S, Rohaut B, Tadel F, Cohen L, Naccache L. Neural signature of the conscious processing of auditory regularities. Proc Natl Acad Sci U S A. 2009 Feb 3;106(5):1672-7. doi: 10.1073/pnas.0809667106. Epub 2009 Jan 21.

ReferenceCitation: Faugeras F, Rohaut B, Weiss N, Bekinschtein T, Galanaud D, Puybasset L, Bolgert F, Sergent C, Cohen L, Dehaene S, Naccache L. Event related potentials elicited by violations of auditory regularities in patients with impaired consciousness. Neuropsychologia. 2012 Feb;50(3):403-18. doi: 10.1016/j.neuropsychologia.2011.12.015. Epub 2012 Jan 3.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere


title: Collecte de données Physiologiques en Continu Chez Des Patients en Insuffisance Respiratoire Pendant et après un épisode d'Exacerbation de BPCO

acronym: DACRE

summary:
Background : Acute exacerbations of COPD (Chronic Obstructive Pulmonary Disease) are frequent events in the course of the disease and they can deteriorate the respiratory function of the patients, impact their quality of life and even potentially threaten their life. It is therefore crucial to prevent these exacerbations from occurring.

Aim of the study : Investigate how cardiorespiratory parameters of COPD patients differ between exacerbation phases and their nominal state in order to identify predictors of COPD exacerbations.

Study design : Patients admitted at one of the investigation centers on a suspicion of COPD exacerbation will be enrolled on a voluntary basis. Enrolled patients' cardiorespiratory parameters will be monitored with a connected wrist-worn pulse oximeter (BORA Band) during the hospitalisation phase and one month after they have been discharged.

Setting : 4 investigative centers across Brittany

Patients : 50 patients will be enrolled in the study

lead_sponsor: Biosency


title: AmbulaNCE Teletransmited PHOtography for Trauma REgulation

acronym: NiCEPHORE

summary:
Physicians in charge of medical regulation within French SAMU have to take difficult decisions regarding patient's orientation (in or out-of hospital care) but suffer from lack of information. Such information usually consist in a simple phone conversation without any visual information. Visual assesment of the situation would be of great help, especially for traumatized patients.

Private Ambulance societies all over territory in charge of SAMU 86 now work with teletransmission devices allowing photography transmission.

The objective of the study is to determine if routine use of teletransmitted photography help SAMU 86's physians for a better orientation of non-severe traumatized patients, especially by avoiding unnecessary transportations to Emergency Departments.

lead_sponsor: Poitiers University Hospital


title: Benefit of Scarf Support on Skin-to-skin Time and Portage in Neonatology and at Home(PAPSE)

acronym: PAPSE

summary:
Carrying (or kangaroo carrying) is known to reduce neonatal and child morbidity and mortality and improves the quality of survival of premature and term children during the most fragile growth period, the first thousand days of life. Carrying is also a growing brain protection technique and becomes a routine of care in all neonatal units around the world.

In University hospital of Saint-Etienne, the developmental care program has been developed since 2002 in all neonatology units and advocates the practice of skin-to-skin carrying between the parent (father or mother) and his baby, from the time of the hospitalization. Professionals in units who have long been thinking about the concept of attachment and the benefits of skin-to-skin, wish to validate the use of the wearing scarf as a tool for the practice of skin -in-skin in neonatology then back home by performing a randomized monocentric prospective longitudinal study.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Benefits of a Perioperative Exercise Program on Maturation of Dialysis Arteriovenous Fistulas

acronym: FAVULOUS

summary:
Arteriovenous fistula (AVF) is the recommended vascular access for chronic hemodialysis, as it is associated with less mortality and better patency than arteriovenous graft (AVG) or central venous catheter (CVC).

Unfortunately, AVF suffers from a high failure rate, due, in part, to poor venous diameter.

The aim of this study is to investigate whether a perioperative handgrip training can improve the diameter of AVF in patients with chronic kidney disease (CKD) (stage IV-V).

location_facility: Service de néphrologie, dialyse et nutrition rénale - Centre Hospitalier Lyon Sud


title: The Roots of Metacognitive Failures in Bipolar Disorders: Clinical Determinants of the Discrepancy Between Objective and Subjective Cognition in the Versailles FACE-BD Cohort

acronym: METACOG-BD

summary:
Metacognitive abilities have been scarcely investigated in bipolar disorders, with inconsistent results. This may appear somewhat surprising, as metacognitive training is a very promising intervention aiming at improving psychosocial functioning in bipolar disorders. One way to investigate metacognition is to address the discrepancy between objectively measured cognition (through neuropsychological testing) and subjective cognition (through self-reported questionnaire investigating one's perception of cognitive functioning).

Objective and subjective cognition are two fundamental determinants of functioning in bipolar disorder. Objectively-measured cognition is directly associated with performance-based functional capacity but not with self-reported or interview-based functional capacity. In contrast, subjectively-measured cognition is associated with self-reported and interview-based functional capacity, but not performance-based functional capacity.

Associations between subjective cognitive functioning and neuropsychological performances are usually weak, with a moderating effect of manic and depressive symptoms. Manic symptoms are associated with a decrease in cognitive complains, whereas depressive symptoms are associated with an increase in cognitive complaints. Predictors of the discrepancy between objective and subjective cognition in bipolar disorder are still weakly understood. One study reported that the subjective overestimation of cognitive dysfunctioning was positively predicted by more subsyndromal depressive and manic symptoms, hospitalizations, and BD type II. This study also reported that the subjective overestimation of cognitive dysfunctioning was associated with greater socio-occupational difficulties, more perceived stress, and lower quality of life.

However, these previous studies had relatively limited sample sizes (below 150). They also ignored other potential predictors of the discrepancy between objective and subjective cognitions such as psychotic features, impulsiveness, and childhood trauma. Moreover, they also ignored whether this discrepancy was associated with medication adherence.

The present study intends to explore the predictors of the discrepancy between objective and subjective cognition in bipolar disorder in a cross-sectional sample of 387 stable outpatients with bipolar disorders (type 1, type 2, not otherwise specified).

The second objective is to determine whether the discrepancy between objective and subjective cognition in bipolar disorder predicts functioning, quality of life and medication adherence.

ReferenceCitation: Haffner P, Quinlivan E, Fiebig J, Sondergeld LM, Strasser ES, Adli M, Moritz S, Stamm TJ. Improving functional outcome in bipolar disorder: A pilot study on metacognitive training. Clin Psychol Psychother. 2018 Jan;25(1):50-58. doi: 10.1002/cpp.2124. Epub 2017 Aug 30.

ReferenceCitation: Lin X, Lu D, Huang Z, Chen W, Luo X, Zhu Y. The associations between subjective and objective cognitive functioning across manic or hypomanic, depressed, and euthymic states in Chinese bipolar patients. J Affect Disord. 2019 Apr 15;249:73-81. doi: 10.1016/j.jad.2019.02.025. Epub 2019 Feb 6.

ReferenceCitation: Miskowiak KW, Petersen JZ, Ott CV, Knorr U, Kessing LV, Gallagher P, Robinson L. Predictors of the discrepancy between objective and subjective cognition in bipolar disorder: a novel methodology. Acta Psychiatr Scand. 2016 Dec;134(6):511-521. doi: 10.1111/acps.12649. Epub 2016 Sep 20.

ReferenceCitation: Ott C, Miné H, Petersen JZ, Miskowiak K. Relation between functional and cognitive impairments in remitted patients with bipolar disorder and suggestions for trials targeting cognition: An exploratory study. J Affect Disord. 2019 Oct 1;257:382-389. doi: 10.1016/j.jad.2019.07.030. Epub 2019 Jul 5.

ReferenceCitation: Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. Erratum in: Biol Psychiatry. 2003 Sep 1;54(5):585.

ReferenceCitation: Van Camp L, Sabbe BGC, Oldenburg JFE. Metacognitive functioning in bipolar disorder versus controls and its correlations with neurocognitive functioning in a cross-sectional design. Compr Psychiatry. 2019 Jul;92:7-12. doi: 10.1016/j.comppsych.2019.06.001. Epub 2019 Jun 6.

ReferenceCitation: Yatham LN, Torres IJ, Malhi GS, Frangou S, Glahn DC, Bearden CE, Burdick KE, Martínez-Arán A, Dittmann S, Goldberg JF, Ozerdem A, Aydemir O, Chengappa KN. The International Society for Bipolar Disorders-Battery for Assessment of Neurocognition (ISBD-BANC). Bipolar Disord. 2010 Jun;12(4):351-63. doi: 10.1111/j.1399-5618.2010.00830.x. Review.

lead_sponsor: Versailles Hospital


title: Cerebral Impact of Cognitive Remediation for People Suffering From Schizophrenia

acronym: IMPACTRCS

summary: Neurocognitive deficits are frequent with people suffering from schizophrenia. Unlike positive symptoms, cognitive deficits are not reduced with antipsychotic medication. They can be very disabling, especially for social and professional rehabilitation. Cognitive deficits can concern primary processes such as attention or more integrative processes. Social cognition is also massively altered. As a consequence, decision making is often altered with the presence of the 'jumping to conclusion' (JTC) phenomenon. People that jump to conclusion are making decisions without having the necessary information to be sure of their judgment. In addition, people suffering from schizophrenia also present differences in cerebral activity. For instance, the P300 involved in executive processes appears later and with a smaller amplitude. Many cognitive remediation programs have been created to overcome these deficits. Their efficiency has been proved. However, their effects on cerebral activity have not been studied extensively in literature, especially concerning decision making changes. The present project will use a cognitive remediation program centered on social decision making to test its efficiency on JTC and the potential changes in cerebral activity it can induce. This program, inspired by the SCIT (Social Cognition and Interaction Technique) will be based on 10 sessions (1 each week). Participants will be tested before and after remediation/control group with 3 experimental tasks. Cerebral activity will be measured with an EEG cap. They will also undergo a neuropsychological evaluation and a symptomatology evaluation.

location_facility: centre de réhabilitation - Hôpital le Vinatier


title: Interventional Study of Antalgic Efficacy of the CycloMesh™ Implant Soaked in Ropivacaine Hydrochloride 10 mg/mL in the Treatment of Uncomplicated Inguinal Hernia. Randomized Comparative Study Versus CycloMesh™ Soaked in Physiological Saline Solution NaCl 9°/°°

acronym: HENRI

summary:
CycloMesh is a polyester visceral implant functionalized by drug delivery systems directly on its surface, targeting a unique intervention, a slow anesthetic release and an in situ activity. Based on the fact that cyclodextrins are capable of forming inclusion complexes with amino-amide anaesthetic agents, ropivacaine and cyclodextrins were combined on a commercial visceral mesh.This enables CycloMesh to release ropivacaine for a sustained period in order to improve patient's comfort after inguinal hernia surgery.

The underlying hypothesis of this work is that clinical gain is achieved by adding a drug delivery system to visceral mesh for the local and prolonged delivery of ropivacaine. This should results in an improvement in quality of life, a reduction in pain and a faster returning to work following treatment of inguinal hernia by lichtenstein technique.

lead_sponsor: Quanta Medical


title: Evaluation of the Performance of Self-monitoring Optimized by Therapeutic Education in the Recurrence of Wet Age-related Macular Degeneration (AMD)

summary: Monocentric and prospective study, evaluating the benefit of self-monitoring optimized by therapeutic education either by the environmental Amsler or the Amsler grid according to the patient's choice and to determine the patient's ability to determine the reality itself recidivism and therefore the need for treatment.

lead_sponsor: Clinique Beau Soleil


title: Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients With Hereditary Bradykinetic Angioedema

acronym: MONOBRAD

summary: The objective is to compare the gene expression of B1 and / or B2 monocyte receptors between patients with hereditary bradykinetic angioedema and control subjects.

lead_sponsor: University Hospital, Rouen


title: Sensory and Psychomotor Profile in Depression

acronym: DEPCOR

summary:
Despite a possible psychomotor retardation during a depressive episode, standardized psychomotor assessment is rare. So, other possible psychomotor disorders or neurological "soft signs" are not known in depression.

The investigator propose in this study to explore the psychomotor characteristics of patients with a major depressive disorder from the realization of a psychomotor assessment in comparison with adult without depressive disorder (control). It will be specifically assess muscle tone, gross motor skills, praxis, body schema and the body image and the perceptions.

lead_sponsor: Centre Hospitalier Esquirol


title: Health and Quality of Life Assessment Project for Caregivers of Idiopathic Pulmonary Fibrosis Patients

acronym: HELP-IPF

summary:
Idiopathic pulmonary fibrosis (IPF) is a chronic, disabling disease characterized by a progressive and irreversible deterioration in respiratory function, resulting in impaired quality of life (QoL) and patient dependence.

The factors involved in the alteration of QoL in these patients are the physical symptoms related to fibrosis (dyspnea, cough, fatigue) and psychological symptoms (anxiety and depression) as well as social, relational and financial factors, the experience of the disease and disability, the time required for diagnosis, the information received, and the initiation of a treatment such as oxygen therapy.

Caregivers primarily in chronic diseases (so-called natural or informal caregivers) provide partial or total assistance to a dependent person for activities of daily living for care, social support and maintenance of autonomy, administrative procedures, psychological support, communication, domestic activities or even financial assistance, often despite their own exhaustion and health issues.

Recent studies on the QoL of patient-caregiver dyads in IPF through semi-structured interviews highlight the role of previously identified factors in caregivers as well.

Investigators want to confirm the data obtained in a large population of patients and their caregivers in order to evaluate the QoL of caregivers and confirm the impact of its various factors on it in order to suggest ways to improve the lives of both the caregiver and the patient.

The hypothesis of investigators' work is that the QoL of caregivers of patients with IPF is altered, particularly by the patient's functional symptoms (cough, dyspnea, fatigue, anxiety and depression), the arrival of oxygen therapy in the home and the caregiver's social isolation.

Investigators believe that there are links and interactions between the caregiver's and patient's quality of life and therefore have an impact on the patient's care.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Prospective and Retrospective Thyroid Cancer Database

summary:
Thyroid cancer database collects clinical and laboratory data from patients with a thyroid tumor who received radioactive Iodine treatment. This database only records information based on patients' medical files in a structured manner.

Thyroid database is used for retrospective non-interventional research projects.

lead_sponsor: Centre Georges Francois Leclerc

location_facility: Methodology, Biostatistics and Data Management


title: Prospective and Retrospective Metastatic Colorectal Cancer Database

summary: The metastatic ColoRectal Cancer (mCRC) Database base contains data collected during the regular clinical patient management in Centre Georges Francois Leclerc, Dijon.


type: EudraCT Number

title: A Multicenter, Prospective, Randomized, Placebo-controlled, Double-blind, Multi-arm, Multi-stage Clinical Trial of Ivabradine for Heart Rate Control In Septic Shock

acronym: IRISS

summary:
Septic shock is a major health problem, with several million cases annually worldwide and a mortality approaching 45%. Tachycardia is associated with excess mortality during septic shock. This pejorative effect could be related to the increase in cardiac metabolic demand, impaired cardiac diastolic function, and/or poorer tolerance of administered exogenous catecholamines. Recent studies suggest that controlling the heart rate with the use of beta blockers has beneficial effects on the morbidity and mortality of septic shock. However, the negative effects of beta-blockers on cardiac contractility and blood pressure complicate their use during septic shock, particularly because about one-half of patients exhibit a septic-associated systolic dysfunction, which often requires the use of inotropes.

Ivabradine is a selective inhibitor of If channels in the sinoatrial node. It is a pure bradycardic agent with no deleterious effect on other aspects of cardiac function (contractility, conduction and repolarization) nor on blood pressure. Ivabradine can therefore alleviate sinus tachycardia without negative inotropic effects nor hypotension. Moreover, the improvement in diastolic function (ventricular filling) with ivabradine may increase stroke volume, even in case of severe impairment of systolic function. Controlling sinus tachycardia with ivabradine during septic shock would allow reducing cardiac metabolic demand (and potentially associated ischemic events) and improving the chronotropic tolerance of exogenous catecholamines. The effectiveness of ivabradine in controlling the heart rate was demonstrated in various clinical settings such as coronary artery disease, chronic heart failure and cardiogenic shock. Encouraging preliminary data are reported in critically ill patients.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Drug


title: Comparative Study of Hypoxia Measured in F-Miso PET/Scan and MRI in Patients With Squamous Cells Carcinoma : Correlation With Immunohistochemistry

acronym: HYPONECK

summary: Hypoxia imaging has not been studied extensively by combining PET and MRI data. Few studies performed the double imaging and none associated anatomopathology with it . This study will use a rigorous methodology through the production of PET/MRI images at the same time by transferring the patient directly from PET to MRI. In addition, the population, unlike other studies, will include preoperative patients with 24-hour surgery for hypoxia imaging by obtaining additional data through specific immunohistochemical analysis of hypoxia.

lead_sponsor: Centre Henri Becquerel


title: Effectiveness of a Schema Therapy on Anxiety in Patients With Multiple Sclerosis .a Randomized Control Study in 106Persian Patients With Relapsing Remitting Multiple Sclerosis (RRMS)

summary: It is a multicentric randomized and controlled study comparing a Scheme therapy program versus local practice in RRMS patients with anxiety. Patients will assist to twenty once-weekly group sessions with a 6-month follow up after the end of the programme. The main criteria is the impact of schema therapy on anxiety evaluated by the questionnaires at the end of the program and at the end of the 6-month follow-up.

lead_sponsor: Paris Nanterre University


title: Study of Locomotor Expectations for Ascending/Descending Slope and Stairs in Patients With Limb Amputations

acronym: JCE

summary:
Patients with lower limb amputations are equipped with prostheses that can be mechanical and/or electronic. These prostheses can be mono-articular (only the ankle) or bi-articular (knee and ankle for example). For amputee patients, situations that may seem trivial, such as climbing and descending stairs, become complex. Thus during the descent of stairs, an unamputated person will slow down the descent by contracting the thigh muscles, which are obviously lacking in the amputee patient. Current prostheses, known as "intelligent" (or "microprocessor") prostheses, make it possible to adjust the locomotion only once the first step has been taken and to assist the patient during ascent/descent situations on slopes and stairs. The next technological challenge in the development of lower limb equipment is to be able to anticipate these complex environmental situations, in order to secure and facilitate movement even before the obstacle is crossed or the terrain changed.

This project plans to use the locomotor expectations commonly made during walking as a means of regulating the locomotor pattern. We believe that these expectations will depend on the situation, i.e. a particular anticipation when climbing or descending a slope, or when approaching a staircase, etc. To understand and describe these locomotor expectations, we plan to use recent techniques called supervised machine learning. These will make it possible to classify locomotor behaviour when walking on a slope or stairs. In the second phase, we would like to describe precisely the characteristics of the movements of the joints, and of the muscles during these adaptations. The final objective of this work is to create an autonomous sensor system to control the anticipatory behaviour of a lower limb prosthesis.


title: Study of Validation of the Advanced Blood Pressure Monitor Withings WPM04 for the Detection of Anomalies of Arterial Pressure, Arrhythmia and Valvular Heart Diseases

acronym: TALISMAN

summary:
The proposed clinical study aims to validate the effectiveness of the WPM04 blood pressure monitor developed by Withings as a diagnostic tool for cardiovascular disorders.

The detection of cardiovascular disorders is oriented along three axes, namely the measurement of blood pressure, the identification of rhythm disorders such as atrial fibrillation and the identification of heart murmur indicating valvular heart disease.

lead_sponsor: Withings


title: Psychological déterminants of the Therapeutic Observance of Osteoporotic Patients

acronym: OSTEOPSY

summary:
Osteoporosis is a skeletal pathology characterized by decreased bone mass and deterioration of bone tissue. This pathology affects predominantly women, which is estimated that 40% of them will suffer an osteoporotic fracture. The incidence of osteoporosis, thus representing a major public health problem where osteoporotic fractures have a higher incidence than those combined with cardiovascular disease and breast cancer (INSERM, 2016; WHO 2008). It causes traumatic fractures that have the effect of dependence and loss of functional autonomy associated, in terms, with the risk of a reduction in life expectancy. The management of osteoporosis therefore becomes an issue for rheumatologists. The latter involves both compliance with hygienic-Dietetic measures (such as calcium intake, physical activities, prevention of falls...) and medicated treatments whose action is intended, for some, to block bone destruction or, for others to stimulate bone formation. The efficacy of drug treatments is now proven, these treatments are however profitable only if the therapeutic adherence of the patients is maximal. However, rheumatologists and researchers generally find an average rate of 70% enrolment after 6 months of treatment, most often lowered to 50% after 12 months of treatment, thus increasing fractures.

On the other hand, the literature informs the medical and educational aspects of the problem of non-observance in osteoporotic patients, but curiously, it does not say anything of the psychological aspects likely to be linked to these behaviors of non-adherence to therapy.

The objective of this thesis work is to take an interest in the underlying psychological determinants that may explain the behaviour of adherence and/or non-adherence of osteoporotic patients.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Focus Thoracic Ultrasound for Dyspnea Diagnosis in Elderly Patient in the ED: Prospective Observational Study

acronym: echoelderly

summary: Brief Summary: The aim of this study is to analyze in elderly patients with undifferentiated dyspnea, the concordance of diagnosis before and after a focus thoracic ultrasound in comparison with the reference one established by an adjudication committee

ReferenceCitation: De Carvalho H, Javaudin F, Le Bastard Q, Boureau AS, Montassier E, Le Conte P. Effect of chest ultrasound on diagnostic workup in elderly patients with acute respiratory failure in the emergency department: a prospective study. Eur J Emerg Med. 2021 Jan 1;28(1):29-33. doi: 10.1097/MEJ.0000000000000732.

family: De Carvalho

full_name: Hugo De Carvalho

given: Hugo

family: Javaudin

full_name: François Javaudin

given: François

family: Le Bastard

full_name: Quentin Le Bastard

given: Quentin

family: Boureau

full_name: Anne-Sophie Boureau

given: Anne-Sophie

family: Montassier

full_name: Emmanuel Montassier

given: Emmanuel

family: Le Conte

full_name: Philippe Le Conte

journal_name: European Journal of Emergency Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Nantes University Hospital


title: Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications

summary: Upper limb (UL) impairment is a common deficit following stroke with only an estimated 20 per cent of patients recovering function.

lead_sponsor: University Hospital, Toulouse


title: Study of the Quality of Life of Patients Treated by Heavy Surgery as Part of an Enhanced Recovery at Beau Soleil Clinic- QUALICHIR

acronym: QUALICHIR

summary:
Heavy and oncological surgery is undergoing a major evolution. Some surgical dogmas are falling and care is better rationalized. The interactions between the patient and the caregivers on the other hand, and from the caregiver to the caregiver are favored. Thus was born, about 10 years ago, the principle of enhanced recovery after surgery (ERAS).

But recovery has improved in the patient in the best possible shape in the operating room, and, during the gesture, minimize the negative effects of surgery and anesthesia. Finally, postoperatively, to re-empower the patient as quickly as possible.

The interest of this study is the benefit of the quality of life of the patient being treated for cystectomy as part of an enhanced recovery program. This is to argue the diffusion of this program and the care teams for its realization.


title: Immune Activation as a Cause of Insulin Resistance in Adults Living With HIV-1 on Effective Antiretroviral Therapy

acronym: MetACTIVIH

summary: The aim of this study is to characterize in non-viremic HIV-1 patients under antiretroviral therapy an immune activation profile that the investigators have previously shown to be strongly linked to hyperinsulinemia. This characterization will be carried out via 3 different approaches. First, the investigators will analyze the metabolites present in the plasma of patients presenting with the profile of interest. Second, the investigators will study the transcriptome of the peripheral blood mononuclear cells of these patients. Finally, the investigators will search whether some factors released by these cells are able to induce insulin resistance. In addition the ability of the profile of interest to predict an increase in insulinemia over time will be assessed.

ReferenceCitation: Psomas C, Younas M, Reynes C, Cezar R, Portalès P, Tuaillon E, Guigues A, Merle C, Atoui N, Fernandez C, Le Moing V, Barbuat C, Marin G, Nagot N, Sotto A, Eliaou JF, Sabatier R, Reynes J, Corbeau P. One of the immune activation profiles observed in HIV-1-infected adults with suppressed viremia is linked to metabolic syndrome: The ACTIVIH study. EBioMedicine. 2016 Jun;8:265-276. doi: 10.1016/j.ebiom.2016.05.008. Epub 2016 May 10. Erratum in: EBioMedicine. 2016 Aug;10:318-322.

lead_sponsor: University Hospital, Montpellier

location_facility: Saint Eloi Hospital, University Hospital of Montpellier


title: Follow up of Increased Nuchal Translucency :Study of 2010 to 2018 of Limoges Hospital

acronym: HYPERCLAIR

summary: The ultrasound of the first trimester allows to determinate the pregnancy beginning, the type of pregnancy and also to detect increased nuchal translucency (NT). Fetuses with common chromosomal abnormalities (trisomies 21, 18 and 13 and monosomy X) and structural abnormalities (particularly cardiac defects) and single-gene disorders frequently show increased NT. The purpose of this study is to evaluate in the population of Limousin, the type and frequency of these abnormalities.

time_perspective: Other

lead_sponsor: University Hospital, Limoges


title: Developmental Dyslexia and Remediation Methods. Phonological, Visual-attentional and Cross-modal Approaches, a Multicentric Study.

acronym: DDMR

summary: At least, three theoretical frameworks are currently involved in therapeutic research in developmental dyslexia. Each theoretical framework relies on the type of underlying cognitive processes that is viewed as impaired: 1°) phonological processing, 2°) cross modal integration, 3°) visual attention processing. In this controlled and randomized study, three types of computerized training are combined in a multi-factorial remedial approach in 8 to 12 year old children with dyslexia. The main objective is to compare the effectiveness of this remedial approach which combines phonological, visual-attentional and cross-modal training with conventional non-intensive and non-specific rehabilitation

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval


title: Focus Cardiac Ultrasound in Patients With Undifferentiated Shock: Prospective Observational Study

acronym: echoshock

summary: The aim of this study is to analyze in patients with undifferentiated shock, the concordance of initial treatment before and after Focus cardiac ultrasound (FoCUS) in comparison with the reference one established by an adjudication committee


title: Optimization of Initial Fluid Challenge by Cardiac and Lung Ultrasound in Patients With Sepsis

acronym: echosepsis

summary: Initial sepsis treatment requires fluid challenge. While the Surviving Sepsis Campaign indicates a 30 ml/kg volume, there is concerns on the efficacy and safety of this fixed volume. The aim of this study is to assess the difference between fluid volume determined par cardiac and lung Ultrasound versus the fixed 30 ml/kg.


title: Pilot Study Evaluating the Effectiveness of Neurofeedback Training in the Improvement of Cognitive Functions of the Elderly With Mild Cognitive Impairment

acronym: NEUROFEEDEL

summary: The purpose of this study is to evaluate the effects of SMR neurofeedback training on cognitive performance and electrical brain activity in elderly with cognitive impairment.


title: Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock

acronym: PRECISE

summary:
Severe sepsis and septic shock remain of particular gravity in children with a current mortality of about 20 % , despite the international prevention campaigns " survival sepsis campaign ". Septic shock associates a macrocirculatory and a microcirculatory dysfunction. The volume expansion remains the treatment of severe sepsis at the initial phase supplemented by the use of vasopressors and / or inotropes. Nevertheless , it is essential to predict the fluid responsiveness after volemic expansion because fluid overload is associated with an increased morbidity in children. In studies , the volume expansion is considered effective if it allows an increase in cardiac output of more than 15 % compared to the basal level. However, their conditions of use remain very restrictive and not applicable to most of our patients ( tidal volume ≥ 7ml / kg , PEEP sufficient , absence of cardiac arrhythmia and effective sedation ) . To date , no index can be used for all patients with invasive mechanical ventilation.

It therefore seems appropriate to develop new tests to predict the response to volume expansion in children with septic shock hospitalized in pediatric intensive care.

A recent study has validated a test to predict the response to volume expansion in adults: injection of a mini-bolus of 50 ml of saline over 10s.

The aim of the study is to evaluate the effect of mini bolus fluid to predict response to fluid expansion in pediatric septic shock.


type: Registry Identifier

title: Efficacy of Mindfulness-based Therapy vs. Relaxation in Prevention of Burnout in Medical Students : A Multicenter, Single Blind Randomized Controlled Study

acronym: MUSTPrevent

summary:
A recent survey exploring mental health in a large cohort of French medical students and young graduates (N = 21.768), observed that 68.2% of participants showed pathologic anxiety. A high level of depressive symptomatology was found in 27.7% of participants, while suicidal ideation was reported by 23.7%. Mindfulness Based Interventions are beneficial for health with a positive impact on mood, anxiety, and well-being. It thus can be hypothesized that such interventions could help to prevent anxio-depressive symptomatology in medical students.

The implementation of prevention programs to promote resilience to stress and empathy among medical students is a priority, included in French National Strategy for Health. Efficacy of Mindfulness Based Interventions in French university must be studied to confirm and strengthen their development. The originality of this project consists in the collaboration of medical schools from different cities and the longitudinal follow-up.

The purpose of this study is to assess the efficacy of a mindfulness-based therapy in burnout prevention in comparison to relaxation.

ReferenceCitation: Baeza-Velasco C, Genty C, Jaussent I, Benramdane M, Courtet P, Olié E. Study protocol of a multicenter randomized controlled trial of mindfulness-based intervention versus relaxation to reduce emotional exhaustion in medical students in France: the "Must prevent" study. BMC Psychiatry. 2020 Mar 11;20(1):115. doi: 10.1186/s12888-020-02529-9.

family: Baeza-Velasco

full_name: Carolina Baeza-Velasco

given: Carolina

family: Genty

full_name: Catherine Genty

given: Catherine

family: Jaussent

full_name: Isabelle Jaussent

given: Isabelle

family: Benramdane

full_name: Myriam Benramdane

given: Myriam

family: Courtet

full_name: Philippe Courtet

family: Olié

full_name: Emilie Olié

given: Emilie

currency_apc_doaj: GBP

journal_name: BMC Psychiatry

repository_institution: PubMed Central - Europe PMC

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Study protocol of a multicenter randomized controlled trial of mindfulness-based intervention versus relaxation to reduce emotional exhaustion in medical students in France: the “Must prevent” study


title: Factors Associated With Normal Exercise Capacity in Patients With Single Ventricle: the Multicenter Cross-sectional Study

acronym: SV

summary:
The congenital heart disease (CHD) is the firts cause of congenital birth defects. Medical and surgical advances completely changed the epidemiology of CHD. Among these CHD, the univentricular heart, or single ventricle (SV), is a disease whose medical-surgical progress has completely changed the epidemiology.

The SV at birth receives systemic and pulmonary venous returns in the single functional cavity and provides systemic and pulmonary flow. The SV undergoes a severe volumetric overload and considerably increases its work, which is not viable for the long time.

In 1968, Professor Francis Fontan created the palliative surgery of the univentricular heart. It consists in establishing a derivation of the systemic venous blood from the two vena cava veins directly to the pulmonary arteries, without a sub-pulmonary ventricle. So, the VU no longer undergoes volumetric overload, and eliminates cyanosis.

In this "Fontan circulation", there is no pump to push the blood in the pulmonary arteries, only the remaining systemic post-capillary energy (reflection of the central venous pressure) allows to drive the blood through the lungs with a risk of stasis upstream (right overload) and a limited pre-charge downstream, which can lead to severe consequences: limited exercise capacity, systolic and diastolic dysfunction of the SV, arrhythmia, cyanosis, cirrhosis and hepatic carcinoma, exudative enteropathy , plastic bronchitis, venous thromboses, deaths.

There is a great heterogeneity within this family of SV with extremely varied evolutionary profiles. The cardiorespiratory exercise test, which has become a "gold standard", makes it possible to assess the severity of CHD. In our study on the aerobic fitness of children with CHD, the investigators found that 44% of children with SV had normal aerobic fitness (> 80% of the theoretical VO2max)1. Some good prognostic criteria are already described: left SV, good VU function, total cavopulmonary shunt in young age, etc. But the investigators know that these elements are not enough to explain why some SV, which the investigators will call the "great-SV", have a better aerobic fitness.

The main objective of our study is to describe the population of "great SV" (VO2max ≥ 80%) within the general population of SV. The investigators thus wish to determine the prognostic criteria favorable to a good aerobic fitness in univenticular heart disease.

ipd_sharing_description: NC


title: PCR Technic Evaluation in the Microbial Diagnostic of Septicemia in Hemodialysis Patients With Catheter.

acronym: PCRDial

summary: The aims of this study are to evaluate the PCR on whole blood approach to determine rapidly both the susceptibility and the identification of Staphylococcus responsible of septicemia in patients under hemodialysis with catheter. The results obtained with this novel experimental approach will be compared to those obtained on the same clinical samples by the routine diagnostic laboratory.

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital Pellegrin - service de néphrologie, transplantation, dialyse et aphérèses


title: REMEDEMPLOI: Social Cognition Training and Vocational Rehabilitation

acronym: REMEDEMPLOI

summary:
Social cognition impairments, frequently encountered in Serial Mental Illness, reduce the ability to find and to keep a job. Cognitive remediation and social cognition training reduce the impact of cognitive impairments on work outcomes . The purpose of this research is to associate a social cognition training program to vocational rehabilitation in the transition network (transitional Workforce Assistance Facilities and Services) to help people to maintain their jobs and to access to work in an ordinary environment. To support the development of social cognition interventions, additional care (users will retain their usual medical follow-up) will be implemented within the Workforce Assistance Facilities and Services.

This project is part of a strong partnership between the Cognitive remediation network (health sector: rehabilitation centers) and the Transition network (medico-social sector: three Workforce Assistance Facilities and Services having partnerships with rehabilitation centers). This partnership has been experienced previously in the RemedRehab project funded by the 2012 hospital clinical research program (PHRC). This project was recently completed.

lead_sponsor: Hôpital le Vinatier


title: Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients. SI-VIM Study

acronym: SI-VIM

summary:
Mirror Therapy (TM) has been shown to be effective in motor rehabilitation of the hemiplegic upper limb, but its implementation in current clinical practice has several difficulties, both from the patient and physiotherapist point of view.

A new computerized Mirror Therapy (TM) device (Intensive Visual Simulation 3 (IVS3), Dessintey) which aims to solve the TM compliance problems and make it more efficient have been developed.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: REHABILITUS: a New Cognitive Remediation Tool for Adults With Intellectual Deficiency With Behavioral Disorders

acronym: REHABILITUS

summary: Adults with intellectual disabilities have great difficulty in adapting to social situations and relationships. Cognitive impairment associated with intellectual disability are important factors to understand their difficulties in processing social information. In the field of recognition of facial emotions in particular, basic cognitive processes such as visuospatial and attentional functions, are heavily involved. Cognitive remediation is a management tool widely used by practitioners to help patients who experience cognitive difficulties. Currently, no program can meet specific and validated the problems are adults with intellectual disabilities manner in their daily functioning


title: Fatigability Compared Men and Women Induced According to the Distance Traveled on an Ultra-marathon in the Mountains

summary:
Acute physiological consequences of ultra-marathon running are still unknown, particularly in women. Some studies have suggested that the proportion of fatigue attributable to peripheral and central mechanisms varies between males and females; however, results are contradictory.

The results from the investigators of the present experiment in two studies conducted in 2009 and 2012 showed that:

A large part of fatigue induced by a mountain ultra-marathon could be attributed to central fatigue in males and that,
Females exhibited less peripheral fatigue in the plantar flexors than males did after a 110-km ultra-trail-running race.

According to the literature, there seems to be a plateau in fatigue after 12-15 hours of running.

ReferenceCitation: Besson T, Parent A, Brownstein CG, Espeit L, Lapole T, Martin V, Royer N, Rimaud D, Sabater Pastor F, Singh B, Varesco G, Rossi J, Temesi J, Millet GY. Sex Differences in Neuromuscular Fatigue and Changes in Cost of Running after Mountain Trail Races of Various Distances. Med Sci Sports Exerc. 2021 Nov 1;53(11):2374-2387. doi: 10.1249/MSS.0000000000002719.

family: Besson

full_name: Thibault Besson

given: Thibault

family: Parent

full_name: Audrey Parent

given: Audrey

family: Brownstein

full_name: Callum G Brownstein

given: Callum G

family: Espeit

full_name: Loïc Espeit

given: Loïc

family: Lapole

full_name: Thomas Lapole

given: Thomas

family: Martin

full_name: Vincent Martin

given: Vincent

family: Royer

full_name: Nicolas Royer

given: Nicolas

family: Rimaud

full_name: Diana Rimaud

given: Diana

family: Pastor

full_name: Frederic Sabater Pastor

given: Frederic Sabater

family: Singh

full_name: Benjamin Singh

given: Benjamin

family: Varesco

full_name: Giorgio Varesco

given: Giorgio

family: Rossi

full_name: Jeremy Rossi

given: Jeremy

family: Temesi

full_name: John Temesi

given: John

family: Millet

full_name: Guillaume Y Millet

given: Guillaume Y

bso_classification: Biology (fond.)

journal_name: Medicine & Science in Sports & Exercise


title: Implementation of a Cardiac Coherence Program to Reduce Anxiety in Patients With Peritoneal Carcinosis Treated by Surgery: Randomized Pilot Study

acronym: COCOON

summary: The investigator proposes to use the cardiac coherence technique to diminish anxiety before the surgery of a peritoneal carcinosis of colon or stomach or ovary and pseudomyxoma or peritoneal mesothelioma.

ReferenceCitation: Dodson RM, McQuellon RP, Mogal HD, Duckworth KE, Russell GB, Votanopoulos KI, Shen P, Levine EA. Quality-of-Life Evaluation After Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy. Ann Surg Oncol. 2016 Dec;23(Suppl 5):772-783. Epub 2016 Sep 8.

ReferenceCitation: Lloyd-Williams M, Dennis M, Taylor F. A prospective study to determine the association between physical symptoms and depression in patients with advanced cancer. Palliat Med. 2004 Sep;18(6):558-63.

ReferenceCitation: Pinquart M, Duberstein PR. Depression and cancer mortality: a meta-analysis. Psychol Med. 2010 Nov;40(11):1797-810. doi: 10.1017/S0033291709992285. Epub 2010 Jan 20.

ReferenceCitation: Elkins G, Staniunas R, Rajab MH, Marcus J, Snyder T. Use of a numeric visual analog anxiety scale among patients undergoing colorectal surgery. Clin Nurs Res. 2004 Aug;13(3):237-44.

ReferenceCitation: Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76.

ReferenceCitation: Sugarbaker PH. Peritonectomy procedures. Ann Surg. 1995 Jan;221(1):29-42.

ReferenceCitation: Tan G, Dao TK, Farmer L, Sutherland RJ, Gevirtz R. Heart rate variability (HRV) and posttraumatic stress disorder (PTSD): a pilot study. Appl Psychophysiol Biofeedback. 2011 Mar;36(1):27-35. doi: 10.1007/s10484-010-9141-y.

ReferenceCitation: Bartoş A, Bartoş D, Raluca S, Mitre C, Hadade A, Iancu I, Cioltean C, Iancu C, Militaru C, Părău A, Breazu C. Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Peritoneal Carcinomatosis: Our Initial Experience. Chirurgia (Bucur). 2019 Mar-Apr;114(2):222-233. doi: 10.21614/chirurgia.114.2.222.

ReferenceCitation: Glehen O, Mohamed F, Sugarbaker PH. Incomplete cytoreduction in 174 patients with peritoneal carcinomatosis from appendiceal malignancy. Ann Surg. 2004 Aug;240(2):278-85.

ReferenceCitation: Piso P, Stierstorfer K, Gerken M, Klinkhammer-Schalke M. Benefit of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy in patients with isolated peritoneal metastases from colorectal cancer. Int J Colorectal Dis. 2018 Nov;33(11):1559-1567. doi: 10.1007/s00384-018-3146-z. Epub 2018 Aug 21.

ReferenceCitation: Balaphas A, Belfontali V, Ris F, Lanitis A, Meier RP, Amram ML, Roth A, Huber O, Berney T, Morel P. [Management of peritoneal carcinomatosis with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy]. Rev Med Suisse. 2016 Jun 15;12(523):1190-4. French.

ReferenceCitation: Minnella EM, Carli F. Prehabilitation and functional recovery for colorectal cancer patients. Eur J Surg Oncol. 2018 Jul;44(7):919-926. doi: 10.1016/j.ejso.2018.04.016. Epub 2018 Apr 30. Review.

ReferenceCitation: Mitchell AJ, Chan M, Bhatti H, Halton M, Grassi L, Johansen C, Meader N. Prevalence of depression, anxiety, and adjustment disorder in oncological, haematological, and palliative-care settings: a meta-analysis of 94 interview-based studies. Lancet Oncol. 2011 Feb;12(2):160-74. doi: 10.1016/S1470-2045(11)70002-X. Epub 2011 Jan 19.

ReferenceCitation: Carlson LE, Angen M, Cullum J, Goodey E, Koopmans J, Lamont L, MacRae JH, Martin M, Pelletier G, Robinson J, Simpson JS, Speca M, Tillotson L, Bultz BD. High levels of untreated distress and fatigue in cancer patients. Br J Cancer. 2004 Jun 14;90(12):2297-304.

ReferenceCitation: Mehnert A, Hartung TJ, Friedrich M, Vehling S, Brähler E, Härter M, Keller M, Schulz H, Wegscheider K, Weis J, Koch U, Faller H. One in two cancer patients is significantly distressed: Prevalence and indicators of distress. Psychooncology. 2018 Jan;27(1):75-82. doi: 10.1002/pon.4464. Epub 2017 Jun 16.

ReferenceCitation: Basak F, Hasbahceci M, Guner S, Sisik A, Acar A, Yucel M, Kilic A, Bas G. Prediction of anxiety and depression in general surgery inpatients: A prospective cohort study of 200 consecutive patients. Int J Surg. 2015 Nov;23(Pt A):18-22. doi: 10.1016/j.ijsu.2015.09.040. Epub 2015 Sep 16.

ReferenceCitation: Kayhan F, Cıcek E, Uguz F, Karababa IF, Kucur R. Mood and anxiety disorders among inpatients of a university hospital in Turkey. Gen Hosp Psychiatry. 2013 Jul-Aug;35(4):417-22. doi: 10.1016/j.genhosppsych.2013.03.004. Epub 2013 Apr 18.

ReferenceCitation: Arrieta O, Angulo LP, Núñez-Valencia C, Dorantes-Gallareta Y, Macedo EO, Martínez-López D, Alvarado S, Corona-Cruz JF, Oñate-Ocaña LF. Association of depression and anxiety on quality of life, treatment adherence, and prognosis in patients with advanced non-small cell lung cancer. Ann Surg Oncol. 2013 Jun;20(6):1941-8. doi: 10.1245/s10434-012-2793-5. Epub 2012 Dec 22.

ReferenceCitation: Foster C, Haviland J, Winter J, Grimmett C, Chivers Seymour K, Batehup L, Calman L, Corner J, Din A, Fenlon D, May CM, Richardson A, Smith PW; Members of the Study Advisory Committee. Pre-Surgery Depression and Confidence to Manage Problems Predict Recovery Trajectories of Health and Wellbeing in the First Two Years following Colorectal Cancer: Results from the CREW Cohort Study. PLoS One. 2016 May 12;11(5):e0155434. doi: 10.1371/journal.pone.0155434. eCollection 2016.

ReferenceCitation: Fox JP, Philip EJ, Gross CP, Desai RA, Killelea B, Desai MM. Associations between mental health and surgical outcomes among women undergoing mastectomy for cancer. Breast J. 2013 May-Jun;19(3):276-84. doi: 10.1111/tbj.12096. Epub 2013 Mar 21.

ReferenceCitation: Wada S, Inoguchi H, Sadahiro R, Matsuoka YJ, Uchitomi Y, Sato T, Shimada K, Yoshimoto S, Daiko H, Shimizu K. Preoperative Anxiety as a Predictor of Delirium in Cancer Patients: A Prospective Observational Cohort Study. World J Surg. 2019 Jan;43(1):134-142. doi: 10.1007/s00268-018-4761-0.

ReferenceCitation: Jamison RN, Parris WC, Maxson WS. Psychological factors influencing recovery from outpatient surgery. Behav Res Ther. 1987;25(1):31-7.

ReferenceCitation: Prieto JM, Blanch J, Atala J, Carreras E, Rovira M, Cirera E, Gastó C. Psychiatric morbidity and impact on hospital length of stay among hematologic cancer patients receiving stem-cell transplantation. J Clin Oncol. 2002 Apr 1;20(7):1907-17.

ReferenceCitation: Scott LE, Clum GA, Peoples JB. Preoperative predictors of postoperative pain. Pain. 1983 Mar;15(3):283-93.

ReferenceCitation: Kim Y, Spillers RL. Quality of life of family caregivers at 2 years after a relative's cancer diagnosis. Psychooncology. 2010 Apr;19(4):431-40. doi: 10.1002/pon.1576.

ReferenceCitation: Satin JR, Linden W, Phillips MJ. Depression as a predictor of disease progression and mortality in cancer patients: a meta-analysis. Cancer. 2009 Nov 15;115(22):5349-61. doi: 10.1002/cncr.24561.

ReferenceCitation: Cossu G, Saba L, Minerba L, Mascalchi M. Colorectal Cancer Screening: The Role of Psychological, Social and Background Factors in Decision-making Process. Clin Pract Epidemiol Ment Health. 2018 Mar 21;14:63-69. doi: 10.2174/1745017901814010063. eCollection 2018. Review.

ReferenceCitation: Smith SK, Loscalzo M, Mayer C, Rosenstein DL. Best Practices in Oncology Distress Management: Beyond the Screen. Am Soc Clin Oncol Educ Book. 2018 May 23;38:813-821. doi: 10.1200/EDBK_201307. Review.

ReferenceCitation: Wagner LI, Spiegel D, Pearman T. Using the science of psychosocial care to implement the new american college of surgeons commission on cancer distress screening standard. J Natl Compr Canc Netw. 2013 Feb 1;11(2):214-21. Review.

ReferenceCitation: Dolbeault S, Boistard B, Meuric J, Copel L, Brédart A. Screening for distress and supportive care needs during the initial phase of the care process: a qualitative description of a clinical pilot experiment in a French cancer center. Psychooncology. 2011 Jun;20(6):585-93. doi: 10.1002/pon.1946. Epub 2011 Mar 22.

ReferenceCitation: Dolbeault S, Bredart A, Mignot V, Hardy P, Gauvain-Piquard A, Mandereau L, Asselain B, Medioni J. Screening for psychological distress in two French cancer centers: feasibility and performance of the adapted distress thermometer. Palliat Support Care. 2008 Jun;6(2):107-17. doi: 10.1017/S1478951508000187.

ReferenceCitation: Maurice-Szamburski A, Auquier P, Viarre-Oreal V, Cuvillon P, Carles M, Ripart J, Honore S, Triglia T, Loundou A, Leone M, Bruder N; PremedX Study Investigators. Effect of sedative premedication on patient experience after general anesthesia: a randomized clinical trial. JAMA. 2015 Mar 3;313(9):916-25. doi: 10.1001/jama.2015.1108.

name: Service d’Anesthésie Réanimation, Hôpital de la Timone Adulte, Marseille, France

family: Maurice-Szamburski

full_name: Axel Maurice-Szamburski

given: Axel

name: Laboratoire Universitaire EA 3279, Santé Publique et Maladies Chroniques, Université Aix-Marseille, Marseille, France

family: Auquier

full_name: Pascal Auquier

given: Pascal

family: Viarre-Oreal

full_name: Véronique Viarre-Oreal

given: Véronique

name: Service d’Anesthésie, Institut du Cancer, Université Montpellier 1, Montpellier, France

family: Cuvillon

full_name: Philippe Cuvillon

given: Philippe

name: Service d’Anesthésie Réanimation, Hôpital Archet, Université Nice Sophia-Antipolis, Nice, France

family: Carles

full_name: Michel Carles

given: Michel

name: Service d’Anesthésie, Pôle ARDU, Hôpital Universitaire Carémeau, Nîmes, Université Montpellier 1, Montpellier, France

family: Ripart

full_name: Jacques Ripart

given: Jacques

name: Expertise Pharmaceutique, Hôpital de la Timone Adulte, Université Aix, Marseille, France

family: Honore

full_name: Stéphane Honore

given: Stéphane

family: Triglia

full_name: Thibaut Triglia

given: Thibaut

name: Unité d’Aide Méthodologique, Direction de la Recherche Clinique, AP-HM, Marseille, France

family: Loundou

full_name: Anderson Loundou

given: Anderson

name: Service d’Anesthésie Réanimation, Hôpital Nord, Pavillon de l’Etoile, Université Aix-Marseille, Marseille, France

family: Leone

full_name: Marc Leone

given: Marc

family: Bruder

full_name: Nicolas Bruder

journal_name: JAMA

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Effect of Sedative Premedication on Patient Experience After General Anesthesia

ReferenceCitation: Karavidas MK, Lehrer PM, Vaschillo E, Vaschillo B, Marin H, Buyske S, Malinovsky I, Radvanski D, Hassett A. Preliminary results of an open label study of heart rate variability biofeedback for the treatment of major depression. Appl Psychophysiol Biofeedback. 2007 Mar;32(1):19-30. Epub 2007 Mar 1.

ReferenceCitation: Trousselard M, Canini F, Claverie D, Cungi C, Putois B, Franck N. Cardiac Coherence Training to Reduce Anxiety in Remitted Schizophrenia, a Pilot Study. Appl Psychophysiol Biofeedback. 2016 Mar;41(1):61-9. doi: 10.1007/s10484-015-9312-y.

ReferenceCitation: Berry ME, Chapple IT, Ginsberg JP, Gleichauf KJ, Meyer JA, Nagpal ML. Non-pharmacological Intervention for Chronic Pain in Veterans: A Pilot Study of Heart Rate Variability Biofeedback. Glob Adv Health Med. 2014 Mar;3(2):28-33. doi: 10.7453/gahmj.2013.075.

ReferenceCitation: Haase O, Langelotz C, Scharfenberg M, Schwenk W, Tsilimparis N. Reduction of heart rate variability after colorectal resections. Langenbecks Arch Surg. 2012 Jun;397(5):793-9. doi: 10.1007/s00423-012-0903-2. Epub 2012 Jan 17.

ReferenceCitation: De Couck M, Caers R, Spiegel D, Gidron Y. The Role of the Vagus Nerve in Cancer Prognosis: A Systematic and a Comprehensive Review. J Oncol. 2018 Jul 2;2018:1236787. doi: 10.1155/2018/1236787. eCollection 2018. Review.

ReferenceCitation: Chambers DA. Sharpening our focus on designing for dissemination: Lessons from the SPRINT program and potential next steps for the field. Transl Behav Med. 2020 Dec 31;10(6):1416-1418. doi: 10.1093/tbm/ibz102.

ReferenceCitation: Chambers DA, Norton WE. The Adaptome: Advancing the Science of Intervention Adaptation. Am J Prev Med. 2016 Oct;51(4 Suppl 2):S124-31. doi: 10.1016/j.amepre.2016.05.011. Epub 2016 Jun 28.

ReferenceCitation: Hijazi Y, Gondal U, Aziz O. A systematic review of prehabilitation programs in abdominal cancer surgery. Int J Surg. 2017 Mar;39:156-162. doi: 10.1016/j.ijsu.2017.01.111. Epub 2017 Feb 2. Review.

ReferenceCitation: Abelson JS, Chait A, Shen MJ, Charlson M, Dickerman A, Yeo HL. Sources of distress among patients undergoing surgery for colorectal cancer: a qualitative study. J Surg Res. 2018 Jun;226:140-149. doi: 10.1016/j.jss.2018.01.017. Epub 2018 Feb 22.

ReferenceCitation: Low CA, Bovbjerg DH, Ahrendt S, Alhelo S, Choudry H, Holtzman M, Jones HL, Pingpank JF Jr, Ramalingam L, Zeh HJ 3rd, Zureikat AH, Bartlett DL. Depressive Symptoms in Patients Scheduled for Hyperthermic Intraperitoneal Chemotherapy With Cytoreductive Surgery: Prospective Associations With Morbidity and Mortality. J Clin Oncol. 2016 Apr 10;34(11):1217-22. doi: 10.1200/JCO.2015.62.9683. Epub 2016 Feb 22.

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


title: Diagnostic Research in Patients With Rare Diseases -Solving the Unsolved Rare Diseases

acronym: AnDDI-Solve-RD

summary:
Most diagnostically unsolved rare disease have a genetic cause. These causes have not been found applying the current methodologies due to technical limitations (e.g. repeat expansions, changes in non-coding (intronic) regions) or, although methodically recorded, their pathophysiological significance but not classified as clinically relevant. A re- and meta-analysis of existing data sets with new algorithms and statistical models as well as the complementation with other omics technologies followed by functional follow-up studies in appropriate disease models (e.g. patient cell lines) allows to elucidate additional causes of diseases and improve the diagnosis of hereditary diseases. In addition to the direct examination of persons affected, the analysis of healthy family members, for example of parents, plays an important role in a so-called trio analysis, especially in the efficient filtering of the extensive data sets for newly created changes, so-called de novo- Variants (new mutations). In the context of the outlined analyzes, new disease genes can be found and validated. The gain of scientific knowledge due to a better understanding of basic cell biological mechanisms can contribute to the development of targeted therapeutic approaches.

In this context, the Solve-RD project has been built and financed by the European Union with the ambitions to solve large numbers of rare disease, for which a molecular cause is not known yet by sophisticated combined omics approaches, and to improve diagnostics of rare disease patients. Solve-RD fully integrates with the newly formed European Reference Networks (ERNs) for rare diseases, and in particular the ERN-RND, -EURO-NMD, -ITHACA, and -GENTURIS. The AnDDI-Rares network is fully affiliated to the ERN ITHACA network and will actively contribute to the project, by the ambition of sharing knowledge about genes, genomic variants and phenotypes.

The project will first reanalyse 18.000 negative exomes from the different ERNs performed in a diagnostic or research context (collection of biomaterial, clinical/phenotypic data plus next-generation sequencing has already been performed, and the patient/family has agreed previously in writing that their sample could be used for research related to their disease, with no study related presence required. The project will also propose new multi-omics analyses with new samples needed in 500 patients and their parents in total, justifying the AnDDI-Solve-RD project.

intervention_type: Genetic


title: The Effect of the Ultrasound-guided Serratus Anterior Plane Block in Combinaison With Thoracic Paravertebral cathéter Versus Thoracic Paravertebral Cather for Perioperative Analgesia in Thoracic Surgery

summary:
Introduction

The paravertebral catheter has been shown to be effective in controlling postoperative pain, but has never been associated with the deep dentate block in thoracic surgery. The objective of this study was to compare the efficacy of single-dose deep dentate block-level postoperative pain control in combination with a continuous perfusion paravertebral catheter versus continuous perfusion paravertebral catheter alone in controlled thoracic surgery.

Materials and methods

We retrospectively included 159 ASA I-III major patients who underwent scheduled thoracic surgery in the operating theater of Dijon University Hospital, between March and November 2018. All patients benefited from the same anesthetic protocol routinely used in controlled thoracic surgery. They were included in two groups: deep serrate deep group (GS) with a deep serrated deep serrate block immediately after orotracheal intubation with 0.2% Ropivacaine at 0.75 mg / kg and paravertebral catheter placed by the surgeon and put in charge at the fall of the surgical drapes versus control group (GC) benefiting from a paravertebral catheter alone. The primary endpoint was 24-hour morphine equivalent consumption. The criteria for secondary judgments were intraoperative remifentanil consumption, VAS at 0h, 24h and 48h, morphine consumption at 0h, 48h and the profile of the various complications. The morphine equivalent was calculated according to an equivalence table with reference to Oxycodone per os. Quantitative data are presented in median and standard deviation and were compared by Student's t-test or Wilcoxon test.

time_perspective: Retrospective


title: Daratumumab as Maintenance After Peripheral Blood Stem Cell Transplantation From HLA-identical or Haploidentical Family Donor in the Treatment of Refractory or Relapsed Multiple Myeloma: a Phase 2 Trial

acronym: DARALLO

summary: The present protocol aims to test, whether an approach using (i) a reduced-toxicity TBF followed by a (ii) Daratumumab maintenance and (iii) prophylactic infusion of donor lymphocytes (pDLI), will be able to improve progression-free survival of patients with refractory or relapsed MM. This trial represents the first prospective protocol aiming to test the use of Daratumumab maintenance after HLA-identical or haploidentical allo-SCT in patients with MM.

status: Withdrawn

location_facility: Service d'hématologie clinique et thérapie cellulaire


title: Positive End-expiratory Pressure Effects to Predict Fluid Responsiveness

acronym: PEEP-TEST

summary: Volume expansion is one of the main treatments for shock. A test to predict the effectiveness of volume expansion prior to administration would avoid the need for excess treatment if it proves to be unnecessary.PEEP test would be an easy alternative to the tests used in current practice.