title: Prevalence of Hypotension Associated With Preload Dependence During Continuous Renal Replacement Therapy

acronym: PRELOAD-CRRT

summary:
Per-dialytic hypotension is common in Intensive Care Unit patients under continuous renal replacement therapy, and occurs in nearly 50% of the patients. To date, there is a lack of study having characterized the underlying mechanism of hypotension in this setting. New diagnostic methods are now available with high reliability to identify hypovolemia as the underlying cause of hypotension, among which change in cardiac index during passive leg raising may be the less affected by restrictive validity criteria. A change in cardiac index greater than 10% during this test is highly predictive of preload dependence, i.e the probability than cardiac index will increase if cardiac preload increases.

The aim of this study is then to identify, among hypotensive episodes occurring during renal replacement therapy in Intensive Care Unit patients, the percentage of episodes related to preload dependence as identified by passive leg raising.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de réanimation médicale- Hôpital de la Croix-Rousse


title: Prevalence of Liver Fibrosis and Cirrhosis in Patients With Squamous Cell Carcinoma of the Head and Neck

acronym: fibr'HOM

summary: Tobacco and alcohol are the two major risk factors for upper respiratory tract cancer (VADS).

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Impact of VeinViewer® Vision to Guide Peripheral Venipuncture in Geriatrics

acronym: VeinGER

summary: Peripheral venipuncture is a common procedure in geriatrics. This procedure due to altered cutaneous alteration and venous capital associated with age poses problems of comfort and quality of life of elderly patients hospitalized. There is little data from the literature that highlights the difficulties of venipuncture in the context of old age. New venous visualization technologies by infrared spectroscopy (NIR) such as VeinViewer® Vision (VVV) have been developed to guide the placement of a peripheral venous (VVP) or venipuncture (PV) route.

study_start_date_type: Actual

status: Recruiting

design_allocation: Randomized

primary_purpose: Diagnostic

ipd_sharing: No

intervention_type: Biological

status_simplified: Ongoing


title: Place of Endoscopic Rectal Ultrasound With Elastosonography and Contrast in Diagnosis and Supported of Deep Pelvic Endometriosis With Bowel Involvement

summary: The aim of the study will be to determine the diagnostic and prognostic value of elastosonography and the use of the contrast agent (Sonovue®) in the endoscopic ultrasound exploration of deep pelvic endometriosis.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Société Française d'Endoscopie Digestive

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: The Potential Impact of Aging Stereotypes in the Assessment of Memory Deficits and Screening for Prodromal State of Alzheimer's Disease

acronym: AGING

summary: Because of the lengthening of life expectancy, more and more people are concerned with the effects of aging on their mental faculties (e.g., memory decline) and with the possibility of getting Alzheimer's Disease (AD) or other forms of dementia. This increasing awareness of AD has already resulted in a growing demand for neuropsychological testing. AD's research also emphasizes the need for early screening to improve the prediction of the disease progression and the efficacy of any future therapy. Such a drive to screen for pre-dementia raises the challenging issue of frontline identification of individuals in the preclinical or early clinical stages of AD. Mild Cognitive Impairment (MCI) is typically considered to be the prodromal state of AD, and is therefore at the core of the drive for early screening. Moreover, Pre-MCI so called SCI (Subjective Cognitive Impairment) can precede AD for 15 years. However, many individuals diagnosed with MCI do not convert to AD, some remaining stable and others even reversing back to normal (with rates of reversion to normal varying from 4.5% to as high as 53%). This over-diagnosis bias, which has been largely overlooked, is at the core of the present project at the interface of human and life sciences. Here, we argue that an important source of overdiagnosis in the prodromal state of AD comes from negative aging stereotypes (e.g., the culturally shared beliefs that aging inescapably causes severe cognitive decline and diseases such as AD) that permeate neuropsychological screening. There is ample evidence in the laboratory that such stereotypes contribute to the differences observed in the healthy population between younger and older adults in explicit memory tasks. Additionally, three pilot (lab) studies specifically conducted for the present ANR project showed that the threat of being judged stereotypically undermines the controlled use of memory of healthy older adults and simultaneously intensifies their automatic response tendencies, resulting in impaired memory performance. The present proposal goes several steps further by examining for the first time whether aging stereotypes are powerful enough to implicitly permeate the clinical neuropsychological testing and thus inflate memory deficits in older adults judged "at risk" (based on either epidemiological criteria or memory complaints), resulting in false-positive detection of SCI and MCI. This provocative hypothesis will be tested while 1) using biomarkers of neurodegeneration to distinguish false-positives from true MCI, and 2) using biomarkers of stress to examine whether and how aging stereotypes can lead to acute physiological stress during neuropsychological testing. This innovative project has the potential to offer new recommendations to improve the diagnosis accuracy of prodromal state of AD, with positive consequences for older people's wellbeing.

ReferenceType: derived

ReferenceCitation: Gauthier K, Morand A, Dutheil F, Alescio-Lautier B, Boucraut J, Clarys D, Eustache F, Girard N, Guedj E, Mazerolle M, Paccalin M, de la Sayette V, Zaréa A, Huguet P, Michel BF, Desgranges B; AGING consortium, Régner I. Ageing stereotypes and prodromal Alzheimer's disease (AGING): study protocol for an ongoing randomised clinical study. BMJ Open. 2019 Oct 7;9(10):e032265. doi: 10.1136/bmjopen-2019-032265.

apc_source: openAPC

family: Gauthier

full_name: Kim Gauthier

given: Kim

sequence: first

family: Morand

full_name: Alexandrine Morand

given: Alexandrine

sequence: additional

family: Dutheil

full_name: Frederic Dutheil

given: Frederic

family: Alescio-Lautier

full_name: Béatrice Alescio-Lautier

given: Béatrice

family: Boucraut

full_name: José Boucraut

given: José

family: Clarys

full_name: David Clarys

given: David

family: Eustache

full_name: Francis Eustache

given: Francis

family: Girard

full_name: Nadine Girard

given: Nadine

family: Guedj

full_name: Eric Guedj

given: Eric

family: Mazerolle

full_name: Marie Mazerolle

given: Marie

family: Paccalin

full_name: Marc Paccalin

given: Marc

family: de la Sayette

full_name: Vincent de la Sayette

given: Vincent

family: Zaréa

full_name: Aline Zaréa

given: Aline

family: Huguet

full_name: Pascal Huguet

given: Pascal

family: Michel

full_name: Bernard F Michel

given: Bernard F

family: Desgranges

full_name: Béatrice Desgranges

family: Régner

full_name: Isabelle Régner

given: Isabelle

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

title: Ageing stereotypes and prodromal Alzheimer’s disease (AGING): study protocol for an ongoing randomised clinical study

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Optimizing Access to Care Through New Technologies: a Randomized Study Evaluating the Impact of Telephone Contact and the Sending by the General Practitioner of Suspicious Lesions Melanoma Photographs Taken With a Smartphone, on the Time Limit to the Consultation With a Dermatologist

acronym: OASE Melanome

summary:
Early detection of melanoma showed an impact on the thickness of the lesions at the time of diagnosis. One challenge is to improve the modalities.

Decrease the rate of non-compliant patients among patients referred to the dermatologist for a suspicious lesion (patients who will never go to the consultation), and reduce the time interval between the first identification of the lesion and the excision allowing the diagnosis are major issues.

Direct contact between the general practitioner (GP) and the dermatologist would probably make it possible to shorten the care pathway of patients with lesions justifying excision.

The objective is to evaluate whether contacting the dermatologist directly by telephone and e-mailing the photograph of a suspicious melanoma lesion can significantly reduce the time required for access to the consultation for the following patients: (a) referred for a suspicious lesion of melanoma by the GP (b) and having a sufficiently suspicious lesion of melanoma so that the dermatologist conclude at the need for excision (true positives).

Expected results: The procedure should shorten the care pathway for patients with melanoma and decrease the proportion of patients who do not consult the dermatologist when they were referred ("non-observing patients").

This should facilitate the identification of thinner lesions. The benefit for the patient is then direct with a survival at 5 years higher.

In public health terms, it is expected a benefit as better optimization of resources. In a situation of shortage of professionals, access to the dermatologist should be optimized by optimizing emergency access for patients who require it.

primary_purpose: Prevention

lead_sponsor: Nantes University Hospital


title: Characterization of Proteins and Forms of Albumin Removal Capacities of the Theranova Membrane by Innovating Proteomic Investigations

acronym: DIALOMIC

summary:
Hemodialysis is the major technique of renal suppleance and membrane improvements allow an efficient depuration. During the past fifty years, improving the architecture of the membranes increased constantly the clearance of uremic toxins. Online-hemodiafiltration allowed a potential interest for decreasing morbi-mortality, but this technique is not available in all hemodialysis centers yet. Theranova membrane, by its innovating architecture, could be a valuable option for the enhancement of toxin removal in patients who are not eligible for online-hemodiafiltration techniques. Interestingly, many works pointed adsorptive capacities of dialysis membranes and these observations suggest that adsorption cannot be considered as an epiphenomenon. However, there is a lack of knowledge about the extent of its benefits in hemodialysis. The efficiency of a session of hemodialysis is routinely based on the clearance of only few generic toxins (urea, ß2-microglobulin, myoglobin). The eKT/V formula permitted to link a good depuration of urea with a better survival. EuTox described in a recent review, a large panel of middle molecules considered as uremic toxins. As there are many involved toxins, modern evaluation of hemodialysis efficiency can't be still based on the only description of ß2-microglobulin and urea removals. Inflammation status is routinely measured with blood levels of CRP. However, its accumulation is not leading to a toxicity. Many others inflammatory markers have been linked with morbidity and atherosclerosis, the main cause of mortality in ESRD patients. Obviously, removal of inflammatory markers by different dialyzers needs to be assess concomitantly but single conventional dosages are time-consuming.

A minimal albumin loss is considered as another important factor for a safe hemodialysis. Due to its multiple biological functions, albumin may be one of the most important protein for the maintenance of body homeostasis. Recent works were interested in the potential toxicity of some isoforms of the albumin and especially in chronic kidney disease. Modified forms of albumin have been linked with toxic properties and the removal of modified forms could be beneficial. Furthermore, albumin oxidation can lead to an under-estimation of albumin levels with the routinely used assay. A modern evaluation of the capacities of depuration of dialyzers clearly needs to integrate the evaluation of the clearance and generation of modified forms of albumin and proteins.

Proteomic techniques allow an interesting non-selective integrative approach. This exhaustive view would be particularly adequate for building a snapshot of blood uremic toxins, permeative and adsorptive capacities of each membrane. Due to a high sensitiveness, proteomic techniques can improve dramatically the characterization of the depuration capacities of different hemodialysis membranes considering a large range of uremic toxins especially with middle molecular weight, a large panel of inflammatory markers and modified forms of albumin. Furthermore, proteomic approach can help to build a quasi-exhaustive description of all the proteins removed by a membrane.

This project aims to compare the removal capacities of each membrane on a large range of proteins and forms of albumin (native and modified) with a highly-sensitive LC-MS/MS proteomic approach. We will also build the complete proteome of depuration of each tested membrane.

design_allocation: Non-Randomized

location_facility: Service de Néphrologie -Hypertension - Hémodialyse, Hôpital Edouard Herriot

intervention_type: Device


title: New Tumor Models in Three Dimensions and in a Human Skin Environment for Personalized Melanoma Therapy

acronym: SkinTher

summary:
The choice of treatment of patients with metastatic melanoma depends on the status of B-RAF of the tumor: in the absence of mutation, treatment with immunotherapy (currently anti-PD1) is proposed in the first line; When B-RAF is mutated, treatment with targeted therapies is retained: B-RAF and MEK inhibitors are prescribed in combination (vemurafenib + cobimetinib or dabrafenib + trametinib).

Patient response rates for targeted therapies range from 50 to 60%, and the occurrence of sometimes severe side effects is not predictable. There are currently no predictive biomarkers of patients' response to targeted therapy molecules. The in vitro evaluation of the intrinsic sensitivity of the cells of patients to different combinations of targeted therapy molecules would make it possible to propose the best therapeutic combinations. The cutaneous metastases are chosen in the model because of easy access to collect tumor tissue.

The most relevant in vitro models for mimicking cutaneous melanoma metastases are explant cultures and human skin equivalents.


title: Analysis of Transcriptomic Profile of Graft-versus-host Disease (GHVD) After Allogeneic Grafting of Hematopoietic Stem Cells

summary:
Graft-versus-host disease (GVHD) is a frequent and severe complication of hematopoietic stem cell transplantation (HSC), and is responsible for significant early mortality despite prophylactic strategies developed in recent decades, Especially since it is resistant to first-line treatment.

The present diagnosis is difficult, non-specific and is based on the combination of an evocative clinical context (CSH allograft, time to appearance before J100, characteristic clinical manifestations), suggestive anatomo-pathological analysis (predominantly inflammatory infiltrate Lymphocyte, mucosal edema and presence of apoptotic bodies), and the exclusion of any differential diagnosis (in particular serology / negative viral PCR).

However, to date there is no molecular characterization of this manifestation, and therefore no specific treatment.

The nCounter® nanostring technology allows the rapid and simple analysis of the simultaneous expression of a group of genes (up to 800 on the same sample), from a very small amount of RNA, and from samples with difficulty Such as fabrics already fixed to formaldehyde and included in paraffin. It allows the detection of a "molecular signature" of the tissue analyzed.

No transcriptomic analysis has ever been performed on human tissues with GVHD.

time_perspective: Retrospective


title: Prospective Study With Biological Assessment: Evolution of Coagulation Activity in Non Valvular Atrial Fibrillation Patients Under Apixaban

acronym: ECAN

summary: Apixaban is a potent, oral, selective reversible direct inhibitor of factor Xa with a favorable efficacy and safety profile in the prevention of non valvular (NV) atrial fibrillation (AF). It has been shown, including by our group, that D-dimers levels (molecular marker of coagulation activity) are predictive of the events (including mortality) in patient with AF independently of the antithrombotic treatment. The aim of the study is to evaluate the changes in plasma levels of biomarkers of coagulation activation: D-dimers, prothrombin fragments F1+2, von Willebrand factor (vWF) and thrombin-antithrombin complexes (TAT) in response to apixaban treatment in patients with NVAF.

primary_purpose: Screening

lead_sponsor: Hopital Lariboisière

location_facility: Department of Cardiology Lariboisiere Hospital

intervention_type: Drug


title: IMMUNOCANDIDA Candida Host Defense Response After Septic Shock in the Critically Ill

acronym: IMMUNOCANDIDA

summary: Septic shock is associated with acquired immunoparalysis which is associated with a high risk of nosocomial acquired infection. Nosocomial candidiasis is associated with a 50% rate of mortality but is difficult to diagnose. The use of colonization indexes and risk factors on the other hand expose to unnecessary use of antifungals. The aim of the present study is to evaluate whether the host response to infection associated with candida biomarkers would help to anticipate the candidiasis onset.

lead_sponsor: University Hospital, Montpellier

intervention_type: Diagnostic Test


title: Retrospective Analysis of Lymphomas and Cancers Synchronous Occurrence in Picardy From 2007 to 2012

acronym: LYMPHOSYNCHRO

summary:
Cancer is the leading cause of death in man and the second leading cause in women with 85,000 and 63,000 deaths, respectively, in 2012. A working group led by Holly L. Howe, PhD, in 2002 defined primary neoplasia Such as the occurrence and diagnosis of two or more independent neoplasms of different histology in the same patient. The occurrence of a new cancer has become more frequent in recent years: the prevalence of multiple primary neoplasia (NPM) is estimated between 0.73% and 11.7%. According to the French data, the risk of second cancer in people who have already had a first cancer is increased by 36% compared to the general population. Several studies have reported an increase in the risk of cancer after treatment of lymphoma but there are currently no studies on the occurrence of lymphoma and cancer of synchronous occurrence.

In our department, 19 patients presented cancer and lymphoma synchronously, that is to say 6 months between 2007 and 2012.

The main objective is to show that there is an increase in the incidence of cancers in patients diagnosed for lymphoma synchronously. Secondary objectives are to describe the clinical and biological characteristics of the patients concerned and to formulate hypotheses on the physiopathological mechanisms involved: peri-tumoral B-cell lymphoproliferation, alteration of the immune system or rearrangement of the BCR.

In a second step, the investigator could propose a multicenter epidemiological study using data from the different Cancer Registries. If results are confirmed in a larger cohort, recommendations could be made.


title: Prevalence of a High-intensity Signal of the Oculomotor Nerve on T2 MRI Sequence in Patients With Ophthalmoplegia

acronym: HYPER-III

summary:
Oculomotor nerve (third cranial nerve or III) palsy is a relatively frequent cause of consultation in ophthalmology.

It may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and therefore need imaging in emergency. Apart from few extreme emergency situations, MRI of the oculomotor tract is the first-line examination required. In the usual clinical practice, the investigators noticed in several patients unusual areas of high-intensity signal within the oculomotor nerve on T2 sequence, observed in various locations along the nerve path (cavernous and/ or intra-orbital segment). This abnormal signal, at the best knowledge of the investigators, has never been reported in the literature and could confirm the nerve impairment.

In patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this new MRI sign could help (i) to confirm the involvement of the oculomotor nerve and eliminate differential diagnoses such as myasthenia (ii) to orientate the etiological diagnosis (inflammatory or ischemic origin). A T2 sequence focused on the III could thus be systematically included in the usual MRI protocol.

time_perspective: Cross-Sectional

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild


title: Evaluation of Endothelial Dysfunction During Aortic Valvular Replacement by Bioprosthesis With and Without Extracorporeal Circulation

summary:
Patients with aortic stenosis present many risk factors for endothelial dysfunction (arterial hypertension, arteriosclerosis, dyslipidemia, chronic renal insufficiency, etc.). It is likely that a significant number of patients suffer from pre-existing endothelial dysfunction that can be evaluated by a molecular approach.

To date, the replacement of the aortic valve can be performed by surgery with extracorporeal circulation (CEC) or percutaneous (Transcatheter Aortic Valve ImplantationTAVI) without CEC.

Two recent studies have demonstrated a sustained improvement in endothelial function with TAVI. On the contrary, studies have demonstrated that post-operative complications (coagulopathy, capillary leak syndrome, acute vasoplastic disorder and acute renal failure) after surgery with extracorporeal circulation (CEC) could be the result of the interaction between pre-existing endothelial dysfunction And the "operative" aggression associated with the CEC.

Thus, patients with preexisting involvement of endothelial function would develop vascular dysfunction after valvular replacement due to "endothelial activation" related to CEC. This phenomenon would not exist in TAVI, and would explain the absence of so-called vascular dysfunction complications (Systemic inflammatory response syndrome, vasoplastic syndrome, disseminated intravascular coagulation).


title: Evaluation of Adherence to Guidelines, and of the Risk to Benefit Ratio, in the Use of TNFα Antagonists in Pregnant Women With Inflammatory Bowel Diseases. Study on the French National PMSI Database

acronym: EVASION

summary: : Inflammatory bowel diseases (IBD), such as Crohn's disease (CD) and ulcerative colitis (UC) need long term treatments which can conflict with a desire of pregnancy in women. Uncontrolled IBD increases the risk of poor pregnancy outcomes [1]. Antitumor Necrosis Factor α (antiTNFα) are commonly used, off-label, in pregnancy but with the risk of treatment-related complications. Existing recommendations on the use of antiTNFα during pregnancy are conflicting and only rely on expert opinions. This study was aimed to assess appropriateness and risk to benefit ratio of antiTNFα treatment during pregnancy in women with IBD, for both the mother and the baby until the end of the first year.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Evaluation of the Contribution of the Ultrasound Tracking and the Positioning of the Distal End During the Implantation of Implantable Chamber or Long-lasting Venous Catheter

acronym: EchoPAC

summary:
Given the increase in the number of PAC implants or long-term catheters, and the ease of access to cardiac ultrasound in the operating theaters, the investigator thought to use ultrasound to PAC or long-term catheters.

The investigator considers cardiac echocardiography through its costal pathway to locate the correct positioning of the distal end of the catheter in a manner equivalent to the scopic locating with all the side effects of the irradiation and with Equivalent efficiency

status: Withdrawn


title: Aortitis and Retroperitoneal Fibrosis: Evaluation of Diagnostic Criteria

summary:
Inflammatory aortitis probably represents a heterogeneous group, and the clinical experience accumulated over the last ten years, shared by the experts of the subject, is that the initial clinical, biological or radiological characteristics should make it possible to differentiate them and dismember the Nosological field.

This will be an essential first step before studying prognosis, risk factors, and therapeutic options.

The search for diagnostic criteria on a large series, similar to the study of classification of vascularites of the ACR in 1990, should make it possible to homogenize the diagnoses for the different teams working on the subject, and to begin work Collaborations, which alone can improve patient care in the future.


title: Repetitive Thoughts in Fibromyalgia: Impact of Rumination on the Emotional and Cognitive Dimensions of Fibromyalgia

summary:
Dysfunctional chronic diffuse pain syndrome, concerning 2% of the French population, Fibromyalgia (FM) is classified either as a psychological disease or as a somatic disease. This dichotomous reasoning does not lead to a better understanding and does not allow the use or development of new psychological tools of care.

The issue of the proximity between FM and depression highlighted by some authors and the presence of anxious comorbidities may arise at a different level, that of the transdiagnostic approach. Rumination is one of these transdiagnostic processes that are the subject of recent studies and one of the dimensions of which (abstract analytical rumination) is at work in depression and a number of psychopathologies. The investigator therefore wishes to explore the process of rumination and its abstract analytical dimension in FM and to explore its link with the depressive and anxious manifestations frequently associated with this disorder.


title: Deficits, Adaptation and Cerebral Functional Reorganization of Visual Retinotopic Treatments During Normal and Pathological Aging (Age-related Macular Degeneration and Glaucoma)

acronym: VISIOPERICENT

summary: The main objective of this research is to study the cognitive and cerebral mechanisms of the integration of central and peripheral visual information during normal and pathological aging (ophthalmological patients with AMD and glaucoma) through fMRI studies. To assess the effect of normal aging, research will be conducted on a group of young participants with normal vision and a group of elderly participants with normal vision. Each participant will be assessed once during an MRI (during which the brain activity and behavioral performance will be measured). In order to evaluate the effect of pathological aging, research will be conducted on AMD patients, glaucomatous patients, and age-matched controls (normal vision), evaluated only once during an MRI examination.

status: Terminated

primary_purpose: Basic Science

lead_sponsor: University Hospital, Grenoble

location_facility: Clinique Ophtalmologique Universitaire de Grenoble

intervention_type: Radiation


title: Attitudes and Feelings of Doctors Caring for Their Colleagues: a Qualitative Study in Picardy

acronym: ATTRESMED

summary: The sick doctor is a patient apart. His right of prescription and his knowledge of semiology easily lead him to self-medication.


title: Evolution of Indications for Transbronchial Ganglionic Ultrasound in the Picardie Region Over the Period 2008 - 2013

acronym: EBUSPicardie

summary: New indications for bronchial echo-endoscopies with transbronchial needle aspiration (EBUS-PTBA) have appeared since the first French centers with this technique were fitted. Evaluate the respective share of each indication of EBUS-AWPB over time over the period 2008 - 2013


title: Predictive Diagnostic Criteria for Diagnosis of Transbronchial Biopsies, Echo-guided by Mini-probe in Peripheral Lung Lesions

acronym: EBUS-R-PTB

summary:
The diagnosis of nodules and peripheral lung masses (lesions not accessible in classical bronchial endoscopy) is a challenge for the pulmonologist especially when these lesions are not accessible to the transparietal aspirate under scanner. The overall sensitivity of flexible fibroscopy for peripheral lesions is 69% (bronchial brushing, transbronchial biopsies, bronchoalveolar lavage and blind trans-mucosal aspiration). This sensitivity varies from 33% when the lesion is less than 2 cm, to 62% when it is greater than 2 cm. The puncture under scan of these lesions remains the gold standard. In the meta-analysis of Schreiber G et al., The diagnostic sensitivity of transparietal aspirate for peripheral lung lesions is 90%. On the other hand, the complication rate of this technique is not negligible, with in the study of Boskovic et al, a pneumothorax rate varying from 8 to 64%. In the literature, the only risk factor actually found is the existence of emphysema. However, thoracic drainage is rarely necessary.

Bronchial echo-endoscopy using a radial mini-probe was developed in 1992 by Thomas Hürter and Peter Hanrath to produce ultrasound guided specimens of these peripheral lung lesions. In the meta-analysis of Steinfort et al., The overall sensitivity of this mini-probe technique is 73% for the histological diagnosis. From the same author, a randomized trial compared the diagnostic sensitivity of transparietal aspirate undergoing ultrasound-guided transbronchial biopsy with a radial mini-probe: this was 93.3% versus 87.5% with no significant difference (p = 1 ), Whereas post-procedure complications are less frequent in the ultrasound procedure (27% versus 3%, p = 0.03). Steinfort also showed that the economic cost of bronchial echo-endoscopy by radial mini-probe and transthoracic puncture under CT was similar both to the success or failure of the first procedure requiring further investigations . Mini-probe-guided specimens are therefore an efficient diagnostic alternative to obtain a histological diagnosis of these peripheral lung lesions


title: Influence of the Operative Day on the Average Duration of Stay in Primary Hip and Knee Replacements

acronym: JourOpDMS

summary: Reducing the length of stay (LOS) after primary arthroplasty is a relatively new target that arouses the attention of orthopedic surgeons in order to return home early through the fast recovery protocols but this goal is also wanted in public health for the sake of overall decline health spending in public costs.


title: Impact of the Assumption in Charge of Medical Aid to the Procreation With Donation of Gametes on the Sexuality of the Couple

acronym: SEXODON

summary: Sexual disorders associated with medical aid for procreation have already been demonstrated in several studies. However, few of them are interested in the problem of patients in charge of donating gametes, and if studied, it is often restricted to donating sperm to a small number of patients. For this reason, it would be interesting to study the impact of the intake and in charge and the treatments of the Medical Aid to the Procreation on this population of patients (including the patients treated in donation of sperm but also Those supported in oocyte donation)


title: Interest of MRI in Preoperative Staging for the Laryngeal and Hypopharyngeal Cancer

acronym: Larynx MRI

summary: To determine if MRI can detect preoperative invasion of cartilage by laryngeal and hypopharyngeal carcinoma, and to compare it to CT imaging and histopathology in excised larynges and/or hypopharynges.

location_facility: Service ORL et chirurgie cervico-faciale, Hôpital de la Croix rousse


title: Neurophysiological Correlates of Sleep Motor Consolidation Following Motor Imagery Practice

summary: This study is designed to determine the neural networks underlying the sleep-related motor consolidation process following motor imagery practice. While beneficial effects of sleep are expected for sequential movement but not for adaptation motor tasks, the corresponding neuroanatomical correlates have not yet been investigated when participants acquired the motor tasks through mental practice. Data should substantially promote how designing motor imagery interventions targeting (re)learning and/or motor recovery in patients suffering from motor disorders.


title: Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults

acronym: COGFRAIL

summary: The current study seeks to examine the prevalence of amyloid pathology, among patients referred to the Toulouse Geriatric Frailty Clinic presenting objective memory impairment. We also aim to fully characterize the clinical progression of frail cognitively impaired patients presenting AD (Alzheimer Disease) pathology vs those who also present a cognitive impairment but do not have AD pathology.

ReferenceType: background

ReferenceCitation: Robertson DA, Savva GM, Kenny RA. Frailty and cognitive impairment--a review of the evidence and causal mechanisms. Ageing Res Rev. 2013 Sep;12(4):840-51. doi: 10.1016/j.arr.2013.06.004. Epub 2013 Jul 4. Review.

ReferenceCitation: Panza F, Solfrizzi V, Barulli MR, Santamato A, Seripa D, Pilotto A, Logroscino G. Cognitive Frailty: A Systematic Review of Epidemiological and Neurobiological Evidence of an Age-Related Clinical Condition. Rejuvenation Res. 2015 Oct;18(5):389-412. doi: 10.1089/rej.2014.1637. Epub 2015 Aug 20. Review.

ReferenceCitation: Kojima G, Taniguchi Y, Iliffe S, Walters K. Frailty as a Predictor of Alzheimer Disease, Vascular Dementia, and All Dementia Among Community-Dwelling Older People: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2016 Oct 1;17(10):881-8. doi: 10.1016/j.jamda.2016.05.013. Epub 2016 Jun 17. Review.

ReferenceCitation: Buchman AS, Schneider JA, Leurgans S, Bennett DA. Physical frailty in older persons is associated with Alzheimer disease pathology. Neurology. 2008 Aug 12;71(7):499-504. doi: 10.1212/01.wnl.0000324864.81179.6a.

ReferenceCitation: Buchman AS, Yu L, Wilson RS, Schneider JA, Bennett DA. Association of brain pathology with the progression of frailty in older adults. Neurology. 2013 May 28;80(22):2055-61. doi: 10.1212/WNL.0b013e318294b462. Epub 2013 May 1.

ReferenceCitation: Tavassoli N, Guyonnet S, Abellan Van Kan G, Sourdet S, Krams T, Soto ME, Subra J, Chicoulaa B, Ghisolfi A, Balardy L, Cestac P, Rolland Y, Andrieu S, Nourhashemi F, Oustric S, Cesari M, Vellas B; Geriatric Frailty Clinic (G.F.C) for Assessment of Frailty and Prevention of Disability Team. Description of 1,108 older patients referred by their physician to the "Geriatric Frailty Clinic (G.F.C) for Assessment of Frailty and Prevention of Disability" at the gerontopole. J Nutr Health Aging. 2014 May;18(5):457-64. doi: 10.1007/s12603-014-0462-z.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Toulouse

location_facility: Toulouse University Hospital (CHU de Toulouse)

intervention_type: Procedure


title: Study of Gesture and Executive Functions in Children With High Intellectual Potential

acronym: MOHPI

summary: The main objective of this study is to determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children.

lead_sponsor: University Hospital, Brest


title: High Intensity Focused Ultrasound Guided by MRI as Thermic Destruction in Primitive Small Size Breast Cancer. Phase II Pilot Study : Effectiveness and Procedures Standardization

acronym: MRHEATBREAST

summary: This is a non-randomized, prospective phase II trial evaluating an innovative treatment, focused MRI-guided ultrasound, as thermic destruction in primitive small size breast cancer.

primary_purpose: Treatment

lead_sponsor: Centre Antoine Lacassagne


title: Assessment of Efficacy, Tolerance and Acceptability of Urgo 310 3166 Dressing in the Treatment of Local Venous or Mixed Leg Ulcers

acronym: CASSIOPEE

summary: Assessment of efficacy & tolerance of Urgo 310 3166 dressing in the treatment of local venous or mixed leg ulcers.

lead_sponsor: Laboratoires URGO


title: Characterization of Inflammatory Muscle Involvement in Patients With Primary Sjögren's Syndrome

acronym: AMISS

summary: The AMISS study will characterize the features of muscle disease in patients with primary Sjogren's syndrome (pSS).


title: Assessment of the Predictive Value of the Acetic Acid Test in Surgery Condition for the Detection of Dysplastic Lesions in Patients With Anal Condylomatosis

summary:
Anal condylomatosis is an anal canal mucosa pathology caused by HPV infection (Human Papilloma Virus). This condition is common, especially in immunodepressed patients.

These lesions are not accessible to topical medical treatment because of their location. They should be treated surgically because they may degenerate into squamous cell carcinoma.

In the operating room, lesions are identified by a complete proctologic examination, more or less supplemented by an acetic acid test. Acetic acid allows to detect mucous degeneration (dysplasia) in the form of intense bleaching. The interpretation of this test may nevertheless be difficult in case of local inflammation or scarring. These false positives may lead to unnecessary surgical gestures. The surgical procedure consists of a mucosectomy or destruction of the condylomatosis by electrocoagulation.

The acetic acid test is used at the discretion of the surgeon. However, there is little data on its performance or consensus on its use.


title: Therapeutic Effects of Motor Imagery Practice Following Lower-limb Amputation

acronym: MIPA

summary: Motor imagery practice (MIP), which is the repeated internal representation of a movement without engaging its physical execution and which shares a neurofunctional equivalence with physical practice, has been show to contribute to promote motor recovery and pain alleviation. Despite the extensive body of evidence concerning MIP therapeutic effects, the impact of mental training during lower-limb amputees' rehabilitation process remains to be investigated. This study was designed to assess MIP effects on the relearning of walking and the frequency and intensity of phantom-limb pain among acute lower-limb amputees. Data should contribute to scale up the tools made available to therapists and extend the scope of MIP application. Moreover, results may contribute to directly provide patients recovering from a lower-limb amputation with a cost-effective and adaptable technique that could considerably improve their quality of life.

primary_purpose: Health Services Research

lead_sponsor: Laboratoire Interuniversitaire de Biologie de la Motricité

location_facility: Centre Médico-Chirirgical de Réadaptation des Massues


title: A Nursing Strategy to Prevent Pressure Sores in the Prone Position in ARDS Patients. A Multicenter Controlled Prospective Stepped Wedge Trial

acronym: PSA

summary: A nursing strategy to prevent pressure sores in the prone position in Acute Respiratory Distress Syndrome (ARDS) patients. A multicenter controlled prospective stepped wedge trial.

location_facility: Hospices Civils de Lyon - Hopital Croix Rousse


title: Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus

acronym: RIP-LC

summary:
The purpose of this study is to determine the role of inflammation in the high prevalence of psychiatric disorders in skin-restricted lupus (SRL) patients. SRL is an inflammatory disease. Inflammation can lead to a decrease in the synthesis of neurotransmitters via the activation of the IDO enzyme and to induce the synthesis of neurotoxic molecules (kynurenin pathway). This leads to the development of psychiatric disorders.

Investigator therefore want to compare inflammation and neurotransmitter synthesis in SRL patients according to the presence or absence of psychiatric disorders.

Investigator expect a decrease in neurotransmitter synthesis and activation of the kynurenin pathway in patients with a psychiatric disorder.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Relationship Between Neuromuscular Fatigue, Perceived Tiredness and Level Of Physical Activity of Patients Living With HIV

acronym: ACT PHY HIV

summary:
Fatigue is a common symptom in people living with HIV (PHAs) that affects all aspects of life . This would include physical deconditioning, a reduction in motor skills . Numerous studies show that physical activity brings benefits for the quality of life of PHAs . However, due to the predominantly reported fatigue, many PHAs are not physically active enough in relation to these recommendations. While it is recognized that fatigue is predominant in PHAs, this complaint has mainly been subjectively quantified and has rarely been physically objectified a better understanding of the relationship between neuromuscular fatigue, perceived fatigue and the level of physical activity of PHAs is needed in line with current work on integrating fatigue.

OBJECTIVES This project, based on an integrative (eg, neurophysiological and psychological) approach to fatigue, aims to better explain and prevent the vicious circle of physical deconditioning in PHAs by examining the relationships between neuromuscular fatigue, perceived fatigue, Physical activity of patients.

The main objective of the study will be to compare the characteristics of neuromuscular fatigue in physically active or inactive PHAs.

The secondary objective will be to examine the relationship between neuromuscular fatigue, level of physical activity and perceived physical fatigue of PHAs.

CONDUCT OF THE STUDY Cross-sectional comparative study without individual benefit for the patient. Monocentric test to quantify and relate neuromuscular fatigue, perceived physical fatigue, and physical activity level. The main inclusion criteria for this study are: PLHIV aged between 40 and 60; Diagnosed and treated with antivirals after 1996, irrespective of the value of the viral load and CD4 lymphocyte level at the last assessment; The physical activity level of the patients will be evaluated before the start of the study in order to constitute two distinct groups

Principal evaluation criterion: Investigation of the neurophysiological characteristics of fatigue will be done by recording the capacity to produce force at the level of the extensor muscles of the knee under conditions of voluntary contractions and evoked by magnetic stimulation at the level of Femoral nerve.
Secondary evaluation criteria: the investigation of the perceived fatigue will be done by a valid psychometric questionnaire.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Cognitive Control of Language and Frontal Cortex

acronym: LANGUAGE

summary: The cognitive control of speech is central to human social communication. Two frontal brain regions seem to have a critical role: 1) Broca's area (BA) and 2) the mid-cingulate cortex (MCC). Current rehabilitation strategy is clearly based on therapies promoting language performance. However, there is few evidence that rehabilitation strategies based on nonlinguistic aspects of brain function may enhance recovery. Such strategies may benefit from knowledge about the primary -nonlinguistic- function of the BA-MCC network. The aim of LANGUAGE is to identify this primary function. One hypothesis is that, in non-speaking primates, this network is involved in cognitive control of voluntary vocal/orofacial production. Specifically, whereas BA may be responsible for the high-level selection of orofacial and vocal responses during learning, the face motor representation within the MCC may be responsible for performance monitoring, a process inherently required in learning. LANGUAGE aims to test this hypothesis by determining in human the anatomo-functional organization of the BA-MCC network thanks to functional magnetic resonance imaging (fMRI).

ReferenceCitation: Hillis AE. Magnetic resonance perfusion imaging in the study of language. Brain Lang. 2007 Aug;102(2):165-75. Epub 2006 Jun 6. Review.

lead_sponsor: Hospices Civils de Lyon


acronym: FABRY-Image

summary:
Anderson-Fabry disease is a genetic lysosomal storage disease, linked to chromosome X (gene GLA), responsible of enzyme synthesis deficit in α-galactosidase A with intracellular sphingolipids accumulation and multiorganic achievement.

If renal complication is principally responsible of the pejorative evolution of the disease, it may also exist a cardiac achievement, symptomatic or not (heart failure symptoms including dyspnea, conduction abnormalities, supra-ventricular and ventricular arrhythmias), with or without left ventricular hypertrophy (LVH).

Administration of agalsidase-α or ß, a genetic engineering synthetic equivalent of the deficient enzyme, should significantly slow disease evolution indeed reduce LVH.

Some patients with Fabry disease without LVH should present, compared to healthy subjects, indirect early markers of intramyocyte lipid overload:

in echocardiography, longitudinal myocardial deformation (strain) should be altered while ejection fraction is preserved, and
in cardiac MRI, T1 mapping should be reduced1. This was also previously demonstrated in Fabry patients with LVH2. However, are these abnormalities of longitudinal deformation in echocardiography and of T1 mapping in MRI correlated to the presence of pejorative cardiac markers (such as clinical and functional tolerances, Brain Natriuretic Peptide (BNP) level and electrical complications)?

lead_sponsor: University Hospital, Bordeaux


title: Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura

acronym: KIT

summary: Assessment of quality of life of patient with chronic idiopathic thrombocytopenic purpura according to the type of treatment

lead_sponsor: University Hospital, Angers


title: High-flow Nasal Cannula Oxygen Therapy With or Without Non-invasive Ventilation (NIV) During the Weaning Period: a Multicenter Randomized Controlled Trial

acronym: HIGH-WEAN

summary: Prospective multicenter randomized controlled open-label trial comparing 2 strategies of oxygenation during the post-extubation period in ICU patients at high risk of extubation failure. Patients will be randomized and assigned to one of the two groups, with a 1:1 ratio.

ReferenceCitation: Thille AW, Monseau G, Coudroy R, Nay MA, Gacouin A, Decavèle M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Levrat Q, Rouzé A, Vivier E, Lascarrou JB, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Massri A, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA research network. Non-invasive ventilation versus high-flow nasal oxygen for postextubation respiratory failure in ICU: a post-hoc analysis of a randomized clinical trial. Crit Care. 2021 Jun 28;25(1):221. doi: 10.1186/s13054-021-03621-6.

family: Thille

full_name: Arnaud W. Thille

given: Arnaud W.

family: Monseau

full_name: Grégoire Monseau

given: Grégoire

family: Coudroy

full_name: Rémi Coudroy

given: Rémi

family: Nay

full_name: Mai-Anh Nay

given: Mai-Anh

family: Gacouin

full_name: Arnaud Gacouin

given: Arnaud

family: Decavèle

full_name: Maxens Decavèle

given: Maxens

family: Sonneville

full_name: Romain Sonneville

given: Romain

family: Beloncle

full_name: François Beloncle

given: François

family: Girault

full_name: Christophe Girault

given: Christophe

family: Dangers

full_name: Laurence Dangers

given: Laurence

family: Lautrette

full_name: Alexandre Lautrette

given: Alexandre

family: Levrat

full_name: Quentin Levrat

given: Quentin

family: Rouzé

full_name: Anahita Rouzé

given: Anahita

family: Vivier

full_name: Emmanuel Vivier

given: Emmanuel

family: Lascarrou

full_name: Jean-Baptiste Lascarrou

given: Jean-Baptiste

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

family: Razazi

full_name: Keyvan Razazi

given: Keyvan

family: Barberet

full_name: Guillaume Barberet

given: Guillaume

family: Lebert

full_name: Christine Lebert

given: Christine

family: Ehrmann

full_name: Stephan Ehrmann

given: Stephan

family: Massri

full_name: Alexandre Massri

family: Bourenne

full_name: Jeremy Bourenne

given: Jeremy

family: Pradel

full_name: Gael Pradel

name: for the HIGH-WEAN Study Group and the REVA research network

ReferenceCitation: Thille AW, Coudroy R, Nay MA, Gacouin A, Decavèle M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Levrat Q, Rouzé A, Vivier E, Lascarrou JB, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Massri A, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group, for the REVA Research Network. Non-invasive ventilation alternating with high-flow nasal oxygen versus high-flow nasal oxygen alone after extubation in COPD patients: a post hoc analysis of a randomized controlled trial. Ann Intensive Care. 2021 Feb 9;11(1):30. doi: 10.1186/s13613-021-00823-7.

name: for the HIGH-WEAN Study Group, for the REVA Research Network

ReferenceCitation: Thille AW, Muller G, Gacouin A, Coudroy R, Decavèle M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouzé A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Sabatier C, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Danin PÉ, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Demoule A, Maamar A, Nay MA, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA Research Network. Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1465-1475. doi: 10.1001/jama.2019.14901. Erratum in: JAMA. 2020 Feb 25;323(8):793.

name: Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France

name: INSERM Centre d’Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France

name: Groupe Hospitalier Régional d’Orléans, Médecine Intensive Réanimation, Orléans, France

name: Centre Hospitalier Universitaire de Rennes, Hôpital Ponchaillou, Service des Maladies Infectieuses et Réanimation Médicale, Rennes, France

name: Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie, Médecine Intensive et Réanimation (Département R3S), AP-HP, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, Paris, France

name: Hôpital Bichat–Claude Bernard, Médecine Intensive Réanimation, AP-HP, Université Paris Diderot, Paris, France

name: Centre Hospitalier Universitaire d’Angers, Département de Médecine Intensive Réanimation, Université d’Angers, Angers, France

name: Centre Hospitalier Universitaire de Rouen, Hôpital Charles Nicolle, Département de Réanimation Médicale, Normandie Université, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), Rouen, France

name: Centre Hospitalier Universitaire Félix Guyon, Service de Réanimation Polyvalente, Saint Denis de la Réunion, France

name: Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Réanimation Médicale, Clermont-Ferrand, France

name: Centre Hospitalier de La Rochelle, Service de Réanimation, La Rochelle, France

name: Centre Hospitalier Universitaire de Lille, Centre de Réanimation, Université de Lille, Lille, France

name: Hôpital Saint-Joseph Saint-Luc, Réanimation Polyvalente, Lyon, France

name: Centre Hospitalier Universitaire de Nantes, Médecine Intensive Réanimation, Nantes, France

name: Hôpital Louis Mourier, Réanimation Médico-Chirurgicale, AP-HP, INSERM, Université Paris Diderot, UMR IAME 1137, Sorbonne Paris Cité, Colombes, France

name: Hôpitaux universitaires Henri Mondor, Service de Réanimation Médicale DHU A-TVB, AP-HP, Créteil, France

name: Groupe Hospitalier Régional Mulhouse Sud Alsace, site Emile Muller, Service de Réanimation Médicale, Mulhouse, France

name: Centre Hospitalier Départemental de Vendée, Service de Médecine Intensive Réanimation, La Roche Sur Yon, France

name: Centre Hospitalier Régional Universitaire de Tours, Médecine Intensive Réanimation, CIC 1415, Réseau CRICS-Trigger SEP, Centre d'étude des pathologies respiratoires, INSERM U1100, Université de Tours, Tours, France

name: Centre Hospitalier de Pau, Service de Réanimation, Pau, France

name: Centre Hospitalier Universitaire La Timone 2, Médecine Intensive Réanimation, Réanimation des Urgences, Aix-Marseille Université, Marseille, France

name: Centre Hospitalier Henri Mondor d’Aurillac, Service de Réanimation, Aurillac, France

name: Centre Hospitalier Universitaire de Brest, Médecine Intensive Réanimation, Brest, France

name: Centre Hospitalier Universitaire Grenoble Alpes, Médecine Intensive Réanimation, INSERM, Université Grenoble-Alpes, U1042, HP2, Grenoble, France

name: Centre Hospitalier Universitaire de Nice, Médecine Intensive Réanimation, Archet 1, Université Cote d’Azur, Nice, France

name: Centre Hospitalier de Versailles, Service de Réanimation Médico-Chirurgicale, Le Chesnay, France

name: Centre Hospitalier Universitaire de Nice, Réanimation Médico-Chirurgicale Archet 2, INSERM U 1065, Nice, France

name: Centre Hospitalier Universitaire de Poitiers, Réanimation Chirurgicale, Poitiers, France

name: Hôpital Tenon, Réanimation et USC médico-chirurgicale, CARMAS, AP-HP, Faculté de médecine Sorbonne Université, Collegium Galilée, Paris, France

name: Centre Hospitalier Emile Roux, Service de Réanimation, Le Puy en Velay, France

name: Hôpital Lariboisière, Réanimation Médicale et Toxicologique, AP-HP, INSERM UMR-S 942, Paris, France

name: for the HIGH-WEAN Study Group and the REVA Research Network

ReferenceCitation: Thille AW, Muller G, Gacouin A, Coudroy R, Demoule A, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouzé A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Picard W, Bourenne J, Pradel G, Bailly P, Terzi N, Buscot M, Lacave G, Danin PE, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Ragot S, Frat JP; REVA research network. High-flow nasal cannula oxygen therapy alone or with non-invasive ventilation during the weaning period after extubation in ICU: the prospective randomised controlled HIGH-WEAN protocol. BMJ Open. 2018 Sep 5;8(9):e023772. doi: 10.1136/bmjopen-2018-023772.


title: Technique of Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer

acronym: RPO-S+

summary: Phase 1/2 study, open, monocenter, non-randomized

status: Active, not recruiting


title: 18F-FDG PET Scan and MRI Diffusion : Correlation Study of the Evaluation of the Early Therapeutic Response of Diffuse Large B-cell Lymphoma

acronym: LYMPHODTECT

summary: Open-label, multicenter, uncontrolled and non-randomized study comparing 18F-FDG PET-Scan and diffusion MRI in the assessment of the early therapeutic response of Diffuse Large B-Cell Lymphoma.


title: Social Deprivation and Pregnancy

summary:
Social deprivation during pregnancy is associated to adverse perinatal outcomes. However, prenatal screening of social deprivation by reliable measurement is not performed. Prevalence of social deprivation is yet underestimated during pregnancy and vulnerable women are not being provided optimal prenatal care.

Our aim is to validate EPICES score during pregnancy.


title: Medico-economic Evaluation of Strategies for the Lead Extraction of Implantable Defibrillator and Pacemakers: a Retrospective Observational Study

acronym: GAINE LASER

summary:
The growing use and the expanding indications for cardiovascular implantable electronic devices (CIEDs) have been associated to an increase of device removal. The indications of CIEDs removal are infectious (55%) or noninfectious (45%) such as upgrading of devices, nonfunctional devices and thrombosis. Removal can be performed according to transvenous or surgical procedures. Transvenous lead removal (TLR) must be done by experimented cardiologists and respecting current consensus. TLR can be done with conventional techniques involving inserting locking stylets and telescoping sheaths around the pacing leads to separate them from the surrounding scar tissue. These conventional procedures have a success rate of ≈65%. TLR thanks to laser sheath has been validated and improved the success rate until >95%. However, the TLR from chronically implanted CIEDs still carries a significant risk of procedural failure, morbidity, and mortality, related to tearing of the great vessels and cardiac structures, even when performed by experienced operators. Even if the transvenous extraction using laser sheath seems to be more effective, this strategy would be more expensive.

Considering the availability of several strategies for TLR and the cost heterogeneity of procedures, a cost assessment in real life of these therapeutic strategies is essential for an optimal choice of therapeutic strategies.


title: Therapeutic Iontophoresis of Treprostinil in Systemic Sclerosis Digital UlcErations. A Proof of Concept Study

acronym: TISSUE-PoC

summary: The study is conducted to confirm the good tolerance of a continuous cathodal iontophoresis of the treprostinil hydrogel administered during 10 days on the pulp of the finger of healthy volunteer and on the ischemic digital ulcerations of Systemic Sclerosis patients, particularly to estimate the cutaneous tolerance of the procedure and the effect on the blood pressure.

ReferenceCitation: Gaillard-Bigot F, Roustit M, Blaise S, Cracowski C, Seinturier C, Imbert B, Carpentier P, Cracowski JL. Treprostinil Iontophoresis Improves Digital Blood Flow during Local Cooling in Systemic Sclerosis. Microcirculation. 2016 Apr;23(3):266-70. doi: 10.1111/micc.12272.

ReferenceCitation: Hellmann M, Roustit M, Gaillard-Bigot F, Cracowski JL. Cutaneous iontophoresis of treprostinil, a prostacyclin analog, increases microvascular blood flux in diabetic malleolus area. Eur J Pharmacol. 2015 Jul 5;758:123-8. doi: 10.1016/j.ejphar.2015.03.066. Epub 2015 Apr 3.

ReferenceCitation: Kotzki S, Roustit M, Arnaud C, Godin-Ribuot D, Cracowski JL. Effect of continuous vs pulsed iontophoresis of treprostinil on skin blood flow. Eur J Pharm Sci. 2015 May 25;72:21-6. doi: 10.1016/j.ejps.2015.02.012. Epub 2015 Feb 21.

ReferenceCitation: Roustit M, Gaillard-Bigot F, Blaise S, Stanke-Labesque F, Cracowski C, Seinturier C, Jourdil JF, Imbert B, Carpentier PH, Cracowski JL. Cutaneous iontophoresis of treprostinil in systemic sclerosis: a proof-of-concept study. Clin Pharmacol Ther. 2014 Apr;95(4):439-45. doi: 10.1038/clpt.2013.255. Epub 2014 Jan 23.

ReferenceCitation: Kotzki S, Roustit M, Arnaud C, Boutonnat J, Blaise S, Godin-Ribuot D, Cracowski JL. Anodal iontophoresis of a soluble guanylate cyclase stimulator induces a sustained increase in skin blood flow in rats. J Pharmacol Exp Ther. 2013 Sep;346(3):424-31. doi: 10.1124/jpet.113.205484. Epub 2013 Jul 9.

ReferenceCitation: Blaise S, Roustit M, Hellmann M, Millet C, Cracowski JL. Cathodal iontophoresis of treprostinil induces a sustained increase in cutaneous blood flux in healthy volunteers. J Clin Pharmacol. 2013 Jan;53(1):58-66. doi: 10.1177/0091270011434352. Epub 2013 Jan 24.

family: Blaise

full_name: Sophie Blaise

given: Sophie

family: Roustit

full_name: Matthieu Roustit

given: Matthieu

name: Clinical Pharmacology Department, Inserm CIC3; University Hospital; Grenoble; France

family: Hellmann

full_name: Marcin Hellmann

given: Marcin

family: Millet

full_name: Claire Millet

given: Claire

name: Vascular Medicine Department; University Hospital; Grenoble; France

family: Cracowski

full_name: Jean-Luc Cracowski

given: Jean-Luc

bso_classification: Chemistry

journal_name: The Journal of Clinical Pharmacology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Cathodal Iontophoresis of Treprostinil Induces a Sustained Increase in Cutaneous Blood Flux in Healthy Volunteers

ReferenceCitation: Blaise S, Roustit M, Millet C, Ribuot C, Boutonnat J, Cracowski JL. Cathodal iontophoresis of treprostinil and iloprost induces a sustained increase in cutaneous flux in rats. Br J Pharmacol. 2011 Feb;162(3):557-65. doi: 10.1111/j.1476-5381.2010.01045.x.


title: Prevalence of Psychological Disorders After Immediate Postpartum Hemorrhage

acronym: PSYCHE

summary: The objective of this cross-sectional study is to assess the prevalence of depression at 2 months, 6 months, and 1 year postpartum in women who had an immediate postpartum hemorrhage (immediate PPH defined as blood loss ≥ 500 mL within 24 hours of delivery). The potential serious consequences of PPH may lead to a greater number of psychological disorders in these women than in women without PPH.

ReferenceCitation: Pranal M, Legrand A, de Chazeron I, Llorca PM, Vendittelli F. Prevalence of maternal psychological disorders after immediate postpartum haemorrhage: a repeated cross-sectional study - the PSYCHE* study protoco. BMJ Open. 2019 Sep 4;9(9):e027390. doi: 10.1136/bmjopen-2018-027390.

family: Pranal

full_name: Marine Pranal

given: Marine

family: Legrand

full_name: Anne Legrand

given: Anne

family: de Chazeron

full_name: Ingrid de Chazeron

given: Ingrid

family: Llorca

full_name: Pierre-Michel Llorca

given: Pierre-Michel

family: Vendittelli

full_name: Françoise Vendittelli

given: Françoise

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

intervention_type: Behavioral


type: EudraCT Number

title: Rate of Prolonged Response After Stopping Thrombopoietin-receptor Agonists Treatment in Immune Thrombocytopenia: a Prospective Multicenter Open Study

acronym: STOP-AGO

summary:
Thrombopoietin-receptor agonists (Tpo-RAs) have profoundly changed the management of ITP. However, today, there are no international recommendations concerning the long-term use of these costly, potentially pro-thrombotic agents, and that could induce bone marrow fibrosis in case of prolonged treatment. Tpo-RAs have been thought to play only a supporting role in ITP management. But our center along with many other research centers, have reported unexpected cases of durable remission after Tpo-RAs discontinuation in adult chronic ITP. In these retrospective studies, more than 20 % of patients were able to achieve prolonged remission.

The purpose of this study is to demonstrate that a substantial proportion of ITP patients may achieve a prolonged response after Tpo-RA discontinuation.

The investigators developed, in this study, a standardized procedure to discontinue Eltrombopag and Romiplostim, wherein the dose will be slowly tapered to limit the risk of bleeding. In case of relapse after Tpo-RA discontinuation, the decision to start a new therapy will be based on the clinician's judgment.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Phase 1/2 Open Single-arm Monocentric Study Evaluating the Tolerance and Interest of Transient Opening of the Blood-Brain Barrier by Low Intensity Pulsed Ultrasound With the SONOCLOUD® Implantable Medical Device in Mild Alzheimer's Disease Patients (MMSE 20-26)

summary: In Alzheimer's disease (AD) an imbalance between the production and clearance of the ß-amyloid peptide is hypothesized as the driving event of the disease. The decreased clearance of Aß could be partly linked to a progressive dysfunction of the brain vasculature and of the blood brain barrier (BBB). Among many possible explanations for these failures of the multiple clinical trials evaluating innovative drugs in AD, one is the lack of target engagement, as none of these drugs is able to readily cross BBB. This barrier acts as a wall that actively and passively prevents the crossing of molecules between the blood and the brain parenchyma compartments. Only 0.3% of intravenously injected anti-Aß immunoglobulins reach the brain despite a half-life of 15-20 days. Low intensity Focal ultrasound associated to microbubble injection can open the BBB in a non invasive way. These openings are reversible in 2 hours to 2 days depending on the intensity of the ultrasound. Ultrasound opening of the BBB was initially used in a transgenic mouse model of AD to increase the brain delivery of an anti-Aß antibody. In this article, the Aß load was reduced in ultrasound treated brain region. Surprisingly it was then demonstrated that the simple opening of the BBB without any adjunct anti-Aß treatment was able to drive the same Aß clearance effects. This is probably linked to endogenous antibodies that are able to penetrate the brain parenchyma and target Aß plaques. Four opening sessions elicited positive promnesic effects in these mice. Our group conceived and developed a mean to easily, reproductively and innocuously open the BBB. A unique extra-dural ultrasound emitter (sonoCloud®) is surgically implanted in the skull under local anesthesia. It emits low intensity contact ultrasound (LICU) that are not deterred by bone and thus are able to open the BBB.Preclinical studies show the SonoCloud® device is safe and efficient as it allowed reproducible and repeatable opening of the BBB in rabbits, dogs and non human primates. Drugs up to 2000 Kilo Daltons (kDa) are able to cross the BBB to reach the brain parenchyma in which the concentration of Carboplatin was increased by 700% in the BBB opened region. No adverse event was evidenced both clinically, by EEG, Evoked potential, MRI, 18 Fluorodeoxyglucose (FDG) PET and histology in the primates after 7 bi-monthly sessions of LICU BBB opening. SonoCloud® and its external generator have been certified by the academic start-up CarThéra (APHP, UPMC). Our multidisciplinary skills (neurology, neurosurgery, neuroimaging, basic science departments in the same University hospital setting) and our previous experience of BBB opening in Man give us the unique opportunity to translate this procedure from neuro-oncology to AD which could 1) Have a positive effect on brain lesion load and symptoms by itself and 2) allow anti-AD (or more broadly, central nervous system) drugs to engage their targe

ReferenceCitation: Carpentier A, Canney M, Vignot A, Reina V, Beccaria K, Horodyckid C, Karachi C, Leclercq D, Lafon C, Chapelon JY, Capelle L, Cornu P, Sanson M, Hoang-Xuan K, Delattre JY, Idbaih A. Clinical trial of blood-brain barrier disruption by pulsed ultrasound. Sci Transl Med. 2016 Jun 15;8(343):343re2. doi: 10.1126/scitranslmed.aaf6086.

ReferenceCitation: Horodyckid C, Canney M, Vignot A, Boisgard R, Drier A, Huberfeld G, François C, Prigent A, Santin MD, Adam C, Willer JC, Lafon C, Chapelon JY, Carpentier A. Safe long-term repeated disruption of the blood-brain barrier using an implantable ultrasound device: a multiparametric study in a primate model. J Neurosurg. 2017 Apr;126(4):1351-1361. doi: 10.3171/2016.3.JNS151635. Epub 2016 Jun 10.

ReferenceCitation: Goldwirt L, Canney M, Horodyckid C, Poupon J, Mourah S, Vignot A, Chapelon JY, Carpentier A. Enhanced brain distribution of carboplatin in a primate model after blood-brain barrier disruption using an implantable ultrasound device. Cancer Chemother Pharmacol. 2016 Jan;77(1):211-6. doi: 10.1007/s00280-015-2930-5. Epub 2015 Dec 8.

family: Goldwirt

full_name: Lauriane Goldwirt

given: Lauriane

family: Canney

full_name: Michael Canney

given: Michael

family: Horodyckid

full_name: Catherine Horodyckid

given: Catherine

family: Poupon

full_name: Joel Poupon

given: Joel

family: Mourah

full_name: Samia Mourah

given: Samia

family: Vignot

full_name: Alexandre Vignot

given: Alexandre

family: Chapelon

full_name: Jean-Yves Chapelon

given: Jean-Yves

family: Carpentier

full_name: Alexandre Carpentier

journal_name: Cancer Chemotherapy and Pharmacology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Enhanced brain distribution of carboplatin in a primate model after blood–brain barrier disruption using an implantable ultrasound device

ReferenceCitation: Beccaria K, Canney M, Goldwirt L, Fernandez C, Piquet J, Perier MC, Lafon C, Chapelon JY, Carpentier A. Ultrasound-induced opening of the blood-brain barrier to enhance temozolomide and irinotecan delivery: an experimental study in rabbits. J Neurosurg. 2016 Jun;124(6):1602-10. doi: 10.3171/2015.4.JNS142893. Epub 2015 Nov 13.

ReferenceCitation: Beccaria K, Canney M, Goldwirt L, Fernandez C, Adam C, Piquet J, Autret G, Clément O, Lafon C, Chapelon JY, Carpentier A. Opening of the blood-brain barrier with an unfocused ultrasound device in rabbits. J Neurosurg. 2013 Oct;119(4):887-98. doi: 10.3171/2013.5.JNS122374. Epub 2013 Jun 21.

ReferenceCitation: Jordão JF, Ayala-Grosso CA, Markham K, Huang Y, Chopra R, McLaurin J, Hynynen K, Aubert I. Antibodies targeted to the brain with image-guided focused ultrasound reduces amyloid-beta plaque load in the TgCRND8 mouse model of Alzheimer's disease. PLoS One. 2010 May 11;5(5):e10549. doi: 10.1371/journal.pone.0010549.

ReferenceCitation: Jordão JF, Thévenot E, Markham-Coultes K, Scarcelli T, Weng YQ, Xhima K, O'Reilly M, Huang Y, McLaurin J, Hynynen K, Aubert I. Amyloid-β plaque reduction, endogenous antibody delivery and glial activation by brain-targeted, transcranial focused ultrasound. Exp Neurol. 2013 Oct;248:16-29. doi: 10.1016/j.expneurol.2013.05.008. Epub 2013 May 21.

ReferenceCitation: Goldwirt L, Beccaria K, Carpentier A, Farinotti R, Fernandez C. Irinotecan and temozolomide brain distribution: a focus on ABCB1. Cancer Chemother Pharmacol. 2014 Jul;74(1):185-93. doi: 10.1007/s00280-014-2490-0. Epub 2014 May 28.

ReferenceCitation: Goldwirt L, Beccaria K, Carpentier A, Idbaih A, Schmitt C, Levasseur C, Labussiere M, Milane A, Farinotti R, Fernandez C. Preclinical impact of bevacizumab on brain and tumor distribution of irinotecan and temozolomide. J Neurooncol. 2015 Apr;122(2):273-81. doi: 10.1007/s11060-015-1717-1. Epub 2015 Jan 13.

ReferenceCitation: Helmer C, Pérès K, Letenneur L, Guttiérez-Robledo LM, Ramaroson H, Barberger-Gateau P, Fabrigoule C, Orgogozo JM, Dartigues JF. Dementia in subjects aged 75 years or over within the PAQUID cohort: prevalence and burden by severity. Dement Geriatr Cogn Disord. 2006;22(1):87-94. Epub 2006 May 18.

ReferenceCitation: Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013 Jan;9(1):63-75.e2. doi: 10.1016/j.jalz.2012.11.007. Review.

ReferenceCitation: Hardy J, Selkoe DJ. The amyloid hypothesis of Alzheimer's disease: progress and problems on the road to therapeutics. Science. 2002 Jul 19;297(5580):353-6. Review. Erratum in: Science 2002 Sep 27;297(5590):2209.

ReferenceCitation: Hardy JA, Higgins GA. Alzheimer's disease: the amyloid cascade hypothesis. Science. 1992 Apr 10;256(5054):184-5. Review.

ReferenceCitation: Zlokovic BV. The blood-brain barrier in health and chronic neurodegenerative disorders. Neuron. 2008 Jan 24;57(2):178-201. doi: 10.1016/j.neuron.2008.01.003. Review.

ReferenceCitation: Dubois B, Feldman HH, Jacova C, Dekosky ST, Barberger-Gateau P, Cummings J, Delacourte A, Galasko D, Gauthier S, Jicha G, Meguro K, O'brien J, Pasquier F, Robert P, Rossor M, Salloway S, Stern Y, Visser PJ, Scheltens P. Research criteria for the diagnosis of Alzheimer's disease: revising the NINCDS-ADRDA criteria. Lancet Neurol. 2007 Aug;6(8):734-46. Review.

ReferenceCitation: Dubois B, Feldman HH, Jacova C, Hampel H, Molinuevo JL, Blennow K, DeKosky ST, Gauthier S, Selkoe D, Bateman R, Cappa S, Crutch S, Engelborghs S, Frisoni GB, Fox NC, Galasko D, Habert MO, Jicha GA, Nordberg A, Pasquier F, Rabinovici G, Robert P, Rowe C, Salloway S, Sarazin M, Epelbaum S, de Souza LC, Vellas B, Visser PJ, Schneider L, Stern Y, Scheltens P, Cummings JL. Advancing research diagnostic criteria for Alzheimer's disease: the IWG-2 criteria. Lancet Neurol. 2014 Jun;13(6):614-29. doi: 10.1016/S1474-4422(14)70090-0. Erratum in: Lancet Neurol. 2014 Aug;13(8):757.

ReferenceCitation: McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.

ReferenceCitation: McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44.

ReferenceCitation: Salloway S, Sperling R, Fox NC, Blennow K, Klunk W, Raskind M, Sabbagh M, Honig LS, Porsteinsson AP, Ferris S, Reichert M, Ketter N, Nejadnik B, Guenzler V, Miloslavsky M, Wang D, Lu Y, Lull J, Tudor IC, Liu E, Grundman M, Yuen E, Black R, Brashear HR; Bapineuzumab 301 and 302 Clinical Trial Investigators. Two phase 3 trials of bapineuzumab in mild-to-moderate Alzheimer's disease. N Engl J Med. 2014 Jan 23;370(4):322-33. doi: 10.1056/NEJMoa1304839.

ReferenceCitation: Tapiola T, Alafuzoff I, Herukka SK, Parkkinen L, Hartikainen P, Soininen H, Pirttilä T. Cerebrospinal fluid {beta}-amyloid 42 and tau proteins as biomarkers of Alzheimer-type pathologic changes in the brain. Arch Neurol. 2009 Mar;66(3):382-9. doi: 10.1001/archneurol.2008.596.

ReferenceCitation: Clark CM, Schneider JA, Bedell BJ, Beach TG, Bilker WB, Mintun MA, Pontecorvo MJ, Hefti F, Carpenter AP, Flitter ML, Krautkramer MJ, Kung HF, Coleman RE, Doraiswamy PM, Fleisher AS, Sabbagh MN, Sadowsky CH, Reiman EP, Zehntner SP, Skovronsky DM; AV45-A07 Study Group. Use of florbetapir-PET for imaging beta-amyloid pathology. JAMA. 2011 Jan 19;305(3):275-83. doi: 10.1001/jama.2010.2008. Erratum in: JAMA. 2011 Mar 16;305(11):1096. Reiman, P Eric M [corrected to Reiman, Eric M].

ReferenceCitation: Klunk WE, Engler H, Nordberg A, Wang Y, Blomqvist G, Holt DP, Bergström M, Savitcheva I, Huang GF, Estrada S, Ausén B, Debnath ML, Barletta J, Price JC, Sandell J, Lopresti BJ, Wall A, Koivisto P, Antoni G, Mathis CA, Långström B. Imaging brain amyloid in Alzheimer's disease with Pittsburgh Compound-B. Ann Neurol. 2004 Mar;55(3):306-19.

ReferenceCitation: Rinne JO, Wong DF, Wolk DA, Leinonen V, Arnold SE, Buckley C, Smith A, McLain R, Sherwin PF, Farrar G, Kailajärvi M, Grachev ID. [(18)F]Flutemetamol PET imaging and cortical biopsy histopathology for fibrillar amyloid β detection in living subjects with normal pressure hydrocephalus: pooled analysis of four studies. Acta Neuropathol. 2012 Dec;124(6):833-45. doi: 10.1007/s00401-012-1051-z. Epub 2012 Oct 10.

ReferenceCitation: Chien DT, Bahri S, Szardenings AK, Walsh JC, Mu F, Su MY, Shankle WR, Elizarov A, Kolb HC. Early clinical PET imaging results with the novel PHF-tau radioligand [F-18]-T807. J Alzheimers Dis. 2013;34(2):457-68. doi: 10.3233/JAD-122059.

ReferenceCitation: Shah M, Catafau AM. Molecular Imaging Insights into Neurodegeneration: Focus on Tau PET Radiotracers. J Nucl Med. 2014 Jun;55(6):871-4. doi: 10.2967/jnumed.113.136069. Epub 2014 May 15. Review.

ReferenceCitation: Zhang W, Arteaga J, Cashion DK, Chen G, Gangadharmath U, Gomez LF, Kasi D, Lam C, Liang Q, Liu C, Mocharla VP, Mu F, Sinha A, Szardenings AK, Wang E, Walsh JC, Xia C, Yu C, Zhao T, Kolb HC. A highly selective and specific PET tracer for imaging of tau pathologies. J Alzheimers Dis. 2012;31(3):601-12. doi: 10.3233/JAD-2012-120712.

ReferenceCitation: Bateman RJ, Xiong C, Benzinger TL, Fagan AM, Goate A, Fox NC, Marcus DS, Cairns NJ, Xie X, Blazey TM, Holtzman DM, Santacruz A, Buckles V, Oliver A, Moulder K, Aisen PS, Ghetti B, Klunk WE, McDade E, Martins RN, Masters CL, Mayeux R, Ringman JM, Rossor MN, Schofield PR, Sperling RA, Salloway S, Morris JC; Dominantly Inherited Alzheimer Network. Clinical and biomarker changes in dominantly inherited Alzheimer's disease. N Engl J Med. 2012 Aug 30;367(9):795-804. doi: 10.1056/NEJMoa1202753. Epub 2012 Jul 11. Erratum in: N Engl J Med. 2012 Aug 23;367(8):780.

ReferenceCitation: Ossenkoppele R, Jansen WJ, Rabinovici GD, Knol DL, van der Flier WM, van Berckel BN, Scheltens P, Visser PJ; Amyloid PET Study Group, Verfaillie SC, Zwan MD, Adriaanse SM, Lammertsma AA, Barkhof F, Jagust WJ, Miller BL, Rosen HJ, Landau SM, Villemagne VL, Rowe CC, Lee DY, Na DL, Seo SW, Sarazin M, Roe CM, Sabri O, Barthel H, Koglin N, Hodges J, Leyton CE, Vandenberghe R, van Laere K, Drzezga A, Forster S, Grimmer T, Sánchez-Juan P, Carril JM, Mok V, Camus V, Klunk WE, Cohen AD, Meyer PT, Hellwig S, Newberg A, Frederiksen KS, Fleisher AS, Mintun MA, Wolk DA, Nordberg A, Rinne JO, Chételat G, Lleo A, Blesa R, Fortea J, Madsen K, Rodrigue KM, Brooks DJ. Prevalence of amyloid PET positivity in dementia syndromes: a meta-analysis. JAMA. 2015 May 19;313(19):1939-49. doi: 10.1001/jama.2015.4669.

ReferenceCitation: Doody RS, Thomas RG, Farlow M, Iwatsubo T, Vellas B, Joffe S, Kieburtz K, Raman R, Sun X, Aisen PS, Siemers E, Liu-Seifert H, Mohs R; Alzheimer's Disease Cooperative Study Steering Committee; Solanezumab Study Group. Phase 3 trials of solanezumab for mild-to-moderate Alzheimer's disease. N Engl J Med. 2014 Jan 23;370(4):311-21. doi: 10.1056/NEJMoa1312889.

family: Doody

full_name: Rachelle S. Doody

given: Rachelle S.

family: Thomas

full_name: Ronald G. Thomas

given: Ronald G.

family: Farlow

full_name: Martin Farlow

given: Martin

family: Iwatsubo

full_name: Takeshi Iwatsubo

given: Takeshi

family: Vellas

full_name: Bruno Vellas

given: Bruno

family: Joffe

full_name: Steven Joffe

title: Phase 3 Trials of Solanezumab for Mild-to-Moderate Alzheimer's Disease

ReferenceCitation: Duits FH, Teunissen CE, Bouwman FH, Visser PJ, Mattsson N, Zetterberg H, Blennow K, Hansson O, Minthon L, Andreasen N, Marcusson J, Wallin A, Rikkert MO, Tsolaki M, Parnetti L, Herukka SK, Hampel H, De Leon MJ, Schröder J, Aarsland D, Blankenstein MA, Scheltens P, van der Flier WM. The cerebrospinal fluid "Alzheimer profile": easily said, but what does it mean? Alzheimers Dement. 2014 Nov;10(6):713-723.e2. doi: 10.1016/j.jalz.2013.12.023. Epub 2014 Apr 8.

ReferenceCitation: Schindowski K, Bretteville A, Leroy K, Bégard S, Brion JP, Hamdane M, Buée L. Alzheimer's disease-like tau neuropathology leads to memory deficits and loss of functional synapses in a novel mutated tau transgenic mouse without any motor deficits. Am J Pathol. 2006 Aug;169(2):599-616.


ReferenceCitation: Ghédira M, Albertsen IM, Mardale V, Loche CM, Vinti M, Gracies JM, Bayle N, Hutin E. Agonist and antagonist activation at the ankle monitored along the swing phase in hemiparetic gait. Clin Biomech (Bristol, Avon). 2021 Oct;89:105459. doi: 10.1016/j.clinbiomech.2021.105459. Epub 2021 Aug 20.

family: Ghédira

full_name: Mouna Ghédira

given: Mouna

family: Albertsen

full_name: Inke Marie Albertsen

given: Inke Marie

family: Mardale

full_name: Valentina Mardale

given: Valentina

family: Loche

full_name: Catherine-Marie Loche

given: Catherine-Marie

family: Vinti

full_name: Maria Vinti

given: Maria

family: Gracies

full_name: Jean-Michel Gracies

given: Jean-Michel

family: Bayle

full_name: Nicolas Bayle

given: Nicolas

family: Hutin

full_name: Emilie Hutin

given: Emilie

journal_name: Clinical Biomechanics

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

acronym: GENUFLEX

source: euctr

title: Partial Blocks of Rectus Femoris and Soleus With Botulinum Toxin Type A to Improve Gait in Hemiparesis. A Randomized Multicenter Placebo-controlled Trial

summary:
The most common motor deficiency after stroke or traumatic brain injury is hemiparesis. Most hemiparetic patients recover walking, but rarely with a speed permitting easy ambulation outdoors with family or friends. One of the mechanisms of gait impairment in hemiparesis is insufficient active hip flexion during swing phase, which leads to insufficient ground clearing at swing phase, with associated gait slowness and risks of fall.

The main hypothesis behind the present study is that insufficient hip flexion during hemiparetic gait is partly due to overactivity of rectus femoris. Focal treatment of lower limb muscle overactivity using botulinum toxin has not been demonstrated to increase walking speed in hemiparesis as yet. However, most studies have focused distally, on improving foot dorsiflexion only. The purpose of this study is to compare the effects of botulinum toxin injection and placebo in rectus femoris (RF) + plantar flexors versus plantar flexors only.


title: Cognitive Adaptation and Frontal Cortex

acronym: ADAPCO

summary: A hallmark of our survival in the real world and of our capacity to navigate the complex social interactions of human society is our ability to show behavioral adaptation. Adaptation can be necessary for a number of reasons, making the study of the process challenging. Two classes of event can signal a need for adaptation: 1) Events caused by one's own actions and specifically FeedBack -FB- from those actions (e.g. the investigators adapt their strategy after an erroneous choice), and 2) Events not linked to our actions, specifically Action-InDependent Events -AiDE- (e.g. the investigators adapt their strategy after a change of rule). These two types of information - FB and AiDE - will frequently occur concurrently. A critical and difficult part of adapting appropriately involves resolving the difference between the two. So for example an incorrect FB can occur because the investigators made an error, or because something unexpected in the environment has changed -the rule switched, someone cheated, etc. The Investigators must work out which it is, as they will frequently require different behavioral adaptations. Their task is made even more complex by the fact that the dynamics of evidence accumulation after FB vs AiDE are very different. FB has a direct temporal and causal link to an executed action, which means that the investigators are certain to derive information about a given action from a given FB. In contrast, AiDE have no such contiguity and no initial relation to actions, which means that the investigators must accumulate evidence to identify the appropriate adaptation to an AiDE. So the crucial dilemma is this: after an unwanted outcome, should the investigators adapt as if they made an error and received a negative FB, or should they continue to accumulate evidence as if there has been an AiDE to which they need to know how to adapt. Animals are able to resolve this credit assignment problem, as evidenced by their ability to appropriately adapt their behavior. A breakdown of this ability to link unexpected events to their correct cause would seem to be at the source of impairments in a wide range of psychological and neurological disorders, from addiction and OCD to psychological symptoms in Parkinson's disease. Yet the neural basis of this process is currently unknown, and FB and AiDE processing have been assessed separately so far. ADAPCO will provide unprecedented characterization of brain systems critically involved in learning from and adapting to FB, AiDE, and their interactions, thanks to fMRI studies.


title: Structure-function Relationships Within the Cingulate Cortex

acronym: EEG-Feedback

summary: Efficient evaluation and monitoring of actions and outcomes are a key feature of primates' efficient adaptive cognition. Deficits in evaluating one's own actions and their consequences is a key feature of prominent disorders such as obsessive compulsive disorders (OCD), schizophrenia, and anxiety. The Investigators know that these evaluative processes implicate medial structures of the brain that are related both to old limbic functions and to more recently evolved higher executive functions. Brain potentials related to performance monitoring have attracted a lot of interest in cognitive neuroscience but also in the clinical domain because they appear to be altered in different neurological or psychiatric disorders, such as schizophrenia, OCD, or anxiety, and could become biomarkers of pathologies. But the neural sources of these markers are not fully determined and are currently highly debated. In addition, our work suggests that non pathological factors, such as normal morphological cortical variations, could affect those markers. Understanding performance monitoring, acting directly on medial cortex, or using electrophysiological markers in clinic are thus currently problematic and challenging. This is mostly because structure-function relationships in the medial wall are ill defined for historical, conceptual, and methodological reasons. Importantly, although individual variability of brain morphology impedes precise assessment of structure function relationships, this variability is almost never taken into account. EEG-Feedback aims to resolve these issues by evaluating the consequences of individual variability in cingulate cortex morphology on 1) surface EEG markers of feedback monitoring and 2) functional connectivity patterns thanks to resting-state fMRI.

location_facility: Hospices Civils de Lyon, Groupement Hospitalier Est


title: Intracellular Phosphate and Adenosine Triphosphate (ATP) Concentration Evolution by Magnetic Resonance (MR) Spectroscopy in Patients During Hemodialysis

acronym: CIPHEMO

summary:
End-stage renal disease is associated with hyperphosphatemia due to a decrease of renal phosphate excretion. This hyperphosphatemia is associated with an increase of cardiovascular risk and mortality. Thus, three therapeutic options have been developed: dietary restriction, administration of phosphate binders and phosphorus clearance by hemodialysis (HD).

During a standard HD session, around 600 to 700mg phosphate is removed from the plasma, whereas it contains only 90 mg inorganic phosphate (Pi); 85% of phosphate is stored in bones and teeth in hydroxyapatite form, 14% is stored in the intracellular space (90% organic phosphate and 10% Pi), and 1% remains in the extracellular space.

Currently, the source of Pi cleared during HD remains to be determined. Phosphorus (31P) magnetic resonance spectroscopy allows reliable, dynamic and non-invasive measurements of phosphate intracellular concentration. The investigator's team recently published data obtained in anephric pigs, suggesting that phosphate intracellular concentration increases during a HD session. In parallel, we showed that ATP intracellular concentration decreased. These results suggest that the source of Pi cleared during HD could be located inside the cell.

In this study, investigators will measure intracellular phosphate and ATP concentrations and intracellular potential of hydrogen (pH) evolution during hemodialysis in 12 patients suffering from end-stage renal disease by MR spectroscopy.

If these results were confirmed in humans, it could explain, at least in part, HD intolerance in some patients and would lead to modify therapeutic approaches of hyperphosphatemia, for example, by modifying HD sessions time.

ReferenceCitation: Chazot G, Lemoine S, Kocevar G, Kalbacher E, Sappey-Marinier D, Rouvière O, Juillard L. Intracellular Phosphate and ATP Depletion Measured by Magnetic Resonance Spectroscopy in Patients Receiving Maintenance Hemodialysis. J Am Soc Nephrol. 2021 Jan;32(1):229-237. doi: 10.1681/ASN.2020050716. Epub 2020 Oct 22.

family: Chazot

full_name: Guillaume Chazot

given: Guillaume

family: Lemoine

full_name: Sandrine Lemoine

given: Sandrine

family: Kocevar

full_name: Gabriel Kocevar

given: Gabriel

family: Kalbacher

full_name: Emilie Kalbacher

family: Sappey-Marinier

full_name: Dominique Sappey-Marinier

given: Dominique

family: Rouvière

full_name: Olivier Rouvière

given: Olivier

family: Juillard

full_name: Laurent Juillard

given: Laurent

journal_name: Journal of the American Society of Nephrology

publisher: American Society of Nephrology (ASN)

publisher_dissemination: American Society of Nephrology

publisher_group: American Society of Nephrology

publisher_normalized: American Society of Nephrology

location_facility: Service de Néphrologie Pavillon P, Hôpital E. Herriot


title: Evaluation of an Online Tool (COBPeer) Dedicated to Junior Peer Reviewers for Assessing the Reporting of Randomized Controlled Trial Reports

summary:
The peer review process is a cornerstone of biomedical research publication. Despite being essential, the assessment of the completeness of the reporting and the identification of switched outcomes are not appropriately performed. Furthermore, these tasks do not suppose a high level of expertise and could be performed by junior researchers.

To assess the completeness of reporting and identified switched outcome(s), junior peer reviewers could use a simple online tool (COBPeer) based on the CONSORT (Consolidated Standards of Reporting Trials) 2010 checklist and Elaboration and Explanation publication for reporting parallel-group RCTs. The tool would feature bullet points eliciting the meaning of each checklist item. The aim of this study that will compare the accuracy of junior peer reviewers using the tool to that of usual peer reviewers when evaluating the completeness of reporting and switched of primary outcome(s) in reports of RCTs

ReferenceCitation: Chauvin A, Ravaud P, Moher D, Schriger D, Hopewell S, Shanahan D, Alam S, Baron G, Regnaux JP, Crequit P, Martinez V, Riveros C, Le Cleach L, Recchioni A, Altman DG, Boutron I. Accuracy in detecting inadequate research reporting by early career peer reviewers using an online CONSORT-based peer-review tool (COBPeer) versus the usual peer-review process: a cross-sectional diagnostic study. BMC Med. 2019 Nov 19;17(1):205. doi: 10.1186/s12916-019-1436-0.

family: Chauvin

full_name: Anthony Chauvin

given: Anthony

family: Ravaud

full_name: Philippe Ravaud

given: Philippe

family: Moher

full_name: David Moher

given: David

family: Schriger

full_name: David Schriger

family: Hopewell

full_name: Sally Hopewell

given: Sally

family: Shanahan

full_name: Daniel Shanahan

given: Daniel

family: Alam

full_name: Sabina Alam

given: Sabina

family: Baron

full_name: Gabriel Baron

family: Regnaux

full_name: Jean-Philippe Regnaux

given: Jean-Philippe

family: Crequit

full_name: Perrine Crequit

given: Perrine

family: Martinez

full_name: Valeria Martinez

given: Valeria

family: Riveros

full_name: Carolina Riveros

given: Carolina

family: Le Cleach

full_name: Laurence Le Cleach

given: Laurence

family: Recchioni

full_name: Alessandro Recchioni

given: Alessandro

family: Altman

full_name: Douglas G. Altman

given: Douglas G.

family: Boutron

full_name: Isabelle Boutron

given: Isabelle

journal_name: BMC Medicine

license: cc-by

license_normalized: cc-by

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

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

ReferenceCitation: Chauvin A, Moher D, Altman D, Schriger DL, Alam S, Hopewell S, Shanahan DR, Recchioni A, Ravaud P, Boutron I. A protocol of a cross-sectional study evaluating an online tool for early career peer reviewers assessing reports of randomised controlled trials. BMJ Open. 2017 Sep 15;7(9):e017462. doi: 10.1136/bmjopen-2017-017462.

location_facility: Hotel Dieu, 1, place du parvis de notre dame


title: Body Image Disorder in Anorexia Nervosa and Virtual Reality

acronym: REVAM

summary: Evaluation of the tolerance and acceptability of the virtual representation of its body image.

primary_purpose: Device Feasibility


title: Relations Between the Level Upper Limb Paresis Recovery in Output of the Hospital Unit Continued Care and Rehabilitation and Its Level of Use in Lifestyle at Three and Six Months

acronym: Post AVC-AVQ

summary:
The aim is to reduct spontaneous use an activities of daily living of the paretic upper limb after stroke i six months after patient discharge from rehabilitation center. The level of functional recovery at rehabilitation discharge could better guide rehabilitation strategies to enhance independence and participation in daily life.

This study aims to determine, in patients after stroke, the optimal affected upper limb recovery threshold at rehabilitation discharge to predict spontaneous level of use of affected upper limb in activities of daily living, six month later.

This study is a multicentric prognostic prospective cohort study. The main prognostic variable will be the Action Arm Test (ARAT, Lyle, 1981) score at rehabilitation discharge and the predicted variable will be the Motor Activity Log - 28 (Taub et al. 1993) score at 6 months post discharge.

ReferenceCitation: Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92.

ReferenceCitation: Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.

ReferenceCitation: Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007 Mar 15;165(6):710-8. Epub 2006 Dec 20.

ReferenceCitation: Uswatte G, Giuliani C, Winstein C, Zeringue A, Hobbs L, Wolf SL. Validity of accelerometry for monitoring real-world arm activity in patients with subacute stroke: evidence from the extremity constraint-induced therapy evaluation trial. Arch Phys Med Rehabil. 2006 Oct;87(10):1340-5.

ReferenceCitation: Veerbeek JM, Kwakkel G, van Wegen EE, Ket JC, Heymans MW. Early prediction of outcome of activities of daily living after stroke: a systematic review. Stroke. 2011 May;42(5):1482-8. doi: 10.1161/STROKEAHA.110.604090. Epub 2011 Apr 7. Review.

ReferenceCitation: Rand D, Eng JJ. Predicting daily use of the affected upper extremity 1 year after stroke. J Stroke Cerebrovasc Dis. 2015 Feb;24(2):274-83. doi: 10.1016/j.jstrokecerebrovasdis.2014.07.039. Epub 2014 Dec 18.


title: Stool Ritual: Impact on the Number of Nights Without Stools Among Dependent Residents in Institutions for Dependent Elderly People

acronym: RITUELIM

summary:
As they age, the intestinal elimination function can be altered by external factors. Sleeping is also a vital need for maintaining health. Sleep time varies with age (from 18h / day for an infant to 7h30 on average for an adult) and sleep disorders increase with age (INSERM source). In our study, the night is from 9 pm to 7 am, corresponding to the working hours of the night shift. Between 42% and 50% of episodes of wakefulness of more than 4 minutes in EHPAD are due to noise, light or the practice of care related to incontinence. 87% of all incontinence care practices have been associated with wake-up episodes. A personalized day care program would allow residents to improve the quality of their sleep by minimizing stools at night and therefore interventions by caregivers.

The ritual of stools, can be defined as the set of rules to observe to defecate in good physiological, physical conditions:

Be in a suitable place for intestinal elimination: personal bathroom preferably on the toilet or on a pierced chair that will perhaps be more secure and comfortable with the armrests. The position to be taken is important.
Propose a small bench to put under the feet to raise the knees higher than the hips and increase the abdominal pressure.
Preserve the visual and auditory intimacy of the resident at the time of defecation. Failure to do so may result in the person repressing his desire to defecate.
Allow the resident the time needed on the toilets the doorbell at hand and with the assurance that the caregiver will come back in a short time. Do not press it and do not forget it, privilege the autonomy and check that there is toilet paper.

The establishment of the stool ritual is not intended to reduce the amount of stool by day, but it aims to postpone the nighttime exemption on the day, and does not prevent the stool emission to other times of the day or night.

lead_sponsor: University Hospital, Limoges