title: Efficacity of a Rigid Ankle Foot Orthosis for Persons With Ankle Osteoarthritis

acronym: SCED-SA

summary:
Ankle osteoarthritis (AOA) is a typical long-term complication of an ankle injury. Pain during walking is the main symptom that limits walking distance. Non-surgical treatments could be used to decrease pain. The gold standard treatment for end-stage OA is definitive surgical ankle arthrodesis.

The purpose of this study was to assess the effectiveness of a rigid ankle-foot orthosis (R-AFO) for walking pain in a population suffering from AOA.

lead_sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

location_facility: Institut Régional de Médecine Physique et de Réadaptation


title: Follow Fever to Decide: Determination of an Algorithm to Quantify and Qualify the Circadian Rhythmicity

summary: Body temperature is one of the markers of biological rhythms. The precise determination of the functioning of the biological clock for an individual is essential to understanding his physiological state at a given time. This condition is dependent on the "timing" of its central clock on the time scale (chronotype). The provision of a simple-to-use (F2D cuff), non-invasive and time-dependable temperature tool and the creation of appropriate algorithms would allow access to the operation of the central clock and open up many therapeutic applications.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Mazerolle SM, Ganio MS, Casa DJ, Vingren J, Klau J. Is oral temperature an accurate measurement of deep body temperature? A systematic review. J Athl Train. 2011 Sep-Oct;46(5):566-73. Review.

ReferenceCitation: Weed HG. Review: Peripheral thermometers do not have clinically acceptable accuracy for measuring core body temperature. Ann Intern Med. 2016 Mar 15;164(6):JC32. doi: 10.7326/ACPJC-2016-164-6-032.

ipd_sharing: No

lead_sponsor: Slb Pharma

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Cardiac Output Assessment by Using Saline Contrast Injection

acronym: CardioLog

summary: Cardiac output (CO) assessment is one of the cornerstone of hemodynamic evaluation in ICU patients. CO is usually measured using invasive methods or non-invasive methods. Thermodilution is considered as the gold standard for CO assessment. Cardiac Doppler as well demonstrated to be accurate but needs manipulations and good knowledge and skills. The investigators developed a new technique using injection of agitated saline solution to evaluate CO without any manual measurement and then observer independent.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Other

lead_sponsor_type: academique


title: Outpatient Management of Patients With a Left Laparoscopic Colectomy

acronym: COATI

summary: The success of the enhanced recovery program after surgery leads us to consider outpatient management of the colectomy. To this end, the investigators have designed an observational and prospective study of left laparoscopic colectomy on an outpatient basis. The objective is to assess the harmlessness of this management compared to standard management in the context of a public hospital.

ipd_sharing: Undecided

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

intervention_type: Procedure


title: The Role of IL-22/IL-22BP Axis in Atopic Dermatitis. A Cross Sectional Monocentric Pilot Study

summary: Interleukin 22 (IL-22) is known to be regulated by IL-22 binding protein (IL-22BP), a soluble, inhibitory receptor. The potential role of IL-22BP in atopic dermatitis (AD) is mostly unknown and deserves further investigation. The main objective of this study is to better understand the potential protective role of IL-22BP through the assessment of its expression at the Messenger Ribonucleic Acid (mRNA) and protein levels in skin and serum which will be correlated to the severity of the diseases and through the identification of its cellular sources in lesions. The results of this study will help to correctly interpret the levels of IL-22 in AD and will potentially allow identifying biomarkers for patient stratification and predicting clinical outcomes to targeted therapeutic agents.

lead_sponsor: Nantes University Hospital


type: Other Identifier

title: Impact of ICU on the Quality of Life and Oncological Care of Patients With Solid Tumors

acronym: QdV-ONCOREA

summary: This is an observational, prospective, monocentric, case-control study. Investigators aim to compare the quality of life and oncological treatment strategy in cancer patients admitted or not in ICU.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: University Hospital, Grenoble

status_simplified: Completed


title: Double Blind, Multicentric, Randomized, Placebo-controlled Trial, Evaluating the Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy

acronym: BEZASCLER

summary: The objectives of this study are to evaluate the effect of bezafibrate treatment compared to placebo on efficacy and safety in patients with primary sclerosing cholangitis (PSC) and persistent cholestasis despite ursodeoxycholic acid therapy

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hepatology department - Hopital Saint Antoine

intervention_type: Drug


title: Assessment of the eFficacy, the Onset-of-Action and the Safety of Tot'héma® in Adults With Moderate Iron Deficiency Anaemia

acronym: FAST

summary: The aim of this study is to assess, in patients with moderate IDA, the Onset-of-Action of a daily treatment with Tot'Héma®. The onset of action is defined as the time required for a mean increase of at least 0,5g/dL from baseline in the haemoglobin level.

lead_sponsor: Laboratoire Innotech International

location_facility: Hopital Pitié Salpétrière - Médecine Interne et Immunologie Clinique


title: Correlation Between Texture Features With CT-PET 18 FDG and Overexpression of PDL1 in Non-small-cell Lung Carcinomas During the Initial Staging.

summary:
Search correlation between texture features in CT-PET 18 FDG and overexpression of PDL1 in non-small cell lung carcinomas during the inital staging.

The hypothesis is that overexpression of PDL1is correlated with at least one texture feature among those selected.

84 CT-PET 18 FDG at the initial staging of a non small cell lung carcinoma (adenocarcinoma or squamous cell carcinoma), whose the biopsed site was the primitive site or the drainage lymphadenopathy, without previous treatment, were recruited and analyzed by a software allowing to estimate texture features.

time_perspective: Retrospective

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Utility of Squamous Cell Carcinoma Antigen (SCCA) in Psoriasis

acronym: SCCAPSO

summary:
Squamous Cell Carcinoma Antigen (SCCA) contributes to the pathogenesis of psoriasis by inhibiting cell apoptosis, exacerbating epidermal hyperplasia and skin inflammation. Three studies have shown a correlation between blood levels of SCCA and the severity of psoriasis.

Clinical scores of psoriasis severity are used in consultation to guide treatment of the disease (initiation of systemic therapy, dose escalation) but they suffer from several pitfalls: lack of inter- and intra-observer reproducibility, consumption of medical time.

A readily available, inexpensive (24 euros) blood marker could be an interesting alternative to these clinical scores.

lead_sponsor: University Hospital, Tours

location_facility: Dermatology Service, University Hospital, Tours


title: Follow-up of Osteo-articular Biomarkers After Spa Therapy at Dax in a Population With Knee Osteoarthritis and Their Correlation With the Clinical Evolution

acronym: BIOMARTHROSE

summary:
Spa therapy is used in the treatment of various diseases and mainly osteoarthritis. Knee osteoarthritis is a very common rheumatic disease whose prevalence increases with longer life span and is a public health problem.

The Forestier and al. study highlighted the actual benefit and confirmed the improvement of the quality of life and pain of the knee osteoarthritis patients from 6 months of spa treatment.[1] A significant decrease of 30% in the rate of Serum Hyaluronic Acid at 6 months after the end of the spa therapy was also highlighted in the Canteloup et al study.[6] This study aims to measure different osteoarticular biomarkers (hyaluronic acid, coll2-1 and CTX1) before, at the end of the spa therapy and 6 months after the spa therapy and correlate with the clinical evaluation.

ReferenceType: result

ReferenceCitation: Forestier R, Desfour H, Tessier JM, Françon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.

family: Forestier

full_name: R. Forestier

given: R.

sequence: first

family: Desfour

full_name: H. Desfour

given: H.

sequence: additional

family: Tessier

full_name: J.-M. Tessier

family: Francon

full_name: A. Francon

given: A.

family: Foote

full_name: A. M. Foote

given: A. M.

family: Genty

full_name: C. Genty

given: C.

family: Rolland

full_name: C. Rolland

family: Roques

full_name: C.-F. Roques

family: Bosson

full_name: J.-L. Bosson

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of the Rheumatic Diseases

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

version: submittedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Ch Mont de Marsan

intervention_type: Biological


title: Early Rehabilitation After Hand or Wrist Ambulatory Surgery : How to Preserve Locomotion at Home Without Rebound Pain? Study Walant " Wide Awake Local Anesthesia No Tourniquet " Versus Axillary Brachial Plexus Block.

acronym: WalantBAX

summary:
The purpose of this retrospective study is to compare the analgesic efficacy of Walant " Wide Awake Local Anesthesia No Tourniquet " with lidocaine and bupivacaine versus axillary brachial plexus block using mepivacaïne, both performed by anesthesiologists, after hand or wrist ambulatory surgery.

The main objective is to prove that Walant block improve pain relief at home measuring time to first analgesic request.

The secondary objectives are to compare maximal pain, consumption of supplementary analgesics, and the duratin of sensory block between groups.


title: 18F-DOPA-PET in Non-tumoral and Tumoral Brain Lesions

acronym: FDOPA

summary:
Background: 3,4-dihydroxy-6-[18F]-fluoro-L-phenylalanine (FDOPA) positron emission tomography (PET) can identify well low and high grade brain tumors. However, increased FDOPA uptake has been reported in non-tumoral brain lesions. The aim was to analyse FDOPA-PET in patients with non-tumoral brain lesions and to compare them with patients with (low and high grade) brain tumors.

Methods: retrospective analyse. Patients consecutively recruited with suspected primary brain tumor (based on clinical and MRI findings) referred for FDOPA-PET at Nimes university Hospital between June 2015 and June 2019. FDOPA-PET parameters (maximum and mean lesion standardized uptake values [SUV] and ratios comparing lesion with different background uptake SUV) and thresholds were analysed in search for those offering optimal discrimination between non-tumoral and tumoral lesions.

ReferenceType: derived

ReferenceCitation: Renard D, Collombier L, Laurent-Chabalier S, Mura T, Le Floch A, Fertit HE, Thouvenot E, Guillamo JS. (18)F-FDOPA-PET in pseudotumoral brain lesions. J Neurol. 2021 Apr;268(4):1266-1275. doi: 10.1007/s00415-020-10269-9. Epub 2020 Oct 21.

family: Renard

full_name: Dimitri Renard

given: Dimitri

family: Collombier

full_name: Laurent Collombier

given: Laurent

family: Laurent-Chabalier

full_name: Sabine Laurent-Chabalier

given: Sabine

family: Mura

full_name: Thibault Mura

given: Thibault

family: Le Floch

full_name: Anne Le Floch

given: Anne

family: Fertit

full_name: Hassan El Fertit

given: Hassan El

family: Thouvenot

full_name: Eric Thouvenot

given: Eric

family: Guillamo

full_name: Jean Sebastien Guillamo

given: Jean Sebastien

journal_name: Journal of Neurology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: 18F-FDOPA-PET in pseudotumoral brain lesions

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

intervention_type: Diagnostic Test


title: Functional Evaluation of the Recovery of Prehension in Quadriplegics by Implanted Neural Stimulation

acronym: AGILIS

summary:
A selective neural stimulation as the investigators propose allows to stimulate several muscles via a single electrode. Neural stimulation requires less energy for muscle activation. In our approach, 2 electrodes will be implanted above the elbow on the median and radial nerves. This considerably reduces the number of implanted elements and therefore i) the risk of infection, ii) the risk of failure, iii) the surgical risk through minimally invasive surgery.

Our main hypothesis is that multipolar neural electrical stimulation of the median nerve (flexion) and the radial nerve (extension) allows:

on the one hand, a selective, individualized motor activation (muscle by muscle)
on the other hand, a synergistic motor activation (association of several muscles) for the purpose of production of functional movements.

location_facility: Service MPR: USSAP Centre Bouffard-Vercelli, Pôle Santé du


title: Satisfaction Assessment After Axillary Brachial Plexus Block for Distal Arm Surgery

acronym: Qual'AXI

summary: Satisfaction assessment at 24 and 48 hours post operatively, after Axillary Brachial Plexus Block for Distal Arm Surgery.

ipd_sharing_description: Individual Participant Data (IPD) Sharing Statement depending on the institutional modality under development

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Intérêt de la protéine S100β Dans Les Traumatismes Crâniens légers Sous Anti-Thrombotiques

acronym: ISTCAT

summary:
Head trauma is a common injury in emergency department. Investigation to search for complication is guided by the clinical examination and the case history, such as taking anti-thrombotics. Cranial computed tomography (CCT) is the gold standard to investigate, and is mandatory in case of antithrombotic drugs.

Recently, some biomarkers have proven their utility to rule-out mild head trauma without CCT in the general population. Among these biomarkers, S100β protein has been added in guidelines for mild head trauma. Some studies have found similar data in population taking anticoagulant or antiplatelet drugs.

The investigators aim to prove medical utility of S100β protein in population under antithrombotics, by the reduction of CCT use. Then, The investigators hypothesize that the add of S100β protein reduces cost of health care in the management of head injury in that population.

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de Rennes


title: Motivating to Exercise and Diet, and Educating to Healthy Behaviors After Breast Cancer

acronym: MEDEA

summary: The primary objective of MEDEA is to compare the effect of a personalised telephone-based health education weight loss program based on motivational coaching, exercise and diet versus a standard health educational program control on fatigue of overweight or obese BC patients (as measured by the EORTC QLQ C30 (Aaronson et al. 1993; Sprangers et al. 1996))

primary_purpose: Prevention

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA: a Multicenter Randomised, Double Blind Placebo Controlled Trial

acronym: TRAAPrevia

summary:
Several randomized, controlled trials, mostly involving women undergoing cesarean delivery, have shown that the prophylactic intravenous administration of 1 g of tranexamic acid after childbirth reduced blood loss. Most were small, single-centre trials with considerable methodologic limitations.

It is important to emphasize that none of these RCTs has included women at increased risk of PPH such as placenta previa, a context in which the prevalence of moderate and severe blood loss is significantly higher and where the magnitude of the effect of TXA may highly differ compared to low risk women

lead_sponsor: University Hospital, Bordeaux


title: A Cost Effective and Time Saving Blood Test to Detect Six Human Bloodborne Infectious Diseases (SAFE-Blood)

acronym: SAFE-Blood

summary: The consortium will develop a new in vitro diagnostic (IVD) test to screen donated blood for bloodborne infectious pathogens, saving blood banks time and costs required for analysis of mandatory pathogens. The IVD test is a multiplex immunoassay that simultaneously screens for six bloodborne infectious diseases per blood sample. In this project, a mix of diagnostic protein markers will be developed and validated to lowdown an IVD test ready for commercial scale-up and CE-IVD certification.

time_perspective: Other


title: Evaluating the Correlation Between the Results of the Allergy Work-up for Different Allergens of the Anacardiaceae Family

acronym: Cross-Anacards

summary:
The prevalence of food allergies has increased in recent decades, ranging from 1 to 3% of the general population. According to international literature and French national surveys, nuts today represent a group of allergens often associated with severe allergic reactions. They are responsible for 18 to 40% of deaths from food-related anaphylaxis.

Among all nuts, the prevalence of anacardiac allergies (mainly cashew and pistachio) continues to increase and has become a growing public health problem. Today, global production is estimated at 4.9 million tonnes of cashews and 1.1 million tonnes of pistachios. The resulting increased exposure may explain the increased prevalence of allergic reactions reported to these fruits. In addition, anaphylactic reactions to anacardiaceae are reported to be even more severe than those occurring in subjects allergic to peanuts.

Cashews and pistachios are known to exhibit immunological cross-reactions with one another. In fact, they have a strong sequential homology between their storage allergens Ana o 1 / Pis v 3 (7S vicilin, 78% homology); Ana o 2 / Pis v 2 (legume 11S, 80% homology) and Ana o 3 / Pis v 1 (albumin 2S, 70% homology). For this reason, some authors talk about the cashew / pistachio syndrome and associate the two allergenic sources by considering them as one, in clinical practice.

The diagnosis of allergy to nuts, and therefore to anacardiaceae, is based on a compatible clinical history, the presence of specific IgE (demonstrated by positivity to realistic skin tests and serum IgE assay), and positivity on the oral food challenge test.

In clinical practice, taking into account the cashew / pistachio syndrome, when the allergy work-up for cashew is negative, allergists tend to advise to reintroduce pistachio at home, considering the two allergens as sufficiently homologous to authorize such a practice. In this context, the investigators decided to check whether this practice, which is based mainly on in vitro homologies, is risk-free, based on the clinical experience of our center.


title: Randomized, Double-blind, Placebo-controlled Clinical Trial of the Effect of Dietary Supplementation With Bifidobacteria and Fructo-oligosaccharides (FOS) on Bowel Movement Frequency and Intestinal Biological Markers in Seniors Presenting Slowed Intestinal Transit

summary:
This randomized, double-blind, controlled clinical trial among healthy volunteers with infrequent bowel movements but not severe constipation evaluate the effects of a supplementation in "symbiotic" on intestinal transit of subjects with few bowel movements per week with a verum group treated with a dietary supplement composed of fructo-oligosaccharides - FOS: 4.95 gr / sachet and Bifidobacterium animalis lactis: VES002 (LMG P-28149): 5 billion / sachet and a placebo group treated with a comparative product hat looked strictly identical to the verum and contained only excipients (60% maltodextrin / 40% sucrose).

The claim investigated corresponds to the section of the new EFSA (European Food Safety Authority) guidance of 2016 entitled "Claims on maintenance of normal defecation".

lead_sponsor: CEN Biotech


title: A Randomized, Controlled Study of the Superiority Between 2 Types of POSToperative Pharmaceutical Support on Patients' Knowledge of Their IMPlant: Breast or Joint Prostheses

acronym: POSTIMP

summary:
Recently joint and breast prostheses were placed under special post-marketing surveillance in order to prevent new occurrence of serious incidents by agency for medicines and health products safety. Few of french patient are able to identify their prosthesis in the event on health security alert. An usual postoperative pharmaceutical support (UPS) for patients with joint prosthesis has been implemented to prepare them for return home. At the request of surgeons, a new pharmaceutical support (NPS) has been developed to improve the ability of these patients to recall or find information that identify their prosthesis.

Objectives :

The main objective is to demonstrate that the new pharmaceutical support (NPS) increase the ability to memorize then find correct information of their prosthesis 6 months post-implantation

Material and method :

This study, approved by an ethic committee, takes place in the orthopedic and plastic surgery departments. The 236 adult patients included are hospitalized following the scheduled placement of either a breast or a hip or knee prosthesis. They are randomized, either in the NPS group or in the UPS comparator group. In both cases, patients benefit from the same written information: a patient-implant file and an information booklet specific to their prosthesis, validated by specialist surgeons, to prepare for their return home. The only difference between these 2 groups is that patients in the NPS group benefit from additional visual and oral information on the characteristics of their implant and on medical device vigilance during their hospitalization. In NPS group, pharmacist use specific photo and quiz.

A telephone follow-up at the 6th month of the patients is carried out by a pharmacist to assess the patient's knowledge, using a standardized questionnaire.

Expected results :

Based on retrospective data already published, the main hypothesis is that the NPS is associated with an improvement in patient ability to remember the correct model or manufacturer of their prosthesis, compared to the UPS, 6 months after the operation.Secondary hypotheses are that NPS compared to UPS leads to an improvement in patients ability to preserve and find correct items related to theirs prosthesis at 6 months as well as an improvement in their knowledge of medical device vigilance and patient satisfaction declarations and a decrease in anxiety associated with prosthesis.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Supportive Care

ipd_sharing: Yes

ipd_sharing_description: data are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information

location_facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR


title: Stools and Life Habits Collection in Heathy Volunteers/Subjects - to Provide Material for in Vitro Model Development

acronym: PEPSIIN

summary: The purpose of this clinical study is to collect well characterized stools from healthy adult subjects, with completed life habits and alimentary questionnaires.

lead_sponsor: Danone Research


title: Evaluation of the Response to CFTR Modulators in Patients With Cystic Fibrosis Less Than 18 Years of Age

acronym: MODUL-CF

summary:
CFTR modulators should improve the prognosis of Cystic Fibrosis. Identifying patients under the age of 18 responding to CFTR modulators as well as detecting possible toxicity is an important medical objective given the potential side effects and the high cost of these molecules.

This observational follow-up cohort study is carried out as part of routine care.

The main objective is to assess the evolution of pulmonary structural impairment by low-dose CF scan at the end of the first year of CFTR modulator therapy.

The secondary objectives are to evaluate structural impairment at low dose scan at 3 years and 5 years of CFTR modulator treatment, the evolution of respiratory functional parameters, growth, puberty, lung infection, sweat test, quality of life and pancreatic function, as well as tolerance of modulators including liver toxicity.

lead_sponsor: Societe Francaise de la Mucoviscidose


title: Assessment of Nutritional Status in Systemic Sclerosis: Prospective Cohort Study in Montpellier University Hospital

acronym: NUTRISCLER

summary:
The main theme of the cohort of systemic sclerosis (SSc) patients is the determination of nutritional status, its evolution and the evaluation of its management in patients with scleroderma.

The main objectives are :

To determine the incidence of malnutrition and its main determinants (disease characteristics, severity, eating habits, physical activity) in patients with scleroderma.
For patients with undernutrition at inclusion or at 18 months follow-up:

evaluate the impact of a standardized nutritional intervention (dietary advice, oral supplements, artificial, enteral or parenteral nutrition) on nutritional and disease parameters.

Follow-up visits will take place every 6 months for 2 years. (M6, M12, M18 et M24).

During each visit: a clinical examination, with anthropometric measurements, a 3-day dietary survey and a blood sample (10 ml), completion a multiple-choice of quality of life and physical activity evaluation.

Paraclinical evaluation : echocardiography, lung function tests, screening for osteoporosis (M6 and M18).

If undernutrition is detected during a follow-up visit, the subject will be referred to a specialized service.


title: THE PHYSIOLOGICAL EFFECTS OF ELECTROMAGNETIC EMISSIONS ON THE GENERAL CONDITION OF THE PATIENT

acronym: EPHEME

summary:
Hospital patients usually experience anxiety caused by physiological, psychological and environmental stimuli. This emotional state corresponds to the psychophysiological response to a perceived threat.

The investigator's goal is to use a non-drug approach to these problems which would help improve the quality of life of patients, prevent the consumption of anti-anxiety drugs / antidepressants; and thus to reduce the direct cost in terms of treatment, but also to reduce the indirect costs linked to work stoppages and the consumption of the care offer.

Working hypothesis: Local magnetic muscle stimulation improves people's well-being and relaxation

design_allocation: Non-Randomized

lead_sponsor: Clinique Bizet


title: Smallest Significant Value in Osteodensitomery in an Obese Population

acronym: PPVS-ob

summary:
The aim of this study is to determined the smallest significant value in osteodensitometry in obese population. The study population will be divided in 3 groups according to their BMI.

Bone mineral density will be measured twice in osteodensitometry, then the smallest significant value will be determined.

Our hypothesis is that the smallest significant value that we use in an non-obese population can be different in an obese population.

primary_purpose: Diagnostic

lead_sponsor: CHU de Reims


title: Assessment of Changes in Vaginal Microbiota Profiles Before and After Vaginal Urogynecologic Surgery

acronym: VAGIBIOTE

summary: Several studies have shown interactions between vaginal microbiota and post-surgical evolution. A study conducted by our team showed a tendency for patients with complications to have a greater diversity of vaginal microbiota. The main objective of the proposed study will therefore be to evaluate the vaginal, urinary and digestive microbiota modifications during and after vaginal surgery and to correlate them with the symptoms of the urogynecological sphere.


title: Nitrous Oxyde Misuse Among Teenagers Consulting in an Addictology Center Dedicated to Young Drug Users: an Observational Study Led in Montpellier

acronym: NC

summary:
Nitrous oxide gas is used in several application areas : medical as an anesthetic drug ; in food industry as a foaming and a mixing agent ; industrial to speed combustion. It is also misused for its hilarant, euphoric and hallucinogenic effect. For this purpose the gas is transfered in a balloon to be inhaled.

As its effects are briefs, its consumption is often perseived as safe. However, some risks exist and are majorated by the way of use and for some groups of people.

Since 2016, the French observatory of drug and substances addiction (OFDT) describes an increasing misuse of nitrous oxide amoung teenagers and young adults. In november 2019, a french press release alerts on the recent increasing of neurologic side effects related to the misuse of nitrous oxide.

That's why, it seems to be interesting to improve the screening of nitrous oxide abuse, in particular amoung adolescents and young adults.

In our study, the investigators would like to determine the characteristics (social, medical, any drug abuse) of teenagers and young adults who misuse nitrous oxide. Through a questionnaire, the investigators plan to select teenagers and young adults who consult in an addictology center dedicated to young drug consumers in Montpellier. This questionnaire is anonymous. The data will be collected only after obtaining the patient's agreement.

The final goal is to create a tool to help general practitioners in screening young people at risk of nitrous oxyde misuse.


title: Evaluation and Comparison of Two Biomarkers (VOP and SCC) for the Prognosis of the Occurrence of Clinical Cardiovascular Events

acronym: VOP-SCC

summary:
The aim of our study is to assess the Cardiovascular risk and the quality of the arteries by comparing the Coronary Calcium Score SCC measured with a CT scann and the Pulse Wave Velocity PWV measured with pOpmeter for the prognosis at 6 months of clinical events.

Is there a superiority of PWV compared to SCC:

status: Active, not recruiting


title: Medico-economic Interest of Single-use Ancillary Efficiency® in Fitting a GMK® Total Knee Arthroplasty (TKA)

acronym: IMEDUU

summary:
Clinical studies on single-use ancillaries are still few; medico-economic benefits have to be assessed regarding their design and use.

A foreseeable increase in the number of surgeries in the future, tends to change the techniques and consequently to question the medico-economic context. Single-use ancillaries attempt to provide solutions to today's imperatives and could be relevant from a global medico-economic point of view.

For the moment, the conventional ancillaries for TKA are reused after sterilization.

The objective of the study is to improve the fluidity of the intervention process with cost control.

lead_sponsor: Nantes University Hospital

location_facility: CHU de Nantes (University Hospital of Nantes)


title: Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer

acronym: REBIMMUNE

summary:
The objective of the study aims to collect tumor tissue at the moment of progression under Immune checkpoint inhibitors (ICI) in biological resources center in Ambroise Paré hospital, in order to insure later study on molecular mechanism involving the progression of NSCLC and SCLC under ICI.

The further analysis of research will be performed in the EA 4340 unity, Biomarkers and Clinical Trials in cancerology and onco-hematology, UVSQ, University of Paris-Saclay.

ReferenceCitation: Giroux Leprieur E, Dumenil C, Julie C, Giraud V, Dumoulin J, Labrune S, Chinet T. Immunotherapy revolutionises non-small-cell lung cancer therapy: Results, perspectives and new challenges. Eur J Cancer. 2017 Jun;78:16-23. doi: 10.1016/j.ejca.2016.12.041. Epub 2017 Apr 11. Review.

location_facility: Service de Pneumologie et Oncologie thoracique, Hôpital Ambroise Paré, APHP


title: Accuracy of the PI-RADS v2.1 Score for Characterizing ISUP ≥2 Prostate Cancers on Multiparametric MRI: a Multiple Reader Study

acronym: MULTI

summary:
The interpretation of prostate multiparametric MRI (mpMRI) is difficult and requires expertise. As a result, it suffers from substantial inter-reader variability. The so-called Prostate Imaging Reporting and Data System (PI-RADS) scoring system has been launched in 2012 to try and standardise prostate mpMRI interpretation. It is a 5-level score that assesses the likelihood that suspicious focal prostatic lesions seen on mpMRI are clinically significant prostate cancers. Despite the use of semi-objective criteria for each category of the score, the inter-reader reproducibility of the first two versions (PI-RADS v1 launched in 2012 and PI-RADS v2 launched in 2015) was moderate at best, even for experienced readers. The last version (PI-RADS v2.1) has been launched in March 2019 in an effort to improve the inter-reader reproducibility. This version has not been evaluated yet.

The purpose of our study is to evaluate the accuracy and inter-reader reproducibility of the PI-RADS v2.1 score on a large set of 163 prostate MRIs using 20 readers of varying experience.

Twenty readers (14 seniors and 6 juniors) from 7 different institutions and with varying experience in prostate mpMRI accepted to participate to the study.

Reader will assess the dataset independently and will be blinded to the other readers' results. They also be blinded to clinical and biochemical data.

lead_sponsor: Hospices Civils de Lyon


title: Stress Disorder Post-stroke: Observational Study of the Evaluation of Post Traumatic Stress Post Stroke (Stroke Post Traumatic Disorder)

acronym: SPTD

summary:
This prospective, observational, multicentre study evaluates the existence of Post-traumatic stress disorder following a stroke at 3 and 6 months after the management of the patient.

Questionnaires will be used to assess the presence of stroke post traumatic disorder.

The evaluation of stroke post traumatic disorder would allow to underline the importance of the awareness of the care teams in the the screening of these disorders and to evaluate if the Post-traumatic Stress Disorder Checklist Scale (PCL5) is an effective screening tool.

status: Withdrawn

status_simplified: Unknown


title: Assessment of Fears of Patients Standing at the Operating Block

summary:
The term "outpatient" refers to all the medical, organizational and administrative care that allows the patient to leave the same day the structure where the ambulatory procedure was performed. The usual rule for patients undergoing endoscopic surgery or surgery under general anesthesia is to transport them to the endoscopy or operating room lying on a stretcher, even if they can walk independently.

In recent years, the procedure of bringing the patient standing in the operating room seems to have many advantages. It is readily accepted by patients and may even lessen their anxiety.

Nevertheless, reluctance and fears are sometimes expressed by patients who do not know this new procedure. Our team has introduced this procedure for patients admitted to the ambulatory hospitalization sector and to join the endoscopy sector.

The aim of our work is therefore to objectify the fears expressed by patients who have to go to the endoscopy room before general anesthesia and to evaluate their progress after endoscopy


title: White Matter Hyperintensities Subtypes in Cerebral Small Vessel Disease : 7 Tesla Ultra-high Resolution Imaging MRI

summary: Cerebral small vessel diseases (SVD) are a very frequent group of disorders all characterized by alterations of the structure and/or function of small arteries, veins and capillaries. In these disorders, brain tissue lesions accumulate years before the occurrence of clinical symptoms which can be devastating such as stroke, cognitive disturbances and gait disorders. So far, chronic hypoperfusion was considered to be responsible for the accumulation of such lesions. However, recent results have suggested that the lesions underlying white matter hyperintensities (WMH), the most common MRI marker of SVD visible on conventional MRI in quite every subject with SVD long before the occurrence of clinical events, may depend on the considered brain area and may correspond to various mechanisms. Some WMH may even be associated with less severe clinical manifestations.The aim of the present study is to identify different types of WMH by studying 100 patients with different forms of SVD with the most advanced MRI (including ultra-high-resolution imaging at 7 Tesla, new diffusion protocol, sodium MRI, contrast-enhanced angiography and relaxometry and post-processing techniques), and post-processing techniques (machine learning, deep learning, artificial intelligence).

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: GENIMOC : Neurological Fate, Prematurity and Genetic Susceptibility Factors

acronym: GENIMOC

summary: This study could help identify aggravating or protective genetic polymorphisms associated with cerebral palsy. Populations of premature babies at different risk of cerebral palsy could thus be individualized with an impact on their monitoring and on the pathophysiological understanding of the processes leading to neurological lesions.


title: Congenital Nevi in the Lower Limb in Children : Which Size Can be Afforded by a Simple Surgical Procedure ?

acronym: NAEVUS

summary:
Depending on its dimensions, it is difficult to predict if a congenital nevi of the lower limb can be surgically removed by a unique simple procedure or by a complex procedure (expander, skin graft etc..), with a good result.

This study retrospectively reviewed the practice of our team of surgeons depending on the size of the naevus to reveal a dimension threshold that can be used in the future to help to choose between a simple or a complex procedure.


title: MICISPORT Patient Questionnaire

acronym: MICISPORT

summary: This study offers a questionnaire to patients with Crohn's disease in order to assess their physical activity and / or sport as well as their eating habits in order to assess the impact of these lifestyle habits on activity and the symptoms of the disease.


title: Effects of Pulmonary Rehabilitation According to Gender, in COPD Patients

acronym: REHABGENRE

summary:
Without calling into question the effectiveness of pulmonary rehabilitation in women, the difference in outcome by gender was not established due to insufficient evidence .

Studies demonstrating the effectiveness of pulmonary rehabilitation include a majority of men, which no longer corresponds to the sex ratio of the disease. The impact of gender on pulmonary rehabilitation outcomes was not established due to insufficient evidence.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Evaluation of Deep Brain Stimulation (DBS) of the Right Operculum 3 (OP3) in Permanent Non-pulsatile Disabling Tinnitus (TINNOP3-DBS)

summary: This pilot study aims at evaluating the effectiveness of the treatment of unilateral or bilateral, non-pulsatile, disabling, tinnitus, without vestibular dysfunction, using Deep Brain Stimulation (DBS) of the parieto-insular right operculum 3 (OP3) in a cross-over, double study design.

ReferenceCitation: Job A, Paucod JC, O'Beirne GA, Delon-Martin C. Cortical representation of tympanic membrane movements due to pressure variation: an fMRI study. Hum Brain Mapp. 2011 May;32(5):744-9. doi: 10.1002/hbm.21063.

ReferenceCitation: Job A, Pons Y, Lamalle L, Jaillard A, Buck K, Segebarth C, Delon-Martin C. Abnormal cortical sensorimotor activity during "Target" sound detection in subjects with acute acoustic trauma sequelae: an fMRI study. Brain Behav. 2012 Mar;2(2):187-99. doi: 10.1002/brb3.21.

ReferenceCitation: Job A, Jacob R, Pons Y, Raynal M, Kossowski M, Gauthier J, Lombard B, Delon-Martin C. Specific activation of operculum 3 (OP3) brain region during provoked tinnitus-related phantom auditory perceptions in humans. Brain Struct Funct. 2016 Mar;221(2):913-22. doi: 10.1007/s00429-014-0944-0. Epub 2014 Dec 12.

ReferenceCitation: Eickhoff SB, Grefkes C, Zilles K, Fink GR. The somatotopic organization of cytoarchitectonic areas on the human parietal operculum. Cereb Cortex. 2007 Aug;17(8):1800-11. Epub 2006 Oct 10.

ReferenceCitation: Mălîia MD, Donos C, Barborica A, Popa I, Ciurea J, Cinatti S, Mîndruţă I. Functional mapping and effective connectivity of the human operculum. Cortex. 2018 Dec;109:303-321. doi: 10.1016/j.cortex.2018.08.024. Epub 2018 Sep 10.

lead_sponsor: University Hospital, Grenoble


title: Non-invasive Monitoring of Cerebral Self-regulation in Perioperative Neonatal Cardiac Surgery

acronym: NEMOCARD

summary: Cardiac surgery under extracorporeal circulation (ECC) in newborns with congenital heart disease causes significant morbidity and mortality. The perioperative period is a period of major vulnerability implicated in the appearance of these sequelae, and it is therefore essential to monitor brain function during ECC. The quality of cerebral oxygenation in the perioperative period is routinely monitored non-invasively by infra-red spectroscopy, which makes it possible to estimate cerebral tissue oximetry from a surface electrode (NIRS). The association between time spent outside the limits of cerebral self-regulation and the occurrence of perioperative encephalopathy is not known. The purpose of this study is to determine whether disturbances in brain self-regulation during the operative period are associated with the occurrence of postoperative encephalopathy in children operated on for congenital heart disease in the neonatal period. The main objective of the research is to determine the association between time spent outside individually determined cerebral self-regulation limits and the appearance of brain lesions suggestive of low brain output. Secondary objectives will investigate the association between time spent outside self-regulatory limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria and will study factors predictive of the development of postoperative encephalopathy.


title: JOint Use of Database to Identify Risk Factors of CARDio-vascular Adverse Reactions Induced by Immune Checkpoint InhibiTors: VigiBase, Entrepot de Données de Santé (EDS), Système National Des Données de Santé (SNDS) Databases and a Retrospective International Multicenter Registry of ICI-associated Myocarditis

acronym: JOCARDITE

summary: Immune checkpoint inhibitors (ICIs) might induce high grade immune-related adverse events (irAEs) involving the cardio-vascular system. This study investigates reports of cardio-vascular toxicity associated with treatment including anti-PD1, Anti-PDL-1, and Anti CTLA4 classes using the World Health Organization (WHO) database VigiBase, Assistance Publique Hopitaux de Paris Entrepot de Données de Santé (APHP.EDS), French Système National Des Données de Santé (SNDS) Databases and a retrospective international multicenter registry of ICI-associated myocarditis

ReferenceCitation: Moslehi JJ, Salem JE, Sosman JA, Lebrun-Vignes B, Johnson DB. Increased reporting of fatal immune checkpoint inhibitor-associated myocarditis. Lancet. 2018 Mar 10;391(10124):933. doi: 10.1016/S0140-6736(18)30533-6.

family: Moslehi

full_name: Javid J Moslehi

given: Javid J

family: Salem

full_name: Joe-Elie Salem

given: Joe-Elie

family: Sosman

full_name: Jeffrey A Sosman

given: Jeffrey A

family: Lebrun-Vignes

full_name: Bénédicte Lebrun-Vignes

given: Bénédicte

family: Johnson

full_name: Douglas B Johnson

given: Douglas B

journal_name: The Lancet

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Salem JE, Manouchehri A, Moey M, Lebrun-Vignes B, Bastarache L, Pariente A, Gobert A, Spano JP, Balko JM, Bonaca MP, Roden DM, Johnson DB, Moslehi JJ. Cardiovascular toxicities associated with immune checkpoint inhibitors: an observational, retrospective, pharmacovigilance study. Lancet Oncol. 2018 Dec;19(12):1579-1589. doi: 10.1016/S1470-2045(18)30608-9. Epub 2018 Nov 12.

family: Manouchehri

full_name: Ali Manouchehri

given: Ali

family: Moey

full_name: Melissa Moey

given: Melissa

family: Bastarache

full_name: Lisa Bastarache

given: Lisa

family: Pariente

full_name: Antoine Pariente

given: Antoine

family: Gobert

full_name: Aurélien Gobert

given: Aurélien

family: Spano

full_name: Jean-Philippe Spano

given: Jean-Philippe

family: Balko

full_name: Justin M Balko

given: Justin M

family: Bonaca

full_name: Marc P Bonaca

given: Marc P

family: Roden

full_name: Dan M Roden

given: Dan M

ReferenceCitation: Salem JE, Allenbach Y, Vozy A, Brechot N, Johnson DB, Moslehi JJ, Kerneis M. Abatacept for Severe Immune Checkpoint Inhibitor-Associated Myocarditis. N Engl J Med. 2019 Jun 13;380(24):2377-2379. doi: 10.1056/NEJMc1901677.

ReferenceCitation: Bonaca MP, Olenchock BA, Salem JE, Wiviott SD, Ederhy S, Cohen A, Stewart GC, Choueiri TK, Di Carli M, Allenbach Y, Kumbhani DJ, Heinzerling L, Amiri-Kordestani L, Lyon AR, Thavendiranathan P, Padera R, Lichtman A, Liu PP, Johnson DB, Moslehi J. Myocarditis in the Setting of Cancer Therapeutics: Proposed Case Definitions for Emerging Clinical Syndromes in Cardio-Oncology. Circulation. 2019 Jul 2;140(2):80-91. Review.

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.


title: Evaluation of Neutrophil Extracellular Traps (NETs) by Flow Cytometry in Patients With Solid Cancers Associated With a High Risk of Venous Thromboembolic Events

acronym: Flownet

summary:
Venous Thromboembolic Events (ETVs) are the second leading cause of death (9.2% of causes of death) in cancer patients after tumor progression (1). Indeed, cancer is associated with a 4 to 7-fold risk of ETV during chemotherapy (2). This complication is observed in 20% of cancer patients (3), and is sometimes an inaugural manifestation of cancer. This risk is particularly increased during the first 3 months after cancer diagnosis (4).

A biomarker correlated with the occurrence of ETVs would make it possible to target patients at high risk of thrombosis who could benefit from primary thromboprophylaxis, thus avoiding the complications, particularly haemorrhagic, and the additional costs associated with the long-term diagnostic and therapeutic management of ETVs. The investigator has implemented in the laboratory an innovative approach to the detection and quantification of circulating NETs by flow cytometry (FCM) allowing the routine determination of NETs. Therefore the investigator propose to assess NETs by CMF in a cohort of cancer patients with a very high risk of ETVs (pancreatic cancer, gastric cancer and colon cancer).

ReferenceCitation: Khorana AA, Francis CW, Culakova E, Kuderer NM, Lyman GH. Thromboembolism is a leading cause of death in cancer patients receiving outpatient chemotherapy. J Thromb Haemost. 2007 Mar;5(3):632-4.

ReferenceCitation: Chew HK, Wun T, Harvey D, Zhou H, White RH. Incidence of venous thromboembolism and its effect on survival among patients with common cancers. Arch Intern Med. 2006 Feb 27;166(4):458-64.


title: Medical Termination of Pregnancy : Evaluation of Patients' Practices and Feelings in Brest Hospital

acronym: IMGEPR

summary: This study evaluate the feelings of patients about a medical termination of pregnancy that they experienced in Brest Hospital. Patients responded to an online questionnaire assessing their feelings at each stage of the medical termination process. Their answers were associated with their medical data.

status: Unknown status


title: Performance Study of BIOPSY SCANNER LLTECH© Technology in the Immediate Diagnosis of Breast Cancer

acronym: LLTECHBreast

summary:
Breast cancer is a frequent pathology and the speed of initial diagnosis makes it possible to improve the course of care and to reduce the anxiety of the patients. For a complete assessment, several biopsies may be necessary, including lymph node biopsies. Once the histological sample has been taken, a preparation is necessary (time consuming technician) then a reading by a pathologist requiring at least 48-72h. Cytology allows immediate diagnosis, but it requires the presence of a pathologist in the collection room. Finally, some biopsies can be non-contributory (if there is not enough tissue removed) and require new samples. A tool allowing immediate control of the tissue and an initial diagnosis without mobilizing the pathologist (who will make the result complete with immunohistochemistry) would make it possible to anticipate the next course of care and facilitate treatment. The BIOPSY SCANNER LLTECH © technology would allow images on fresh unprepared tissue to obtain images allowing immediate diagnosis by a non-pathologist, the same tissue could then be technical for a complete analysis by the pathologist.

The investigators propose a study evaluating the diagnostic capacities by non pathologists from images obtained by the BIOPSY SCANNER LLTECH © technology on breast and lymph node biopsies. Based on this study, an atlas on breast lesions could be created to allow a broader evaluation of this technology in daily practice in diagnostic of breast pathology.


type: Registry Identifier

title: Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis

acronym: MICROBIART

summary: The primary objective of the study aims to compare the biodiversity of intestinal microbiota between spondylarthritis (SPA) or rheumatoid arthritis (RA) patients and healthy volunteers, by microbiota DNA sequencing in order to further and respond the prior results, which suggested that there is a specific dysbiosis for each of the 2 diseases. A comparative analysis will allow to identify the biomarkers of the specific bacteria.

ReferenceCitation: Breban M, Tap J, Leboime A, Said-Nahal R, Langella P, Chiocchia G, Furet JP, Sokol H. Faecal microbiota study reveals specific dysbiosis in spondyloarthritis. Ann Rheum Dis. 2017 Sep;76(9):1614-1622. doi: 10.1136/annrheumdis-2016-211064. Epub 2017 Jun 12.

location_facility: Service de Rhumatologie, Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris


title: "Antibioprophylaxis for Excision-graft Surgery in Burn Patient: a Multicenter Randomized Double-blind Study: A2B Trial"

summary:
The indication of antibiotic prophylaxis in burn patients remains highly controversial and hasn't reached a consensus. The objective of antibiotic prophylaxis would be to reduce the risk of post-operative local and systemic infections. Burn surgery is associated with a high risk of bacteremia and postoperative infections and sepsis. However, antibiotic prophylaxis exposes to the risk of selecting drug-resistant pathogens as well as adverse effects of antibiotics (i.e Clostridium difficile colitis).

Recommendations regarding perioperative prophylaxis using systemic antibiotics vary across sources. The lack of data precludes any international strong recommendations regarding the best strategy regarding antibiotic prophylaxis.

The goal of this project is therefore to determine whether peri-operative systemic antibiotics prophylaxis could reduce the incidence of post-operative infections in burn patients.

ReferenceCitation: Dépret F, Farny B, Jeanne M, Klouche K, Leclerc T, Nouette-Gaulain K, Pantet O, Rémerand F, Roquilly A, Rousseau AF, Sztajnic S, Wiramus S, Vicaut E, Legrand M; A2B trial investigators. The A2B trial, antibiotic prophylaxis for excision-graft surgery in burn patients: a multicenter randomized double-blind study. Trials. 2020 Nov 25;21(1):973. doi: 10.1186/s13063-020-04894-y.

family: Dépret

full_name: François Dépret

given: François

family: Farny

full_name: Boris Farny

given: Boris

family: Jeanne

full_name: Mathieu Jeanne

given: Mathieu

family: Klouche

full_name: Kada Klouche

given: Kada

family: Leclerc

full_name: Thomas Leclerc

given: Thomas

family: Nouette-Gaulain

full_name: Karine Nouette-Gaulain

given: Karine

family: Pantet

full_name: Olivier Pantet

given: Olivier

family: Rémerand

full_name: Francis Rémerand

given: Francis

family: Roquilly

full_name: Antoine Roquilly

family: Rousseau

full_name: Anne-Françoise Rousseau

given: Anne-Françoise

family: Sztajnic

full_name: Simon Sztajnic

given: Simon

family: Wiramus

full_name: Sandrine Wiramus

given: Sandrine

family: Vicaut

full_name: Eric Vicaut

family: Legrand

full_name: Matthieu Legrand

given: Matthieu

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central


title: Recovering Arm Function in Chronic Post-stroke Patients Using Combined HD-tDCS and Virtual Reality Therapy

acronym: ReArm

summary: The study aims to determine the added value of combining high-definition transcranial direct current stimulation (HD-tDCS) in a rehabilitation program based on virtual reality therapy (VRT) to potentiate the effects on neuroplasticity and further improve functional recovery of the arm in chronic stroke patients.

ReferenceCitation: Levin MF, Weiss PL, Keshner EA. Emergence of virtual reality as a tool for upper limb rehabilitation: incorporation of motor control and motor learning principles. Phys Ther. 2015 Mar;95(3):415-25. doi: 10.2522/ptj.20130579. Epub 2014 Sep 11.

name: M.F. Levin, PT, PhD, School of Physical and Occupational Therapy, McGill University, 3654 Promenade Sir William Osler, Montreal, Quebec H3G 1Y5, Canada, and Centre for Interdisciplinary Research in Rehabilitation, Jewish Rehabilitation Hospital, Laval, Quebec, Canada.

family: Levin

full_name: Mindy F. Levin

given: Mindy F.

name: P.L. Weiss, OT, PhD, Department of Occupational Therapy, University of Haifa Mount Carmel, Haifa, Israel.

family: Weiss

full_name: Patrice L. Weiss

given: Patrice L.

name: E.A. Keshner, PT, EdD, Department of Physical Therapy, College of Health Professions and Social Work, Temple University, Philadelphia, Pennsylvania.

family: Keshner

full_name: Emily A. Keshner

given: Emily A.

journal_name: Physical Therapy

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Emergence of Virtual Reality as a Tool for Upper Limb Rehabilitation: Incorporation of Motor Control and Motor Learning Principles

ReferenceCitation: Laffont I, Bakhti K, Coroian F, van Dokkum L, Mottet D, Schweighofer N, Froger J. Innovative technologies applied to sensorimotor rehabilitation after stroke. Ann Phys Rehabil Med. 2014 Nov;57(8):543-551. doi: 10.1016/j.rehab.2014.08.007. Epub 2014 Aug 26. Review.

family: Laffont

full_name: I. Laffont

given: I.

family: Bakhti

full_name: K. Bakhti

given: K.

family: Coroian

full_name: F. Coroian

given: F.

family: van Dokkum

full_name: L. van Dokkum

given: L.

family: Mottet

full_name: D. Mottet

given: D.

family: Schweighofer

full_name: N. Schweighofer

given: N.

family: Froger

full_name: J. Froger

given: J.

journal_name: Annals of Physical and Rehabilitation Medicine

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11:CD008349. doi: 10.1002/14651858.CD008349.pub4. Review.

name: Flinders University; Department of Rehabilitation, Aged and Extended Care; Level 1, C Block, Repatriation General Hospital, Daws Road, Daw Park Adelaide South Australia Australia 5041

family: Laver

full_name: Kate E Laver

given: Kate E

name: Flinders University; School of Health Sciences, Discipline of Physiotherapy; Adelaide Australia

family: Lange

full_name: Belinda Lange

given: Belinda

family: George

name: Rutgers University; Department of Rehabilitation and Movement Science; Newark New Jersey USA

name: University of Toronto; Department of Medicine (Neurology), St Michael's Hospital; Toronto Canada M5C 1R6

repository_institution: Flinders University - Flinders Academic Commons

ReferenceCitation: Polanía R, Nitsche MA, Ruff CC. Studying and modifying brain function with non-invasive brain stimulation. Nat Neurosci. 2018 Feb;21(2):174-187. doi: 10.1038/s41593-017-0054-4. Epub 2018 Jan 8. Review.

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15. Review.

evidence: open (via crossref license, author manuscript)

ReferenceCitation: Chhatbar PY, Chen R, Deardorff R, Dellenbach B, Kautz SA, George MS, Feng W. Safety and tolerability of transcranial direct current stimulation to stroke patients - A phase I current escalation study. Brain Stimul. 2017 May - Jun;10(3):553-559. doi: 10.1016/j.brs.2017.02.007. Epub 2017 Feb 27.

title: Safety and tolerability of transcranial direct current stimulation to stroke patients – A phase I current escalation study

ReferenceCitation: Flöel A. tDCS-enhanced motor and cognitive function in neurological diseases. Neuroimage. 2014 Jan 15;85 Pt 3:934-47. doi: 10.1016/j.neuroimage.2013.05.098. Epub 2013 May 30. Review.

ReferenceCitation: Teo WP, Muthalib M, Yamin S, Hendy AM, Bramstedt K, Kotsopoulos E, Perrey S, Ayaz H. Does a Combination of Virtual Reality, Neuromodulation and Neuroimaging Provide a Comprehensive Platform for Neurorehabilitation? - A Narrative Review of the Literature. Front Hum Neurosci. 2016 Jun 24;10:284. doi: 10.3389/fnhum.2016.00284. eCollection 2016. Review. Erratum in: Front Hum Neurosci. 2017 Feb 03;11:53.

title: Does a Combination of Virtual Reality, Neuromodulation and Neuroimaging Provide a Comprehensive Platform for Neurorehabilitation? – A Narrative Review of the Literature

ReferenceCitation: Allman C, Amadi U, Winkler AM, Wilkins L, Filippini N, Kischka U, Stagg CJ, Johansen-Berg H. Ipsilesional anodal tDCS enhances the functional benefits of rehabilitation in patients after stroke. Sci Transl Med. 2016 Mar 16;8(330):330re1. doi: 10.1126/scitranslmed.aad5651. Epub 2016 Mar 16.

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

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

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

publisher: American Association for the Advancement of Science (AAAS)

ReferenceCitation: Bakhti KKA, Laffont I, Muthalib M, Froger J, Mottet D. Kinect-based assessment of proximal arm non-use after a stroke. J Neuroeng Rehabil. 2018 Nov 14;15(1):104. doi: 10.1186/s12984-018-0451-2.

journal_name: Journal of NeuroEngineering and Rehabilitation

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

ReferenceCitation: Chhatbar PY, Ramakrishnan V, Kautz S, George MS, Adams RJ, Feng W. Transcranial Direct Current Stimulation Post-Stroke Upper Extremity Motor Recovery Studies Exhibit a Dose-Response Relationship. Brain Stimul. 2016 Jan-Feb;9(1):16-26. doi: 10.1016/j.brs.2015.09.002. Epub 2015 Sep 7.

title: Transcranial Direct Current Stimulation Post-Stroke Upper Extremity Motor Recovery Studies Exhibit a Dose–Response Relationship

ReferenceCitation: Figlewski K, Blicher JU, Mortensen J, Severinsen KE, Nielsen JF, Andersen H. Transcranial Direct Current Stimulation Potentiates Improvements in Functional Ability in Patients With Chronic Stroke Receiving Constraint-Induced Movement Therapy. Stroke. 2017 Jan;48(1):229-232. doi: 10.1161/STROKEAHA.116.014988. Epub 2016 Nov 29.

name: From the Hammel Neurorehabilitation Centre and University Research Clinic, Denmark (K.F., J.M., J.F.N., H.A.); Centre for Functionally Integrative Neuroscience, Aarhus University Hospital, Denmark (J.U.B.); and Department of Neurology, Aarhus University Hospital, Denmark (K.E.S., H.A.).

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Muller CO, Muthalib M, Mottet D, Perrey S, Dray G, Delorme M, Duflos C, Froger J, Xu B, Faity G, Pla S, Jean P, Laffont I, Bakhti KKA. Recovering arm function in chronic stroke patients using combined anodal HD-tDCS and virtual reality therapy (ReArm): a study protocol for a randomized controlled trial. Trials. 2021 Oct 26;22(1):747. doi: 10.1186/s13063-021-05689-5.

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

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

ipd_sharing_description: Data available upon request through a data access


title: Multicentric Phase III Trial Comparing Two Strategies in Intermediate-risk Differentiated Thyroid Cancer Patients: Systematic Radioiodine Administration (3.7 GBq I131 After rhTSH) Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up Based on Serum Tg Values and Diagnostic RAI Scintigraphy

acronym: INTERMEDIATE

summary: This trial is comparing two strategies in intermediate-risk differentiated thyroid cancer patients: Systematic radioiodine administration (3.7 GBq I131 after rhTSH) versus decision of radioiodine treatment guided by a post-operative work-up based on serum Tg values and diagnostic RAI scintigraphy

lead_sponsor: Centre Francois Baclesse


title: Monitoring the Neurological Toxicity of Enzalumatide Through VigiBase, a Pharmacovigilance Study

acronym: VENDY

summary: Enzalutamide may lead to various adverse reactions. This study investigates reports of different neurological toxicities in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière


title: Optimization of Frozen Embryo Transfers by Studying Progesterone on the Day of Transfer

acronym: OTEC

summary:
The number of embryo transfers after freezing has increased over the last 10 years due to improvements in embryo freezing techniques and in particular the development of vitrification. This has also been made possible by changes in clinical protocols favouring freezing in patients at high risk of hyperstimulation and by different methods of endometrial preparation to receive embryos after rewarming.

In fact, embryo transfer requires endometrial preparation to make implantation possible. There are various protocols for endometrial preparation. Endometrial preparations in the natural cycle, with or without induction of ovulation by FSH, require more regular monitoring, and allow the development of a main follicle that will give a corpus luteum that will secrete progesterone in the luteal phase, which can be supported by the supply of exogenous progesterone. In contrast, endometrial preparations in hormone replacement therapy (HRT) cycles are done by administering estradiol orally or transdermally to stimulate endometrial growth while blocking the patient's gonadotropic axis, and administering progesterone in the luteal phase to differentiate the endometrium. This preparation has the advantage of being simpler to monitor and organize.

There is currently no consensus on a type of preparation that would give better results, and although the literature seems to show that there would be more miscarriages in a substituted cycle, there does not seem to be any difference in the birth rate per cycle in the end, whatever the type of endometrial preparation.

Some teams have shown that in HRT, there appears to be more miscarriage when the progesterone level measured on the day of the frozen embryo transfer is lower, especially below a threshold of 9ng/mL. Labarta showed ESHRE in July 2019 that modifying the endometrial preparation if the progesterone level is below 9ng/mL on the day of transfer by adding subcutaneous progesterone (Progiron) resulted in a lower miscarriage rate, comparable to the usual miscarriage rates in spontaneous pregnancy.

Thus, if the miscarriage rate is higher in HRT than in the natural cycle, and if this is related to "luteal insufficiency" characterized by a lower circulating serum progesterone level, the hypothesis of this study in the investigator's population would be that the serum progesterone level on the day of the frozen embryo transfer would be lower in HRT than in the spontaneous cycle.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Atrial Fibrillation on Holter Monitoring After Percutaneous Patent Foramen Ovale Closure : a Prospective Observational Study

acronym: AFEPFO

summary: An increased risk of atrial fibrillation (AF) after patent foramen ovale (PFO) closure was observed in randomized trials but systematic screening of AF was not performed in these studies. Purpose: The objective of this study was to evaluate incidence of AF in patients who underwent percutaneous PFO closure with serial 24-hours ambulatory ECG (AECG) monitoring during 6 months follow-up. Primary endpoint was incidence of AF on ECG monitoring. Secondary endpoints were clinical outcomes (symptoms, hospitalization from cardiovascular causes, ischemic stroke, or bleeding) up to 6 month follow-up.

lead_sponsor: University Hospital, Montpellier


title: Collection of Biological Samples From Patients Treated With CAR-T Cells for Hematological Malignancies in Montpellier University Hospital

acronym: CAR-T BANK

summary: Development of CAR-T cell against CD19 B lymphoma and Acute Lymphoblastic Leukemia leaded to 2 authorized medication: Yescarta and Kymriah. Despite impressive outcomes in 3 phase II studies, never met in relapsed or refractory diseases, half of the patients don't respond to this treatment.This can be explained by a low expansion, functional alteration or short persistence of infused cells. Determination of reasons for treatment failure is the first step for optimization of this therapeutics. This project aims to bank blood samples from a cohort of patients treated with CAR-T cell for hematological malignancies in Montpellier University Hospital. Clinical data related to samples will be collected. This samples will be used to determine factors influencing efficacy of CAR-T cells treatments.


title: Evaluation of a Virtual Reality Tool for Identifying the Cognitive Functions of the Right Hemisphere in Patients With Glioma -TANGO

acronym: TANGO

summary: Evaluate the diagnostic performance of a virtual reality application to detect the presence of cognitive impairment of the non-dominant hemisphere in patients with glioma

lead_sponsor: University Hospital, Angers


title: Multicenter Open Label Phase 2 Study of Isatuximab Plus Pomalidomide and Dexamethasone With Carfilzomib in Relapsed or Refractory Multiple Myeloma

summary:
Study a quadruplet-based regimen with Minimal Residual Disease (MRD) 10-5 negative rate as primary end point in patients with early Relapsed or Refractory Multiple Myeloma.

Therapeutic study, phase II, prospective, multicenter, open-label. The patients will be treated until progression. Each cycle of treatment lasts 28 days. Cycle 1 to 13 : treatment phase After cycle 13 : maintenance phase

lead_sponsor: Poitiers University Hospital


title: Efficacy of Intravenous Clonazepam According to the Dosage in Children Status Epilepticus

acronym: UHAPA

summary:
•Background: Intravenous clonazepam is the most widely used first-line benzodiazepine in Europe for the initial management of status epilepticus in children.

The guidelines of the "Société de reanimation de langue francaise" (SRLF) and the "société française de médecine d'urgence" (SFMU) published in 2018 recommend an initial loading dose of 0.015 mg / kg of clonazepam in this situation (maximum 1.5 mg).

To our knowledge, there is no specific study of the efficacy of clonazepam according to the dose used.

Objective: To compare the effectiveness of the initial loading dose of clonazepam in children treated for status epilepticus

•Methods: Monocentric retrospective study including children < 16 years who have benefited from an initial loading dose of clonazepam in the context of status epilepticus treated at the Montpellier University Hospital between January 2016 and June 2019.

The investigators collected data from medical records (clinic, treatment , evolution) and compared these according to the dosage of clonazepam used.

•Discussion: Among the benzodiazepines used in the first-line treatment of pediatric status epileptic, lorazepam and midazolam are the most widely used drugs in the world.

Lorazepam is not so much used in Europe because the injectable form is not available for a daily use. Conversely, clonazepam is used in a large number of European countries but is rarely used in the United States due to the lack of an injectable form.

About the tolerance of treatment, except overdose situations, clonazepam is a drug well tolerated in the pediatric populatin. The main side effects of clonazepam are respiratory depression and impaired alertness.

To our knowledge, this study is the first to examine the efficacy depending on the initial loading dosage of clonazepam in children status epilepticus.


title: Evaluation of the Effectiveness of Cryotherapy in Slimming of the Abdomen and Saddlebags

acronym: Cryotherapy

summary:
The purpose of this study is to evaluate the efficacy of cryotherapy on the slimming of subcutaneous fat mass in the abdomen and saddlebags. Cryotherapy is a completely non-invasive method that induces a selective reduction of fat cells by localized and controlled cooling in areas such as the abdomen, flanks, inner knees, inner thighs, back and arms.

Adipose tissue is composed of two types of tissue: white and brown adipose tissue. Studies have shown that exposure to cold induces an increase in the number of brown adipocytes (detected by PET/CT-scan) under the effect of the hormone irisin produced by the muscles. In addition, another study has shown that prolonged exposure to cold reduces the size of brown adipocytes leading to thermogenesis, suggesting that cold exposure may contribute to the control of obesity.

The freezing technology of this cryotherapy unit allows the temperature of the subcutaneous adipose tissue to move almost instantaneously from -6°C to -10°C, gradually causing the reduction of subcutaneous adipose tissue.

ReferenceCitation: Aronne LJ. Epidemiology, morbidity, and treatment of overweight and obesity. J Clin Psychiatry. 2001;62 Suppl 23:13-22. Review.

ReferenceCitation: Kennedy J, Verne S, Griffith R, Falto-Aizpurua L, Nouri K. Non-invasive subcutaneous fat reduction: a review. J Eur Acad Dermatol Venereol. 2015 Sep;29(9):1679-88. doi: 10.1111/jdv.12994. Epub 2015 Feb 9. Review.

name: Department of Dermatology and Cutaneous Surgery; University of Miami Miller School of Medicine; Miami FL USA

family: Kennedy

full_name: J. Kennedy

family: Verne

full_name: S. Verne

given: S.

family: Griffith

full_name: R. Griffith

given: R.

family: Falto-Aizpurua

full_name: L. Falto-Aizpurua

family: Nouri

full_name: K. Nouri

journal_name: Journal of the European Academy of Dermatology and Venereology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Avram MM, Harry RS. Cryolipolysis for subcutaneous fat layer reduction. Lasers Surg Med. 2009 Dec;41(10):703-8. doi: 10.1002/lsm.20864. Review. Erratum in: Lasers Surg Med. 2012 Jul;44(5):436.

family: Avram

full_name: Mathew M. Avram

given: Mathew M.

family: Harry

full_name: Rosemary S. Harry

given: Rosemary S.

journal_name: Lasers in Surgery and Medicine

title: Cryolipolysis™ for subcutaneous fat layer reduction

ReferenceCitation: Mulholland RS, Paul MD, Chalfoun C. Noninvasive body contouring with radiofrequency, ultrasound, cryolipolysis, and low-level laser therapy. Clin Plast Surg. 2011 Jul;38(3):503-20, vii-iii. doi: 10.1016/j.cps.2011.05.002. Review.

family: Mulholland

full_name: R. Stephen Mulholland

given: R. Stephen

family: Paul

full_name: Malcolm D. Paul

given: Malcolm D.

family: Chalfoun

full_name: Charbel Chalfoun

given: Charbel

journal_name: Clinics in Plastic Surgery

title: Noninvasive Body Contouring with Radiofrequency, Ultrasound, Cryolipolysis, and Low-Level Laser Therapy

ReferenceCitation: Bernstein EF. Longitudinal evaluation of cryolipolysis efficacy: two case studies. J Cosmet Dermatol. 2013 Jun;12(2):149-52. doi: 10.1111/jocd.12036.

name: Main Line Center for Laser Surgery; Ardmore Pennsylvania USA

family: Bernstein

full_name: Eric F Bernstein

given: Eric F

journal_name: Journal of Cosmetic Dermatology

ReferenceCitation: van der Lans AA, Wierts R, Vosselman MJ, Schrauwen P, Brans B, van Marken Lichtenbelt WD. Cold-activated brown adipose tissue in human adults: methodological issues. Am J Physiol Regul Integr Comp Physiol. 2014 Jul 15;307(2):R103-13. Review.

ReferenceCitation: Lee P, Swarbrick MM, Ho KK. Brown adipose tissue in adult humans: a metabolic renaissance. Endocr Rev. 2013 Jun;34(3):413-38. doi: 10.1210/er.2012-1081. Epub 2013 Apr 2. Review.

name: School of Medicine (P.L., K.K.Y.H.), University of Queensland, Department of Diabetes and Endocrinology (P.L., K.K.Y.H.), Princess Alexandra Hospital, Brisbane, Queensland 4107, Australia;

family: Lee

full_name: Paul Lee

given: Paul

name: Diabetes and Obesity Program (M.M.S.), Garvan Institute of Medical Research, Sydney, New South Wales 2010, Australia and Faculty of Medicine (M.M.S.), School of Medical Sciences, University of New South Wales, Sydney, New South Wales 2052, Australia

family: Swarbrick

full_name: Michael M. Swarbrick

given: Michael M.

title: Brown Adipose Tissue in Adult Humans: A Metabolic Renaissance

ReferenceCitation: Manstein D, Laubach H, Watanabe K, Farinelli W, Zurakowski D, Anderson RR. Selective cryolysis: a novel method of non-invasive fat removal. Lasers Surg Med. 2008 Nov;40(9):595-604. doi: 10.1002/lsm.20719.

title: Selective cryolysis: A novel method of non-invasive fat removal

ReferenceCitation: Zelickson B, Egbert BM, Preciado J, Allison J, Springer K, Rhoades RW, Manstein D. Cryolipolysis for noninvasive fat cell destruction: initial results from a pig model. Dermatol Surg. 2009 Oct;35(10):1462-70. doi: 10.1111/j.1524-4725.2009.01259.x. Epub 2009 Jul 13.

title: Cryolipolysis for Noninvasive Fat Cell Destruction

ReferenceCitation: Coleman SR, Sachdeva K, Egbert BM, Preciado J, Allison J. Clinical efficacy of noninvasive cryolipolysis and its effects on peripheral nerves. Aesthetic Plast Surg. 2009 Jul;33(4):482-8. doi: 10.1007/s00266-008-9286-8. Epub 2009 Mar 19.

title: Clinical Efficacy of Noninvasive Cryolipolysis and Its Effects on Peripheral Nerves

ReferenceCitation: Dierickx CC, Mazer JM, Sand M, Koenig S, Arigon V. Safety, tolerance, and patient satisfaction with noninvasive cryolipolysis. Dermatol Surg. 2013 Aug;39(8):1209-16. doi: 10.1111/dsu.12238. Epub 2013 May 2.

title: Safety, Tolerance, and Patient Satisfaction With Noninvasive Cryolipolysis

ReferenceCitation: Garibyan L, Sipprell WH 3rd, Jalian HR, Sakamoto FH, Avram M, Anderson RR. Three-dimensional volumetric quantification of fat loss following cryolipolysis. Lasers Surg Med. 2014 Feb;46(2):75-80. doi: 10.1002/lsm.22207. Epub 2013 Dec 3.

name: Wellman Center for Photomedicine and Department of DermatologyMassachusetts General HospitalHarvard Medical SchoolBostonMaryland02114

name: Department of MedicineDivision of DermatologyUniversity of CaliforniaLos AngelesLos AngelesCalifornia90095

title: Three‐dimensional volumetric quantification of fat loss following cryolipolysis

ReferenceCitation: Saarelainen J, Hakulinen M, Rikkonen T, Kröger H, Tuppurainen M, Koivumaa-Honkanen H, Honkanen R, Hujo M, Jurvelin JS. Cross-Calibration of GE Healthcare Lunar Prodigy and iDXA Dual-Energy X-Ray Densitometers for Bone Mineral Measurements. J Osteoporos. 2016;2016:1424582. doi: 10.1155/2016/1424582. Epub 2016 Apr 27.

name: Kuopio Musculoskeletal Research Unit (KMRU), Surgery, Institute of Clinical Medicine, University of Eastern Finland, 70211 Kuopio, Finland

name: Department of Applied Physics, University of Eastern Finland, 70211 Kuopio, Finland

name: Department of Clinical Physiology and Nuclear Medicine, Kuopio University Hospital, 70029 Kuopio, Finland

name: Department of Orthopaedics, Traumatology and Hand Surgery, Kuopio University Hospital, 70029 Kuopio, Finland

name: Department of Obstetrics and Gynaecology, Kuopio University Hospital, 70029 Kuopio, Finland

name: Institute of Clinical Medicine, Psychiatry, University of Eastern Finland, 70211 Kuopio, Finland

name: Departments of Psychiatry, Kuopio University Hospital, 70029 Kuopio, Finland

name: South-Savonia Hospital District, 50520 Mikkeli, Finland

name: North Karelia Central Hospital, 80210 Joensuu, Finland

name: School of Computing, University of Eastern Finland, 70211 Kuopio, Finland

name: Diagnostic Imaging Centre, Kuopio University Hospital, 70029 Kuopio, Finland


title: Cosmetic Satisfaction and Undercorrection After One-stage Bone Lengthening in the Management of Brachymetatarsia

acronym: BRACHYONESTAGE

summary:
Brachymetatarsia is a shortening in length of a metatarsal exceeding 5mm. This congenital anomaly most often affecting women and the second metatarsal is associated with frequent aesthetic disorders leading patients to consult. The one-time lengthening technique is described for the management of brachymetatarsia with good functional results. However, the metatarsal elongation in one time is limited to 15 millimeters, to avoid complications.

No study has presented the consequences of hypocorrection, especially cosmetic. Our hypothesis is that undercorrection (Hypocorrection) is associated with a higher rate of cosmetic dissatisfaction.


title: Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury : the TROPUTILE Score. A Non-interventional Prospective Study

acronym: TROPUTILE

summary:
Myocardial injury after noncardiac surgery (MINS) is common, silent, and strongly associated with morbi-mortality.

There are some evidences in the littérature showing that troponin elevation pre and/or postoperatively and surgical Apgar score are strongly and independently associated with postoperative morbi-mortality.

In this cohort study of orthopedic surgery patients (> 50years), the aim is to determine MINS incidence and to assess wich peri-operative factors are associated with the occurrence of MINS. The final objective is to create a score to better identified the patients with a MINS and a poor outcome.


acronym: EVNS-SpA

summary:
The primary objective of the study is to demonstrate a greater proportion of patients with significant improvement, according to ASAS20 definition, after 12 weeks of vagus nerve stimulation (VNS) treatment than with placebo non-specific stimulation (control group).

The secondary objectives of the study are to show differences in improvement between the active and placebo periods of treatment with active SNV and SNV placebo of the following items:

Improvement according to "ASAS40" criteria
Obtaining a partial remission according to the ASAS definition
Improvement of BASFI
Decrease of C-reactive protein (CRP) serum level and erythrocytes sedimentation rate (ESR),
Improvement of ASDAS_CRP and ASDAS_ESR
Difference in levels of circulating cytokines: IL-6, IL-23, IL-17, IL-33 and of matrix metallopeptidases (MMP3-8-9)
Improvement of quality of life: assessment according to the following indexes: SF-36, AS Quality of Life (ASQOL)
Improvement of Health Index of patient with SpA (ASAS HI) and of the Productivity at Work Index (WPI)
Improvement of fatigue (BASDAI 1st question) and global pain
Improvement of Anxiety and Depression Assessment (HAD)
Improvement of BASMI
Decrease of non-steroidal anti-inflammatory drugs (NSAID) intake score.

ReferenceCitation: Azabou E, Bao G, Costantino F, Jacota M, Lazizi C, Nkam L, Rottman M, Roux AL, Chevallier S, Grimaldi L, Breban M. Randomized Cross Over Study Assessing the Efficacy of Non-invasive Stimulation of the Vagus Nerve in Patients With Axial Spondyloarthritis Resistant to Biotherapies: The ESNV-SPA Study Protocol. Front Hum Neurosci. 2021 Jun 30;15:679775. doi: 10.3389/fnhum.2021.679775. eCollection 2021.

family: Azabou

full_name: Eric Azabou

given: Eric

family: Bao

full_name: Guillaume Bao

given: Guillaume

family: Costantino

full_name: Félicie Costantino

given: Félicie

family: Jacota

full_name: Madalina Jacota

given: Madalina

family: Lazizi

full_name: Chanez Lazizi

given: Chanez

family: Nkam

full_name: Lionelle Nkam

given: Lionelle

family: Rottman

full_name: Martin Rottman

given: Martin

family: Roux

full_name: Anne-Laure Roux

given: Anne-Laure

family: Chevallier

full_name: Sylvain Chevallier

given: Sylvain

family: Grimaldi

full_name: Lamiae Grimaldi

given: Lamiae

family: Breban

full_name: Maxime Breban

given: Maxime

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: Frontiers in Human Neuroscience

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

location_facility: Clinical Neurophysiology Laboratory, Department of Physiology and Functional Explorations, Raymond Poincaré Hospital, APHP


title: Analysis of the Motion Activity Manual Wheelchair Users

acronym: Acti-FRM

summary: Currently, there is no system in place to allow manual wheelchair users to know their quantities of movement activities and the intensity of effort to be provided during these propulsion movements. Based on recent work by Routhier et al. in 2017, and in light of the scientific literature related to wheelchair propulsion, it would seem appropriate to validate the use of inertial units as tools to quantify and categorize the intensity of manual wheelchair propulsion.

ReferenceCitation: Boninger ML, Cooper RA, Baldwin MA, Shimada SD, Koontz A. Wheelchair pushrim kinetics: body weight and median nerve function. Arch Phys Med Rehabil. 1999 Aug;80(8):910-5.

ReferenceCitation: Boninger ML, Souza AL, Cooper RA, Fitzgerald SG, Koontz AM, Fay BT. Propulsion patterns and pushrim biomechanics in manual wheelchair propulsion. Arch Phys Med Rehabil. 2002 May;83(5):718-23.

location_facility: Raymond Poincaré Hospital - Spinal Cord Injury Unit


title: Natural History Study of Retinitis Pigmentosa Due to RHO, PDE6a or PDE6b Mutations

summary: This is natural history study of rods and cones degenerations in patients with Retinitis Pigmentosa (RP) caused by pathogenic mutations in RHO, PDE6a or PDE6b gene mutations.

primary_purpose: Screening

lead_sponsor: SparingVision


title: Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning Risk and Accompaniment of Patients' Trajectories-ovary/Elderly Women With Ovarian Cancer-2, a GINECO Multicenter Randomized Study (PROADAPT-ovary/EWOC-2)

summary:
PROADAPT is a standardized geriatric intervention that is currently being co-constructed during an exploratory phase on a multi-professional and multi-disciplinary basis after a systematic analysis of published data (Figure).

It consists in: 1) before surgery: a prehabilitation of the patients including a nutritional, physical and educational preparation; 2) during the hospitalization for surgery: an optimisation of their treatments through a pharmaceutical conciliation, educational interventions, standardization of surgical procedures and enhanced rehabilitation after surgery; 3) bridging and post-discharge interventions for hospital-to-home transition.

This intervention is based on a logic change model, constructed with literature data and validated by an expert group through a DELPHI method : the rehabilitation model.

This intervention was designed to be implemented pragmatically in the centers according local habits and is currently being evaluated in several distinct hospital contexts under the name of "PROADAPT pilot study" in different tumor contexts thanks to a grant from the Regional Health Agency of Rhône-Alpes Auvergne region.

PROADAPT intervention is planned to be evaluated in 4 tumor models inducing complex medico-surgical procedures considered at high risk of geriatric deconditioning. They have the same primary objectives in order to be evaluated into a meta-analysis. Results will be used to test the validity of the rehabilitation model. Therefore, it is a study reaching the goal of the population health intervention research.

The purpose of the PROADAPT-ovary/EWOC-2 study is to evaluate the impact of PROADAPT on patient's post-surgical outcomes in patients ≥ 70 years old with an advanced ovarian cancer (AOC).

location_facility: Service de Gériatrie, Centre Hospitalier Lyon Sud, 165 chemin du Grand Revoyet

intervention_type: Behavioral


title: Role of Lysophosphatidic Acid and Autotaxin in Rheumatoid Arthritis-associated Interstitial Lung Disease

acronym: LYSLUNG

summary:
Rheumatoid arthritis (RA) is a common chronic systemic autoimmune relapsing disease characterized by joint inflammation. Beside arthritis leading to progressive joint damage and loss of function, RA is also associated to extraarticular inflammatory conditions such as interstitial lung disease (ILD). This one develops in 30% of all RA patients with a median survival expectancy of 3 to 10 years once symptomatic. Unfortunately, there is no medical care recommendation so far as the pathophysiology is unknown. However, ILD share many similarities with idiopathic pulmonary fibrosis (IPF).

Autotaxin (ATX), due to its lysophospholipase activity, produces a bioactive lipid, lysophosphatidic acid (LPA) under inflammation. LPA has pleiotropic actions inducing cell proliferation, survival, motility and differentiation. Increased ATX and LPA levels have been detected in synovial fluid of RA patients and in IPF patients. ATX is also currently the target for a phase 3 clinical trial in IPF.

Given the previous described role of ATX/LPA axis in arthritis and inflammation-induced bone loss in RA and the similarities between RA-ILD and IPF, the investigators hypothesized that ATX/LPA axis may be also an attractive drug target for this pulmonary condition in RA and therefore that ATX and LPA may be increased in sputum from RA patients with ILD in comparison with sputum from RA patients without ILD.

primary_purpose: Basic Science


title: Oxytocin Treatment in Neonates and Infants Aged From 0 to 3 Months With Prader-Willi Syndrome : a Study of Safety and Efficacy on Oral and Social Skills and Feeding Behavior of Intranasal Administration of Oxytocin vs Placebo

summary: Prospective, randomized, placebo-controlled, double-blind part of the phase III trial to assess the safety and efficacy of 4 weeks oxytocin (OT) administration on oral and social skills in neonates/infants with Prader-Willi Syndrome (PWS) aged less than 3 months at inclusion. Phase III clinical trial.

ReferenceCitation: Borie AM, Dromard Y, Guillon G, Olma A, Manning M, Muscatelli F, Desarménien MG, Jeanneteau F. Correction of vasopressin deficit in the lateral septum ameliorates social deficits of mouse autism model. J Clin Invest. 2021 Jan 19;131(2). pii: 144450. doi: 10.1172/JCI144450.

family: Borie

full_name: Amélie M. Borie

given: Amélie M.

family: Dromard

full_name: Yann Dromard

given: Yann

family: Guillon

full_name: Gilles Guillon

given: Gilles

family: Olma

full_name: Aleksandra Olma

given: Aleksandra

family: Manning

full_name: Maurice Manning

given: Maurice

family: Muscatelli

full_name: Françoise Muscatelli

given: Françoise

family: Desarménien

full_name: Michel G. Desarménien

given: Michel G.

family: Jeanneteau

full_name: Freddy Jeanneteau

given: Freddy

journal_name: Journal of Clinical Investigation

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

publisher: American Society for Clinical Investigation

lead_sponsor: University Hospital, Toulouse


title: Validation Study of Posturology Platforms for Evaluating Postural Control of Hemiparetic and Neuro-muscular Patients

acronym: KPLATES

summary:
The instrumental evaluation of standing postural control by posturographic analysis supplements the clinical evaluation and, as such, is recommended by the French National Authority for Health (HAS 2007). The quantitative data obtained after a standardized postural examination appear relevant for the longitudinal follow-up of neuromuscular patients and hemiparetic patients. Neuro muscular (NM) diseases are progressive, these instrumental evaluations can highlight a deterioration or stabilization of postural control possibly not observable with the scores on clinical scales.

The K-Force Plates, recently developed appear to be an interesting alternative to the stabilometry platforms currently used.


title: Efficacy of 10 Days Intravenous Milrinone Treatment to Optimize Cerebral Hemodynamic and Prevent Delayed Cerebral Ischemia (DCI) in Patients With Severe Subarachnoid Hemorrhage Due to Intracranial Aneurysm Rupture

acronym: OPTIMIL

summary: The present study is a randomized, multi-center, double-blind, prospective study that tests the efficacy of intravenous milrinone to optimize cerebral hemodynamic and prevent delayed cerebral ischemia (DCI) during the high-risk period (day 4- day 14) in patients with severe subarachnoid hemorrhage due to intracranial aneurysm rupture (SAHa) (WFNS IV-V). The main objective is to evaluate, in comatose patients and / or sedated on D3 following a severe SAHa (WFNS IV -V), the effect of 10 days of milrinone versus placebo, in addition to the usual management, on the volume of DCI lesions measured on CT scan at 1 month.


title: Improvement of Executive Functions With the CO-OP Method in the Adult Subject After Stroke

acronym: FéCO-OPSA

summary: The research focuses on top-down intervention approaches and more specifically on the Cognitive Orientation to daily Occupational Performance (CO-OP) method in the rehabilitation of executive function disorders in adult post-stroke subjects in chronic phase. The main objective of this study is therefore to improve performance in significant activities of daily living for people with chronic post-stroke dysexecutive disorders.


title: Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)

summary: Children supported by Extra-Corporeal Membrane Oxygenation (ECMO) present a high risk of neurological complications and cerebral autoregulation (CA) impairment may be a risk factor. Our first objective is to investigate the feasibility of CA continuous monitoring during ECMO treatment. The second objective is to analyze the relationship between CA impairment and neurological outcome.

ReferenceCitation: Joram N, Beqiri E, Pezzato S, Andrea M, Robba C, Liet JM, Chenouard A, Bourgoin P, Czosnyka M, Léger PL, Smielewski P. Impact of Arterial Carbon Dioxide and Oxygen Content on Cerebral Autoregulation Monitoring Among Children Supported by ECMO. Neurocrit Care. 2021 Oct;35(2):480-490. doi: 10.1007/s12028-021-01201-8. Epub 2021 Mar 9.

family: Joram

full_name: Nicolas Joram

given: Nicolas

family: Beqiri

full_name: Erta Beqiri

given: Erta

family: Pezzato

full_name: Stefano Pezzato

given: Stefano

family: Andrea

full_name: Moscatelli Andrea

given: Moscatelli

family: Robba

full_name: Chiara Robba

given: Chiara

family: Liet

full_name: Jean-Michel Liet

given: Jean-Michel

family: Chenouard

full_name: Alexis Chenouard

given: Alexis

family: Bourgoin

full_name: Pierre Bourgoin

given: Pierre

family: Czosnyka

full_name: Marek Czosnyka

given: Marek

family: Léger

full_name: Pierre-Louis Léger

given: Pierre-Louis

family: Smielewski

full_name: Peter Smielewski

given: Peter

journal_name: Neurocritical Care

ReferenceCitation: Joram N, Beqiri E, Pezzato S, Andrea M, Robba C, Liet JM, Chenouard A, Bourgoin P, Czosnyka M, Léger PL, Smielewski P. Continuous Monitoring of Cerebral Autoregulation in Children Supported by Extracorporeal Membrane Oxygenation: A Pilot Study. Neurocrit Care. 2021 Jun;34(3):935-945. doi: 10.1007/s12028-020-01111-1. Epub 2020 Oct 8.


title: Evaluation of the Effect of Daily Consumption of Sodium Bicarbonate Water for 15 Days on Blood Pressure in Normotensive Subjects

summary:
ROX_TENSIO18 is a randomised cross-over trial and the main objective is to evaluate the effect of daily consumption of sodium bicarbonate water for 15 days on blood pressure.

Secondary objective are:

Evaluation of the effect of daily consumption of sodium bicarbonate water on total salt intake
Evaluation on blood pressure of the usual food groups that are the strongest contributors of salt intake.

lead_sponsor: My Goodlife SAS

location_facility: Institut de Diabétologie Et Nutrition Du Centre


title: Medication Exposure in Older Patients (AGEd > 65 Years) With Constitutional HEMORRHagic Disease (Haemophilia or Willebrand Disease).

acronym: M-HEMORRH'AGE

summary:
The improvements observed in the care of patients with hemophilia or Willebrand disease have led to an increase in their life expectancy, which today approaches that of the general population. This increase in life expectancy leads in these patients to the development of comorbidities related to aging (cardiovascular and neurological diseases, cancers and kidney diseases) (e.g "Franchini & Mannuccio", BJH, 2009). The care of these comorbidities represents a new challenge for the medical teams. Toward multiple comorbidities, polypharmacy is often associated.

Many studies about medication exposure and management in older patients were published but no study was conducted to explore the medication management of older patients with hemophilia or Willebrand disease.

time_perspective: Cross-Sectional

location_facility: Hôpital des Charpennes, Institut du Vieillissement


title: Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation

acronym: COM-ENDO

summary: The aim of this retrospective, multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures performed without EndoNaut.

lead_sponsor: Therenva


title: Assessment of the Prevalence of Sarcopenia in Early Palliative Cancer Patients

acronym: SPACE

summary:
Cancer is one of the leading causes of death in the world after cardiovascular disease (8.7 million deaths in 2015 for 17.5 million cases) 1. Despite a great deal of progress in disease detection and treatment, the incidence of cancer is steadily increasing (+ 33% in 2015) and particularly in certain locations (pancreas, lungs, brain and stomach), including risk factors are not always identified.

Advanced stage cancer (= metastatic) is most often incurable with the exception of germ cell tumors. Palliative care is then most often offered. Palliative care favors the patient's quality of life as a whole (medical, physical, psychological and social).

The symptoms most often reported by patients are: pain, fatigue, decreased appetite, nausea, and are directly related to phenomena such as cachexia, loss of autonomy and deterioration of psychological state, resulting in decreased overall survival. Chemotherapies and targeted therapies (immunotherapy, hormonal therapy, participation in a clinical trial) can provide a benefit in quality of life and survival only in the early phase (little benefit in the terminal phase).

Other prognostic factors can impact the quality of life and overall survival in these situations: sarcopenia and disorders of nutritional status (obesity, undernutrition).

The study of sarcopenia by CT scan of patients in a palliative situation is still too scarce. Sarcopenia is an often underestimated event and is associated with older age, co-morbidities, increased infectious complications, and early mortality.

The study of the prevalence of sarcopenia by CT scan would confirm its prognostic impact in a palliative situation.

lead_sponsor: Weprom

location_facility: Clinique Victor Hugo / Centre Jean Bernard


title: MIcroorganisms as Triggers in Acute Severe Ulcerative Colitis and Their Influence on Medical Therapy Efficacy: a Multi-omics Pilot Approach.

acronym: ITAC

summary: This pilot prospective study will investigate the role of microbiota and known enteropathogens in Acute Severe Ulcerative Colitis (ASUC). Investigators will compare a group of patients hospitalized for an ASUC with patients experiencing a Non-Severe Ulcerative Colitis (NSUC) flare by investigating microbiome, metabolome and transcriptome and integrating this data through a multi-omic framework. This systems biology approach aims at enhance our understanding of this severe event, define diagnosis and prognosis biomarkers to improve medical therapy and avoid colectomy and/or death.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Universitaire de Bordeaux