title: Genital Haemorrhage in Woman of Childbearing Age Treated for Venous Thromboembolism Disease : Comparison According to Oral Anticoagulant and Impact on Quality of Life.

acronym: GENB-OAB

summary:
Little data are available on the genital haemorrhages in woman of childbearing age treated for venous thromboembolic disease by oral anticoagulant, especially the impact on the quality of life. A recent systematic review in 2016 described for the first time in patients with venous thromboembolic a lower incidence in men of major haemorrhages and minor haemorrhages but clinically significant compared with women (5,3% and 7,9% respectively; RR: 0,635, 95%CI 0,54-0,74 ; p<0,001). It appears that this difference is related to genital haemorrhages and some direct oral anticoagulants are more associated with hemorrhagic surge. In post-hoc analyzes of phases III trials, rivaroxaban was most of the time associated with genital haemorrhages compared to vitamine K antagonists, effect not found with apixaban. Four other retrospective studies seem to find the same conclusions with a higher haemorrhagic risk with the rivaroxaban than with vitamine K antagonist or apixaban.

However, haemorrhagic risk is defined in these studies with criteria of severity (anemia, transfusion, use of a health professional, menstrual periods of more than 8 days, inter mentrual bleeding, presence of blood clots) and these studies do not take into account of minor haemorrhages that may affect on the quality of life and asthenia due to anemia.

Our objective is : 1- studying the proportion of women with abnormal genital haemorrhages among women of childbearing age treated for venous thromboembolism disease by oral anticoagulant including using a semi quantitative score of menorrhagia. 2- To compare this proportion according to the four molecules of oral anticoagulants (fluindione, warfarin, rivaroxaban and apixaban) and 3- to evaluate the impact of these haemorrhages on the quality of life. Our study would have a control group of women of childbearing age followed in vascular medicine for superficial venous insufficiency without thrombosis and without oral anticoagulant because the proportion of genital haemorrhages in women of childbearing age in PACA region is not known.


title: Evaluation of the Use of an Analog Scale to Estimate Dietary Intakes, EPA, for Hemodialysis Patients

acronym: EDDEN

summary:
The aim of this clinical research is to evaluate the relevance of using the EPA slide to estimate dietary intakes in dialysis patients. The obtained results will be compared with the reference technique validated by the HAS: food intake over 3 days.

The aim is also to improve the global management of dialysis patients and improve their quality of life. The aim is to evaluate a quick and easy-to-use tool whose use has been demonstrated in hospitals but for which no study has been carried out in an ambulatory hospitalization context.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: University Hospital, Caen

lead_sponsor_type: academique

status_simplified: Completed


title: Anatomopathology of the Subscapularis and Infraspinatus Muscles in Children With Brachial Plexus Obstetric Paralysis

acronym: POPB

summary:
POPB is a consequence of the stretching of the nerve roots (C5, C6 + / C7, C8 or T1) of the brachial plexus at birth. One third of patients will have sequelae. The most common is the appearance of a deficit of passive and active mobilities in the movements in external rotation of the shoulder especially in external rotation (RE) elbow to the body, despite daily rehabilitation. At present, this stiffness is attributed to an imbalance between the external rotator muscles (mainly infraspinatus) that would be atrophied and the internal rotator muscles (subscapularis, pectoralis major, latissimus dorsi) that would be slightly affected In case of no or negative RE from the age of 1 year, there is a surgical indication to operate these children. At present, surgery to lift internal retractions is the only therapy used, but despite this surgery and intensive rehabilitation, in some patients mobility deficits re-occur in a few years. Thus, some teams systematically perform a muscle transfer to strengthen the outer rotator muscles deficit during the initial operation. Other teams (of which principal investigator is part) do this transfer only secondarily and in some patients. Investigators lack objective and scientific criteria for the indication of this second muscle transfer surgery and the etiology of retractions is not clearly defined.

In humans, subscapularis is innervated by the C5 and C6 roots, which are constantly affected in POPB. It can be assumed that subscapularis may have an atrophy in POPB patients. To date, no anatomopathological study has been performed on the internal / external rotator muscles of patients with POPB that can give indications on recurrences.

Based on our clinical observations and literature data, the main hypothese is there is amyotrophy of subscapularis and / or infraspinatus in POPB patients with shoulder stiffness.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Montpellier

intervention_type: Procedure

status_simplified: Unknown


title: Construction and Validation of a Simplified Provocation Test for the Diagnosis of Paracetamol Hypersensitivity

acronym: Paracetamol

summary:
Background : Paracetamol (acetaminophen) drug hypersensitivity reactions (DHR) are oonfirmed in about 10% of alleged cases. The diagnosis is made via an empirical drug provocation test (DPT).

Objective: Detect eliciting dose thresholds during Paracetamol DPT in order to suggest optimal step doses and to identify variables and potential risk factors associated with Paracetamol hypersensitivity.

Methods:This retrospective study, using the survival analysis and the multivariate analysis, will comprise all patients who attended the allergy service of the University Hospital of Montpellier from 1996 till 2018 with a clinical history related to Paracetamol DHR, who underwent Paracetamol DPT and who gave their consent to be included in the study. The patients are selected from the Drug Allergy & Hypersensitivity Database (DAHD).

time_perspective: Retrospective


type: Other Identifier

type: Other Grant/Funding Number

title: Rheumatism and Dietetic: RHUMADIET Study (Food Practices and Beliefs)

acronym: RHUMADIET

summary: Cross sectional study assessing food practices and beliefs in RA, AS and DA (digital arthritis)

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Rhumatologie - Hôpital Saint Antoine


type: EudraCT Number

title: Cyclophosphamide and Azathioprine vs Tacrolimus in Antisynthetase Syndrome-related Interstitial Lung Disease : Multicentric Randomized Phase III Trial

acronym: CATR-PAT

summary:
"Antisynthetase syndrome (ASS) is one of the most severe inflammatory myopathy (IM), due to pulmonary involvement (interstitial lung disease, ILD). Until now, the most commonly used immunosuppresive therapy in Europe is Cyclophosphamide followed by different immunosuppressive drugs as maintenance therapy, including Azathioprine (and so called " European Strategy "). In the USA however, the first-line immunosuppressive treatment is Tacrolimus (so called " American Strategy "). None of these two different strategies has ever been studied prospectively, and there is no clear comparison of short and long-term treatment efficacy and tolerance. Thus, there are yet no evidences helping the clinicians in the therapeutic management of patients with ASS-related ILD.

The aim of this study is therefore to compare both strategies as first line treatments or in relapsing patients : CATR.PAT study is a 52 weeks, randomized, comparative, controlled, open-labeled, phase III, therapeutic clinical trial, comparing two treatment strategies."

status: Recruiting

design_allocation: Randomized

primary_purpose: Treatment

intervention_type: Drug

status_simplified: Ongoing


title: Attentats - Continuité Des Soins

summary: On November 13th 2015, a terrorist attack killed 129 victims in Paris. An emergency crisis unit (CUMP) has been activated in Paris in the days following the attack and a subunit was in charge to answer to the phone calls of victims and their relatives. The same emergency crisis unit have been activated for the terrorist attack in London, 2017 june 3, terrorist attack in Barcelone 2017 august 17-18, terrorist attack in Strasbourg 2018 December 11 The purpose of this observational study is to document the evolution of psychiatric symptoms among subjects who called the CUMP and to collect information about the type of medical or non-medical care they were seeking for.

intervention_type: Behavioral


acronym: DFG HEP

title: Description of the Evolution of Plasma and Urinary Concentrations of Iohexol in a Cirrhotic Patient Population: "Pilot Study on 9 Patients"

lead_sponsor: University Hospital, Limoges

source: euctr

summary:
Background: It is important to accurately assess the glomerular filtration rate (GFR) of patients with liver diseases, particularly cirrhosis, to deliver care and adjust the drugs' posology.

Purpose: The frequency of chronic renal failure is underestimated in patients with advanced liver disease and the difficulty to assess kidney failure justifies the investigator's study, which aims to describe, by means of a population pharmacokinetic model, the evolution of plasma and urinary concentrations of iohexol, an effective non-ionic, water-soluble contrast agent which is used in radiographic procedures, in cirrhotic patients.


title: Everyday Life Cognition and Non-conventional Magnetic Resonance Markers in RRMS Patients Treated With Aubagio® in a Real-life Setting

acronym: AUBACOG

summary:
Cognitive impairment is nowadays more and more recognized as an important feature of the multiple sclerosis (MS) disease which contributes largely to disability. Cognitive assessment using classical neuropsychological tests are poorly correlated with patient's complaints and daily functioning. Ecological evaluations, recent and innovative way to assess cognitive functions with the true impact of cognitive impairment in everyday daily life of patients. One goal of an ecological test could be to identify MS patients in whom cognitive impairment has a strong interaction with daily life. Different type of ecological evaluation have been recently proposed in MS, including assessment cognitive tasks in a virtual reality environment using the Urban DailyCog® software developed in our laboratory (Hamel et al, 2015). Virtual reality environment assessments are promising in detecting cognitive impairment while providing friendly assessments for patients and simulating daily activities. . Cognitive dysfunction is correlated with white matter diffuse injury in relapsing-remitting MS (RRMS) patients and brain atrophy However, the relationships between structural brain damage and brain connectivity with cognitive functioning assessed by ecological evaluation are also unknown. The use of new techniques for morphological and functional MRI can study the contribution of diffuse white matter (WM) alteration and diffuse gray matter (GM) alterations in cognitive impairment and on their evolution.

The objectives are to evaluate the ecological assessment (Urban DailyCog® and actual reality) to detect cognitive impairment in everyday daily life of patients and their changes and to investigate structural WM and GM damages and the dynamic of functional connectivity for explaining and predicting cognitive disability during two years in RRMS patients treated by the same treatment Aubagio®.

status: Active, not recruiting

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Bordeaux

intervention_type: Other


title: Necrotizing External Otitis : Study in a Regional Bone and Joint Infection

summary: The malignant external otitis is a rare disease which arises more frequently at the elderly and the diabetics patients. To our knowledge, there are few data and it is not wellc known byclinicians. Nevertheless it exposes to neurological complications potentially serious and crippling.

lead_sponsor: Hospices Civils de Lyon


title: Nudging for Vaccination : Efficacity and Acceptability Among Medical Students

summary:
Nudge is a set of methods aimed at helping people adopt a behavior by a gentle prompt, conscious or not. Classically, Nudges rely on heuristics and cognitive biases. These methods have been studied for years in social psychology and are receiving renewed attention since the awarding of the Nobel Prize in economics to Richard Thaler for his work on the application of Nudge to the economy.

Health professionals are very inadequately vaccinated (25 to 45% of the population). Some studies have shown that a Nudge based on intent implementation can significantly increase vaccination coverage. However, few studies evaluate the acceptability of Nudge or its application to health professionals.

The investigators sought to apply a Nudge based on availability heuristics to health professionals, in order to evaluate its effectiveness and terms of behavior adoption (influenza vaccination) and its acceptability.

The investigator's hypothesis is that Nudging is both effective and acceptable and that people found nudging more acceptable if they have been exposed to a nudge.

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Barbaroux A, Benoit L, Raymondie RA, Milhabet I. Nudging health care workers towards a flu shot: reminders are accepted but not necessarily effective. A randomized controlled study among residents in general practice in France. Fam Pract. 2021 Jul 28;38(4):410-415. doi: 10.1093/fampra/cmab001.

ipd_sharing: Yes

ipd_sharing_description: all IPD that underlie results in a publication

lead_sponsor: Adriaan Barbaroux

lead_sponsor_type: industriel


title: MTBVAC in Newborns: Epidemiological Study In Tuberculosis-Endemic Regions of Sub-Saharan Africa

acronym: MTBVAC-EPI

summary: A cross-sectional childhood M. tuberculosis infection survey of age-specific rates (defined by positivity to the test QuantiFERON-TB Gold Plus) will be conducted in Senegal to collect information on the local TB endemic to inform site selection, sample size, and recruitment strategies for a future efficacy trial of vaccine candidate MTBVAC in young children.

ReferenceType: background

ReferenceCitation: Arbues A, Aguilo JI, Gonzalo-Asensio J, Marinova D, Uranga S, Puentes E, Fernandez C, Parra A, Cardona PJ, Vilaplana C, Ausina V, Williams A, Clark S, Malaga W, Guilhot C, Gicquel B, Martin C. Construction, characterization and preclinical evaluation of MTBVAC, the first live-attenuated M. tuberculosis-based vaccine to enter clinical trials. Vaccine. 2013 Oct 1;31(42):4867-73. doi: 10.1016/j.vaccine.2013.07.051. Epub 2013 Aug 17.

ReferenceCitation: Marinova D, Gonzalo-Asensio J, Aguilo N, Martin C. MTBVAC from discovery to clinical trials in tuberculosis-endemic countries. Expert Rev Vaccines. 2017 Jun;16(6):565-576. doi: 10.1080/14760584.2017.1324303. Epub 2017 May 12. Review.

ReferenceCitation: Cuevas LE, Browning R, Bossuyt P, Casenghi M, Cotton MF, Cruz AT, Dodd LE, Drobniewski F, Gale M, Graham SM, Grzemska M, Heinrich N, Hesseling AC, Huebner R, Jean-Philippe P, Kabra SK, Kampmann B, Lewinsohn D, Li M, Lienhardt C, Mandalakas AM, Marais BJ, Menzies HJ, Montepiedra G, Mwansambo C, Oberhelman R, Palumbo P, Russek-Cohen E, Shapiro DE, Smith B, Soto-Castellares G, Starke JR, Swaminathan S, Wingfield C, Worrell C. Evaluation of tuberculosis diagnostics in children: 2. Methodological issues for conducting and reporting research evaluations of tuberculosis diagnostics for intrathoracic tuberculosis in children. Consensus from an expert panel. J Infect Dis. 2012 May 15;205 Suppl 2:S209-15. doi: 10.1093/infdis/jir879. Epub 2012 Apr 3.

ReferenceType: result

ReferenceCitation: Nemes E, Rozot V, Geldenhuys H, Bilek N, Mabwe S, Abrahams D, Makhethe L, Erasmus M, Keyser A, Toefy A, Cloete Y, Ratangee F, Blauenfeldt T, Ruhwald M, Walzl G, Smith B, Loxton AG, Hanekom WA, Andrews JR, Lempicki MD, Ellis R, Ginsberg AM, Hatherill M, Scriba TJ; C-040-404 Study Team and the Adolescent Cohort Study Team. Optimization and Interpretation of Serial QuantiFERON Testing to Measure Acquisition of Mycobacterium tuberculosis Infection. Am J Respir Crit Care Med. 2017 Sep 1;196(5):638-648. doi: 10.1164/rccm.201704-0817OC.

ipd_sharing_description: A plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers will be defined in the next semester by partners of the project.

lead_sponsor: Biomedical Research Center EPLS

intervention_type: Diagnostic Test


title: Effect of Unimodal (EEG) and Bimodal (EEG-fMRI) Neurofeedback on Upper Limb Recovery After Stroke

acronym: NeuroFB-AVC

summary: Interventional study with minimal risks and constraints, prospective, monocentric.

primary_purpose: Other

lead_sponsor: Rennes University Hospital


title: Evaluation of the Benefits of Decompressive Craniectomy for Severe Traumatic Brain Injury in Children With Refractory Intracranial Hypertension

acronym: RANDECPED

summary:
Severe traumatic brain injury (TBI) is the leading cause of mortality and severe disability in the pediatric population. The prognosis of these patients depends on the severity of the initial lesions but also on the effectiveness of the therapies used to prevent or at least limit secondary lesions mainly intracranial hypertension (HTIC).

The medical therapeutic strategy for the control of HTIC in children with TBI is well codified: starting with hyperosmolar therapy, then hyperventilation and ultimately the use of barbiturates to deepen sedation. However, these therapies are not devoid of adverse effects (hypernatremia, cerebral hypoxemia, systemic vasodilation) and, for some, their efficacy is diminished over time. When these treatments are insufficient to lower intracranial pressure (ICP), decompressive craniectomy is proposed. Decompressive craniectomy is used in a well-coded manner in malignant ischemic stroke in adults.

In TBI, to date, there are two randomized studies in adults and one in children but with a small number of patients, evaluating the benefit of decompressive craniectomy. None of them showed significantly superiority of the surgery compared to the maximal medication treatment on the functional prognosis in the medium term.

However, these studies have many biases, including a significant cross-over from the conservative treatment group to the surgery arm.

Nevertheless, the pediatric literature on the subject seems to yield better results on neurological prognosis in the long term. There are guidelines on the medical management of childhood TBI published by the National Institute of Health in 2012, which emphasize the need for controlled and randomized studies to define the place of decompressive craniectomy in children. That is why the investigators are proposing this national multicentre study.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Fondation Lenval


title: Randomized Study on the Evaluation of the Regular Practice of Standardized Postures Stretching Postural® in Secondary Prevention of Low Back Pains During Pregnancy.

acronym: GEMALODO

summary:
Lower back pain (LBP) during pregnancy is a frequent syndrome: it concerns two thirds of pregnant women. This complaint isn't routinely searched for and therefore underdiagnosed. Furthermore, few solutions are given to these women in order to reduce their pain, and indirectly to improve everyday life. What's more, LBP is the cause of many work interruptions. Physical exercise during pregnancy is recommended by the National College of Gynaecologists and Obstetricians for low risk pregnancies. Several techniques have proven to be efficient.

The main objective of our study is to assess the benefit of regular practice of standardised Stretching Postural® postures in patients presenting "de novo" lower back pain during pregnancy.

The Stretching Postural® technique comprises of static postures involving muscular contractions and stretches. This allows the strengthening of the postural muscles, including the paravertebral muscles. After a short learning period, postures can be done autonomously by the patients. The postures are adaptable to each and everyone's morphology and physical limitations.

Our study is an open, prospective, randomised monocentric superiority trial in parallel branches involving major patients during low risk pregnancies. These women suffer from "de novo" lower back pain during the second and third trimesters of their pregnancies. Each patient will be randomly assigned to one of the following 2 groups:

Stretching Postural® group (group A): usual prevention methods (ergonomic education) and Stretching Postural® postures.
"Control" group (group B): usual prevention methods only.

Patients presenting "de novo" LBP are included in the study after a routine consult then randomly separated into two groups. During the initial consult, the physician assesses inclusion and judgement criteria, collects informed consent from the patients and teaches them the usual prevention methods as well as, concerning group A, Stretching Postural® postures. Computerized support agendas are given in order to improve observance.

Patients are evaluated at day 0 (initial evaluation), after 4 weeks (intermediate) and after 8 weeks (final), according to the main judgment criterion, as well as on secondary pain criteria by the Concise Pain Questionnaire, on their quality of life, the rate of work interruptions and their satisfaction rate. Neonatal outcome is collected at birth. Intermediate phone interviews will allow psychological support and improve observance. Inclusion is scheduled to last 22 months; each subject will be followed during a period of 2 months. The total duration of the study is 2 years.

Expected results are a decrease in back pain and an improvement of the quality of life in group A. Decrease in pain scale, equivalent to overall pain during the last week between the two groups will be our main judgment criterion. In order to detect a difference of 1.5 pain scale points (on a scale from 1 to 10) with an alpha risk of 5%, 80% magnitude and a standard deviation of 2, 56 subjects are necessary; 28 in each group.

Perspectives: This study will allow for a better diagnosis of lower back pain during pregnancy, and, consequently, for the implementation of routine means of care such as collective or private lessons in Stretching Postural® and the supply of personalised prevention documents.

primary_purpose: Prevention

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Service de Gynécologie Obstétrique - Hôpital Nord


title: Développement de Tests Fonctionnels in Vitro à Partir de Cellules Primaires de Patients Atteints de Maladies Monogéniques

acronym: OPERANDO

summary:
The objective of this project is to build a collection of biological samples consisting of fibroblasts and primary keratinocytes from patients with orphan monogenic diseases and to use these cells in the customization of functional tests. The miniaturized tests we are setting up make it possible to distinguish patient cells from control cells. They can be used to test molecules or for the development of diagnostic tests.

As part of the research protocol, the investigating physicians will be able to perform a skin biopsy on their patient included in the study. APTEEUS will isolate fibroblasts and keratinocytes and ensure their preservation. As part of the project, it is planned to preserve the biological samples collected and to preserve the collection after the end of the study. Skin fibroblasts and keratinocytes that are isolated from the biopsy are cells that can be preserved and amplified. They are a material of choice for the functional study of many monogenic diseases.

This study will allow the adaptation of tools dedicated to the functional study of monogenic diseases in order to help in the research and development of new treatments for these diseases, but also to highlight and explain the inter-individual variability of symptoms and responses to treatments, and finally, to help in the development of diagnostic methods.

Patients with orphan monogenic diseases whose genetic defect has been confirmed and for whom the study of the disease can be performed on fibroblasts, keratinocytes or cells derived from them, may be included in the study. Subjects, after information and consent, will undergo a skin biopsy. The sample will be sent directly to the promoter company APTEEUS, which will carry out all in vitro developments. The fibroblasts and keratinocytes will be preserved and will constitute a collection of cells "orphan monogenic diseases". The samples can be reused for new research in the same field.

status: Enrolling by invitation

lead_sponsor: Apteeus


title: Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome

acronym: PreMiTE-ARDS

summary: The Superior Vena cava Respiratory Collapse Index (cVCS) is a haemodynamic parameter measured exclusively by transoesophageal ultrasound (TEE), which is used to assess cardiac precharge-dependence status. This may be an important prognostic factor in ARDS because it is a sign of hypervolemia and right heart failure.

lead_sponsor: University Hospital, Lille


title: Daily Urinary Urea Excretion to Guide Renal Replacement Therapy Weaning in Intensive Care Units

acronym: D-STOP

summary:
Evaluation of daily urinary urea excretion, to guide Renal Replacement Therapy weaning, in Intensive Care Units.

The objective is to show that remove the dialysis catheter, once daily urinary urea excretion is greater than 1.35 mmol/kg/d, would increase more than 3 days the number without dialysis catheters, and thus without dialysis, the first 28 days after insertion.

Daily urinary urea excretion = urea (mmol/L) x diuresis (L/d) / weight (kg).

time_perspective: Other

ReferenceCitation: Aniort J, Ait Hssain A, Pereira B, Coupez E, Pioche PA, Leroy C, Heng AE, Souweine B, Lautrette A. Daily urinary urea excretion to guide intermittent hemodialysis weaning in critically ill patients. Crit Care. 2016 Feb 19;20:43. doi: 10.1186/s13054-016-1225-5.

lead_sponsor: Dr Alexandre Gros


title: How Nicardipine and Labetalol Affect Cerebral Hemodynamics in Severe Preeclamptic Patients: A Pilot Observational Study

acronym: PREMODYM

summary: Realization of transcranial doppler and optic nerve sheath in severe preeclamptic patients to evaluate the impact of nicardipine and labetalol on cerebral hemodynamics.

lead_sponsor: Hopital Antoine Beclere


title: NK Cell Deregulation in HBV Patients

acronym: LiNKeB

summary: Natural Killer (NK) cells play a large role in the innate immune response as they are equipped to kill infected or tumor cells. They express a panel of activating and inhibitory receptors that regulate the destruction of the target cell. Many reports have shown that NK cell function is suppressed in CHB patients. Exhaustion occurs when activating receptors become over stimulated leading to the loss of NK function. The investigators hypothesize that NK cells are rendered dysfunctional/ exhausted by HBV. The primary objective is to determined the phenotypical modifications and mechanisms associated to NK cell dysfunction, during different phases of CHB infection, in not treated patients.


title: Detection of Myocardial Dysfunction in Non-severe Subarachnoid Hemorrhage (WFNS 1-2) Using Speckle-tracking Echocardiography (STRAIN)

acronym: SAH-STRAIN

summary: Subarachnoid hemorrhage (SAH) can cause transient myocardial dysfunction. Recently, it have been reported that myocardial dysfunctions that occur in SAH are associated with poor outcomes. It therefore appears essential to detect theses dysfunctions with the higher sensitivity as possible. Strain measurement using speckle-tracking echocardiography may detect myocardial dysfunction with great sensitivity. The main objective of this study is to assess the prevalence of myocardial dysfunction in "non-severe" SAH (defined by a WFNS grade 1 or 2), using speckle-tracking echocardiography. This study also aims to analyse Strain measurement with classical echocardiography and serum markers (troponin, BNP) of cardiac dysfunction.


title: A Phase-I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Escalating Oral Doses of GRT0151Y in Healthy Male and Female Subjects

summary: The aim of this clinical study in healthy participants is to investigate the safety and tolerability of GRT0151Y after multiple oral intake of different increasing doses and to evaluate the pharmacological effects (action of the compound) by means of pupillometry (measuring the pupil size of the eye) and Cold Presser Test (measuring the pain when immersing the hand in 2 degree Celsius cold water). An additional aim of the study is to investigate the pharmacokinetics of GRT0151Y (how it is taken up into the body and how it is excreted from the body)."

lead_sponsor: Grünenthal GmbH


title: Gait Parameters as Predictors of Functional and Activity Scores in Ankylosing Spondylitis : the FoLoMI Study

acronym: FoLoMI

summary:
FoLoMI is a pilot study in which the investigators will seek to determine if gait spatio-temporal and kinematic parameters can explain the evolution of a functional score, the Bath Ankylosing Spondylitis Functional Index (BASFI), at 18 months.

The secondary objectives are: (1) to study the relationship between gait parameters measured at T0 and the BASFI at T0, (2) to study the relationship between gait parameters at T0 and the BASDAI at T0, (3) to assess general state of health of the patients and its evolution by appreciating: level of physical activity, state of fatigue, diurnal sleepiness and quality of life, and (4) to compare spatio-temporal gait parameters between patients and healthy controls.

ReferenceCitation: Zochling J. Measures of symptoms and disease status in ankylosing spondylitis: Ankylosing Spondylitis Disease Activity Score (ASDAS), Ankylosing Spondylitis Quality of Life Scale (ASQoL), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Global Score (BAS-G), Bath Ankylosing Spondylitis Metrology Index (BASMI), Dougados Functional Index (DFI), and Health Assessment Questionnaire for the Spondylarthropathies (HAQ-S). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S47-58. doi: 10.1002/acr.20575. Review.

ReferenceCitation: Auvinet B, Chaleil D, Cabane J, Dumolard A, Hatron P, Juvin R, Lanteri-Minet M, Mainguy Y, Negre-Pages L, Pillard F, Riviere D, Maugars YM. The interest of gait markers in the identification of subgroups among fibromyalgia patients. BMC Musculoskelet Disord. 2011 Nov 11;12:258. doi: 10.1186/1471-2474-12-258.

ReferenceCitation: Viccaro LJ, Perera S, Studenski SA. Is timed up and go better than gait speed in predicting health, function, and falls in older adults? J Am Geriatr Soc. 2011 May;59(5):887-92. doi: 10.1111/j.1532-5415.2011.03336.x. Epub 2011 Mar 15.

ReferenceCitation: Del Din S, Carraro E, Sawacha Z, Guiotto A, Bonaldo L, Masiero S, Cobelli C. Impaired gait in ankylosing spondylitis. Med Biol Eng Comput. 2011 Jul;49(7):801-9. doi: 10.1007/s11517-010-0731-x. Epub 2011 Jan 13.

ReferenceCitation: Verweij NM, Schiphorst AH, Pronk A, van den Bos F, Hamaker ME. Physical performance measures for predicting outcome in cancer patients: a systematic review. Acta Oncol. 2016 Dec;55(12):1386-1391. Epub 2016 Oct 8. Review.

ReferenceCitation: Zebouni L, Helliwell PS, Howe A, Wright V. Gait analysis in ankylosing spondylitis. Ann Rheum Dis. 1992 Jul;51(7):898-9.

ReferenceCitation: Mangone M, Scettri P, Paoloni M, Procaccianti R, Spadaro A, Santilli V. Pelvis-shoulder coordination during level walking in patients with ankylosing spondylitis. Gait Posture. 2011 May;34(1):1-5. doi: 10.1016/j.gaitpost.2011.02.002. Epub 2011 Mar 4.

ReferenceCitation: Soulard J, Vaillant J, Baillet A, Gaudin P, Vuillerme N. The effects of a secondary task on gait in axial spondyloarthritis. Sci Rep. 2021 Oct 1;11(1):19537. doi: 10.1038/s41598-021-98732-z.

ReferenceCitation: Soulard J, Vaillant J, Baillet A, Gaudin P, Vuillerme N. Gait and Axial Spondyloarthritis: Comparative Gait Analysis Study Using Foot-Worn Inertial Sensors. JMIR Mhealth Uhealth. 2021 Nov 9;9(11):e27087. doi: 10.2196/27087.

ReferenceCitation: Soulard J, Vaillant J, Balaguier R, Vuillerme N. Spatio-temporal gait parameters obtained from foot-worn inertial sensors are reliable in healthy adults in single- and dual-task conditions. Sci Rep. 2021 May 13;11(1):10229. doi: 10.1038/s41598-021-88794-4.

ReferenceCitation: Soulard J, Vaillant J, Balaguier R, Baillet A, Gaudin P, Vuillerme N. Foot-Worn Inertial Sensors Are Reliable to Assess Spatiotemporal Gait Parameters in Axial Spondyloarthritis under Single and Dual Task Walking in Axial Spondyloarthritis. Sensors (Basel). 2020 Nov 12;20(22). pii: E6453. doi: 10.3390/s20226453.

ReferenceCitation: Soulard J, Vuillerme N, Gaudin P, Grange L, Baillet A, Cracowski JL, Juvin R, Vaillant J. Gait as predictor of physical function in axial spondyloarthritis: the prospective longitudinal FOLOMI (Function, Locomotion, Measurement, Inflammation) study protocol. Rheumatol Int. 2019 Oct;39(10):1681-1688. doi: 10.1007/s00296-019-04396-4. Epub 2019 Aug 7.

lead_sponsor: University Hospital, Grenoble


title: Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care

acronym: Colon-Ambu

summary:
Enhanced recovery after surgery (ERAS) significantly decreases mortality, morbidity and hospital length of stay without increasing the rate of re-hospitalization. It reduces psychologic stress caused by surgery and decreases postoperative complications about 50 %, especially in colorectal surgery. ERAS is now the object of several Good Practices Recommendations and is about to become the reference strategy.

The development of ambulatory surgery is a French national concern. Its interest has been demonstrated in many surgical fields. It requires a reflection centered on the patient and a health care pathway organization involving all health care actors.

While hospitalization is still the standard practice for colonic surgery, the objective of this study is to evaluate the medical and economic impact of an ambulatory care for colorectal surgery.

Ambulatory care will be compared to standard hospitalization of patients who benefit from the ERAS program.

primary_purpose: Health Services Research

ReferenceCitation: Gignoux B, Pasquer A, Vulliez A, Lanz T. Outpatient colectomy within an enhanced recovery program. J Visc Surg. 2015 Feb;152(1):11-5. doi: 10.1016/j.jviscsurg.2014.12.004. Epub 2015 Feb 7.

ReferenceCitation: Chasserant P, Gosgnach M. Improvement of peri-operative patient management to enable outpatient colectomy. J Visc Surg. 2016 Nov;153(5):333-337. doi: 10.1016/j.jviscsurg.2016.07.006. Epub 2016 Sep 23.

ReferenceCitation: Slim K; Groupe GRACE (Groupe francophone de réhabilitation améliorée après chirurgie), Amalberti R. Ambulatory colectomy: no innovation without evaluation. J Visc Surg. 2015 Feb;152(1):1-3. doi: 10.1016/j.jviscsurg.2015.01.001. Epub 2015 Jan 31.

ReferenceCitation: Wind J, Polle SW, Fung Kon Jin PH, Dejong CH, von Meyenfeldt MF, Ubbink DT, Gouma DJ, Bemelman WA; Laparoscopy and/or Fast Track Multimodal Management Versus Standard Care (LAFA) Study Group; Enhanced Recovery after Surgery (ERAS) Group. Systematic review of enhanced recovery programmes in colonic surgery. Br J Surg. 2006 Jul;93(7):800-9. Review.

ReferenceCitation: Walter CJ, Collin J, Dumville JC, Drew PJ, Monson JR. Enhanced recovery in colorectal resections: a systematic review and meta-analysis. Colorectal Dis. 2009 May;11(4):344-53. doi: 10.1111/j.1463-1318.2009.01789.x. Epub 2009 Feb 4. Review. Erratum in: Colorectal Dis. 2010 Jul;12(7):728.

ReferenceCitation: Gouvas N, Tan E, Windsor A, Xynos E, Tekkis PP. Fast-track vs standard care in colorectal surgery: a meta-analysis update. Int J Colorectal Dis. 2009 Oct;24(10):1119-31. doi: 10.1007/s00384-009-0703-5. Epub 2009 May 5.

ReferenceCitation: Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29.

ReferenceCitation: Adamina M, Kehlet H, Tomlinson GA, Senagore AJ, Delaney CP. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery. Surgery. 2011 Jun;149(6):830-40. doi: 10.1016/j.surg.2010.11.003. Epub 2011 Jan 14.

ReferenceCitation: Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev. 2011 Feb 16;(2):CD007635. doi: 10.1002/14651858.CD007635.pub2. Review.

ReferenceCitation: Slim K, Delaunay L, Joris J, Léonard D, Raspado O, Chambrier C, Ostermann S; Le Groupe francophone de réhabilitation améliorée après chirurgie (GRACE). How to implement an enhanced recovery program? Proposals from the Francophone Group for enhanced recovery after surgery (GRACE). J Visc Surg. 2016 Dec;153(6S):S45-S49. doi: 10.1016/j.jviscsurg.2016.05.008. Epub 2016 Jun 14. Review.

ReferenceCitation: Gustafsson UO, Oppelstrup H, Thorell A, Nygren J, Ljungqvist O. Adherence to the ERAS protocol is Associated with 5-Year Survival After Colorectal Cancer Surgery: A Retrospective Cohort Study. World J Surg. 2016 Jul;40(7):1741-7. doi: 10.1007/s00268-016-3460-y.

ReferenceCitation: Lawrence JK, Keller DS, Samia H, Ermlich B, Brady KM, Nobel T, Stein SL, Delaney CP. Discharge within 24 to 72 hours of colorectal surgery is associated with low readmission rates when using Enhanced Recovery Pathways. J Am Coll Surg. 2013 Mar;216(3):390-4. doi: 10.1016/j.jamcollsurg.2012.12.014. Epub 2013 Jan 23.

ReferenceCitation: Bardram L, Funch-Jensen P, Jensen P, Crawford ME, Kehlet H. Recovery after laparoscopic colonic surgery with epidural analgesia, and early oral nutrition and mobilisation. Lancet. 1995 Mar 25;345(8952):763-4.

ReferenceCitation: Levy BF, Scott MJ, Fawcett WJ, Rockall TA. 23-hour-stay laparoscopic colectomy. Dis Colon Rectum. 2009 Jul;52(7):1239-43. doi: 10.1007/DCR.0b013e3181a0b32d.

ReferenceCitation: Gash KJ, Goede AC, Chambers W, Greenslade GL, Dixon AR. Laparoendoscopic single-site surgery is feasible in complex colorectal resections and could enable day case colectomy. Surg Endosc. 2011 Mar;25(3):835-40. doi: 10.1007/s00464-010-1275-8. Epub 2010 Aug 24.

ReferenceCitation: Rogers JP, Dobradin A, Kar PM, Alam SE. Overnight hospital stay after colon surgery for adenocarcinoma. JSLS. 2012 Apr-Jun;16(2):333-6.

ReferenceCitation: Dobradin A, Ganji M, Alam SE, Kar PM. Laparoscopic colon resections with discharge less than 24 hours. JSLS. 2013 Apr-Jun;17(2):198-203. doi: 10.4293/108680813X13654754535791.

ReferenceCitation: Martín-Ferrero MÁ, Faour-Martín O, Simon-Perez C, Pérez-Herrero M, de Pedro-Moro JA. Ambulatory surgery in orthopedics: experience of over 10,000 patients. J Orthop Sci. 2014 Mar;19(2):332-338. doi: 10.1007/s00776-013-0501-3. Epub 2014 Jan 7.

ReferenceCitation: Verrier JF, Paget C, Perlier F, Demesmay F. How to introduce a program of Enhanced Recovery after Surgery? The experience of the CAPIO group. J Visc Surg. 2016 Dec;153(6S):S33-S39. doi: 10.1016/j.jviscsurg.2016.10.001. Epub 2016 Nov 16. Review.

ReferenceCitation: Daams F, Wu Z, Lahaye MJ, Jeekel J, Lange JF. Prediction and diagnosis of colorectal anastomotic leakage: A systematic review of literature. World J Gastrointest Surg. 2014 Feb 27;6(2):14-26. doi: 10.4240/wjgs.v6.i2.14. Review.

ReferenceCitation: Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil


title: USE OF ENDOCUFF SECOND GENERATION IN THE COLIC POLYPS DETECTION: HISTORIC COHORTE PROSPECTIVE COMPARATIVE

acronym: CUFF-TROCADERO

summary:
The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate in routine colonoscopy.

This is a prospective comparative cohort, on 1034 patients, 517 patients with ECV in prospective group and 517 without ECV in retrospective group

lead_sponsor: Clinique du Trocadéro


title: Multicenter Study, Randomized, Parallel Group Controlled, Testing the Effectiveness of a Behavioral Cognitive Therapy (BCT) vs Usual Local Practice on the Fatigue of Patients With Relapsing Remittent Multiple Sclerosis (RRMS)

summary:
Multiple sclerosis (MS) is a chronic inflammatory disease that leads to demyelination of the central nervous system. Fatigue is one of the most frequent and most disabling symptoms of MS. Up to 86% of individuals with MS experience fatigue at any one time; 65% consider it to be one of their three most troubling symptoms. Fatigue may limit or prevent participation in dayly activities and reduce psychological well-being (1, 2). Pharmacological and non-pharmacological treatments are available for MS-related fatigue, but evidence on effectiveness is mostly inconclusive or non-existent. The psychological approaches of fatigue management are interesting. To date, three RCTs using cognitive-behavioral group-based approaches in MS fatigue management programs have demonstrated their effectiveness (3-6). The results demonstrated a reduction in fatigue scores and better self-management of the disease in general. However, if these programs are effective at the time of their application and in the medium term, the issue of maintaining long-term therapeutic benefits is problematic.

The aim of this research is to assess the effectiveness of the FACETS program (6), on a population of French patients with RRMS over a 18 month period. This program focuses on the management of fatigue and is based on a conceptual framework that incorporates elements of cognitive-behavioral, self-efficacy, self-management and energy effectiveness theories. It consists of six once-weekly sessions of 90 minutes, with homework activities between the sessions. It is designed for groups of 6 to 10 people. The investigators propose to add 4 booster sessions to the FACETS program, at week 6, 12, 18 et 36 after the end of the program, in order to activate and reinforce the cognitive and behavioral processes and enhance the benefits of FACETS in the longer term.

This trial is randomized controlled comparative comparing a group receiving a FACETS program with a group receiving only a current local practice. Socio-demographic and medical data are measured as well as fatigue impact, fatigue severity, anxiety and depression, sleep disorder and quality of life.

The expected results are a significantly greater decrease in fatigue severity and impact in the FACETS group than the control group post intervention and this difference will be maintained at 1 year.

primary_purpose: Supportive Care

ReferenceCitation: Edgley KJ. Sullivan M, Dehoux E. A survey of multiple sclerosis: II. Determinants of employment status. Can J Rehabil 4:127-132, 1991

ReferenceCitation: Multiple Sclerosis Council. Fatigue and Multiple Sclerosis - Clinical Practice Guidelines, 1998.

ReferenceCitation: Bowcher H, May M. Occupational Therapy for the Management of Fatigue in Multiple Sclerosis, Br J Occup Ther, 61(11):488-492, 1998.

ReferenceCitation: Castell BD, Kazantzis N, Moss-Morris RE. Cognitive Behavioral Therapy and Graded Exercise for Chronic Fatigue Syndrome: A Meta-Analysis. Clin Psychol Sci Pract. 18(4):311-324, 2012.

ReferenceCitation: Amato MP, Ponziani G, Siracusa G, Sorbi S. Cognitive dysfunction in early-onset multiple sclerosis: a reappraisal after 10 years. Arch Neurol. 2001 Oct;58(10):1602-6.

ReferenceCitation: van Kessel K, Moss-Morris R, Willoughby E, Chalder T, Johnson MH, Robinson E. A randomized controlled trial of cognitive behavior therapy for multiple sclerosis fatigue. Psychosom Med. 2008 Feb;70(2):205-13. doi: 10.1097/PSY.0b013e3181643065. Epub 2008 Feb 6.

ReferenceCitation: Thomas S, Thomas PW, Kersten P, Jones R, Green C, Nock A, Slingsby V, Smith AD, Baker R, Galvin KT, Hillier C. A pragmatic parallel arm multi-centre randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based fatigue management programme (FACETS) for people with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2013 Oct;84(10):1092-9. doi: 10.1136/jnnp-2012-303816. Epub 2013 May 21.

ReferenceCitation: Compston A, Coles A. Multiple sclerosis. Lancet. 2002 Apr 6;359(9313):1221-31. Review. Erratum in: Lancet 2002 Aug 24;360(9333):648.

ReferenceCitation: Brañas P, Jordan R, Fry-Smith A, Burls A, Hyde C. Treatments for fatigue in multiple sclerosis: a rapid and systematic review. Health Technol Assess. 2000;4(27):1-61. Review.

ReferenceCitation: Johansson S, Ytterberg C, Hillert J, Widén Holmqvist L, von Koch L. A longitudinal study of variations in and predictors of fatigue in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):454-7. doi: 10.1136/jnnp.2007.121129.

ReferenceCitation: Debouverie M, Pittion-Vouyovitch S, Guillemin F. [Reconsidering fatigue at the onset of multiple sclerosis]. Rev Neurol (Paris). 2009 Mar;165 Suppl 4:S135-44. doi: 10.1016/S0035-3787(09)72125-3. Review. French.

ReferenceCitation: Monks J. Experiencing symptoms in chronic illness: fatigue in multiple sclerosis. Int Disabil Stud. 1989 Apr-Jun;11(2):78-83.

ReferenceCitation: Grima DT, Torrance GW, Francis G, Rice G, Rosner AJ, Lafortune L. Cost and health related quality of life consequences of multiple sclerosis. Mult Scler. 2000 Apr;6(2):91-8.

ReferenceCitation: Flensner G, Landtblom AM, Söderhamn O, Ek AC. Work capacity and health-related quality of life among individuals with multiple sclerosis reduced by fatigue: a cross-sectional study. BMC Public Health. 2013 Mar 15;13:224. doi: 10.1186/1471-2458-13-224.

ReferenceCitation: White LJ, Castellano V. Exercise and brain health--implications for multiple sclerosis: Part 1--neuronal growth factors. Sports Med. 2008;38(2):91-100. Review.

ReferenceCitation: Ritvo PG, Fisk JD, Archibald CJ, Murray TJ, Field C. Psychosocial and neurological predictors of mental health in multiple sclerosis patients. J Clin Epidemiol. 1996 Apr;49(4):467-72.

ReferenceCitation: Schwid SR, Covington M, Segal BM, Goodman AD. Fatigue in multiple sclerosis: current understanding and future directions. J Rehabil Res Dev. 2002 Mar-Apr;39(2):211-24. Review.

ReferenceCitation: Racke MK, Hawker K, Frohman EM. Fatigue in multiple sclerosis: is the picture getting simpler or more complex? Arch Neurol. 2004 Feb;61(2):176-7.

ReferenceCitation: Bakshi R. Fatigue associated with multiple sclerosis: diagnosis, impact and management. Mult Scler. 2003 Jun;9(3):219-27. Review.

ReferenceCitation: Kos D, Kerckhofs E, Nagels G, D'hooghe MB, Ilsbroukx S. Origin of fatigue in multiple sclerosis: review of the literature. Neurorehabil Neural Repair. 2008 Jan-Feb;22(1):91-100. Epub 2007 Apr 4. Review.

ReferenceCitation: Tejani AM, Wasdell M, Spiwak R, Rowell G, Nathwani S. Carnitine for fatigue in multiple sclerosis. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD007280. doi: 10.1002/14651858.CD007280.pub2. Review. Update in: Cochrane Database Syst Rev. 2012;5:CD007280.

ReferenceCitation: Vanage SM, Gilbertson KK, Mathiowetz V. Effects of an energy conservation course on fatigue impact for persons with progressive multiple sclerosis. Am J Occup Ther. 2003 May-Jun;57(3):315-23.

ReferenceCitation: Mathiowetz VG, Finlayson ML, Matuska KM, Chen HY, Luo P. Randomized controlled trial of an energy conservation course for persons with multiple sclerosis. Mult Scler. 2005 Oct;11(5):592-601.

ReferenceCitation: Lee MA, Smith S, Palace J, Matthews PM. Defining multiple sclerosis disease activity using MRI T2-weighted difference imaging. Brain. 1998 Nov;121 ( Pt 11):2095-102.

ReferenceCitation: Gay MC, Vrignaud P, Garitte C, Meunier C. Predictors of depression in multiple sclerosis patients. Acta Neurol Scand. 2010 Mar;121(3):161-70. doi: 10.1111/j.1600-0404.2009.01232.x. Epub 2010 Jan 12.

ReferenceCitation: Feinstein A, Magalhaes S, Richard JF, Audet B, Moore C. The link between multiple sclerosis and depression. Nat Rev Neurol. 2014 Sep;10(9):507-17. doi: 10.1038/nrneurol.2014.139. Epub 2014 Aug 12. Review.

ReferenceCitation: Knoop H, van Kessel K, Moss-Morris R. Which cognitions and behaviours mediate the positive effect of cognitive behavioural therapy on fatigue in patients with multiple sclerosis? Psychol Med. 2012 Jan;42(1):205-13. doi: 10.1017/S0033291711000924. Epub 2011 Jun 15.

ReferenceCitation: Gronwall DM. Paced auditory serial-addition task: a measure of recovery from concussion. Percept Mot Skills. 1977 Apr;44(2):367-73.

ReferenceCitation: Ruet A, Deloire MS, Charré-Morin J, Hamel D, Brochet B. A new computerised cognitive test for the detection of information processing speed impairment in multiple sclerosis. Mult Scler. 2013 Oct;19(12):1665-72. doi: 10.1177/1352458513480251. Epub 2013 Mar 4.

ReferenceCitation: Stankoff B, Waubant E, Confavreux C, Edan G, Debouverie M, Rumbach L, Moreau T, Pelletier J, Lubetzki C, Clanet M; French Modafinil Study Group. Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study. Neurology. 2005 Apr 12;64(7):1139-43.

lead_sponsor: Réseau Sep Idf Ouest


title: A Randomized, Evaluator Blinded, Within Subject, Single-Centre Evaluation of the Vasoconstriction Properties of MC2-01 Cream, Compared to 5 Other Corticosteroids in Healthy Subjects

summary: The objective of this trial is to compare the vasoconstriction potential

ipd_sharing_description: Single site study

lead_sponsor: MC2 Therapeutics


title: Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera

acronym: ELAROP

summary:
Pain management in premature infants is essential because they are exposed to repeated minor painful procedures such as screening for premature retinopathy (ROP). Acupuncture has shown its analgesic effectiveness in many studies. Laser acupuncture is a simple, fast, side-effect-free method, but no study exists on the contribution of acupuncture in the management of pain caused by the examination of the fundus in addition to conventional therapies (suction, Glucose G30%, anaesthetic eye drops) which are not sufficiently effective.

Hypothesis: Laser acupuncture is a medical device that would reduce the pain and discomfort of premature newborns when examining the fundus with a digital camera.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Device


title: Extra-pulmonary Clinical Manifestations of Influenza Virus and Respiratory Syncitial Virus Infections

acronym: GIVRE

summary: The purpose of this study is to describe extra-pulmonary clinical manifestations of Influenza virus and Respiratory Syncitial Virus infections in hospitalized adults at a French university hospital.

lead_sponsor: Poitiers University Hospital


title: A Multicentre Open-label Phase II Study of Ixazomib -Daratumumab Without Dexamethasone (IDara) in Elderly Relapse Refractory Multiple Myeloma

acronym: IDARA

summary: Multiple myeloma is an incurable hematological malignancy that affects older patients. Currently, despite recent progress, the disease relapses more or less quickly after initial treatment and requires the resumption of treatment with new drugs associated with cortisone, whose side effects are important. The investigators propose to conduct a phase 2 testing the combination ixazomib - daratumumab without dexamethasone.

lead_sponsor: University Hospital, Caen

intervention_type: Combination Product


title: Skin Antisepsis With Chlorhexidine-Alcohol Versus Povidone Iodine-Alcohol, Combined or Not With Use of a Bundle of New Devices, for Prevention of Intravascular-catheter Colonization and Catheter Failure: An Open Label, Single Center, Randomized Controlled, Two-by-two Factorial Trial

summary:
Short peripheral intravenous catheters (PVC) are the most frequently used invasive medical devices in hospitals. Unfortunately, PVCs often fail before the end of treatment due to the occurrence of complications, which can be mechanical, vascular or infectious. Complications lead to infusion failure and device replacement, which results in interrupted therapy, pain associated with resiting and increased health care costs for resources and staff time. Catheter related bloodstream infections (CR-BSIs) prolong hospitalization and increase treatment costs and mortality.

Prevention of these complications is based on the respect of hygiene rules and the use of bio-compatible catheters. The choice of the antiseptic solution for skin disinfection is key. Similarly, the use of new technologies such as catheters designed to minimize blood exposure, zero-reflux needleless-connectors, disinfecting caps, and flushing PVCs before and after each medication administration to maintain catheter patency are of theoretical interest, but little scientific data support their use in routine.

The primary objectives of this study are, first, to demonstrate that skin preparation with 2% chlorhexidine (CHG)-70% isopropanol decreases the risk of PVC colonization compared to skin preparation with 5% povidone iodine (PVI)-69% ethanol. Second, to demonstrate that use of a bundle of technologies including a new PVC, zero-reflux needless-connectors, disinfecting caps, and single-use prefilled flush syringes extends the time between catheter insertion and catheter failure.

The secondary objectives are to compare between the four study group incidence of phlebitis, accidental catheter removal, infiltration, catheter occlusion, CR-BSI, local infection, all-cause bloodstream infections, catheter colonization, duration of catheter remaining in place without complication, length of hospital stay, safety and patient satisfaction.

The CLEAN 3 study is an open-label, single centre, investigator-initiated, randomised, four-parallel group, two-by-two factorial trial. Patients requiring PVC for an expected 48 h will be randomised in one of four groups according to skin disinfection method and type of devices used. Randomization will be carried out through a secure web-based randomization system. Inclusions are expected to begin in January 2019 and continue until July 2019, once the number of catheters required has been reached.

Patients will be enrolled at the Emergency department of the Poitiers University Hospital before being hospitalised in one of five wards (neurology, neurology, pneumology, internal medicine and downstream emergency unit).

ReferenceCitation: Maunoury F, Drugeon B, Boisson M, Marjanovic N, Couvreur R, Mimoz O, Guenezan J; CLEAN-3 Study. Cost-effectiveness analysis of bundled innovative devices versus standard approach in the prevention of unscheduled peripheral venous catheters removal due to complications in France. PLoS One. 2022 Jun 14;17(6):e0269750. doi: 10.1371/journal.pone.0269750. eCollection 2022.

ReferenceCitation: Guenezan J, Marjanovic N, Drugeon B, Neill RO, Liuu E, Roblot F, Palazzo P, Bironneau V, Prevost F, Paul J, Pichon M, Boisson M, Frasca D, Mimoz O; CLEAN-3 trial investigators. Chlorhexidine plus alcohol versus povidone iodine plus alcohol, combined or not with innovative devices, for prevention of short-term peripheral venous catheter infection and failure (CLEAN 3 study): an investigator-initiated, open-label, single centre, randomised-controlled, two-by-two factorial trial. Lancet Infect Dis. 2021 Jul;21(7):1038-1048. doi: 10.1016/S1473-3099(20)30738-6. Epub 2021 Feb 1. Erratum in: Lancet Infect Dis. 2021 Apr 6;:.

ReferenceCitation: Guenezan J, Drugeon B, O'Neill R, Caillaud D, Sénamaud C, Pouzet C, Seguin S, Frasca D, Mimoz O. Skin antisepsis with chlorhexidine-alcohol versus povidone iodine-alcohol, combined or not with use of a bundle of new devices, for prevention of short-term peripheral venous catheter-related infectious complications and catheter failure: an open-label, single-centre, randomised, four-parallel group, two-by-two factorial trial: CLEAN 3 protocol study. BMJ Open. 2019 Apr 2;9(4):e028549. doi: 10.1136/bmjopen-2018-028549.


title: Biomechanical Characterization of the Locomotion in Multiple Sclerosis Patients : Determination of Indicators of the Premature Degradation of the Orthostatic Posture, Gait Initiation and Walking

acronym: WALKING-SEP

summary:
Multiple sclerosis (MS) is an inflammatory chronic disease of the central nervous system. Patients are suffering from balance and gait impairments at the early stage of the disease.

85 % of the MS patients report gait disorders, which impact their autonomy and their quality of life and increase the risk of fall.

The three-dimensional analysis of the walking by a motion capture system associated with force platforms allows the quantification of the complex walking disorders, to look for the cause, as well as side effects such as compensation strategies.

According to the 2006 report of the French National Authority for Health, the 3D analysis of walking is essential in chronic pathologies to evaluate and quantify gait disorders. This analysis allows the functional follow-up of the patients throughout their rehabilitation. Some studies, on a small and heterogeneous population of MS patients, showed changes during the walking concerning spatiotemporal, kinematic, dynamic parameters and muscular activation of lower limbs at early stages of the disease. Only two studies evaluate the joint power during walking in MS patients. However, these studies have some limits.

The 3D analysis of the walking proposed in this study would allow the biomechanical characterization of the gait impairments of MS patients through tasks such as walking, gait initiation and orthostatic posture. This methodology would contribute to adapt treatments and the rehabilitation care, at an early stage of the disease.

From a functional point of view, the gait initiation is an interesting dynamic task to be evaluated. Indeed, it represents the transition between the upright posture and the stabilized walking. Throughout this complex task, a stereotypical motor program is set up during a first phase of anticipatory postural adjustments, which allows the creation of dynamic conditions essential for the execution of the first step. The gait initiation is little documented for MS patients despite the risk of fall clinically highlighted. The articular power during the gait initiation was never estimated in MS patients. On the other hand, there is no study establishing correlations between the Expanded Disability Status Scale functional features and the impairments of the gait initiation.

lead_sponsor: Lille Catholic University


title: Randomized Trial Comparing the Hypnosis Versus Standard Care of Anxiety and Pain in Patients With Brachytherapy

acronym: HYCUDES

summary:
Formal hypnosis is a non-drug technique known to decrease anxiety and pain during the preoperative procedure.

In brachytherapy, the practice of hypnosis has been shown to be feasible and beneficial for patients treated for prostate cancer The goal of the study is to demonstrate the added value of hypnosis during a brachytherapy detachment by improving the comfort of the patient.

The investigators want to evaluate the contribution of hypnosis during brachytherapy detachment by quantifying the anxiety and pain felt by the patient during the procedure.

lead_sponsor: Institut de Cancérologie de Lorraine


title: Immediate Efficacy Assessment of SCENAR's Session on a Common Spinal Pain Syndrome

summary: Randomized, singled blinded, controlled trial of the efficacy of a SCENAR session in patients with vertebral pain. SCENAR is an electrotherapy device.

lead_sponsor: Hopital Foch


title: Impact of a Preoperative Education on the Quality of Postoperative Analgesia Management in Outpatient Surgery

acronym: PELOPS

summary:
In 2015, more than 50% of surgical procedures were performed in outpatient settings. Successful pain management after outpatient surgery is crucial, and requires a perfect cooperation between caregivers and patients, with clear information on the analgesics use at home. Different strategies to control postoperative pain were adopted by hospitals performing outpatient surgery. However, up to half of patients receive little or no information about the treatment of postoperative pain, and at least one third of them are not able to follow postoperative analgesia instructions. There is a clear unmet need in pain treatment during first 48-72 hours after discharge, with important number of emergency calls and readmissions. The most common causes of rescue calls after outpatient surgery are uncontrolled pain and questions about medications or post-operative care.

Structured education interventions using psychological techniques to enhance engagement and behavior were found to be beneficial for better acute pain management in outpatient settings after orthopedic surgery.

We hypothesize that an educational intervention based on the rational perception of postoperative pain and discomfort, and the proper use of analgesics would improve the quality of pain management at home and reduce analgesics-related side effects.

Principal objective of this study is to evaluate the impact of a preoperative educational intervention on effectiveness of postoperative pain self-management in outpatient settings compared to the current practice.

Secondary objectives are to evaluate the prevalence of analgesics use and the incidence of severe pain episodes, as well as side effects. The occurrence of neurological pain, quality of sleep, and patient's comfort will be evaluated at 30th day after surgery.

ReferenceCitation: Dziadzko M, Bouteleux A, Minjard R, Harich J, Joubert F, Pradat P, Pantel S, Aubrun F. Preoperative Education for Less Outpatient Pain after Surgery (PELOPS trial) in orthopedic patients-study protocol for a randomized controlled trial. Trials. 2022 May 21;23(1):422. doi: 10.1186/s13063-022-06387-6.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hopital de la Croix Rousse - Anaesthesia Reanimation unit


title: Microscopic Peritoneal Metastases After Complete Macroscopic Cytoreductive Surgery for Epithelial Ovarian Cancer

acronym: MicroPCI

summary: The objective of the cytoreductive surgery carried out for the management of ovarian cancers is to obtain a complete macroscopic cytoreduction. This means that all visible peritoneal metastases must be resected. The peritoneum is the most frequent site of recurrence after initial management. There is no data on the existence, prevalence of microscopic peritoneal metastases. It nevertheless represents a therapeutic target (intraperitoneal chemotherapy). The main objective is the demonstration of microscopic peritoneal metastases in macroscopically healthy peritoneum after complete macroscopic cytoreductive surgery.

location_facility: Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix


title: Evaluation of the Prevalence, the Diagnosis Tests, and the Associated Morbimortality of Sarcopenia in Hepatobiliary Surgery

acronym: SARFO

summary: The sarcopenia is defined as a loss of muscle mass and a loss of muscle function ( strength or performance). Some studies showed that the sarcopenia increase the postoperative complications and the overall survival in abdominal surgery. But the sarcopenia is not evaluated in the Hepatobiliary surgery. This prospective, monconcentrique study aim to evaluate the prevalence of sarcopenia, and its associated morbimortality in hepatobiliary surgery for malignant or benign tumors.

lead_sponsor: University Hospital, Angers


title: Microglial Activation in Narcolepsy Type 1 and Kleine-Levin Syndrome: Positron Emission Tomography (PET) Study in [18F] DPA-714

acronym: NARCOGLIE

summary: Type 1 narcolepsy (NT1) is a chronic sleep disorder caused by the selective and irreversible loss of neurons from the hypothalamus, which synthesizes a neurotransmitter: hypocretin (Hcrt) / orexin. The exact cause of this destruction is still unknown, but the autoimmune hypothesis is strongly favored, involving the interaction of genetic and environmental factors. The treatment of NT1 is currently only symptomatic, targeting hypersomnolence and cataplexy. To prevent the destruction of Hcrt neurons, immunomodulatory agents have been tested, with varying efficacy, probably due to varying degrees of hypothalamic impairment and stages of disease progression. During microglial activation, a condition associated with neuroinflammation in the brain, there is an increase in the mitochondrial translocation protein (TSPO), which can be quantified in vivo by specific tracers, such as the [18F] DPA- 714, in positron emission tomography (PET), a very sensitive nuclear imaging technique. The aim here is to study microglial activation in PET [18F] DPA-714 in NT1 patients with recent evolution in comparison with controls; then analyze the effect of age, and the severity of symptoms on this PET imaging biomarker. The hypothesis is that microglial activation, especially of the hypothalamic region, is greater in NT1 than controls.

lead_sponsor: University Hospital, Montpellier

intervention_type: Radiation


title: SubArachnoid Hemorrhage HEadache Treated by Lumbar Puncture

acronym: SAH-HELP

summary: Headache control is one of the major challenges in patients who suffered an acute aneurysmal subarachnoid hemorrhage (aSAH). Headache affects 90% of the patient and is resistant to the major pain medication. It results from the increased intracranial pressure and the inflammation caused by the accumulation of arterial blood in the subarachnoid space. Hemorrhagic cerebrospinal fluid (CSF) removal by a lumbar puncture (LP), is well tolerated, reduces intracranial pressure and accelerates the clearance of the blood products from CSF. Nonetheless it has never been tested in a randomized trial. The investigators aim to compare in patients who experienced a low grade aSAH, the variation of headache intensity after CSF removal by LP vs. Sham LP in addition to predefined analgesic protocol management.

lead_sponsor: University Hospital, Toulouse


title: Prediction Value of Perfusion and Dual Energy Computer Tomography for Microvascular Invasion in Hepatocellular Carcinoma

acronym: PERCAHEC

summary: The aim of this study is to evaluate the hepatic perfusion computer tomography and dual energy computer tomography in the assessment of tumor characterization of Hepatocellular carcinoma in patients with resectable Hepatocellular carcinoma by comparing the quantitative parameters computer tomography obtained with the pathological data of the surgical specimens.

ReferenceCitation: Lewin M, Laurent-Bellue A, Desterke C, Radu A, Feghali JA, Farah J, Agostini H, Nault JC, Vibert E, Guettier C. Evaluation of perfusion CT and dual-energy CT for predicting microvascular invasion of hepatocellular carcinoma. Abdom Radiol (NY). 2022 Jun;47(6):2115-2127. doi: 10.1007/s00261-022-03511-7. Epub 2022 Apr 13.


title: Feasibility of Modified Constraint-induced Movement Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke

acronym: ITHEMICAL

summary: The aim of this study is to test the feasibility of a constraint intervention combined with visual-spatial cueing strategy in patients with acute stroke to improve their daily life activities.

status: Terminated

lead_sponsor: Nantes University Hospital


title: Initiation of an in Vitro Model of the Cystic Fibrosis Bronchial Epithelium Via Induced Pluripotent Stem Cell Technology

acronym: PaCyFIC

summary: In order to further enable physiopathology studies, the aim of this project is to validate an in vitro model of cystic fibrosis created using induced pluripotent stemcell (iPS) differentiated bronchial epithelium from cystic fibrosis (CF) patients homozygous for the p.Phe508del mutation of the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

location_facility: Hôpital Arnaud de Villeneuve - CHU de Montpellier


title: Estimated Impact of Fungal Colonization in Cystic Fibrosis From Secondary Exploitation of MucoFong Database.

summary: The main objective of the project "MucoFong" (19021906 national french program n which Vaincre La Mucoviscidose participated: N82006/ 351) was to determine the fungi present the respiratory tract of CF patients responsible for either colonization or authentic infectious diseases. The Mucofong data allowed the team to provide for the 1st time national French guidelines for the management of CF sputum mycological analysis (MucoMicrobes work group coordinated by Prof. Plésiat published in 2015 in the REMIC book). Nevertheless, the team has a comprehensive database that it still has to analyze beyond these initial results. The main goal today is to clarify the role of fungi in the lung function degradation of these patients by studying the overall risk and estimated impact of fungal colonization in our cohort.

lead_sponsor: University Hospital, Bordeaux


acronym: HOMEORAD

title: Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

summary:
Breast cancer is the second most frequent cancer worldwide. Principal therapy consists in radiotherapy, but this technic has sides effects as radiodermatitis, concerning about 90 percent of women treated.

Risk of flushing could be reduced by hygienic rules, but no treatment proved its efficacy to prevent radiodermatitis.

Homeopathy is popular but also contested. No clinical trial proved its efficacy for this indication. The present study aims at evaluating Radium bromatum efficacy (homeopathy), compared to placebo, to prevent radiodermatitis apparition for women treated for breast cancer.


title: A Study of the Relationship Between Personality Disorders and Substance Use Disorders in a Sexual Context in the Man Having Sex With Other Men Population - An Observational Study Based on a Cross-sectional Survey.

acronym: PSYCHEMS

summary:
Chemsex refers to the use of psychoactive drugs in a sexual context, mainly cathinones, GHB/GBL, methamphetamine, cocaine and ketamine. This can cause infectious or psychiatric complications, addictions, and often goes with high risk sexual behaviours. Recent studies have highlighted the relationship between personality disorders, substance use disorders and risky sexual behaviours. It is important to understand the factors associated with chemsex in order to offer adapted prevention and care plans.

The study hypothesis is that personality disorders, evaluated with the PDQ-4+ questionnaire, are more frequent among man having sex with other men with a substance use disorder linked to chemsex than among man having sex with other men who have never practised chemsex.

time_perspective: Cross-Sectional

location_facility: CSAPA - Service Hépato-gastroentérologie


title: Central Venous Pressure (CVP) Changes do Not Predict Preload Unresponsiveness

summary:
Passive leg raising (PLR) is routinely used to predict preload responsiveness in critically ill patients. However, real-time measurements of cardiac output are required to assess its effects. Some authors have suggested that in fluid non-responders, central venous pressure (CVP) increased markedly. By analogy with the CVP rules proposed by Weill et al to assess a fluid challenge, it has been hypothesized that an increase in CVP ≥ 5 mmHg during PLR can predict preload unresponsiveness.

Objective Investigation of whether an increase in CVP ≥ 5 mmHg during PLR predict preload unresponsiveness diagnosed by the absence of increase in velocity-time integral (VTI) of the flow in the left ventricular outflow tract by more than 10% (4).

Methods Critically ill patients with a central venous catheter in place and for whom the physician decided to test preload responsiveness by PLR were prospectively included. Transthoracic echocardiography was performed to obtain VTI. The CVP and VTI were measured before and during PLR.

ReferenceCitation: Hamzaoui O, Gouëzel C, Jozwiak M, Millereux M, Sztrymf B, Prat D, Jacobs F, Monnet X, Trouiller P, Teboul JL. Increase in Central Venous Pressure During Passive Leg Raising Cannot Detect Preload Unresponsiveness. Crit Care Med. 2020 Aug;48(8):e684-e689. doi: 10.1097/CCM.0000000000004414. Erratum in: Crit Care Med. 2021 Jun 1;49(6):e662.

lead_sponsor: Hopital Antoine Beclere


title: Development of a Software Correlating Simultaneously fMRI, EEG and Peripheral Physiological Activity

acronym: NEUREXPLO

summary: The study aim to improve the quality of EEG recordings during simultaneous fMRI acquisitions. The second aim is to validate the correspondence between cerebral areas activated in fMRI and cortical areas identified with high density EEG during the listening of emotional musical pieces.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Colonoscopy With Low Volume bowEl prepAration in iNflammatory Bowel Diseases

acronym: CLEAN

summary: National multicentric observatory of low bowel preparations in patients with IBD


title: Identification of Respiratory Profiles From Nasal Pressure Signals

acronym: IPR-SAINS

summary:
Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease caused by smoking and associated with significant morbidity due to recurrent exacerbations or even hospitalizations. It is one of the leading causes of death in rich countries.

Early detection of exacerbations of the disease is thus an economic and public health issue in the world. Finding tools for automatic and early detection of an exacerbation is the subject of the study. A continuous analysis of the frequency and shape of the patients' breathing will be used.

As a first step in this study, investigators want to measure the frequency and shape of breathing in healthy subjects as they execute standard activities. These activities include resting, drinking, coughing, speaking, breathing through the mouth, physical exercise and recuperation.

ReferenceCitation: Pegoraro JA, Lavault S, Wattiez N, Similowski T, Gonzalez-Bermejo J, Birmelé E. Machine-learning based feature selection for a non-invasive breathing change detection. BioData Min. 2021 Jul 18;14(1):33. doi: 10.1186/s13040-021-00265-8.

lead_sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

location_facility: INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière


title: Assessment of the Depth of Anesthesia During Intravenous Anesthesia: Comparison of the Bispectral Index Monitor and the qCON Monitor.

acronym: Bis-qCON-IV

summary: Quantium Medical Company has an ElectroEncephalograph-based (EEG-based) algorithm with two outputs: qCON for unconsciousness and qNOX for anti-nociception. qCON, is designed to provide information about the depth of the hypnotic state, similar to that provided by the BIS™.


title: Efficacy and Safety of the Inter-laminar Device IntraSPINE® Associated With Discectomy in the Treatment of Lumbar Disc Herniation. A Single-blind, Randomised, Comparative, Multicentre Clinical Trial vs. Discectomy Alone.

acronym: INTREUR

summary:
IntraSPINE® is a novel device that, unlike interspinous positioned implants, is unique in being placed more anteriorly in an interlaminar position, closer to the normal center of rotation of the motion segment. Mechanical advantages are thus conferred over more posteriorly positioned devices through the possibility of more physiological 'rocking' type movements in flexion and extension . This enables IntraSPINE® to off-load the facet joints in extension without blocking movement. Having a more anteriorly placed fulcrum also helps control excessive flexion movements by virtue of an improved lever arm in conjunction with an intact posterior tension band.

The underlying hypothesis of this work is that a clinical gain is achieved by adding an IntraSPINE® interlaminar device to discectomy in patients suffering from a lumbar disc herniation. This should result in an improvement in incapacity level and a reduction in pain.

ReferenceCitation: Schmidt S, Franke J, Rauschmann M, Adelt D, Bonsanto MM, Sola S. Prospective, randomized, multicenter study with 2-year follow-up to compare the performance of decompression with and without interlaminar stabilization. J Neurosurg Spine. 2018 Apr;28(4):406-415. doi: 10.3171/2017.11.SPINE17643. Epub 2018 Jan 26.

ReferenceCitation: Galarza M, Gazzeri R, De la Rosa P, Martínez-Lage JF. Microdiscectomy with and without insertion of interspinous device for herniated disc at the L5-S1 level. J Clin Neurosci. 2014 Nov;21(11):1934-9. doi: 10.1016/j.jocn.2014.02.029. Epub 2014 Oct 3.

ReferenceCitation: Bae J, Lee SM, Lee SH, Shin SH, Kim HJ, Kim KH. The Likelihood of Reaching Substantial Clinical Benefit After an Interlaminar Dynamic Spacer for Chronic Low Back Pain: A Clinical and Radiologic Analysis of a Prospective Cohort. World Neurosurg. 2017 May;101:589-598. doi: 10.1016/j.wneu.2017.02.083. Epub 2017 Feb 27.

lead_sponsor: Quanta Medical


title: Interest of Treatment With Cranial Osteopathy in Functional Disorders of the Newborn

summary: To evaluate, from the maternity stay, the interest of the cranial osteopathy in the reduction of the hyper irritability of the newborn and the improvement of the postural abnormalities

lead_sponsor: University Hospital, Lille


title: Genetic an Functional Studies of Patient With Inflammatory Bowel Disease

acronym: MINOTOR

summary: The objective of this study is to study the response of macrophages, isolated from patients with ulcerative colitis (Crohn's disease) or Crohn's disease (CD), to 6 candidate enterogenous and their derivatives, depending on the genotype for associated polymorphisms. to the development of IBD


title: Prospective Study, Monocentric, Randomized, Double Blind Evaluating the Non Inferiority of Non Capsular Suture in Arthroscopic Treatment of Cam or Mixed-type Femoroacetabular Impingement Without Hip Dysplasia

acronym: SUTURCAP

summary:
Since last past decade, arthroscopic hip surgery proved its efficacy in femoroacetabular impingement treatment. However, no consensus exist concerning capsular suture or not. According to capsular incision size, articular instability can persist if no suture is performed. In contrast, tightly suture can cause post-operative joint stiffness.

This study aims to evaluate the non inferiority of non capsular suture after hip arthroscopy treatment of cam or mixed-type femoroacetabular impingement, without hip dysplasia, after 2 years follow-up.

lead_sponsor: Clinique de la Sauvegarde


type: Registry Identifier

title: Assessment of the Impact of the Use of the ARA 2 Connected Toothbrush on Short-term Oral Hygiene During the Pre-operative Period of Alveolar Bone Grafts for Patients With Unilateral or Bilateral Cleft Lip and Palate. Oral Hygiene and Connected Toothbrush Before Alveolar Bone Graft for Cleft Lip and Palate.

acronym: HBD-GPP

summary:
Alveolar bone graft is an essential step in the primary surgical treatment of unilateral or bilateral cleft lip and palate. The procedure involves repairing the alveolar cleft by an autologous iliac bone graft.

Clinical experience suggests that a large number of the post-operative complications in this procedure are related to pre-and post-operative oral hygiene issues.

The main objective of this research is the evaluation of pre-operative oral hygiene in children benefiting from alveolar bone graft and having a type Quad Helix orthodontic device.

The secondary objectives are to describe the use of the Ara ® Toothbrush by a population of children with a cleft lip and palate and to know whether the use of the Ara ® toothbrush has an influence on the occurrence of post-operative complications evaluated at 6 months of intervention (delays in scarring, suture dehiscence, fistulas, surgical site infections, total or partial graft loss).

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Comparison of the Stiffness of the Lumbar Back Muscles Between Low Back Pain and Healthy Controls Using Magnetic Resonance Elastography and Shear Wave Elastography

acronym: PARA-ELASTO

summary: Chronic low back pain remains a major public health issue. Low back pain is frequently associated with stiffness changes of the lumbar back muscles. The techniques which assess the stiffness of the back muscles are poorly reliable and do not allow the quantification of stiffness changes. Elastography (magnetic resonance imaging and ultrasound) can be used to objectively and non-invasively quantify in vivo tissue elasticity. The aim of the investigator's study is to compare the stiffness in the main lumbar back muscles (i.e. the erector spinae and the multifidus) by using magnetic resonance elastography and shear wave elastography.


title: Nutritional Strategies to Increase Nitric Oxide Signaling in Raynaud's Phenomenon

acronym: NivOSe

summary: The investigators aim at comparing the efficacy of a 2 weeks supplementation by L-citrulline or beetroot juice to L-citrulline placebo or denitrated beetroot juice respectively on Raynaud's phenomenon severity. Raynaud's phenomenon severity will be assessed through the Raynaud Condition Score, daily frequency of attacks or cumulative attack duration (expressed as min) daily collected by patients in a diary. Each Volunteer will choose his own main outcome among these 3 criteria.

lead_sponsor: University Hospital, Grenoble

intervention_type: Dietary Supplement


title: Monitoring Analgesia by ANI (Analgesia The Nociception Index) During Surgery Inflammatory Bowel

acronym: ANI-MICI

summary: The objective of this research is to study the variations of the ANI(Analgesia The Nociception Index) according to 2 periods: the "NoStim" period before surgical incision under general anesthesia and the period of hemodynamic reactivity "ReactHemo" peroperative. This period is defined by a 20% increase in FC and / or PAS (the only gold standard today).


title: Prevalence of Obstructive Sleep Apnea Syndrome in Patients With a History of Sudden Sensorineural Hearing Loss

acronym: SAS-SB

summary: This study studies the prevalence between obstructive sleep apnea syndrome and sensorineural hearing loss. We recruit patients who have been treated for sudden sensorineural hearing loss in Poitiers' University Hospital between 2010 et 2017, and we detect if they have OSA with a ventilatory polygraphy.

primary_purpose: Screening

lead_sponsor: Poitiers University Hospital


title: Prospective Evaluation of the Biomechanical Properties of the Thoracic Aorta Coupling Magnetic Resonance Imaging and In-vitro Elasticity Tests in Patients With Ascending Aortic Aneurysm

acronym: MECATHOR

summary: The biomechanical properties of the aorta are currently poorly understood. A better understanding would optimize surgical indications and monitoring techniques for patients with thoracic aortic aneurysms.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Evaluation of a New Long-term Total Articular Prosthesis Follow-up Strategy by Simple Questionnaire and Radiography

acronym: Follow-up

summary:
Ever-evolving prosthetic activity as described in a Swedish study that predicts 469 TKA per 10,000 inhabitants in 2130. Increased consultation of controls and post-arthroplasty follow-up is expected. There is a legal obligation to ensure long-term follow-up without official recommendation on follow-up procedures. The objective is to compare a consultation + Xray by the surgeon versus an Xray and a questionnaire completed by the patient who had a knee or hip replacement. This is to demonstrate the equivalence of both.

All patients who come back for an annual check of a prosthesis should complete this questionnaire and perform an X-ray of their prosthesis. The study lasts one year and includes all the patients with a previous knee or hip arthroplasty.

The result of the questionnaire and Xray will be compared to that of the consultation and Xray.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability

acronym: HRV REEDUC

summary:
Cardiac rehabilitation reduces morbidity and mortality after myocardial infarction (MI) and improve the sympathovagal balance. The autonomic nervous system (ANS) can be explored by the variation of heart rate (HRV). The HRV is a fatigue marker and guides the athletes training programs. A smartphone app can measure the HRV via a heart rate monitor.

The main study objective is to compare the effect on the functional capacities of a re-training adapted to the HRV compared to a standard program in the post-MI The secondary objective is to compare the patients' quality of life according to the rehabilitation program and to validate the HRV smartphone app.

This is a prospective, multicenter study. Post-MI patients treated with angioplasty with a LVEF> 40% are randomized into 2 groups: HRV (re-training adapted to HRV daily: 10W decrease or increase in workload according to the HRV) or control (continuous training in SV1). Patients underwent a cardiopulmonary test, a walking test (TM6) and a SF36 questionaries' at the entrance and exit. The taking of HRV was done every morning in a standardized way via the smartphone app during the 20 re-training sessions.


title: A Randomized Controlled Study Comparing the Influence of a Mindfulness-based Stress Reduction Program vs. Routine Management on Psychological Variables and Biological Markers Related to Immuno-inflammation Associated With Psychological Stress in Caregivers of Patients With Severe Psychiatric Disorders.

acronym: MindInfCare

summary:
The objective of this project is to study the influence of mindfulness meditation on psychological health (stress level, affects, emotions) and physical health parameters (rate of inflammatory markers in the blood, activity of white blood cells involved in immuno-inflammation) in caregivers of people with psychiatric disorders. This study will provide the objective scientific data required for the development of mindfulness meditation programs for psychiatric caregivers.

80 participants will be randomly assigned to one of the following two groups:

40 participants in the "Mindfulness" group who will attend mindfulness meditation sessions in addition to their standard follow-up
40 participants in the "Control" group who will have a standard follow-up The duration of participation is 12 months and includes 3 visits and 8 mindfulness-based meditation sessions for the "Mindfulness" group.

intervention_type: Biological


title: Becoming Children With Perinatal Anoxo-Ischemic Encephalopathy Without Indication of Therapeutic Hypothermia

acronym: SARNATUN

summary:
There are 3 levels of severity of anoxo-ischemic encephalopathy (EAI): mild, moderate and severe. Therapeutic hypothermia is beneficial in children with moderate EAI. It is ineffective in severe EAI and may be deleterious if there is no EAI. He continues to question his interest in light EAIs.

There are few studies on the becoming of children with a mild anoxic-ischemic encephalopathy and not set hypothermia.

The main hypothesis of the study is that term newborns with anoxo-ischemic encephalopathy who did not require therapeutic hypothermia have normal psychomotor development at 2 years.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Réanimation néonatale - Hôpital de la Croix Rousse


title: Analysis of B Cell Differentiation in Multiple Sclerosis

acronym: ABCD-SEP

summary: Interventional study with minimal risks and constraints, prospective, monocentric.

lead_sponsor: Rennes University Hospital


title: Description the Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia : Prospective Descriptive Non-comparative Cohort ( QUALI Cohort)

acronym: QUALI

summary: The aim of this study is to describe the impact of : Geriatric intervention contribution on quality of life of elderly patients receiving systemic treatments for metastatic neoplasia

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Non Invasive Prenatal Diagnosis on Isolated Circulating Fetal Trophoblastic Cells (CFTC) for Monogenic Diseases

acronym: DIAFEXOME

summary: The purprose of this study is to develop a single test based on circulating fetal trophoblastic cells (CFTC) analysis from maternal blood, searching for the familial mutation for a wide range of monogenic diseases.

lead_sponsor: University Hospital, Montpellier

intervention_type: Genetic


title: Primary Prevention ICD Implantation in STEMI With Severe Left Ventricular Dysfunction : Input of Early Cardiac MRI in Order to Predict Left Ventricular Recovery

acronym: STEMI-MR

summary:
Patients presenting with STEMI and late revascularization can suffer from severe left ventricular dysfunction. Midterm and longterm mortality can be determined by the risk of fatal ventricular arrythmias. For this specific population, ESC guidelines currently recommend a waiting period of up to 40 days after a STEMI with severe left ventricular dysfunction before considering ICD implantation for primary prevention of sudden death.This delay is allocated to judge left ventricular recovery.

This study aims to see whether early cardiac MRI with specific sequences can help predict which patients will most probably not recover their left ventricular function and benefit from earlier ICD implantation.

ReferenceCitation: Daly C, Kwong RY. Cardiac MRI for myocardial ischemia. Methodist Debakey Cardiovasc J. 2013 Jul-Sep;9(3):123-31. Review.

ReferenceCitation: Perazzolo Marra M, Lima JA, Iliceto S. MRI in acute myocardial infarction. Eur Heart J. 2011 Feb;32(3):284-93. doi: 10.1093/eurheartj/ehq409. Epub 2010 Nov 25. Review.

ReferenceCitation: Schelbert EB, Wong TC. Imaging the area at risk in myocardial infarction with cardiovascular magnetic resonance. J Am Heart Assoc. 2014 Aug 21;3(4). pii: e001253. doi: 10.1161/JAHA.114.001253.

ReferenceCitation: Haaf P, Garg P, Messroghli DR, Broadbent DA, Greenwood JP, Plein S. Cardiac T1 Mapping and Extracellular Volume (ECV) in clinical practice: a comprehensive review. J Cardiovasc Magn Reson. 2016 Nov 30;18(1):89. Review.

ReferenceCitation: Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimský P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393.


title: Comparison of Haemodynamic Effects During Orotracheal Intubation, by Direct or Indirect Laryngoscopy With Airtraq, Controlled, Prospective, Randomized, Simple-blind, Monocentric Study at the Lille University Hospital Specialties Block.

acronym: HEMODAIRTRAQ

summary:
News techniques of intubation by indirect laryngoscopy have arrived in operating rooms but they are still too restricted to situations (difficult intubation criteria ..). It wanted to focus on indirect laryngoscopy by Airtraq. This technique allows better exposure during intubation while limiting mouth opening and cervical hyper extension, but also dental trauma and lip wounds. It also reduces the duration of laryngoscopy and therefore at the same time the apnea time. After a review of the literature, it has been proven that its use reduces haemodynamic changes during intubation. But these studies have been realized only in very particular patients (obese, heart failure) and with induction protocols that are not used routinely in our operating theaters.

Reasons why it decided to carry out this study, on the one hand to find these results and especially to be able to extend them to the whole population.


title: Screening of Obstructive Sleep Apnea by Smartphone Homemade Video in Childood Snoring Population

acronym: SMARTSAS

summary: The aim of the study is to evaluate the value of a video recording of the child sleep on smartphone made by the parents and comparing it to ventilatory polygraphy (PV) on the one hand and to the clinical evaluation method (clinical examination + Spruyt and Gozal score) on the other hand.

ReferenceCitation: Pateron B, Marianowski R, Monteyrol PJ, Couloigner V, Akkari M, Chalumeau F, Fayoux P, Leboulanger N, Franco P, Mondain M. French Society of ENT (SFORL) guidelines (short version) on the roles of the various treatment options in childhood obstructive sleep apnea-hypopnea syndrome. Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Aug;135(4):265-268. doi: 10.1016/j.anorl.2018.04.005. Epub 2018 May 3.

ReferenceCitation: Spruyt K, Gozal D. Screening of pediatric sleep-disordered breathing: a proposed unbiased discriminative set of questions using clinical severity scales. Chest. 2012 Dec;142(6):1508-1515. doi: 10.1378/chest.11-3164.

ReferenceCitation: Nguyên XL, Lévy P, Beydon N, Gozal D, Fleury B. Performance characteristics of the French version of the severity hierarchy score for paediatric sleep apnoea screening in clinical settings. Sleep Med. 2017 Feb;30:24-28. doi: 10.1016/j.sleep.2016.01.021. Epub 2016 Mar 14.

ReferenceCitation: Sivan Y, Kornecki A, Schonfeld T. Screening obstructive sleep apnoea syndrome by home videotape recording in children. Eur Respir J. 1996 Oct;9(10):2127-31.

ReferenceCitation: Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, Marcus CL, Mehra R, Parthasarathy S, Quan SF, Redline S, Strohl KP, Davidson Ward SL, Tangredi MM; American Academy of Sleep Medicine. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012 Oct 15;8(5):597-619. doi: 10.5664/jcsm.2172.


title: Construction and Validation of a Simplified Provocation Tests for the Diagnosis of Non Steroidal Anti-inflammatory Drugs (NSAID) Hypersensitivity

acronym: NSAID

summary:
Background : Non steroidal anti-inflammatory drugs are responsible for 25% of reported adverse drug events which include immunological and non-immunological hypersensitivity reactions. NSAIDs have been reported to be the second most common cause of drug-induced hypersensitivity reaction (DHR). They are almost mandatory in a human life and therefore, the drug allergy work-up goes up until a DPT in order to confirm or rule out the diagnosis.

Objective: Detect eliciting dose thresholds during NSAIDs DPT in order to suggest optimal step doses and to describe subgroups at higher risk during the DPT

Methods:This retrospective study, using the survival analysis, comprised all patients who attended the allergy service of the UH of Montpellier from 1997 till 2017 with a clinical history related to NSAIDs DHR, who underwent NDAIDs DPT that turned positive and who gave their consent to be included in the study . The Patients are selected from the Drug Allergy & Hypersensitivity Database (DAHD).


title: Study of Peripartum Haemostasis and Effects of Tranexamic Acid in Caesarean Delivery: Biologic Ancillary Study in TRAAP2 Patients Recruited at the Bordeaux University Hospital: BIO-TRAAP

acronym: BIO-TRAAP

summary: The aim of the study is to evaluate haemostasis and fibrinolysis in peripartum of caesarean delivery and the effect of tranexamic acid (TXA) given in prevention of post-partum haemorrhage (PPH).

lead_sponsor: University Hospital, Bordeaux


title: Intraoperative Ventilatory Leak Flow to Predict Prolonged Alveolar Air Leak After Lung Resection Surgery: a Prospective Study

acronym: AIR-LEAK

summary:
After lung resection surgery, patients usually receive a postoperative pleural drain. Prolongated alveolar air leak (PAAL) is a frequent complication after lung surgery (6 to 26% of patients), defined by the European Society of Thoracic Surgeons (ESTS) as a duration of drainage greater than or equal to five days. PAAL is most often due to prolongated bubbling of the drain. Prolonged drainage is a leading cause of prolongated hospital stay, increasing care costs.

The risk of prolongated drainage can not be predicted with sufficient accuracy. Existing risk scores for PAAL do not take into account the intraoperative ventilatory leakage (IVL). IVL is a parameter displayed on the ventilator (anaesthetic machine that make the patient breathing during surgical procedure). There is new evidences suggesting that IVL could predict the risk of PAAL after lung resection surgery, but these data have to be supplemented by a well conducted prospective study.


title: Does Energy Replacement Modify Post-exercise Energy Intake in Adolescents With Obesity?

summary: The aim of the present study is to compare the effect of an exercise alone versus. An exercise followed by the ingestion of an energy replacement snack on the following energy intake, food reward and appetite feelings in adolescents with obesity.