title: Evaluation of 3D Selection Tasks in Parabolic Flight Conditions: Pointing Task in Augmented Reality User Interfaces

summary: During a space mission the crew has to perform a wide variety of tasks under different acceleration conditions. For handling of displays and control items during a mission, the astronaut's performance is strong depended on an intuitive usability. Currently investigators are exploring and developing different Augmented Reality interfaces for the International Standard Payload Rack (ISPR) Biolab that is installed in the International Space Station (ISS) module Columbus. Augmented reality (AR) is a live, direct or indirect, view of a physical, real-world environment whose elements are augmented by computer-generated sensory input such as sound, video, graphics or GPS data. Using AR technologies provides user-oriented support for working procedures in development, production, and operating of complex technical products and systems. It is conceivable that in future manned missions such interfaces will be applied to space operations, where the astronaut will handle virtual information that enriches the physical reality. To improve the support for the operational ground team and the space crew by performing service and maintenance tasks at the Columbus space laboratory Biolab, investigators explore innovative tridimensional (3D) interaction techniques that allow an intuitive way to interact with the virtual content. The developed AR interfaces for the ISPR Biolab ought to offer support while handling standardize service and maintenance procedures. This research is primarily focused on supporting the ground team during their work at the engineering model of Biolab that is located in Cologne at the Institute of Aerospace Medicine. Applying these interfaces subsequently to space operations requires previous exploration regarding the influence of different acceleration conditions that ought to be considered at the investigators' current stage of designing and development. Thereby one important aspect is focused on the correct placement of virtual user interfaces while interacting with it. To explore human adaption of handling and controlling virtual AR interfaces, this experiment denotes a usability study that will supply findings about human mental workload and sensorimotor coordination while performing the experimentation task under different accelerations of gravity. The proposed experiment will supply essential information about understanding the adequate quality characteristics concerning placement of virtual interfaces in physical reality and identify disturbing factors while applying in hyper-g and micro-g conditions.


title: The Effect of Gravity on the Muscular Control of Landing From a Jump

acronym: SLS-JUMP

summary:
In this project, investigators propose to study the jump in different reduced gravity fields obtained during parabolic flights profiles but also during increased gravity fields obtained during turns of the airplane or during the pull-up phase of the parabola. By means of a pneumatic device, an additional pull-down force will be added to the vertical force caused by the gravity field. By combining different levels of gravity to different levels of the added pull-down force it will be possible to dissociate the respective contribution of the otolithic and proprioceptive systems to the anticipatory landing response. To the investigators' knowledge, only one study has modified the gravity field during a jump. However, these authors did not add a pull-down force and only analyzed the vertical ground reaction force.

A better knowledge of the sensory-motor control of the landing phase of a jump will also increase the investigators' understanding of the physiopathology of joint instability. Indeed, similarities could be found between the evolution of the motor response due to the absence gravity during long-duration space flights and the pathological process of chronic ankle and knee instability. The knowledge generated by this study will thus provide invaluable information in the context of human performance and rehabilitation.

status: Unknown status

study_type: Interventional

primary_purpose: Basic Science

enrollment_type: Anticipated

lead_sponsor: University Hospital, Caen

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: Bariatric Surgery for Obese Patients With Chronic Renal Insufficiency

acronym: BOKID

summary:
The creatinine clearance will be measured using two consecutive 24 hour urine collections, with the objective of minimizing errors due to poor quality urine collection.

The GFR will be measured by a reference method, because its estimation from blood creatinine levels (eGFR) by the MDRD study formula may be confounded by variations in muscle mass, and therefore creatinine production, following bariatric surgery. The method will remain the same in each center, and therefore consistent for any given patient, throughout the duration of the study. The GFR measurements will be performed after stopping any medication blocking the RAAS, and reducing diuretics for one week, with the introduction or increase of alpha-blockers or centrally-acting hypotensive agents. If it is impossible to stop RAAS-blockade (heart failure), the dose will at least be reduced for one week. This precaution is required to minimize the bias of functional renal insufficiency because the state of extracellular hydration is difficult to assess in obese subjects. Subsequent measurements of GFR will be performed in the same way.

The choice of the tracer to measure GFR may vary according to study center. 51Cr-EDTA, 99Tc-DTPA, iohexol or inulin may all be utilized. Because the assessment of edema is hazardous in extremely obese patients and because kidney disease favors edema formation, the simplified single injection method and the determination of plasma clearance measurement of the tracer is not reliable . Only the constant infusion method will be used to measure GFR. Briefly, GFR will be determined by calculating the glomerular clearance (Cl) from plasma concentrations (P) and renal excretions per unit of time (UxV) during infusion at a constant plasma level of the tracer (Cl=UxV/P). The result will be given as mean value of several consecutive clearances. Because correct urine collection is key for the procedure, seven collection periods (instead of 5 usually) will be performed for the calculation of the mean clearance. Bladder catheterization will be used only when it can be anticipated that the patient will not void satisfactorily. In the last 30 consecutive patients with mGFR below 60 ml/min/1,73m2, this occurred twice and the subjects were 70 and 79 years old. Therefore, this might occur exceptionably in the study. Raw data from each center will be sent to the coordination center (Nice) to examine and validate the calculation of mean clearance values. To that aim, extreme and non-representative clearances will be excluded. At least 3 of the 7 periods will be taken into account to calculate the mean values. For instance, in the last 30 consecutive patients with mGFR below 60 ml/min/1,73m2, investigators considered on average 4.7 periods and obtained a mean non-indexed GFR value of 40,7 ± 2,5 ml/min.

Primary assessment will be performed at one year, as a previous study has already suggested a significant benefit within this period [66], and because surgery can't be delayed further in these patients strongly expecting the intervention, but follow-up will be extended to three years or until the end of the study, in order to document whether the initial benefits of surgical intervention are maintained.

A reduction in the absolute value of measured GFR (mGFR) following bariatric surgery is expected in the first six months after surgery (M0 - M6). However, the weight loss may allow an increased in mGFR indexed to body surface area up until M6, and above all towards M12.
the investigators expect a subsequent stabilization of mGFR between M12 and M36 in the bariatric surgery group, and will seek to measure the anticipated reduction in mGFR in the control group who remain in a state of glomerular hyperfiltration.

All relevant cardiovascular, metabolic and nutritional parameters necessary to study the risk/benefit ratio of the intervention will be analyzed.

Primary: bariatric surgery slows the progression of chronic kidney disease in the obese.
Secondary: bariatric surgery improves survival, cardiovascular prognosis, metabolic, nutritional and inflammatory parameters, quality of life, and access to transplantation in the sub-group of patients whose GFR < 20ml/min/1.73m2 at inclusion, and there could be a chance loss for the patients in delaying surgery by one year.

study_start_date_type: Actual

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Procedure


title: Interest of Combining Speech Therapy With a Non-invasive Brain Stimulation (tDCS) for the Aphasic Patient

acronym: Taph

summary: Aphasia is a frequent symptom after a left hemisphere stroke. It has serious impacts on social, family and professional lives. Aphasic patients need to be rehabilitated. To date, no pharmacological treatment being available only speech and language therapy (SLT) can improve patients, but its efficiency is moderate. Several studies have investigated the link between the recovery of language and neural reorganization. tDCs, a noninvasive technology for modulating neural excitability, could potentiate the effects of the SLT. About 25 studies in literature have described beneficial effects of tDCs coupled with SLT on aphasic patients. However to the investigator knowledge the feasibility of tDCs and speech therapy in clinical pathways has never been investigated. That is why the investigator propose to study in real care conditions how SLT proves more efficient on the recovery of language in a discursive assessment when coupled with active stimulation than with placebo stimulation.

primary_purpose: Treatment

ReferenceType: result

ReferenceCitation: Greener J, Enderby P, Whurr R. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2000;(2):CD000425. Review. Update in: Cochrane Database Syst Rev. 2010;(5):CD000425.

ReferenceCitation: Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3:633-9.

ReferenceCitation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving aphasia in patients with aphasia after stroke. Cochrane Database Syst Rev. 2015 May 1;(5):CD009760. doi: 10.1002/14651858.CD009760.pub3. Review. Update in: Cochrane Database Syst Rev. 2019 May 21;5:CD009760.

name: Technical University Dresden; Department of Public Health, Dresden Medical School; Fetscherstr. 74 Dresden Sachsen Germany 01307

family: Elsner

full_name: Bernhard Elsner

given: Bernhard

sequence: first

family: Kugler

full_name: Joachim Kugler

given: Joachim

sequence: additional

name: Klinik Bavaria Kreischa; Abteilung Neurologie und Fachübergreifende Rehabilitation; An der Wolfsschlucht 1-2 Kreischa Germany 01731

family: Pohl

full_name: Marcus Pohl

given: Marcus

name: Private Europäische Medizinische Akademie der Klinik Bavaria in Kreischa GmbH; Wissenschaftliches Institut; An der Wolfsschlucht 1-2 Kreischa Germany 01731

family: Mehrholz

full_name: Jan Mehrholz

given: Jan

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Robey RR. A meta-analysis of clinical outcomes in the treatment of aphasia. J Speech Lang Hear Res. 1998 Feb;41(1):172-87.

ReferenceCitation: Klippi A, Sellman J, Heikkinen P, Laine M. Current clinical practices in Aphasia Therapy in Finland: challenges in moving towards national best practice. Folia Phoniatr Logop. 2012;64(4):169-78. doi: 10.1159/000341106. Epub 2012 Oct 25.

family: Klippi

full_name: A. Klippi

given: A.

family: Sellman

full_name: J. Sellman

given: J.

family: Heikkinen

full_name: P. Heikkinen

given: P.

family: Laine

full_name: M. Laine

given: M.

journal_name: Folia Phoniatrica et Logopaedica

publisher: S. Karger AG

publisher_dissemination: S. Karger AG

publisher_group: S. Karger AG

publisher_normalized: S. Karger AG

title: Current Clinical Practices in Aphasia Therapy in Finland: Challenges in Moving towards National Best Practice

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

intervention_type: Device

lead_sponsor_type: industriel


title: Identification and Quantification of a Mechanical Hyper-synchronicity State in Hypertrophic Cardiomyopathy (HCM) With Left Outflow-tract Obstruction and Description of Its Electrical and Electro-mechanical Characteristics Thanks to an Innovative Multi-imaging Approach to Predict a Positive Response to Dual Chamber Pacing. The Hsync Study.

acronym: HSYNC

summary:
Hypertrophic cardiomyopathy (HCM) is a common genetic cardiovascular disease. Outflow-tract gradient of 30 mmHg or more under resting conditions is an independent determinant of symptoms of progressive heart failure and death.

The investigators hypothesize that the electrical approach by dual chamber pacing could improve symptoms and reduce outflow-tract obstruction in a specific sub-group of selected patients with a mechanical hyper-synchronicity. The aim of the study is to identify and describe this phenomenon in HCM with (O-HCM) and without (NO-HCM) outflow-tract obstruction thanks to innovative multi-imaging approach.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Bordeaux


type: Registry Identifier

title: Efficacy of Deep Transcranial Magnetic Stimulation (TMS) for Treatment-resistant Depression and Neuroanatomical Correlates: a Randomized Clinical Study Coupled With Positon Emission Tomography (PET)

summary:
Repetitive transcranial magnetic stimulation (TMS) is an emergent non-invasive treatment for treatment resistant depression (TRD). The exact neuro-functional mechanisms related to TMS efficiency remains however unknown; besides local effect on the target, TMS may induce interaction changes between remote cerebral regions. On the other hand, few studies have been performed in comparison to sham placebo stimulation. The investigators recently showed that non-responder depressive patients to TMS exhibited deeper and wider brain functional abnormalities hardly reachable by standard coils. The H1-Coil is a novel TMS (H-TMS) device capable of inducing a magnetic field with a deeper and wider distribution than standard coils.

The investigators design here a randomized controlled study in which the investigators will compare the clinical effects of H-coil TMS and standard TMS in patients with TRD, and their functional neuroanatomical correlates and changes in connectivity by Positron Emission Tomography (PET). The general objective is to better understand the mechanisms related to TMS efficiency in pharmacoresistant depression, in order to propose the best therapeutic approach for the patient.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: STT Study : Pediatric Follow-up of Children's From Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome

acronym: STT

summary:
The twin pregnancies monochorionic are specifically explained to two main types of complications: the anomalies of the embryo affecting a symmetry and in particular the median line on one hand and malformative sequences of vascular origin on the other hand. This last category of anomalies (twin-to-twin syndrome, TTTS) develops because of the presence of a division of the foeto-placentary circulation between both twins through the pooling of certain placentary cotyledons. The latter are then vascularized by an arterial and venous foot belonging to both foetuses (anastomoses arteria-venous or veinous-arterial). It results from it an imbalance moderate but very early hemodynamic which is going to return a hypovolume twin (the donor) and its plethoric co-twin (the recipient).

These anomalies in utero could not only have consequences during the fetal life, on the born weight and the later development of newborns, but also on the organization and the functioning of a whole series of physiological systems. So these anomalies of the pregnancy could have also consequences which exceed by very far from the perinatal period, by favoring the development of the atheroma, the high blood pressure, the resistance in the insulin, and many other metabolic and endocrine functions were known for their importance in human pathology.

For these reasons the investigators suggest estimating the tensional, cardiac and metabolic status of children ex-transfusers and of children ex-transfused in 2 different age classes: between 4 and 8 years then when these children will have between 12 and 16 years.

There are also some evaluation clinical and biological of the puberty (only at the age of 12-16)

To understand a possible effect of the prenatal status of these children on the endocrinology of the puberty, the measures and the following dosages will be realized:

Test in the GnRH (T0, T30, T60, T90): dosages of LH and FSH (relationship of peaks to determine the puberty evolution),
Dosages of the sexual steroids, the oestradiol for the girl and the testosterone for the boy,
Clinical examination looking for the signs of puberty

This if study leans on the big originality of the physiopathological model of TTTS in which the children present the peculiarity to have an identical genetic and postnatal status and a different prenatal environment.

The follow-up of these children should allow:

To understand better the postnatal impact anomalies on these children in the course of pregnancy
To anticipate and thus to improve their care in case of appearance of biological or clinical signs

status: Active, not recruiting

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

status_simplified: Ongoing


title: A Phase III Study, Randomized, to Evaluate the Reduction of Chemotherapy Intensity in Association With Nilotinib (Tasigna®) in Philadelphia Chromosome-positive (Ph+) ALL of Young Adults (18-59 Years Old) (GRAAPH-2014)

summary: The Primary objective is to assess the non-inferiority of the experimental arm (arm B) compared to the control arm (arm A) in terms of Major Molecular Response (MMolR) after the 4th cycle (MRD4) in patients aged 18-59 years old with de novo Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL)

status: Recruiting

intervention_type: Drug


title: Comparison of the PillCamCOLON (C2) Capsule With Standard Endoscopy for the Evaluation of the Severity and the Endoscopic Healing of Patients With Ulcerative Colitis (UC)

summary:
Ulcerative colitis (UC) is an inflammatory bowel disease progressing through flare-ups. The therapeutic objective, which was originally based on clinical remission, is currently evolving with the development of biotherapies towards the achievement of endoscopic remission. Current recommendations for therapeutic management advocate the achievement of endoscopic mucosal healing (EMH), with an observed decrease in the necessity for colectomy in the case of EMH. Endoscopic evaluation of the severity of UC is performed during a digestive endoscopy (colonoscopy for a complete colonic exploration, or recto-sigmoidoscopy for a partial exploration of the colon) from endoscopic activity scores adapted for UC.

Currently, the score the most commonly used is the MAYO endoscopic score. This is a global score of increasing intensity from 0 to 3, taking into account the following basic lesions: vascular pattern, granularity or/and friability of the mucosa, spontaneous bleeding, erosion and ulceration. However this score has limits: it does not distinguish deep cavitating ulcerations with mucous detachment from simple ulcerations which have a better prognosis.

A new endoscopic score specific for UC has been developed and is currently being validated. It is termed Ulcerative Colitis Endoscopic Index of Severity (UCEIS). This evaluation takes into account the three most reproducible factors - the vascular pattern, the presence of bleeding, and erosions or ulcerations including cavitating ulceration - in the total score.

To ensure optimal patient care and an adaptation of the therapeutic medical care to the endoscopic severity of the disease, endoscopic exploration should be performed recurrently. However, this exploration is an invasive procedure, requires general anaesthesia for colonoscopy, and can lead to potential complications such as perforation. This explains the poor acceptance by patients, resulting in a sub-optimal therapeutic support.

lead_sponsor: Dr. Arnaud Bourreille


title: Evaluation of Spinal Mobility Reeducation in Patients Treated for a Lumbar Spinal Stenosis After Epidural Infiltration. Randomized and Comparative Study: Kyphosis Reeducation Versus Spinal Mobility Reeducation

acronym: CLEMOB

summary: In actual practice the patients with mild or moderate lumbar spinal stenosis symptoms receive an epidural infiltration and participate in kyphosis reeducation in first intention. Yet the kyphosis reeducation did not show a real profit in the time compared with the natural evolution of the pathology. The study assume that the spinal mobility reeducation will reduce the incidence of pain recurrences compared with the classic kyphosis reeducation.

status: Terminated

study_completion_date_type: Actual

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Berney J. [Epidemiology of narrow spinal canal]. Neurochirurgie. 1994;40(3):174-8. French.

ReferenceCitation: Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007 May 31;356(22):2257-70.

ReferenceCitation: Yamashita K, Ohzono K, Hiroshima K. Five-year outcomes of surgical treatment for degenerative lumbar spinal stenosis: a prospective observational study of symptom severity at standard intervals after surgery. Spine (Phila Pa 1976). 2006 Jun 1;31(13):1484-90.

ReferenceCitation: Rillardon L, Guigui P, Veil-Picard A, Slulittel H, Deburge A. [Long-term results of surgical treatment of lumbar spinal stenosis]. Rev Chir Orthop Reparatrice Appar Mot. 2003 Nov;89(7):621-31. French.

ReferenceCitation: Lieberman I. Surgery reduced pain and disability in lumbar spinal stenosis better than nonoperative treatment. J Bone Joint Surg Am. 2007 Aug;89(8):1872.

location_facility: University Hospital of Bordeaux - Hospital Pellegrin


title: Coding and Memorisation of Phonologic Information Among Preschool and School Children With Oral Language Developement Disorder.

acronym: MEMENTO

summary:
The disorder of oral language development is defined by the delay in language acquisition in children who possess efficient auditory acuity and normal non verbal intellect.

The diversity of language developement disorders depends either in the expressive level or in the receptive level leading to divers syndromes and symptoms. These syndromes and symptoms are regrouped under the name of STOL (Specific Troubles of Oral Language).

In the current project the visual exploitation and learning capability of children presenting a STOL condition will be compared to patients with a normal development. The investigator's hypothesis is as follows: STOL patients for whom the STOL disorder is reduced between 4 and 7 years of age will present a better performance at verbal memorisation, compared to patients with a persistent STOL condition after the age of 6.

time_perspective: Prospective

lead_sponsor: Lille Catholic University


title: Assessment of Body Composition Via Dual-energy X-ray Absorptiometry Bone Densitometry: Cross Calibration and Reproducibility Between the "Stratos DR" and "Discovery A" Bone Densitometers

acronym: STRATOS

summary:
The main objective of this study is to validate the measurement characteristics of a new bone densitometer, the Stratos DR:

Via cross calibration to the results of body composition (BC) measurement results to those of a reference device (the "Discover A" by Hologic) in terms of body fat percentage, lean mass percentage of total body mass and for different subregions (left and right arms, left and right sides, lumbar and thoracic spine, pelvis, left and right legs, head, android area, gynecoid area, visceral region).
And by the evaluation of the reproducibility of the BC measurement results in terms of fat mass and lean mass.

status: Completed

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

status_simplified: Completed


title: Evaluation of an Algorithm for Identifying Persistent Nasal Staphylococcus Aureus Carriage in a Cohort of Healthy Volunteers and Patients Regularly Monitored at the CHU of Saint-Etienne

acronym: ScreenStaph

summary:
The nasal carriage of Staphylococcus aureus is a major risk factor of S. aureus infection, notably in hemodialysis patients (HPs). Decolonization strategies were shown able to reduce the rate of S. aureus infection in this category of patients although the risk of emergence of antimicrobial resistance persists. Approximately one quarter of the general population is colonized by S. aureus in the anterior part of the nostril (vestibulum nasi). Three main categories of nasal carriers have been historically identified: persistent carriers (20%, 12-30%]), intermittent carriers (30%, [16-70%]) and non-carriers (50% [16-69%]). By contrast to intermittent carriers and non-carriers, persistent nasal carriers have a higher risk of S. aureus infection, especially in continuous peritoneal dialysis and in orthopedic surgery.

Persistent carriers are characterized by a higher nasal bacterial load, a longer duration of carriage, a lower rate of exchange of S. aureus strains, and a particular affinity for the carried strain. However, there is no consensual definition of this persistent carriage state. In previous studies, 5 to 12 nasal sampling episodes were realized for a period ranging from 5 weeks to 8 years. The index of carriage, corresponding to the number of samples positive for S. aureus divided by the total number of samples, has been proposed to standardize the definition of the carriage state. According to standard tools, it is almost impossible to determine the nasal carriage state in routine practice.

Recently, an algorithm based on one or two quantitative cultures from nasal samples taken within 2 days that was able to distinguish accurately persistent and non-persistent nasal carriers of S. aureus has been described; only one nasal sample was needed in more than 9 cases out of 10. The aim of the present study was to assess prospectively the reliability of this algorithm in clinical practice in a cohort of healthcare workers (HCWs) and HPs and to check its ability for identifying patients with the highest risk of S. aureus infection

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: A Prospective Pilot Study to Evaluate a New Marker of Ischemia in Chest Pain Triage

summary:
A Single-center prospective pilot study enrolling chest pain patients. CD 26 measurement will be performed and compared to troponin µs for early triage of these patients. This novel biomarker of myocardial ischemia (CD26) will be measured at the time of first medical contact (T0) and after 30 min simultaneously o troponin Ic.

All patients aged over 18 years with chest pain which may be related to acute coronary syndrome requiring pre hospital medical contact through the Emergency Medical Service.

location_facility: Assistance Publique Hopitaux de Marseille


title: Impact of [68 Ga]-DOTANOC PET-CT on the Management of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): Prospective, Multicentric Study.

acronym: GEP-NOC

summary:
Somatostatin receptors are overexpressed in GEP-NETs and can be visualized in vivo by radiolabeled somatostatin-analogs.

During the last decades, conventional scintigraphy using 111In-DTPA-Octreotide (often named somatostatin receptor scintigraphy or SRS) was considered as the gold standard nuclear imaging technique in the evaluation of GEP-NETs. However, SRS may be suboptimal in this clinical setting because of the low intrinsic resolution of the technique and its selectivity for SST2 only. Its overall sensitivity is estimated to 60-70% (per lesion analysis), even when using the most recent SPECT-CT cameras. MRI have also a higher sensitivity than CT and SRS for the detection of liver metastases from GEP-NETs.

In recent years, positron emission tomography (PET) imaging, a high resolution and sensitive technology, has gained an increasing role in oncology. It has also been evaluated in GEP-NETs with somatostatin agonists (SSTa) radiolabelled with Gallium-68 [68Ga], a positron emitter with very promising results. Its diagnostic sensitivity is clearly superior to SRS and many European centers have already replaced SRS by [68Ga]-PET-SSTa.

Currently, three different [68Ga]-coupled peptides can be used in trials: DOTA-TOC, DOTA-TATE and DOTA-NOC with excellent affinities for SST2 (IC50: 2.5; 0.2 and 1.9 nM, respectively). Sensitivities of DOTA-TOC and DOTA-TATE PET/CT are quite similar.

[68Ga]-DOTANOC which also binds to SST5 was recently found to detect significantly more lesions than the SST2-specific radiotracer [68Ga]-DOTATATE in patients with GEP-NETs but this requires further evaluation.

It is therefore important to determine the interest of [68Ga]-DOTANOC combined with the standard diagnosis strategy in GEP-NETs and evaluate medicoeconomic impact of adding [68Ga]-DOTANOC in the work-up of patients.

The investigators hypothesis is that [68Ga]-DOTANOC will modify the management in at least 20% of patients in a more adapted way according to the 2012 ENETS guidelines in comparison to the decision based on the standard imaging work up (multiphasic WB CT, liver MRI and SRS).

110 patients will be included prospectively in 5 different French experienced centers (Marseille, Bordeaux, Toulouse, Paris, Clermond-Ferrand).


title: Impact of Two Standardized Clinical Care Protocols on Pregnancy Outcomes in Women With Monogenic Diabetes MODY2

summary:
Maturity-onset diabetes of youth (MODY) are the most frequent monogenic diabetes with autosomic dominant inheritance (2% of diabetes). The MODY2 diabetes is related to a defect in the glucokinase (GCK) enzyme, the first limiting step of insulin secretion. An abnormal GCK leads to a delayed insulin secretion. Patients with GCK mutations have only mild raised fasting plasma glucose. Treatment is usually unnecessary since hyperglycemia is stable and MODY2 patients have no microvascular complications of diabetes. In contrast, pregnancy in MODY2 women is a challenging situation. A non-mutated fetus will produce excess insulin in response to raised maternal blood glucose leading to an accelerated growth and a higher risk of macrosomia. The mother of non-mutated fetus should therefore be treated to normalize her blood glucose levels. On contrary, a mutated fetus will produce a delayed insulin secretion (as his MODY2 mother) in response to maternal hyperglycemia. Consequently insulin therapy during pregnancy would reduce fetal insulin secretion and result in a low birth weight.

Moreover, insulin therapy exposes pregnant women to more labor induction, prematurity and cesarean deliveries. In these MODY2 women whose glucose set point is physiologically higher, glycemic goals are difficult to achieve while often requiring extensive insulin therapy. An optimal situation would consist in initiating insulin therapy only for women with non-mutated offsprings. Unfortunately no antenatal diagnosis of the GCK mutation on fetal cells is available yet. In literature, birth weight differences between mutated and non-mutated neonates may reach up to 700g. In clinical practice, two strategies are used but without standardized protocol on glycemic targets, delay and doses of insulin : 1) insulin at diagnosis of pregnancy 2) treatment based on fetal abdominal circumference and fetal weight measurements by ultrasonography (US) and initiated if fetal biometry is greater than the 75th percentile.

The purpose of the study is to evaluate for the first time these two management strategies through a prospective and standardized study. Hypothesis: US assessment would be sufficient to identify fetuses at risk of macrosomia and to initiate insulin treatment in mothers.

primary_purpose: Other


acronym: GANCIMVEAR

type: EudraCT Number

source: euctr

title: Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance

summary:
Congenital cytomegalovirus (CMV) infection is the leading cause of non-genetic neurosensory deafness and affects 0.5 to 1% of births. Twenty to thirty per cent of children will develop deafness, some of whom will progress gradually to profound bilateral deafness.

No curative treatment is currently offered for this deterioration in hearing and management involves the use of a hearing aid or cochlear implant. Many studies describe the utility of antiviral treatment on the course of the deafness. These mostly involve neonates with multi-system symptomatic forms of the infection who have been given 6 weeks of ganciclovir possibly switched to valganciclovir, which has shown benefit in stabilising auditory loss, or even improvement.


title: Peri-sphincter Injection of Autologous Myofibres to Treat of Urinary Incontinence by Sphincter Deficiency

acronym: IPSMA

summary:
Stress urinary incontinence related to intrinsic sphincter deficiency (ISD) is a severe form of incontinence that may have a major impact on the quality of life. The main treatment is surgical and consists in the implantation of medical devices such as the artificial urinary sphincter, adjustable continence therapy, compressive sling, or injection of bulking agent.

The investigator has developed a new therapeutic strategy for ISD that consist to implant myofibers with their attached satellite cells (the main source of muscle progenitor cells) at the vicinity of the striated urethral sphincter. The principle of this method relies on the in vivo activation of satellite cells leading to the formation of regenerated myofibers (myotubes) generating a distinct and tonic muscular activity . The proof of concept was investigated in a Phase I clinical trial: Investigator found that the periurethral implantation of myofiber strips around the urethra generated an electromyographic activity improving urethral closure pressure in women with severe urinary incontinence associated to ISD. In this previous study, the technique of myofiber implantation was invasive, as it required a surgical approach and dissection of the urethra to place the myofiber. For the clinical trial IPSMA, the investigator sought to optimize the myofiber transplantation process using a method injection of myofibers core obtained by hydro-dissection. The injection technique is performed percutaneously under fluoroscopic and endoscopic control and does not require a surgical approach of the urethra.

This clinical trial is prospective, open-label, non-randomized, uncontrolled, single-center for the first stage and multicenter for the second stage, of 13 months for each patient aims to assess the efficacy and safety of IPSMA in the treatment of urinary incontinence in women with ISD.

ReferenceCitation: Yiou R, Hogrel JY, Loche CM, Authier FJ, Lecorvoisier P, Jouany P, Roudot-Thoraval F, Lefaucheur JP. Periurethral skeletal myofibre implantation in patients with urinary incontinence and intrinsic sphincter deficiency: a phase I clinical trial. BJU Int. 2013 Jun;111(7):1105-16. doi: 10.1111/j.1464-410X.2012.11682.x. Epub 2013 Mar 7.

family: Yiou

full_name: René Yiou

given: René

family: Hogrel

full_name: Jean-Yves Hogrel

given: Jean-Yves

family: Loche

full_name: Catherine-Marie Loche

given: Catherine-Marie

family: Authier

full_name: François-Jerome Authier

given: François-Jerome

family: Lecorvoisier

full_name: Philippe Lecorvoisier

given: Philippe

family: Jouany

full_name: Pauline Jouany

given: Pauline

family: Roudot-Thoraval

full_name: Françoise Roudot-Thoraval

given: Françoise

family: Lefaucheur

full_name: Jean-Pascal Lefaucheur

given: Jean-Pascal

journal_name: BJU International


title: Feasibility Study of a Treatment Protocol of Pediatric Chemo- and Radiotherapy-induced Oral Mucositis by Low-level Laser Therapy

acronym: PEDIALASE

summary: Low Level Laser Therapy has been used for a few years in some pediatric hospital centers for chemo- and radiotherapy-induced oral mucositis care. It may promote ulceration's healing, limits mucositis severity and associated pain. As its use is recommended in the treatment of radio induced mucositis in adults, the level of evidence in pediatric studies does not allow a precise treatment protocol. The investigators present here the protocol of a feasibility study in the haemato-oncology department of the Children University Hospital of Toulouse, with the view to a future efficacy study.

ReferenceCitation: Qutob AF, Gue S, Revesz T, Logan RM, Keefe D. Prevention of oral mucositis in children receiving cancer therapy: a systematic review and evidence-based analysis. Oral Oncol. 2013 Feb;49(2):102-7. doi: 10.1016/j.oraloncology.2012.08.008. Epub 2012 Sep 7. Review.

ReferenceCitation: Sonis ST. Oral mucositis in head and neck cancer: risk, biology, and management. Am Soc Clin Oncol Educ Book. 2013. doi: 10.1200/EdBook_AM.2013.33.e236. Review.

ReferenceCitation: Glenny AM, Gibson F, Auld E, Coulson S, Clarkson JE, Craig JV, Eden OB, Khalid T, Worthington HV, Pizer B; Children's Cancer and Leukaemia Group (CCLG)/Paediatric Oncology Nurses Forum's (CCLG-PONF) Mouth Care Group. The development of evidence-based guidelines on mouth care for children, teenagers and young adults treated for cancer. Eur J Cancer. 2010 May;46(8):1399-412. doi: 10.1016/j.ejca.2010.01.023. Epub 2010 Mar 11. Review.

ReferenceCitation: Huang YY, Sharma SK, Carroll J, Hamblin MR. Biphasic dose response in low level light therapy - an update. Dose Response. 2011;9(4):602-18. doi: 10.2203/dose-response.11-009.Hamblin. Epub 2011 Sep 2.

ReferenceCitation: Bensadoun RJ, Nair RG. Low-level laser therapy in the prevention and treatment of cancer therapy-induced mucositis: 2012 state of the art based on literature review and meta-analysis. Curr Opin Oncol. 2012 Jul;24(4):363-70. doi: 10.1097/CCO.0b013e328352eaa3. Review.

lead_sponsor: University Hospital, Toulouse


title: Interest of Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity by Transepithelial Brushing in Liquid-based

acronym: Cytobuccale

summary:
Prospective study of diagnosis validation of a cytological technique. 200 patients with oral cavity cancerous and precancerous lesions will be enrolled.

A cytological sample of the lesion will be performed by transepithelial brushing ( Orcellex® Rovers brush) in cytology liquid-based technology (methode ThinPrep 2000 (Hologic®)). A microscopic double blind reading will be performed. A biopsy sampling will be carried out in accordance with current strategy of screening. The brushing diagnosis quality will be compared to the biopsy which is the gold standard.

primary_purpose: Screening


title: " Virtual Brain "-Based Interpretation of Electrophysiological Signals in Epilepsy

acronym: VIBRATIONS

summary:
Epilepsy is a major neurological disorder, affecting of the order of 0.5 to 1% of the population. It is a very invalidating disease, with high impact on quality of life. In a large proportion of cases, medication cannot prevent seizures; surgical removal of the regions responsible for seizures is then the only way to cure patients. However, results crucially depend on the correct delineation of the epileptogenic zone.

In this context, computational modeling, under the form of a "virtual brain" is a powerful tool to investigate the impact of different configurations of the sources on the measures, in a well-controlled environment.

In this project, the simulate in a biologically realistic way MEG (Magnetoencephalography) and EEG (Electroencephalography) fields produced by different configurations of brain sources, which will differ in terms of spatial and dynamic characteristics will be offered to participants. The research hypothesis is that computational and biophysical models can bring crucial information to clinically interpret the signals measured by MEG and EEG. In particular, the hypothesis can help to efficiently address some complementary questions faced by epileptologists when analyzing electrophysiological data.

The strategy will be three-fold:

i) Construct a virtual brain models with both dynamic aspects (reproducing both hyperexcitability and hypersynchronisation alterations observed in the epileptic brain) and a realistic geometry based on actual tractography measures performed in patients ii) Explore the parameter space though large-scale simulations of source configurations, using parallel computing implemented on a computer cluster.

iii) Confront the results of these simulations to simultaneous recordings of EEG, MEG and intracerebral EEG (stereotactic EEG, stereoelectroencephalography (SEEG)). The models will be tuned on SEEG signals, and tested versus the surface signals in order to validate the ability of the models to represent real MEG and EEG signals.

The project constitutes a translational effort from theoretical neuroscience and mathematics towards clinical investigation. A first output of the project will be a database of simulations, which will permit in a given situation to assess the number of configurations that could have given rise to the observed signals in EEG, MEG and SEEG. A second - and major - output of the project will be to give the clinician access to a software platform which will allow for testing possible configurations of hyperexcitable regions in a user-friendly way. Moreover, representative examples will be made available to the community through a website, which will permit its use in future studies aimed at confronting the results of different signal processing methods on the same 'ground truth' data.


title: 4D FLOW: Feasibility Study of a Sequence 4D of Flow Applied to the Cervico-encephalic Vascular Pathologies

summary:
The dynamic angio-MR sequences with injection of contrast (CE ARM) allow the study of the vascular anatomy. These sequences, widely used in clinical routine have shown their utility, in particular in the detection of the cerebrovascular diseases. The 4D flow MR sequences allow to quantify arterial parameters such as the speed of the circulating flow. By allowing an anatomical analysis and a functional analysis of quantitative parameters, 4D flow MR sequences could replace 1/ the currently used dynamic MRA sequences that are less precise in term of spatial and temporal resolution; 2/ the invasive exploration by DSA for the detection of vascular lesion and complete the exploration of the cervico-encephalic vascular pathologies by providing hemodynamical measures not yet accessible in clinical settings.

In this context, the aim of the study is to evaluate the feasibility and the clinical usefulness of this 4D Flow technique to image brain vascular disorders including steno occlusive disorders. The evaluation will include several steps: 1/ optimization of acquisition parameters for the cranio-cervical arteries; 2/ comparison of two strategies for the post-processing 3/ feasibility for imaging of brain vascular disorders.

lead_sponsor: Centre Hospitalier St Anne


acronym: Tgcyto

summary:
Cytological examination of punctured lymph nodes is the gold standard for confirming metastatic lymph node spread of differentiated thyroid cancers. In order to increase the diagnostic sensitivity of fine-needle cyto-punctured lymph nodes, an assessment of Tg levels of the aspirate could be included. Although this technique has been well proven, many uncertainties remain, especially with regards to a pathological cut-off value and its clinical utility when the thyroid is still intact. This uncertainty is mainly due to discordancy between low Tg levels found in cytopunctured lymph nodes with normal cytology, and their final histopathological analyses.

To eliminate this uncertainty, cyto-punction will be performed intra-operatively after localizing and isolating the target lymph nodes for assessment of cytology and Tg values. The thyroid gland might be present or absent (already operated) depending on the case. Finally, the cyto-punctured lymph nodes will be excised for complete histopathological analysis. In order to determine whether the Tg values are appropriate in cases where the thyroid is intact, a control group has been included (First operation for thyroid cancer or benign pathology). To eliminate the possible iatrogenic risks of lymph node dissection and resection in patients for whom it is not indicated, only lymph nodes found along the incision path for neuromonitoring of the recurrent laryngeal nerve (performed systematically) will be analysed and excised.


title: Prone Position Effects on Work of Breathing and Intrinsic PEEP in Children With Severe Acute Viral Bronchiolitis

acronym: BRONCHIO-DV

summary: Acute viral bronchiolitis is the first cause of respiratory distress in infant. Airway inflammation increases the respiratory system resistances and dynamic hyperinflation. This leads to an increase in the work of breathing. In Chronic obstructive pulmonary disease patients as in neonates, prone position (PP) improves lung function and decreases the end expiratory lung volume. The investigators hypothesized that in infants with severe bronchiolitis, prone position reduces the intrinsic Positive End Expiratory Pressure (PEEPi) and the work of breathing (WOB). The investigator designed a prospective randomized crossover study with 16 infants younger than six months who need ventilatory support by nasal continuous positive airway pressure (nCPAP) for severe acute viral bronchiolitis. Work of breathing (product time pressure) and PEEPi will be estimated using an esophageal pressure probe in prone and supine position.

ReferenceType: derived

ReferenceCitation: Baudin F, Emeriaud G, Essouri S, Beck J, Portefaix A, Javouhey E, Guerin C. Physiological Effect of Prone Position in Children with Severe Bronchiolitis: A Randomized Cross-Over Study (BRONCHIO-DV). J Pediatr. 2019 Feb;205:112-119.e4. doi: 10.1016/j.jpeds.2018.09.066. Epub 2018 Nov 14.

family: Baudin

full_name: Florent Baudin

given: Florent

family: Emeriaud

full_name: Guillaume Emeriaud

given: Guillaume

family: Essouri

full_name: Sandrine Essouri

given: Sandrine

family: Beck

full_name: Jennifer Beck

given: Jennifer

family: Portefaix

full_name: Aurelie Portefaix

given: Aurelie

family: Javouhey

full_name: Etienne Javouhey

given: Etienne

family: Guerin

full_name: Claude Guerin

given: Claude

journal_name: The Journal of Pediatrics

oa_host_type: repository

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Hospices Civils de Lyon


title: Study of Dendrogenin A / Oxysterols Balance Between Healthy Volunteers and Acute Myeloid Leukemia Patients. Modulations of the Balance During Cytarabine/Anthracycline Treatment - OxyLAM

acronym: OXYLAM

summary: Dendrogenin A is present in mammals normal tissues and fluids, notably blood. It is down-represented or absent in cancer cell lines and tumors. In the opposite, OCDO is accumulated in cancerous conditions and virtually absent of normal tissues. This study will try to determine modulations of these oxysterols and protein involved in their metabolism between Acute myeloid leukemia (AML) patient samples and normal blood or marrow, for evaluation of these markers as companion biomarkers for Dendrogenin A treatment.

intervention_type: Biological


title: Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy

summary: The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.

lead_sponsor: BBraun Medical SAS


title: PET-based Evaluation of Chemotherapy-induced Brain Damage in Lymphoma Patients -Implication in the Evaluation of Neuro-cognitive Function Alteration (LYMCOTEP)

acronym: LYMCOTEP

summary: Positron emission tomography (PET) with 18-fluoro-deoxy-glucose (PET-FDG) is emerging as a promising approach for detecting brain lesions in dementia, among which Alzheimer's disease has been the most widely studied.


title: Assessment of Breast Cancer Response to Neoadjuvant Anthracycline-based Chemotherapy by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) and Molecular Markers

summary:
A correlation between early changes in the tumor maximum standardized uptake value (SUVmax) on FDG-PET after one or two cycles of neoadjuvant chemotherapy (NAC) and the pathological response after 6 to 8 cycles has been demonstrated in several independent small series of patients.

Breast tumor proliferation status has previously been demonstrated to be a good predictive factor of response to chemotherapy. The best method for assessing proliferation status is unclear. Proportion of cells staining for nuclear Ki67 antigen is the most widely used assay for comparing the proliferation status between tumors. However major variations in analytical procedure and interpretation limited its clinical value. Taking into account the prognosis and predictive value of proliferation gene as a common "signature" in breast cancer transcriptome analysis, quantitative assessment of mRNA expression of genes involved in proliferation has been developed by the investigators team and others. The evaluation of these parameters is quantitative and reliable and can be standardized for a clinical use.

The main objective of the investigators study is to early predict pathological response to anthracycline-based neoadjuvant chemotherapy (NAC) using a combination of parameters based on FDG-PET imaging performed at baseline and after 2 cycles, and molecular markers of proliferation measured on pre-treatment biopsy (Ki67 protein level by immunohistochemistry and Ki67 mRNA level and the mRNA (messenger RNA) expression of the most pertinent genes of the Genomic Grade Index (GGI) component by RT (reverse transcriptase) - qPCR).


title: Improvement of Team Performance With a Pre-critical Staff Within the Team Prior to Admission of Critical Simulated Patient in High Fidelity Simulation Session for Anesthesiology Resident During Their Education Curriculum

acronym: Simstaf&perf

summary: Simulated environment allowed safe learning of critical events and knowledge of appropriate response and treatment. Anesthesiology resident education curriculum in Lyon plans several high fidelity simulation session with a large panel of critical events. Anticipation of critical events before they may occur and plannification of team resources and priority in the treatment strategy may help to improve team performance during the scenario. The investigators' goal is to compare team performance during the scenario with or without a liberal preparation team staff of 4 min, suggested after the briefing of the scenario but before the scenario starts.

ipd_sharing: Undecided

lead_sponsor: Claude Bernard University

intervention_type: Behavioral


title: Measured FiO2 With Nasal Canula O2 Versus Noninvasive Ventilation (NIV) With the Same O2 Flow, in COPD Patients the NIV LEAKS Study

acronym: NIVLEAKS

summary: The purpose of this study is to compare pharyngeal FiO2 in day time with nasal normobaric O2 with inhaled FiO2 in the night time with home care ventilator NIV at the same O2 flow.

ReferenceCitation: Cardinale M, Cungi PJ, Esnault P, Castagna O, Nguyen C, Daranda E, Bordes J, Arnal JM, Meaudre E, Goutorbe P. In COPD, Nocturnal Noninvasive Ventilation Reduces the FIO2 Delivered Compared With Long-Term Oxygen Therapy at the Same Flow. Respir Care. 2020 Dec;65(12):1897-1903. doi: 10.4187/respcare.07570. Epub 2020 Jul 21.

family: Cardinale

full_name: Michael Cardinale

given: Michael

family: Cungi

full_name: Pierre-Julien Cungi

given: Pierre-Julien

family: Esnault

full_name: Pierre Esnault

given: Pierre

family: Castagna

full_name: Olivier Castagna

given: Olivier

family: Nguyen

full_name: Cédric Nguyen

given: Cédric

family: Daranda

full_name: Erwan Daranda

given: Erwan

family: Bordes

full_name: Julien Bordes

given: Julien

family: Arnal

full_name: Jean-Michel Arnal

given: Jean-Michel

family: Meaudre

full_name: Eric Meaudre

given: Eric

family: Goutorbe

full_name: Philippe Goutorbe

journal_name: Respiratory Care

publisher: Daedalus Enterprises

publisher_dissemination: Daedalus Enterprises

publisher_group: Daedalus Enterprises

publisher_normalized: Daedalus Enterprises

lead_sponsor: Breas Medical S.A.R.L.


title: Characterization of Post-operative Pain Trajectories Over Seven Days and Their Potential Links With Chronicity After 3 Months: a Single-center, Prospective, Pilot Cohort Study at the Nîmes University Hospital

acronym: PATCH

summary: The main objective of this study is to establish the postoperative "pain pathways" observed from D1 to D7 in the context of the current management after orthopedic, digestive, obstetrics and gynecology, urology, neurosurgery, vascular and thoracicn surgeries.

ReferenceCitation: Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lantéri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. Epub 2005 Jan 26.

ReferenceCitation: Sullivan, M. J., Bishop, S. R., & Pivik, J. The pain catastrophizing scale: development and validation. Psychological assessment, 1995, 7(4), 524.

ReferenceCitation: L'Hermite J, Pagé MG, Chevallier T, Occean B, Viel E, Bredeau O, Lefrant JY, Cuvillon P. Characterisation of pragmatic postoperative PAin Trajectories over seven days and their association with CHronicity after 3 months: a prospective, pilot cohort study (PATCH study). Anaesth Crit Care Pain Med. 2021 Feb;40(1):100793. doi: 10.1016/j.accpm.2020.100793. Epub 2020 Dec 23.

family: L’Hermite

full_name: Joël L’Hermite

given: Joël

family: Pagé

full_name: M. Gabrielle Pagé

given: M. Gabrielle

family: Chevallier

full_name: Thierry Chevallier

given: Thierry

family: Occean

full_name: Bob Occean

given: Bob

family: Viel

full_name: Eric Viel

family: Bredeau

full_name: Olivier Bredeau

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

family: Cuvillon

full_name: Philippe Cuvillon

given: Philippe

journal_name: Anaesthesia Critical Care & Pain Medicine


title: Randomized, Double Blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics After Single Ascending Doses or Multiple Ascending Doses of OSCN-, bLF or ALX-009 in Healthy Male and CF and Non-CF Bronchiectasis Patients

summary: This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of a single ascending doses (SAD) and multiple ascending doses (MAD) of Hypothiocyanite (OSCN-), bovine lactoferrin (bLF) and their combination (ALX-009) in healthy male volunteers and patients suffering from cystic fibrosis (CF) and non-CF bronchiectasis (NCFBE).

lead_sponsor: Alaxia SAS


title: Evaluation of the Effectiveness of Self Management Program on Changes in Physical Activity Level of Knee Osteoarthritis Patients in Spa Therapy

acronym: GEET One

summary: The primary purpose is to evaluate the benefit of an education action of exercise on the level of physical activity in patients with knee osteoarthritis with the waning of a spa treatment for three weeks, three months after the start of the cure.

ReferenceCitation: Gay C, Guiguet-Auclair C, Pereira B, Goldstein A, Bareyre L, Coste N, Coudeyre E. Efficacy of self-management exercise program with spa therapy for behavioral management of knee osteoarthritis: research protocol for a quasi-randomized controlled trial (GEET one). BMC Complement Altern Med. 2018 Oct 16;18(1):279. doi: 10.1186/s12906-018-2339-x.

family: Gay

full_name: Chloe Gay

given: Chloe

family: Guiguet-Auclair

full_name: Candy Guiguet-Auclair

given: Candy

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Goldstein

full_name: Anna Goldstein

given: Anna

family: Bareyre

full_name: Loïc Bareyre

given: Loïc

family: Coste

full_name: Nicolas Coste

given: Nicolas

family: Coudeyre

full_name: Emmanuel Coudeyre

given: Emmanuel

currency_apc_doaj: GBP

journal_name: BMC Complementary and Alternative Medicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

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

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Clermont-Ferrand


title: PROGNOSTIC VALUE OF CIRCULATING TUMORAL FREE DNA Versus CIRCULATING TUMORAL CELLS IN PATIENTS WITH COLORECTAL CANCER STAGE II-III

acronym: CTC

summary:
After curative surgical resection, detection of metastatic lymph node remains the main prognostic validated criteria on which is based the decision of adjuvant therapy. To date, none of the molecular alterations, identified as potentially predictive factor, are used in routine for therapeutic decision. The circulating markers, either in the form of free circulating DNA or in the form of circulating tumoral cells seems important potential candidates. To investigators knowledge, only one study estimated with several interesting results the prognostic interest of a coupled detection of the free circulating mutant DNA (gene KRAS) and by the hypermethylation of the p16 gene. Definitive conclusions remain however difficult to achieve because of the small number of patient included (n=58) and the fact that this study included different stages. For colorectal cancer a Chinese team presented a series of results suggesting that the presence of CTC during the postoperative course is a factor significantly related to the risk of recurrence. In multivariate analysis integrating the lymph node status and the vascular invasion, the presence of CTC appeared as an independent factor for recurrence with a hazard ratio of 29.5.

The aim of the present study is to compare the prognostic value of two circulating tumoral markers KRAS point mutations and RASSF2A methylation (free tumoral DNA) and Circulating tumoral cells (CTC). The primary objective is to compare sensibility and specificity of two circulating markers (free tumoral DNA and tumoral cells) on 2 years disease free survival rate. Secondary objective is to confirm the prognostic value of circulating free tumoral DNA and circulating tumoral cells in localised colorectal cancer.

lead_sponsor: University Hospital, Rouen


title: Evaluation of the Metrological Characteristics of the Inertial Unit FOX HiKoB© in Comparison With the Reference System for the Adaptive Trigger System "Functional Electrical Stimulation" of Foot Elevators in Hemiplegic Post-stroke Patients

acronym: MASEA 2

summary: The main objective of this study is to evaluate the metrological characteristics of the data processing algorithms from inertial sensors (FOX © HiKoB) for the reconstruction of movement relative to the reference system (VICON) for measurement of dorsiflexion at the beginning of a step and in the middle of the oscillating phase.


title: Role of Epoxyeicosatrienoic Acids in Chronic Allograft Nephropathy

acronym: TRANSPLANTEETs

summary:
Endothelial lesions within the transplanted kidney are a major determinant of chronic allograft nephropathy. Epoxyeicosatrienoic acids (EETs) are endothelium-derived hyperpolarizing factors with anti-inflammatory, antiproliferative and vasodilator properties.

The main goal of the investigators' study is to evaluate whether genetic polymorphisms of specific enzymes responsible for the bioavailability of EETs are associated with post-transplant kidney function.

To this end, 80 kidney transplant recipients will be included. Prespecified genetic polymorphisms of CYP 2J2, CYP 2C8, CYP 2C9, CYP 2C9, CYP 2C19 and EPHX2 will be determined. Kidney function will be recorded 3, 6, 12 and 36 months after transplantation. Flow-mediated dilatation, EETs and circulating biomarkers of endothelial function will be measured in the radial artery.

The expected results of this study to provide preliminary evidence supporting a beneficial role of an increase in the bioavailability of EETs in kidney transplant recipients.


title: Evaluation of Post-voiding Residual Urine: a Before-after, Post-partum Study

acronym: RPM-Eval

summary: The primary objective of this study is to evaluate the impact of systematic catheter-drainage of urine for parturient women immediately in the delivery room on the occurrence of post-voiding urine residue.


acronym: RIPORT

title: Multicentric Randomized Study of Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis.

summary: Open randomized therapeutic study to assess the efficacy of Xarelto 15mg/day in the recurrence of thromboembolic event compared to an untreated group in patients with chronic portal vein thrombosis without high risk thrombophilia.


title: Non Invasive IDentification of Gliomas With IDH1/2 Mutation by Analysis of Circulating Plasmatic DNA, D-2-hydroxyglutarate Dosage in Biological Liquids and Detection by Brain SPEctro-MRI: Impact for Diagnosis and Follow-up

acronym: IDASPE

summary:
This trial develops a non invasive diagnostic approach of IDH1 mutated gliomas combining mutation detection from free plasmatic DNA, D-2HG dosage in urine samples, and D-2HG detection by Brain Spectro MRI.

In group 1 (25 patients), patients with presumed grade II-III gliomas candidate to surgery will undergo spectro MRI, plasma, urine dosages. Results will then be confronted to tumor mutational status and D-2HG.

In group 2 (15 patients), patients with known IDH1 mutation will undergo spectro MRI, plasma, urine dosages overtime in order to correlate results with the response to treatment.


title: An Open-label, Non-randomized, Multicenter, Two Stage Designed Phase II Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN)

acronym: AXIPAN

summary:
Axitinib (AXITINIB) is an oral, potent, and selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3 which has achieved objective response rate of 44.2% in phase II study in cytokine-refractory metastatic renal-cell cancer patients.

Pre-surgical treatment with Axitinib could allow a substantial proportion of patients with large organ confined tumors to benefit from NSS.

The Objective is to determine the efficacy of Axitinib administered prior to surgery in patients with large organ confined tumors not primarily suitable for NSS (cT2aNoNxM0) for shifting from a radical nephrectomy indication to a nephron sparing procedure.


title: Study of Cortical Excitability in Healthy Subjects With Transcranial Magnetic Stimulation (TMS) and a Neuronavigation Device

acronym: RC-TMS

summary:
This study has two main goals :

to investigate the impact of aging on cortical excitability (CE)
to investigate the impact of "state dependency" on CE, using a cognitive task and an emotional one.

A Neuronavigation system of transcranial magnetic stimulation is used, and electromyographic response are recorded.

lead_sponsor: University Hospital, Grenoble

location_facility: Department of Psychiatry & Neurology - University Hospital Grenoble


title: WittyFit - Live Your Work Differently

acronym: WittyFit

summary: Individuals spend one third of their life working. Age of retirement is regularly pushed back. The main challenge in the nearest future will be to maintain workers health to deal with their work till retirement. Morbidity before retirement has a huge cost, both in public health and economically for companies. Numerous factors increase morbidity such as stress at work, sedentary and low physical activity, and poor nutrition habits. Nowadays, digital world wildly invades lives and offer a no-limit possibility to interact with individuals, everywhere. Thus, a software able to understand an individual in its globality seems to address this challenge. Moreover, managers need to understand the actions needed within their company. The objective of WittyFit is to increase life expectancy and well-being. WittyFit will constitute a powerful database to build strong evidence and new knowledge on the relationships between work, behavior, and health, based on a large amount of epidemiological data.

ReferenceCitation: Sérole C, Auclair C, Prunet D, Charkhabi M, Lesage FX, Baker JS, Mermillod M, Gerbaud L, Dutheil F. The Forgotten Health-Care Occupations at Risk of Burnout-A Burnout, Job Demand-Control-Support, and Effort-Reward Imbalance Survey. J Occup Environ Med. 2021 Jul 1;63(7):e416-e425. doi: 10.1097/JOM.0000000000002235.

family: Serole

full_name: Claire Serole

given: Claire

family: Auclair

full_name: Candy Auclair

family: Prunet

full_name: Denis Prunet

given: Denis

family: Charkhabi

full_name: Morteza Charkhabi

given: Morteza

family: Lesage

full_name: Francois-Xavier Lesage

given: Francois-Xavier

family: Baker

full_name: Julien S. Baker

given: Julien S.

family: Mermillod

full_name: Martial Mermillod

given: Martial

family: Gerbaud

full_name: Laurent Gerbaud

given: Laurent

family: Dutheil

full_name: Frédéric Dutheil

given: Frédéric

bso_classification: Biology (fond.)

journal_name: Journal of Occupational & Environmental Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: The Forgotten Health-Care Occupations at Risk of Burnout – A Burnout, Job Demand-Control-Support, and Effort-Reward Imbalance Survey

ReferenceCitation: Clinchamps M, Auclair C, Prunet D, Pfabigan D, Lesage FX, Baker JS, Parreira L, Mermillod M, Gerbaud L, Dutheil F. Burnout Among Hospital Non-Healthcare Staff: Influence of Job Demand-Control-Support, and Effort-Reward Imbalance. J Occup Environ Med. 2021 Jan 1;63(1):e13-e20. doi: 10.1097/JOM.0000000000002072.

family: Clinchamps

full_name: Maëlys Clinchamps

given: Maëlys

family: Pfabigan

full_name: Daniela Pfabigan

given: Daniela

family: Parreira

full_name: Lenise Parreira

given: Lenise

ReferenceCitation: Dutheil F, Duclos M, Naughton G, Dewavrin S, Cornet T, Huguet P, Chatard JC, Pereira B. WittyFit-Live Your Work Differently: Study Protocol for a Workplace-Delivered Health Promotion. JMIR Res Protoc. 2017 Apr 13;6(4):e58. doi: 10.2196/resprot.6267.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

title: WittyFit—Live Your Work Differently: Study Protocol for a Workplace-Delivered Health Promotion


title: Study of the Effect of an Active rTMS Session in Pathological Gamblers: Impact on Craving and Severity of These Behaviors

summary:
The gambling problem is characterized by a loss of control and an excessive focus on the gambling practice. Currently, the treatment of pathological gamblers is often complex and multidimensional, it notably includes psychological techniques including cognitive behavioral therapy and the use of psychotropic drugs.

In pathological gambling and addictions, craving (or urge to play) and loss of control are two essential clinical elements. The neurobiological level, they are associated with a dysfunction of dorsolateral prefrontal cortex (DLPFC) (Goldstein et al, 2001, Volkow and Goldstein, 2002).

One therapeutic avenues explored in addictions is repeated transcranial magnetic stimulation (rTMS).

ReferenceCitation: Gay A, Boutet C, Sigaud T, Kamgoue A, Sevos J, Brunelin J, Massoubre C. A single session of repetitive transcranial magnetic stimulation of the prefrontal cortex reduces cue-induced craving in patients with gambling disorder. Eur Psychiatry. 2017 Mar;41:68-74. doi: 10.1016/j.eurpsy.2016.11.001. Epub 2017 Feb 3.

family: Gay

full_name: A. Gay

given: A.

family: Boutet

full_name: C. Boutet

given: C.

family: Sigaud

full_name: T. Sigaud

given: T.

family: Kamgoue

full_name: A. Kamgoue

family: Sevos

full_name: J. Sevos

given: J.

family: Brunelin

full_name: J. Brunelin

family: Massoubre

full_name: C. Massoubre

journal_name: European Psychiatry

publisher: Cambridge University Press (CUP)

publisher_dissemination: Cambridge University Press

publisher_group: Cambridge University Press

publisher_normalized: Cambridge University Press

ipd_sharing: No


title: Evaluation of Fibrin Structure Marker in Cancer Patients Treated and Not Treated With LMWH

acronym: FICT

summary: The purpose of the study is to assess the fibrin structure marker in the plasma of cancer patients, treated or not treated with LMWH at prophylactic or therapeutic doses, in order to determine the venous thromboembolic risk. The occurrence of thromboembolic events in patients without treatment and in patients under LMWH treatment will be recorded, depending on the location and type of cancer, metastases, and treatment of cancer.

ReferenceCitation: Meyer G. [Looking for the best molecule. A short history of anticoagulants]. Rev Mal Respir. 2011 Oct;28(8):951-3. doi: 10.1016/j.rmr.2011.09.006. Epub 2011 Oct 15. Review. French.

ReferenceCitation: Campbell RA, Aleman M, Gray LD, Falvo MR, Wolberg AS. Flow profoundly influences fibrin network structure: implications for fibrin formation and clot stability in haemostasis. Thromb Haemost. 2010 Dec;104(6):1281-4. doi: 10.1160/TH10-07-0442. Epub 2010 Sep 30.

ReferenceCitation: Wolberg AS, Gabriel DA, Hoffman M. Analyzing fibrin clot structure using a microplate reader. Blood Coagul Fibrinolysis. 2002 Sep;13(6):533-9.

ReferenceCitation: Varin R, Mirshahi S, Mirshahi P, Kierzek G, Sebaoun D, Mishal Z, Vannier JP, Yvonne Borg J, Simoneau G, Soria C, Soria J. Clot structure modification by fondaparinux and consequence on fibrinolysis: a new mechanism of antithrombotic activity. Thromb Haemost. 2007 Jan;97(1):27-31.

ReferenceCitation: Pieters M, Philippou H, Undas A, de Lange Z, Rijken DC, Mutch NJ; Subcommittee on Factor XIII and Fibrinogen, and the Subcommittee on Fibrinolysis. An international study on the feasibility of a standardized combined plasma clot turbidity and lysis assay: communication from the SSC of the ISTH. J Thromb Haemost. 2018 May;16(5):1007-1012. doi: 10.1111/jth.14002. Epub 2018 Apr 15.

ReferenceCitation: Longstaff C; subcommittee on fibrinolysis. Development of Shiny app tools to simplify and standardize the analysis of hemostasis assay data: communication from the SSC of the ISTH. J Thromb Haemost. 2017 May;15(5):1044-1046. doi: 10.1111/jth.13656. Epub 2017 Mar 17.

lead_sponsor: Diagnostica Stago R&D

location_facility: Internal Medecine Department - Adults Pole and Hematology Laboratory Hôpital Louis Mourier (AP-HP)


title: Efficiency of Hydroxychloroquine on the Endothelial Dysfunction in Antiphospholipid Syndrome (APLAQUINE)

acronym: APLAQUINE

summary:
This study evaluates the benefits of hydroxychloroquine on arterial function in antiphospholipid syndrome.

Briefly, the patients will be randomized in two groups, one will receive hydroxychloroquine and standard treatment, the other will receive placebo in addition of standard treatment.


title: Assessment of the Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery - a Pilot Study

acronym: Pilot pCLE

summary: Intraoperative histological examination is a fundamental tool in surgery. Probe-based Confocal Laser Endomicroscopy (pCLE) is a new imaging technique which enables real-time, microscope-resolution imaging, currently used in endoscopy. This pilot study aims to evaluate pCLE in surgical setting. The objective is the depiction of histological rendering of normal and pathological tissues through pCLE. Feasibility of real-time diagnosis will also be assessed. All surgical conditions usually necessitating frozen section will be investigated. A total of 30 patients, with various pathology of the thyroid / parathyroid, stomach, esophagus, pancreas, adrenal, colon / small intestine, liver will be included. Diagnostic criteria will be defined by a surgeon - pathologist team and further validated by retrospective analysis of the video sequences in comparison to conventional histology slides. The data will be used to create an image bank of reference optical biopsy images. The study will allow to point out the surgical conditions in which pCLE is the most effective and reliable and could eventually replace the frozen section technique.

ReferenceCitation: Wallace MB, Fockens P. Probe-based confocal laser endomicroscopy. Gastroenterology. 2009 May;136(5):1509-13. doi: 10.1053/j.gastro.2009.03.034. Epub 2009 Mar 28.

ReferenceCitation: Ignat M, Aprahamian M, Lindner V, Altmeyer A, Perretta S, Dallemagne B, Mutter D, Marescaux J. Feasibility and reliability of pancreatic cancer staging using fiberoptic confocal fluorescence microscopy in rats. Gastroenterology. 2009 Nov;137(5):1584-92.e1. doi: 10.1053/j.gastro.2009.07.045. Epub 2009 Jul 24.

ReferenceCitation: Kwan AS, Barry C, McAllister IL, Constable I. Fluorescein angiography and adverse drug reactions revisited: the Lions Eye experience. Clin Exp Ophthalmol. 2006 Jan-Feb;34(1):33-8.

ReferenceCitation: Ignat M, Lindner V, Vix M, Marescaux J, Mutter D. Intraoperative Probe-Based Confocal Endomicroscopy to Histologically Differentiate Thyroid From Parathyroid Tissue Before Resection. Surg Innov. 2019 Apr;26(2):141-148. doi: 10.1177/1553350618814078. Epub 2018 Nov 23.

name: University Hospital of Strasbourg, Strasbourg, France

name: IRCAD/IHU: Institute of Image-Guided Surgery, Strasbourg, France

family: Ignat

full_name: Mihaela Ignat

given: Mihaela

family: Lindner

full_name: Veronique Lindner

given: Veronique

family: Vix

full_name: Michel Vix

given: Michel

family: Marescaux

full_name: Jacques Marescaux

given: Jacques

family: Mutter

full_name: Didier Mutter

given: Didier

journal_name: Surgical Innovation

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: IHU Strasbourg

location_facility: Service de chirurgie digestive et endocrinienne - Nouvel Hôpital Civil


title: Contribution of Near-InfraRed Spectroscopy (NIRS) to the Evaluation of Microcirculation Following Trans-tibial Amputation for Peripheral Artery Disease

acronym: NIRS

summary:
50 patients will be included for each of the 2 procedures:

- For procedure 1: Patients will be selected during multidisciplinary consultations for amputees who are stabilized with their definitive prosthesis and have returned to their usual place of residence. The aim of this procedure is to show the validity and reproducibility of measurements of tissue oxygenation using NIRS (TcPO2 being the reference measurement), to determine the way in which NIRS measurements are more precise (i.e. in terms of validity and reproductibility) (values at rest with the patient lying perfectly flat or with the amputated limb raised 30°). These patients will require a single visit which will include measurements by NIRS and TCPO2, a walk test and the completion of 2 questionnaires (visual scale).

- For procedure 2: The patients will be included in the initial phase of postamputation rehabilitation, during the period of in-hospital rehabilitation. The main problems of healing and tolerance to the temporary prosthesis arise during this phase. The specific objectives will be: To show that measurement by NIRS predicts the quality of healing in trans-tibial amputees; to show that the zone of uncertainty concerning the predictive values for the viability of the stump is smaller with NIRS than with TcPO2 (better discrimination). NIRS and TCPO2 measurements as well as the evaluation of stump healing will be done 15, 30 and 45 days after the amputation.

ReferenceCitation: Laroche D, Barnay JL, Tourlonias B, Orta C, Obert C, Casillas JM. Microcirculatory Assessment of Arterial Below-Knee Stumps: Near-Infrared Spectroscopy Versus Transcutaneous Oxygen Tension-A Preliminary Study in Prosthesis Users. Arch Phys Med Rehabil. 2017 Jun;98(6):1187-1194. doi: 10.1016/j.apmr.2016.12.001. Epub 2016 Dec 31.

family: Laroche

full_name: Davy Laroche

given: Davy

family: Barnay

full_name: José-Luis Barnay

given: José-Luis

family: Tourlonias

full_name: Bastien Tourlonias

given: Bastien

family: Orta

full_name: Cyril Orta

given: Cyril

family: Obert

full_name: Christine Obert

given: Christine

family: Casillas

full_name: Jean-Marie Casillas

given: Jean-Marie

journal_name: Archives of Physical Medicine and Rehabilitation

title: Microcirculatory Assessment of Arterial Below-Knee Stumps: Near-Infrared Spectroscopy Versus Transcutaneous Oxygen Tension—A Preliminary Study in Prosthesis Users

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Prognostic Value of Residual Hypoventilation in Mechanically Ventilated Neuromuscular Patients

summary: Different tools may be used to monitor the efficacy of home mechanical ventilation. Investigators aimed to compare the prognostic value of the different data obtained by capno-oxymetry in a mechanical ventilated neuromuscular disease's population.

ReferenceCitation: Ogna A, Nardi J, Prigent H, Quera Salva MA, Chaffaut C, Lamothe L, Chevret S, Annane D, Orlikowski D, Lofaso F. Prognostic Value of Initial Assessment of Residual Hypoventilation Using Nocturnal Capnography in Mechanically Ventilated Neuromuscular Patients: A 5-Year Follow-up Study. Front Med (Lausanne). 2016 Sep 13;3:40. doi: 10.3389/fmed.2016.00040. eCollection 2016.

family: Ogna

full_name: Adam Ogna

given: Adam

family: Nardi

full_name: Julie Nardi

given: Julie

family: Prigent

full_name: Helene Prigent

given: Helene

family: Quera Salva

full_name: Maria-Antonia Quera Salva

given: Maria-Antonia

family: Chaffaut

full_name: Cendrine Chaffaut

given: Cendrine

family: Lamothe

full_name: Laure Lamothe

given: Laure

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Annane

full_name: Djillali Annane

given: Djillali

family: Orlikowski

full_name: David Orlikowski

given: David

family: Lofaso

full_name: Frederic Lofaso

given: Frederic

currency_apc_doaj: USD

journal_name: Frontiers in Medicine

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


summary:
Chronic Obstructive Pulmonary Disease (COPD) had systemic repercussion and lead to peripheral muscular dysfunction. Muscular atrophy limits aerobic capacity and is a major limitation of daily activity and quality of life. Technologies likes' neuromuscular electrical stimulation (NMES) are currently being adapted and tested to support exercise training.

The investigators hypothesized that functional electrical stimulation cycling improves VO2 and aerobic capacities during exercise compared to endurance training.

ReferenceCitation: Medrinal C, Prieur G, Combret Y, Quesada AR, Debeaumont D, Bonnevie T, Gravier FE, Dupuis Lozeron E, Quieffin J, Contal O, Lamia B. Functional Electrical Stimulation-A New Therapeutic Approach to Enhance Exercise Intensity in Chronic Obstructive Pulmonary Disease Patients: A Randomized, Controlled Crossover Trial. Arch Phys Med Rehabil. 2018 Aug;99(8):1454-1461. doi: 10.1016/j.apmr.2018.02.002. Epub 2018 Mar 7.

family: Medrinal

full_name: Clément Medrinal

given: Clément

family: Prieur

full_name: Guillaume Prieur

given: Guillaume

family: Combret

full_name: Yann Combret

given: Yann

family: Quesada

full_name: Aurora Robledo Quesada

given: Aurora Robledo

family: Debeaumont

full_name: David Debeaumont

family: Bonnevie

full_name: Tristan Bonnevie

given: Tristan

family: Gravier

full_name: Francis Edouard Gravier

given: Francis Edouard

family: Dupuis Lozeron

full_name: Elise Dupuis Lozeron

given: Elise

family: Quieffin

full_name: Jean Quieffin

given: Jean

family: Contal

full_name: Olivier Contal

given: Olivier

family: Lamia

full_name: Bouchra Lamia

given: Bouchra

title: Functional Electrical Stimulation—A New Therapeutic Approach to Enhance Exercise Intensity in Chronic Obstructive Pulmonary Disease Patients: A Randomized, Controlled Crossover Trial

ReferenceCitation: Medrinal C, Prieur G, Debeaumont D, Robledo Quesada A, Combret Y, Quieffin J, Contal O, Lamia B. Comparison of oxygen uptake during cycle ergometry with and without functional electrical stimulation in patients with COPD: protocol for a randomised, single-blind, placebo-controlled, cross-over trial. BMJ Open Respir Res. 2016 Apr 12;3(1):e000130. doi: 10.1136/bmjresp-2016-000130. eCollection 2016.

family: Robledo Quesada

given: Aurora

journal_name: BMJ Open Respiratory Research


title: Pedal Rate Influence on Oxygen Consumption in Eccentric

acronym: PRIOx

summary:
Nowadays, ECC exercise can be realized using various modalities that target small or large muscle masses in a segmentary or dynamic way. The training program proposed in this study is realised on an handmade ergocycle which allows eccentric contractions.

With this type of ergometer, O2 consumption (VO2) is three to five fold lower than during an exercise realised at the same power output with a concentric ergocycle. Due to this later propertie, which origins are not yet fully identified, there is an increasing interest to embed ECC in rehabilitation programs.

The investigators hypothesis that a higher pedal rate will induce a lower oxygen consumption, with the same benefits.

This study aims to compare oxygen consumption at two pedal rates : 50 and 80 rotation per minute (rpm).

The ultimate goal is to assess efficacy and tolerance of eccentric training on ergocycle and to enhance comprehension of the physiological mecanisms involved in the lower O2 consumption observed.


title: A Prospective, Single-center, Randomized, Two-arm, Interventional Study to Evaluate the Implantation Rate of Embryos Selected on the Basis of Morphology and Granulocyte-Colony Stimulating Factor (G-CSF) Concentration in the Ovarian Follicular Fluid (FF) - FF G-CSF - Compared to the Implantation Rate of Embryos Selected on the Basis of Morphology Alone When Elective Single Embryo Transfer (SET) of a Fresh Embryo is Performed on Day 2/3 After Oocyte Retrieval

acronym: DESTINy

summary: Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study.

lead_sponsor: Forest Laboratories

location_facility: Centre D'Assistance Médicale À La Procréation


title: Phase II Trial Assessing the Efficacy of a Reduced Dose Strategy of Darunavir to 400 mg/d in HIV-1 Infected Patients Virologically Suppressed Under a Once Daily Regimen Including Darunavir 800 mg/d and Two Nucleoside Reverse Transcriptase Inhibitors (NRTI), to Maintain the Viral Load Lower Than 50 Copies / mL at 48 Weeks of Treatment

acronym: DARULIGHT

summary: Phase II trial assessing the efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain the viral load lower than 50 copies / mL at 48 weeks of treatment.

ReferenceCitation: Lê MP, Chaix ML, Chevret S, Bertrand J, Raffi F, Gallien S, El Abbassi EMB, Katlama C, Delobel P, Yazdanpanah Y, Saillard J, Molina JM, Peytavin G; ANRS 165 DARULIGHT Study Group. Pharmacokinetic modelling of darunavir/ritonavir dose reduction (800/100 to 400/100 mg once daily) in a darunavir/ritonavir-containing regimen in virologically suppressed HIV-infected patients: ANRS 165 DARULIGHT sub-study. J Antimicrob Chemother. 2018 Aug 1;73(8):2120-2128. doi: 10.1093/jac/dky193.

name: IAME, UMR 1137, Université Paris Diderot, Sorbonne Paris Cité and INSERM, Paris, France

name: AP-HP, Hôpital Bichat-Claude Bernard, Laboratoire de Pharmacologie-Toxicologie, Paris, France

family: Lê

full_name: Minh P Lê

given: Minh P

name: AP-HP, Hôpital Saint Louis, Laboratoire de Virologie, INSERM U941 - Université Denis Diderot Paris VII, F-75010 Paris, France

family: Chaix

full_name: Marie-Laure Chaix

given: Marie-Laure

name: AP-HP, Hôpital Saint Louis, SBIM-URC, Paris, France

family: Bertrand

full_name: Julie Bertrand

given: Julie

name: Hôpital Universitaire Hôtel Dieu, Service de Maladies Infectieuses et Tropicales, Nantes, France

family: Raffi

full_name: François Raffi

given: François

name: AP-HP, CHU Henri Mondor, Service d'Immunologie Clinique et Maladies Infectieuses, Créteil, France

family: Gallien

full_name: Sébastien Gallien

given: Sébastien

family: El Abbassi

full_name: El Mountacer Billah El Abbassi

given: El Mountacer Billah

name: AP-HP, Hôpital Pitié-Salpêtrière, Service de Maladies Infectieuses et Tropicales, Paris, France

family: Katlama

full_name: Christine Katlama

given: Christine

name: CHU de Toulouse, Service de Maladies Infectieuses et Tropicales, Toulouse, France

family: Delobel

full_name: Pierre Delobel

given: Pierre

family: Yazdanpanah

full_name: Yazdan Yazdanpanah

given: Yazdan

name: France Recherche Nord & Sud SIDA-HIV Hépatites (ANRS), Paris, France

family: Saillard

full_name: Juliette Saillard

given: Juliette

name: AP-HP, Hôpital Saint Louis, Service de Maladies Infectieuses et Tropicales, INSERM U941, Université Denis Diderot Paris VII, F-75010 Paris, France

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Peytavin

full_name: Gilles Peytavin

given: Gilles

family: Ponscarme

full_name: D Ponscarme

given: D

family: Lascoux

full_name: C Lascoux

given: C

family: Girard

full_name: P M Girard

given: P M

family: Rami

full_name: A Rami

given: A

full_name: Y Yazdanpanah

given: Y

family: Simon

full_name: A Simon

family: Tubiana

full_name: R Tubiana

given: R

family: Duvivier

full_name: C Duvivier

family: Jeantils

full_name: V Jeantils

given: V

family: Loreillard

full_name: D Loreillard


title: Characterization of Obesity-related Cardiomyopathy Through Exploration of Human Atrial Trabeculae Contraction

summary: The investigators aim to explore obese cardiomyopathy by studying contractile twitch force, sarcomere sensitivity to calcium and mitochondrial function in atrial myocardial samples of patients grouped according to their body mass index, i.e. normal weight, overweight and obese.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Lille


type: Other Grant/Funding Number

title: Study of Metabolic Modifications in Children With Noonan Syndrome

acronym: MetabNoonan

summary: Noonan syndrome (NS) is a rare genetic disease (incidence 1/2500 live births) characterized by the association of craniofacial manifestations, cardiopathies, short stature, and tumor predisposition. The genetic causes of Noonan Syndrome are mutations of genes involved in the Ras/Mitogen-Activated Protein Kinases (MAPK) pathway, mainly the gene encoding the tyrosine phosphatase Shp2 (50% of patients).Shp2 appears to be involved in many facets of energy metabolism control (glucose homeostasis, adipose tissue function…), through mechanisms that are poorly understood. Several metabolic anomalies (reduced adiposity, improved glucose tolerance) have been recently identified in an original mouse model carrying Shp2 mutation. Moreover, recent clinical survey has shown that adult Noonan Syndrome patients are protected from developping overweight and obesity when compared to the general population. However, the metabolic status associated with Noonan Syndrome condition has not been explored to date.

ReferenceCitation: Tartaglia M, Gelb BD, Zenker M. Noonan syndrome and clinically related disorders. Best Pract Res Clin Endocrinol Metab. 2011 Feb;25(1):161-79. doi: 10.1016/j.beem.2010.09.002. Review.

ReferenceCitation: Tidyman WE, Rauen KA. The RASopathies: developmental syndromes of Ras/MAPK pathway dysregulation. Curr Opin Genet Dev. 2009 Jun;19(3):230-6. doi: 10.1016/j.gde.2009.04.001. Epub 2009 May 19. Review.

ReferenceCitation: Montagner A, Yart A, Dance M, Perret B, Salles JP, Raynal P. A novel role for Gab1 and SHP2 in epidermal growth factor-induced Ras activation. J Biol Chem. 2005 Feb 18;280(7):5350-60. Epub 2004 Dec 1.

ReferenceCitation: Yart A, Laffargue M, Mayeux P, Chretien S, Peres C, Tonks N, Roche S, Payrastre B, Chap H, Raynal P. A critical role for phosphoinositide 3-kinase upstream of Gab1 and SHP2 in the activation of ras and mitogen-activated protein kinases by epidermal growth factor. J Biol Chem. 2001 Mar 23;276(12):8856-64. Epub 2000 Dec 27.

ReferenceCitation: Zhang SQ, Tsiaras WG, Araki T, Wen G, Minichiello L, Klein R, Neel BG. Receptor-specific regulation of phosphatidylinositol 3'-kinase activation by the protein tyrosine phosphatase Shp2. Mol Cell Biol. 2002 Jun;22(12):4062-72.


title: A Prospective, Randomized and Controlled Study Estimating the Neurally Adjusted Ventilatory Assist (NAVA) Versus the Pressure Support Ventilatory (PSV) in Difficult Weaning From Mechanical Ventilation

acronym: SENA

summary: The NAVA, by its more physiological aspect and a better adaptation of the patient to the ventilator with a decrease of asynchronies patients-ventilators, could decrease the duration of weaning and so decrease the duration of invasive mechanical ventilation and the morbi-mortality. The objective of this study is to compare the neurally adjusted ventilatory assist versus the usual management of weaning from mechanical ventilation, in term of duration of weaning, at the patients in period of difficult weaning from the invasive mechanical ventilation.

lead_sponsor: University Hospital, Bordeaux


title: Assesment by Ultrasonography of the Perineal-cephalic Distance in Consistence With the Notion of Clinical Fetal Head Engagement

acronym: ECHOTRANS

summary:
The practice of ultrasounds increases in delivery rooms every year. Indeed, this method can help to visualize elements that may not be observable after clinical examination. Moreover, it is known that a fetal head engagement can lead to an instrumental extraction and in case of error, which happens in some cases, fetal and maternal risks are possible.

These elements led to the investigators' hypothesis which is that a trans-perineal ultrasonography may facilitate the evaluation of a clinical fetal head engagement in case of doubt.

lead_sponsor: Lille Catholic University


title: Hearing Aid Versus Surgical Rehabilitation as Treatment of Otosclerosis: Pilot Study

acronym: PARCO

summary: This is a French pilot study in the Toulouse University Hospital that will include a minimum of 30 patients with proven unilateral or asymmetric otosclerosis. Each one will receive a hearing aid for a minimum of 2 months and then undergo otosclerosis surgery.

lead_sponsor: University Hospital, Toulouse

location_facility: Toulouse University Hospital (CHU de Toulouse)


title: Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial

summary:
Objective : To assess the analgesic effect of maternal breast milk odor in preterm neonates Design : A prospective, randomised, controlled, double blinded, monocentric trial.

Méthods : The neonates were included from 01/01/2012 to 31/12/2014. Inclusion criteria were: neonates fed with their mother breast milk, gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days, a postnatal age ≤ 10 days and a birth weight greater than the 5th percentile according to Olsen curves et al. They also had to be: clinically stable, with 48 hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease. The two legal representatives must have signed an informed consent. The study excluded the neonates for whom no video was recorded during the venipuncture.

In the first group "breast milk", venipuncture was performed to the neonate while his mother's milk odor was being diffused. In a second control group, the same gesture was made with an odorless diffusor. The primary outcome was the clinical score assessment PIPP (Premature Infant Pain Profile). The secondary outcomes were the DAN score (Acute Pain of Newborn) and the salivary cortisol level.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique des Hopitaux de Marseille


title: Assessment of Cardiac Resynchronization Therapy in Patients With Wide QRS and Non-specific Intraventricular Conduction Delay: a Randomized Trial

acronym: NICD-CRT

summary:
The aim of the NICD-CRT study is to assess whether CRT may be clinically beneficial in HF patients with NICD and reduced ejection fraction on 12-month HF status.

In effect, the effectiveness of cardiac resynchronization therapy in heart failure (HF) with reduced ejection fraction patients with non specific intraventricular conduction delay (NICD) has never been confirmed even if it is recommended.

At the moment, no dedicated study has already been performed to assess the benefit of CRT in patients with NICD. Results from CRT therapy are contradictory in this patient group and have only been obtained from subgroup analysis. Some of them don't show clinical benefit but others show a benefit in term of an end-diastolic and/or end-systolic left ventricular volume (decrease of the size and the volumes of left ventricule).

The AHA/ACCF guidelines, published in 2005 and updated in 2009, considered only QRS duration (≥120 ms) for the indication of CRT implantation, without any consideration for the type of conduction disorder (i.e. LBBB vs. non-LBBB), current updated 2012 ACCF/AHA/HRS guidelines, consider QRS morphology (i.e. LBBB) as the first step for CRT candidate selection in addition to QRS duration (>150 ms). Indications for resynchronization have been restricted since indication of CRT in non-LBBB patients (e.g. NICD) is only a class IIa (>150 ms, only in NYHA III and ambulatory IV; level of evidence A). The same modifications have been applied between 2011 and 2013 in the European guidelines. None is known about patients with NICD and QRS > 130 ms.

ReferenceCitation: Eschalier R, Ploux S, Pereira B, Clémenty N, Da Costa A, Defaye P, Garrigue S, Gourraud JB, Gras D, Guy-Moyat B, Leclercq C, Mondoly P, Bordachar P. Assessment of cardiac resynchronisation therapy in patients with wide QRS and non-specific intraventricular conduction delay: rationale and design of the multicentre randomised NICD-CRT study. BMJ Open. 2016 Nov 11;6(11):e012383. doi: 10.1136/bmjopen-2016-012383.

family: Eschalier

full_name: Romain Eschalier

given: Romain

family: Ploux

full_name: Sylvain Ploux

given: Sylvain

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Clémenty

full_name: Nicolas Clémenty

given: Nicolas

family: Da Costa

full_name: Antoine Da Costa

given: Antoine

family: Defaye

full_name: Pascal Defaye

given: Pascal

family: Garrigue

full_name: Stéphane Garrigue

given: Stéphane

family: Gourraud

full_name: Jean-Baptiste Gourraud

given: Jean-Baptiste

family: Gras

full_name: Daniel Gras

given: Daniel

family: Guy-Moyat

full_name: Benoît Guy-Moyat

given: Benoît

family: Leclercq

full_name: Christophe Leclercq

given: Christophe

family: Mondoly

full_name: Pierre Mondoly

family: Bordachar

full_name: Pierre Bordachar

journal_name: BMJ Open

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

endpoint_id: HAL