acronym: TEPVAD

summary:
Early detection of viable residual tumor or early neoplastic recurrence represents a real challenge in monitoring patients treated with concomitant chemoradiotherapy squamous cell carcinoma of the upper aerodigestive tract.

The locoregional recurrence rate is indeed high (up 40%) over the first two years of this therapeutic method.

The conventional imaging methods such as CT and MRI appear limited in terms of sensitivity because of the many post-treatment changes are fibrosis, tissue edema and the tissue distortion.

PET-CT 18F-FDG proves to be a non-invasive, reliable for the detection of residual tumor and metastasis, even in the absence of clinical signs.

To date, the acquired CT examination in the same time and in the same position that PET is performed without iodinated contrast injection, used for anatomical identification and attenuation correction of PET fused images. The patient usually has a second CT imaging, centered on the neck with contrast injection iodized within the radiology department.

To date, no team has yet studied the interest of the PET-CT 18F-FDG coupled with a CT scan with contrast injection iodized in the diagnosis of early recurrence in head and neck malignancies while interest of the contrast agent injection has been demonstrated in ovarian neoplastic recurrence research, pancreatic and colon.

lead_sponsor: University Hospital, Caen


summary:
Malnutrition is currently a major factor of morbidity and mortality, which poses a major public health problem in developing countries but also, albeit to a lesser degree and for different reasons, for industrialized countries. It is recognized that in countries "of the North", from 30 to 60% of hospitalized patients suffer from dénutrition.

In any case, it is covered by an imbalance between the contributions and needs; the two main mechanisms are a delivery failure (fasting, ingesting difficulty ...) and / or increased requirements (hypermetabolism ...). In cancer patients the Aero-Digestive Upper Airways (VADS), this imbalance is even more pronounced than the two mechanisms exist and potentiate. Patients included in this study are a population at risk, because of their therapeutic containing at least radiotherapy. It is recognized that this form of therapy exposes dental complications, mucous, saliva. These complications have a deleterious effect on the nutritional status of patients.

The diagnosis, treatment and prevention of dénutritions have an important place in the therapeutic strategies of this type of cancer because it is events whose incidence and morbid consequences are high and for which there are appropriate nutritional treatments in most cas. While the complete correction of malnutrition generally passes by the effective etiological treatment of the causal pathology, therapeutic efficacy of the latter is often conditioned by the nutritionnel state.

In addition to these concepts, investigators wants to study the benefits of a diet followed during the irradiation phase of patients with head and neck cancers and New treaties. We propose a randomized, phase III, open, multicenter, to evaluate the impact of a dietary consultation at home on the life quality of patients with head and neck cancer including first therapeutic sequence involves radiotherapy more or less aware. The duration of the study is 24 months.

The main objective is to evaluate the impact of a dietary consultation at home on the life quality of patients with head and neck cancer including first therapeutic sequence involves a more or less sensitized radiotherapy.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Actual

location_facility: Service ORL et de chirurgie cervico- faciale

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Impact of an Intensive Multimodal Educative Program on Behavioral Disorders of Patients With Profound Multiple Disabilities and on the Quality of Life and Feelings of Caregivers

acronym: TDCHandi

summary: Profound multiple disabilities also called in French polyhandicap are defined by the combination of a deep mental disability and severe motor deficit with extreme restriction of autonomy. Life in institution for people with profound multiple disabilities induces emotional and educative deficiency and often conducts to behavioral disorders. These behavioral disorders also impact on quality of life and feelings of caregivers. An intensive multimodal educative program proposed to patients with profound multiple disabilities can improve their psychic well-being, reduce chronic pain and improve also quality of life and feelings of caregivers. The intensive multimodal educative program will be compared to the usual practice of educative program.

study_start_date_type: Actual

study_completion_date_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Behavioral


title: Stress and Emotional Memory : Functional Neuroanatomy of Post-traumatic Stress Disorder in Adolescents

acronym: SEME

summary:
A broad group of disorders is associated with severe stress existence in children or adolescents. The most characteristic result, and one of the most serious being the state of post-traumatic stress disorder (PTSD), whose main source consists of physical or sexual violence, and to a lesser extent, accidents public road or natural disaster, whose child was the subject or witness. PTSD is associated with a deleterious effect on cognition and including the mnemonic operation. The painful reminder of the traumatic event is one of the most disabling symptoms. However, there are many other memory disorders that experimental studies gradually update. They maintain a close link with emotional regulation that disturbed you know if PTSD. However the majority of studies on emotion and cognition and their relationship with brain activity took adult subject. Work in adolescents are few on the morphological study, on rare neurobehavioral and reduced to two studies of functional neuroimaging. Contrary to what is observed in adults, morphological studies report consistently, no reduction in hippocampal volume. There is no study in the idle state. Two studies in functional MRI, the first highlighted in PTSD patients inhibition of the activity of the anterior cingulate cortex (ACC) to stimuli such as to evoke the trauma, a second reported increased activity in the prefrontal cortex Median (mPFC) in a inhibition. The objective task of our study is to evaluate the impact of psychological trauma on brain structures involved in the emotional component of the memory (amygdala, hippocampus, prefrontal cortex in particular). For this, the investigators will take in 33 adolescents, including patients with posttraumatic symptomatology and matched controls free of trauma age, several neuroimaging exams, anatomical and functional. The functional review will include some rest and another in activation during episodic memory task designed to assess the influence of self-perception on memory impairment observed in patients. The investigators will check, for each group of patients and controls, the involvement of cortical structures in relation to the regulation of emotional memory (CCA, amygdala and hippocampus). The anatomy of the hippocampus benefit specific imaging methods developed in the unit INSERM U923. Endocrine correlates of stress tests will be studied by a fully-traumatic by salivary cortisol sampling.

This research will clarify the mechanisms involved in emotional and memory impairments secondary to psychological trauma, their relationship with self (judgment and self-esteem) and studying their morphological substrates. A longer-term goal is to offer help in the diagnosis and monitoring of young patients with posttraumatic symptomatology.

design_allocation: Non-Randomized

primary_purpose: Diagnostic


acronym: D-TEP

summary:
Type 2 diabetes is associated with early and diffuse abnormalities of endothelial function, especially in the coronary arteries, which are a factor of poor prognosis. Following acute coronary syndrome, the endothelial function abnormalities usually persist for several weeks before regressing. Their persistence 6-8 weeks after myocardial infarction is a poor prognostic factor. Investigators assume that global abnormalities of endothelial function in patients with diabetes may be additive with segmental abnormalities in revascularized myocardium, and contribute to worsening the prognosis in these patients. Furthermore, there is no published data showing any relationship between calcium score and endothelial function abnormalities in these patients. The investigators seek a relationship between calcium score and persistence of abnormalities of coronary endothelial function in these patients.

The main objective of this study was to compare coronary endothelial function by quantitative method (TEP at 15O-H2O) in diabetic patients and nondiabetic following acute coronary syndrome.


acronym: FAST DOGS

summary:
The prognosis of patients with heart failure has improved due to recent breakthrough in medical treatment and cardiac resynchronization devices. However, there is no paraclinical parameter to assess response to cardiac resynchronization therapy (CRT). This is a major issue since about a third of implanted patients will not be improved by CRT. CZT SPECT allows to perform myocardial perfusion imaging in less than 4 minutes and is able to study myocardial perfusion, viability, left ventricular function, but also ventricular asynchrony.

Using low-dose dobutamine gated SPECT and CZT camera, we aimed to assess left ventricular dyssynchrony in viable segments in patients with heart failure eligible for CRT.

location_facility: Service de Médecine Nucléaire du CHU de Caen


acronym: ELECTRODIAB

summary:
Type 2 diabetes is a major public health problem because of its increasing prevalence and morbidity and mortality that accompanies it. Therapeutic management of this pathology, lifestyle measures, dietary and physical activity are fundamental. Their observance is unfortunately too often insufficient, leading to a therapeutic climbing with first oral antidiabetic (OAD) then the use of insulin therapy.

Yet there is now ample evidence that physical activity improves glucose control in these patients in particular improving insulin sensitivity after a training period but also after a single session of physical activity.

Neuro-myo-electrical stimulation (NMES) is used in common clinical practice in physical therapy, patients with neurological or after orthopedic surgery in particular. In fact, this method enables improvement of volume and strength, even for denervated muscles. Recent studies have also shown the benefits of NMES in situations of cardiac or respiratory readjustments. In addition, NMES is used by top athletes supplements classical training in order to develop muscle strength or speed recovery.

Investigators propose to test the impact of bilateral quadriceps NMES on insulin sensitivity in type 2 diabetic patients treated with OAD (excluding glitazone). To do this, investigators plan to assess their insulin sensitivity by the reference method of hyperinsulinemic euglycemic clamp before surgery, after a single session of bilateral quadriceps NMES and after a sequence of daily training 6 days a quadriceps NMES bilateral.

Investigators hope to show an improvement in insulin sensitivity by this method, which would constitute an alternative to physical activity in the treatment of diabetes type 2. This procedure would be particularly interesting in diabetic subjects with type 2 counter- indications or an inability to perform a conventional physical activity.

primary_purpose: Treatment

location_facility: Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen


title: Tomodensitometric Study of Pulmonary Effects of Intrapulmonary Percussive Ventilation in ARDS Patients

acronym: PERVE-ARDS

summary: The study is intended to elucidate the pulmonary effects of Intrapulmonary Percussive Ventilation (IPV) with VDR4 ventilator of patients with ARDS, using computed tomography (CT).

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Godet T, Jabaudon M, Blondonnet R, Tremblay A, Audard J, Rieu B, Pereira B, Garcier JM, Futier E, Constantin JM. High frequency percussive ventilation increases alveolar recruitment in early acute respiratory distress syndrome: an experimental, physiological and CT scan study. Crit Care. 2018 Jan 11;22(1):3. doi: 10.1186/s13054-017-1924-6.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Device

status_simplified: Unknown


title: Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer

summary: This cross-sectional study of pathophysiology will bring additional informations on body composition of patients treated by adjuvant hormonal therapy for breast cancer. This is a complementary study of Metaca study (AU882).

primary_purpose: Basic Science

ReferenceType: result

ReferenceCitation: Ginzac A, Thivat É, Mouret-Reynier MA, Dubray-Longeras P, Van Praagh I, Passildas J, Abrial C, Kwiatkowski F, Boirie Y, Duclos M, Morio B, Gadea É, Durando X. Weight Evolution During Endocrine Therapy for Breast Cancer in Postmenopausal Patients: Effect of Initial Fat Mass Percentage and Previous Adjuvant Treatments. Clin Breast Cancer. 2018 Oct;18(5):e1093-e1102. doi: 10.1016/j.clbc.2018.06.010. Epub 2018 Jun 18.

lead_sponsor: Centre Jean Perrin

lead_sponsor_type: industriel


title: Comparison of the Use of VAC (Vacuum Assisted Closure) System in Transplants of Leg Ulcers Versus Usual Dressing Method. A Monocentric, Prospective, Randomized, Parallel Groups Study

summary:
To evaluate the VAC (Vacuum Assisted Closure) therapy in transplants of leg ulcers versus usual dressing method. The VAC Therapy system consists of:

A unit delivering a precise under atmospheric pressure, controlled and regulated in the wound site,
Consumables necessary for the implementation of the dressing,
Collecting tanks exudates with gel. VAC therapy is a system using negative pressure. It is known to be efficient into care of chronic wounds and ulcerous wounds by increasing the cicatrisation.

This system is systematically used into the dermatology unit of the CHU of Saint-Etienne after transplants of leg ulcers, but no data confirms the interest of this method compared to usual dressing method. This study will provide this data.

status: Terminated

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Pilot Study: Measure of the Potential Evoked With Electroencephalography and Electrocorticography by Electric Stimulation of the Brain During the Neurosurgery Awakened of the Infiltrative Glioma of Low Grade (OMS Type II)

acronym: PE&CE

summary:
This study is about an experimental biomedical monocentric search concerning twelves patients presenting a infiltrative glioma of low rank OMS type II and realizing a surgery awakened on the site of the CHU of Montpellier.

The objective of this search is to understand exactly how the electric impulses, delivered by the neurosurgeon to make a functional mapping of the brain during the surgery awakened by tumors infiltrates of low rank, propagate in this one and to identify the nervous networks inhibited by these electric impulses.

Having verified the eligibility of the patients and having obtained their consent, they will be included in the study. Before the beginning of the surgery, the electroencephalography activity of the brain of every patient will be recorded. Before and after the surgical resection, the electrocorticography activity will be recorded.

The collected data will then be analyzed, after the operation. Analyses will try to identify what we call potential evoked by the stimulation and which are small electric waves which appear after the electric stimulation was delivered.

status: Active, not recruiting

ReferenceType: background

ReferenceCitation: Berger MS, Rostomily RC. Low grade gliomas: functional mapping resection strategies, extent of resection, and outcome. J Neurooncol. 1997 Aug;34(1):85-101. Review.

ReferenceCitation: Borchers S, Himmelbach M, Logothetis N, Karnath HO. Direct electrical stimulation of human cortex - the gold standard for mapping brain functions? Nat Rev Neurosci. 2011 Nov 30;13(1):63-70. doi: 10.1038/nrn3140. Review.

ReferenceCitation: DeAngelis LM. Brain tumors. N Engl J Med. 2001 Jan 11;344(2):114-23. Review.

ReferenceCitation: Duffau H. Lessons from brain mapping in surgery for low-grade glioma: insights into associations between tumour and brain plasticity. Lancet Neurol. 2005 Aug;4(8):476-86. Review.

ReferenceCitation: Duffau H, Capelle L, Sichez N, Denvil D, Lopes M, Sichez JP, Bitar A, Fohanno D. Intraoperative mapping of the subcortical language pathways using direct stimulations. An anatomo-functional study. Brain. 2002 Jan;125(Pt 1):199-214.

ReferenceCitation: Duffau H, Lopes M, Arthuis F, Bitar A, Sichez JP, Van Effenterre R, Capelle L. Contribution of intraoperative electrical stimulations in surgery of low grade gliomas: a comparative study between two series without (1985-96) and with (1996-2003) functional mapping in the same institution. J Neurol Neurosurg Psychiatry. 2005 Jun;76(6):845-51. Review.

ReferenceCitation: Duffau H, Sichez JP, Lehéricy S. Intraoperative unmasking of brain redundant motor sites during resection of a precentral angioma: evidence using direct cortical stimulation. Ann Neurol. 2000 Jan;47(1):132-5.

ReferenceCitation: Keles GE, Lundin DA, Lamborn KR, Chang EF, Ojemann G, Berger MS. Intraoperative subcortical stimulation mapping for hemispherical perirolandic gliomas located within or adjacent to the descending motor pathways: evaluation of morbidity and assessment of functional outcome in 294 patients. J Neurosurg. 2004 Mar;100(3):369-75.

ReferenceCitation: Keller CJ, Honey CJ, Mégevand P, Entz L, Ulbert I, Mehta AD. Mapping human brain networks with cortico-cortical evoked potentials. Philos Trans R Soc Lond B Biol Sci. 2014 Oct 5;369(1653). pii: 20130528. doi: 10.1098/rstb.2013.0528.

ReferenceCitation: Matsumoto R, Nair DR, LaPresto E, Bingaman W, Shibasaki H, Lüders HO. Functional connectivity in human cortical motor system: a cortico-cortical evoked potential study. Brain. 2007 Jan;130(Pt 1):181-97. Epub 2006 Oct 17.

ReferenceCitation: Matsumoto R, Nair DR, LaPresto E, Najm I, Bingaman W, Shibasaki H, Lüders HO. Functional connectivity in the human language system: a cortico-cortical evoked potential study. Brain. 2004 Oct;127(Pt 10):2316-30. Epub 2004 Jul 21.

ReferenceCitation: Szelényi A, Bello L, Duffau H, Fava E, Feigl GC, Galanda M, Neuloh G, Signorelli F, Sala F; Workgroup for Intraoperative Management in Low-Grade Glioma Surgery within the European Low-Grade Glioma Network. Intraoperative electrical stimulation in awake craniotomy: methodological aspects of current practice. Neurosurg Focus. 2010 Feb;28(2):E7. doi: 10.3171/2009.12.FOCUS09237. Review.

ReferenceCitation: Taphoorn MJ, Klein M. Cognitive deficits in adult patients with brain tumours. Lancet Neurol. 2004 Mar;3(3):159-68. Review.

ReferenceCitation: Walker DG, Kaye AH. Low grade glial neoplasms. J Clin Neurosci. 2003 Jan;10(1):1-13. Review.

lead_sponsor: University Hospital, Montpellier

location_facility: CHU de Montpellier - Service de neurochirurgie

intervention_type: Procedure

status_simplified: Ongoing


title: Hyperfibrinogenemia Within the First Days After Major Trauma : Kinetic, Functionality, Impact of Fibrinogen Replacement Therapy and Trauma, Thrombosis Risk

summary: Assessment of the evolution of fibrinogen plasma level within the first ten days after major trauma in order to determine prevalence of hyperfibrinogenemia (Fg > 4 g/L) and its time to onset.

location_facility: Department of Anesthesiology and critical care, Lapeyronie University Hospital


title: Validation of an Electrode Internal Globus Pallidum Deep Brain Stimulation Lead Implantation for Treatment of Dystonia

acronym: MONOCONTACT

summary: The main objective of the trial is to study the technical feasibility of the implantation of a new electrode Monocontact deep brain stimulation electrode in dystonia.


title: Double Upper Limb Allograft: Intervention and Clinical Evaluation. A Pilot Study of 5 Cases

acronym: DAMIE

summary:
The case of patients with amputation of forearm on one side and arm on the other is particularly interesting to study because in this situation of handicap greater than a double amputation in forearm. We should bring a functional benefit to the patient with the transplant of forearm and this situation allows to have the best possible control to compare the result of the transplant of arm to that of forearm because it is realized at the same patient.

Amputation of both arms deprives patients of an elbow what establishes a major factor of limitation of autonomy and makes patients totally dependent for the realization of the essential gestures of the current life requiring the prehension (dress, dressing, food, hygiene of the elimination). The various equipments are not always adaptable and usable. Psychologically, an amputation in arm is unanimously considered as an infringement very badly accepted of the physical integrity and establishes a major handicap factor of family, professional and social exclusion.

The results of this study should allow a better appreciation of indications and modalities of care of biamputed patients with at least one lesion level above the elbow.

This clinical research will determine the potential place of a reconstructive surgery as allograft in biamputed patients on the basis of functional results and assessment of disorders of the body schema perception.

status: Recruiting

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Edouard Herriot - Service d'Urologie et Chirurgie de la Transplantation


acronym: ORB

summary:
There are no equivalent experiment setups to create comparable changes of gravitation such as during parabolic flights. To determine the initial orthostatic responses of the cardiovascular system under the gravitational conditions of mars and moon is an essential step for a better understanding of 1) the fundamental functions of the human cardiovascular system (basic research) 2) specific impact of partial-g on the human heart, lungs and vessels in a spaceflight-context 3) approaches for countermeasure development against orthostatic intolerance on moon and mars (applied research).

Non-invasive measurement methods will be used to achieve the cardiovascular key values of the study: stroke volume (SV) and cardiac output determination by pulse contour analysis, impedance cardiography and inert gas rebreathing, beat-to-beat finger blood pressure measurement, heart rate and heart rate variability determination by ECG. All of these methods have proven their accuracy during parabolic flights. Nevertheless pulse contour analysis and impedance cardiography are known to provide only relative SV and CO values. Thus inert gas rebreathing gives us the possibility to calibrate these stroke volumes and cardiac outputs to absolute values. Success of this procedure was shown during former parabolic flights.


acronym: DIRECT

summary:
Cardiac exploration almost systematically requires the acquisition and / or calculating function indices. The ejection fraction (LVEF) is probably based index most widely used in all cardiac exploration methods. This relatively universal overall index has very many qualities. LVEF is widely used in clinical practice through the exploration and monitoring of all heart disease.

Current progress in the management of various cardiomyopathies pass through the detection of early attacks. This testing often takes place upstream changes in LVEF that remains long normal or normalized. Sensitive indicators capable of detecting early abnormalities of regional functions are essential in addition to conventional echocardiography. Various studies have shown the contribution of these new markers in early detection of abnormalities of the cardiac function. The most widely used indicator in these studies because of its high sensitivity to analyze the movements of the heart is the tissue Doppler. Tissue Doppler however has limitations in particular its dependence on the incident angle, which makes it impossible to correct analysis of non-aligned in the axis of the ultrasonic beam components.

A new way of exploring the regional function of the heart, speckle tracking, can analyze heart deformations along the principal axes of the heart. The advantage of this technique has been shown in various pathological situations. Currently, this technique is mostly used in longitudinal and transverse view 2D imposing multiple planes cuts. 3D potential of this technique is not currently known, acquisition of 3D technology is recent (2004) and dedicated software is confidential dissemination and unvalidated.

The validated technique, 3D reference analysis of myocardial deformation is tagged MRI. In the 90s, studies have demonstrated the feasibility of this technique, the ability to access all of the myocardial deformation in space and to define normal values. The cost of the procedure, duration, limited accessibility and post-processing very time consuming limited the scope of the clinical benefits of this modality.

Echocardiography has major advantages over MRI, particularly its high availability, low cost and flexibility of use. The ability to access with MRI as the 3D deformation of the heart is a new opportunity that it is essential to validate.

The main purpose of the study is to compare the strain values obtained 3D ultrasound to those obtained by MRI tagged in a control group and a group of subjects with an anterior infarction sequela.


acronym: HopMot

summary:
Previous studies have neglected two important aspects for the China National Space Administration. First, while biomechanical models are very sensitive to the characteristics of the subjects, data have been collected on subjects with biomechanical characteristics very different from those of "typical" Chinese astronauts. Second, pure video analysis techniques and kinematic data lack the necessary acceleration information important to understanding the forces exerted during movement and control of human motion. While some studies used force and moment sensors to aid in robot torque control and human joint work estimation, investigators are unaware of any studies performed in a microgravity environment that have combined the kinetic force and moment information with acceleration measurements to enable more reliable motion tracking without the need for acceleration estimation.

This is why MICR0-G sensors and accompanying kinematic video system have been developed in order to provide for detailed analyses of the astronaut movement control strategy (joint forces and torques, kinetic and acceleration measurements). Knowledge of the joint torques permits us to calculate the joint and musculoskeletal dynamics required to execute the microgravity motions, as well to provide insight into the altered movement strategies in reduced gravity as compared to 1-G locomotion.


acronym: Blindpulling

summary:
Parabolic flight is the only ground-based condition in which weightlessness (0G) can be created long enough for safely testing changes in human perception and behavior. In addition to the 0G period, parabolic flight generates equal duration periods of 1.8G, which present another unique opportunity to test the same responses to hypergravity and back to 1G.

Cognitive function, together with good oculomotor control, eye-hand coordination, and spatial orientation perception, is a critical subsystem that is used by the CNS in the control of vehicles and other complex systems in a high-level integrative function. Evidence from space flight research demonstrates that the function of each of these subsystems is altered by the transitions in gravito-inertial force levels. These neuro-vestibular alterations, unfortunately, correspond to mission phases where physical and cognitive performance are particularly critical for crew safety and mission success. To date, there is only limited operational evidence that these alterations cause functional impacts on mission-critical vehicle (or complex system) control capabilities. However, the true operational risks will be estimable only after the investigators have filled the knowledge gaps and when the investigators can accurately assess integrated performance in off-nominal operational settings.

Accurate perception of self-in-space motion and self-motion relative to other objects are critical to piloting, driving, and remote manipulator operations. Immediately after space flight, most crewmembers have reported some degree of disorientation/perceptual illusion, often accompanied by nausea (or other symptoms of motion sickness), and frequently manifested by lack of coordination, particularly during locomotion. Despite recent, intensive training, some Shuttle landings were outside of the desired performance boundaries. Scores indicating neurovestibular dysfunction in returning astronauts generally correlated with poorer flying performances, including a lower approach and landing shorter, faster, and harder. An underestimation of distance, coupled to an overestimation of tilt magnitude or misperception of the type of motion, could be at the origin of these poorer performances.

This study should confirm that the unloading of the otoliths in weightlessness induces an alteration in the egocentric reference during space flight. Errors in egocentric localization might contribute at a higher level to the computation of misleading world-centered representations, and therefore be partly responsible for illusory sensations and motion sickness symptoms during space flight, and postural instability and oscillopsia after returning in a reduced or terrestrial gravitational force level.

Beside their fundamental implications, the results of this study have also practical implications in the design of man-machine interfaces. Changes in judgment of distance in microgravity or in reduced gravity affect crew posture and reach, display orientation, and other visual cues, which should be considered in hardware and operations design.


title: Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF Agents in the Management of Patients With Inflammatory Bowel Disease Treated With Anti-TNFalpha Biotherapy.

acronym: ATAIM

summary: Since their appearance more than a decade ago, anti-tumor necrosis factor (TNF) inhibitors have demonstrated beneficial activity in the treatment of inflammatory bowel diseases (IBD). However, more than one-third of patients present primary resistance, and one more third become resistant over time. One of the main factors associated with loss of response is the immunogenicity of anti-TNF biologics leading to the production of antibodies targetting the TNF inhibitor, namely anti-drug antibodies (ADAbs), that accelerate drug elimination from the serum and decrease its therapeutic activity. In this study the investigators propose a medico-economic evaluation of the measurement of anti-TNF agents and anti-drug antibodies serum concentrations in the management of patients with inflammatory bowel disease treated with anti-TNFalpha inhibitors. 280 patients with Crohn's disease (CD) or ulcerative colitis (UC) will be included and randomized in 2 groups with or without drug and ADAbs monitoring. In the monitored group, in case of loss of response, the clinician will use biological informations to adapt the treatment following a simple treatment algorithm. In the unmonitored group, drug and ADAbs measurements will not be transmitted to the clinician. Clinical and economical benefits of the biological monitoring will be evaluated after a follow-up period of two years.

primary_purpose: Other

ReferenceCitation: Baert F, Noman M, Vermeire S, Van Assche G, D' Haens G, Carbonez A, Rutgeerts P. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med. 2003 Feb 13;348(7):601-8.

ReferenceCitation: Bartelds GM, Wijbrandts CA, Nurmohamed MT, Stapel S, Lems WF, Aarden L, Dijkmans BA, Tak PP, Wolbink GJ. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis. 2007 Jul;66(7):921-6. Epub 2007 Feb 14.

ReferenceCitation: de Vries MK, Brouwer E, van der Horst-Bruinsma IE, Spoorenberg A, van Denderen JC, Jamnitski A, Nurmohamed MT, Dijkmans BA, Aarden LA, Wolbink GJ. Decreased clinical response to adalimumab in ankylosing spondylitis is associated with antibody formation. Ann Rheum Dis. 2009 Nov;68(11):1787-8. doi: 10.1136/ard.2009.109702.

ReferenceCitation: Lecluse LL, Driessen RJ, Spuls PI, de Jong EM, Stapel SO, van Doorn MB, Bos JD, Wolbink GJ. Extent and clinical consequences of antibody formation against adalimumab in patients with plaque psoriasis. Arch Dermatol. 2010 Feb;146(2):127-32. doi: 10.1001/archdermatol.2009.347.

ReferenceCitation: Ben-Horin S, Yavzori M, Katz L, Kopylov U, Picard O, Fudim E, Coscas D, Bar-Meir S, Goldstein I, Chowers Y. The immunogenic part of infliximab is the F(ab')2, but measuring antibodies to the intact infliximab molecule is more clinically useful. Gut. 2011 Jan;60(1):41-8. doi: 10.1136/gut.2009.201533. Epub 2010 Jun 2.

ReferenceCitation: Karmiris K, Paintaud G, Noman M, Magdelaine-Beuzelin C, Ferrante M, Degenne D, Claes K, Coopman T, Van Schuerbeek N, Van Assche G, Vermeire S, Rutgeerts P. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn's disease. Gastroenterology. 2009 Nov;137(5):1628-40. doi: 10.1053/j.gastro.2009.07.062. Epub 2009 Aug 5.

ReferenceCitation: Nanda KS, Cheifetz AS, Moss AC. Impact of antibodies to infliximab on clinical outcomes and serum infliximab levels in patients with inflammatory bowel disease (IBD): a meta-analysis. Am J Gastroenterol. 2013 Jan;108(1):40-7; quiz 48. doi: 10.1038/ajg.2012.363. Epub 2012 Nov 13. Review.

ReferenceCitation: Vande Casteele N, Gils A, Singh S, Ohrmund L, Hauenstein S, Rutgeerts P, Vermeire S. Antibody response to infliximab and its impact on pharmacokinetics can be transient. Am J Gastroenterol. 2013 Jun;108(6):962-71. doi: 10.1038/ajg.2013.12. Epub 2013 Feb 19.

ReferenceCitation: Steenholdt C, Svenson M, Bendtzen K, Thomsen OØ, Brynskov J, Ainsworth MA. Severe infusion reactions to infliximab: aetiology, immunogenicity and risk factors in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2011 Jul;34(1):51-8. doi: 10.1111/j.1365-2036.2011.04682.x. Epub 2011 May 3.

ReferenceCitation: Afif W, Loftus EV Jr, Faubion WA, Kane SV, Bruining DH, Hanson KA, Sandborn WJ. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol. 2010 May;105(5):1133-9. doi: 10.1038/ajg.2010.9. Epub 2010 Feb 9.

ReferenceCitation: Bartelds GM, Krieckaert CL, Nurmohamed MT, van Schouwenburg PA, Lems WF, Twisk JW, Dijkmans BA, Aarden L, Wolbink GJ. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA. 2011 Apr 13;305(14):1460-8. doi: 10.1001/jama.2011.406.

ReferenceCitation: Steenholdt C, Brynskov J, Thomsen OØ, Munck LK, Fallingborg J, Christensen LA, Pedersen G, Kjeldsen J, Jacobsen BA, Oxholm AS, Kjellberg J, Bendtzen K, Ainsworth MA. Individualised therapy is more cost-effective than dose intensification in patients with Crohn's disease who lose response to anti-TNF treatment: a randomised, controlled trial. Gut. 2014 Jun;63(6):919-27. doi: 10.1136/gutjnl-2013-305279. Epub 2013 Jul 22.

ReferenceCitation: Velayos FS, Kahn JG, Sandborn WJ, Feagan BG. A test-based strategy is more cost effective than empiric dose escalation for patients with Crohn's disease who lose responsiveness to infliximab. Clin Gastroenterol Hepatol. 2013 Jun;11(6):654-66. doi: 10.1016/j.cgh.2012.12.035. Epub 2013 Jan 26.

ReferenceCitation: Paul S, Del Tedesco E, Marotte H, Rinaudo-Gaujous M, Moreau A, Phelip JM, Genin C, Peyrin-Biroulet L, Roblin X. Therapeutic drug monitoring of infliximab and mucosal healing in inflammatory bowel disease: a prospective study. Inflamm Bowel Dis. 2013 Nov;19(12):2568-76. doi: 10.1097/MIB.0b013e3182a77b41.

ReferenceCitation: Roblin X, Marotte H, Rinaudo M, Del Tedesco E, Moreau A, Phelip JM, Genin C, Peyrin-Biroulet L, Paul S. Association between pharmacokinetics of adalimumab and mucosal healing in patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2014 Jan;12(1):80-84.e2. doi: 10.1016/j.cgh.2013.07.010. Epub 2013 Jul 23.


title: Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy

summary: This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.

lead_sponsor: BBraun Medical SAS


acronym: E-NOSE

summary: The main goal of the study is demonstrate that e-Nose system function is not altered in weightlessness and more specifically that gas concentration measurements are the same in weightlessness and normal gravity.


acronym: Massper

summary:
Parabolic flight is the only ground-based condition in which free-fall (0G) can be created long enough for safely testing changes in human perception and behavior. In addition to the 0G period, parabolic flight generates equal duration periods of 1.8G, which present another unique opportunity to test the same responses to hypergravity and back to 1G.

It is well known that performance decrements occur in astronauts during and after gravity level transitions. Illusions are commonly felt in orbit as well disorientation and perceptual limitations, mainly due to both psycho-physiological changes and adaptation and lack of familiar points of reference in the space environment. Studies performed during previous space missions showed several changes occurring in different gravity conditions, pointing out, for example, that colors and shadows were misleading, the depth and distance perception were weakened, and the linear perspective was lost. Visual perception is of primary importance for spatial orientation and object recognition because the static vestibular (otolithic) and proprioceptive signals are absent when free-floating. Consequently, astronauts become increasingly dependent on vision to perceive motion and orientation. All these factors play an important role in the adaptation of humans to spaceflight that needs to be analyzed to understand the underlying mechanisms that regulate human psycho-physiological adaptive process to changing gravity. Human psycho-physiological health has to be safeguarded and possibly improved when long-term human space missions are programmed in the near future.

The primary objective of this experiment is to investigate if the SWI illusion is present in altered gravity environments. Since weight cannot be estimated in 0G, investigators have developed a procedure during which the subject is asked to estimate the objects' mass by shaking them rather than lifting them. Our results in 1G indicate that a size-mass illusion (SMI) is also present in 1G. Our hypothesis is that the previously observed alteration in 3D visual perception in 0G, particularly in the height of 3D objects, as well as the change in proprioceptive inputs, will be responsible for changes in the SMI in 0G and 1.8G compared to 1G. In a separate proposal, investigators will also propose to perform this experiment using the ESA short-arm human centrifuge (SAHC), with subjects exposed to various centrifugal force levels, to further investigate the role of proprioceptive cues in the size-mass illusion.


title: Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components

summary: MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.

study_start_date_type: Anticipated

status: Withdrawn

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: MicroPort Orthopedics Inc.


title: Evaluation of Physiological and Biomechanical Efficiency of the PAPAW

acronym: SmartDrive

summary:
The main objective is to quantify energy expenditure when using the SmartDrive system during manual wheelchair propulsion in external conditions (slope, straight line). For this two comparisons are performed:

Comparison of energy expenditure with and without the use of a system SmartDrive 6 minute propulsion test.

Comparison the risk of musculoskeletal disorders of the wrist during a 6 minute propulsion test.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Observational Study of the Analgesic Effect of Treatment With rTMS in Patients Suffering From Chronic Neuropathic Pain Refractory to Conventional Treatment and Monitored and Evaluated in Consultation Multidisciplinary Chronic Pain in Lower Normandy

acronym: rTMSDOULNEURO

summary:
For ten years, rTMS, repetitive transcranial magnetic stimulation of the motor cortex, has found its place in the treatment of drug-resistant neuropathic pain. Patients relieved by some sessions may thereafter receive a chronic invasive stimulation via electrodes implanted through a neurosurgical procedure. This is common practice at the University Hospital of Caen and in different CHU with the proper equipment rTMS. It seems permissible to provide in our center only a non-invasive technique for patients challenged with brain surgery, since according to the various meta-analyzes the analgesic efficacy of rTMS seems to be correlated to the repetition of sessions.

Assessment centers and the treatment of pain allow a multidimensional assessment, bio-psycho-social of patients in order to optimize their management and experience efficiently analgesics first- and second-line.

We propose a study evaluating the analgesic efficacy of rTMS, in relevant stimulation parameters reproduced according to a literature review, during 3 months after 5 active sessions separated by one week apart, in 15 patients with neuropathic pain chronic refractory to treatment of first and second line, followed by multidisciplinary center specializing in chronic pain Lower Normandy. The quality of life will also be assessed by validated scales, and the results will be compared to the literature data.

location_facility: Centre d'évaluation et de traitement de la douleur (CETD)


title: Contribution of an Endermologie LPG Cellu M6 Treatment in the Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema, During an Intensive Decongestive Treatment.

acronym: ELOCS

summary: This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive treatment in reducing secondary lymphoedema in breast cancer.

ReferenceCitation: Lawenda BD, Mondry TE, Johnstone PA. Lymphedema: a primer on the identification and management of a chronic condition in oncologic treatment. CA Cancer J Clin. 2009 Jan-Feb;59(1):8-24. doi: 10.3322/caac.20001. Review.

ReferenceCitation: Kärki A, Anttila H, Tasmuth T, Rautakorpi UM. Lymphoedema therapy in breast cancer patients: a systematic review on effectiveness and a survey of current practices and costs in Finland. Acta Oncol. 2009;48(6):850-9. doi: 10.1080/02841860902755251. Review.

ReferenceCitation: Mayrovitz HN. The standard of care for lymphedema: current concepts and physiological considerations. Lymphat Res Biol. 2009;7(2):101-8. doi: 10.1089/lrb.2009.0006.

ReferenceCitation: Vignes S, Porcher R, Arrault M, Dupuy A. Long-term management of breast cancer-related lymphedema after intensive decongestive physiotherapy. Breast Cancer Res Treat. 2007 Mar;101(3):285-90. Epub 2006 Jul 7.

lead_sponsor: University Hospital, Toulouse


type: Registry Identifier

title: Evaluation of Perioperative Use of Hypnosis in Pediatric Surgery: Clinical and Medico-economic Interests

summary:
In adults, it is common to perform a number of superficial and non invasive surgeries under local anesthesia in order to limit the use of general anesthesia.

Hypnosis is a nonpharmacological therapies that can be used during surgery to improve the patient comfort and experience. The benefit of this practice has been widely demonstrated in adults, decreasing perioperative anxiety, postoperative pain scores as well as nausea and vomiting.

In pediatric surgery, hypnosis is an effective technique for the management of preoperative anxiety. It is used by many teams in their daily practice, particularly during anesthetic induction.

For 2 years, the team of pediatric anesthesia and surgery of the Montpellier University Hospital also offers for selected short and superficial non-invasive surgeries, an intraoperative management under hypnosis in association with ocal anesthesia as an alternative to general anesthesia. If this clinical practice of hypnosis is fully accepted and recognized in our intraoperative surgical unit, to date, no studies have evaluated the benefits of this technique compared to general anesthesia.

The objective of the study is to compare the impact of these techniques (hypnosis vs. general anesthesia) on postoperative experiences of children (rehabilitation time, anxiety, pain, nausea and vomiting, negative behavioral disorders).


title: ARTEMIS Synovial Markers in Arthritis Childhood

acronym: ARTEMIS

summary: The aim of this study is to find markers that could differentiate infectious and inflammatory arthritis. The investigators want to find markers by differential analysis by compare synovial fluids of septic and inflammatory arthritis. The investigators will use for this analysis, proteomics, cytokine dosage and monocyte typing by flow cytometry analysis. The investigators will use one marker or a score with biological and clinical data to discriminate arthritis of infectious and inflammatory etiology.

ReferenceCitation: Nziza N, Jeziorski E, Delpont M, Cren M, Chevassus H, Carbasse A, Mahe P, Abassi H, Joly-Monrigal P, Schordan E, Mangé A, Jorgensen C, Apparailly F, Duroux-Richard I. Synovial-Fluid miRNA Signature for Diagnosis of Juvenile Idiopathic Arthritis. Cells. 2019 Nov 26;8(12). pii: E1521. doi: 10.3390/cells8121521.

ReferenceCitation: Cren M, Nziza N, Carbasse A, Mahe P, Dufourcq-Lopez E, Delpont M, Chevassus H, Khalil M, Mura T, Duroux-Richard I, Apparailly F, Jeziorski E, Louis-Plence P. Differential Accumulation and Activation of Monocyte and Dendritic Cell Subsets in Inflamed Synovial Fluid Discriminates Between Juvenile Idiopathic Arthritis and Septic Arthritis. Front Immunol. 2020 Jul 31;11:1716. doi: 10.3389/fimmu.2020.01716. eCollection 2020.


title: Treatment of Pleural Effusion by Routine Thoracic Ultrasound

acronym: ECHOPLEV

summary: The main objective of the study is to assess the cost-effectiveness ratio of two management strategies of pleurisy in adults : a strategy by systematic thoracic ultrasound versus a strategy without thoracic ultrasound.

ReferenceCitation: Havelock T, Teoh R, Laws D, Gleeson F; BTS Pleural Disease Guideline Group. Pleural procedures and thoracic ultrasound: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii61-76. doi: 10.1136/thx.2010.137026.

ReferenceCitation: Reissig A, Copetti R, Mathis G, Mempel C, Schuler A, Zechner P, Aliberti S, Neumann R, Kroegel C, Hoyer H. Lung ultrasound in the diagnosis and follow-up of community-acquired pneumonia: a prospective, multicenter, diagnostic accuracy study. Chest. 2012 Oct;142(4):965-972. doi: 10.1378/chest.12-0364.

ReferenceCitation: Jones PW, Moyers JP, Rogers JT, Rodriguez RM, Lee YC, Light RW. Ultrasound-guided thoracentesis: is it a safer method? Chest. 2003 Feb;123(2):418-23.

ReferenceCitation: Ikezoe J, Morimoto S, Arisawa J, Takashima S, Kozuka T, Nakahara K. Percutaneous biopsy of thoracic lesions: value of sonography for needle guidance. AJR Am J Roentgenol. 1990 Jun;154(6):1181-5.

ReferenceCitation: Chen HJ, Yu YH, Tu CY, Chen CH, Hsia TC, Tsai KD, Shih CM, Hsu WH. Ultrasound in peripheral pulmonary air-fluid lesions. Color Doppler imaging as an aid in differentiating empyema and abscess. Chest. 2009 Jun;135(6):1426-1432. doi: 10.1378/chest.08-2188. Epub 2009 Mar 2.


title: Efficacy of Preoperative Re-education on Patients With an Anterior Cruciate Ligament Rupture: a Randomized Controlled Trial

acronym: PRELIG

summary:
Anterior cruciate ligament (ACR) rupture is a common lesion of sportsmen that leads to functional deficits which are difficult to overcome. To prevent from an unfavorable evolution, patients can either get a non-surgical treatment or an ACR surgery, which is very common. Knee functional performance level could impact on the postoperative outcome and it's of common knowledge that early re-education after an ACR rupture improves knee functioning.

Patients with an ACR rupture enrolled in this study will be randomized either in an experimental group (with preoperative reeducation) or in a control group (without preoperative reeducation). Both groups will then have post-operative re-education (40 sessions) based on HAS recommendations.

The main aim of this study is to assess the impact of preoperative re-education on knee functional performance 4 month after surgical reconstruction of an ACR.

Secondary aims are to determine the impact of the 4-week preoperative re-education on knee functional performance after an ACR rupture, before surgery and 7 months after surgery.

Functional performance, muscular strength, proprioception and anterior knee laxity will be measured at inclusion (V0), 4-5 days before surgery (V1), 4 month (V4M) and 7 months (V7M) after surgery. Lysholme-Tegner scoring and IKDC2000 questionnaire will be added to the previous assessments.


title: Pharmacokinetics of Ertapenem Following Subcutaneous or Intravenous Infusion in Patients Aged Over 75 (PHACINERTA)

acronym: PHACINERTA

summary:
In geriatric departments, physicians are faced with two difficulties, first the increasing number of infections caused by multiresistant bacteria, especially extended spectrum β-lactamase (ESBL) producing enterobacteria strains and second, the poor venous access frequently encountered in elderly population. Giving antibiotics subcutaneously would be an interesting alternative, all the more as intramuscular injection is contraindicated in case the of anticoagulant therapy. Unfortunately, few data are available about subcutaneous (SC) administration. Ertapenem is a recent long-acting parenteral carbapenem indicated especially in the treatment of ESBL infection. Its subcutaneously administration has been tested in several studies in Intensive Care Units (ICU) and internal medicine wards with promising results regarding clinical and pharmacokinetics data.

An alternative to the IV Ertapenem administration is needed because of poor venous access and behavioural abnormalities commonly present in infected elderly population. Ertapenem is currently SC administrated in geriatric departments if no other option is available. Moreover elderly patients often present several comorbdities, polymedication, renal insufficiency, cachexia which may disturb antibiotics pharmacokinetics.

The aim of the study is to obtain pharmacokinetic data of SC and IV Ertapenem administration in elderly population, obtain PK/PD parameters adapted to time-dependent antibiotics (T%>MIC) and descriptive data of occurrence of adverse effects and evolution of signs of infection.

ReferenceCitation: Roubaud Baudron C, Legeron R, Ollivier J, Bonnet F, Greib C, Guerville F, Cazanave C, Kobeh D, Cressot V, Moneger N, Videau MN, Thiel E, Foucaud C, Lafargue A, de Thezy A, Durrieu J, Bourdel Marchasson I, Pinganaud G, Breilh D. Is the subcutaneous route an alternative for administering ertapenem to older patients? PHACINERTA study. J Antimicrob Chemother. 2019 Dec 1;74(12):3546-3554. doi: 10.1093/jac/dkz385.

lead_sponsor: University Hospital, Bordeaux

intervention_type: Drug


title: Comparaison Biochimique et Histologique Des Cartilages Nasal et Auriculaire Chez le fœtus et le Nouveau-né Porteur de Fente Labiale

acronym: CARTOON

summary:
We seek to compare biochemically and histologically the nasal cartilage and ear in the newborn cleft lip and slot carrier in order to improve the quality of care and patient comfort after surgery of cheilorhinoplasty which is the primary treatment slots .

The concentration of hyaluronic acid as well as in type 1 collagen and 3 are assayed by immunohistochemistry and study of mRNA and then they are compared according to the type of cartilage.

This comparison is done on nasal cartilage samples and atrial newborns holders of cleft lip and operated in the neonatal period.

Given the difficulty and constraint of time it takes to reach the 20 subjects of our study , we will also add to our population the stillborn babies before 25SA and newborns who die before the age of 28 days and having had an autopsy.


title: A Randomized Double-blind Clinical Trial on the Efficacy of Transcranial Direct Current Stimulation (tDCS) in Reducing Alcohol Consumption in Non-abstinent Patients With Alcohol Use Disorder

acronym: REDSTIM

summary: The study evaluates the efficacy of 1 week of tDCS (5 sessions) placebo in reducing alcohol consumption within the 24 weeks following the treatment in non-abstinent patients with alcohol use disorders versus placebo.

ReferenceCitation: Trojak B, Soudry-Faure A, Abello N, Carpentier M, Jonval L, Allard C, Sabsevari F, Blaise E, Ponavoy E, Bonin B, Meille V, Chauvet-Gelinier JC. Efficacy of transcranial direct current stimulation (tDCS) in reducing consumption in patients with alcohol use disorders: study protocol for a randomized controlled trial. Trials. 2016 May 17;17(1):250. doi: 10.1186/s13063-016-1363-8.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Impact of Complementary Medicine Techniques (Therapeutic Touch and Hypno Analgesia) on the Term of Delivery of Patients Hospitalized for Preterm Labor (Hypnorelax)

acronym: Hypnorelax

summary:
The threat of premature birth (MAP) is the leading cause of hospitalization during pregnancy complicated by preterm delivery in 5-10% of cases in developed countries. Psychological stress that encompasses anxiety and anxiety resounding including sleep quality can be a work of preacher and premature delivery.

Preterm birth before 37 has an impact on the survival and health of the newborn. It is the leading cause of mortality and obstetric complications. It has a cost both for the newborn, the term parturient health but also the financial cost by the management before delivery and the consequences of a premature birth.

The usual management of MAP is hospitalized with tocolysis, monitoring and rest. The hospitalization and invasive procedures contribute to increasing stress. It therefore seems necessary to seek to diversify and master reputable techniques for their effectiveness on mastering stress and improving sleep quality as hypnosis and feel relaxing.

Hypnosis in obstetrics is used primarily to control pain, nausea and postpartum depression. It also reduces preoperative anxiety and during induction of anesthesia, as well as behavioral disorders during the first postoperative week. Hypnosis can play an important role in the prevention of preterm birth. In a non-randomized study, hypnosis combined with drug therapy has prolonged pregnancy of patients followed in high risk pregnancy.

The relaxing touch brings relaxation and well being. In obstetrics, it has an influence on the anti-stress hormones and plays a role in reducing pain during childbirth.

Few studies interested in hypnosis and relaxation therapies in pregnant women, especially in case of MAP. The published data relate to a small number of patients and a low level of evidence. Although there seems promising results, prospective studies are needed to conclude its effectiveness in improving the stress, pain or other parameters.

Health workers trained in these techniques could observe during their production improved sleep disorders, stress, better communication between doctor and patient. Moreover, these treatments could induce an improvement in the overall care of patients, and therefore have an impact on the continuation of pregnancy.

These findings are based on these hypothesis. There is a clinical gain the contribution of hypnosis and relaxing touch in women hospitalized for MAP before 32 weeks of gestation. This would, among other improvements in sleep disorders and stress, decrease pain, and acting on the extension of the term of pregnancy in women followed by these techniques and a decrease in hospitalizations of newborns premature neonatology and neonatal intensive care units.

primary_purpose: Prevention


title: Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation (TAVI) Platelet Activation in TAVI

acronym: TAVI

summary: Study of platelet activation by severe aortic stenosis and its correction by Transcatheter Aortic Valve Implantation (TAVI)


acronym: FLASH

title: Fluid Loading in Abdominal Surgery: Saline Versus Hydroxyethyl Starch: A Double-blinded Multicenter Prospective Randomized Trial (FLASH Study)

type: EudraCT Number

source: euctr

ReferenceCitation: Futier E, Garot M, Godet T, Biais M, Verzilli D, Ouattara A, Huet O, Lescot T, Lebuffe G, Dewitte A, Cadic A, Restoux A, Asehnoune K, Paugam-Burtz C, Cuvillon P, Faucher M, Vaisse C, El Amine Y, Beloeil H, Leone M, Noll E, Piriou V, Lasocki S, Bazin JE, Pereira B, Jaber S; FLASH Trial Group, Lasocki S, Huet O, Cadic A, Jacob C, Paugam-Burtz C, Restoux A, Ouattara A, Feitita I, Deloge E, Defaye M, Joannes-Boyau O, Carles P, Napolitano G, Monziols S, Futier E, Vignaud M, Paul S, Gahbiche K, Fayon J, Laroche E, Bazin JE, Brandely A, Le Moal C, Lebuffe G, Garot M, Piriou V, Jaber S, Chanques G, Verzilli D, De Jong A, Millot A, Castagnoli A, Leone M, Pastene B, Castelli C, Medam S, Velly L, Vaisse C, Faucher M, Asehnoune K, Samba E, Roquilly A, Le Penndu M, Cuvillon P, Yves Lefrant J, Wira O, Dubout E, Mfam WS, Lescot T, Begneu E, Burey J, Cirilovic T, Beloeil H, Allo G, Pottecher J, Lebas B, Venot C, Rameau JP, Dimache F, Léger PS, El Amine Y. Effect of Hydroxyethyl Starch vs Saline for Volume Replacement Therapy on Death or Postoperative Complications Among High-Risk Patients Undergoing Major Abdominal Surgery: The FLASH Randomized Clinical Trial. JAMA. 2020 Jan 21;323(3):225-236. doi: 10.1001/jama.2019.20833.

ReferenceCitation: Futier E, Biais M, Godet T, Bernard L, Rolhion C, Bourdier J, Morand D, Pereira B, Jaber S; FLASH trial management committee. Fluid loading in abdominal surgery - saline versus hydroxyethyl starch (FLASH Trial): study protocol for a randomized controlled trial. Trials. 2015 Dec 21;16:582. doi: 10.1186/s13063-015-1085-3.

summary: The primary purpose of the study is to evaluate whether the type of fluid (0.9% saline or 6% Hydroxyethyl starch 130/0.4) in the context of an individualized goal-directed fluid therapy is associated with a difference in morbidity and mortality within the first 14 days in patients at moderate-to-high risk of postoperative complications after abdominal surgery.


title: Study of Anti-glycan Antibodies Stability in Saint-Etienne IBD Cohort - A Monocentric Study

summary: Prognostic factors in Inflammatory Bowel Diseases (IBD) are currently mainly based on clinical factors (disease extension, perianal involvement, need for surgery, use of immunomodulators…). All of immunological markers (or serological) of IBD have a diagnostic role in indeterminate colitis (ulcerative colitis vs crohn's disease) but they never have been considered as predictors of IBD course in adults. Among the most used, anti-neutrophil cytoplasm antibodies (ANCA) and Anti-Saccaromyces cerevisiae antibodies (ASCA) allow the distinction between ulcerative colitis (ANCA+/ASCA-) and Crohn's disease (ANCA-/ASCA+), and their combined use has a sensitivity and a specificity of about 85%. However, 10 other antibodies have been identified and recently evaluated individually in IBD and especially in pediatric Crohn's disease: anti-ompC, anti-I2, anti-flagellins, anti-glycan (anti-laminaribioside carbohydrate antibodies (ALCA), anti-mannobioside carbohydrate antibodies (AMCA), anti-chitobioside carbohydrate antibody (ACCA), anti-chitin and anti-laminarin), anti-goblet cells and anti-C.albicans specific mannans antibodies. These complementary tests improve the reliability of the diagnosis. In a previous cross-sectional work on a cohort of 195 IBD patients, the investigator showed a prognostic role of some of anti-glycan Abs and especially a correlation with a pejorative form of the disease both in Crohn's disease than in Ulcerative Colitis (UC) and a prediction of corticodependency in IBD.


title: Cellular and Molecular Adaptations to Exercise-induced Inflammatory Response in Children With Autoimmune Diseases

acronym: AJI-APA

summary: Juvenile idiopathic arthritis (JIA) is a chronic disease characterized by persistent joint inflammation. The immune system disruption that leads to overproduction of pro-inflammatory cytokines (TNF-α, IL-1, IL-6) is a cascade of events on different levels-some molecular, some cellular, and some systemic. Our objective is to identify the mechanisms through which physical activity is liable to mediate inflammatory balance in autoimmune disease settings, and specifically in JIA patients.


title: Study of the Colonic Carriage of Staphylococcus Aureus in a Prospective Cohort of Patients Undergoing Endoscopic Screening for Digestive Cancer in the University Hospital of Saint-Etienne.

acronym: ColoStaph

summary: Epidemiological study aiming to describe the carriage (nasal, throat, groin, rectal and colonic) of S. aureus in patients without chronic digestive disease who are going to have a colonoscopy for cancer screening. The carriage will be analyzed globally and the similarity of strains isolated from each site will be analyzed using molecular tools. The aim of this study is to better estimate the digestive reservoir of S. aureus to better prevent endogenous infections due to this bacterium.


title: PRODIGE 33 - BALLAD - Phase III Trial Investigating the Potential Benefit of Adjvant Chemotherapy for Small Bowel Adenocarcinoma

acronym: BALLAD

summary:
The utility of adjuvant chemotherapy in the management of Small Bowel Adenocarcinoma (SBA) remains unproven and awaits the results of a large, global, prospective, phase III, randomised, controlled trial. Across the 830 million population of North America and Europe, there are approximately 3,000 patients with stage I-III SBA every year who would be potentially eligible for such an adjuvant chemotherapy trial.

Given the absence of good-quality and evidence-based data, it has been agreed that a trial considering adjuvant chemotherapy versus no chemotherapy was appropriate for patients with stage I-III SBA in whom the oncologist and patient feel that the benefit of adjuvant chemotherapy is uncertain. For those patients with stage I-III SBA who, with their oncologists, feel that the potential benefit of adjuvant chemotherapy is certain (and hence are not willing to accept randomisation to the 'no chemotherapy' arm), a randomisation between single agent fluoropyrimidine versus doublet fluoropyrimidine and oxaliplatin chemotherapy will be offered. Tumour stage will be used as a stratification factor. Those patients who do not consent to be randomised will be offered registration to allow collection of demographic, clinicopathological and survival data, thereby making optimal use of the rare patient population available. In addition, archival Formalin Fixed Paraffin Embedded (FFPE) tissue and contemporaneous venous blood samples will be collected from every registered patient to allow molecular profiling and future translational research. A questionnaire about underlying risk factors (e.g. Crohn's disease, coeliac disease, Lynch syndrome etc) will be completed along with the other collected data on all registered patients.

status: Not yet recruiting

ReferenceCitation: Kitahara H, Honma Y, Ueno M, Kanemitsu Y, Ohkawa S, Mizusawa J, Furuse J, Shimada Y; Colorectal Cancer Study Group and Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group. Randomized phase III trial of post-operative chemotherapy for patients with stage I/II/III small bowel adenocarcinoma (JCOG1502C, J-BALLAD). Jpn J Clin Oncol. 2019 Mar 1;49(3):287-290. doi: 10.1093/jjco/hyy188.


title: Comparaison du Pied Bionique Proprio-Foot® Versus le Pied Habituel Chez Les amputés Tibiaux

acronym: PROPRIO-FOOT

summary: Evaluate a new porosthetic device in lower limb amputees.

lead_sponsor: University Hospital, Angers


title: Natural History of Cardiac and Respiratory Function in Patients With Muscular Dystrophies on Home Mechanical Ventilation

summary: Muscular dystrophies are inherited disorders that affect skeletal muscle. Cardiac and respiratory function may be affected in this group of diseases. The investigators sought to analyze the long term cardiac and respiratory function in patients with muscular dystrophies recquiring home mechnaical ventilation .

time_perspective: Retrospective

ReferenceCitation: Fayssoil A, Lazarus A, Wahbi K, Ogna A, Nardi O, Lofaso F, Clair B, Orlikowski D, Annane D. Cardiac implantable electronic devices in tracheotomized muscular dystrophy patients: Safety and risks. Int J Cardiol. 2016 Nov 1;222:975-977. doi: 10.1016/j.ijcard.2016.08.040. Epub 2016 Aug 6.

ReferenceCitation: Fayssoil A, Ogna A, Chaffaut C, Chevret S, Guimarães-Costa R, Leturcq F, Wahbi K, Prigent H, Lofaso F, Nardi O, Clair B, Behin A, Stojkovic T, Laforet P, Orlikowski D, Annane D. Natural History of Cardiac and Respiratory Involvement, Prognosis and Predictive Factors for Long-Term Survival in Adult Patients with Limb Girdle Muscular Dystrophies Type 2C and 2D. PLoS One. 2016 Apr 27;11(4):e0153095. doi: 10.1371/journal.pone.0153095. eCollection 2016.


acronym: CMHStress

summary: Hypertrophic cardiomyopathy (HCM) is a primitive myocardic disease and the first of genetic cardiac diseases. The definition of HCM is an increase of the myocardial thickness of the left ventricle (LV) wall without any other causes of hypertrophy. It's characterized by an important heterogeneity of prognosis and clinical expression going from a asymptomatic state until the devastating sudden death occurring in a young person.The diagnosis of HCM is definite by a myocardial thickness greater or equal to 15mm (or 13mm if there is a familial history).This hypertrophy is often accompanied by other abnormalities detected by echocardiography: dynamic left ventricular outflow obstruction at rest or stress, mitral regurgitation …Now, the current challenge is to determine the prognosis factors of the disease that could help to identify the patients with high risk of sudden death. Some prognosis factors are knowed and used in the calculation of a new risk score. This risk score allows to estimate the risk of sudden death at 5 years and propose depending on the result, the implantation of a defibrillator for primary prevention.The physiopathological mechanism of HCM is very complex and still misunderstood. Myocardial fibrosis could be a major mechanism of the disease evolution. Indeed, fibrosis is responsible of scar areas where ventricular tachycardia may develop. Moreover, if the fibrosis is very extensive, it can be the responsible of a systolic or diastolic dysfunction of the left ventricle leading to heart failure.Myocardial ischemia caused by a microvascular dysfunction is now recognized as an important mechanism of the disease evolution. Acute ischemic events could be a trigger of malignant arrhythmia whereas chronic ischemia leads to fibrosis.Left ventricle function is long time preserved in HCM. Segmentary hypokinesia corresponding to extensive fibrosis appears at a very advanced stage of the disease. Exercice stress echocardiography permits to detect myocardial ischemia caused by microvascular dysfunction in the HCM before the fibrosis apparition. Moreover the investigators suggest to study the deformation parameters by speckle tracking or 2D strain witness of a contractile LV dysfunction before the apparition of segmentary hypokinesia.Magnetic resonance imaging (MRI) is now recognized as the more sensible technique to identify focal myocardial fibrosis resulting in areas of late gadolinium enhancement (LGE). LGE is frequent in HCM and his extension is correlated with the severity of the hypertrophy and the risk of sudden death. Myocardial ischemia is detected by hypoperfused defects in the perfusion sequences and as LGE, is correlated with the degree of hypertrophy. Some studies using stress MRI with vasodilatator agent show inductible hypoperfused areas correlated to the degree of hypertrophy. T1 mapping is a new hopeful sequence of MRI permitting to detect the diffuse and early myocardial fibrosis. Some studies show that T1 mapping values are reduced in the areas of LGE in HCM but also in areas without LGE which reflects the presence of new fibrosis.The objective of study is to compare these two imagery techniques in order to detect ischemia and fibrosis. These techniques are usually used in the diagnosis or the monitoring of the disease. The investigators propose to realize an exercise stress echocardiography to study: the segmentary kinetic of the left ventricle and the 2D strain and a stress MRI to study the LGE, the stress perfusion and the T1 mapping.Actually the investigators consider that LGE is a risk factor of the disease (although not yet involved in the calculation of the risk of sudden death) and need to be study in each MRI realized for HCM. From the same way, the investigators suggest to follow patients to determine if the abnormalities detected by these two techniques and particularly 2D strain abnormalities, stress myocardial ischemia and T1 mapping abnormalities are prognosis factors of the disease and appear more precociously than LGE.

location_facility: Hôpital Arnaud de Villeneuve - CHRU de Montpellier


title: Comparative Effects of Variable Pressure Support, Neurally Adjusted Ventilatory Assist (NAVA) and Proportional Assist Ventilation (PAV) on the Variability of the Breathing Pattern and on Patient Ventilator Interaction

summary:
Experimental animal data suggest that increasing breathing pattern variability in mechanical ventilation could be beneficial. Variable ventilation can be induced through the following modes: Neurally Adjust Ventilatory Assist (NAVA), Proportional Assist Ventilation (PAV) and Variable-Pressure Support Ventilation (V-PSV). These modes have not yet been compared to each other. Pilot observations in our department suggest a feasibility in patients.

The objectives of the study are to compare the impact of PSV, NAVA, PAV and V-PSV on the variability of the breathing pattern, patient-ventilator asynchrony, risk of lung overdistension, gas exchange, and repartition of ventilation.

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

location_facility: Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière


title: Perinatal Consequences of Endometriosis: Multicenter Prospective Comparative Study

acronym: ENDOBST

summary:
Endometriosis is a benign gynecological disease, characterized by the presence of endometrium-like tissue outside the uterine cavity that affect up to 10-15% of women in reproductive age worldwide, with an extensive impact on women's wellbeing and their reproductive life. Endometriosis lesions are heterogeneous and three phenotypes of the disease are well recognized and are fundamentally different from each other: superficial peritoneal endometriosis (peritoneal implants), ovarian endometrioma (cyst ovarian endometriosis), and deeply infiltrating endometriosis (invasive nodules greater than 5 mm).

The investigators performed a prospective multicenter comparative study to assess the maternal and fetal risks related to endometriosis during pregnancy, regarding disease phenotype, This study will evaluate with sufficient power the risk of prematurity and obstetrical complications associated with endometriosis according to disease phenotype.

This study aims to provide new informations to pregnant women with endometriosis, guide the monitoring of pregnancy, optimize management strategies based on the nature of complications and ultimately to improve the health of women and their unborn child

intervention_type: Biological


title: Comparison of Preoperative Haemoglobin Level After Administration of Epoetin Alfa Associated With an Oral Versus Intravenous Iron Supplementation

acronym: Cross Iron

summary: Patients were recruited at the scheduled preoperative visit for hip or knee arthroplasty. If the haemoglobin (Hb) level was below 13 g/dl with no contraindication to iron supplementation the patients were randomized to the oral or intravenous (IV) group. The oral group received 160 mg ferrous glycine sulfate daily during the month prior surgery, associated with 3 epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day - 14 and day-7). The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery, associated with 3 EPO injections. Primary efficacy endpoint was the change in Hb level from the day of the preoperative visit to the day before surgery (day-1). Secondary endpoints comprised the Hb level on day 3 and 5 after surgery, allogenic transfusion during and after surgery, and the change in iron indices from the day of the preoperative visit to day - 1.

location_facility: Hôpital Lapeyronie - Département Anesthésie Réanimation A


title: Ultrasound-guided Pudendal Nerve Block in Children: A Descriptive Study of Feasibility

summary:
Objective: Description of a new transperineal technique of pudendal nerve block (PNB), under ultrasound-guidance.

Methods : Successive inclusions after parental consent of 60 children undergoing perineal surgery under general anesthesia and pudendal nerve block. Data were collected from induction of anesthesia to second post-operative day (24 hrs. after admission in recovery room). Ease of PNB achievement was the primary objective evaluated. Efficiency in preoperative and postoperative period was also reported.


title: Hypospadias and Exome: Identification of New Genes for Familial Hypospadias

summary:
Hypospadias is the second most common malformation of the male genitalia and consists in a congenital hypoplasia of its ventral face. Hypospadias results from abnormal development of the penis that leaves the urethral meatus proximal to its normal glanular position. Meatus position may be located anywhere along the penile shaft, but more severe forms of hypospadias may have a urethral meatus located at the scrotum or perineum. Glandular and penile anterior represents approximately 70% of all the diagnosed cases.

The frequency of family reached depend on the severity of hypospadias. The number of children which have hypospadias mutation discovered by classical technique is low. Families are often the cause of the discovery of new genes involved in sexual differentiation because they allow comparison of genomes of related persons, and detect more easily mutations.

intervention_type: Genetic


title: Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome (SAOS)

acronym: RICAOS

summary:
Obstructive sleep apnea (OSA) syndrome affects up to 5% of the general population. The prevalence is multiplied by 13 in coronary artery disease (CAD) patients. Many studies have shown that OSA syndrome was the main risk factor for cardiovascular morbidity and mortality (RR = 9.1 [95%, 2.6 to 31.2]).

If the value of treatment with Continuous Positive Airway Pressure (CPAP) in symptomatic CAD patients (daytime sleepiness and/or 2 clinical symptoms with Apnea Hypopnea Index (AHI) ≥ 20) appears to be established, treatment with CPAP in asymptomatic CAD patients (with AHI> 30) may be too demanding. Alternative treatments are rare and results are highly variable. Therefore, it would be interesting to suggest other treatment modalities with moderate coronary and/or minimally symptomatic OSA syndrome.


title: Illiteracy and Vulnerability to Alzheimer's Disease: Evaluation of Amyloid Pathology by PET Imaging

acronym: AVILL

summary: The goal of this study is to improve the diagnosis of Alzheimer's disease (AD) at two different stages (MCI and dementia) in illiterate subjects, using FDG- fluorodeoxyglucose - and florbetapir F 18 -PET imaging. This study will compare amyloid load and cerebral metabolism dysfunction in literate versus illiterate MCI and AD patients.

intervention_type: Radiation


title: Does the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP)

acronym: MYCOPID

summary: The main objective is to study if the mycophenolate could decrease the proportion of patients who relapse during the IVIG tapering period and after the IVIG withdrawal.


title: Treatment of the Bilateral Severe Uveitis by IVT of Regulator T-cells: Study of Tolerance of Dose

acronym: UVEREG

summary: Uveitis is a leading cause of blindness in the children and young adult's populations. One third of etiology are idiopathic. The reference treatments are corticosteroids and immunosuppressive agents. They have significant side effects, and patient's compliance is often poor. In addition, some uveitis are more resistant. Also, in these situations of deadlock therapeutic, investigators propose a cell therapy by administering regulatory T cells (Tregs) in the vitreous of patients.

status: Suspended

location_facility: Department of ophthalmology Groupe Hospitalier Pitié-Salpêtrière - Charles FOIX


title: Medico-economic Comparative Assessment of Conventional and CAD/CAM Dental Restorations; Impact on Hospital Dentistry Departments

acronym: EVACFAOD

summary:
Dental restorations (crowns, inlays or onlays) can be made conventionally or by CAD/CAM. The current literature is weak and does not separate the medical results of these two techniques. However, the efficiencies enabled by CAD/CAM could, for the price of an initial investment, improve service to the patient by reducing the time required for these restorations, and possibly lower care costs.

The aim of the study is to compare immediate medical results and short-term prosthetic restorations made conventionally or by CAD/CAM in randomized patients, and evaluate economic impacts and organizational aspects.

location_facility: Service d'Odontologie Hôpital Pitié salpêtrière


title: Evaluation of Efficacy and Safety of a Cashew Apple Extract on Weight Management and Associated Metabolic Risk Factors in Overweight/Obese Volunteers: a Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial

summary: The purpose of this study is to assess the efficacy and safety of a cashew apple extract on weight management and associated metabolic risk factors in overweight/obese volunteers, versus placebo, after 12 weeks of treatment.

ReferenceCitation: Janssen I, Katzmarzyk PT, Ross R. Waist circumference and not body mass index explains obesity-related health risk. Am J Clin Nutr. 2004 Mar;79(3):379-84.

ReferenceCitation: Ribeiro da Silva LM, Teixeira de Figueiredo EA, Silva Ricardo NM, Pinto Vieira IG, Wilane de Figueiredo R, Brasil IM, Gomes CL. Quantification of bioactive compounds in pulps and by-products of tropical fruits from Brazil. Food Chem. 2014 Jan 15;143:398-404. doi: 10.1016/j.foodchem.2013.08.001. Epub 2013 Aug 9.

ReferenceCitation: Kuczmarski RJ, Flegal KM. Criteria for definition of overweight in transition: background and recommendations for the United States. Am J Clin Nutr. 2000 Nov;72(5):1074-81.

ReferenceCitation: P. Suganya and R. Dharshini. Value added products from cashew apple - an alternate nutritional source. International Journal of current research, Vol. 3, Issue 7, pp. 177-180, July 2011

ReferenceCitation: Prasertsri P, Roengrit T, Kanpetta Y, Tong-Un T, Muchimapura S, Wattanathorn J, Leelayuwat N. Cashew apple juice supplementation enhanced fat utilization during high-intensity exercise in trained and untrained men. J Int Soc Sports Nutr. 2013 Mar 7;10(1):13. doi: 10.1186/1550-2783-10-13.

ReferenceCitation: Vergara CMAC, Honorato TL, Maia GA, Rodrigues S. Prebiotic effect of fermented cashew apple (Anacardium occidentale L) juice. LWT-Food Sci Technol. 2010; 43:141-145.

lead_sponsor: Dialpha

location_facility: Clinical Nutrition Center Naturalpha (CNCN)

intervention_type: Dietary Supplement


title: Passage à l'Acte en Maison d'arrêt : Recherche d'éléments Contextuels récurrents Prospectifs et rétrospectifs

acronym: CoDiRCE

summary: The prediction of dangerousness remains a delicate subject, relevant in current psychiatry. Scalable psychopathological elements identified in schizophrenia and mood disorders are considered as most at risk for crime committing. The French High Authority of Health (HAS) recommends to identify and prevent risk situations of violence and to develop research at this level. Some authors have worked on criminal career and became interested in risk factors for aberrant driving behaviors but also in environmental or clinical elements accompanying these phases. To our knowledge, no specific study about contextual elements before misconduct and which could lead to aberrant driving behaviors among individuals diagnosed with antisocial personality disorder has been described to date The investigators propose to follow individuals diagnosed with antisocial personality disorder in prison during 6 months in order to list their conduct disorders and contextual elements upstream of these misconducts. The investigators will also study the effect of contextual factors related to judicial steps on the appearance of aberrant driving behaviors.

ReferenceCitation: Haute Autorité de Santé. Dangerosité psychiatrique : étude et évaluation des facteurs de risque de violence hétéro-agressive chez les personnes ayant des troubles schizophréniques ou des troubles de l'humeur. In: Service des bonnes pratiques professionnelles. Saint-Denis La Plaine: Service documentation - information des publics; 2011.

ReferenceCitation: Quinsey VL, Harris GT, Rice ME, Cormier CA. Violent Offenders: Appraising and Managing Risk, Second Edition. American Psychological Association. Washington, DC, US 2006. 462 p.

ReferenceCitation: Moulin V, Favard A-N.

ReferenceCitation: Moulin V, Senon J-L. Évaluation de la dynamique criminelle et des processus qui sous-tendent l'agir infractionnel dans un cadre expertal, 2010.

ReferenceCitation: Litinetskaia M. Dangerosité, délinquance et passage à l'acte : psychopathologie et prédictivité. Annales médico-psychologiques 170. 99-102; 2012.

ReferenceCitation: Côté G. Vers une définition de la psychopathie. Pham TH & Côté. Villeneuve d'Ascq, France: Presse Universitaire du Septentrion; 2000. 240 p.

ReferenceCitation: Balier C. Psychanalyse des comportements violents. Puf. Rouge LF. Paris1988

ReferenceCitation: Gravier B. Violence et psychopathie. Psychiatrie légale et criminologie clinique. Issy-les-Moulineaux : Elsevier Masson, 2013. Les âges de la vie. ISBN : 978-2-294-73163-1; 2013.

ReferenceCitation: Hare RD, Craigen D. Psychopathy and physiological activity in a mixed-motive game situation. Psychophysiology. 1974 Mar;11(2):197-206.

ReferenceCitation: Vanderstukken O. Troubles de l'attention et des fonctions executives chez les psychopathes. Université catholique de Louvain;1998.

ReferenceCitation: Pham TH. [Psychometric evaluation of the Hare Psychopathy Questionnaire in a Belgian prison population]. Encephale. 1998 Sep-Oct;24(5):435-41. French.

ReferenceCitation: Etude de Cote G, Sheilagh H, Toupin J. citée par Pham TH, Cote G. Psychopathie : Théorie et Recherche. Septentrion Presse Universitaire; 2000.

ReferenceCitation: Sreenivasan S, Kirkish P, Eth S, Mintz J, Hwang S, Van Gorp W, Van Vort W. Predictors of recidivistic violence in criminally insane and civilly committed psychiatric inpatients. Int J Law Psychiatry. 1997 Spring;20(2):279-91.

ReferenceCitation: Méry B. Diplôme Inter-Universitaire de psychiatrie criminelle et médicolégale. "Organisation du système pénitentiaire " ; Mars 2014.

ReferenceCitation: Hare RD, Neumann CN. The PCL-R Assessment of Psychopathy: Development, Structural Properties, and New Directions. C. Patrick ed. New York: Guilford; 2006.

ReferenceCitation: Cote G, Hodgins S, Toupin J. Psychopathie : Prévalence et spécificité clinique. Psychopathie : théorie et recherche. Paris : Septentrion Presse Universitaire, 2000, p 47-75. ISBN 2-85939-612-8; 2000.

ReferenceCitation: COTE G., HODGINS S., TOUPIN J. Psychopathie : Prévalence et spécificité clinique. Psychopathie : théorie et recherche. Paris : Septentrion Presse Universitaire, 2000, p 47-75. ISBN 2-85939-612-8. 2000.

ReferenceCitation: Salekin RT, Rogers R, Sewell KW. Construct validity of psychopathy in a female offender sample: a multitrait-multimethod evaluation. J Abnorm Psychol. 1997 Nov;106(4):576-85.

ReferenceCitation: Ministère de la Justice, Statistiques trimestrielles de la population prise en charge en milieu fermé [Consulté le 30/01/2015]. Disponible à partir de l'URL : http://www.justice.gouv.fr/art_pix/trimestrielle_MF_janvier_2014.pdf - Tableau 1. 2014.)

ReferenceCitation: Pham TH. L'évaluation de la psychopathie. Psychiatrie légale et criminologie clinique. Les âges de la vie. Issy-les-Moulineaux : Elsevier Masson; 2000

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis


title: Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease

acronym: EPMR-MA

summary: Unrandomized, unblinded, monocentric comparative Functional Magnetic Resonance Imaging study.

lead_sponsor: Rennes University Hospital


title: Development and Implementation of a Computerized Adaptative Testing (CAT) of Self-perceived Quality of Care in Psychiatry

acronym: QDSPsyCAT

summary:
Objectives

to develop and validate a Computerized Adaptative Testing (CAT) of self-perceived quality of care in Psychiatry.
to analyze the implementation of this new measure in clinical practice : qualitative analysis of the relationship patient/professional.

ReferenceCitation: Fernandes S, Fond G, Zendjidjian X, Michel P, Lançon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Misdrahi D, Llorca PM, Coldefy M, Auquier P, Baumstarck K, Boyer L. A conceptual framework to develop a patient-reported experience measure of the quality of mental health care: a qualitative study of the PREMIUM project in France. J Mark Access Health Policy. 2021 Feb 23;9(1):1885789. doi: 10.1080/20016689.2021.1885789.

ReferenceCitation: Fernandes S, Fond G, Zendjidjian XY, Baumstarck K, Lançon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Llorca PM, Coldefy M, Auquier P, Boyer L; French PREMIUM Group. Measuring the Patient Experience of Mental Health Care: A Systematic and Critical Review of Patient-Reported Experience Measures. Patient Prefer Adherence. 2020 Nov 3;14:2147-2161. doi: 10.2147/PPA.S255264. eCollection 2020. Review.

ReferenceCitation: Fernandes S, Fond G, Zendjidjian X, Michel P, Baumstarck K, Lancon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Llorca PM, Coldefy M, Auquier P, Boyer L. The Patient-Reported Experience Measure for Improving qUality of care in Mental health (PREMIUM) project in France: study protocol for the development and implementation strategy. Patient Prefer Adherence. 2019 Jan 21;13:165-177. doi: 10.2147/PPA.S172100. eCollection 2019.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hopital de la conception Assistance Publique Hôpitaux de Marseille


title: Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie About the Pathway of the Child in Pediatric Surgery.

summary:
The purpose of the study is to measure the interest of a movie explaining the path of the children in surgery, in order to reduce the anxiety of the children and his parents.

This study is interventional, method randomized, controled, open-label, comparing two parallel arms: anesthesist explanations versus anesthesist explanations + a movie explanation.

ipd_sharing: Yes

ipd_sharing_description:
De-identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected

Supporting Information:

Time Frame:

12 months after the main publication

Access Criteria:

Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.

Identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected

Supporting Information:


title: Study of the Angiogenesis Measured by PET/CT With 18F-RGD-K5 in Patients With Lymphoma : a Preliminary Study

acronym: RGDLymphome

summary: The aim of the study is to measure tumoral angiogenesis modifications by RGD-K5 PET/CT before and after 2 cycles of chemotherapy in patients with lymphoma and a large tumoral mass

lead_sponsor: Centre Henri Becquerel


title: Comparative Study of the Hypoxia Measured in FAZA and F-miso TEP/CT Scan in Patients With Non-small Cell Lung Cancer at the Time of Diagnosis : Correlation With Immunohistochemistry

summary: The purpose of the study is to compare the intratumoral biodistribution of FAZA and F-miso in patients with non-small cell lung cancer and correlate the results of PET scans with immunohistochemistry.

ReferenceCitation: Texte E, Gouel P, Thureau S, Lequesne J, Barres B, Edet-Sanson A, Decazes P, Vera P, Hapdey S. Impact of the Bayesian penalized likelihood algorithm (Q.Clear®) in comparison with the OSEM reconstruction on low contrast PET hypoxic images. EJNMMI Phys. 2020 May 12;7(1):28. doi: 10.1186/s40658-020-00300-3.


title: Evaluation of Cytidine Deaminase for Patient Suffering of a Myelodysplasic Syndrom or an Acute Myeloid Leukemia and Treated by Azacytidine

summary: Myelodysplastic syndrome (MDS) is a group of medical conditions derived from progressive bone marrow failure that result in ineffective production of blood cells. Depending on the severity, MDS reduces the quality of life to the point of being life-threatening. There is a probability of death at all stages of the disease, due to complications and co-morbidities, with progression to acute myeloid leukemia (AML) being the worst evolution. Azacytidine is a nucleosidic analog with original epigenetic mechanism of action that is widely used for treating a variety of myelodysplasic syndromes. Although generally well tolerated, severe and sometimes life-threatening toxicities were unexpectedly observed in some patients. Genetic polymorphism affecting cytidine deaminase (CDA), the liver enzyme responsible for azacytidine detoxification step, could be responsible for poor clinical outcome due to on the one hand to severe toxicities in deficient patients, and on the other hand on treatment failure in ultrametabolizer patients.This clinical study aims at correlating the values in CDA levels with the risk of drug-related toxicities and to the clinical response to azacytidine treatment.

location_facility: Assistance Publique - Hopitaux de Marseille


title: Effect of a Silicone Hydrocoated Double Loop Ureteral Stent on Symptoms and Quality of Life in Patients Undergoing F-URS for Kidney Stone; a Comparative Randomized Multicenter Clinical Study.

summary: This study is a prospective, randomized multicenter study conducted in Europe. It is designed to compare two double loop ureteral stents in terms of the quality of life in patients operated on a kidney stone and requiring the placement of a double loop ureteral stent at the end of the operation.

lead_sponsor: Coloplast A/S

location_facility: Service de Chirurgie Urologique de l'Hôpital Tenon


title: Interest of Propionibacterium Freudenreichii for the Treatment of Mild to Moderate Ulcerative Colitis

acronym: EMMENTAL

summary:
Ulcerative colitis (UC) is an immune mediated chronic inflammatory bowel disease that results at least in part of an abnormal immune response to environmental factors including the intestinal microbiota. Thus, use of probiotics (microorganisms that are believed to provide health benefits when consume) may restore the gastrointestinal microbiota and reduce intestinal inflammation.

Propionibacterium freudenreichii is used for the production of fermented food products (cheese). Some selected strains have strong anti-inflammatory properties. Use of cheese based on a monoxenic culture of anti-inflammatory strain of Propionibacterium freudenreichii may decrease disease activity during ulcerative colitis.


title: Postoperative Sedation After Cardiac Surgery: Pilot Study

acronym: SEDCAR

summary: This pilot study evaluates the effectiveness of a closed-loop administration of propofol and remifentanil guided by the bispectral index for short-term sedation after cardiac surgery.

ReferenceCitation: Le Guen M, Liu N, Bourgeois E, Chazot T, Sessler DI, Rouby JJ, Fischler M. Automated sedation outperforms manual administration of propofol and remifentanil in critically ill patients with deep sedation: a randomized phase II trial. Intensive Care Med. 2013 Mar;39(3):454-62. doi: 10.1007/s00134-012-2762-2. Epub 2012 Dec 6.

lead_sponsor: Hopital Foch


title: Study on the Diagnostic Qualities of the Positron Emission Tomography Coupled to the Scanner (PET / CT) in the Assessment of Response to Non-Hodgkin's Lymphoma Therapy in Children and Adolescents

acronym: TEP-LYMPHOME

summary:
This is a diagnostic prospective multicenter study. This study will be conducted in 32 centers of the Société Française des Cancers et Leucémies de l'Enfants et de l'Adolescent (SCFE) in patients with non-Hodgkin lymphoma and treated according to recommendations of the SFCE for each type of non-Hodgkin lymphoma. All patients will have a PET / CT associated with conventional imaging time of remission assessment. Histological examination of residual tumor will be conducted whenever practicable in patients with pathologic residual image on conventional imaging and / or PET / CT. A central review of conventional imaging examinations and PET / CT will be performed independently from each other.

Moreover, whenever possible, patients will have a PET / CT at diagnosis and an early PET / CT (between J8 and J28 according to the type of lymphoma and toxicities due to treatment). The results of the early PET / CT should not lead to treatment modifications.

In case of residual tumor at remission assessment, therapeutics changes as recommended therapeutic protocols will be based on histologic findings and not on the results of PET / CT alone.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Gustave Roussy Cancer Campus Grand Paris


title: Phase II Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas

acronym: PROPAC

summary:
For many years, the treatment of jaundice due to head pancreatic adenocarcinoma is based on the endoscopic biliary stent. This technique has been shown to be preferable to a surgical shunt.

Recently, adjuvant chemotherapy with FOLFIRINOX regimen (clinical trial) has revolutionized the treatment of metastatic pancreatic adenocarcinoma increasing overall survival in a major way. This design will also be developed in patients with neoadjuvant tumor called "borderline" (the limit of the resectability).

However, several conditions (protocol) are required to consider the implementation of this design : age ≤ 75 years, PS 0 or 1, good hematological parameters and bilirubin ≤ 1.5 times the ULN.

In addition, a randomized study showed that preoperative biliary stent treatment, despite a success rate of 94%, is associated with more complications than surgery fast (related gesture bladder).

It would be interesting to analyze, prospectively, the fate of a series of patients with cancer of the pancreatic head with compression of the lower part of the bile duct, PS 0 or 1 and for which the only limit to FOLFIRINOX design is jaundice or high risk of jaundice.

lead_sponsor: Institut Paoli-Calmettes


title: Phase Ib Dose Finding Study of BKM 120 in Combination With LH-RH Agonists and Bicalutamide in Men With Non Castrate Metastatic Prostate Cancer

acronym: NCMPC-BKM

summary: To determine the maximum-tolerated dose (MTD) of BKM120 when administered orally in combination with daily bicalutamide and LH-RH agonists to men with non castrate metastatic prostate cancer.


title: Daily Glycaemic Variability in Frail or Disabled Older Patients With Diabetes Over 75 Treated With Basal Insulin

acronym: VARQUOGLY

summary:
Basal insulin is widely used in older patients with diabetes. Human insulin Neutral Protamine Hagedorn (NPH) has been proposed as basal insulin in older (75 years or older) frail and dependent patients due to its shorter action. However, no study has analysed the glycaemic profile in elderly subjects according to the basal insulin used, particularly in frail or disabled patients.

The aim of this study is to measure intra-day glycaemic variability according basal insulin (human NPH or long acting analogues) in older (75 and older) frail or disabled patients with diabetes using continuous glucose monitoring system.

primary_purpose: Health Services Research

location_facility: University Hospital of Bordeaux - Xavier Arnozan Hospital