acronym: BIGGER

title: Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects Commencing Antiretroviral Therapy: the BIGgeR Study.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

summary: Co-morbidities, including low bone mineral density, increased visceral adiposity and chronic kidney disease (CKD) are frequent in people living with HIV, and may be driven by ongoing inflammation and immune activation. Initiation of ART reduces inflammation and immune activation and is associated with changes in bone and renal biomarkers and gut microbiota. Investigators hypothesise that changes in gut microbiome when starting antiretroviral therapy correlate to changes in bone and renal biomarkers and wish to explore possible mechanisms linking these by investigating changes in markers of inflammation and immune activation.


title: Interventional Trial in Primary Care of Medico-social Mediation on the Prevention of the Return to Emergencies Among People in a Precarious Social Situation

summary:
This research aims to evaluate a new mode of care for precarious public through a medico-social mediation device after emergencies, with the aim of improving their care and to prevent possible complications.

The main objective is to evaluate the effectiveness of management by a medico-social mediation device set up within 48 hours after leaving emergency on the 90-day emergency readmission rate. people living in precarious situations.

prospective randomized interventional trial with two arms. Patients will complete questionnaires assessing precariousness, quality of life, health literacy, and time perspective. Eligible patients (726 subjects) are randomized : control group (usual management) or experimental group (patient is contacted within 48 hours by a medico-social mediator familiar with the territory), and followed for 90 days by the latter, in order to optimize and secure the care path.

Readmissions are identified from emergency database and Regional Emergency Terminal and documented.

Patients in the experimental group benefit from the support of a local health mediator who carries out a diagnosis of the person's needs in order to follow his or her care path in an optimal way. It implements and ensures with the patient and his entourage the follow-up of the care through his network of professionals of the social sector and the health.

The study will be under the responsibility of a multidisciplinary scientific committee experienced in public health, epidemiology and social psychology of health, in the field of emergencies, precariousness and medico-social mediation, and excellent knowledge. territories concerned.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hopitaux de Marseille

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Effects of Butyrate Enemas on Postoperative Intestinal Mobility Disorders in Hirschsprung's

acronym: Buty-Hirsch

summary:
Hirschsprung's disease (HD) is a rare disease defined as a congenital absence of enteric ganglia, resulting usually in neonatal bowel obstruction. The current treatment is the operative removal of the aganglionic bowel and anastomosis to the ganglionic zone considered as 'healthy'. However, postoperative course remains unpredictable.

Functional intestinal disorders are present in up to 45% of patients and can occur in the immediate postoperative period or few weeks/years later.

Until now, there are neither predictive factors of postoperative digestive complications nor established treatment for postoperative dysmotility in HD. Abnormalities in enteric nervous system (ENS) phenotype and functions in the 'healthy' ganglionic segment are increasingly suspected to be directly responsible for postoperative intestinal dysfunctions in HD. Therefore, approaches aimed at restoring the nitrergic phenotype could be of major therapeutical interest. Among targets regulating the nitrergic phenotype of ENS are the microbiota and/or derived metabolites. Indeed preclinical animal models deficient in bacterial sensing molecules have a loss of nitrergic neurons and reduced colonic transit. Conversely, microbiota transfer to newborn germ-free mice restored colonic transit time. Alternatively the investigators has shown that bacterial metabolites such as short-chain fatty acids, in particular butyrate, can increase nitrergic phenotype and enhance colonic motility in a gut immaturity animal model. Therefore the investigators hypothesize preoperative butyrate enema will reduce postoperative intestinal complications at short-term and medium/long-term.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Treatment


title: Evaluation of Long-term Health-related Quality of Life After Massive Burn Injury : A Twenty Years' Experience in a Burn Center

acronym: HR - QOL MR

summary: Massive burns are serious life-threatening conditions. Recent advances in their management now allow the survival of a growing number of patients. The burn care paradigm is transformed: the evaluation of survival at the end of acute care is no longer sufficient for a good evaluation of practices; the attention now focuses on long-term health-related quality of life (HR-QOL).The recently validated French translation of the burn specific health scale brief version makes this evaluation now feasible in French burn centers. The objectives of this study are to evaluate the HR-QOL of massive burn survivors, to compare it to another chronic condition (necrotizing fasciitis) and to determine the main predictive factor of health-related quality of life. This study is retrospectively conducted in 18 patients who survived a massive burn injury involving more than 80% of the total body surface area, or more than 70% of the total body surface area if the injury occured during childhood and who were treated between 1997 and 2017 in our Lyon burn center. Short Form-36 Medical Outcomes Survey (SF-36), and Brief Version of Burn Speciﬁc Health Scale (BSHS-B) are used for the present evaluation.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon, Croix-Rousse Hospital

status_simplified: Completed


title: Grey Matter Damage at the Earliest Phase of Multiple Sclerosis : a Longitudinal 7T Magnetic Resonance Imaging Study

summary: The present study is an opportunity to assess grey matter damage at the earliest phase of Multiple Sclerosis (MS) allowing to a better understanding of its origins and its impact and disease severity. This study is a preliminary longitudinal study to precisely depict the kinetic of grey matter damage and the links with disease aggravation. Thirty MS patients without time and spatial dissemination criteria (only one symptomatic MRI lesion detected) but with oligoclonal bands detected on cerebro spinal fluid analysis will be included for a monocentric transversal MRI study at 7T to assess grey matter injury. Clinical and neuropsychological assessments will be performed in the population the same day of a multi-parametric MRI. A longitudinal clinical and MRI follow up will be performed during 2 years.

primary_purpose: Diagnostic


title: Phase I Dose-escalation Study of Adapted Physical Activity in Children and Adolescent Suffering From Advanced Malignancies.

summary:
Adapted physical activity (APA) in the context of cancer is a field of growing interest and has been explored in numerous publications. In adults, the effects of APA on survival, symptoms and quality of life are established and its physiological consequences on immunity, angiogenesis and hormone secretion are under investigation.

In children and adolescents, evidence is scarce: pilot studies show clinical benefit of physical activity practiced in a wide variety of situations and protocols with low level of scientific evidence. It is therefore not possible to recommend this practice in pediatrics despite the large number of initiatives and the conviction of many clinicians that there is a benefit for patients. In particular, there are few trials in children with advanced cancer pathologies or in palliative care. However, these patients have a high prevalence of severe symptoms (pain, digestive disorders, asthenia, and anxiety) for which physical activity may represent a therapeutic option.

The purpose of our study is to describe a protocol of adapted physical activity and to evaluate its feasibility and toxicity according to a well-known and validated methodology in oncology used in drug development.

Methodology is based on a simple and reproducible intervention combining brisk walking on treadmill and exercises of muscular strengthening with varying durations and intensities depending on physical capabilities of patients.

The primary objective is to define the volume of physical activity that can be proposed to a patient starting APA based on the assessment of his physical condition evaluated by a 6-minutes walking distance test.

Inclusion criteria are broad to allow study population to represent the diversity of patients in pediatric palliative oncology. Stratification of patients in three groups based on a 6-minutes walking distance test aims to adapt intervention to physical capability of patients and improve tolerance.

Dose escalation will be set with a "3 + 3" regimen used in drug early phases trials.

Primary outcome measure is perceived tolerance evaluated by the patient with a subjective scoring on CREST scale. Any score greater than 8/10 defines intolerance.

status: Unknown status

location_facility: Assiatnce Publique Des Hopitaux de Marseille

status_simplified: Unknown


type: Other Identifier

title: Prospective Multicentre Randomized Clinical Trial on the Management of Pregnancies With High Risk of Venous Thrombosis

acronym: PRESCOT

summary:
The management of venous thromboembolism (VTE) risk in pregnancy still remains a challenge. An individual assessment of the VTE risk is crucial for optimal thromboprophylaxis, but there is no validated tool to help clinicians stratify the risk in pregnant women and introduce prophylactic anticoagulation at the appropriate time. Recommendations mostly based on case-control studies and expert opinions do not accurately reflect the physician's need. In view of the lack of international recommendations with a high level of evidence regarding prophylactic treatment of pregnant women at risk of thrombosis, the use of a risk stratification tool that takes all individual risk factors for VTE into consideration and which aids decisions over prophylaxis regimens may help. Investigators have previously described a VTE risk score (the Lyon-VTE-score), rating patients at increased risk of VTE and recommending individually tailored management. A retrospective evaluation of the initial score showed favorable outcomes in pregnancies with a high risk of thrombosis. A subsequent multicenter prospective study reported promising results using this score and related management strategy. The efficacy and safety after 10 years of prospective use of the Lyon-VTE-score in daily practice to guide the prescription of antithrombotic prophylaxis during pregnancy was recently evaluated and the results showed that the Lyon-VTE-score allows a standardized approach with objective criteria and can help non-specialized centers and young doctors manage these high-risk pregnancies.

The results of previous studies provide consistent conclusions on the safety and efficacy of the approach of investigators and give background for a medico-economic study to evaluate costs and consequences of this procedure. The most recent study (2005) evaluating the cost of prophylaxis in pregnant women, evaluated this cost as $1292 for each 6-week cycle of treatment. In addition, the use of such a score offers the prospect of personalized medicine, which is probably more cost-efficient compared to "inclusive, equal treatment for all".

In antepartum, the decision to administer thromboprophylaxis should be considered on an individual basis with regard to lowering the absolute risk of thrombosis, the inconvenience of daily subcutaneous heparin therapy and the potential risks of bleeding, heparin-induced thrombocytopenia and osteoporosis. An individual assessment of the VTE risk is crucial for optimal thromboprophylaxis, but there is no validated tool to help clinicians to stratify VTE risk in pregnant women and to introduce prophylactic anticoagulation at the right time.

Most of the recommendations are grade 2C. They are mostly based on case-control studies and expert opinions and do not entirely highlight the physicians' need. The originality of this approach is the use of a risk stratification tool that takes all individual risk factors for VTE into consideration and that aids the decision-making process of antenatal anti-thrombotic prophylaxis. This study will personalize care using a score to individually assess the risk and propose appropriate prevention.

The main objective of this study is to conduct a medico-economic study to evaluate the efficiency of an innovative strategy integrating the Lyon-VTE-score in the management of pregnant patients with venous thromboembolism risk versus standard care.

status: Recruiting

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3:CD001689. doi: 10.1002/14651858.CD001689.pub4.

intervention_type: Procedure


title: Effects of Combined Treatment by Botulinum Toxin A and Robot-Assisted Gait Training (Lokomat®) on Walking Ability in Patients With Chronic Stroke: a Prospective, Controlled, Randomized Study

acronym: Lokomat

summary:
75% patients in the chronic phase of a stroke keep walking disabilities. Focal spasticity in the paretic lower limb frequently causes these walking disabilities, and the gold standard treatment is intramuscular injection of Botulinum toxin A in the spastic muscles.

To potentiate the effects of toxin, walking rehabilitation is usually prescribed in the weeks following injection, but the protocols vary and few have been evaluated in the medical literature.

In particular, the effect on walking ability of combined treatment by botulinum toxin A and robot-assisted gait training has never been evaluated.

Tested hypothesis: Robot-assisted gait training by Lokomat® motorized exoskeleton potentiates botulinum toxin's effects better than conventional walking therapy.

The aim of this study was to evaluate the effects on walking ability of the association of focal spasticity treatment by Botulinum toxin and Lokomat-assisted walking rehabilitation in patients suffering from spastic hemiparesia after stroke in the chronic phase.

Outcome:

-Primary: distance walked (meters) in the six-minute walk test (SMWT)

Prospective, randomized, controlled, opened, monocentric study with a crossover design.

Recruitment of patients over 18 years of age, in the chronic phase of stroke, who have already been treated by Botulinum toxin injection for focal spasticity in our PMR ward.

Assessment at Day one (D0), Week four (W4) and Week eight (W8).

Following a preliminary study which had the six-minute walk test as a secondary outcome, the expected results are a significant improvement of the distance walked in the SMWT after robotic rehabilitation, and a lack of significant improvement following conventional therapy.

The study should serve to further harmonize and optimize rehabilitation protocols after toxin injections, and to justify the use of robotic rehabilitation for patients in the chronic phase of stroke.


title: Impact of the Introduction of ORKAMBI on Anxiety, Depression, Quality of Life and Adherence of Adolescents and Young Adults

acronym: ORK-AJA

summary: The aim of this project is to evaluate the psychological reshuffle induced by ORKAMBI. The particular focus of this study is the consequence of its introduction on anxiety, depression, quality of life and adherence to all cystic fibrosis (CF) treatment. To answer this question investigators will monitor the psychological function of CF adolescents and young adults treated with ORKAMBI and compare them to CF adolescents and young adults not treated with ORKAMBI.

ReferenceType: background

ReferenceCitation: Pendleton DA, David TJ. The compliance conundrum in cystic fibrosis. J R Soc Med. 2000;93 Suppl 38:9-13. Review.

ReferenceCitation: Bucks RS, Hawkins K, Skinner TC, Horn S, Seddon P, Horne R. Adherence to treatment in adolescents with cystic fibrosis: the role of illness perceptions and treatment beliefs. J Pediatr Psychol. 2009 Sep;34(8):893-902. doi: 10.1093/jpepsy/jsn135. Epub 2009 Feb 5.

ReferenceCitation: Zindani GN, Streetman DD, Streetman DS, Nasr SZ. Adherence to treatment in children and adolescent patients with cystic fibrosis. J Adolesc Health. 2006 Jan;38(1):13-7.

ReferenceCitation: Butner J, Berg CA, Osborn P, Butler JM, Godri C, Fortenberry KT, Barach I, Le H, Wiebe DJ. Parent-adolescent discrepancies in adolescents' competence and the balance of adolescent autonomy and adolescent and parent well-being in the context of Type 1 diabetes. Dev Psychol. 2009 May;45(3):835-49. doi: 10.1037/a0015363.

ReferenceCitation: Arias Llorente RP, Bousoño García C, Díaz Martín JJ. Treatment compliance in children and adults with cystic fibrosis. J Cyst Fibros. 2008 Sep;7(5):359-67. doi: 10.1016/j.jcf.2008.01.003. Epub 2008 Mar 4.

ReferenceCitation: Marciel KK, Saiman L, Quittell LM, Dawkins K, Quittner AL. Cell phone intervention to improve adherence: cystic fibrosis care team, patient, and parent perspectives. Pediatr Pulmonol. 2010 Feb;45(2):157-64. doi: 10.1002/ppul.21164.

ReferenceCitation: Blackwell LS, Marciel KK, Quittner AL. Utilization of patient-reported outcomes as a step towards collaborative medicine. Paediatr Respir Rev. 2013 Sep;14(3):146-51. doi: 10.1016/j.prrv.2013.04.003. Epub 2013 May 27.

ReferenceCitation: Girerd X, Radauceanu A, Achard JM, Fourcade J, Tournier B, Brillet G, Silhol F, Hanon O. [Evaluation of patient compliance among hypertensive patients treated by specialists]. Arch Mal Coeur Vaiss. 2001 Aug;94(8):839-42. French.

ReferenceCitation: Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7.

ReferenceCitation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13.

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Department of Pneumology -CRCM - Necker - Enfants maladies Hospital (AP-HP)

intervention_type: Behavioral


title: Multicenter Prospective Observational Study of the Outcome of Patients With Acute Myeloblastic Leukemia (AML) and Myelodysplastic Syndrome (MDS) Receiving Iron Chelation Therapy (Exjade) After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)

acronym: GREFFE

summary:
Iron chelation, mostly associated with multiple red blood cell transfusion, is relatively common in patients with hematological malignancies receiving allo-HSCT.

This multicenter prospective observational study is designed to establish the impact of iron chelation on relapse after allo-HSCT in patients with acute myeloid leukemia and myelodysplastic syndrome. The investigators will compare the results obtained in the prospective study to those observed in a historical retrospective cohort of paired patients who did not receive chelation. Given our clinical experience and literature results, the investigators will evaluate the Exjade chelator. Although not demonstrated, the presence of mutations of the HFE gene could play an indirect role on leukemogenesis by promoting overload. It is therefore important to evaluate the status in this patient population.

time_perspective: Prospective

intervention_type: Drug


title: Identification of Predictive Neuroinflammatory Biomarkers of Neuro-radiological Evolution in Severe Traumatic Brain Injury

acronym: ICON-TBI

summary:
Tertiary lesions responsible of the neurological decline after severe traumatic brain injury (TBI) are partially due to a persistent neuro-inflammation directly modulated by inflammatory mediators during the acute phase and detectable by using both multimodal MRI imaging and biological biomarkers during the acute phase after traumatic brain injury.

The main objective is to identify if the level of IL-1beta in cerebrospinal fluid predict in a reliable and reproducible way, the neuro-radiological evolution evaluated by the comparison of a quantitative MRI performed in post-resuscitation and at one year (quantitative ΔIRM) in traumatic brain injuried patients.

The secondary objectives are:

To understand the links between the acute and chronic neuro-inflammatory phase in a population of TBI,
To explore the contribution of the adaptive immune response in the persistent activation of the immune response,
To Examine the links between persistent neuroinflammation, clinical deterioration and neuroimaging,
To establish a correlation between the pathology and the physio-pathology of TBI.

location_facility: Anesthesy department - Hôpital Pitié Salpêtrière

intervention_type: Biological


title: Population-Based Pharmacokinetic / Pharmacodynamic Modeling of the Effect of Free Ticagrelor Fraction on the Platelet Membrane in Post Myocardial Infarction Patients

acronym: PLATIME

summary:
The purpose of this study is to assess:

the population pharmacokinetics of unbound ticagrelor and its metabolite in acute coronary syndrome patients treated by ticagrelor
ticagrelor and its metabolite levels by LC-MS/MS

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Time Trend Analysis of Pulmonary Embolism Diagnosis With SPECT V/Q: a Single Institution Observational Study From 2011 to 2016

acronym: TOMOBS

summary: Following the implementation of SPECT V/Q imaging for PE diagnosis, the investigators previously conducted an observational study over the period 2011-2013 that showed the safety of a diagnostic management based on SPECT V/Q to rule out PE. However, PE prevalence was high (28%), which may seem a bit high as compared with other recent studies. The hypothesis was that the use of SPECT V/Q may be responsible for an overdiagnosis of PE, especially at the implementation phase of the test. The aim of this study was to perform a time trend analysis of the evolution over the years of PE diagnosis with SPECT V/Q.

lead_sponsor: University Hospital, Brest


title: Transversus Abdominis Plane (TAP) Block in Open Abdominal Aortic Surgery : Randomized Controlled Doubled-blind Trial Comparing Ropivacaine 0.2% Versus Placebo

acronym: TAP-CACAO

summary: The primary outcome of this study was the evaluation of the efficacy of TAP block on pain intensity following open abdominal aortic surgery.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Cardiovascular and thoracic surgery unit, CHU Dijon


title: Combined Thoracic Ultrasound Using Speckle Tracking for the Prediction of Weaning Failure : a Prospective Multicenter Study

summary: Deciding the optimal timing for extubation in patients who are mechanically ventilated can be challenging, and traditional weaning predictor tools are not accurate. Recent studies suggest that isolated sonographic assessment of the respiratory and cardiac function (ie diastolic function and filling pressure), in mechanically ventilated patients may assist in identifying patients at risk of weaning failure. Recently, the association of conventional echocardiography and lung ultrasound showed promising results for the prediction of post extubation distress. Speckle Tracking is an emerging tool in intensive care medicine that has never been investiguated for the prediction of weaning failure. It could early detects diastolic dysfunction and and elevated filling pressure. Of more, speckle tracking is known to be less operator dependant. The main objective of our study is to evaluate the diagnosis accuracy of speckle tracking echocardiography performed during a weaning trial to predict weaning failure. The secondary objectives are to assess the diagnosis accuracy of combined heart and lung ultrasound to predict weaning failure.

design_allocation: Non-Randomized

location_facility: Assistance Publique Hôpitaux de Marseille


title: Monocentric Pilot Study, for a Randomized, Crossover, Blinded Trial: Comparison of the Therapeutic Efficacy of Low Frequency Repeated Transcranial Magnetic Stimulation on Cortical Area 9 Compared to Brodmann Area 46 in the Treatment of Depressive Disorders.

acronym: rTMS

summary:
Repetitive transcranial magnetic stimulation (rTMS) is a new therapeutic tool used in psychiatry. Non-invasive, well tolerated and requiring no premedication, it is performed on an outpatient basis. The principle of this technique is to stimulate the cerebral cortex from an electromagnetic coil placed on the scalp. Unlike electroconvulsive therapy, rTMS induces an electrical current on a well-defined region of the cerebral cortex.

In psychiatry, this technique is mainly considered in the treatment of depressive disorders resistant to antidepressant medication. The brain target, obtained from brain imaging data in depressed patients, is the dorsolateral prefrontal cortex (DLPFC). The Food and Drug Administration (FDA) has recognized the interest of rTMS for treating depressive disorders (October 7, 2008).

However, some stimulation parameters still need to be optimized before rTMS can be considered a therapeutic method in its own right and used routinely. Indeed, its effectiveness over time has not yet been evaluated, and rTMS has shown a lack of reproducibility between subjects [Foucher, 2007]. Finally, the therapeutic results of rTMS are very modest whatever the study [Daskalakis, 2008]. Additional studies are therefore needed to optimize stimulation parameters.

intervention_type: Radiation


title: Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.

acronym: HAGED

summary:
Diabetes is a major public health problem that has been growing steadily in recent years. Its prevalence is very high in the elderly, in whom there is an increased risk of hypoglycemia.

Hypoglycaemia in elderly diabetics has serious consequences:

increased mortality,
increased cardiovascular morbidity,
increased risk of falling,
impairment of quality of life.
Hypoglycaemia is also a risk factor for dementia in type 2 diabetes. The frequency of asymptomatic and atypical hypoglycemia has been shown to be greater in the elderly, but the exact prevalence of hypoglycemia in the elderly remains unknown.

Elderly diabetic patients in institutions are particularly fragile and have more frequent cognitive problems than non-diabetic subjects. A study conducted in this population of patients showed that a third of them had HbA1C <6.5%, which suggests a higher frequency of hypoglycemia though the figures were not available.

We therefore decided to conduct a study to assess the frequency of hypoglycemia in order to better understand the contributing factors and to improve the management of this fragile population.


title: Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation

acronym: MAVUFERT

summary:
Uterine arteriovenous malformations (UAVM) are short circuits between systemic arterial and venous networks within the uterus. They are congenital or acquired (in the course of an endo-uterine gesture such as curettage or interventions such as caesareans or myomectomies).

They can be manifested by severe metrorrhagia that can go as far as to put the patient's vital prognosis at risk.

There are no recommendations for the management of UAVM since this pathology is rare and therefore series are performed with few cases. If some of these UAVM disappear spontaneously after a therapeutic abstention, when the clinical context allows it, in case of symptomatic UAVM, a selective embolization with arteriography is often carried out to postpone the hysterectomy of hemostasis.

There are also more marginal management options such as Gonadotropin-Releasing Hormone agonists, methotrexate or curettage that are decided on a case by case basis depending on the symptoms and protocols of each medical team.

Regarding subsequent fertility and pregnancy outcomes after conservative treatment, the number of studies is even lower.

lead_sponsor: Rennes University Hospital


title: Investigating the Value of Reticulocyte Haemoglobin Content (RET-he) in the Management of Functional Martial Deficiency Anaemia in Patients With Solid Tumours

acronym: RET-HE

summary: Determine the value of the initial measurement of the hemoglobin content of reticulocytes (RET-He) for predicting the response to martial treatment for patients with a solid tumor with a functional martial deficiency as defined NCCN2016 (with or without inflammation). The aim is to refine the current definition of functional martial deficiency in order to best adapt the iron prescription in oncology by giving iron only if necessary, i.e. if the RET is low.

lead_sponsor: Institut Cancerologie de l'Ouest

lead_sponsor_type: industriel


title: Therapeutic Efficacy Comparison of a Six-month Treatment by Itraconazole and Nebulised Ambisome® Versus Treatment by Itraconazole Alone in Non- or Mildly- Immunocompromised Patients With Chronic Pulmonary Aspergillosis: a Prospective, Randomized, Single Blind Study, (Single Aspergilloma Excluded)

summary:
This study compares the therapeutic (clinical and radiological) efficacy of a six-month treatment by itraconazole and nebulised Ambisome® (liposomal amphotericin B = LAmB) versus treatment by itraconazole alone, in non - or mildly - immunocompromised patients affected by Chronic Pulmonary Aspergillosis (single aspergilloma excluded).

• Control arm: Itraconazole 200 mg x 2/day associated with inactive nebulised treatment twice a week during 24 weeks.

• Experimental arm: Itraconazole 200 mg x 2/day associated with nebulised LAmB, at 25 mg twice a week during 24 weeks.

Follow up duration for the patients will be 24 months (12 months minimum) after discontinuation of the treatment being studied.

lead_sponsor: Poitiers University Hospital


title: Study of the Link Between Retinal Atrophy and Demyelinating Inflammatory Processes on Visual Pathways in Relapsing Multiple Sclerosis in Magnetic Resonance Imaging and Optical Coherence Tomography

acronym: VWIMS

summary: This study will interest in the pathophysiology of silent retinal axonal loss in multiple sclerosis. Recent studies have suggested that silent retinal axonal loss (no past history of optic neuritis [ON]) may be due to inflammatory lesions within the optic radiations and a transsynaptic degenerative process. The objective is to measure the exact role of silent optic nerve lesion in the occurrence of silent retinal axonal loss by performing OCT, brain and optic nerve MRI in a cohort of patients without recent disease activity.

ReferenceCitation: Hodel J, Outteryck O, Bocher AL, Zéphir H, Lambert O, Benadjaoud MA, Chechin D, Pruvo JP, Vermersch P, Leclerc X. Comparison of 3D double inversion recovery and 2D STIR FLAIR MR sequences for the imaging of optic neuritis: pilot study. Eur Radiol. 2014 Dec;24(12):3069-75. doi: 10.1007/s00330-014-3342-3. Epub 2014 Aug 23.

ReferenceCitation: Hadhoum N, Hodel J, Defoort-Dhellemmes S, Duhamel A, Drumez E, Zéphir H, Pruvo JP, Leclerc X, Vermersch P, Outteryck O. Length of optic nerve double inversion recovery hypersignal is associated with retinal axonal loss. Mult Scler. 2016 Apr;22(5):649-58. doi: 10.1177/1352458515598021. Epub 2015 Jul 30.

ReferenceCitation: Gabilondo I, Martínez-Lapiscina EH, Martínez-Heras E, Fraga-Pumar E, Llufriu S, Ortiz S, Bullich S, Sepulveda M, Falcon C, Berenguer J, Saiz A, Sanchez-Dalmau B, Villoslada P. Trans-synaptic axonal degeneration in the visual pathway in multiple sclerosis. Ann Neurol. 2014 Jan;75(1):98-107. doi: 10.1002/ana.24030. Epub 2014 Jan 2.

ReferenceCitation: Jindahra P, Petrie A, Plant GT. The time course of retrograde trans-synaptic degeneration following occipital lobe damage in humans. Brain. 2012 Feb;135(Pt 2):534-41. doi: 10.1093/brain/awr324. Epub 2012 Feb 1.

ReferenceCitation: Petzold A, Balcer LJ, Calabresi PA, Costello F, Frohman TC, Frohman EM, Martinez-Lapiscina EH, Green AJ, Kardon R, Outteryck O, Paul F, Schippling S, Vermersch P, Villoslada P, Balk LJ; ERN-EYE IMSVISUAL. Retinal layer segmentation in multiple sclerosis: a systematic review and meta-analysis. Lancet Neurol. 2017 Oct;16(10):797-812. doi: 10.1016/S1474-4422(17)30278-8. Epub 2017 Sep 12. Review.

ReferenceCitation: Martinez-Lapiscina EH, Arnow S, Wilson JA, Saidha S, Preiningerova JL, Oberwahrenbrock T, Brandt AU, Pablo LE, Guerrieri S, Gonzalez I, Outteryck O, Mueller AK, Albrecht P, Chan W, Lukas S, Balk LJ, Fraser C, Frederiksen JL, Resto J, Frohman T, Cordano C, Zubizarreta I, Andorra M, Sanchez-Dalmau B, Saiz A, Bermel R, Klistorner A, Petzold A, Schippling S, Costello F, Aktas O, Vermersch P, Oreja-Guevara C, Comi G, Leocani L, Garcia-Martin E, Paul F, Havrdova E, Frohman E, Balcer LJ, Green AJ, Calabresi PA, Villoslada P; IMSVISUAL consortium. Retinal thickness measured with optical coherence tomography and risk of disability worsening in multiple sclerosis: a cohort study. Lancet Neurol. 2016 May;15(6):574-84. doi: 10.1016/S1474-4422(16)00068-5. Epub 2016 Mar 18.

lead_sponsor: University Hospital, Lille


title: Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients

summary: Posterior Reversible Encephalopathy Syndrome prospective (PRES) registry. Data collection using a standardized form : demographic data and data related to the PRES, including circumstances of onset, dates and times of onset and of symptoms control, on-scene clinical findings, clinical and radiological features of PRES, pre-hospital and hospital care providers, timing of antiepileptic, antihypertensive drugs and supportive treatments, results of etiological investigations, cause of PRES, type and dosage of antiepileptic and antihypertensive drugs. Dates and times of EEG monitoring, EEG results, radiological and biological investigations. Outcomes including vital status and Glasgow Outcome Scale score at ICU and hospital discharge, day-90 and 1-year after SE and determined based on data in the ICU and/or neurologist charts and/or patients phone interview

lead_sponsor: Ictal Group

location_facility: Intensive Care Unit - Versailles Hospital


title: Validation of a Self-questionnaire in French on the Use of the Upper Limbs in Patients With Multiple Sclerosis

acronym: MS-SEP

summary: Multiple sclerosis (MS) is an inflammatory and demyelinating disease of the central nervous system that causes disability in young adults. This disability can take many forms depending on the neurological systems affected: disability walking, cognitive impairment or disability in the upper limbs. The development of validated measurement tools for these different disabilities is essential for the follow-up of patients in clinical routine and for the evaluation of new therapies.

ReferenceCitation: Samejima F. Estimation of latent ability using a response pattern of graded scores. Richmond, VA: The Psychometric Society, 1969.


title: Study of the Cellular Diffusion of Tacrolimus Across the Membrane of Mononuclear Cells

acronym: DIFF-TAC

summary:
Pharmacokinetics of tacrolimus are highly variable and may result in graft rejection (underdosing) or toxicity (overdosing).

The risk of transplant rejection and the toxicity of tacrolimus can be reduced by pharmacological therapeutic monitoring of the molecule, based on the measurement of residual blood concentrations. Nevertheless, some patients are victims of rejections or toxic signs even though their blood concentrations are in the therapeutic target.

The aim of the study is to describe the pharmacokinetics of tacrolimus diffusion in mononuclear cells as well as the kinetics of effect of the drug on its target protein

ReferenceCitation: Blanchet B, Hulin A, Duvoux C, Astier A. Determination of serine/threonine protein phosphatase type 2B PP2B in lymphocytes by HPLC. Anal Biochem. 2003 Jan 1;312(1):1-6.

ReferenceCitation: Blanchet B, Hulin A, Ghaleh B, Giraudier S, Jouault H, Astier A. Distribution of calcineurin activity in blood cell fractions and impact of tacrolimus inhibition. Fundam Clin Pharmacol. 2006 Apr;20(2):137-44.


title: Bronchial Obstruction in Dairy Farmers

acronym: BPCO Airbag

summary:
Chronic Obstructive Pulmonary Disease (COPD) is a major public health problem and is expected to become the 3rd leading cause of death globally by 2020.

The main risk factor is tobacco. Tobacco poisoning is found in 80 to 90% of patients with COPD. However, non-smoking COPD is also described, with increasing prevalence figures, particularly related to occupational exposure, especially among farmers.

ReferenceCitation: Jouneau S, Chapron A, Ropars C, Marette S, Robert AM, Gouyet T, Belleguic C, Rochefort-Morel C, Guillot S, Mailloux C, Desrues B, Viel JF; AIRBAg research group. Prevalence and risk factors of asthma in dairy farmers: Ancillary analysis of AIRBAg. Environ Res. 2022 Nov;214(Pt 4):114145. doi: 10.1016/j.envres.2022.114145. Epub 2022 Aug 20.

location_facility: Rennes University Hospital - Service de Pneumologie


title: Longitudinal Study by 2D-speckle-tracking Echocardiography of the Ventricular Wall Motion During Postnatal Adaptation

acronym: BABYSTRAIN

summary: The left ventricular torsion during systole and diastole is a normal dynamic mechanism which participates in the ejection and the filling of the left ventricle. Postnatal hemodynamic modifications are major and probably affect this mechanism. The aim of this study is to compare the left ventricular twist in healthy newborns, between their first days of life and their third month of life, using the 2D-speckle tracking echocardiography.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Grenoble


title: Intra-abdominal Umbilical Vein Aneurysm

acronym: AVO

summary: The purpose of this study is to investigate the ultrasound characteristics and outcome of pregnancies with fetal Intra-abdominal umbilical vein aneurysm.

lead_sponsor: Centre Hospitalier René Dubos

intervention_type: Diagnostic Test


title: Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump Coupled With the Continuous Measurement of Interstitial Glycemia in Type 1 Diabetic Adults

acronym: AAHPI

summary: This study compares the apparition of hypoglycaemia in type I diabetic patients between 2 phases: the one without the use of SmartGuard® function and the one with the use of SmartGuard® function.

status: Terminated

lead_sponsor: ARAIR Assistance

intervention_type: Device


title: Effects of a Neuroscience-based Technique on Post-traumatic Stress Disorder Symptoms, Inflammation, and Survival in Cancer Patients Announced of a Palliative Disease Progression and Their Partners

acronym: NeuroPrevPTSD

summary:
The diagnosis and treatment trajectory of cancer can constitute a traumatic event because these can be perceived as sudden, catastrophic and life threatening. One common mental disorder following traumatic events is post-traumatic stress disorder (PTSD), described as reexperiencing of the event (e.g., having intrusive thoughts), having avoidance of trauma memories, emotional numbing, and experiencing hyperarousal symptoms. To date, and to the best of the investigator's knowledge, few studies have focused on PTSD in advanced cancer, but the existing data show that these patients are at risk for experiencing PTSD symptoms.

Among the early interventions for preventing PTSD in people confronted by traumatic events is group debriefing, the retelling of the event, receiving empathy and compassion, and being encouraged to express feelings. However, four meta-analyses found debriefing to be ineffective. A neuroscience-based and evidence-based alternative may be the Memory Structuring Intervention (MSI) that tries to shift trauma processing from a limbic, emotional and somatic level to a frontal-cortical, cognitive and verbal level of processing. The MSI tries to achieve this shift by teaching people confronted with traumatic events to chronologically organize the segments of the event, to verbally label feelings or somatic sensations rather than re-experience them, and to provide causal links between the event's segments and causality to their feelings and sensations Since in males, sympathetic responses were more predictive of PTSD than in females , parasympathetic activation may be needed to be added to the MSI, for men. A main branch of the parasympathetic response is the vagus nerve, whose non-invasive index is Heart Rate Variability (HRV). One way to increase HRV, and thus parasympathetic activation, is through vagal breathing (i.e., deep, paced breathing). Therefore, adding to the MSI deep vagal breathing (VB) to reduce sympathetic hyperactivity, may increase connectivity between the amygdala and the frontal cortex. This may also increase the emotional regulation possibly yielded by the MSI, however in both genders.

The effects of the MSI + vagal breathing on PTSD symptoms and on prognosis in advanced cancer patients receiving announcement of terminal cancer have never been investigated. Furthermore, whether reduced inflammation and increased emotional regulation may account for such effects needs to be investigated at the fundamental level. This project reflects the merging of neuroscience, psychooncology and psychoneuroimmunology for better understanding and treating cancer patients, as well as their partners.

lead_sponsor: Centre Oscar Lambret


title: Evaluation of the Detection of B D Glucan in Peritonitis Fluid in Intensive Care Unit (ICU) Patients With Peritonitis for the Diagnosis of Fungal Peritonitis, Compared to Routine Microbiology Diagnosis Method. The PERICAND Study

acronym: PERICAND

summary:
Invasive candidiasis has a high mortality rate, around 40%. Outcome remains tightly linked to the time of treatment administration. Routine microbiological techniques give results too lately to allow prompt antifungal therapy initiation (at least 48 hours). It is important to develop diagnostic tools to initiate antifungal therapy as early as possible.

The B D glucan detection, one of the major components of the candida cell wall, can be useful for a early diagnosis.

There are several techniques on the market for the detection of glucan. In Europe and America, the most used is Fungitell (Associated of Cape Cod, Inc).

There is several studies about the use of such kits for fungemia. A number of studies are reporting evidences of a early diagnosis.

But, in medical literature, there isn't study focused on the detection of B D glucan in peritoneal fluid for Candida peritonitis diagnosis.


title: Evaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System). Prospective, Monocentric, Randomized, Open Label Study.

acronym: PUC NAVIO

summary:
Unicompartmental knee arthroplasty by unicompartmental prosthesis (PUC) is a treatment for isolated internal femoro-tibial osteoarthritis. This intervention is justified in cases of significant discomfort, failure of medical treatment and the absence of osteoarthritis in femoro tibial external and patellofemoral femoro compartments. It aims to replace the native internal femoral tibial articulation by a joint between two implants, without intervening on the other compartments. The functional results of PUC are superior and faster than those obtained with total knee arthroplasty (TKA). Its indications and its realization are on the other hand very demanding to allow an optimal functional result.

Robotic-assisted surgery provides an excellent level of precision, which could allow better positioning of implants, compared to the use of a mechanical ancillary, according to the first published studies. The functional results and survival of these implants could also be improved.

The internal PUC with mechanical ancillary is carried out for many years in the orthopedic surgery department of Croix Rousse. For 3 years this surgery is sometimes performed with robotic assistance.

The investigators would like to prospectively evaluate the clinical and radiological impact of robotic-assisted surgery when performing a Journey unicompartmental prosthesis (Smith & Nephew).

The assessment of alignment during walking seems to be a paramount parameter in the results of the PUC and has not so far been evaluated in this type of robotic-assisted surgery.


title: Study of Diaphragm Mobility on Tissue Doppler (Thoracotomy vs Sternotomy in Diaphragm Dysfunction Following Heart Surgery)

acronym: DD

summary:
Diaphragm dysfunction is found in 10 to 90% of patients following heart surgery.

In current practice diaphragm dysfunction is evaluated by 2D ultrasonography. Tissue Doppler is a validated technique to study heart contractility. Its use in the analysis of diaphragm function must be evaluated to determine its interest as a diagnostic tool.

Better understanding of diaphragm dysfunction following heart surgery will lead to earlier management of post-operative respiratory complications and the implementation of preventive pre-operative measures.

We intend to look for correlations between the TM (Time-Movement) mode and tissue Doppler in the assessment of diaphragm mobility.


title: Study of Natural Killer Immunity During Infections With CMV or AdV After Allogeneic Hematopoietic Stem Cells

acronym: Allo-NK-CMV

summary: NK cells are lymphocytes who play a role in the control of viral infections , tumor and fœtal tolerance. They belong to innate immune cells but they have a link with adaptative immunity. Indeed, after some viral infections such as CMV, Chikungunya, B hepatitis etc, a subset of NKG2C+ NK cells expands and can transfer, in murine models, a " memory " that can better control CMV infections. CMV reactivation is a major cause of morbidity and mortality after allogeneic hematopoietic ste cell transplantation in humans. The aim of this prospective study is to evaluate the role of NK cells, in particular NKG2C+ NK cells in the control of CMV but also Adenovirus after allo HSCT. Peripheral NK cells from 30 and 10 patients who reactivated respectively CMV and AdV are prospectively studied (extensive phenotyping and functional studies before and after administration of anti viral drugs) and compared with 30 allotransplanted patients who didn't reactivate CMV in a pair analysis, and 30 healthy donors serologically + for CMV.


type: EudraCT Number

title: Safety and Efficacy of the ONCOlytic VIRus Armed for Local Chemotherapy, TG6002/5-FC, in Recurrent Glioblastoma Patients

acronym: ONCOVIRAC

summary:
Glioblastoma is the most common and the most aggressive primary brain cancer in adults. Indeed, despite very intensive treatments (i.e. maximal safe surgery, radiotherapy and several lines of cytotoxic chemotherapies), inducing significant adverse events, the prognosis of glioblastoma patients remains dismal with a median overall survival of ~15 months. Therefore, more efficient and less toxic therapies are urgently needed to improve survival and quality of life of glioblastoma patients.

The oncolytic virus TG6002 has shown efficacy and good safety profile in several preclinical models of glioblastoma in vitro (i.e. cell line) and in vivo (i.e. xenografts in Swiss/Nude mice). Comprehensive toxicology studies of TG6002/Flucytosine have been completed in rabbits and monkeys supporting safety investigations of TG6002/Flucytosine in human patients.

Taken these data all together, TG6002/Flucytosine appears as a very promising therapeutic strategy in glioblastoma patients that merits consideration for early phase clinical trial.


title: TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma - A Phase Ib Clinical Study

acronym: TICIMEL

summary: This is a Phase 1b, open-label study of immune checkpoints inhibitors Nivolumab+Ipilimumab administered in combination with the anti-TNF-α either Infliximab or Certolizumab, in patients with advanced melanoma.

ReferenceCitation: Montfort A, Filleron T, Virazels M, Dufau C, Milhès J, Pagès C, Olivier P, Ayyoub M, Mounier M, Lusque A, Brayer S, Delord JP, Andrieu-Abadie N, Levade T, Colacios C, Ségui B, Meyer N. Combining Nivolumab and Ipilimumab with Infliximab or Certolizumab in Patients with Advanced Melanoma: First Results of a Phase Ib Clinical Trial. Clin Cancer Res. 2021 Feb 15;27(4):1037-1047. doi: 10.1158/1078-0432.CCR-20-3449. Epub 2020 Dec 3.

lead_sponsor: Institut Claudius Regaud

intervention_type: Combination Product


title: Phenotypic and Functional Characterization of Regulatory T Lymphocytes in the Synovial Fluid of Patients Affected by Rheumatoid Arthritis, a Pilot Study.

acronym: CATERLIS

summary:
In rheumatoid arthritis (RA) the clinical response to anti-TNFα is related to an increase in the number or in the function of Treg lymphocytes in the peripheral blood of patients. This observation suggests the central role of Tregs in homeostasis of the immune response during RA.

In the literature the Tregs frequency and phenotype in the peripheral blood are well documented, however the analyses done on the Tregs in inflamed environment are still fragmentary or disparate.

In this project Tregs phenotype as well as expression of several transcripts will be analysed in order to better characterize the Treg cell subsets within the synovial fluid. Moreover, the local inflammatory cytokines (TNF, IL-6 and IL-1) may affect both the phenotype and the suppressive function of these Tregs and a comparison between peripheral and tissue Tregs will allow us to better understand the cause of functional loss.

Outcomes:

Primary outcome: Identification and characterization of the Tregs subpopulation present in the synovial fluid for RA patients suffering an episode of acute arthritis.

Secondary outcomes: compare the phenotypic and expression profile of the Tregs present in the synovial fluid with the Tregs present in the peripheral blood of RA patients suffering from an episode of acute arthritis.

lead_sponsor: University Hospital, Montpellier


title: MISOBOLD - Prostate Cancer Hypoxia Using BOLD MRI and 18F-MISO PET Imagin

acronym: MISOBOLD

summary: This feasibility exploratory study objective is to assess the ability of combined MRI BOLD and 18F-MISO PET imaging to visualize tumor hypoxia compare to histological results obtained after radical prostatectomy in order to, in time, be able to identify patient with bad prognostic and to offer them the best therapeutic strategy.

status: Withdrawn

lead_sponsor: University Hospital, Bordeaux


title: Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early

acronym: PRECOCE TC

summary:
Observational retrospective study that included all patients meeting the inclusion criteria from 1st January 2014 to 31st December 2015.

The objective of the study is to describe and compare two populations of patients with severe traumatic head injury arriving under sedation in the Department in whom the sedation was not continued.


title: Clinical and Molecular Characterization of Cerebral Proliferative Vasculopathy

acronym: VPCA

summary:
As principal objective, the study aims to:

Describe the spectrum and evaluate the frequency of angiodysplasia of the nevrax;
Establish the physiopathological basis of Fowler's syndrome;
Identify FLVCR2 partners and the signaling pathways involved;
Test new candidate genes: GPR124 and possible partners of FLVCR2.

As second objective, the study aims to:

perform phenotype / genotype correlation if necessary;
and propose a prenatal diagnosis in families with identified mutations.

time_perspective: Other

ReferenceType: result

ReferenceCitation: Thomas S, Encha-Razavi F, Devisme L, Etchevers H, Bessieres-Grattagliano B, Goudefroye G, Elkhartoufi N, Pateau E, Ichkou A, Bonnière M, Marcorelle P, Parent P, Manouvrier S, Holder M, Laquerrière A, Loeuillet L, Roume J, Martinovic J, Mougou-Zerelli S, Gonzales M, Meyer V, Wessner M, Feysot CB, Nitschke P, Leticee N, Munnich A, Lyonnet S, Wookey P, Gyapay G, Foliguet B, Vekemans M, Attié-Bitach T. High-throughput sequencing of a 4.1 Mb linkage interval reveals FLVCR2 deletions and mutations in lethal cerebral vasculopathy. Hum Mutat. 2010 Oct;31(10):1134-41. doi: 10.1002/humu.21329.


title: Work Productivity in Hyperventilation Syndrome

acronym: WHY

summary: Hyperventilation syndrome is associated with impaired quality of life. The aim of the study is to assess the relationship between work productivity, including absenteeism and presenteeism, and the severity of hyperventilation syndrome


title: Assessment of Symptoms and Their Consequences on Patients Quality of Life After Coloanal Continuity Reconstruction Following a Proctectomy for Rectal Cancer

acronym: QUALIPRO

summary: This study is a prospective, monocentric study whose aim is to assess the quality of life for patients who underwent a coloanal continuity reconstruction and to understand the functional issues they encounter. This will potentially provide predictive factors identification of bad functional outcomes allowing to guide future decisions. Also, it will allow patients to have a reinforced follow-up during the year after the reconstruction.

primary_purpose: Health Services Research


title: Venous to Arterial Carbon Dioxide Difference (P₍ᵥ-ₐ₎CO₂): Predictor of Septic Patient Prognosis Depending on the ScvO₂

summary: the investigators will include 120 patients with a diagnosis of septic shock in accordance with the definition given by the 2001 expert consensus. Two groups of patients are likely to participate in this study: Patient hospitalized in intensive care for a septic shock = Primary patient + patient who develops, the waning of his hospitalization in intensive care for another reason, a septic shock = Secondary patient. Haemodynamic monitoring by transpulmonary thermodilution allow a patient's close monitoring during the initial phase supported. The clinical and biological data, demographic and the severity scores are collected for each patient during the first three days of stay. To predict the unfavorable evolution of the patients, a measure of the SOFA score at the input (J0) and third day (J2) is performed. the investigators analyzed mortality at day 28 in patients with increased P₍ᵥ-ₐ₎CO₂ and those with increasing of organ failure. This research will be conducted according to good clinical practice. An information will be distributed to patients.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assisitance Publique Hopitaux de Marseille


title: Interest of Fluorescein in Fluorescence-guided Resection of Gliomas: A Randomized Study

acronym: FLEGME

summary: Fluorescence guidance is a safe and efficient tool for glioblastomas resection. The most widely used technique is based on 5-aminolevulinic acid (5ala), which stains glioblastoma cells through a metabolic abnormality and thus helps in defining tumoral edges through a modified microscope. A multicentric, randomized study comparing 5ala guided surgery with conventional procedures showed that this technique doubles the rate of complete removal on post-operative magnetic resonance imaging (MRI), and increases the 6 months progression-free survival. More recently, fluorescein appeared as an interesting alternative fluorophore for glioblastomas, with a highly reduced cost (2.5 euros versus 1000 euros per dose). However its use remains scarcely studied and its clinical benefit unsure. In that context, the investigators propose a randomized trial comparing conventional " white light " surgery with fluorescein-guided resection of glioblastomas, in order to assess the relevance of this technique in glioblastomas removal.


title: Itch and Pain Characteristics in Skin Carcinomas

acronym: PRURITCC

summary: The objective of this study is to have better knowledge about sensations of patients with skin carcinomas and to have data about characteristics of pain and pruritus . All patients presenting with a suspicions lesion for skin carcinomas will be included and will respond to a questionnaire. Demographics data, and histological data about skin carcinomas will be collected.


title: Preliminary Study About the Feasibility of Ambulatory Hysterectomy: Bicentric Study in Caen UH and Amiens UH

acronym: AMETHYST

summary:
Hysterectomy is one of the most performed surgery in women. Public authorities wish that one-day surgery become a majority and hysterectomy could be part of it in the future. The aim of this study is to determine the feasibility of ambulatory hysterectomy.

Patients and methods: Investigators will realize an observational descriptive survey based on questionnaires in two surgical gynecology units. Women under 70 years old, who undergo hysterectomy will be included.

lead_sponsor: University Hospital, Caen


title: Hypnosis as a Therapeutic Tool in Patients With Reccurent Cystitis

acronym: HYPNOCYST

summary:
Half of the women present an episode of cystitis once in their lives. A recurrence occurs in about 20% to 30% of the patients, and half of these patients will make more than 4 episodes per year, defining recurrent cystitis (CR).

Complications such as pyelonephritis are rare (less than 0.5% of patients in the absence of underlying complication), however, CRs are responsible for a significant impact on women but also on society. Pain is at the forefront, but also the fear of not managing pollakiuria, with its social exclusion. The impact on sexuality is major. The medical circuit imposed on the patients is long and arduous. The clinical assessment sometimes reveals favorable factors, variable in pre- or post-menopause, but in the majority of cases, no explanatory cause can resolve the problem and some authors suggest resignation as a classic reaction to this problem. The only study on psychological disorders associated with recurrent cystitis suggests patients who are much more anxious than the average of female.

Hypnotherapy is an old technique, used for care in Western societies for at least two hundred years. By the word, the practitioner induces in the patient a particular state of consciousness characterized by an indifference on the outside and a hyper suggestibility. This "hypnotic" state of consciousness can be used to amplify the patient's internal resources to fight against anxiety and pain, and to eliminate symptoms.

The physiological mechanisms at work in hypnosis are the subject of recent studies becoming more and more precise. The results of these studies made it possible to objectify changes in cerebral functioning related to hypnotic trance.

A report by Inserm of 2015 confirms the effectiveness of this practice in hypnosedation, hypnoanalgesia and hypnotherapy, particularly in irritable bowel syndrome, although the methodology to be used in its evaluation is difficult and subjective. The principal investigator hypothesizes that the symptoms presented in recurrent cystitis (pain, anxiety) can be improved by hypnotherapy, and that thus the prognosis of this pathology can be totally modified.

In the absence of any study published in the literature, the investigator propose an intervention pilot study with minimal risks and constraints monocentric prospective non-randomized prospectively in 15 patients.

The main objective of this project is to demonstrate that hypnotherapy improves the psycho-emotional parameters of patients suffering from recurrent cystitis after 3 hypnosis sessions combined with home exercises performed by the patient. The evaluation will be carried out during the last session of hypnosis.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Early Identification of Patients in Surgical Intensive Care With a Risk of Acute Respiratory Distress Following Visceral Surgery: Prognostic Value of Pulmonary Extravascular Water Revealed by Pulmonary Ultrasound.

acronym: ODR

summary:
Today there are few studies in the literature involving patients in an ICU following major visceral surgery. There are thus few results about the prognostic value of pulmonary extravascular water in this population of patients, but also the prognostic value of pulmonary extravascular water measured at the bedside using pulmonary ultrasound.

In addition, pulmonary ultrasound will be combined with echocardiography to measure left ventricular function (LVEF) and to study the profile of the mitral valve to assess filling pressure in patients with immediate post-operative ventilation. This will make it possible to distinguish between increases in pulmonary extravascular water associated with high filling pressure and increased pulmonary water associated with low filling pressure: characteristic of lesional oedema.

The aim of this study is to determine the prognostic value of extravascular pulmonary water (PEVW) diagnosed using pulmonary ultrasound in patients admitted to an ICU following scheduled or emergency visceral surgery in the onset of acute respiratory distress requiring invasive mechanical ventilation, or prolonged post-operative intubation, or non-invasive.


title: Study of the Effects of Docosahexaneoic Acid (DHA) on Post-operative Fibrosis of Trabulectomy Blebs in Glaucoma Surgery

acronym: DHA

summary: Post-operative fibrosis of trabulectomy blebs is a major cause of surgical failure leading to a renewed increase in intraocular pressure. The use of anti-metabolites over many years has made it possible to improve success rates for this surgery but these drugs have numerous adverse effects as they are toxic. Alternative therapies are thus necessary, and we believe that DHA could have antifibrotic effects on fibroblasts and could thus improve success rates in this surgery.


title: Clinical Evaluation of a Brain Computer Interfaces (BCI)-Based Training of Attention in Children With Attention Deficit Hyperactivity Disorder (ADHD)

acronym: MyB

summary:
This project aims to assess the evolution of symptoms in ADHD children from 8 to 17 years, with various types of attention training.

Different groups A, B and C will be evaluated: the first with Neurofeedback training, the second with a similar training but not indexed on brain activity and the third without training.

30 patients will be randomly assigned to groups A and B according to a ratio 2:1.

Others patients who meet the same criteria but for logistical reasons cannot comply with the training constraints will be assigned to group C.

Children included in groups A and B will participate in training sessions (Neurofeedback and control training, respectively) as well as in four evaluation sessions. Children in group C will only participate in evaluation sessions (baseline control group).

Patients of groups A and B will be followed over 6 months: 4 months of training and a follow-up evaluation 2 months after training.

Patients of group C will be followed each 2 months for 6 months. This study uses electro-encephalography measures, serious video game, neuropsychological tests and questionnaires.

It also uses actigraphy measures to evaluate sleep quality.

lead_sponsor: Hospices Civils de Lyon


title: Preeclampsia Ratio (sFlt-1/PlGF) Evaluation for Clinical and Obstetrical Guidance

acronym: PRECOG

summary: The aim of the PRECOG study is to determine in a prospective interventional randomized study whether the implementation of a predictive test based on the sFLT-1/PlGF ratio improves perinatal care and reduces costs, in patients with suspected preeclampsia before 35 weeks of gestation.

ReferenceCitation: Tsatsaris V, Goffin F, Munaut C, Brichant JF, Pignon MR, Noel A, Schaaps JP, Cabrol D, Frankenne F, Foidart JM. Overexpression of the soluble vascular endothelial growth factor receptor in preeclamptic patients: pathophysiological consequences. J Clin Endocrinol Metab. 2003 Nov;88(11):5555-63.

ReferenceCitation: Sibiude J, Guibourdenche J, Dionne MD, Le Ray C, Anselem O, Serreau R, Goffinet F, Tsatsaris V. Placental growth factor for the prediction of adverse outcomes in patients with suspected preeclampsia or intrauterine growth restriction. PLoS One. 2012;7(11):e50208. doi: 10.1371/journal.pone.0050208. Epub 2012 Nov 28.

ReferenceCitation: Zeisler H, Llurba E, Chantraine F, Vatish M, Staff AC, Sennström M, Olovsson M, Brennecke SP, Stepan H, Allegranza D, Dilba P, Schoedl M, Hund M, Verlohren S. Predictive Value of the sFlt-1:PlGF Ratio in Women with Suspected Preeclampsia. N Engl J Med. 2016 Jan 7;374(1):13-22. doi: 10.1056/NEJMoa1414838.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: A Pilot Randomized Controlled Trial Evaluating the Effect of Two Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile Measured by Continuous Glucose Monitoring System (CGMS), in Type 2 Diabetic Patients

summary: The study is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS).

ReferenceCitation: Breyton AE, Goux A, Lambert-Porcheron S, Meynier A, Sothier M, VanDenBerghe L, Brack O, Disse E, Laville M, Vinoy S, Nazare JA. Starch digestibility modulation significantly improves glycemic variability in type 2 diabetic subjects: A pilot study. Nutr Metab Cardiovasc Dis. 2021 Jan 4;31(1):237-246. doi: 10.1016/j.numecd.2020.08.010. Epub 2020 Aug 25.

lead_sponsor: Mondelēz International, Inc.

location_facility: Centre de Recherche en Nutrition Humaine Rhone-Alpe


title: Pilot Study Evaluating a Perioperative E-follow-up Protocol in Patients With Ambulatory Surgery for Breast Cancer

acronym: PITCA

summary:
This is a monocentric, prospective cohort study evaluating the feasibility of a perioperative e-follow-up protocol in patients with ambulatory surgery for breast cancer.

This protocol will be based on:

A coordinated ambulatory follow-up performed by a dedicated nurse
An electronic follow-up tool used in pre- and post-surgery

Patients will be followed 8 days before the surgery until 30 days after the surgery of breast cancer.


title: Effects at 12 Weeks of Transcranial Direct Current Stimulation on the Cognitions of People Presenting Early Alzheimer's Disease (tDCS-AD)

acronym: tDCS-AD

summary:
TDCS is a rapidly expanding technique, used to treat cognitive difficulties associated with many pathologies (Parkinson's disease, rehabilitation after head trauma, etc.), but which remains of the field of research.

Its use remains very experimental, and concerns the exploration of cognitions, in healthy and diseased subjects. There are not many studies on the elderly subject with Alzheimer's disease, nor do they document the medium- and long-term effect (more than one month), nor the effect on geriatric parameters such as Fragility indices and the risk of falls, especially at home. These characteristics are decisive because they define the level of autonomy.

The investigators therefore wish to study the effect of a 2-week treatment with tDCS (tDCS active) versus placebo (2-week tDCS group) for a three-month period.

lead_sponsor: Benjamin CALVET


title: Fatigue After Stroke

acronym: Fatigue AVC

summary:
Cerebral infarction is a type of stroke that can lead to sometimes disabling sequelae. Among these sequelae, fatigue is frequently reported by patients. It is therefore important for doctors to understand why patients suffer from fatigue after cerebral infarction and to determine whether treatments given for the cerebral infarction may have an impact on this fatigue.

The aim of this research was to study the frequency of fatigue after cerebral infarction, the associated factors, in particular the impact of treatments administered in the acute phase.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Brain Markers of Suicide Risk and Psychological Pain in Elderly Depressed Patients

acronym: SPAD-IRM

summary: The main objective of this study is to show MRI functional and structural differences between depressed elderly patients with a history of attempted suicide compared to depressed elderly patients with no history of attempted suicide and to elderly subjects with no personal history of depression or attempted suicide (healthy controls).

time_perspective: Cross-Sectional

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Cartography and Quantitative Characterization of Achilles Tendon Fibrocartilage by TE = 0ms Imaging at3T MRI

acronym: SILENZ

summary: The purpose of this study is to accurately map calcaneal fibrocartilage using TE = 0 ms imaging, and then apply measurements of our control population to SpA patients with peripheral enthesis study using the calcaneal tendon as a clinical model


title: Effect of a Combined Language Therapy (Linguistic/Communication) on Aphasia After Stroke in Acute Phase: A Prospective, Controlled, Monocentric Pilot Study

acronym: ORACLE

summary: Linguistic training is traditionally the gold standard for rehabilitation of aphasia after stroke and efficacy criteria count early stage, intensity as well as personalized treatment. To date, no clear evidence showed a specific effect of any therapy in the acute phase of aphasia after stroke. This study aims to compare the effect of a combined therapy (linguistic/communication) versus a linguistic therapy on communication performance in patients in the acute phase of aphasia after a first stroke.

primary_purpose: Supportive Care

ReferenceCitation: Galletta EE, Barrett AM. Impairment and Functional Interventions for Aphasia: Having it All. Curr Phys Med Rehabil Rep. 2014 Jun 1;2(2):114-120.

ReferenceCitation: Bhogal SK, Teasell R, Speechley M. Intensity of aphasia therapy, impact on recovery. Stroke. 2003 Apr;34(4):987-93. Epub 2003 Mar 20.

ReferenceCitation: Tippett DC, Niparko JK, Hillis AE. Aphasia: Current Concepts in Theory and Practice. J Neurol Transl Neurosci. 2014 Jan;2(1):1042.

ReferenceCitation: Jorm AF, Jacomb PA. The Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE): socio-demographic correlates, reliability, validity and some norms. Psychol Med. 1989 Nov;19(4):1015-22.

ReferenceCitation: Behrmann M, Lieberthal T. Category-specific treatment of a lexical-semantic deficit: a single case study of global aphasia. Br J Disord Commun. 1989 Dec;24(3):281-99.

ReferenceCitation: Crosson B. An intention manipulation to change lateralization of word production in nonfluent aphasia: current status. Semin Speech Lang. 2008 Aug;29(3):188-200; quiz C-4. doi: 10.1055/s-0028-1082883.

ReferenceCitation: Jones EV. Building the foundations for sentence production in a non-fluent aphasic. Br J Disord Commun. 1986 Apr;21(1):63-82.

lead_sponsor: University Hospital, Toulouse


title: Identification of the Molecular and/or Pathophysiological Bases of Developmental Diseases

acronym: DISCOVERY

summary: Developmental diseases include more than 3000 diseases and can associate organ malformation, dysmorphism, development disorders and/or intellectual deficiency. Even though the considerable effort in the search for genes in the last 20 years has led to the identification of thousands of genes associated with Mendelian diseases, half of the individuals with severe development anomalies remain without a genetic diagnosis. It is important to pursue the ambition to contribute to the goal fixed by Europe, namely the identification of the large majority of genes responsible for rare diseases with development anomalies, and to be able to provide genetic counselling to patients and their families. In the past, scientific research to discover genes required a large number of families and individuals and was slow and expensive to carry out. Today, this approach has been facilitated by next generation sequencing.


title: Interest of tDCS in Help for Supporting Alcohol Abstinence

acronym: ITAMAA

summary: The aim of the study is to evaluate in patients with alcohol disorder and forehand weaned the efficiency of 10 active tDCS sessions versus 10 sham (placebo) sessions in the support of abstinence at 3 months.

lead_sponsor: Centre Hospitalier Henri Laborit


title: Incidence of pNeumonia and Related ConseqUences in Nursing Home

acronym: INCUR

summary: In the present proposal, we hypothesize that specifically targeting pneumonia events with preventive interventions in the French EHPAD (Etablissements d'Hébergement pour Personnes Agées Dépendantes) setting (thus, improving the health status and quality of life of patients) may simultaneously produce relevant reductions in the healthcare costs. In fact, although the number of pneumonia cases may be numerically limited, the consequences of each event are potentially catastrophic for both the patient and the healthcare system. Unfortunately, to date, information about the incidence and economical effects of pneumonia in the older population living in the French EHPAD are extremely scare. To adequately evaluate whether there is room to implement preventive interventions aimed at reducing the onset of pneumonia in a cost-effective fashion on a large scale, preliminary data from this specific population are needed. This first step is crucial towards the appropriate design and conduction of possible future large-scale intervention trials in the EHPAD setting.


title: Sensori-motor and Perceptual Functions of the Posterior Parietal Cortex (PPC) in Patients With Optic Ataxia (AO) and Healthy Subjects.

acronym: PPCfonctions

summary:
To produce hand's movement directed towards a target, the investigator must combine several sensory information, such as vision or proprioception. The posterior parietal cortex (PPC) is a region of the cortex involved in this multisensory integration. A lesion of the PPC cause a visuo-motor trouble called optic ataxia but these patients also have perceptual troubles.

The aim of the study is to understand the different functions of the PPC and especially how the processes of spatial coding of the sensory information influences perception and motor planning.

In this study, the investigator want to explore the sensory motor and the perceptual performance of patients with optic ataxia compared with healthy subjects, using 6 behavioral tests.

location_facility: U1028 INSERM - CNRS UMR 5292 Equipe ImpAct


title: Contextual Associations During Episodic Recall of Everyday or Virtual Reality

acronym: BREAL

summary:
The project is dedicated to development of new paradigms to investigate memory and attention in the rich and realistic environments. The investigator will use modern interactive digital technologies for encoding complex episodes either using mobile phone technology in everyday life or using a virtual reality life-like simulation.

He aims to characterize the role of the medial temporal lobe and prefrontal cortex during recall of naturalistic episodic experiences, using functional neuroimaging (fMRI) in healthy participants. The secondary aim is assess how the allocation of attention during memory encoding contribute to mechanisms of the subsequent recall. He will achieve this by monitoring gaze direction during encoding and by analyzing the retrieval data as a function of the elements that participants attended / fixated during encoding.

The protocol will involve, first, behavioral testing of memory performance with encoding in the real-life or in virtual reality, followed by the main hypothesis testing phase when fMRI will be used to measure brain activity during retrieval.


title: Comparison of a Classical Rehabilitation Method and a Specific Rehabilitation Method of the Cervical Spine to Improve Balance in Elderly Patients

acronym: SATRACE

summary:
In more than 90% of cases, victims of fall are elderly people over 65. Nearly the third of those people fall at least 1 time by year. The incidence substantially increases for people over 80 and women are at higher risk than men.

The value of balance rehabilitation no longer needs to be demonstrated in Gerontology. Nevertheless, a more specific therapy based on the aged-related cervical problems seems to be essential. Indeed, those problems are numerous (arthrosis-like pains, joint stiffness, muscular contractures…) and often lessen vestibular and/or proprioceptive afferents. The cervical spine is a link between different systems which regulate balance, as the visual, vestibular and cervical systems (muscular, articular afferents…), and this role is key to balance control. Indeed, the cervical spine owns an exceptional function thanks to Ruffinian corpuscles, muscle and neurotendinal spindles.

Many studies point up the importance of the relation between balance, cervical spine and vestibular system, and others between tissue changes and postural adaptations in elderly people. Nevertheless, the take into consideration of all these data and their impacts in rehabilitation has not been reported yet.

This brings us to question the added-value of a cervical mobility management in balance rehabilitation in Gerontology.


title: Impact of Transcranial Direct Current Stimulation of the Dorsolateral Prefrontal Cortex on Emotional Processing in Healthy Subjects.

acronym: EmoStimH

summary:
The dorsolateral prefrontal cortex (DLPFC) plays a key part in emotional processing and regulation.

Emotions continually influence other cognitive functions such as attentional resources .Emotions also influence a subject's automatic physiological responses .

Transcranial direct current stimulation (tDCS) is an innovative neuro-modulation treatment, often used in major depression.

Various studies have shown that it is possible to modulate emotional processing in healthy subjects, however the impact of this modulation on attentional resources and physiological responses has not been studied. Also, the mechanisms of action of the tDCS on emotional processing are still unclear.

It is necessary to explore the modulation of the DLPFC in healthy subjects in order to better understand the network and mechanisms at stake in the processes.

Thus, investigators plan to study the modulation of the DLPFC (left and right) by tDCS (anode, cathode and placebo) on the processing of emotions and the impact on attentional resources, and physiological responses.

lead_sponsor: Hôpital le Vinatier


title: Evaluation of the Visuo-attention Field of Symbols Versus Objects Visual Search in Dyslexic Subjects. DyslexiaSPOTLIGHT

summary:
dyslexia is often considered like a phonological deficit but some researches show that a visual attention (V-A) deficit can occur in dyslexia. The investigator want to show that some dyslexics have a reduced V-A field in visual search when the investigator use separable feature (letter-like).

If the investigator demonstrate that, he will show that V-A deficit can be transpose to an ability acquired before reading, the visual search. Therefore, the V-A deficit can't be a consequence of reading problem but a cause of it for some dyslexics.

The investigator could imagine an earlier diagnosis for children at risk to develop dyslexia and make reeducation more specific for the deficit observed.


title: Transcranial Direct Current Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorders -Pilot Study (tDCS-TOC Pilot)

acronym: tDCS-TOC

summary: The purpose is to show that bifocal tDCS with an anodal stimulation on the orbitofrontal cortex and cathodic stimulation on supplementary motor areas is an effective treatment for patients with resistant and severe obsessive compulsive disorders.


type: Registry Identifier

title: A Pilot Study of the Effect of Taping in the Hemiplegic Patient With a Deficit of the Footbrowers

acronym: NEUROTAP

summary:
A majority of people undergoing rehabilitation following a stroke have a deficit of the dorsal flexors of the foot. The implementation of rehabilitation techniques in accordance with the recommendations of learned societies is not sufficient to compensate for this deficit. Also Kinesio Taping's method of Dr. Kenzo Kase has caught our attention by its action on muscle, joint, circulatory and pain functions.

The use of taping would increase the duration of stimulation of the muscles of the dorsiflexors of the foot which would facilitate the motor recovery.

Data from the literature do not support the conclusion that taping is effective, but no studies evaluating the efficacy of this technique in the foot-lift deficiency of the hemiplegic patient have been found.

The investigators hypothesize that the use of taping in conjunction with common rehabilitation for hemiplegic patients following a stroke improves the stimulation of the muscles of the dorsiflexors of the foot with a positive impact on the walking.


title: Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of First Rank Symptoms on Schizophrenia: Controlled, Randomised, Double Blind Trial

acronym: Schirang

summary:
First rank symptoms are core symptoms of schizophrenia. the investigators want to offer an integrative approach to better understanding of the mechanisms involved in the first rank symptoms and therefore, in schizophrenia, as well as the neuronal modulation mechanisms obtained by rTMS. It will be to pass a functional magnetic resonance imaging (fMRI) at rest for healthy volunteers, and for patients before and after rTMS modulation, to view brain structures activated in the resting state network, and in order to study

the difference of the resting-state network between healthy volunteers and people with schizophrenia,
if the response to rTMS boost can be predicted by resting-state network of patients before treatment and
if rTMS changes activations in the brain of patients. This will ultimately provide rTMS as a treatment of first rank symptoms.


title: Lengthening Temporalis Myoplasty and Improvement of Primary Swallowing Disorders in Facial Paralysis

acronym: MATPF

summary:
The facial paralysis is a frequent disease causing important functionals swallowing dysfunctions. The purpose of our study was to evaluate the improvement of the swallowing disorders after surgery by lengthening temporalis myoplasty (LTM) in the facial paralysis.

This prospective study has realised on the following of patients affected by facial paralysis treated by LTM. Self-administered questionnaires and clinics tests had realized to analyze three components oh the oral phase of the swallowing ( drooling, mastication and handicap). The evaluations was realized before the surgery and at 3 and 6 months after .

lead_sponsor: University Hospital, Tours

location_facility: Service de chirurgie maxillo-faciale, CHRU de TOURS


title: Social Cognition Training and Cognitive Remediation : a New Tool for 22q11.2 Deletion Syndrome

acronym: RCKID

summary:
Social cognition refers to mental operations that enable people to perceive, interpret constantly changing social informations. These processes allow people to rapidly, effortlessly and flexibly perceive and interpret rapidly-changing social information, and respond appropriately to social stimuli. Besides, this ability gives meaning to the actions of others. Impairments in this field may largely underlie social dysfunctions and reduce adaptive skills. Moreover, social cognitive disabilities contribute more or less directly to behavioral disturbances and psychiatric symptoms The "RC KID" program involves a variety of exercises in a paper and/or pencil or a computerized format or role playing and a strategy coaching approach. "RC KID" targets the emotion recognition and social interaction.

A little cartoon character (a pirate), is supposed to be very friendly and kind toward children. The pirate will accompany them throughout the program for an effective and positive reinforcement. The main goal of "RC KID" is to adjust to children's difficulties in daily life.

Moreover, since the cognitive remediation benefit is complex to apply in daily life, the program is based on a metacognitive strategy.

After a complete neuropsychological assessment and a psychoeducational session (with the child and the parents), 16 1-h-sessions of cognitive remediation with the therapist are proposed. Each session is composed of three parts: (1) computerized tasks focusing on specific emotion recognition components (20 min). RC KID is composed of 2 modules : Emotion recognition and social interaction. These tasks contain photo or video. (2) pen and paper or role playing tasks focusing on the same processes (20 min) (3) a proposal of a home-based task (during 20 min). Weekly, home tasks are proposed to the child and analyzed with the parents and the therapist. Indeed, home exercises are useful to promote the transfer of strategies to daily life and their subsequent automation. The heterogeneity of cognitive deficits in 22q11.2 deletion necessitates an individualized cognitive remediation therapy. In this regard, "RC KID" seems to be a promising tool.


title: Hemodynamic Assessment in Cardiogenic Shock Regarding the Etiology

summary:
The classic physiopathology of cardiogenic shock is explained by a systolic ventricular failure, responsible for a decrease in cardiac output associated with high systemic vascular resistances (SVR). This theory is currently challenged in light of the data collected in the SHOCK study, which assessed outcome of early revascularization versus initial medical stabilization, in cardiogenic shock following myocardial infarction.13 A sub-study highlighted depressed SVR in the population with ischemic cardiogenic shock, related to a systemic inflammatory response syndrome.14 Furthermore, mean FEVG was 30% in the SHOCK trial,13 with a similar distribution with post myocardial infarction heart failure patients without signs of shock.15-19 Thus, alteration of myocardial contractility can be only moderate in cardiogenic shock and isn't the only cause responsible for the hemodynamic instability.20 Recent studies suggest the important roles of the peripheral vascular system and neurohormonal system in the genesis and prolongation of cardiogenic shock.12 Vasodilation caused by nitrous oxide synthase activation27 explains the absence of compensating vasoconstriction observed during the SHOCK trial13, and leads to decreased systemic and coronary perfusion, thus increasing myocardial ischemia and initial ventricular dysfunction. 28,29 Cotter et al. conducted an interesting study of hemodynamic evaluation of various cardiac conditions where they observed a significant variability in the peripheral vascular status, with systemic vascular resistances collapsed in certain patients (similar to those observed in septic shock) and rather close to normal or very high resistances in other patients.21 However these data were obtained from a selected group of patients without differentiating the etiology of cardiogenic shock. Finally, the majority of available studies were limited to cardiogenic shock whose etiology was myocardial infarction.

Therapeutic management of cardiogenic shock is based in first intention on an inotropic support by Dobutamine.11,23 However, better outcomes on contractility and microcirculatory state have been observed with the use of a vasopressor support by Norepinephrine, suggesting the importance of SVR decreasing in genesis of cardiogenic shock.14,24 Recent reviews showed very few data on inotropic treatment and association with vasopressor support,22 hence the low level of recommendations in current guidelines.11,23

So far it is crucial to accurately characterize hemodynamic status and in particular the systemic vascular resistance for patients with cardiogenic shock. Important variabilities in hemodynamic profiles observed in Cooter's trial could explain the difficulty in defining an optimal therapeutic strategy.

the investigators hypothesize that the hemodynamic profile, particularly SVR, of patients with cardiogenic shock is different depending on their etiology. Ischemic cardiogenic shock should be characterized by lower SVR, in relation to a major role of systemic inflammatory response syndrome. On the contrary, non-ischemic cardiogenic shock could be associated with normal or elevated SVR, and thus could explain the variability in distribution of SVR.

location_facility: Assisatnce Publique Hopitaux de Marseille


title: Identifying New Genetic Causes to the Disorders of Growth, Puberty and Sex Development

acronym: FORDEV

summary: Disorders of growth, puberty and sex development can have genetic causes. The exome analysis could detect new mutations responsible for these disorders and the frequency of these mutations in these disorders, their association with other malformations.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

intervention_type: Genetic


title: Perception of the Risk Associated With the Use of Cosmetics Products During Pregnancy - a Qualitative Study

acronym: PERICOS

summary:
The use of cosmetics is an important source of exposure to many chemicals including endocrine disruptors. Recently, national and international scientific recommendations have been issued to limit exposure to chemicals during pregnancy. However, the perception and the use of cosmetics by pregnant women is still little studied. The objectives of the PERICOS study are to identify the risk perception and the attitudes regarding cosmetic's use by the pregnant women.

Understanding the risk perception, the knowledge, attitudes and expectations of women about the use of cosmetics during pregnancy will help to set up effective strategies to improve prevention of chemical exposure.

lead_sponsor: University Hospital, Clermont-Ferrand


title: A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Transplant (LTx) Recipients With Bronchiolitis Obliterans Syndrome (BOS) Grade 0p-1-2

acronym: INFINITx-BOS

summary:
Lung transplantation (TxP) is now a validated treatment of end-stage pulmonary diseases, but long-term graft and patient survival are still hampered by the development of chronic allograft dysfunction (CLAD) affecting > 50% of patients.

The investigators propose to conduct a phase III clinical randomized trial that will assess the efficacy of Nintedanib to hamper the lung decline in LTx recipients with BOS. This is the first trial testing this molecule in lung Tx recipients. If case of demonstrated effectiveness of Nintedanib, the benefit for lung transplant patients carrying a BO is high in terms of stabilization of lung function and enhancement of survival.


title: Comparative Study of Captive Great Ape and Human Intestinal Microbiomes

acronym: SHAPES-CAP

summary: The SHAPES-Captivity study seeks to identify metagenomic components of the intestinal microbiome shared by human beings and captive great apes living in proximity and in direct, daily contact. The investigators will determine the phylogenetic diversity of enterotypes (bacterial and viral) shared between human beings and great apes and will link these results with participant-observations of caretakers' activities (and contacts) with these great apes.

lead_sponsor: Institut Pasteur


title: Prediction of Chronic Renal Disease After Acute Kidney Injury in the Intensive Care Unit

acronym: PREDICT

summary:
The study aims to develop and validate a prediction score of chronic renal disease occurrence within 3 years after ICU discharge in patients who suffered an acute kidney failure during ICU stay and recovered normal renal function at 90 days following their discharge.

The primary study outcome is the incidence of chronic renal disease within the first 3 years after ICU discharge, defined by a lower glomerular filtration rate (GFR) under 60 mL/minute/1.73m2.

ReferenceCitation: Geri G, Stengel B, Jacquelinet C, Aegerter P, Massy ZA, Vieillard-Baron A; PREDICT investigators. Prediction of chronic kidney disease after acute kidney injury in ICU patients: study protocol for the PREDICT multicenter prospective observational study. Ann Intensive Care. 2018 Jul 6;8(1):77. doi: 10.1186/s13613-018-0421-7.

location_facility: Intensive care unit, Ambroise Pare Hospital


title: Lung MORphological Modifications Evaluated by Electrical Impedance Tomography During Preoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation (MORPHEIT Study, an Ancillary Study of PREONIV Trial)

acronym: MORPHEIT

summary:
Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients.

Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation


title: Efficacy of a Nurse-based Intervention on Tobacco Consumption in Hospitalized Patients

acronym: HOT

summary:
Tobacco consumption is a major public health problem, ranking second in the leading cause of morbidity and mortality worldwide, in 2010. The prevalence of tobacco smoking in hospitalized patients is evaluated around 20% and the management of tobacco reduction/cessation is an major issue for the course and outcome of many disorders.

Recent recommendations published by the French National Health Authority ("Haute Autorité de Santé", HAS) call for the involvement of all health professionals in helping patients to stop smoking and hospitalized patients are identified as a specific target. In addition, the meta-analysis of Rigotti et al. (2012) showed that the most effective programs (tobacco cessation) were those that include all patients, starting during the hospitalization with a specific follow-up of at least one month, and with the addition of nicotine replacement therapy. This combination increased the odds of successful tobacco cessation by 54%.

The project aims to evaluate the short-term efficacy (1 month) of a nurse-based program on tobacco smoking consumption in a population of hospitalized patients.


title: Prospective Study of Quality of Life After Laparoscopic Removal of Essure®

acronym: ABLIMCO

summary: A lot of patients seem to complain after hysteroscopic tubal occlusion by Essure® device with a worce quality of life. Investigators' hypothesis is that Essure® laparoscopic removal may improve quality of life. This prospectice study aim to assess the quality of life 1, 3, 6 and 12 months after Essure® removal.

location_facility: Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon


title: Comparison of Positive End Expiratory Pressure Titration Methods in Patients With Acute Respiratory Distress Syndrome: a Physiological Study

acronym: ELSE

summary: This study aims at assessing the short-term physiological effects of 2 positive end expiratory pressure titration strategies in patients with ARDS.

lead_sponsor: University Hospital, Angers


title: Efficacy of In-bag Morcellation

acronym: FIBROSAC

summary:
Laparoscopic mini-invasive surgery supplanted laparotomy for many years, including hysterectomy or myomectomy (less postoperative complications compared to laparotomy) However the US Federal Drug Administration (FDA) strongly warned against the use of power morcellation in 2014 because of the risk of iatrogenic spread of malignant cells.

The hypothesis is that in-bag morcellation may prevent cells dissemination. The investigator compare in this prospective randomized study two groups of patients: group A (in bag-morcellation during laparoscopic myomectomy or hysterectomy) versus group B (morcellation without any bag during laparoscopic myomectomy or hysterectomy)

location_facility: Gynaecology Department, Hôpital Femme Mère Enfant


title: Le Syndrome vasoplégique en Post-opératoire de Chirurgie Cardiaque: étude de Construction et de Validation d'un Score prédictif (Etude ISYVACC).

acronym: ISYVACC

summary: Vasoplasmic syndrome in cardiac surgery is one of the major postoperative complications.This syndrome is characterized by persistent low blood pressure despite an optimization of preload and inotropism.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Study of the Impact of Welding Fumes on the Arterial System : RISCAS Study

acronym: RISCAS

summary: Metals and oxydes are found in welding fumes and are thought to participate in increasing cardiovascular risk in exposed workers. Investigators aimed to evaluate the impact of this occupational exposure on cardiovascular system in a highly exposed population, ship repairing welders and to compare this population to paired controls.

lead_sponsor: University Hospital, Brest


title: Diagnostic Performance of MRI as an Alternative to CT Following a Non-diagnostic Ultrasonography in Young Women With Acute/Subacute Abdominal Pain : a Prospective Multicenter Study

acronym: IRMADA

summary:
Objective :

To demonstrate diagnostic performances of Magnetic Resonance Imaging (MRI) as compared to Computed Tomography (CT) as a second intention imaging modality in young women with acute non traumatic abdominopelvic pain and non contributive ultrasonography.

lead_sponsor: University Hospital, Montpellier


title: Exploratory Study of the Impact of a Preoperative Formal Hypnosis Session on Perioperative Anxiety Among Female Patients Hospitalised for Hysterectomy Due to Pelvic Gynecological Cancer

acronym: HYPPOGYN

summary: The research hypotheses that preoperative formal hypnosis session reduces perioperative anxiety among women undergoing a hysterectomy for pelvic gynecological cancer. The key objective is to estimate the effect of preoperative hypnosis on preoperative anxiety among this population

lead_sponsor: University Hospital, Bordeaux


title: Community Acquired Sepsis Cohort

acronym: CASC

summary: The aim of this project is to constitute a prospective cohort of all the patients presenting to the adult emergencies of the University Hospital Centre (CHU) of Rennes for a septic syndrome of community origin.

lead_sponsor: Rennes University Hospital