title: Cholesterol Metabolites (Dendrogenin A or DDA, 6-oxo-cholestane-3β,5α-diol or OCDO,...) Quantification in Malignant Versus Normal Human Thyroid Tissue Refractory to Iodine

acronym: OXYTHYR

summary: The study team previously shown that a cholesterol metabolite, dendrogenin A (DDA) differentiates anaplastic thyroid cancer cell lines and that its mRNA expression is diminished in human radioiodine refractory thyroid cancer samples. The team aim to quantify via mass spectrometry and immunohistochemistry DDA and other cholesterol metabolites in thyroid cancer versus healthy thyroid tissue human samples.

ReferenceCitation: Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.

ReferenceCitation: Zerdoud S, Giraudet AL, Leboulleux S, Leenhardt L, Bardet S, Clerc J, Toubert ME, Al Ghuzlan A, Lamy PJ, Bournaud C, Keller I, Sebag F, Garrel R, Mirallie E, Groussin L, Hindie E, Taieb D. Radioactive iodine therapy, molecular imaging and serum biomarkers for differentiated thyroid cancer: 2017 guidelines of the French Societies of Nuclear Medicine, Endocrinology, Pathology, Biology, Endocrine Surgery and Head and Neck Surgery. Ann Endocrinol (Paris). 2017 Jul;78(3):162-175. doi: 10.1016/j.ando.2017.04.023. Epub 2017 Jun 1. No abstract available.

ReferenceCitation: Nixon IJ, Whitcher MM, Palmer FL, Tuttle RM, Shaha AR, Shah JP, Patel SG, Ganly I. The impact of distant metastases at presentation on prognosis in patients with differentiated carcinoma of the thyroid gland. Thyroid. 2012 Sep;22(9):884-9. doi: 10.1089/thy.2011.0535. Epub 2012 Jul 24.

ReferenceCitation: de la Fouchardiere C, Alghuzlan A, Bardet S, Borget I, Borson Chazot F, Do Cao C, Godbert Y, Leenhardt L, Zerdoud S, Leboulleux S. The medical treatment of radioiodine-refractory differentiated thyroid cancers in 2019. A TUTHYREF(R) network review. Bull Cancer. 2019 Sep;106(9):812-819. doi: 10.1016/j.bulcan.2019.04.012. Epub 2019 Jun 11.

ReferenceCitation: Schlumberger M, Tahara M, Wirth LJ. Lenvatinib in radioiodine-refractory thyroid cancer. N Engl J Med. 2015 May 7;372(19):1868. doi: 10.1056/NEJMc1503150. No abstract available.

ReferenceCitation: Fugazzola L, Elisei R, Fuhrer D, Jarzab B, Leboulleux S, Newbold K, Smit J. 2019 European Thyroid Association Guidelines for the Treatment and Follow-Up of Advanced Radioiodine-Refractory Thyroid Cancer. Eur Thyroid J. 2019 Oct;8(5):227-245. doi: 10.1159/000502229. Epub 2019 Aug 28.

ReferenceCitation: Durante C, Haddy N, Baudin E, Leboulleux S, Hartl D, Travagli JP, Caillou B, Ricard M, Lumbroso JD, De Vathaire F, Schlumberger M. Long-term outcome of 444 patients with distant metastases from papillary and follicular thyroid carcinoma: benefits and limits of radioiodine therapy. J Clin Endocrinol Metab. 2006 Aug;91(8):2892-9. doi: 10.1210/jc.2005-2838. Epub 2006 May 9.

ReferenceCitation: Keutgen XM, Sadowski SM, Kebebew E. Management of anaplastic thyroid cancer. Gland Surg. 2015 Feb;4(1):44-51. doi: 10.3978/j.issn.2227-684X.2014.12.02.

ReferenceCitation: Ibrahimpasic T, Ghossein R, Shah JP, Ganly I. Poorly Differentiated Carcinoma of the Thyroid Gland: Current Status and Future Prospects. Thyroid. 2019 Mar;29(3):311-321. doi: 10.1089/thy.2018.0509.

ReferenceCitation: Lazar V, Bidart JM, Caillou B, Mahe C, Lacroix L, Filetti S, Schlumberger M. Expression of the Na+/I- symporter gene in human thyroid tumors: a comparison study with other thyroid-specific genes. J Clin Endocrinol Metab. 1999 Sep;84(9):3228-34. doi: 10.1210/jcem.84.9.5996.

lead_sponsor: Institut Claudius Regaud

sponsor_collaborators:
Institut Claudius Regaud
Cancer Research Center of Toulouse


title: An Evaluation of the Radio/Pathological Correlation of Depth Of Invasion for Oral Squamous Cell Carcinoma, a Retrospective Study in a University Hospital in Lyon

acronym: RaP E ToC

summary: The aim of the study is to assess the good correlation and prediction of the DOI for the post-operative pathological results and prognosis.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Assessment of Autonomic Regulation During the Listening of Mother Heart Beat in Newborns

summary:
Prematurity birth lead to an early breaking link with the in utero environment. A special attention is brought in the neonatal intensive care units to reduce noise and lighting surrounding aiming to protect the newborn.

During the uterine life fetus benefits previously of several auditory stimulations by the maternal voice, the mother's heartbeat. After birth the auditory environment is dramatically modified.

Aim of this study is to submit to the newborn an audio recording of his mother's heart beat to analyze the comfort, stress and autonomic response. Heart rate variability (HRV) analysis is a non-invasive tool able to consider autonomic nervous system activity. Previous studies have shown that pleasant feelings are associated with an increase of high frequencies variations index (HFnu index) reflecting a prevalence of parasympathetic activity in the sympathetic-parasympathetic balance. This one can be simply assess by a monitor named NIPΣ and can provide a comfort index by quantifying the parasympathetic tone.

status: Completed

study_completion_date_type: Actual

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Device

status_simplified: Completed


title: Analyse de la Composition du Microbiote Vaginal à différents Temps de la Prise en Charge en FIV et corrélation Avec le Taux de progestérone sérique le Jour du Transfert d'Embryon

acronym: MICROFIV

summary: The composition of the vaginal microbiota varies throughout a woman's life and is sensitive to hormonal and environmental factors. Specifically, hormonal treatments necessary in the medically assisted procreation (MAP) processes can influence the vaginal microbiota. New sequencing techniques have been used to characterize the vaginal microbiota, demonstrating that the microbiota could be divided into 5 classes. The composition of the vaginal microbiota seems to have an implication in the evolution of a pregnancy after IVF. It is therefore essential to have more data on the evolution of the vaginal microbiota at the different stages of IVF treatment and to analyze whether this evolution can be predictive of the success of embryo implantation. Good endometrial progesterone impregnation is an essential prerequisite for ensuring embryo implantation. Indeed, supporting the luteal phase through vaginal progesterone is an essential step in IVF protocols to ensure synchronization between endometrial maturation and embryonic age. However, the serum progesterone level on the day of embryo transfer varies widely between patients. Several factors such as age, vaginal mucosa trophicity, estrogen impregnation and sexual activity are known to affect the vaginal absorption of progesterone. The treatments and vaginal examinations performed during the IVF procedure could also have an impact on the constitution of the vaginal microbiota. The hypothesis of this research is that there is an alteration in the vaginal microbiota during the IVF process which may alter the absorption of vaginal progesterone, with an impact on the failure or success of embryo implantation.

status: Recruiting

ReferenceType: background

ReferenceCitation: Smith SB, Ravel J. The vaginal microbiota, host defence and reproductive physiology. J Physiol. 2017 Jan 15;595(2):451-463. doi: 10.1113/JP271694. Epub 2016 May 5.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

status_simplified: Ongoing


title: Validation of New Therapeutic Targets to Prevent Collagen Accumulation During Cardiac Fibrosis: Procollagen C-proteinase Enhancers

acronym: CARDIACTIV

summary: Heart failure is characterized by cardiac fibrosis linked to extracellular collagen deposits. Collagens are synthesized as soluble precursors, procollagens, which must undergo proteolytic maturation to assemble into fibres. This step is under the control of two extracellular proteins, procollagen C-proteinase enhancer 1 and 2 (PCPE-1 and -2). The mechanism of action of these highly effective and specific activators was recently elucidated by one of our partners. Preliminary results, as well as data from the literature, indicate a strong correlation between the expression rates of PCPEs and cardiac fibrosis. The aim of this study is to validate in humans, by analysis of endomyocardial tissue biopsies, the hypothesis that PCPEs contribute to the anarchic accumulation of collagen during cardiac fibrosis and to evaluate the interest of developing new diagnostic and therapeutic strategies for cardiac fibrosis using PCPE agonists.

study_type: Interventional

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Biological


title: Evolution of Children and Adolescents With Disruptive Mood Dysregulation Disorder Refereed to Hospital for Suicidal Behavior After Three Year: Diagnostic Stability, Psychiatric Comorbidity, Psychosocial Functioning, Identification of Clinical and Actigraphy-measured Prognosis Factors

summary:
Little is known about the natural course and prognosis factors of inpatients and outpatients with Disruptive Mood Dysregulation Disorder (DMDD). The investigators conducted a cross-sectional study to determine the evolution of a sample of DMDD patients referred to the hospital for suicidal behaviors between 2013 and 2018 in terms of diagnostic stability, psychiatric comorbidity, and psychosocial factors. A group of patients with various episodic mood disturbances was used as a clinical case control group.

In addition to change in DMDD symptoms across time, the investigators examined the onset and persistence of psychiatric comorbidity using the KIDDIE-SADS PL and suicidal behaviors using the Colombia Suicidality Severity Rating Scale. The investigators also examined the persistence of depressive symptoms using the Beck Depression Inventory (BDI-II), the persistence of emotional lability (Affective Lability Scale-18), borderline traits (Abbreviated Diagnostic of Inventory Borderline). Socio-demographic, clinical features and actigraphy-measured sleep characteristics determined between 2013 and 2018 were used to predict the evolution of the DMDD patients and the clinical control group.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Defining a Standard Set of Value-Based Patient-Centered Outcomes for Endometriosis: A Delphi Study Conducted by the Study Group VALue Based HEalth CaRe In Endometriosis (VALHERIE).

summary: Endometriosis is a chronic disease that affects one out of 10 women. Endometriosis care is full of variation. Recommendations for optimal management vary between clinician and centers. One way of dealing with this unwanted variation is the shift towards a value -based endometriosis care. Value-based healthcare (VBHC) is a strategy focused on the optimization of the balance between outcomes that are important to patients and cost to achieve these outcomes. To do so, for a given condition it is important to define a standardized set of outcomes metrics allowing quality of care monitoring and comparison in order to optimize clinical practices and patient pathways. A common set of outcomes combining clinical outcomes (Clinical Reported Outcome Measures, CROMs) as well as quality of life and functional recovery indicators through Patient Reported Outcome Measures (PROMs). Different standardized data sets have already been developed to measure outcomes in other pathologies, however a standardized set of outcome measurements have not yet been determined for endometriosis. The objective of this study is to determine a standard set of outcome measurements for endometriosis.

lead_sponsor: One Clinic

location_facility: Hopital Intercomunal Poissy Saint Germain en Laye

lead_sponsor_type: industriel


title: Study of the Involvement of Fatty Acids in Retinopathy of Prematurity: Relationship Between Retinopathy of Prematurity and the Rate of Expression of Transplacental Fatty Acid Receptors.

acronym: OMEGAROP 2

summary: The development of the retinal vascular network is completed during the third trimester of pregnancy and and the first 15 days of life of the newborn. This late maturation can be problematic in cases of preterm births and result in immature retinal vascularization, known as retinopathy of prematurity (ROP). Among the various factors influencing retinal vascular development, the tissue content of omega-3 polyunsaturated fatty acids (PUFAs) appears to be a crucial element. In a previous project, OMEGA-ROP, we showed a difference in the blood bioavailability of omega-3 PUFAs in infants born at less than 28 weeks of amenorrhea who develop ROP compared to healthy newborns with no retinopathy. This study also showed that mothers experienced variations in the blood levels of omega-3 PUFAs that were contrary to the types of variations observed in their children. This suggests a sequestration of omega-3 PUFAs in the mothers of children who will develop ROP. This new project aims to better understand the underlying molecular mechanisms by studying the expression levels of placental fatty acid receptors in relation to the development of ROP in newborns.


type: Other Identifier

title: Microvascular Flow Alteration and Endothelial Dysfunction in Critically Ill Patient With Covid-19

acronym: MICROVID

summary: Microcirculatory dysfunction appears to play a key role in the development of organ failure leading to the death of patients with coronavirus disease 2019 (Covid-19). It is still uncertain today whether this damage is secondary to direct viral infection of endothelial cells or the consequence of the inappropriate inflammatory response induced by the infection. The analysis of endothelial and microcirculatory dysfunctions and glycocalyx degradation therefore appears to be necessary in the understanding of the pathophysiological mechanisms of Covid sepsis and could play a role in the evaluation of the efficacy of certain therapeutics which would aim at improving regional perfusion by decreasing microcirculatory dysfunction.However, the analysis of microcirculatory failure, endothelial dysfunction and glycocalyx degradation has so far only been evaluated in small cohorts, without quantitative analysis of microcirculatory perfusion

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Surgical Intensive Care Unit - Kremlin Bicêtre Hospital, APHP


title: Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles

acronym: BANDOCELE

summary:
Lymphocele secondary to a mastectomy whether or not associated with a lymph node procedure (sentinel lymph node or axillary dissection) is an almost systematic consequence observed in the postoperative situation in this type of surgery.

This can be the source of pain, skin complications, and infection with a significant impact on the length of hospitalization for patients treated for breast cancer.

There is no consensus regarding the management of lymphocele. The placement of a compression bandage after mastectomy and / or axillary dissection would allow a more efficient and rapid reduction of the lymphocele and a reduction in recurrences.

This would make it possible to reduce the duration of the wearing of the drain, which determines the length of hospitalization and reduce the recurrence of lymphoceles, the punctures of which can be one of the risk factors for secondary lymphedema.

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: University Hospital, Toulouse


title: Study of the Relationship Between Coronary Flow and Myocardial Viability: the Single-centre, Observational, Prospective FloVITA Study

acronym: FloVita

summary:
Evaluation of fractional flow reserve (FFR) is a key method for assessing ischemia with a view to guiding revascularization strategy following acute coronary syndrome. A stenosis that appears to be severe by angiography may cause limited ischemia (with an FFR value >0.80) due to the incapacity of the necrotic zone to achieve physiological hyperemia, i.e. maximal coronary flow. Recently, it has been demonstrated that absolute coronary flow, and micro- and macrovascular resistance, as measured by a thermodilution technique, using the Rayflow microcatheter (Hexacath) are strongly associated with myocardial mass. In extensive necrosis, there is a loss of myocardial mass, and these tools could be of potential interest in measuring myocardial viability, which reflects the extent of remaining viable myocardial mass.

Therefore, this study aims to investigate the relationship between both absolute coronary flow and microvascular resistance, and myocardial viability assessed by MRI.

In a prospective, single-centre, interventional study, we will compare absolute coronary flow and microvascular resistance in the left anterior descending artery, in patients with and without a history of ST segment elevation MI.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Epidemiology and Prognosis of ARDS After Pulmonary Resection Surgery

summary:
The improvement in ARDS mortality over the last 20 years seems to be largely explained by the reduction of mechanical ventilation-induced injury (VILI). VILI is essentially related to volotrauma closely associated with "strain" and "stress". The pulmonary stress corresponds to the transpulmonary pressure (alveolar pressure - pleural pressure), and the strain to the change in lung volume related to the functional residual capacity (FRC) of the injured lung at PEEP = 0. The volotrauma corresponds therefore to the generalized excess of stress and strain on the injured lung.

The initial therapeutic strategy consists in protective ventilation with a tidal volume of 6 ml/kg of theoretical ideal weight (predicted by height), associated with a high respiratory rate between 25 and 30 cycles per minute to control PaCO2 (< 50 mmHg), apply a high positive expiratory pressure PEEP according to FiO2, maintain a plateau pressure (PP) lower than 30 cmH20, reduce instrumental dead space, use curarization, recruitment maneuvers such as alternate prone, improve ventilation-perfusion adequacy using inhaled NO.

As a last resort, extracorporeal oxygenation by veno-venous ECMO is a device to supplement respiratory function by improving oxygenation and ensuring decarboxylation. Veno-venous ECMO is indicated in severe ARDS with PaO2/FiO2 < 80 mmHg and/or when mechanical ventilation becomes unsafe due to increased plateau pressure despite optimized ARDS management including high PEEP levels, curarization and prone position.

After lung resection surgery, the incidence of ARDS is 2-8% and its prognosis remains more poor, despite advances in management, with a mortality of up to 60%. Risk factors include intraoperative vascular filling, type of pulmonary resection, and predicted postoperative respiratory function. Early support with VV ECMO is vital in some patients to treat severe hypoxemia, due to variable surgical reduction of lung parenchyma depending on carcinological involvement or initial lung pathology. ). There are very few data concerning these patients with pulmonary resection. The primary objective of this study is to describe the prevalence of ARDS and the risk factors for its occurrence after pulmonary resection surgery. The secondary objective is to compare the ventilation parameters (especially motor pressure) in patients with reduced lung parenchyma in ARDS under VV ECMO with those who did not use VV ECMO assistance.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Circulating Cancer Cells/Macrophage HYbrid Cells in Patients With Breast Cancer.

acronym: CARMMYC

summary:
Pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating cancer cell/macrophage hybrid cells in the peripheral blood.

The study will be conducted on a population of patients with breast cancer (regardless of stage of the disease and the immunohistochemical subtype).

For each included patient, blood samples will be taken and tumor specimens will be collected for the study.

At the end of the blood collection, the patient will have completed his participation in the study.

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: Epidemiology of Chronic Pain as Part of Post-resuscitation Syndrome. Multicenter Prospective Non-interventional Study

acronym: ALGO-REA

summary: Post-intensive care syndrome is an entity of cognitive, physical and mental health disorders occurring and persisting after ICU discharge and responsible of disabilities and decrease of quality of life. Nowadays mental and cognitive health impairments appear to be well known but few data are available about chronic pain after a critical care illness. The aim of the study is to determine the incidence and the risks factors of chronic pain after ICU.

lead_sponsor: Nantes University Hospital


title: Analysis of Volatile Organic Compounds in Exhaled Air and Sweat: Interest in Rapid Screening for SARS-CoV-2 Infection.

acronym: VOCSARSCOVDep

summary:
In the context of the actual pandemia of the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which requires a better diagnostic strategy for the management of patients.

The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The analysis of VOC can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases.

Moreover, it has recently been shown that properly trained dogs would be able to detect an olfactory signature of SARS-CoV-2 infection with a specificity greater than 90%; this olfactory signature corresponds to VOCs detectable by the flair of dogs (Nosaïs-Covid19 study).

Validation of the diagnostic value of VOC analyzes by non-invasive and rapid methods (electronic nose analysis or mass spectrometry; detection by the scent of dogs) for the rapid detection and early diagnosis of a SARS-CoV-2 infection warrants the performance of this clinical study.

design_allocation: Non-Randomized

lead_sponsor: Hopital Foch


title: Evaluation of Mood Disorders Under Biologics (Anti-TNF Alpha) in Chronic Inflammatory Rheumatic Disease

acronym: EMOTION

summary: Chronic inflammatory rheumatic diseases (CIRD) affect many organ systems. Painful sensations within the joints spine, hand and foot deformities, low quality of life and psychosocial status in patients with rheumatoid arthritis, spondyloarthritis and psoriatic arthritis can lead to the development of anxiety and depression. Prevalences of anxiety increase in patients suffering of CIRD, compared with healthy individuals. Another connection has been identified by the links between depression and systemic inflammation. It is proven that higher plasma levels of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNFa) affect neurotransmitter metabolism, with influence on patients mood. The purpose of EMOTION study is therefore to analyze thymic variation under TNFa therapy, as treatment of CIRDs.

primary_purpose: Basic Science

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon


title: Validation of an Educational Evaluation Plan and Assessment of Its Usefulness in Therapeutic Patient Education: Case of Pediatric Home Parenteral Nutrition

acronym: DISEPEIN

summary:
The department of gastroenterology, hepatology and pediatric nutrition at the Necker-Enfants Malades hospital has created an evaluation system for the initial therapeutic education program followed by parents of children requiring parenteral nutrition at the Necker-Enfants Malades hospital.

The aim of the study is to test this evaluation plan and assess its interest in the learning process of parents and then include it in the initial therapeutic education program for parents of children requiring parenteral nutrition of Necker-Enfants Malades hospital.

primary_purpose: Prevention


title: Volatolom Variation in Severe COPD During Hospitalization for Exacerbation and After Hospitalization (VOC-BPCO-Exa)

acronym: VOC-BPCO-Exa

summary:
Chronic obstructive pulmonary disease (COPD) is a public health issue due to its prevalence of 8% in the general population (although it is underestimated), particularly due to the number of severe patients suffering from chronic respiratory failure and the number of hospitalizations estimated at 100,000 each year. Total health insurance expenditure in 2017 for chronic respiratory diseases (excluding cystic fibrosis and cancers) was approximately €3.5 billion, including €1 billion for hospitalizations.

Hospitalizations are mainly related to a worsening of the disease (severe exacerbations mainly of viral and/or bacterial origin). Although the majority of exacerbations are treated on an outpatient basis with antibiotics and/or oral corticosteroids, those occurring in the most severe and often the oldest patients may require hospitalization. It should be noted that almost one out of two patients hospitalized for COPD exacerbation is re-hospitalized within six months; on the other hand, age and length of stay are the two main factors of mortality in the year following hospitalization for COPD in the Intensive Care Unit. Early detection of a worsening of the health status related to COPD could allow appropriate management and avoid at least part of the hospitalizations for exacerbation with a consequent reduction of the associated morbi-mortality.

The objective of this clinical study is to determine the evolution of the profile of volatile organic compounds (VOCs) present in the exhaled air (volatolom) in patients with severe COPD after hospitalization for exacerbation. This step should allow the identification of VOCs (modification of the volatolom) which would be associated with a severe COPD exacerbation, by comparing the volatolom at the acute phase of the exacerbation to the volatoloms during the progressive return to a stable state after hospitalization and to those of patients with a stabilized severe COPD (VOC-BPCO clinical study also sponsored by Foch Hospital)

sponsor_collaborators:
Hopital Foch
Air Liquide SA


title: Consequences of Post Stroke Polysomnographic Abnormalities on Functionnal Recovery and Survival After an Ischemic Stroke

acronym: PSG-AVC

summary:
Ischemic stroke is a major public health issue, likely to cause functional disability. It is well known that sleep has an impact on brain plasticity, and after an ischemic stroke, studies have shown subjective sleep quality alterations and sleep architecture abnormalities.

Furthermore, there is no clear guideline showing the usefulness of a systematic sleep investigation following an ischemic stroke.

The aim of the study is to identify retrospectively correlation between polysomnographic abnormalities (sleep apnea, periodic limb movements, disturbed sleep architecture…) and functional recovery after an ischemic stroke. The study also assesses the impact of sleep abnormalities on survival, and the risk of new cardiovascular event.


title: SERUR : Etude sérologique COVID-19 (Anti-SARS CoV 2) du Personnel de l'Université de Reims Champagne-Ardenne

acronym: SERUR

summary: This study was designed to determine, in a screening situation within the framework of university preventive medicine, the prevalence of positive anti-SARS-Cov 2 serology among the staff of the University of Reims Champagne-Ardenne. The serological tests chosen will allow systematic detection of anti-SARS-CoV-2 IgM and anti-SARS-Cov-2 IgG to assess the moment of potential contamination prior to resumption of occupational activity.

primary_purpose: Screening

lead_sponsor: Université de Reims Champagne-Ardenne

intervention_type: Diagnostic Test


title: Evolution of Cardiopulmonary Fitness in Children With Congenital Heart Disease : a Longitudinal Multi-center Study

acronym: Follow-Heart

summary:
With an incidence of 0.8 %, congenital heart disease (CHD) is the leading cause of congenital anomalies at birth. Medical advances in CHD have transferred the mortality from childhood to adulthood and today there are more adults with CHD than children. After focusing on survival, more attention is being given to health-related quality of life and secondary prevention in this population where warning signals are launched on the risk of sedentary lifestyle, obesity, cardiovascular risk 1.

The cardiopulmonary exercise test (CPET), which is a non-invasive and dynamic examination, is becoming the gold standard to the follow-up 2 of these patients by allowing to quantify disease severity, to evaluate the quality of life 3, to give important prognostic information on functional capacity and haemodynamic response 4, to facilitate a safe decision-making when prescribing exercise programmes and sport participation for these children with CHD 5.

In this context, in a cross-sectional study from 2010 to 2015, the investigators evaluated the cardiopulmonary fitness of children with CHD by comparing them with healthy children 6. In this study, 496 children with CHD compared to 302 healthy children were included. It showed that maximum oxygen uptake (VO2max) and ventilatory anaerobic threshold (VAT) are decreased in CHD children compared to healthy children, clinical determinants of decreased VO2max have been defined for CHD children. This study was proposed, despite the cross-sectional nature, an average decrease in annual VO2max (0,84 ml/kg/min per year) to make pediatric and congenital cardiologist aware of the need to a regular follow up for these patients.

In this new study, the main objective was to know the real evolution of VO2max in these patients from this same cohort, with a longitudinal design, by collecting a new CPET carried out between 2015 and 2020 and compared these results to healthy pediatric population.

The secondary objectives were: to know the evolution of the VAT, to define the clinical determinants in relation to the annual decrease of the VO2max. And to describe the population lost to follow-up in this retrospective study which represents current practice.

ReferenceCitation: Amedro P, Mura T, Matecki S, Guillaumont S, Requirand A, Jeandel C, Kollen L, Gavotto A. Use of new paediatric VO2max reference equations to evaluate aerobic fitness in overweight or obese children with congenital heart disease. Eur J Prev Cardiol. 2023 Nov 30;30(17):1865-1873. doi: 10.1093/eurjpc/zwad201.

ReferenceType: derived

ReferenceCitation: Gavotto A, Ladeveze M, Avesani M, Huguet H, Guillaumont S, Picot MC, Requirand A, Matecki S, Amedro P. Aerobic fitness change with time in children with congenital heart disease: A retrospective controlled cohort study. Int J Cardiol. 2023 Jan 15;371:140-146. doi: 10.1016/j.ijcard.2022.09.068. Epub 2022 Sep 29.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

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

repository_normalized: HAL

version: submittedVersion

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: Elsevier


title: Experience and Understanding of the Mouth, Oral Health and Function Amongst

acronym: FAULKS

summary: Oral health is the one of the commonest causes of health problems in the world, with almost all individuals suffering from reduced oral health at some stage over their life span. As such, oral health is a major public health issue and a major consumer of health spending. Poor oral health results in pain, infection, structural degradation, functional restrictions in chewing, swallowing and speech, change in facial appearance, social stigma, altered body image, and reduced capacity to participate in social events, amongst others. Global problems of human functioning, disability, health and environment in turn affect oral status in many complex ways (for example, ability to maintain oral hygiene, nutritional restrictions, neuromotor incapacity, dysphagia, ability to access and cooperate with treatment, etc). Disability arises from a social environment that fails to enable everyone to access it regardless of his or her impairment. Disabilities are thus socially created and not dependent on the individual's type or location of impairment. There is currently very limited qualitative research exploring perceptions of the mouth, or oral health within a social environment, from the perspective of disabled adults. No universal, holistic, comprehensive tool exists to describe oral health, the functional impact of oral health, and the environmental factors influencing oral health within the biopsychosocial model. It has been suggested that a framework for such an instrument may be supplied by the International Classification of Functioning, Disability and Health (ICF: World Health Organisation, 2001) This research seeks to address these gaps by describing perceptions of the mouth from the perspective of adults with disabilities and complex health conditions, and by linking this qualitative data to the ICF in order to assess the feasibility of using the ICF to conceptualise oral health. Adults with disabilities and complex health conditions were chosen for this ICF core set preliminary study as existing literature suggests that these respondents would accumulate not only a high level of oral health need but also experience high impact of functioning and environment on oral health.

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Centre de Recherche en Odontologie Clinique (CROC), Clermont-Ferrand

collaborators: Dental institute, King's College, Londres, UK


title: Patient Dyspnea Under Veno-arterial Extracorporeal Circulation: Quality, Mechanisms and Sensitivity to Increased Sweep Gas Flow Through the Membrane Lung and Positive Expiratory Pressure

summary:
Rationale: Patients with severe heart failure increasingly benefit from extracorporeal circulatory assistance (Extracorporeal Membrane Oxygenation - ECMO) that completely replaces the function of the heart and is in addition to mechanical ventilation (veno-arterial ECMO). In clinical practice, some of these patients have been found to be dyspneic, although circulatory assistance ensures satisfactory hematosis. Indeed, nearly half of the patients undergoing mechanical ventilation in intensive care have a generally intense dyspnea. In addition to the immediate discomfort caused by dyspnea, which can be assimilated to pain, this symptom is associated with a prolonged duration of mechanical ventilation and contributes to the genesis of neuropsychological sequelae of resuscitation such as post-traumatic stress syndrome.

Objectives :

To study the effectiveness and impact of an increase in ECMO sweep gas flow through the membrane lung or positive tele-expiratory pressure (PEP) on dyspnea in patients under ECMO.
To understand the mechanism involved in this relief of dyspnea. Methods: in 30 patients of Intensive Care Unit, dyspnea will be evaluated by psychophysiological scales and scores as well as by neurophysiological tools (electromyography of inspiratory muscles) during sweep gas flow through the membrane lung incrementation and PEP increase.

Ethical framework: Changes in ventilation parameters and ECMO will be performed in the usual manner, without additional or unusual diagnostic, treatment or monitoring procedures.

Expected results and outlook: the investigators hypothesize that half of the patients on veno-arterial ECMO have dyspnea related to pulmonary edema. Therefore, an increase in PEP would alleviate this dyspnea. The investigators hypothesize that by using a relief method related to increased sweep gas flow through the membrane lung, the investigators can reduce the discomfort without inducing any associated complication.

This study will improve the knowledge of the mechanisms determining dyspnea in patients under ECMO and the principle of therapeutic strategy to improve it.

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

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


title: Hypophosphatemia In Infants With Severe Bronchiolitis: Prevalence And Risk Factors

summary: Bronchiolitis is a major public health problem and the leading cause of paediatric intensive care unit admission in infants. Hypophosphatemia is common in adult intensive care units and was associated with an increase of the duration of mechanical ventilation and the length of stay. Our hypothesis is that hypophosphatemia is common in bronchiolitis and could be a marker of severity.

location_facility: Hopital Femme Mere Enfant - Groupement Hospitalier Est


title: Contribution of Transnasal Humidified Rapid-insufflation Ventilatory Exchange (THRIVE) to Optimize Maternal Pre-oxygenation and Anaesthetic Preparation Time for General Anaesthesia for Urgent Caesarean Section A Prospective Experimental Study on Healthy Volunteers.

acronym: PREOXCE

summary: The main objective of this study is to determine if the use of transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) can reduce by 90 seconds the time between the entry into the operating room of the volunteer and the moment when the anaesthetic drugs are ready and when the Oxygen Reserve Index has reached a plateau value for more than 10 seconds, a moment which would therefore allow the induction of general anaesthesia, compared to the pre-oxygenation with the face mask applied by the anaesthetist alone in charge of anaesthesia.

study_start_date_type: Anticipated

intervention_type: Procedure


title: Efficacy of the Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts

acronym: VAC-WARTS

summary: Cutaneous viral warts are very common and are caused by the human papilloma virus (HPV). Most people experience warts in one form or another at some point in their lives. Cutaneous warts are related to different types of HPV. For the palms and soles, HPV 2 has been the most frequently found but HPV 1, 4, 27, and 57 have also been described. Our hypothesis is that vaccination by nonavalent vaccine against HPV could lead to a complete resolution of difficult-to-treat palmo-plantar warts patients of more than 15 years and 3 months of age.

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: VAC-WARTS

titre: Efficacité du vaccin nonavalent anti-HPV dans la guérison des verrues résistantes aux traitements usuels

discipline_principale: dermatologie

nom_porteur: CHANAL

prenom_porteur: Johan


title: VASCular Impact of Angiogenic Treatment in Patients With Advanced Colorectal Cancer

acronym: VASCATAQ

summary:
Antiangiogenic treatments are used in many tumor locations such as metastatic colorectal cancer (mCRC) with a significant improvement in carcinological results on overall survival and / or progression-free survival. However, their use is characterized by an increase in side effects and in particular cardiovascular effects such as high blood pressure (hypertension). One of the main classes of antiangiogens used in this indication is that of monoclonal antibodies, the leader of which is bevacizumab (Avastin®, Roche, Bale, Switzerland). Bevacizumab works by inhibiting endothelial vascular growth factor-dependent neoangiogenesis (vascular endothelial growth factor VEGF). In the reference studies, the inhibition of VEGF, whether extracellular (monoclonal antibody directed against VEGFA) or intracellular (receptor inhibitors with tyrosine kinase activity), induces hypertension of all grades, observed in 25% to 40 % of patients including 8 to 17% of severe grades (≥ grade 3 NCI-CTCAE). In terms of pathophysiology, inhibition of VEGFA results in a decrease in the availability of nitric oxide (NO) at the endothelial level and the appearance of arteriolar rarefaction. This induces an increase in peripheral resistance responsible ultimately for an increase in blood pressure. The occurrence of hypertension induced by anti-VEGF treatment seems to be predictive of the carcinological response in certain oncological situations such as metastatic breast cancer9, glioblastoma and mRCC. Furthermore, it has also been shown that there is an early attack on the elastic conductance arteries (branches of the aorta and its main ones) characterized by an increase in their rigidity in patients exposed to a VEGF receptor inhibitor with tyrosine activity. kinase or bevacizumab. This increase, whose poor prognostic impact is known at the cardiovascular level is largely independent of the rise in blood pressure and reflects a direct toxicity of treatments at the level of the artery wall. This increase in rigidity, refused when the pressure rises, would be predictive of a low carcinological response rate at 6 months. However, these data are based on populations that are heterogeneous in terms of carcinology and the position prior to or concomitant with other antineoplastic treatments.

In this context, the evaluation of arterial stiffness in the same patient population would make it possible to better define the involvement of the conductive arteries in a clearly defined clinical situation. Joint measurements of the plasma concentration of the treatment as well as those of factors derived from the endothelium and circulating tumor markers which, to our knowledge, have never been carried out in these patients, would make it possible to better specify the mechanisms of involvement and the links between exposure, arterial toxicity and carcinologic efficacy of bevacizumab. Of course, in order to assess more precisely the inherent impact of chemotherapy on the conductance arteries, the evolution of arterial stiffness must take into account the possible effects in patients receiving, for essentially clinical and biological reasons, systemic treatment without antiangiogenic.

lead_sponsor: University Hospital, Rouen

intervention_type: Drug


title: Statement of Care of Anemia in Delivering Patients at Nord Franche-Comte Hospital

acronym: ANEMIA

summary: Anemia is a common pregnancy condition that has multiple origins. Its frequency and severity seem to be increasing, despite the existing management recommendations and the awareness of health professionals. The objective of this study is to make a statement of this pathology within our establishment, to evaluate the proportion of patients presenting this pathology and to highlight possible risk factors.

time_perspective: Cross-Sectional

lead_sponsor: Hopital Nord Franche-Comte


title: Quality of Life and Neurodevelopment Assessment of Children With Congenital Heart Disease Aged 2 to 4 Years : a Multicentre Controlled Cross-sectional Study

acronym: QoLCHD

summary: Congenital heart diseases (CHD) are the firt cause of congenital malformations (8 for 1000 births). Since the 90's, great advances in prenatal diagnosis, pediatric cardiac surgery, intensive care, and cardiac catheterization have reduced morbidity and early mortality in this population. Nowadays, health-related quality of life (HRQoL) assessment of this population is in the foreground. Our team is a tertiary care center for management of patients with CHD, from the fetal period to adulthood. The investigators have been conducting a clinical research program on HRQoL in pediatric and CHD. The investigators thus demonstrated the link between cardiopulmonary fitness and HRQoL in children with CHD aged 8 to 18 years, the correlation between functional class and HRQoL in adults with CHD, the impact of therapeutic education on HRQoL in children under anticoagulants and the lack of difference between the HRQoL of children CHD aged 5 to 7 years old and that of control children. Currently, no controlled cross-sectional quality of life study assessment has been leded in the youngest children with CHD. This present study therefore extends our work in younger children aged 2 to 4 years.

collaborators: University of Montpellier - Inserm 1046 - PhyMeddExp

collaborators: Saint Pierre Institute - Palavas les Flots

collaborators: Congenital Cardiology Department of university hospital of Bordeaux


title: Study of Macrophage Function and of the GM-CSF Signaling Pathway in Alveolar Proteinosis by Mutations of the MARS Gene

acronym: MacroMARS

summary:
Mutations in the MARS gene encoding methionyl-tRNA synthetase are responsible for a genetic form of alveolar proteinosis (PAP), but the pathophysiological mechanisms of the respiratory phenotype are not known.

The main hypothesis is that the PAP phenotype in these patients is secondary to a defective clearance of the surfactant by the alveolar macrophages.

The main objective of the study is to study the clearance capacity of lipoproteinaceous material by macrophages of patients with MARS related PAP. This will be investigate in cultured macrophages derived from peripheral blood monocytes of patients (patients with MARS related PAP) and controls (patients without MARS related PAP).


title: Pharmaceutical Consultation and Exchange Between the Pharmacy and the Hospital

acronym: EPHET

summary: Investigators hypothesize that the implementation of a hospital pharmacy consultation and the transmission of its report to pharmacies may improve knowledge, adherence and encourage the development of pharmacist medication reviews. A before-and-after study of the implementation of pharmaceutical consultations will allow the investigators to evaluate the validity of the hypothesis.

lead_sponsor: Hospices Civils de Lyon

intervention_type: Behavioral


title: EXPRESON-INTRA : Intracerebral Recordings of P3a Responses to Own-names Uttered by Expressive and Neutral Voices in Pharmacoresistant Epilepsy Adult Patients

acronym: EXPRESON-IN

summary:
Neurophysiologic evaluation of disorders of consciousness (DOC) patients in intensive care unit include late auditory evoked potentials. It allows the physicians to record cerebral responses of patients to auditory stimuli and in particularly to their own name (as the P3a response). Numerous studies try to improve the relevance of the auditory stimuli used in this paradigm and notably using more expressive stimuli.

Here the investigators investigate the intracerebral correlates of the P3a responses recorded on the scalp with neutral and more expressive stimuli.

lead_sponsor: Centre Hospitalier St Anne


title: Impact of Von Willebrand Factor and Its Multimers on Angiogenesis

acronym: WILLANGIO

summary: The study aims to study the expression of numerous proteins involved in angiogenesis in 70 patients with von Willebrand disease in order to try to identify markers of interest. Secondly, the investigators plan to investigate whether there is a relationship between the proteins tested, the distribution of multimers and the clinical phenotype of the patients, in particular by looking for the presence of bleeding linked to the presence of angiodysplasias.

status: Not yet recruiting


title: Evaluation of the Pronostic Value of Vascular Refilling Rate on Mortality in Chronic Kidney Disease Patients on Dialysis (Stage 5D)

acronym: REMVAMIR

summary:
Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) during an observational period of 3 years:

the prognostic value of vascular refilling rate on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number
the prognostic value of interdialytic weight gain on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number
the prognostic value of perdialytic weight loss on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number.


title: Towards Participatory Paediatric Asthma Action Plans

acronym: PACAP

summary: Asthma is the most common chronic disease in children. The management of asthma attacks at home is based on asthma action plans that are very heterogeneous and reflect the diversity of recommendations on this subject. The purpose of this study is to observe using smartinhalers how children and their families use their emergency treatment at home in case of asthma symptoms and asthma attacks, to allow building new recommendations based not only on the literature, but also on real-world data.

ReferenceCitation: Marguet C, Michelet I, Couderc L, Lubrano M. [Management of acute asthma exacerbation in childhood: French recommendations]. Arch Pediatr. 2009 Jun;16(6):505-7. doi: 10.1016/S0929-693X(09)74046-1. No abstract available. French.

ReferenceCitation: Pinnock H, Parke HL, Panagioti M, Daines L, Pearce G, Epiphaniou E, Bower P, Sheikh A, Griffiths CJ, Taylor SJ; PRISMS and RECURSIVE groups. Systematic meta-review of supported self-management for asthma: a healthcare perspective. BMC Med. 2017 Mar 17;15(1):64. doi: 10.1186/s12916-017-0823-7.

ReferenceCitation: Heidi M, Emily K, Benjamin H, Michael C, Robert K, Mitch B, Chris G, Mando W, Andrew B. Patient reported outcomes for preschool children with recurrent wheeze. NPJ Prim Care Respir Med. 2019 Mar 26;29(1):7. doi: 10.1038/s41533-019-0120-3.


title: Comparison of the Accuracy of the Neurological Prognosis at 6 Months of Traumatic Brain Injury Between Junior and Senior Doctors.

acronym: PREDICT II

summary: PREDICT II is an observational, prospective design, single-center study aiming to determine whether the prognosis of neurological outcome at 6 months in patients undergoing traumatic brain injury established by a doctor at his initial management is more accurate in experienced doctors versus junior doctors.

location_facility: Réanimation neurochirurgicale, Hôpital Pitié-Salpêtrière


title: Homemade Fenestrated Physician-modified Stent-grafts for Arch Aortic Degenerative Aneurysm

summary:
The aim was to evaluate early and medium-term outcomes of single and double fenestrated physician-modified endovascular grafts (PMEGs) for endovascular aortic arch degenerative aneursym repair.

The evolution of stent-graft technology recently has meant the development of custom-made branched stent-grafts to achieve total endovascular aortic arch repair for high-risks patients. The disadvantages of custom-made include manufacture and deliver times for urgent cases and the associated high costs. Unfortunately there is also a high rate of embolization associated with this approach probably related to the complexity of deploying a multi-branched unibody stent-graft. A further alternative is physician modified endografts (PMEGs) for zone 0 TEVAR involving the deployment of a conventional stent-graft device ex-vivo, fashioning of customized fenestrations (for supra aortic trunk) and re-constrainment into the delivery system. The authors have previously shown the feasability in vitro and they have reported their experience for arch aortic lesion. The aim of this study is to evaluate the outcomes for aortic arch degenerative aneursym repair which is the most risky procedure


title: Study of the Activity and Role of Notch1 Signalling in Glioma

acronym: GLIONOTCH

summary: The investigators showed in 2015 (Guichet et al) that the Notch1 pathway has an anti-proliferative role on glial brain tumors. In this project, the investigators investigated which genes downstream of Notch1 pathway activation produce the anti-proliferative effect. The investigators hypothesized that the SNAI2 and TAL1 genes act downstream of Notch1


title: Bio-collection for the Discovery of New Biomarkers for the Prediction of Cardiovascular Events

acronym: CDPA-Biobank

summary: The main goal of this project is to constitute a collection of biological samples, obtained through the clinical activity of the Centre for Screening and Prevention of Atherosclerosis at Toulouse University Hospital, managing patients in primary or secondary prevention for cardiovascular (CV) diseases. The main objective is to validate new biomarkers with prognostic value regarding the onset of future CV events. Besides, the biological collection will enable patho-physiological studies on atherosclerosis related diseases.


title: Evaluation of the Effect of Isonatremic (vs Conventional) Dialysis Treatment on the Control of Interdialytic Weight Gain in Chronic Kidney Disease Patients on Dialysis (Stage 5D)

acronym: DISON-IRC

summary:
Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of treatment with isonatremic dialysis (vs conventional dialysis), during an observational period of 2 months each, on:

control of interdialytic weight gain
perdialytic tolerance in terms of adverse events occurring during all of the sessions of the study
body composition and thirst measured monthly during the 4 months of follow-up.
tolerance to treatment.


type: Registry Identifier

title: ANTIcoagulation in Severe COVID-19 Patients: a Multicenter, Parallel-group, Open-label, Randomized Controlled Trial

acronym: ANTICOVID

summary: Coronavirus disease 2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), may predispose patients to thrombotic disease due to a state of profound inflammation, platelet activation, and endothelial dysfunction leading to respiratory distress and increased mortality. The incidence of macrovascular thrombotic events varies from 10 to 30% in COVID-19 hospitalized patients depending on the type of arterial or vein thrombosis captured and severity of illness . Observational results in patients receiving routine low-dose prophylactic anticoagulation (LD-PA), several institutions have recently released guidance statement to prevent macrovascular thrombotic events with dose escalation anticoagulation. In these recommendations, high-dose prophylactic anticoagulation (HD-PA) and therapeutic anticoagulation (TA) can be employed either empirically or based on the body mass index and increased D-dimer values. No randomized trial has validated this approach, and other recent recommendations challenge this approach. Microvascular thrombotic events are also of major concern in critically ill patients with COVID-19, even in the absence of obvious macrovascular thrombotic events. A large review of autopsy findings in COVID-19-related deaths reported micro thrombi in small pulmonary vessels. More generally, COVID-19-induced endothelitis and coagulopathy across vascular beds of different organs lead to widespread microvascular thrombosis with microangiopathy and occlusion of capillaries. Thus, in severe COVID-19 patients requiring oxygen therapy without initial macrovascular thrombotic event, a HD-PA or a TA could be beneficial by limiting the extension of microvascular thrombosis and the evolution of the lung and multi-organ microcirculatory dysfunction. In a large observational cohort of 2,773 COVID-19 patients, a lower in-hospital mortality in ventilated patients receiving TA as compared to those receiving PA (29.1% vs. 62.7%). Our hypothesis is dual: i) first, that TA and HD-PA strategies mitigate microthrombosis and each limit the progression of COVID-19, including respiratory failure and multi-organ dysfunction, with in fine a decreased mortality and duration of disease, as compared to a low-dose PA; ii) second, that TA outperforms HD-PA in this setting.

ReferenceCitation: Labbe V, Contou D, Heming N, Megarbane B, Ait-Oufella H, Boissier F, Carreira S, Robert A, Vivier E, Fejjal M, Doyen D, Monchi M, Preau S, Noel-Savina E, Souweine B, Zucman N, Picos SA, Dres M, Juguet W, Mariotte E, Timsit JF, Turpin M, Razazi K, Gendreau S, Baloul S, Voiriot G, Fartoukh M, Audureau E, Mekontso Dessap A. Comparison of standard prophylactic, intermediate prophylactic and therapeutic anticoagulation in patients with severe COVID-19: protocol for the ANTICOVID multicentre, parallel-group, open-label, randomised controlled trial. BMJ Open. 2022 Apr 26;12(4):e059383. doi: 10.1136/bmjopen-2021-059383.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

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

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

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

ipd_sharing_description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION


title: Evaluation of Intubation Conditions With the Use of Atracurium After a Fixed Three-minute Delay

acronym: CINTROI

summary: The purpose of this study is to evaluate intubation conditions with the use of atracurium after a fixed three-minute delay

ReferenceCitation: Debaene B, Beaussier M, Meistelman C, Donati F, Lienhart A. Monitoring the onset of neuromuscular block at the orbicularis oculi can predict good intubating conditions during atracurium-induced neuromuscular block. Anesth Analg. 1995 Feb;80(2):360-3. doi: 10.1097/00000539-199502000-00026.

ReferenceCitation: Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.

ReferenceCitation: Plaud B, Baillard C, Bourgain JL, Bouroche G, Desplanque L, Devys JM, Fletcher D, Fuchs-Buder T, Lebuffe G, Meistelman C, Motamed C, Raft J, Servin F, Sirieix D, Slim K, Velly L, Verdonk F, Debaene B. Guidelines on muscle relaxants and reversal in anaesthesia. Anaesth Crit Care Pain Med. 2020 Feb;39(1):125-142. doi: 10.1016/j.accpm.2020.01.005. Epub 2020 Jan 8.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

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

unpaywall_oa_status: hybrid

location_facility: Service Anesthésie Réanimation Chirurgicale Hôpital Cochin


title: Neurovegetative Decoupling in the Visceral-brain Axis and Cognitive-emotional Vulnerability in Somatoform Disorders : Interest of Vagal Biofeedback

acronym: BIOFEESOMATO

summary: Evaluation of the physiological and clinical effects of the biofeedback training with patients suffering from somatoform disorders, depending on their neurovegetative profile related to a visceral-brain decoupling.

primary_purpose: Supportive Care

ReferenceCitation: Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

ReferenceCitation: Laborde S, Mosley E, Thayer JF. Heart Rate Variability and Cardiac Vagal Tone in Psychophysiological Research - Recommendations for Experiment Planning, Data Analysis, and Data Reporting. Front Psychol. 2017 Feb 20;8:213. doi: 10.3389/fpsyg.2017.00213. eCollection 2017.

ReferenceCitation: Muller L, Spitz E. [Multidimensional assessment of coping: validation of the Brief COPE among French population]. Encephale. 2003 Nov-Dec;29(6):507-18. French.

ReferenceCitation: Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.

ReferenceCitation: Varon C, Morales J, Lazaro J, Orini M, Deviaene M, Kontaxis S, Testelmans D, Buyse B, Borzee P, Sornmo L, Laguna P, Gil E, Bailon R. A Comparative Study of ECG-derived Respiration in Ambulatory Monitoring using the Single-lead ECG. Sci Rep. 2020 Mar 31;10(1):5704. doi: 10.1038/s41598-020-62624-5.

ReferenceCitation: de Vroege L, Emons WHM, Sijtsma K, van der Feltz-Cornelis CM. Psychometric Properties of the Bermond-Vorst Alexithymia Questionnaire (BVAQ) in the General Population and a Clinical Population. Front Psychiatry. 2018 Apr 23;9:111. doi: 10.3389/fpsyt.2018.00111. eCollection 2018.

ReferenceCitation: Bulut NS, Wurz A, Yorguner Kupeli N, Carkaxhiu Bulut G, Sungur MZ. Heart rate variability response to affective pictures processed in and outside of conscious awareness: Three consecutive studies on emotional regulation. Int J Psychophysiol. 2018 Jul;129:18-30. doi: 10.1016/j.ijpsycho.2018.05.006. Epub 2018 May 19.

ReferenceCitation: Schumann A, Kohler S, Brotte L, Bar KJ. Effect of an eight-week smartphone-guided HRV-biofeedback intervention on autonomic function and impulsivity in healthy controls. Physiol Meas. 2019 Jul 1;40(6):064001. doi: 10.1088/1361-6579/ab2065.

ReferenceCitation: Sarason IG, Johnson JH, Siegel JM. Assessing the impact of life changes: development of the Life Experiences Survey. J Consult Clin Psychol. 1978 Oct;46(5):932-46. doi: 10.1037//0022-006x.46.5.932. No abstract available.

ReferenceCitation: Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

lead_sponsor: University Hospital, Grenoble

collaborators: Laboratoire de Psychologie et NeuroCognition

collaborators: Laboratoire interuniversitaire de psychologie : personnalité, cognition et changement social - LIP-PC2S


title: Attenuation of Tonal Tinnitus by Lateral Inhibition Therapy

acronym: TIL

summary: Lateral Inhibition Therapy (TIL) corrects the patient's hearing by notched amplification on the patient's listening soundtrack. This half-octave notch is targeted at tinnitus frequencies measured tonal. The device slightly increases the amplification around the notch, so that the cerebral cortex compensates for this "gap" in the sound spectrum, masking the crippling tinnitus at the same time. This research is based on a new algorithm developed by the SIEMENS Company which proposes an attenuation of tonal tinnitus by a TIL by notched amplification emitted by the hearing device, object of the study.

lead_sponsor: Ramsay Générale de Santé

sponsor_collaborators:
Ramsay Générale de Santé
Dr Quemar


title: Bacteriological Evaluation of Spontaneous Otorrhea in Children

summary: After pneumococcal conjugate vaccine implementation, the number of acute otitis media (AOM) episodes has decreased, but AOM still remains among the most common diagnoses in childhood. From 2% to 17% of cases of AOM feature spontaneous perforation of the tympanic membrane (SPTM). The aim of this study was to describe the bacteriological causes of SPTM several years after PCV13 implementation, in 2010.

lead_sponsor: Association Clinique Thérapeutique Infantile du val de Marne


title: Comparison Between Calculated Bioavailable Testosterone Level With Radio-immunoassay Result.

acronym: TESTOBIO

summary:
Currently, the gold standard to obtain bioavailable testosterone results is radioimmunoassay (RIA). However, this assay requires specific equipment.

Giton in 2006 proposed an optimized calculation of the Vermeulen equation, the results of which seem to be well correlated with those obtained by RIA.

The aim of this study is to determine if the bioavailable testosterone levels determined by both methods are similar in order to replace the usual RIA assay of bioavailable testosterone by this calculation.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Decompensation of Cirrhosis and Iron Metabolism

acronym: DeCiFer

summary:
Iron is a crucial metal whose metabolism is tightly regulated. Iron deficiency or iron overload are both deleterious at the cellular, organic and systemic levels. In line with the major role of the liver in iron homeostasis, links between iron metabolism and acute on chronic liver failure have been highlighted. Nevertheless, due to the difficulty of accurately assessing iron metabolism in this situation, therapeutic intervention on iron metabolism in this setting is currently not codified.

A better understanding of these mechanisms is therefore essential, in particular by characterizing the impact of exposure to non-transferrin-bound iron in acute on chronic liver failure on short-term mortality.

Overall, a better understanding of the physiopathological mechanisms of iron should allow to optimize the martial balance in this condition and also improve therapeutic approaches.

lead_sponsor: Rennes University Hospital


title: Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia Through an Innovative Organizational Strategy

acronym: SePaRIC

summary: The project proposes to evaluate a strategy for prioritizing teleconsultation for patients with chronic inflammatory rheumatic diseases during the COVID-19 pandemia. This selection will be done through telephone contact by medical students, supervised by residents and rheumatologists on a patient database. The other objectives are to assess the impact of the pandemia on the physical and mental health of patients classified as being at risk

lead_sponsor: University Hospital, Limoges


title: Effects of Different Forms of Fatigue on Double-Task Performance in the Elderly

summary:
The dual task (walking and cognitive task at the same time) is increasingly used in geriatrics in protocols for detecting people who are falling and/or for highlighting cognitive disorders. However, frail elderly people tend to get tired quickly and a lack of awareness of the effects of fatigue on dual-task performance could alter the diagnosis.

There are two types of fatigue: mental fatigue and peripheral muscle fatigue. Each participant will do both types of fatigue over 2 appointments spaced by 7 days so that the subject can recover from induced fatigue. The sequence of fatigue tasks will be randomized.

At the first appointment (day 0):

Pre-fatigue assessment :

The subject must walk on 10m with round trip for 1min.
the subject must do the arithmetic count of 3 in 3
Then comes the evaluation in double task (walking and counting at once for 1min). The subject must walk on 10m with round trip for 1min by doing the arithmetic count of 3 in 3 at the same time.
mental fatigue task or muscle fatigue task (randomized)
post-fatigue assessment (the same as pre-fatigue assessment)

7 resting days

Second appointment (day 7)

Pre-fatigue assessment :

The subject must walk on 10m with round trip for 1min.
the subject must do the arithmetic count of 3 in 3
Then comes the evaluation in double task (walking and counting at once for 1min). The subject must walk on 10m with round trip for 1min by doing the arithmetic count of 3 in 3 at the same time.
mental fatigue task or muscle fatigue task (randomized)
post-fatigue assessment (the same as pre-fatigue assessment)

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Comparison of Hemodynamic and Respiratory Parameters During Physical Activity Without Mask, With Surgical Mask and General Public

acronym: PAM

summary:
The COVID-19 pandemic has completely changed societal activity, including physical activity.

Recommendations for wearing masks vary from country to country, region to region, and may be mandatory or optional in indoor or outdoor environments.

During physical activities, the latest ministerial recommendations are that wearing a mask is not mandatory even in case of close distance of less than one meter and in case of physical contact (ministerial recommendations of September 19, 2020), even in regions where wearing a mask is mandatory outdoors. This is based on elements not explained by the Ministry of Sports and partly on elements showing a limitation of respiratory capacities during exercise tests with gas exchange measurements. Indeed, subjects with FFP2 masks have their maximal capacity to effort and VO2max decreased as well as the respiratory capacities whether at rest or during effort in comparison with subjects without mask and to a lesser degree with surgical masks.

However, the FFP2 mask is not recommended by the medical or sports authorities, and surgical or general public masks are recommended. Moreover, during leisure time physical activities, it is not frequent that the subjects need to be at their maximum physical capacity. This moderate loss of physical capacity at the peak of the effort is for most amateur athletes not relevant in their practice.

In addition, airborne transmission of COVID-19 has been shown in several studies: in a choir, on a commercial airplane, on a bus, and close contact is a secondary source of contamination.

There is concern that physical activity in non-open environments is becoming a source of COVID-19 contamination. In studies in non-open environments (bus, church, airplane), the degree of contamination in a so-called confined atmosphere varies between 35 and 85%. In Miller's study, in a church choir with a distance of 0.75 m between choristers and 1.4 m between each row, after 2.5 hours of rehearsal including breaks and buffet, without wearing a mask and with social distancing, hand washing with a hydro-alcoholic solution and reduction of contacts, the contamination with a single patient was 85% on a total of 61 choristers. One can imagine what the degree of contamination would be during a physical activity in a gymnasium without wearing a mask, even with hand and foot washing and floor decontamination.

Currently, all sports activities are stopped but they will start again sooner or later.

Before the recontainment, according to the directives of the Ministry of Sports, the wearing of masks was not compulsory and it was not recommended in outdoor activities (golf...) and in gymnasiums including activities with contact (judo, dance...). Many people are reluctant to wear a mask during sports activities: discomfort, fear of loss of performance, hypoxia...

However, it seems essential to us to determine, during a physical activity, what are the cardiac and respiratory consequences of wearing a surgical or general public mask, before resuming sports activities in a few weeks or months.

It seems important to us to determine the degree of deterioration of the cardiac and pulmonary physical capacities during physical leisure activities which concern more than 99% of the leisure activities as opposed to the sports activities practised by professionals, this to enlighten the practitioners and the ministerial authorities on the possible non-deterioration of the physical capacities with the effort and the absence of deleterious effect of the wearing of a mask.

ReferenceType: result

ReferenceCitation: Fikenzer S, Uhe T, Lavall D, Rudolph U, Falz R, Busse M, Hepp P, Laufs U. Effects of surgical and FFP2/N95 face masks on cardiopulmonary exercise capacity. Clin Res Cardiol. 2020 Dec;109(12):1522-1530. doi: 10.1007/s00392-020-01704-y. Epub 2020 Jul 6.

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

publisher_dissemination: Springer-Nature

ReferenceCitation: Miller SL, Nazaroff WW, Jimenez JL, Boerstra A, Buonanno G, Dancer SJ, Kurnitski J, Marr LC, Morawska L, Noakes C. Transmission of SARS-CoV-2 by inhalation of respiratory aerosol in the Skagit Valley Chorale superspreading event. Indoor Air. 2021 Mar;31(2):314-323. doi: 10.1111/ina.12751. Epub 2020 Oct 13.

evidence: oa journal (via publisher name)

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

version: acceptedVersion

repository_institution: Edinburgh Napier University - Edinburgh Napier Research Repository

repository_institution: Queensland University of Technology - QUT ePrints

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

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Virginia Tech - Virginia Tech Works

repository_institution: University of Colorado Boulder - CU Scholar

repository_normalized: cuscholar

repository_institution: California Digital Library - eScholarship

repository_institution: Cold Spring Harbor Laboratory - medRxiv

repository_normalized: medRxiv

publisher_dissemination: Hindawi

ReferenceCitation: Moser MR, Bender TR, Margolis HS, Noble GR, Kendal AP, Ritter DG. An outbreak of influenza aboard a commercial airliner. Am J Epidemiol. 1979 Jul;110(1):1-6. doi: 10.1093/oxfordjournals.aje.a112781.

ReferenceCitation: Shen Y, Li C, Dong H, Wang Z, Martinez L, Sun Z, Handel A, Chen Z, Chen E, Ebell MH, Wang F, Yi B, Wang H, Wang X, Wang A, Chen B, Qi Y, Liang L, Li Y, Ling F, Chen J, Xu G. Community Outbreak Investigation of SARS-CoV-2 Transmission Among Bus Riders in Eastern China. JAMA Intern Med. 2020 Dec 1;180(12):1665-1671. doi: 10.1001/jamainternmed.2020.5225. Erratum In: JAMA Intern Med. 2021 May 1;181(5):727.

publisher_dissemination: American Medical Association

lead_sponsor: Fondation Hôpital Saint-Joseph


title: Prognostic Value of Trichoscopy in Patients With Systemic Scleroderma

acronym: TRICHLOSCLERO

summary:
Few data are available on scalp involvement in systemic scleroderma.
Few data are available on the association between scalp abnormalities and features of systemic scleroderma
Trichoscopy is a simple, reproducible, noninvasive examination that is part of the examination of hairy areas in routine dermatologic practice
There is a lack of simple, noninvasive examinations to evaluate patients with systemic scleroderma

The objective will be to evaluate the contribution of trichoscopy in the evaluation of patients with systemic scleroderma

lead_sponsor: University Hospital, Lille


title: Assessment of the Prevalence of Sarcopenia by CT Scan in Patients Diagnosed With Head & Neck Carcinoma

acronym: SARVADS 1

summary:
Sarcopenia is defined by the reduction in skeletal muscle mass and physical performance. It results in a decrease in muscle strength, overall physical activity, walking and the development of balance disorders and falls. It is one of the natural consequences of aging and contributes to frailty and the appearance of geriatric syndrome (s) (Chandapasirt et al, 2015; Cruz-Jentoft et al, 2010).

Its prevalence in patients with Head & Neck cancer is 39% (Hua et al, 2020) and is associated with an increase in postoperative complications (Achim et al, 2017; Bril et al, 2019), with greater toxicity of chemotherapy. (Wendrich et al, 2017) and reduced overall survival (Hua et al, 2020).

It is measured by CT scan (assessment of muscle volume with respect to L3 using IMAGE J software) (Teigen et al, 2018) and by clinical tests (performance tests) (Swartz et al, 2016, Cruz-Jentoft et al, 2010).

Several studies have shown a possible assessment of sarcopenia by measuring skeletal muscle mass with regard to C3 (Ufuk et al, 2019; Swartz et al, 2016).

This trial aims to evaluate the prevalence of sarcopenia in head and neck cancer evaluated by CT at C3.

lead_sponsor: Weprom

location_facility: Clinique Victor Hugo / Centre Jean Bernard


title: Emotions Recognition in Multiple Sclerosis

acronym: RECODE

summary: Through this study, a group composed of multiple sclerosis patients will be compared to a healthy volunteers group to determine if the positive emotions recognitions is preserved in the first group.

primary_purpose: Diagnostic

lead_sponsor: Lille Catholic University


title: Effects of Sage Extracts on Cognitive Function During Aerobic Exercise in Healthy Individuals

summary: Extracts of sage have been reported to interact with central nervous system (CNS) mechanisms relevant to cognitive performance but, to date, no trial has clearly demonstrated the possible effects in healthy individuals in fatiguing conditions. The current study investigates the effects of this supplementation in healthy males and females versus placebo on cognition, heart rate and perceived exertion, during a fatiguing cycling exercise.

lead_sponsor: University of Burgundy

intervention_type: Dietary Supplement


title: Assessment of the Functional Impact of a Closed-loop Controlled Prehension Neuroprosthesis in Post-stroke Patients. PREHENS-STROKE

acronym: PREHENS-STROKE

summary: The aim of the PREHENS-STROKE study is to propose a functional replacement device to restore grip capacities in patients with hemiparesis after stroke, unable to actively open the hand to seize objects. The main objective is to evaluate the impact of the use of a self-controlled prehension neuroprosthesis on the ability to perform a standardized grasping task, consisting of grasping, relocating and releasing a glass (palmar grasp) or a spoon (key-pinch), compared to a condition without the use of the prehension neuroprosthesis.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Toulouse


title: Study of the Difference Between Anorexia Nervosa With a History (s) of Psychological Trauma (AM-T) and Classical Anorexia Nervosa (AM-C) on the Neurocognitive and Neurophysiological Factors

acronym: ATAC

summary: Recent studies suggest that patients with an history of trauma may represent a specific subtype of anorexia nervosa (AM) underlined by specific neurobiological and psychopathological mechanisms. Thus, AM-T subjects would manifest cognitive (specific difficulties in executive functions), emotional (emotional disruption, impulsivity, etc.) and neurobiological (secretion of kynurenine and neurokinins in the face of stress) caracteristics different from those of AM subjects.

lead_sponsor: University Hospital, Montpellier


title: Clinical Intuition for PRedicting Evolution in Sepsis in the Emergency Department - CIPRES-ED Study

acronym: CIPRES-ED

summary:
Sepsis is a syndrome involving infection and an abnormal systemic inflammatory response in the infected organism, resulting in organ dysfunction and possibly death. It is a major cause of hospital mortality. A large proportion of sepsis diagnoses are made in emergency departments. Early diagnosis and appropriate treatment have been shown to reduce mortality from this disease.

In a context of limited resources, it is therefore important to be able to quickly stratify patients presenting to the emergency department with a suspected infection into those who require rapid and intensive management because they are at risk of developing sepsis and septic shock and those who can be managed conventionally The objective of this study is to compare the clinical intuition of emergency room physicians and nurses with the qSOFA score to predict the clinical course of patients presenting to the emergency room with potential sepsis.

lead_sponsor: Centre Hospitalier le Mans


title: Interplay Between Immune and Metabolic Programs in Myelodysplastic Syndromes: Involvement in Leukemia Transformation and Therapeutic Targeting

acronym: IMET-MDS

summary: Myelodysplastic syndromes (MDS) are a pre-leukemic condition with an extremely poor prognosis despite current treatments that justify new therapeutic approaches. Various studies have described the potential involvement of both immune compartment and cellular metabolism in the pathophysiology of MDS. The aim of this study is to determine the specific immune and metabolic profiles of the different classes of MDS and to identify predictive markers of progression/survival/response to therapy.


type: EudraCT Number

title: An Ascending Dose Tolerability Study and Pharmacokinetic Assessment in Healthy Male and Female Volunteers After Single & Multiple Oral Administration of DF2755A

summary:
Primary objective:

•To evaluate the tolerability and safety of ascending single doses of DF2755A in healthy adultmale and female volunteers.

Secondary Objectives:

To determine the pharmacokinetics parameters of DF2755A
To establish a dose concentration-response relationship over a wide range of doses in order toselect a narrower range of dose and dosing regimen to be subsequently studied in patients aftersingle administration
To evaluate the effect of ascending single doses on the pharmacodynamics parameters
To compare metabolites pathway in Human with the one observed in animals

lead_sponsor: Dompé Farmaceutici S.p.A


title: Feasibility of Immunotherapy Plus Chemotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting - CombHADom

acronym: CombHADom

summary:
This observational prospective monosite study aims to describe, for the first time, management in a hospital-at-home programme of patients treated by immunotherapy-chemotherapy combo for bronchial cancer in maintenance phase of first row metastatic treatment.

The feasibility in good conditions of this management, the patients' quality of life and their satisfaction will be evaluated. A cost-benefit analysis will be done to compare hospital-at-home programme and classical day hospitalization.

status: Active, not recruiting

lead_sponsor: Centre Hospitalier de PAU


title: Hemodynamic Effect of Alveolar Recruitment Manoeuver Through Stepwise Increase and Decrease in Irway Pressure or Sustained 30 Secondes 30 cmH2O Continuous Positive Airway Pressure. A Randomized Study.

summary: Objective: to compare the effect of alveolar recruitment manouver through stepwise increase and decrease in airway pressure or sustained 30 secondes 30 cmH2O continuous positive airway pressure on cardiac stroke volume estimated by oesophageal doppler in preload independent anesthetized patients scheduled for surgery.

lead_sponsor: University Hospital, Caen


title: To Compare Anatomical and Functionnal Outcomes in Patients Undergoing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Peeling

acronym: ERMP&ILM

summary: To study and compare visual acuity in patients undergoing removal of the epiretinal membrane with and without the removal of the internal limiting membrane at baseline versus 6 month.

status: Terminated

lead_sponsor: University Hospital, Clermont-Ferrand


title: Optimization of the Self-exclusion Procedure

acronym: OSE

summary:
It has been shown that self-excluded gamblers are very heavy gamblers, and that it is not possible to distinguish between those who report self-exclusion for addictive reasons and those who self-exclude for commercial reasons, which strongly suggests that all self-excluded people are "self-diagnosed" problem gamblers. Several studies converge in recognizing self-excluded people as problem gamblers who have lost control of their gambling and are seeking to protect themselves by taking action, self-exclusion, to change their behaviour and protect themselves.

Several reviews of the literature on interventions for problem gamblers have recently identified self-exclusion as an intervention for problem gamblers.

However, the effectiveness of the current self-exclusion system appears to be limited, particularly for short self-exclusions and for heavier gamblers.

Considering that self-exclusion is an intervention for and by people who have developed a gambling disorder, it currently consists exclusively of a behavioural intervention, in the sense that it prevents the behaviour. It would then be possible to optimize this intervention by enriching it with other components that have been shown to be effective with problem gamblers or in other addictions: a brief intervention including a motivational, cognitive approach, personalized normative feedback, referral to online help services (cresus and gambling infoservice), and repeated contact to suggest an extension of the self-exclusion period without having to return to the gambling environment. We hypothesize improved efficacy as measured by reduced gambling for longer after an initial optimized self-exclusion compared to self-exclusion with the standard procedure. Days will be randomized according to an a priori randomization list, not players.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Short-term Clinical Follow-up of the Vascular Closure Device MANTATM in Minimally Invasive Cardiac Surgery

acronym: MANTA-MICS

summary: The percutaneous MANTA Vascular Closure Device is dedicated to the closure of large bore arteriotomies. It appears to be a safe and doable option for vascular access closure in patients undergoing transfemoral Transcatheter Aortic Valve Implantation. Data concerning safety and efficacy of MANTA Vascular Closure Device in Minimally Invasive Cardiac Surgery are scarce. This study aim to assess this novel collagen-based technology in minimal invasive aortic valve replacement surgery.

time_perspective: Other

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Hemodynamic-guided Fluid Balance Neutralization During Continuous Renal Replacement Therapy in Critically Ill Patients: the GO NEUTRAL Randomized Controlled Multi-center Study

acronym: GO-NEUTRAL

summary:
Fluid overload is associated with increased mortality in critically ill patients with acute kidney injury. Fluid balance controlled is associated with improved outcome in observational studies, and is deemed safe in interventional trials.

The objective of the study is to keep fluid balance neutral by matching the net ultrafiltration rate to fluid inputs in patients with vasoplegia, and treated with continuous renal replacement therapy (CRRT), while insuring its security using advanced hemodynamic monitoring with continuous cardiac output monitoring.

ReferenceCitation: Bitker L, Pradat P, Dupuis C, Klouche K, Illinger J, Souweine B, Richard JC. Fluid balance neutralization secured by hemodynamic monitoring versus protocolized standard of care in critically ill patients requiring continuous renal replacement therapy: study protocol of the GO NEUTRAL randomized controlled trial. Trials. 2022 Sep 22;23(1):798. doi: 10.1186/s13063-022-06735-6.

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

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

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse


title: Study of Somatosensory Responses During Millimeter Waves Application (RESOM)

acronym: RESOM

summary: The brain activity induced by a sensory stimulus and measured by magnetoencephalography will be compared before and after exposure to millimeter waves. We hypothesize that brain activity is modified after exposure to millimeter waves. The neuromodulatory effects of millimeter waves may lead to future development on therapeutic management in anxiety and pain.

ReferenceCitation: Fioravanti C, Kajal SD, Carboni M, Mazzetti C, Ziemann U, Braun C. Inhibition in the somatosensory system: An integrative neuropharmacological and neuroimaging approach. Neuroimage. 2019 Nov 15;202:116139. doi: 10.1016/j.neuroimage.2019.116139. Epub 2019 Aug 30.

ReferenceCitation: Radzievsky AA, Gordiienko OV, Alekseev S, Szabo I, Cowan A, Ziskin MC. Electromagnetic millimeter wave induced hypoalgesia: frequency dependence and involvement of endogenous opioids. Bioelectromagnetics. 2008 May;29(4):284-95. doi: 10.1002/bem.20389.

ReferenceCitation: Rojavin MA, Ziskin MC. Electromagnetic millimeter waves increase the duration of anaesthesia caused by ketamine and chloral hydrate in mice. Int J Radiat Biol. 1997 Oct;72(4):475-80. doi: 10.1080/095530097143248.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
Commissariat A L'energie Atomique
Remedee SA


title: Optimisation of Potential Dental Implant Sites Protection for Rehabilitation in Patients With Head and Neck Cancer: Impact of Virtual Implants Visualisation on Dosimetry (OPPIDOM)

acronym: OPPIDOM

summary: This is a monocentric, non-randomized, prospective, in silico feasibility study conducted by Strasbourg Europe Cancerology Institute. The purpose of this study is to evaluate the optimisation of potential dental implant sites protection, without degrading tumor volume coverage, through designation of potential dental implant sites before volume delineation and dosimetry calculations in patients with oropharyngeal or oral cavity squamous cell carcinoma treated by radiotherapy.

lead_sponsor: Institut de cancérologie Strasbourg Europe


title: Pilot-Study for SAS Treatment in Acute Cerebral InfarctiOn: the PISTACIO Trial

acronym: PISTACIO

summary: Sleep Apnea Syndrome (SAS) is highly prevalent in acute stroke and it is related to worst outcome. We aim to assess if SAS treatment, started immediately after acute ischemic stroke, impacts infarct growing and clinical prognosis.

lead_sponsor: SOS Attaque Cérébrale


title: Collection of Medical Events Occurring During Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)

acronym: ESADAfollow-up

summary:
The European database ESADA, containing data from more than 30,000 patients with very different severities of obstructive sleep apnea (OSA) syndrome, prospectively collects data from patients referred to academic sleep laboratories in many European countries (https://esada.med.gu.se/). Since 2007, Grenoble is one of the two French centers with Paris and is a very active participant in this European database for patient inclusion and data exploitation.

The first objective of the "ESADA Follow-up and outcomes" project is to collect cardiovascular events during the follow-up of patients in the European database through telephone interviews and a structured questionnaire. Other objectives are to collect metabolic events, incident cancers and deaths in the same population using the same mean.

An additional objective is to assess the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.


title: Evaluation of Patient Satisfaction and Therapeutic Impact Regarding Joint Consultation Rheumatologist/Dermatologist

acronym: RHUMPSO

summary: Current increase in the number of multidisciplinary consultations, but little documentation on their impact on patient management. More specifically, in the context of psoriatic arthritis, we are seeking to investigate the interest for the patient, through his or her satisfaction and the evolution of the activity of his or her pathology, of a global, joint management in Rheumatology and Dermatology.


title: Mucogain Matrix Versus Connective Tissue Graft: "MUCOGREFFE Project"

acronym: Mucogreffe

summary: Limitation of donor site and significant postoperative morbidity are often described in connective tissue graft. We want to show if mucogain matrix used in tunnel technique to recover RTI Cairo recessions defects could be an alternative to connective tissue graft

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Persistent Olfactory Loss After COVID-19 : Olfactive Disorder, Psychiatric and/or Cognitive Assessments With and Without a Treatment

summary: Covid 19 cause an olfactory loss in more than 80% of cases. This loss most often regresses but leaves 20% of patients with an olfactory complaint, particularly with regard to the quality of daily life. The neuro-cognitive implications involved with COVID19 and the consequences of persistent olfactory loss remain unknown. The effectiveness of therapeutic management, in particular olfactory re-education, has not yet been clarified. Objectives are the assessment of patients olfactory disorders, psychiatrics and neurocognitives specificities after a COVID, before and after treatment or specific cares.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: Comparison of 2 Ventilatory Support Strategies in Patients With Covid-19 Pneumonia Admitted in ICU : Retrospective Monocentric Study

acronym: STRATIC

summary: This retrospective monocentric study compares 2 ventilatory support strategies on outcomes (length of stay, intubation, mortality) in patients admitted in Intensive Care Unit with Covid-19 related pneumonia : invasive strategy used during the first period and non-invasive strategies (Continuous Positive Airway Pressure, High Flow Nasal Canula, Prone Position) used during the second period.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer


title: Association Between Early Change in PaCO2 After ECMO Initiation and Neurological Outcome in Newborns

summary: Investigation of the association between PaCO2 change after extra corporeal membrane oxygenation (ECMO) initiation and neurological outcome and mortality in neonates treated by ECMO for respiratory failure.

lead_sponsor: Nantes University Hospital


title: Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis

summary: The study aims at identifying the type of B and CD4 T cell subsets with pathogenic properties in the different clinical forms of multiple sclerosis. This research might open new therapeutic approaches for the treatment of multiple sclerosis particularly progressive MS.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
University of Bordeaux


title: EXPRE-SON-REA : Expressive Versus Neutral Own Names in Neurophysiologic Prognosis Assessment of Intensive Care Unit Comatose Patients.

acronym: EXPRESONREA

summary:
Evaluating the neurologic prognosis in disorders of consciousness (DOC) patients is still a crucial issue in intensive care units.

Neurophysiology allows the investigators to record cerebral responses of patients to auditory stimuli and in particularly to their own name. Numerous studies try to improve the relevance of the auditory stimuli used in this paradigm.

Here the investigators assess if the use of own name stimuli uttered by more expressive voices (for example smiling voices) modulates the cerebral responses recorded. They then correlate these cerebral responses to the neurologic prognosis at three months.

lead_sponsor: Centre Hospitalier St Anne


title: Integrating a Prevention Care Path Into Daily Life of Elders With Mobility Disability Risk: Introducing a Predictive Model to a Functional Exercise Response

acronym: ICARE

summary:
One of the main challenges of ageing is to prevent the onset of mobility disability and its co-morbidities. Screening the risk of mobility disability in community-dwelling elders is therefore very important and at the uppermost for the care of sarcopenia and frailty. A multicomponent intervention, integrating multidisciplinary actions and combining physical exercise and nutrition, is recognized as an effective therapy for the care of mobility disability risk factors. The diagnosis of either pre-frail/frailty and/or sarcopenia at least probable is sufficient to trigger a sustained intervention as it can prevent the onset of mobility disability. Therefore, it is difficult to identify the best responder for this type of care path. As a result, studies have been interested in exploring the predictive factors related to the functional response to exercise within lifestyle interventions. It has been shown that SPPB provides useful information when associated with demographic or physical activity factors. Those predictions are reliable to an ageing population with a SPPB ≤9 but it is still unknown if these reports are reproducible to older adults with high baseline physical function. Therefore, we hypothesized that a more inclusive SPPB score at baseline could also be related to other factors to predict the functional response to exercise. We assumed that strength, age, sex or body mass index could be interesting to elicit better predictions. It is an important issue for the development of targeted-interventions and specific care orientations.

The training has to be established through an accurate schedule to optimize the response to exercise. However, it is difficult to make consensus on the best method to apply, especially for elders with mobility disability risk. Hence, the present study also focus on a specific training method planned toward different exercises modes. We aimed to propose a training with cost-effective material and the absence of machines to transpose it into daily life participants. We expected to observe benefits on physical performance after this exercise intervention.


title: "Patient's TeleMonitoring With Amyotrophic Lateral Sclerosis Treated by Non Invasive Ventilation at Home." Tele Monitoring Ventilation At Home (TM-VAH)

acronym: TS-VAD

summary: Single-center, prospective pilot study on patients with amyotrophic lateral sclerosis fitted with noninvasive ventilation. The objective is to assess the satisfaction of remote monitoring of patients on non-invasive ventilation after 12 months.

lead_sponsor: University Hospital, Toulouse