title: Causes of Chronic Pruritus: a Retrospective Study

acronym: PRURISINE

summary: The aim of this study is to include all patients followed between 2008 and 2018 in order to analyze the etiologie of the chronic pruritus


type: Other Identifier

title: Self Medication and Pulpal and Periapical Dental Pain

acronym: AUDE

summary: To describe and understand the self-medication behaviours of a population of adults coming to the Clermont-Ferrand dentistry department for acute pain of pulpal origin and of a population of adults coming to the specific care unit of the Clermont-Ferrand dentistry department or the Riom hospital for treatment under general anaesthesia.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Ongoing


title: Collection of SARS-CoV-2 RNA Extracted From Nasopharyngeal and Saliva Samples From Same Patients

summary: Constitution of a collection of SARS-CoV-2 RNA extracts from nasopharyngeal and saliva / sputum samples, from the same patients (paired samples), taken during the same consultation in an indication of detection of SARS-CoV-2 in with a view to developing tests / diagnostic tools for SARS-CoV-2.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: No

ipd_sharing_description: the data will not be shared to other researchers since the research is an internal collection of samples; for ID SOLUTIONS

lead_sponsor: ID Solutions

intervention_type: Other

lead_sponsor_type: industriel


title: Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism: a Monocentric Cohort Study With Patient Reported Outcome

summary:
Dystonia is a disabling symptom affecting both patients with idiopathic Parkinson's disease (PD) and atypical parkinsonism (AP).

Botulinum toxinum (BoNT), by blocking muscle contraction, is a possible treatment for focal dystonia.

The benefit of BoNT treatment has been proven in some focal dystonia associated with PD or AP.

The investigators aim to give an overview of the efficacy of BoNT in a variety of focal dystonia in a large cohort of parkinsonian patients.

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Dressler D. Botulinum toxin drugs: brief history and outlook. J Neural Transm (Vienna). 2016 Mar;123(3):277-9. doi: 10.1007/s00702-015-1478-1. Epub 2015 Nov 11. Review.

ReferenceCitation: Jankovic J. Botulinum toxin: State of the art. Mov Disord. 2017 Aug;32(8):1131-1138. doi: 10.1002/mds.27072. Epub 2017 Jun 22. Review.

ReferenceCitation: Tolosa E, Compta Y. Dystonia in Parkinson's disease. J Neurol. 2006 Dec;253 Suppl 7:VII7-13. Review.

ReferenceCitation: Marsili L, Bologna M, Kojovic M, Berardelli A, Espay AJ, Colosimo C. Dystonia in atypical parkinsonian disorders. Parkinsonism Relat Disord. 2019 Sep;66:25-33. doi: 10.1016/j.parkreldis.2019.07.030. Epub 2019 Jul 23. Review.

ReferenceCitation: Mills R, Bahroo L, Pagan F. An update on the use of botulinum toxin therapy in Parkinson's disease. Curr Neurol Neurosci Rep. 2015 Jan;15(1):511. doi: 10.1007/s11910-014-0511-3. Review.

ReferenceCitation: Pacchetti C, Albani G, Martignoni E, Godi L, Alfonsi E, Nappi G. "Off" painful dystonia in Parkinson's disease treated with botulinum toxin. Mov Disord. 1995 May;10(3):333-6.

ReferenceCitation: Giladi N, Meer J, Honigman S. The use of botulinum toxin to treat "striatal" toes. J Neurol Neurosurg Psychiatry. 1994 May;57(5):659.

ReferenceCitation: Rieu I, Degos B, Castelnovo G, Vial C, Durand E, Pereira B, Simonetta-Moreau M, Sangla S, Fluchère F, Guehl D, Burbaud P, Geny C, Gayraud D, Ory-Magne F, Bouhour F, Llinares E, Derost P, Marques A, Durif F. Incobotulinum toxin A in Parkinson's disease with foot dystonia: A double blind randomized trial. Parkinsonism Relat Disord. 2018 Jan;46:9-15. doi: 10.1016/j.parkreldis.2017.10.009. Epub 2017 Oct 19.

lead_sponsor: Hospital Avicenne

status_simplified: Completed


title: Impact of Geriatric Care in the Treatment of Older People Hospitalised for COVID-19

acronym: COVAGERT

summary:
Current COVID-19 pandemic implies regular treatment adaptation by physician, according to scientific publication evolution. Older adults are particularly affected by COVID-19, with the higher severe form prevalence and the higher mortality rate. Furthermore older peoples are at high risk of complications cascade, due to the SARS-Voc-2 infection but also because of chronic diseases decompensation. If risk factors in this population have been identified, specific treatments to reduce complications or to be curative are less known. However geriatric care, thanks to its holistic approach, could reduce these complications and improve survival.

Our study aims to determine if geriatric care provided in geriatric COVID-19 hospitalisation units improves survival of older people (aged 65 years and over) at one month in comparison with conventional COVID-19 hospitalisation unit during the first wave in the Montpellier University Hospital. Secondary objectives are to determine if clinical characteristics of older patients are different between conventional and geriatric COVID-19 hospitalisation units, to assess influence of clinical characteristics of older patients on their survival, and to determine wich treatment have been delivered for older people during the COVID-19 pandemic first wave in our hospital in view of bibliographic data available at this time.

COVAGERT is a monocentric, descriptive, observational and retrospective study, including all older adults aged 65 years and over hospitalised in the geriatric COVID-19 and the conventional COVID-19 units of the Montpellier University Hospital during the first wave of the SARS-Cov-2 pandemic (between March 1th 2020 and September 1th 2020). Principal outcome is the survival one months after the RT-PCR positive test. Some data about treatments, medical history, socio-demographic and clinical characteristics will be collected from the medical record.

Statistical analysis will be performed using univariate and multivariate regressions according to the study's objectives.

Results will be useful to determine the bring of geriatric care during the current pandemic, but also to highlight the importance of multidisciplinary assessment in this complex disease and for further emergency medical challenges.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Evaluation of the Efficacy of Management of Patients With Lymphomas Diagnosed at Nimes University Hospital Over 20 Years (1999-2018) Under Real-life Circumstances

acronym: DVR-Lym-Nim

summary: Observation of a cohort of 400 patients with different types of lymphomas.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


type: Registry Identifier

title: Contribution of Subclavian Vein Diameter Variations to Assess Vascular Filling Among Critical Care Patients

acronym: VSC MIR

summary:
Haemodynamic optimisation is a fundamental step and a daily issue in the management of intensive care patients with acute circulatory failure. Failure to optimise haemodynamics is recognised as a factor associated with morbidity and mortality.

Although the first line of treatment is often vascular filling, many studies have found that excessive vascular filling alone is deleterious and leads to increased morbidity and mortality due to pulmonary and interstitial oedema. The use of catecholamines avoids this undue vascular filling.

At present, the therapeutic strategy in acute circulatory failure is to perform a personalised "titrated" vascular filling after assessing the need for it.

To do this, predictive criteria for the need to continue vascular filling in order to optimise cardiac output and tissue perfusion pressure, particularly by ultrasound, have been developed, notably by transesophageal approach.

It also appeared to us that offering an alternative to the transesophageal approach would reduce invasiveness on the one hand, but would also offer an alternative when the transesophageal approach is contraindicated.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Intensive care unit, Ambroise Paré hospital, APHP


title: Clindamycin in Prosthetic Joint Infections Caused by Staphylococcus

acronym: CISTA

summary: The alternatives to the combination of Fluoroquinolone and Rifampicin in prosthetic joint infections (PJI) caused by staphylococcus are currently unclear. Clindamycin is prescribed as dual therapy in this indication, and provides many advantages. We conducted a multicenter retrospective observational study evaluating the efficacy and safety of Clindamycin in prosthetic joint infections due to staphylococcus between January 2013 and December 2019.

status: Active, not recruiting

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: " SAVE Study (Switch AdVagraf® to Envarsus®) for Fast Metabolizers Kidney Transplant Recipients"

acronym: SAVE

summary:
The use of calcineurin inhibitors (CNIs) in kidney transplantation is the gold standard treatment to prevent episodes of rejection. Nevertheless, CNIs have side effects and are in particular nephrotoxic for the kidney transplant. Monitoring CNI dosages is fundamental for the clinician, in order to find the right balance between toxicity and prevention of rejection. Several recent studies suggest that a Radio Residual Concentration / Dosage (C0 / D) less than 1.05 (patients with rapid metabolizers) is associated with poor graft function (eGFR) and decreased kidney transplant survival. LCPT prolonged-release tacrolimus (Novel Once-Daily Extended-Release Tacrolimus. Prolonged-release tacrolimus: Envarsus®) is a marketed form of tacrolimus with interesting pharmacokinetic properties: daily intake, reduction of the absorption peak (Meltodose® technology ) and reduction of the total CNI dose by 30% to obtain an equivalent CO compared to other molecules on the market (Advagraf®, Prograf®). Thus, the use of LCPT in patients rapid metabolisers in relay of Advagraf® or Prograf® could make it possible to decrease renal toxicity while preserving rejection, by increasing the C0 / D ratio.

The investigators propose a pilot study aiming to study a prospective cohort of rapid metabolisers patients put on Envarsus at one month of transplant compared to a historical cohort, in terms of C0 / D ratio, function and survival of the renal graft.

time_perspective: Cross-Sectional

lead_sponsor: Nantes University Hospital


title: Assessment of the Impact of Endoscopic Gastric Revision by Application of Additional Sutures on Weight Loss After Endoscopic Sleeve Gastroplasty in Obese Patients

acronym: ESG-IRM

summary: Endoscopic sleeve gastroplasty (ESG) is a technique used for bariatric surgery, with results comparable to conventional surgery, in order to treat morbid obesity. It has also less risks of complications, and it is not an irreversible technique. It can be repeated overtime, regarding the evolution of the gastroplasty. There is little data in the literature on the effectiveness of endoscopic "revision". This study will assess the benefits and costs of a revision during the follow-up endoscopy.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

ReferenceCitation: Willett WC, Dietz WH, Colditz GA. Guidelines for healthy weight. N Engl J Med. 1999 Aug 5;341(6):427-34. Review.

ReferenceCitation: Sharaiha RZ, Kedia P, Kumta N, DeFilippis EM, Gaidhane M, Shukla A, Aronne LJ, Kahaleh M. Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population. Endoscopy. 2015 Feb;47(2):164-6. doi: 10.1055/s-0034-1390773. Epub 2014 Nov 7.

ReferenceCitation: Lopez-Nava G, Galvao M, Bautista-Castaño I, Fernandez-Corbelle JP, Trell M. Endoscopic sleeve gastroplasty with 1-year follow-up: factors predictive of success. Endosc Int Open. 2016 Feb;4(2):E222-7. doi: 10.1055/s-0041-110771. Epub 2016 Jan 15.

ReferenceCitation: Lopez-Nava G, Galvão MP, Bautista-Castaño I, Jimenez-Baños A, Fernandez-Corbelle JP. Endoscopic Sleeve Gastroplasty: How I Do It? Obes Surg. 2015 Aug;25(8):1534-8. doi: 10.1007/s11695-015-1714-7.

ReferenceCitation: Lopez-Nava G, Galvão MP, da Bautista-Castaño I, Jimenez A, De Grado T, Fernandez-Corbelle JP. Endoscopic sleeve gastroplasty for the treatment of obesity. Endoscopy. 2015 May;47(5):449-52. doi: 10.1055/s-0034-1390766. Epub 2014 Nov 7.

ReferenceCitation: Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24.

lead_sponsor: IHU Strasbourg

location_facility: Service de chirurgie digestive et endocrinienne, NHC

intervention_type: Procedure


title: Follow-up During the Peripubertal Period of Preterm Children (Under 35 Weeks of Amenorrhea) Included in the "EPIPOD" Protocol : Evaluation of Insulin Resistance and of Neuropsychological Development

acronym: INFANTPOD

summary:
Prematurity is associated with an increased risk of developing cardiovascular and metabolic disturbances in adulthood.

It has been demonstrated that the body composition of children born prematurely is different from that of children born under term with a deficit in fat free mass.

It can thus be wondered if this excessive adiposity does or does not predict the risk of insulin resistance in adulthood.

Children born prematurely, with a body composition measurement performed at discharge from neonatal hospitalization as part of the EPIPOD protocol, and now aged between 8 and 14 years, will be included in the INFANTPOD protocol.

Analysis of body composition, insulin resistance, renal function, pulse wave velocity, eating behaviour and of neuropsychological development will be performed.

primary_purpose: Basic Science


title: Study of Self-Recognition and Self/Other Distinction Disorders in Patients With Psychological Vulnerability (ALTER EGO)

acronym: ALTER-EGO

summary: The main objective of this study is to establish whether there are differences in self-recognition and self/other distinction in subjects with psychological vulnerability compared to healthy volunteer controls.

design_allocation: Non-Randomized

ReferenceCitation: Frith CD, Corcoran R. Exploring 'theory of mind' in people with schizophrenia. Psychol Med. 1996 May;26(3):521-30.

ReferenceCitation: Fusar-Poli P, Borgwardt S, Bechdolf A, Addington J, Riecher-Rössler A, Schultze-Lutter F, Keshavan M, Wood S, Ruhrmann S, Seidman LJ, Valmaggia L, Cannon T, Velthorst E, De Haan L, Cornblatt B, Bonoldi I, Birchwood M, McGlashan T, Carpenter W, McGorry P, Klosterkötter J, McGuire P, Yung A. The psychosis high-risk state: a comprehensive state-of-the-art review. JAMA Psychiatry. 2013 Jan;70(1):107-20. doi: 10.1001/jamapsychiatry.2013.269. Review.

ReferenceCitation: Thirioux B, Wehrmann M, Langbour N, Jaafari N, Berthoz A. Identifying Oneself with the Face of Someone Else Impairs the Egocentered Visuo-spatial Mechanisms: A New Double Mirror Paradigm to Study Self-other Distinction and Interaction. Front Psychol. 2016 Aug 25;7:1283. doi: 10.3389/fpsyg.2016.01283. eCollection 2016.

ReferenceCitation: Keromnes G, Motillon T, Coulon N, Berthoz A, Du Boisgueheneuc F, Wehrmann M, Martin B, Thirioux B, Bonnot O, Ridereau R, Bellissant E, Drapier D, Levoyer D, Jaafari N, Tordjman S. Self-other recognition impairments in individuals with schizophrenia: a new experimental paradigm using a double mirror. NPJ Schizophr. 2018 Nov 28;4(1):24. doi: 10.1038/s41537-018-0065-5.

ReferenceCitation: Keromnes G, Chokron S, Celume MP, Berthoz A, Botbol M, Canitano R, Du Boisgueheneuc F, Jaafari N, Lavenne-Collot N, Martin B, Motillon T, Thirioux B, Scandurra V, Wehrmann M, Ghanizadeh A, Tordjman S. Exploring Self-Consciousness From Self- and Other-Image Recognition in the Mirror: Concepts and Evaluation. Front Psychol. 2019 May 7;10:719. doi: 10.3389/fpsyg.2019.00719. eCollection 2019. Review.

ReferenceCitation: Uddin LQ, Davies MS, Scott AA, Zaidel E, Bookheimer SY, Iacoboni M, Dapretto M. Neural basis of self and other representation in autism: an FMRI study of self-face recognition. PLoS One. 2008;3(10):e3526. doi: 10.1371/journal.pone.0003526. Epub 2008 Oct 29.

ReferenceCitation: Ionta S, Gassert R, Blanke O. Multi-sensory and sensorimotor foundation of bodily self-consciousness - an interdisciplinary approach. Front Psychol. 2011 Dec 23;2:383. doi: 10.3389/fpsyg.2011.00383. eCollection 2011.

ReferenceCitation: Parnas J, Møller P, Kircher T, Thalbitzer J, Jansson L, Handest P, Zahavi D. EASE: Examination of Anomalous Self-Experience. Psychopathology. 2005 Sep-Oct;38(5):236-58. Epub 2005 Sep 20.


title: Role of Alternating Hemiplegia of Childhood Genotype in Cardiac Repolarization. HEART: HEmiplegia Arrhythmia Retrospective Trial

acronym: HEART

summary: Alternating Hemiplegia of Childhood (AHC) is a rare and severe disease that is in need of effective, and hopefully even curative, therapies. Afflicted patients suffer from severe paralyzing crises, often excruciatingly painful muscle spasms, severe often life threatening epileptic seizures, frequently severe developmental and psychiatric/psychological disabilities and other comorbidities, such as cardiac disturbances. Recent data indicate that AHC genotype is in relation to cardiac repolarization troubles and to cardiac arrhythmias. The primary hypothesis to explore is that there is an association between genotype and cardiac phenotype in AHC.

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of Clinical Epileptology, Sleep Disorders and Functional Neurology in Children, Hôpital Femme Mère Enfant, University Hospitals of Lyon (Hospices Civils de Lyon)


title: Development of New Models for the Evaluation of Preclinical Treatment for Urothelial Carcinomas of the Upper Excretory Tract.

acronym: CICLOP

summary:
Upper Urinary Tract Urothelial Carcinomas are rare, aggressive tumors, accounting for 5 to 10% of all urothelial tumors. These include tumors which develop in the renal cavities (renal pelvis, calices) and ureteral tumors. Nephro-ureterectomy is the standard treatment but 80% of patients will have a relapse within 2 years. Only one trial has (Birtle et al. 2020), has shown the interest of postoperative chemotherapy. Neoadjuvant systemic treatment seems particularly interesting for a population which is going to undergo a nephronic loss and therefore reduction in kidney function which is likely to make patients ineligible for cisplatin. In favor of additional immunotherapy, it has been described that upper excretory tract tumors have a high immunogenic potential with a high rate of microsatellite instability.

From surgical samples of patient tumors obtained after nephroureterectomy or biopsy material collected before treatment, we are going to generate patient-derived cell lines and xenograft models in the mouse. A recent publication has demonstrated the feasibility of this approach by specifying that the capture rate of tumor cells is 50% for patient-derived xenografts and 25% for patient-derived cells (Coleman et al. 2020). As tumors harvested from biopsies do not grow in patient-derived xenografts,we plan to graft the biopsies onto chorioallantoic chicken embryo membranes, a model which has never been used for this indication and which is one of the original features of our approach. These three concomitant approaches will allow us to increase our chances of obtaining stable upper urinary tract urothelial carcinoma lines to be used for the screening and identification of new treatments or new combinations of molecules that would benefit patients with upper urinary tract urothelial carcinomas, knowing that very few studies dedicated to this type of cancer have been conducted or published due to the rarity of the disease and the lack of existing models published on the subject of these particular tumors.

.

time_perspective: Other

ReferenceCitation: Birtle A, Johnson M, Chester J, Jones R, Dolling D, Bryan RT, Harris C, Winterbottom A, Blacker A, Catto JWF, Chakraborti P, Donovan JL, Elliott PA, French A, Jagdev S, Jenkins B, Keeley FX Jr, Kockelbergh R, Powles T, Wagstaff J, Wilson C, Todd R, Lewis R, Hall E. Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, open-label, randomised controlled trial. Lancet. 2020 Apr 18;395(10232):1268-1277. doi: 10.1016/S0140-6736(20)30415-3. Epub 2020 Mar 5.

location_facility: Centre Hospitalier Universitaire de Nîmes


title: Association Between Covid-19 Disease and Mortality After Hip Fracture Surgery in Elderly: a Multicentre National French Survey

acronym: COLCOVID

summary:
Hip fracture in the elderly is a worldwide public health issue and a medical challenge for early postoperative rehabilitation. More than 2 million people are treated annually with an annual incidence between 100 and 300/100,000 (USA, Europe, China), resulting in a cost of billion dollars and a strain on most surgical facilities. In this context, an early surgical management of patient with fracture within the first 24-48h has been shown to reduce morbidity, length of hospital stay and mortality.

During the Covid-19 pandemics, a higher risk of 30-day mortality has been reported in patients with pre-operative SARS-CoV-2 infection diagnosed 0-2 weeks, 3-4 weeks and 5-6 weeks before surgery compared with patients who did not have a pre-operative SARS-CoV-2 infection. However, this risk seems to disappear in patients diagnosed with SARS-CoV-2 ≥ 7 weeks before surgery. These findings led to propose delayed elective surgery when the benefit-risk ratio was acceptable (cancer, cardiac surgeries). However, delaying surgery in COVID-19 patients (with high risk of immune and thrombotic disorders) with hip fracture could be questionable as the risk related to COVID-19 could be counteracted by the risk delayed surgery.

For assessing the mortality risk related to hip fracture surgery associated with COVID-19, we decided to use the French national hospital discharge records database for comparing the 30-day postoperative mortality in patients with hip fracture and with or without an hospitalization for SARS-COV-2 infection in the 30 previous days before surgery.


title: se of ADAPT Assisted by a Compliant Balloon (ADAPT-AB) When ADAPT Fails for Acute Stroke Thrombectomy

summary:
The superiority of mechanical thrombectomy (MT) in patients with acute ischemic stroke from large vessel occlusion compared to standard medical therapy alone has been demonstrated by several randomized clinical trials and become the standard of care for these patients. A direct aspiration first pass technique (ADAPT) for the endovascular treatment of stroke using a large-bore catheter has been reported to be an effective method of achieving MT. Recent studies reported that ADAPT is as efficient and safe as stent retrievers, with a similar successful recanalization rate, but may have better functional outcomes, fewer procedure related-adverse events, and a tendency for faster revascularization compared to the stent-retriever thrombectomy.

However, navigation of a large-bore aspiration catheter is not always possible due to unsuccessful passage of the ophthalmic artery origin ("ledge effect") or tortuous vascular anatomy. The coaxial technique comprises guiding the large-bore catheter with a smaller inner catheter and can facilitate distal access. However, there is a gap between the inner catheter and the distal tip of the large-bore outer catheter that creates a risk of damaging the vessel wall and causing dissection or subarachnoid hemorrhage. Even with this coaxial technique, it is not always possible to reach the clot site with the large-bore catheter. To decrease the gap between the two catheters, several authors have used, in place of the inner microcatheter, a compliant balloon catheter positioned and inflated at the distal tip of the large-bore catheter. The aim of the present study was to evaluate the safety and efficacy of ADAPT assisted by a compliant balloon (ADAPT-AB) when ADAPT using the coaxial technique fails to reach the clot site.

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Device


title: Voice Biomarkers to Predict Excessive Daytime Sleepiness

acronym: SOMVOICE

summary: This study aims at measuring the impact of a night of sleep deprivation over the vocal characteristics of healthy subjects.To do so, the subjects takes a Multiple Sleep Latency Test (MSLT) the day after a night of total sleep deprivation (or a supervised normal night for the control subjects). Before each iteration of the MSLT, the subjects are recorded during the reading of a text and fill three medical questionnaires : Karolinska Sleepiness Scale (KSS), Visual Analogue Scale for Fatigue (VAS-F) and Visual Analogue Scale for Anxiety (VAS-A), allowing to link variations of vocal markers to the variations of these measures.

lead_sponsor: University Hospital, Bordeaux


title: Lung Perfusion PET / CT Using Gallium68-MMA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy

acronym: PEGASUS

summary: This is a prospective study evaluating the feasibility of treatment planning integrating lung perfusion PET/CT using Ga68-MAA to preserve functional lung areas during stereotactic body radiation therapy (SBRT).

intervention_type: Drug


title: Translational Study Using Human Abdominal Adipose Tissue Biopsies to Investigate the Role of Cannabinoid Receptor 1 (CB1) in Controlling Endocannabinoid and Adipokine Secretion

acronym: ENDOCATA

summary:
Abdominal obesity and type 2 diabetes are associated with the hyperactivation of the endocannabinoid system. Several animal and human studies indicate that circulating endocannabinoid (EC) levels are correlated with body fat. Thus, adipose tissue, which possesses the enzymatic machinery for the synthesis of ECs, could be the main producer of plasma ECs.

Today, it is clearly established that stimulation of the endocannabinoid system, via activation of cannabinoid receptor 1 (CB1s) located in the brain, leads to increased food intake and weight gain. Moreover, peripheral CB1s present in organs such as the liver, muscles and adipose tissue are involved in the establishment of metabolic deregulations linked to obesity (steatosis, insulin resistance, dyslipidemia).

Thus, ECs produced by adipose tissue could play a key role in the regulation of carbohydrate-lipid homeostasis through their autocrine or paracrine actions by activating central and peripheral CB1s. Therefore, the objective of this study is to:

clarify whether obesity, associated or not with diabetes, leads to an overproduction of ECs (specifying which ones) by visceral or subcutaneous adipose tissue
to determine whether blocking CB1s with new peripherally acting antagonists can lead to a reduction in the production of ECs by adipose tissue.

This study will also provide an opportunity to evaluate the production of adipokines and cytokines involved in the control of energy homeostasis under the different experimental conditions.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Phase 2, Open Label Study of DS-1062a, an Anti-TROP-2-Antibody-Drug Conjugate (ADC), in Patients With Advanced and/or Unresectable Non-Small Cell Lung Cancer (NSCLC), With Biomarker Analysis to Characterize Response to Therapy

summary:
This study aims to evaluate the efficacy and safety of DS-1062a in participants with metastatic, unresectable NSCLC having progressed on one, but not more than three previous standard therapies. Moreover, the immune effects, the predictors of resistance and response to treatment, the effect of the chemotherapy on deoxyribonucleic acid (DNA) replication will be assessed and will help identify the subgroups that will mostly benefit from the treatment. The pharmacokinetics of the product and the anti-drug antibody (ADA) will be also evaluated.

A total of 100 participants are planned to be included in the study. Participants will receive, every three weeks, a dose of DS-1062a equivalent to 6 mg/kg of body weight until progression or until unacceptable toxicity.

Tumor evaluation will be performed every six weeks by the mean of a computed tomography for the thorax, abdomen and pelvis (TAP CT-scan) or a magnetic resonance imaging (MRI). Brain and/or bone CT scans will be also performed throughout the study for participants with brain and/or bone metastasis.

The safety of the product will be assessed at each cycle, through complete clinical exams, biological tests, electrocardiograms (ECGs), cardiac echographies (ECHOs) and through the collection of ongoing toxicities or adverse events.

primary_purpose: Treatment

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Evaluation of the Interest of a Video-assisted Remote Speech Therapy Consultation in Patients With ORL Cancer (TELE ORTHOPHONIE)

summary:
Interventional, prospective, single-centre study aimed to evaluate the impact of a video-assisted remote speech therapy consultation in relation to the complexity and specificity of the care of patients with ORL cancer. Three indications will be studied: phonation problems, swallowing problems and other problems.

The study will be conducted on a population of patients with T3, T4 ORL cancer requiring speech therapy.

Each patient included will have a video-assisted speech therapy consultation with a private speech therapist and an expert speech therapist. At the end of this video consultation, the patient and the private speech therapist will be asked to complete a satisfaction questionnaire.

At the follow-up visit following the video-assisted consultation, the patient will have completed participation in the study.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: Concordance Between Ultra-low Dose (ULD) and Conventional Standard Dose CT Scans in the Search for Traumatic Brain Injury at the Emergency Department

acronym: ULD-CRANE

summary: The aim of this research is to evaluate the diagnostic concordance of ultra low-dose and standard dose reconstructed computed tomography acquisitions using the ADMIRE algorithm to search for intracranial lesions - both hemorrhagic and bone lesions - in trauma patients at the emergency department. The study will also evaluate the diagnostic performance of the two protocols, as well as the speed of image reading. For the first time, acquisitions ≤ 10 mGy (lower value than reported in the literature) will be performed with top-of-the-range scanners available in the emergency room to search for intracranial lesions. These scanners are equipped with the latest generation of ADMIRE iterative algorithms.

primary_purpose: Diagnostic

ReferenceCitation: Greffier J, Fernandez A, Macri F, Freitag C, Metge L, Beregi JP. Which dose for what image? Iterative reconstruction for CT scan. Diagn Interv Imaging. 2013 Nov;94(11):1117-21. doi: 10.1016/j.diii.2013.03.008. Epub 2013 Jun 22.

ReferenceCitation: Greffier J, Macri F, Larbi A, Fernandez A, Khasanova E, Pereira F, Mekkaoui C, Beregi JP. Dose reduction with iterative reconstruction: Optimization of CT protocols in clinical practice. Diagn Interv Imaging. 2015 May;96(5):477-86. doi: 10.1016/j.diii.2015.02.007. Epub 2015 Mar 19.

ReferenceCitation: Larbi A, Orliac C, Frandon J, Pereira F, Ruyer A, Goupil J, Macri F, Beregi JP, Greffier J. Detection and characterization of focal liver lesions with ultra-low dose computed tomography in neoplastic patients. Diagn Interv Imaging. 2018 May;99(5):311-320. doi: 10.1016/j.diii.2017.11.003. Epub 2018 Feb 1.

ReferenceCitation: Maas AI, Hukkelhoven CW, Marshall LF, Steyerberg EW. Prediction of outcome in traumatic brain injury with computed tomographic characteristics: a comparison between the computed tomographic classification and combinations of computed tomographic predictors. Neurosurgery. 2005 Dec;57(6):1173-82; discussion 1173-82.

ReferenceCitation: Macri F, Greffier J, Pereira F, Rosa AC, Khasanova E, Claret PG, Larbi A, Gualdi G, Beregi JP. Value of ultra-low-dose chest CT with iterative reconstruction for selected emergency room patients with acute dyspnea. Eur J Radiol. 2016 Sep;85(9):1637-44. doi: 10.1016/j.ejrad.2016.06.024. Epub 2016 Jul 1.

ReferenceCitation: Macri F, Greffier J, Pereira FR, Mandoul C, Khasanova E, Gualdi G, Beregi JP. Ultra-low-dose chest CT with iterative reconstruction does not alter anatomical image quality. Diagn Interv Imaging. 2016 Nov;97(11):1131-1140. doi: 10.1016/j.diii.2016.06.009. Epub 2016 Jul 20.

ReferenceCitation: Widmann G, Juranek D, Waldenberger F, Schullian P, Dennhardt A, Hoermann R, Steurer M, Gassner EM, Puelacher W. Influence of Ultra-Low-Dose and Iterative Reconstructions on the Visualization of Orbital Soft Tissues on Maxillofacial CT. AJNR Am J Neuroradiol. 2017 Aug;38(8):1630-1635. doi: 10.3174/ajnr.A5239. Epub 2017 Jun 8.

intervention_type: Radiation


title: Involvement of Skeletal Muscle Fibrocytes in sarcOpenia in Patients With Chronic ObstRuctive bronchopneumopaThia

acronym: MOTOR

summary:
Chronic obstructive pulmonary disease (COPD) is presently the third leading cause of death worldwide and is characterized by irreversible airflow limitation diagnosed by spirometry. COPD is currently considered as a systemic disease with predominantly respiratory involvement, associated with numerous comorbidities. Among these, muscle wasting, present in about one third of patients, is associated with a higher mortality (up to 10-fold, irrespective of the severity of the obstruction). Muscle wasting is classically characterized by a decrease in muscle strength and volume (sarcopenia), which can be defined by a decrease in the muscle mass measured by dual X-ray absorptiometry: Appendicular Skeletal Muscle Mass or ASM / height < 7.0 kg/m2 in men and 5.5 kg/m2 in women. However, sarcopenia is largely underestimated in current clinical practice. Moreover, there is no specific treatment: only exercise training as part of respiratory rehabilitation has shown some efficiency. The underlying pathophysiological mechanisms are indeed poorly characterized.

Fibrocytes, cells derived from blood monocytes and able to migrate to different organs in order to play pro-fibrotic or pro-inflammatory roles, play a key role in bronchial obstruction. They are recruited in the blood of COPD patients during an acute exacerbation according to a CXCL12/CXCR4 chemotactic axis. Their role in COPD sarcopenia is currently unknown, but recent data show that they are involved in a mouse model of muscular dystrophy.

The hypothesis is that fibrocytes are involved in COPD sarcopenia.

primary_purpose: Prevention


title: Analyse du Profil moléculaire Des Exosomes de la Veine Pulmonaire Dans le Cancer Bronchique de Stade précoce

acronym: ExOnSite-Pro

summary: This is an observational prospective single-center study of 30 patients operated for early-staged non-small cell lung cancer. The main aim is the analysis of molecular profiling of exosome with a sample in tumor-draining vein in order to identify prognostic molecular characteristics associated with cancer recurrence after surgery.

lead_sponsor: University Hospital, Limoges

intervention_type: Biological


title: Ultrasound Evaluation of Abdominal Muscle Thickness During Mechanical Ventilation

acronym: ABDO-VM

summary: Weakness of respiratory muscles is frequent after several days of mechanical ventilation. Thereby an acquired diaphragm weakness has been demonstrated, linked to an atrophy which may be identified by a decrease of muscle thickness in echography. This study aims to evaluate with ultrasound the variation of thickness of abdominal muscles after 7 days of mechanical ventilation.

lead_sponsor: Centre Hospitalier de Roanne


title: Assessment of Health Related Quality of Life in Women Who Underwent Breast Reconstruction After Radical Surgery (RMQOL)

acronym: RMQOL

summary:
Nowadays, breast reconstruction is an integral care after mastectomy in breast cancer patient.

With the personalized care, choice a breast reconstructive is an important step involving decisions and mutual accord between patients and their physicians in order to anticipate clinical and psychosocial results.

Two main families of breast reconstruction techniques are often performed including advantages and complications impacting health related quality of life.

Routine assessment of health related quality of life in patients underwent breast reconstruction could allow to identify factors of satisfaction o be taken into account in the choice of breast reconstruction technique in order to improve practices and quality of life of patients

lead_sponsor: Centre Georges Francois Leclerc


title: D-dimer Prognostic Marker of Cerebral Infarction After Revascularization Procedure

acronym: D-Dimer

summary:
Cerebral infarction is the leading cause of acquired disability in adults. Absence of biological marker used in current practice and identified as a prognostic factor for recovery. D-dimers are degradation products of stabilized fibrin translating an activation of coagulation whatever the cause. Studies have shown that increased D-dimer levels in patients with MI is associated with a higher mortality rate, the link with post-intervention non-revascularization has been demonstrate.

The purpose of this project is to search for a correlation between the level of D-dimer and the degree of recovery evaluated by the NIHSS score

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: 68Gallium-citrate Positron Emission Tomography/Computed Tomography (68Ga-citrate PET/CT) for the Diagnosis of Chronic Prosthetic Hip or Knee Infection

acronym: Gal-I-TEP

summary: Diagnosis of chronic prosthetic joint infection (PJI) can be difficult. 68Ga-citrate Positron Emission Tomography/Computed Tomography (PET/CT) has been recently developed and has many advantages such as high resolution and low radiation exposure. To date, 68Ga-citrate PET/CT has not been specifically assessed in prosthetic joint infection. In this prospective study, patients referred for a suspected PJI will benefit from both a 68Ga-citrate PET/CT and a 99mTc-HMPAO-labelled leukocyte SPECT/CT. The primary outcome is the assessment of the 68Ga-citrate PET/CT accuracy for the diagnosis of chronic prosthetic hip or knee infection.

location_facility: CHU de Bordeaux - service de maladies infectieuses

intervention_type: Diagnostic Test


title: Study of Arrhythmia and ECG Abnormalities in Patients With COVID-19

acronym: RYTHMO-COV

summary: Cardiac involvement has been described in Severe Acute Respiratory Syndrome - Coronavirus-2 (SARS-CoV-2) infection. Although there are no approved drugs to prevent or treat SARS-CoV-2 infection at present time, several medications used have the potential to increase QT interval and eventually provoke torsades de pointe. The investigators therefore create a study that include all patients with SARS-CoV-2 infection having an electrocardiogram (ECG). The investigators evaluate the percentage of patients with ECG abnormalities, describe the abnormalities and evaluate the occurrence of syncope, ventricular arrhythmia and corrected QT (cQT) interval modification in patients receiving treatment.


title: RETR(Osteomyelitis)

summary: This is a retrospective study describing the management of osteomyelitis in a referece center, with success and failures.


title: Pilot Study on the Evaluation of the Effectiveness of a Virtual Reality Device on Anxiety During Procedural Sedation in Traumatology in Emergency Department

acronym: VIRTUAL DREAM

summary: The aim of this study is to evaluate the efficiency of a reality device and a virtual hypnosis software to reduce the anxiety during reduction procedure in traumatology in an emergency department. These devices have recently been evaluated in the management of pain and anxiety in different specialties but never in the context of analgesia-sedation protocols in emergencies.

lead_sponsor: Poitiers University Hospital


title: Randomized Double-blind Study of rTMS Analgesic Effect in Chronic Neuropathic Pain. Comparison Between Three Groups: Motor Cortex Stimulation by the Classic Coil B65, Deeper Stimulation by the Coil B70 and Placebo Stimulation. Analysis of Long-term rTMS-induced Brain Changes Using fMRI.

acronym: NEUROSTIM

summary:
The purpose of this study is to compare the analgesic effectiveness of three modes of repetitive Transcranial Magnetic Stimulation (rTMS) in chronic neuropathic pain:

Classical rTMS stimulation
Deeper rTMS stimulation
Sham rTMS stimulation

lead_sponsor: University Hospital, Grenoble

location_facility: Centre de la douleur, CHU Grenoble Alpes


title: Contribution of an Electrotherapy Technique Such as TENS ECOMODYN® vs Electrotherapy Only Type TENS in the Management of Myofascial Syndrome After Breast Surgery

acronym: MODYMYO

summary: Myofascial syndrome is defined as "musculoskeletal pain characterized by local and referred pain perceived to be deep and constant, and by the presence of myofascial trigger points in any part of the body" Post-breast surgery myofascial syndrome affects up to 44.7% of operated women, mainly on the muscles of the greater shoulder girdle. The repercussions are significant, functional, somatic, psychological and socio-professional affecting the quality of life. The treatments offered may or may not be medicinal. Transcutaneous electrical nerve stimulation (TENS) is a therapy that uses low voltage electrical current to provide pain relief. A TENS unit consists of a battery-powered device that delivers electrical impulses through electrodes placed on the surface of your skin. The electrodes are placed at or near nerves where the pain is located or at trigger points.

primary_purpose: Supportive Care

lead_sponsor: Institut Cancerologie de l'Ouest


title: Long-term Evaluation of the Efficacy and Safety of a Continent Cutaneous Urinary Diversion in Spinal Cord Injury Patients

acronym: ELESDUCCBM

summary:
Continent Cutaneous Urinary Deviation (CUD), using the Mitrofanoff, Yang-Monti or Casale principle, is offered to patients with neurological diseases who are unable to perform intermittent catheterisation through the native urethra due to upper limb disability.

There is very little data in the literature examining the long-term efficacy and complications of this technique. The main objective of this study is to evaluate the effectiveness of long-term CUDs in spinal cord injury patients. The secondary objectives are to evaluate the surgical complications and the impact on the patient's quality of life.

For each patient, several data will be collected and analyzed: age at operation, sex, Body Mass Index (BMI), ASA score, ASIA score, type of bladder dysfunction assessed by urodynamic evaluation, urinary abnormalities assessed by morphological examination (ultrasound and / or computed tomography) and cystoscopy, creatinine clearance, operative indications, initial mictional mode, surgical assembly and any immediate or late complications. In a second stage, a questionnaire survey will be conducted by telephone.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: PROSPECTIVE STUDY EVALUATING THE SAFETY AND EFFECTIVENESS OF ADJUSTABLE CONTINENCE THERAPY (ACT) BALLOONS FOR THE MANAGEMENT OF URINARY INCONTINENCE IN CHILDREN WITH BLADDER EXSTROPHY OR INCONTINENT EPISPADIAS

acronym: ACT

summary:
The purpose of this study is to evaluate the effectiveness and safety of a minimally invasive surgical procedure with ACT (Adjustable Continence Therapy) balloons implantation for the treatment of urinary incontinence in children with bladder exstrophy or isolated epispadias.

The ACT therapy consists of two small adjustable silicone balloons connected with a tubing to a port, surgically placed around the bladder neck, one on each side of the urethra.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Cardiac Output Response to Vasopressin Infusion In Abdominal Surgery Patients Under Mechanical Ventilation: A Clinical Pharmacodynamics Study

acronym: CORVaso

summary: In this study, the investigators propose to explore the hemodynamic variations induced by vasopressin and its influence on cardiac output, mean systemic pressure, and venous return resistance measured through cardiopulmonary interactions, according to the approach proposed by Guyton, in patients undergoing major abdominal surgeries.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Study of Analgesic Effect of Virtual Reality During Oocyte Retrieval in In Vitro Fecondation Protocols: Controlled Randomized Trial

acronym: REVPO

summary: The aim of the study is to ass wether or not the use of virtual reality during oocyte retrieval provides a better pain relief for patients, compared to a standard analgesic procedure.


title: Study of Mechanisms of Anti COVID-19 Humoral and Cellular Immune Response Between 1 and 3 Months After Vaccination in a Sample of Patients and Salaried Staff From a French Anti-cancer Center

acronym: CANSEROVAX

summary:
Special populations are people with a risk to dévelop severe forms of a disease. The immunogenicity and efficacy of vaccines in this population may be different compared of the general population.

For Covid-19, special populations are people with chronic diseases (obesity, diabetes, cancer, etc.) and / or immunocompromised and / or elderly. It is therefore important that the safety of new vaccines as well as their efficacy be evaluated.

Thus, in cancer, most immunosuppressions and immunosuppressive treatments (in particular chemotherapy or certain targeted therapies) risk negatively impacting the effectiveness of the anti-SARS-COV-2 vaccine both for the humoral immune responses (antibodies ) and cellular (T lymphocytes). These patients may develop an insufficient post-vaccination immunity. However, it seems that immunosenescence (ie the aging of the immune system) has little impact on the effectiveness of mRNA vaccines and viral vector vaccines.

The Canserovax study evaluates the impact of anticancer treatments on the quality of the humoral (development of antibodies) and cellular (development of a specific T response) immune response to SARS-CoV-2 in patients treated for cancer after vaccination. It is carried out in patients undergoing treatment and in subjects not suffering from cancer, and not treated for this pathology (vaccinated salaried staff of a french cancer center). The aim is to qualitatively and quantitatively compare the post-vaccination immune responses in these 2 populations.


title: Comparative Study of Gender Dysphoria Phenomenology and Neurophysiology: Clinical and Experimental Exploration of Gender Identity Disorder

acronym: TRANSIDENT

summary: Gender dysphoria is manifested by an internal tension between biological sex and gender, that is, by a non-congruence, in the subjects who suffer from it, between their sex of birth and their social gender identity.

lead_sponsor: Centre Hospitalier Henri Laborit


title: Comprehensive and Comparative Analysis of Venous Oxygen Saturation During ECMO Support: a Pilot Study

acronym: ECMOxygen

summary:
Extracorporeal veno-arterial membrane oxygenation" (ECMO-VA), are used to manage refractory cardiogenic shocks by replacing the failed "heart-lung" block. The Extracorporeal Life Support Organisation guidelines considers that the effectiveness of these techniques must be evaluated on the adequacy of tissue perfusion biomarker, of which is O2 saturation of venous blood found in the pulmonary artery using a Swan-Ganz catheter (SVO2) or in the superior vena cava/right atrium using a central venous catheter (ScVO2). During ECMO support, it can be also measured directly in the venous ECMO cannula (SmVO2).

However, due to the difference in tips locations of the venous cannula of ECMO-VA, the central venous catheter and the Swan-Ganz catheter, and rheological issues, the SmVO2, SVO2 and ScVO2 values obtained may be different.

Further we hypothesised that the level of admission flow may also affect the correlation between these different variables.

The aim of this experimental study is to investigate the concordance of the saturation of venous blood collected from these 3 measurement sites.

The primary objectives is to compare the concordance of ScVO2 and the SmVO2, the two more easily and systematically available variables

The secondary objectives were :

to evaluate the concordance of the 3 variables describing oxygen saturation
to analyse the primary objectives during prespecified and calibrated flow changes
analyse the association between these 3 variables with prognosis variables (Perfusion index, lactatemia, CO2 veno-arterial differences, SOFA score, SAPS II, successful weaning from the ECMO)
analyse in an ancilary study the concordance between SmVO2 measured using blood sample and the value obtained using a continuous monitoring of SVO2 through the circuit.

lead_sponsor: University Hospital, Lille

location_facility: Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille


title: Normative Nasalance Scores for Native French-speaking Children

summary:
The velopharyngeal mechanisms (in particular the movements of the soft palate) is frequently affected by craniofacial anomalies such as cleft lip and palate. Nasofibroscopy is frequently used in clinical care to assess the velopharyngeal function because it allows for direct visualization of the velopharyngeal port. However, it is an invasive procedure that could not be tolerated well by children.

Nasometry is a non-invasive acoustic measurement technique which can be used to objectively assess a velopharyngeal dysfunction (whether it can be heard or not), and thus supplement the perceptual evaluation conducted by a trained clinician.

The main objective of this study is to establish normative nasalance scores with the KayPENTAX Nasometer (Nasometer II 6450 model) for native French-speaking children between 8 and 10 years old.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Virtual Reality for Children in Radiotherapy (REVER)

acronym: REVER

summary:
For a young patient, the conditions of proton therapy treatment can be stressful. Adjusting the environment can be a source of avoiding this physical and psychological discomfort impacting the quality of treatment.

A fixed, long, uncomfortable position is the main cause of stress, already present due to the cancerous therapeutic course. It extends the positioning time. For the patient and the optimization of his treatment, solutions must be sought.

Relaxation in virtual reality is efficient, simple and non-medicinal and could reduce stress in children and allow irradiation in very good conditions.

We will assess the effectiveness of the virtual reality session using objective (placement time, helmet tolerance) and subjective (perceived anxiety via a dedicated questionnaire) criteria. This is the first pediatric virtual reality study, supported by the French Group of Pediatric Radiotherapists, to reduce anxiety in radiotherapy.

Multiple benefits from this pilot study are expected, such as improved reception conditions, treatment parameters and better acceptance of proton therapy sessions.

primary_purpose: Health Services Research

lead_sponsor: Centre Antoine Lacassagne


title: Clinical Evaluation of a New Multipurpose Whole-body CZT Camera in DaTSCAN Brain Scintigraphy: a Head-to-head Comparison With a Conventional System.

acronym: STARDAT

summary:
DaTSCAN is an important tool in the diagnosis and clinical management of Parkinson's syndromes.

New cadmium-zinc-telluride (CZT) systems allow time and/or dose reduction. This can be interesting in DaTSCAN acquisitions as those are long-lasting, often on difficult patients.

This study will evaluate the diagnostic performances of a new 3D-ring CZT camera in DaTSCAN SPECT.

ReferenceCitation: Benamer TS, Patterson J, Grosset DG, Booij J, de Bruin K, van Royen E, Speelman JD, Horstink MH, Sips HJ, Dierckx RA, Versijpt J, Decoo D, Van Der Linden C, Hadley DM, Doder M, Lees AJ, Costa DC, Gacinovic S, Oertel WH, Pogarell O, Hoeffken H, Joseph K, Tatsch K, Schwarz J, Ries V. Accurate differentiation of parkinsonism and essential tremor using visual assessment of [123I]-FP-CIT SPECT imaging: the [123I]-FP-CIT study group. Mov Disord. 2000 May;15(3):503-10.

ReferenceCitation: Suwijn SR, van Boheemen CJ, de Haan RJ, Tissingh G, Booij J, de Bie RM. The diagnostic accuracy of dopamine transporter SPECT imaging to detect nigrostriatal cell loss in patients with Parkinson's disease or clinically uncertain parkinsonism: a systematic review. EJNMMI Res. 2015 Mar 17;5:12. doi: 10.1186/s13550-015-0087-1. eCollection 2015.

ReferenceCitation: Kupsch AR, Bajaj N, Weiland F, Tartaglione A, Klutmann S, Buitendyk M, Sherwin P, Tate A, Grachev ID. Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study. J Neurol Neurosurg Psychiatry. 2012 Jun;83(6):620-8. doi: 10.1136/jnnp-2011-301695. Epub 2012 Apr 6.

family: Kupsch

full_name: Andreas R Kupsch

given: Andreas R

sequence: first

family: Bajaj

full_name: Nin Bajaj

given: Nin

sequence: additional

family: Weiland

full_name: Frederick Weiland

given: Frederick

family: Tartaglione

full_name: Antonio Tartaglione

given: Antonio

family: Klutmann

full_name: Susanne Klutmann

given: Susanne

family: Buitendyk

full_name: Melanie Buitendyk

given: Melanie

family: Sherwin

full_name: Paul Sherwin

given: Paul

family: Tate

full_name: Ann Tate

given: Ann

family: Grachev

full_name: Igor D Grachev

given: Igor D

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Tolosa E, Borght TV, Moreno E; DaTSCAN Clinically Uncertain Parkinsonian Syndromes Study Group. Accuracy of DaTSCAN (123I-Ioflupane) SPECT in diagnosis of patients with clinically uncertain parkinsonism: 2-year follow-up of an open-label study. Mov Disord. 2007 Dec;22(16):2346-51.

ReferenceCitation: Djang DS, Janssen MJ, Bohnen N, Booij J, Henderson TA, Herholz K, Minoshima S, Rowe CC, Sabri O, Seibyl J, Van Berckel BN, Wanner M. SNM practice guideline for dopamine transporter imaging with 123I-ioflupane SPECT 1.0. J Nucl Med. 2012 Jan;53(1):154-63. doi: 10.2967/jnumed.111.100784. Epub 2011 Dec 8.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Nice Healthy Brain - Cohort of Healthy People in Brain MRI, Together With a Language and Cognitive Assessment at the University Hospital of Nice

acronym: NHB

summary: The aim of this study is to constitute a cohort of healthy subjects in brain MRI, including functional and diffusion sequences, together with a language and cognitive assessment. This will make it possible to compare the data with those obtained in the same center and under the same examination conditions in brain tumor patients. The investigators seek to evidence general patterns of cerebral morphological and functional changes, correlated with behavioural scores, in brain-damaged patients.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections

acronym: PKTOXDAP

summary: the aim of this study is to investigate the relationship between exposure to daptomycin and the occurrence of muscle toxicity or eosinophilic pneumonia in patients treated with daptomycin for bone and joint infection

lead_sponsor: Hospices Civils de Lyon


title: Evaluation of a New Screening Method for Sarcopenia in Rheumatoid Arthritis

acronym: SARCO-RA

summary: Evaluation of a new screening method for sarcopenia in rheumatoid arthritis

lead_sponsor: CHU de Reims


title: Impact of Multidisciplinary Team Approach on the Utilization and Risks Related to Antithrombotic Drugs in Older Patients With Atrial Fibrillation

acronym: ANTITHROMBOTEA

summary: Antithrombotic drugs, which include antiplatelet and anticoagulant therapies, are used to prevent and treat many cardiovascular disorders. With the increase in prevalence of cardiovascular diseases and medical progress, these treatments are increasingly being prescribed, particularly in older patients. One of the main indications of antithrombotic drugs is atrial fibrillation (AF), a disease highly prevalent in older people, a population at high risk of adverse drug events. Notably, antithrombotic drugs are the first involved in serious adverse drug events, among which 40-70% may be preventable. In this context, six units of the hospital group "Assistance Publique - Hôpitaux de Paris" have created a multidisciplinary team which assesses antithrombotic prescriptions in older patients with AF. This team, gathering geriatricians, cardiologists, neurologists and haematologist specialized in haemostasis, evaluates the patient medical profile and suggests the most appropriate antithrombotic treatment based on their expertise and the available recommendations. Here we want to look at patients outcomes in light of the intervention of this multidisciplinary team.

location_facility: Unité de gériatrie aiguë, hôpital Pitié-Salpêtrière (Pr Marc Verny)


title: Predicting Fluid Responsiveness During Shock State by End-expiratory Occlusion Test in Newborns and Infants : EVEOC Study

acronym: EVEOC

summary:
To date, the end-expiratory occlusion test in infants or children has never been evaluated as a marker of preload dependence. It therefore appears clinically relevant to evaluate this new indicator to predict fluid responsiveness in all infants hospitalized in pediatric and neonatal intensive care.

The main objective of this study is to determine whether the hemodynamic effects of a 15-second end-expiratory occlusion were able to predict fluid responsiveness in the mechanically ventilated infant or newborn in pediatric intensive care.


title: Gustave Roussy Cancer Profiling

acronym: STING

summary: The objective of STING study is to perform high throughput molecular analysis (next generation sequencing +/- immunological profiling) to estimate the proportion of patients with cancer presenting at least one targetable genomic alteration.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Gustave Roussy Cancer Campus Grand Paris


title: Outcome of Patients With CBF and/or NPM1-mutated AML in First Molecular Relapse.

acronym: MOLAM

summary: Despite good initial response, some patients with core binding factor and/or NPM1-mutated AML eventually relapse. Some of these patients can be identified earlier on, before overt cytological relapse, when followed for minimal residual disease. The outcome of patients treated when molecular relapse is confirmed, before overt cytological relapse, is not well known. This multi-center retrospective will therefore study the outcome of these patients and try to specify the role of allogeneic stem cell transplantation in this setting.

lead_sponsor: University Hospital, Angers


title: Validation of the French Version of the Fremantle Back Awareness Questionnaire (FreBAQ) in Patients With Chronic Low Back Pain

acronym: FreBAQ

summary:
In patients with chronic low back pain, the Fremantle Back Awareness Questionnaire (FreBAQ) measures the duration and intensity of pain and functional limitations. The FreBAQ is a simple tool created to assess disturbances in the body representation of the back, and the only one existing in chronic low back pain. It is a 9-item self-questionnaire in which each item is measured on a 5-point Likert scale ranging from "Never (score of 0)" to "Always (score of 4)". It assesses neglect, perceived body image of the back, accuracy in proprioceptive perception of back movements.

The psychometric properties of the FreBAQ in English, Japanese, Dutch, Turkish and German are validated and acceptable; however, they have never been studied in French and no validated version of this questionnaire in French exists.

The study investigators hypothesize that the French version of the FreBAQ has good psychometric qualities, allowing it to be used in the French chronic low back pain population.


title: Impact of an Onco-haematology Vigilance Card in the Optimisation of the Town-hospital Relationship.

acronym: THERANOVA-LIM

summary: The objective of this study is to show the interest of setting up a drug vigilance card in Oncology in order to reinforce patient safety, develop compliance and avoid drug interactions when the patient consults town professionals or other specialists.

lead_sponsor: University Hospital, Limoges


title: LANdiolol MIcrocirculatory Effects During Septic chOc

acronym: MILANOS

summary: The objectives of this study are to evaluate the effect of continuous intravenous Landiolol injection (from 0.5 to 10 µg/kg/min during 12 hours ) up to a 15% decrease in Heart Rate (HR) on microcirculatory vascular reactivity vs. usual tachycardia management and evaluate the hemodynamic effects of Landiolol vs. usual management in patients with septic shock.

location_facility: Intensive care department, Hôpital Saint Antoine


title: B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome

acronym: BRAISES-DiaPSS

summary: The objectif is to study the diagnosis performance of the different classification criteria in reference to the gold standard consisting of the diagnosis made by expert doctors after standardized assessment, of pSS (primary Sjogren syndrome)

lead_sponsor: University Hospital, Brest


title: EVALUATION OF THE CAPACITY OF A BIOMARKER BASED ON THE RAMAN ANALYSIS OF SYNOVIAL FLUID TO IDENTIFY ARTHROSIC PATIENTS RESPONDING TO VISCOSUPPLEMENTATION / VISCODIAG

acronym: VISCODIAG

summary:
Osteoarthritis (OA) is the most common joint disease in the world and induces major physical, psychological, societal and economic burdens.

The management of osteoarthritis is complex. Viscosupplementation by local injection in the arthritic knee is a validated therapy used after failure of conventional analgesic treatments and non-pharmacological modalities. The size effect of this treatment is modest between 0.3 and 0.6. We do not currently have any predictive criteria for the effectiveness of this treatment.

The procedure tested in this research is the characterization of synovial fluid (SF) by an in vitro Raman microspectroscopy technique.

The results obtained will make it possible to compare the effectiveness of visco-supplementation with hyaluronic acid from the Hyalgan© trade according to classic criteria in the literature.

lead_sponsor: University Hospital, Grenoble


title: IncIncidence and Prognosis of Coronary Artery Disease in Elderly People Over 80 Years Referred for TAVI

acronym: CEPTAVI

summary:
The investigators prognostic impact of coronary artery disease (CAD) and of percutaneous coronary intervention (PCI) in patients with indication of TAVI is controversial, particularly in elderly population where CAD and aortic stenosis (AS) are frequent and commonly coexisted. (1-2) The primary end point of this prospective study is to compare major cardiovascular event at one year of follow up in patients over 80 years with severe aortic stenosis who referred for TAVI with or without associated CAD.

The investigators will also assess (secondary endpoint) the impact of PCI on symptoms, major events and quality of life using geriatric parameters. The study will be conducted in the University hospital of Montpellier between November 2020 and November 2022

ReferenceCitation: Cao D, Chiarito M, Pagnotta P, Reimers B, Stefanini GG. Coronary Revascularisation in Transcatheter Aortic Valve Implantation Candidates: Why, Who, When? Interv Cardiol. 2018 May;13(2):69-76. doi: 10.15420/icr.2018:2:2. Review.

ReferenceCitation: Matta AG, Lhermusier T, Parada FC, Bouisset F, Canitrot R, Nader V, Blanco S, Elbaz M, Roncalli J, Carrié D. Impact of Coronary Artery Disease and Percutaneous Coronary Intervention on Transcatheter Aortic Valve Implantation. J Interv Cardiol. 2021 Mar 24;2021:6672400. doi: 10.1155/2021/6672400. eCollection 2021.

lead_sponsor: University Hospital, Montpellier


title: TRANSCOV Cohort. An Epidemiological Study Assessing the Impact of Critically Ill COVID-19 Patients Long Distance Transfers Between Intensive Care Units

acronym: TRANSCOV

summary: The TRANSCOV cohort is a multicentre observational retrospective study aiming at assessing the health impact of extra regional transfers of critically ill COVID-19 patients.

ipd_sharing_description: undecided

lead_sponsor: Ecole des Hautes Etudes en Santé Publique


title: Feasability and Impact of Enhanced Recovery Programs After Surgery for Small Bowel Obstruction

acronym: RACO

summary: Small bowel obstruction surgery is frequent and would benefit from enhanced recovery programs. While some studies advocate for their feasibility, it has never been proved and prospective studies are required to confirm the feasibility of such program and the impact on postoperative outcomes.


title: Cognition Sociale et caractéristiques Psychotiques : Approche génétique et phénomique

acronym: COG-PSYCHO

summary:
Bipolar disorder (BD), schizophrenia and depression can feature cognitive impairment, especially in social cognition (SC). According to previous studies, some genes from the oxytocin and dopamine pathways may be involved SC performance. Our endophenotype approach aimed to demonstrate that SC deficits are more severe in schizophrenia and BD or depression with psychotic symptoms (PBP) and are associated with certain Single Nucleotide Polymorphisms (SNPs) variants.

600 patients with schizophrenia, BD ou depression with and without psychotic symptoms will be recrited. Social Cognition was assessed using 4 paradigms: Reading the Mind in the Eyes Test (RMET), Interpersonal Reactivity Index (IRI), Empathy Quotient (QE), and a modified Delay Discounting task. After DNA extraction from blood or saliva sample, we used PCR amplification and real-time detection to genotype SNPs from Oxytocin pathways. he level of ocytocine will be also mesured.

intervention_type: Genetic


title: Psycho-social Impact of Amelogenesis and Dentinogenesis Imperfecta in Young People

acronym: AiDiBull

summary: The purpose of this research is to study the impact of dentinogenesis (DI) and amelogenesis (AI) imperfecta on oral quality of life, exposure to bullying and dental anxiety in a population of adolescents. We will use validated scales to evaluate the impact of bullying on the oral quality of live of youth aged 10 to 18 years, with non-syndromic DI or AI treated in seven national competence or reference centers in rare oral diseases.

lead_sponsor: University Hospital, Toulouse


title: Evaluation of Myocardial Reperfusion and Residual Thrombotic Burden After Primary PCI for STEMI in Patients With High on Ticagrelor Platelet Reactivity Treated by IV Cangrelor Versus Ticagrelor Alone

acronym: ERMIT

summary: This study aims to evaluate the impact on myocardial reperfusion and residual thrombotic burden of adding Cangrelor -a potent and immediate P2Y12 inhibitor- to ticagrelor in primary PCI patients with high on ticagrelor platelet reactivity compared to standard of care with ticagrelor alone.

lead_sponsor: University Hospital, Caen


title: Detection of Small Fiber Neuropathies by the Non-invasive SUDOSCAN Method During Chronic Autoimmune Pathologies and / or Unexplained Pain Syndromes

acronym: SUDOCU

summary:
Very few studies have evaluated the prevalence of small fiber neuropathy (SFN) during pathologies that may be responsible for small fibers damage.

SUDOSCAN is a new rapid (2 minutes), automated, reproducible and non-invasive technology to assess small fiber neuropathy by sweat function.

With quantitative and reproducible results, SUDOSCAN allows physicians to early detect and follow-up peripheral neuropathy to monitor disease progression and assess treatment efficacy for a better patient management.

SUDOSCAN® could allow the identification of SFN in painful patients apart from another pathology already diagnosed responsible for SFN.

The purpose of the study SUDOCU is to assess the prevalence of small fiber neuropathies (SFN) in patients with systemic autoimmune pathologies or unexplained pain syndrome.

lead_sponsor: Hôpital Européen Marseille


title: Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Patients at Increased Risk for the Development of Ventilator-associated Pneumonia in the Intensive Care Unit

acronym: BIOPAVIR

summary: Ventilator-associated pneumonia (VAP) remains the most frequent healthcare-associated infection (HAI) in the intensive care unit (ICU) and one of the most critical risk factors associated with both significant morbidity as well as mortality. Although VAP treatment relies on early and appropriate antimicrobial therapy, several preventive measures have been described in the literature in order to limit its incidence and clinical impact in the ICU. Among these, preventing biofilm formation on the inner surface of the endotracheal tube appears to hold promise. Yet there is a lack of clinical relevant data documenting a causal relation between biofilm formation and VAP. Designed to overcome this critical limitation, the BIOPAVIR study intends to provide a better structural and microbiological characterization of endotracheal tube biofilm in critically ill patients at increased risk for the development of VAP in ICU during COVID-19 pandemic.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Efficiency of Speech and Language Intervention on Achievement of Children With Developmental Language Disorder

acronym: DYSPHADEV

summary:
Children with Developmental Language Disorder (DLD) have many linguistic difficulties in syntax, lexicon, morphology and phonology. Frequently, they also present co-occurrent (or comorbidities) impairments which further impaired school learning. Thus, they have poor academic outcomes and many of these children have been maintained at least one time in a classroom, sometime more.

The purpose of this project is to determine which modalities of speech and language therapy are the more efficient on academic outcomes of children with DLD. The main modalities that will be studied are the duration of speech and language intervention, the age at which begins the intervention and the intensity (number of intervention sessions per week).

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Glycemic Control Before, During and After the 2016 Paris Marathon in 12 Patients With Type 1 Diabetes Using Continuous Glucose Monitoring

acronym: MARADIAB

summary: This is an observational mono-centric retrospective study carried out at the University Hospital of Brest The main objective of this study is to assess the glycemic control before, during and after the 2016 Paris Marathon in patients with type 1 diabetes using continuous glucose measurement (CGM) by DEXCOM sensor.


title: Evaluation of the Comfort of a Continuous Positive Airway Pressure Nasal Mask in the Treatment of Obstructive Sleep Apnea Syndrome

acronym: NINADOM

summary:
Continuous positive airway pressure (CPAP) is the first-line treatment for obstructive sleep apnea syndrome (OSA). It consists of a pressure generator connected to a mask applied to the patient's face. CPAP treatment is restrictive, and nearly a quarter of patients abandon it over the long term. Various factors can influence adherence to CPAP therapy, including adverse events associated with the mask. However, it is clear that compliance with CPAP treatment, even if it has tended to improve over the last 30 years, is still sub-optimal.

Air Liquide Medical Systems has developed a mask that aims to improve comfort and ease of use for the patient. This leaky nasal mask has a "silent" intentional leak port, which significantly reduces the noise caused by the escape of air. The noise associated with intentional leakage is one of the discomforts reported by patients and their spouses. In addition, this mask is equipped with a new generation headgear with adjustment indicators to assist the patient in fitting the mask. Optimal headgear fit is a prerequisite for comfort during treatment, as it reduces unintentional leakage.

The main objective is to evaluate, through a questionnaire, the comfort and general appreciation of a nasal mask equipped with a silent leak system and a headgear with adjustment aids, of patients with OSA treated with CPAP.

Secondary objectives are :

To evaluate the appearance of CPAP side effects related to the mask,
To collect the patient's appreciation of the mask headgear,
To evaluate the discomfort caused by the nasal obstruction reported by the patient,
To evaluate the daytime sleepiness of the patient,
To study the parameters of the CPAP treatment.

lead_sponsor: AGIR à Dom


title: Migraine and High Flow Oxygenotherapy at the Emergency Department

acronym: MiOx

summary:
Migraine is a common pathology, affecting around 12% of the general population, up to 25% in some cohorts, as well as a significant part of the reasons for emergency room visits.

Unlike cluster headaches, the use of high-flow oxygen therapy has not yet been validated in patients with migraine.

However, several aspects of its pathophysiology, still studied to this day, suggest that the use of normobaric oxygen could have beneficial effects on migraine attacks: tissue hypoxia, cerebrovascular dysfunction with vasodilation, inflammation, etc.

In addition, high-flow oxygen therapy has no significant side effects and almost no contraindication (mainly COPD and other chronic respiratory failure) Its use in the event of a migraine attack would thus allow less recourse to conventional analgesics (with significant side effects for some), a shorter stay in the emergency room, and therefore a benefit in terms of cost and relief for the patient.

In this context, the sponsor wish to carry out a multicenter prospective interventional, single-blind randomized placebo-controlled in parallel groups study.

ipd_sharing_description: No data sharing is planned


title: Evaluation of Knowledge About Fever After Consultation in the Pediatric Emergency Department: Standard Consultation Versus Standard Consultation With Distribution of an Information Leaflet About Fever in Pre-consultation

acronym: FEARVER

summary:
The purpose of this study is to evaluate the effect of an information brochure on parent / legal guardians' knowledge of what to do about their child's febrile episode after a pediatric emergency department visit.

Single-center randomized controlled trial.

ReferenceCitation: Schmitt BD. Fever phobia: misconceptions of parents about fevers. Am J Dis Child. 1980 Feb;134(2):176-81.

ReferenceCitation: Poirier MP, Davis PH, Gonzalez-del Rey JA, Monroe KW. Pediatric emergency department nurses' perspectives on fever in children. Pediatr Emerg Care. 2000 Feb;16(1):9-12.

ReferenceCitation: Burokienė S, Kairienė I, Strička M, Labanauskas L, Čerkauskienė R, Raistenskis J, Burokaitė E, Usonis V. Unscheduled return visits to a pediatric emergency department. Medicina (Kaunas). 2017;53(1):66-71. doi: 10.1016/j.medici.2017.01.003. Epub 2017 Jan 31.

ReferenceCitation: Bereznicki BJ, Tucker MG, Beggs SA, Zosky GR, Bereznicki LR. Emergency department presentations of febrile children to an Australian public hospital. J Paediatr Child Health. 2018 Dec;54(12):1308-1313. doi: 10.1111/jpc.14071. Epub 2018 Jun 6.

ReferenceCitation: Enarson MC, Ali S, Vandermeer B, Wright RB, Klassen TP, Spiers JA. Beliefs and expectations of Canadian parents who bring febrile children for medical care. Pediatrics. 2012 Oct;130(4):e905-12. doi: 10.1542/peds.2011-2140. Epub 2012 Sep 10.

ReferenceCitation: Betz MG, Grunfeld AF. 'Fever phobia' in the emergency department: a survey of children's caregivers. Eur J Emerg Med. 2006 Jun;13(3):129-33.

ReferenceCitation: Morrison AK, Chanmugathas R, Schapira MM, Gorelick MH, Hoffmann RG, Brousseau DC. Caregiver low health literacy and nonurgent use of the pediatric emergency department for febrile illness. Acad Pediatr. 2014 Sep-Oct;14(5):505-9. doi: 10.1016/j.acap.2014.05.001. Epub 2014 Jun 16.

ReferenceCitation: Walsh A, Edwards H. Management of childhood fever by parents: literature review. J Adv Nurs. 2006 Apr;54(2):217-27. Review.

ReferenceCitation: Walsh A, Edwards H, Fraser J. Parents' childhood fever management: community survey and instrument development. J Adv Nurs. 2008 Aug;63(4):376-88. doi: 10.1111/j.1365-2648.2008.04721.x.

ReferenceCitation: Peetoom KK, Smits JJ, Ploum LJ, Verbakel JY, Dinant GJ, Cals JW. Does well-child care education improve consultations and medication management for childhood fever and common infections? A systematic review. Arch Dis Child. 2017 Mar;102(3):261-267. doi: 10.1136/archdischild-2016-311042. Epub 2016 Jul 18. Review.

ReferenceCitation: Considine J, Brennan D. Effect of an evidence-based education programme on ED discharge advice for febrile children. J Clin Nurs. 2007 Sep;16(9):1687-94.

ReferenceCitation: Monsma J, Richerson J, Sloand E. Empowering parents for evidence-based fever management: An integrative review. J Am Assoc Nurse Pract. 2015 Apr;27(4):222-9. doi: 10.1002/2327-6924.12152. Epub 2014 Jul 25. Review.

ReferenceCitation: Broome ME, Dokken DL, Broome CD, Woodring B, Stegelman MF. A study of parent/grandparent education for managing a febrile illness using the CALM approach. J Pediatr Health Care. 2003 Jul-Aug;17(4):176-83.

ReferenceCitation: Baker MD, Monroe KW, King WD, Sorrentino A, Glaeser PW. Effectiveness of fever education in a pediatric emergency department. Pediatr Emerg Care. 2009 Sep;25(9):565-8. doi: 10.1097/PEC.0b013e3181b4f64e.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: APHP Assistance Publique des Hôpitaux de Paris


title: Impact on Duration of Antibiotic Therapy of Rapid Molecular Diagnostic Method for Rapid Analysis of Susceptibility of Peritoneal Samples in Postoperative Peritonitis in ICU Patients

acronym: DIRECTABDO

summary:
Hospitals, and more specifically Intensive Care Units (ICU), face the challenging issue of emergence and rapid spread of multi-drug resistant bacteria (MDR). In some cases, the therapeutic choice is extremely limited. Prevention and adequacy of antibiotic therapy (AB) are the key responses applied toward these threats. A delayed adequate AB is a known factor of poor prognosis. Intra-abdominal infections (IAI) are frequent, polymicrobial and life threatening diseases. Source control and adequate AB are instrumental issues in this setting. Despite technical advances, susceptibility testing of the microorganisms collected from peritoneal samples is not usually available before day two or three after surgery. In this time lapse, empiric AB might be inadequate (not targeting all the pathogens, which leads to a prolonged duration of AB and potential increased morbidity/mortality risk) or too broad (with the two issues of ecology with an increased risk of selection of MDR bacteria and additional costs). In a pilot study evaluating the potential benefit of a direct culture of peritoneal samples from resuscitation patients treated for peritonitis, we observed that conventional treatment made it possible to obtain microbiological results within a median of 3 [extremes 2-7] days whereas a direct microbiological technique by E-test gave results in 1 [1-2] days (p <0.0001). With this technique close to conventional microbiological, a change in antibiotic therapy could have been achieved within an average of 1 [1-2] days versus 4 [1-11] days with conventional management (p = 0, 0006).

The development of modern molecular techniques suggests that a large margin of improvement for the rendering and the precision of the results is possible.


title: Study of Cortical Cerebral Response and Neurovegetative Response to a Nociceptive Stimulus Among Healthy Volunteers

summary:
Evaluating the intraoperative pain is a major challenge for the anesthesia team. During anesthesia, changes in heart rate and blood pressure are interpreted qualitatively to evaluate the sympathetic response to nociceptive stimulation or the adaptation of analgesia during surgery. The new nociception monitors under development quantitatively explore other variables dependent on sympathetic activity or sympathetic / parasympathetic balance, such as the pulse wave amplitude measurement (Surgical Pleth Index (SPI index)), the pupil dilation reflex, respiratory sinus arrhythmia (ANI, Analgesia Nociception Index), or skin conductance index. Taken independently, these tools provide an assessment of nociception based on variations in the autonomic system, more robust than simply observing heart rate or blood pressure raw values.

However, the relationship between variations in the neurovegetative system and pain can be compromised by various factors or intraoperative events such as hypovolemia, bleeding, certain sympathomimetic or sympatholytic treatments, the hypnosis depth, ventilation variation, fast filling, or body temperature. Moreover, investigators do not know the delay between the application of the painful stimulus and the observation of the variation of the different neurovegetative variables. This constitutes a limit of the practitioners' confidence in these monitoring tools.

The nociception transmission pathways of to the vegetative centers and cortical areas are complex. Investigators hypothesis is that neurovegetative variations in response to nociceptive stimulation are not always associated with a cortical somatosensory response. In this project investigators investigate the relation between cortical (EEG) and vegetative reactions to acute and tonic nociceptive stimuli, as a preliminary step to apply these procedures to assess intraoperative reactions to nociceptive procedures in anesthetized patients.

location_facility: Service de Neurologie Fonctionnelle et Epileptologie Hôpital Neurologique, GHE Hospices civils de Lyon


title: VALIDATION OF A GMP-COMPLIANT BIOPRINTING PROCESS FOR MANUFACTURING A DERMO-EPIDERMAL AUTOLOGOUS SKIN SUBSTITUTE FOR FURTHER THERAPEUTIC USE

acronym: BIOPSKIN

summary:
Innovative technologies in the emerging field of regenerative medicine might allow an improvement in the treatment of deep complex wounds leading to faster and better wound healing. Among them, the bioprinting technology, consisting in "printing human cells and biomaterials" to create a "dermo-epidermal substitute" that mimics an alternative of the physiological skin is the most promising alternative.

Besides improving skin substitutes properties, bioprinting allows to translate the manufacturing process of tissue-engineered products from manual, operator-dependent processes to a reproducible and automated solution. This paves the way to the manufacturing of therapeutic bioprinted products at the point of care, as close as possible from patients.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: assistance publique hôpitaux de Marseille


title: Study to Evaluate Physician Awareness and Knowledge of Safety and Safe Use Information for Androcur and Other Cyproterone Acetate Monotherapies in Europe: an Observational Post-Authorisation Joint Safety Study (Safe-CAM)

acronym: Safe-CAM

summary:
Androcur is a type of treatment called cyproterone acetate (CPA). Androcur and other CPA treatments work by blocking a group of male sex hormones called androgens in the body. It can be given to men and women to treat conditions that are caused by higher levels of androgens.

CPAs, including androcur, are currently available as treatments for doctors to give to patients who have these types of conditions. But, in a study, researchers found that participants had a certain medical problem when they took CPAs for a long time. This medical problem was a tumor of the brain or spinal cord that is mostly not malignant and is called meningioma. This eventually led health authorities to change the instructions for how doctors should use CPAs to treat patients. This included what health conditions should be treated with CPAs, how long patients should receive them, and what dose of CPA should be given.

In this study, the researchers want to learn more about how doctors are using CPAs to treat patients after the update to the instructions.

To answer this research question, they will give to the doctors a web-based questionnaire asking about the advisability or necessity of the treatment (also called "indications of approved use"), the measures to be followed to reduce the risk and how much the doctors knew about the risk of meningioma.

The researches will then analyze the answers to the questionnaire. The results will be the percentage of physicians with correct answers for each individual knowledge question from the questionnaire.

The study will include information collected from a diverse sample of doctors during approximately 3 months.

The doctors must have given CPAs as a treatment to at least 1 patient in the last 12 months.

There are no required visits or tests in this study.

ipd_sharing_description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer


title: Evaluation of Episodic Memory and Accelerated Long-term Forgetting in Patients With Drug-resistant Focal Epilepsy

acronym: EPIMNESIE

summary: Drug-resistant focal epilepsy (DRFE) is frequently associated with complications of varying severity that impair patient's quality of life. Among these complications, cognitive disturbances and especially episodic memory difficulties, play a determinant part. Episodic memory can be defined as a function that allows the mental reconstruction of a past life episode, through complex associative mechanisms that link the vivid experience to its context of occurrence, called encoding context. It is a dynamic cognitive function, which calls on a widely distributed cerebral network, mainly involving the medial temporal lobe, particularly the hippocampus. Epilepsy could have a specific impact on this crucial network, disrupting the binding mechanisms between the experienced events and their encoding context, which are essential for efficient memory. Although patients with DRFE frequently demonstrate memory impairment as assessed by standardised neuropsychological tests, it only imperfectly reflects their difficulties. As a matter of fact, despite a subjective memory complaint, about 20% have no memory impairment on these tests, resulting from a phenomenon called accelerated long-term forgetting (ALF). ALF is indeed characterised by normal performance on standardised neuropsychological tests involving retention delays of 20-30 minutes, but disabling memory complaint and abnormally marked forgetting within hours or days that follow the learning period. This phenomenon is widely described at the conceptual level, but remains difficult to measure in daily practice, at least partly due to methodological limits. Thus, the validated tools available in clinical routine are poorly adapted to the complexity and the associative dimension of memory networks. There is therefore a clinical need for a specific assessment tool that would be able to detect ALF, in order to better quantify it and to enable the appropriate care of patients suffering from DRFE. The aim of the EPIMNESIE study is to evaluate the diagnostic capacity of a behavioural associative memory task, based on the analysis of encoding and consolidation mechanisms, in order to measure ALF. In this prospective study, 40 patients with DRFE and 40 healthy subjects will be proposed to complete a new associative memory task involving a learning phase and two recall sessions which will take place at 30 minutes and 72 hours after the learning phase.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon Service de Neurologie Fonctionnelle et d'Epileptologie


title: Epidemiology of CoV-2 SARS Infections: Dynamics of Community Contamination in Children and Adults - Impact of Variants

summary: Unlike other respiratory viruses such as influenza and RSV where the child is the essential reservoir and central vector of intrafamilial contamination, the child is likely to be a small player in the transmission of CoV2-CoRSA infection. This study aims to describe the age category of the first contact, within 14 days before the appearance of the first symptoms of the index case in order to describe the age categories of this first contaminant, globally, in the group of children and finally in the group of adults. This work is intended to provide food for discussion and to justify the distancing and containment measures imposed on children when their isolation has a deleterious impact that has now been established for some children.


title: Etude épidémiologique Monocentrique contrôlée Des Populations Leucocytaires périphériques et du Microbiote Chez le Patient Ayant un Syndrome Néphrotique Idiopathique (SNI)

summary:
Idiopathic nephrotic syndrome (INS) is a clinical entity defined by the association of selective albuminuria resulting in hypoalbuminemia, and nonspecific glomerular lesions, called minimal change disease (MDC) for corticosteroid-sensitive forms and lesions of Focal Segmental Glomerulosclerosis (FSGS) for severe forms, generally corticosteroid-resistant (CR-INS) (Korbet 1995). The specific complication of this renal disease is its immediate recurrence on the graft (Dantal 1996, Dantal 1995) leading, in 50% of cases, to the failure of the transplantation, condemning these patients to dialysis for life. The origin of this syndrome is currently unknown, but a number of clinical observations tend to show an involvement of the immune system (Shaloub 1974). A number of studies have demonstrated a link between atopy, diet and nephrotic attacks (Lagrue 1982, 1984; Laurent 1987, 1988, 1989). Our team has also shown that plasma exchanges and immunoadsorptions can lead to total or partial remissions, supporting the evidence for the presence of a pathogenic plasma factor linked to immunoglobulins (Dantal 1991, Dantal 1994, Dantal 1998), previously suggested by the observation of immediate recurrence of the initial disease on the graft after renal transplantation (Hoyer 1972, Dantal 1995, Dantal 1996). Finally, more recently the use of anti-CD20 treatment specifically depleting B lymphocytes has made it possible to favorably treat a significant number of patients (Haffner 2009; CaraFuentes 2013; Iijima 2017; Siligato 2018). In 2009, the study of a patient with IPEX syndrome, who displayed INS/MCD, highlighted the importance of regulatory T cells in the pathogenesis of INS (Hashimura 2009). These results were corroborated by two studies showing regulatory T cell dysfunction in INS patients (Prasad 2015; Bertelli 2016). This alteration is also linked to allergies (Stelmaszczyk-Emmel 2015) and could be due to an aberrant microbiota or dysbiosis (Rodrigé 2011; Ohnmacht 2016). The hypothesis of a causality between dysbiosis, lymphocyte alteration and the onset of an INS has recently been raised (Uy 2015; Kaneko 2017). Two studies have shown intestinal dysbiosis in pediatric INS/MCD, with reduction of circulating Tregs (Tsuji 2018, 2020).

Hypothesis and objectives Our hypothesis is that in INS/FSGS patients, the alteration of the immune system could be linked to an imbalance of the microbiota. Our objective is to compare the intestinal (and/or urinary) microbiota of the adult INS patient, in nephrotic attacks vs in remission with in parallel a complete monitoring of peripheral immune cells (T and B subtypes, NK, monocytic and dendritic cells) to estimate the possible change in the microbiota between the 2 disease states, and its potential impact on the immune system. The investigators will also compare the microbiota and the immune system of recurrent INS/FSGS patients after transplantation with non-recurrent post-transplant patients.

Stages of the study This study should make it possible to 1 / bring together the cohort and the associated samples, necessary to achieve our goals; 2 / carry out the most exhaustive cytometric analysis of the peripheral sub-populations of these patients and 3 / analyze the intestinal and urinary microbiota. We will first collect a group of INS patients (n = 25) in nephrotic surge, then these same patients in remission. The second group to be collected will be a group of recurrent INS/FSGS patients after renal transplantation and a group of non-recurrent INS receiving the same therapeutic protocol (n = 5/5). As control groups, the investigators will collect proteinuric patients of other origin as well as healthy volunteers (n = 10/10). All patients and healthy individuals will sign an informative consent.

lead_sponsor: Nantes University Hospital


title: Interest of Triphenyl Tetrazolium Chloride (TTC) for the Early Diagnosis of Acute Myocardial Infarction at Autopsy

acronym: INFARCTOPSY

summary: Ischemic heart disease is the leading cause of death worldwide and the leading cause of sudden cardiac death. However, its post-mortem diagnosis is particularly difficult because the gross examination of the heart is usually normal at the autopsy . The diagnosis is therefore often based on a set of indirect arguments, such as the patient's medical and clinical history and the degree of occlusion of the coronary arteries. The formal diagnosis of acute myocardial infarction (AMI) currently relies on standard histological examination. However, histological findings often require a prolonged survival time of several hours to be highlighted. Triphenyltetrazolium chloride (TTC) is a salt that reacts with lactate dehydrogenases contained in still viable myocardial cells, forming a red pigment visible to the naked eye, (1,3,5 triphenylformazan). Ischemia-induced cell death, which occurs within minutes of the causative event, is responsible for the leakage of lactate deshydrogenase into the extracellular medium and thus results in the absence of formazan formation in the infarcted area, which displays an easily identifiable pale unstained color. It has been suggested that the use of TTC would allow the identification of MI as early as one hour of survival in animal models, before the usual macroscopic and microscopic signs are visible. It could therefore represent an attractive forensic tool for the early diagnosis of AMI at the autopsy.


title: WALANT (Wide Awake Local Anaesthesia With No Tourniquet) Procedure in Carpal Tunnel Release: a Prospective Randomized Study

summary:
The possible benefits expected from the use of the WALANT procedure are a decrease in intraoperative pain at the surgical site, a decrease in hospitalization time, and a decrease in the time required to lift the anesthesia postoperatively.

The risks identified are those inherent to each type of anesthesia (WALANT or traditional ALR), as encountered in current practice, and are therefore not specific to the study: risks related to the local anesthetic agent or risks related to the puncture procedure.

The main objective is to determine whether the patient's intraoperative pain at the surgical site is less after a WALANT procedure compared to a traditional ALR procedure (axillary or trunk).

ReferenceCitation: Lalonde DH. Conceptual origins, current practice, and views of wide awake hand surgery. J Hand Surg Eur Vol. 2017 Nov;42(9):886-895. doi: 10.1177/1753193417728427. Epub 2017 Sep 8. Review.

ReferenceCitation: Tulipan JE, Kim N, Abboudi J, Jones C, Liss F, Kirkpatrick W, Rivlin M, Wang ML, Matzon J, Ilyas AM. Open Carpal Tunnel Release Outcomes: Performed Wide Awake versus with Sedation. J Hand Microsurg. 2017 Aug;9(2):74-79. doi: 10.1055/s-0037-1603200. Epub 2017 May 22.

ReferenceCitation: Lalonde D, Martin A. Tumescent local anesthesia for hand surgery: improved results, cost effectiveness, and wide-awake patient satisfaction. Arch Plast Surg. 2014 Jul;41(4):312-6. doi: 10.5999/aps.2014.41.4.312. Epub 2014 Jul 15. Review.

ReferenceCitation: Steiner MM, Calandruccio JH. Use of Wide-awake Local Anesthesia No Tourniquet in Hand and Wrist Surgery. Orthop Clin North Am. 2018 Jan;49(1):63-68. doi: 10.1016/j.ocl.2017.08.008. Review.

ReferenceCitation: Wright J, MacNeill AL, Mayich DJ. A prospective comparison of wide-awake local anesthesia and general anesthesia for forefoot surgery. Foot Ankle Surg. 2019 Apr;25(2):211-214. doi: 10.1016/j.fas.2017.10.015. Epub 2017 Nov 6.

ReferenceCitation: Fayad F, Lefevre-Colau MM, Gautheron V, Macé Y, Fermanian J, Mayoux-Benhamou A, Roren A, Rannou F, Roby-Brami A, Revel M, Poiraudeau S. Reliability, validity and responsiveness of the French version of the questionnaire Quick Disability of the Arm, Shoulder and Hand in shoulder disorders. Man Ther. 2009 Apr;14(2):206-12. doi: 10.1016/j.math.2008.01.013. Epub 2008 Apr 23.

ReferenceCitation: Estèbe JP, Gentili ME, Langlois G, Mouilleron P, Bernard F, Ecoffey C. Lidocaine priming reduces tourniquet pain during intravenous regional anesthesia: A preliminary study. Reg Anesth Pain Med. 2003 Mar-Apr;28(2):120-3.

lead_sponsor: Elsan