title: Morbimortality of Covid-19 in Patients With Chronic Inflammatory Rheumatism Treated With Immunosuppressants

acronym: CORhum

summary: A retrospective monocentric study with large active files of patients monitored for rheumatoid arthritis, spondyloarthritis and systemic lupus erythematosus with as main endpoint the morbimortality of Covid-19 in these patients (number of patients hospitalized in conventional units and/or in intensive care and/or deceased). The results will be compared with those of the general population based on the epidemiological data of Covid-19.

ReferenceCitation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

name: From the State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University (W.G., W.L., J.H., R.C., C.T., T.W., S.L., Jin-lin Wang, N.Z., J.H., W.L.), the Departments of Thoracic Oncology (W.L.), Thoracic Surgery and Oncology (J.H.), and Emergency Medicine (Z.L.), First Affiliated Hospital of Guangzhou Medical University, and Guangzhou Eighth People’s Hospital,...

family: Guan

full_name: Wei-jie Guan

given: Wei-jie

family: Ni

full_name: Zheng-yi Ni

given: Zheng-yi

family: Hu

full_name: Yu Hu

given: Yu

family: Liang

full_name: Wen-hua Liang

given: Wen-hua

family: Ou

full_name: Chun-quan Ou

given: Chun-quan

family: He

full_name: Jian-xing He

given: Jian-xing

family: Liu

full_name: Lei Liu

given: Lei

family: Shan

full_name: Hong Shan

given: Hong

family: Lei

full_name: Chun-liang Lei

given: Chun-liang

family: Hui

full_name: David S.C. Hui

given: David S.C.

family: Du

full_name: Bin Du

given: Bin

family: Li

full_name: Lan-juan Li

given: Lan-juan

family: Zeng

full_name: Guang Zeng

given: Guang

family: Yuen

full_name: Kwok-Yung Yuen

given: Kwok-Yung

family: Chen

full_name: Ru-chong Chen

given: Ru-chong

family: Tang

full_name: Chun-li Tang

given: Chun-li

family: Wang

full_name: Tao Wang

given: Tao

full_name: Ping-yan Chen

given: Ping-yan

family: Xiang

full_name: Jie Xiang

given: Jie

full_name: Shi-yue Li

given: Shi-yue

full_name: Jin-lin Wang

given: Jin-lin

full_name: Zi-jing Liang

given: Zi-jing

family: Peng

full_name: Yi-xiang Peng

given: Yi-xiang

ReferenceCitation: Monti S, Balduzzi S, Delvino P, Bellis E, Quadrelli VS, Montecucco C. Clinical course of COVID-19 in a series of patients with chronic arthritis treated with immunosuppressive targeted therapies. Ann Rheum Dis. 2020 May;79(5):667-668. doi: 10.1136/annrheumdis-2020-217424. Epub 2020 Apr 2.

ReferenceCitation: Gianfrancesco MA, Hyrich KL, Gossec L, Strangfeld A, Carmona L, Mateus EF, Sufka P, Grainger R, Wallace Z, Bhana S, Sirotich E, Liew J, Hausmann JS, Costello W, Robinson P, Machado PM, Yazdany J; COVID-19 Global Rheumatology Alliance Steering Committee. Rheumatic disease and COVID-19: initial data from the COVID-19 Global Rheumatology Alliance provider registries. Lancet Rheumatol. 2020 May;2(5):e250-e253. doi: 10.1016/S2665-9913(20)30095-3. Epub 2020 Apr 16.

ReferenceCitation: Haberman R, Axelrad J, Chen A, Castillo R, Yan D, Izmirly P, Neimann A, Adhikari S, Hudesman D, Scher JU. Covid-19 in Immune-Mediated Inflammatory Diseases - Case Series from New York. N Engl J Med. 2020 Jul 2;383(1):85-88. doi: 10.1056/NEJMc2009567. Epub 2020 Apr 29.

ReferenceCitation: Michaud K, Wipfler K, Shaw Y, Simon TA, Cornish A, England BR, Ogdie A, Katz P. Experiences of Patients With Rheumatic Diseases in the United States During Early Days of the COVID-19 Pandemic. ACR Open Rheumatol. 2020 Jun;2(6):335-343. doi: 10.1002/acr2.11148. Epub 2020 May 9.

ReferenceCitation: Favalli EG, Ingegnoli F, De Lucia O, Cincinelli G, Cimaz R, Caporali R. COVID-19 infection and rheumatoid arthritis: Faraway, so close! Autoimmun Rev. 2020 May;19(5):102523. doi: 10.1016/j.autrev.2020.102523. Epub 2020 Mar 20. Review.


title: Medical-economic Evaluation Comparing Intensive Outpatient Monitoring of Neuro-cardiovascular Diseases by Nurses, Doctors and Hospital and Private-sector Pharmacists, Compared to Usual Monitoring.

acronym: DiVa

summary:
Cerebral Vascular Accidents (stroke) and Myocardial Infarction (MI), which share the same risk factors, treatments and pathophysiological mechanisms, have become two major public health problems due to the increase in their prevalence rate and the longer survival after such an event in developed countries.

International data, including French data and data from our own registries, illustrate that:

risk factors that are common, mainly hypertension, smoking, high cholesterol or diabetes, remain insufficiently controlled, although they are easily detectable and treatable;
the incidence rate of stroke has doubled in 20 years in people under 55 years of age, increasing the number of people with chronic disabilities;
1-month and 1-year mortality rates for stroke and MIs have decreased by 17% in 5 years, increasing the number of survivors but with chronic disabilities;
the aging of the population and the arrival of the baby boomers of the 1950s in the at-risk age groups has increased the at-risk population;
Stroke and MI recurrence rates reached a threshold of 6% / year, in contrast to the very high rates of re-hospitalization at 1 year: 30% post-stroke and 20% post-MI, due to poorly anticipated and controlled complications. These reasons explain the lack of significant progress in preventing recurrences, preventable complications (heart failure and arrhythmias after MI; falls, sphincter and swallowing disorders, dementia and arrhythmias after stroke) and re-admission. This observation is aggravated by problems of medical demography and therefore the availability of neurologists, cardiologists and general practitioners.

Local and foreign experiments have demonstrated the value of intensive, coordinated and multi-professional stroke and MI monitoring, including nurses, in terms of: better control of risk factors and reduction of the rate of re-hospitalization by recurrence in stroke follow-up; improvement of the patient's general condition, control of risk factors, reduction in the number of events, decrease in the number of re-hospitalizations and their duration in MI follow-up. The value of pharmacists' additional intervention in intensive post-MI follow-up compared to routine follow-up has also been demonstrated, particularly in terms of significant improvement in patient compliance.

The hypothesis is that 2 years of intensive follow-up for both post-stroke or post-MI patients, by trained hospital and liberal nurses, in conjunction with doctors and pharmacists, is of medico-economic interest compared to usual follow-up. Therefore a medico-economic evaluation was designed to evaluate the efficiency of this model, which combines community-based and recourse care, prevention and coordination of care compared to usual follow-up.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: A Randomized Phase III Study Comparing Maintenance Treatment With Fluoropyrimidine + Bevacizumab Versus Fluoropyrimidine After Induction Chemotherapy for a Metastatic Colorectal Cancer

acronym: BEVAMAINT

summary: The aim of BEVAMAINT is to improve benefic effect of maintenance therapy after a first line of induction chemotherapy for patients with colorectal cancer

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

intervention_type: Drug


type: Other Identifier

title: Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic - PRO-SERO-COV

acronym: PRO-SERO-COV

summary: The question of the immune response of the population, particularly of professional populations in contact with vulnerable populations (such as those with chronic conditions such as cancer), is an important issue. Knowing the evolution of this response over time in this population can help answer outstanding questions. The PRO-SERO-COV study is a seroprevalence study of caregivers working in the hospital sector with a follow-up at 3 months and 12 months. The objective is to evaluate and monitor at 3 and 12 months the serological immune status to an infection by the SARS-CoV-2 virus in active volunteer professionals working at the Institut Bergonié with different types of exposure: healthcare professionals and professionals in other services.

status: Active, not recruiting

primary_purpose: Prevention

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Institut Bergonié

lead_sponsor_type: industriel


title: Longitudinal Analysis of Right Ventricular Remodeling in Response to Prolonged Strength Training Using 3D-echocardiography

acronym: FORCE-VD

summary: Right ventricular (RV) physiological remodeling in response to prolonged strength exercise remains poorly studied. This prospective, non-randomized, single-center study, proposes to follow 24 healthy sedentary volunteers who will benefit from a high-intensity pure resistance training program over a 6-month period. The volunteers, aged between 18 and 40 years old and male, will be recruited and evaluated at the University Hospital center of Caen Normandy. Cardiac remodeling in response to physical exercise will be analyzed by trans-thoracic echocardiography repeated during the follow-up. The physical impact of the training program will be assessed by a treadmill exercise test predicting maximal oxygen consumption (VO2max) before and after completing the training, and an isokinetic muscular test repeated every 3 months. Participants rest/activity cycles will be monitor before and after 3 months of training. The aim of the study is to demonstrate the existence of a physiologic RV remodeling in response to pure high-load resistance chronic exercise. The results will help to improve the understanding of the physiological RV response expected in strength athletes.

status: Unknown status

primary_purpose: Basic Science

lead_sponsor: University Hospital, Caen

status_simplified: Unknown


title: Comparative Long-term Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy and Moderated Pseudophakic Bullous Keratopathy

acronym: DEMOGRAFT

summary: Purpose of the research is to describe and compare the evolution of BSCVA after DMEK, DSAEK and UT-DSAEK for Fuchs Endothelial Corneal Dystrophy (FECD) and Moderate Pseudophakic Bullous Keratopathy (PBK). To secondarily research the correlates criterions with best spectacle corrected visual acuity (BSCVA) 12 months postoperatively.

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

status_simplified: Completed


title: Effectiveness of the Pressure Recording Analytical Method in Predicting the Fluid Responsiveness in Pediatric Surgical Critical Care Patients

acronym: MOSTCARE-PED

summary:
The Pressure Recording Analytical Method, invasive hemodynamic monitoring, is an uncalibrated pulse contour analysis, installed in the Mostcare® system that allows a continuous estimation of the stroke volume and thus the cardiac output, by the relationship between the area under the curve of the systolic portion of the arterial blood pressure curve and the dynamic impedance of the cardiovascular system.

The objectives of the study are to determine if the parameters measured by Mostcare® make it possible to predict the response to volume expansion in pediatric surgical critical care patients, sedated, intubated and ventilated, by comparing the changes in stroke volume, induced by a volume expansion, measured by trans-thoracic echocardiography.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Deformation of the Diaphragm Zone of Apposition During the Loading of the Respiratory System in the Healthy Volunteer. Evaluation of a New Index Measured by Speckle Tracking

acronym: ZADSPECTRA

summary:
The assessment of the work of the respiratory muscles is a fundamental clinical data in intensive care, especially to guide the management of patients requiring ventilatory support. This data is difficult to access in current practice. The reference technique to estimate the work of breathing (transdiaphragmatic pressure) is not feasible in clinical routine and evaluates only the respiratory work of the diaphragm, not that of the accessory muscles. The ultrasound technique of speckle tracking allows a fine and multidimensional analysis of the deformation of the respiratory muscles during the respiratory cycle.

The investigators hypothesize that the analysis of the multidimensional deformation of the diaphragm at the level of the apposition zone can produce a robust and reproducible index, which is correlated with the work of breathing. The performance of this index will be compared to that of the thickening fraction of the diaphragm. On the other hand, the investigators will evaluate the feasibility of measuring the thickening of the accessory respiratory muscles (scalene and intercostal).

time_perspective: Other

lead_sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon


title: Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD) of the Feta Lung in Congenital Diaphragmatic and Parietal Malformations

acronym: BOLD FETUS

summary:
The objective is to evaluate the quality of the response to the Blood Oxygen Level Dependent effect in fetuses with diaphragmatic hernias and abdominal wall malformations and to correlate with postnatal respiratory outcome. Pulmonary involvement is a constant in diaphragmatic hernias, it is classic in omphaloceles and especially hepatomphaloceles, and exceptional in laparoschisis. As this is an original exploratory study, no preliminary data are available.

If a correlation is found, the Blood Oxygen Level Dependent effect of the fetal lung may be considered as an early functional marker of postnatal lung function. It can be used in addition to lung-to-head-ratio during prenatal counseling.

The final goal is to be able to detect early in the fetus pulmonary insufficiency to help prenatal counseling and perinatal care.

primary_purpose: Diagnostic

intervention_type: Diagnostic Test


title: Role of Butyrophilins in Colon Cancers Aggressiveness Evaluation

summary: quantification of BTNL molecules in colon cancer in order to determinate if their could be used as a prognostic marquer

design_allocation: Non-Randomized

lead_sponsor: Institut Paoli-Calmettes

intervention_type: Biological


title: Retrospective Clinical Study to Evaluate of Cranio-vertebral Abnormalities Through Radiological Analysis in Patients With Achondroplasia Treated/Followed at the Hôpital Femme Mère Enfant

acronym: Achondroplasia

summary: Achondroplasia is a genetic disorder characterized by disproportionate short stature. It affects about 1 in 2500 live births in the world. The cause of Achondroplasia was identified to be a gain-of-function mutations in the fibroblast growth receptor 3 (FGFR3). In these children compression of the spinal cord at the foramen magnum stenosis can occur in early childhood which, can lead to central sleep apnea. It can lead to morbidity and mortality. A surgical intervention may be indicated in patients who present a foramen magnum stenosis. However, surgical indications are still under discussion. The objective of this retrospective study is to analyse the degree of stenosis and its clinical tolerance/evolution from radiological data monitored at the Hospital Femme Mère Enfant.

lead_sponsor: Hospices Civils de Lyon


title: An Observational, Clinical Study to Collect the Medical Data in Order to Determine the Craniofacial Characteristics Through Phenotypic Analysis on Children With Sensenbrenner Treated/Followed at the Hôpital Femme Mère Enfant From 2005

acronym: Sensenbrenner

summary: Sensenbrenner syndrome, also known as cranioectodermal dysplasia (CED), is a rare autosomal-recessive disorder belonging to the ciliopathy group of diseases. It is characterized by a facial dysmorphism, abnormal bone development and ectodermal defects including dental anomalies. CED is a heterogeneous condition with significant phenotypic and molecular variability, whose spectrum may include cases of renal impairment, hepatic fibrosis, retinitis pigmentosa and/or brain anomalies. In many cases, patients develop chronic kidney disease (CKD) due to nephronophthisis between 2 and 6 years of age. The aim of this retrospective study is to better understand the characteristics of this syndrome and to find prognostic factors of CKD. We make the hypothesis that an early diagnosis of the syndrome would lead to a better global management of patients (quality of life, delayed onset of end-stage renal disease).


lead_sponsor: Centre Hospitalier Universitaire de Nīmes

acronym: CAPEMCHAR

type: EudraCT Number

type: Registry Identifier

source: euctr

title: Evaluation of the Safety, Tolerability, Distribution and Dose Effect of Neoadjuvant Transarterial Chemoembolization With Doxorubicin in Prostate Cancer Patients at a High Risk of Recurrence Before Radical Prostatectomy: A Phase IIa Study

summary:
Our hypothesis is that the doxorubicin eluting-beads currently used in hepato-oncology might be applicable to high-grade prostate cancer before radical prostatectomy.

The primary objective of this Phase IIa pilot study is to evaluate the safety of performing prostate embolization with doxorubicin eluting-beads according to different loading doses. Four dose levels will be tested: doxorubicin-free beads to test the effect of embolization alone, 2.5 mg of doxorubicin (1/20 of the dose administered for liver cancers), 5 mg and 10 mg of doxorubicin.

The secondary objectives of the study are to evaluate the tolerance (functionnal questionaries at D0, D14 M1 and M3; collection of complications at D1, D5, D14, M1, M3; MRI at D14), evaluate the systemic diffusion of doxorubicin (doxorubinemia at D1), evaluate an early anti-tumor effect of the treatment (via a prostate-specific antigen test at D14 M1, M3 and magnetic resonance imaging at D14), describe the distribution of beads observed on the surgical specimen and evaluate the dose effect at 1 month and 3 months after surgery (via a prostate-specific antigen test at D14, M1, M3 and magnetic resonance imaging at D14).


title: Contributions and Limitations of the Stress Test on the Prediction of Cardiovascular Events in a High-risk Firefighter Population

acronym: FIRE-PREV

summary: If the risk of myocardial infarction in activity is widely demonstrated to date for firefighters, and the realization of a stress test in those at high cardiovascular risk included in the practice habits, no study has evaluated the contributions and limits of the realization of a stress test in this specific population of firefighters at high cardiovascular risk for the prediction of cardiovascular events.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Clinical and Economic Evaluation of Outpatient Bariatric Surgery

acronym: Bariatric Ambu

summary: This study first presents the organizational path and the health interventions included in the care episode for outpatient bariatric surgery, as compared to the health interventions usually performed in the care episode for bariatric surgery (including a conventional hospitalization with at least one-night inpatient). Then, the study aims to estimate and to compare the costs of bariatric surgery inpatient care episode to the costs of outpatient care episode, and also to evaluate the postoperative medical consequences.

primary_purpose: Health Services Research

ReferenceType: background

ReferenceCitation: Cobourn C, Mumford D, Chapman MA, Wells L. Laparoscopic gastric banding is safe in outpatient surgical centers. Obes Surg. 2010 Apr;20(4):415-22. doi: 10.1007/s11695-009-0065-7.

ReferenceCitation: McCarty TM, Arnold DT, Lamont JP, Fisher TL, Kuhn JA. Optimizing outcomes in bariatric surgery: outpatient laparoscopic gastric bypass. Ann Surg. 2005 Oct;242(4):494-8; discussion 498-501.

ReferenceCitation: Ignat M, Vix M, Imad I, D'Urso A, Perretta S, Marescaux J, Mutter D. Randomized trial of Roux-en-Y gastric bypass versus sleeve gastrectomy in achieving excess weight loss. Br J Surg. 2017 Feb;104(3):248-256. doi: 10.1002/bjs.10400. Epub 2016 Nov 30.

name: Department of Digestive and Endocrine Surgery, Research Institute Against Digestive Cancer (IRCAD), Institute of Image-Guided Surgery (IHU), University Hospital of Strasbourg, Strasbourg, France

family: Ignat

full_name: M Ignat

given: M

sequence: first

family: Vix

full_name: M Vix

sequence: additional

family: Imad

full_name: I Imad

given: I

family: D'Urso

full_name: A D'Urso

given: A

family: Perretta

full_name: S Perretta

given: S

family: Marescaux

full_name: J Marescaux

given: J

family: Mutter

full_name: D Mutter

given: D

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: British Journal of Surgery

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: IHU Strasbourg

location_facility: University Hospital of Strasbourg, Department of Digestive and Endocrine Surgery


title: Plasma Levels of Danger-Associated Molecular Patterns (DAMPs) in Young Children After Cardiac Surgery Under Cardiopulmonary Bypass (IMMUNOPED 2)

summary: The investigators have previously reported that cardiac surgery with CPB ( cardiopulmonary bypass) in young infants induced a drastic reduction in mHLA-DR ( Human Leucocyte Antigen) expression, which represents one of innate immune mediator. Danger-Associated Molecular Patterns (DAMPs) can elicit immune response and may subsequentely induce an immune-suppressed state. The investigators hypothesize that CPB causes excessive DAMP release, leading to the development of immune suppression. Thus, DAMPs release will be assessed in patients undergoing CBP, and consequences on immune suppression will be evaluated.

lead_sponsor: Nantes University Hospital


title: Pilot Study Evaluating the Impact of the Intervention of a Pharmacist in the Operating Room on the Appropriate Use of Sterile Medical Devices and the Economic Repercussions

acronym: OPTIBLOC

summary: assess the impact of the intervention of a clinical pharmacist expert in sterile medical devices


title: Foci of Tumor Heterogeneity in IDH1-mutated Diffuse Low-Grade Gliomas Reveal STAT3 Activation and Downregulation of the Phosphoethanolamine Enzyme ETNPPL Acting as a Negative Regulator of Glioma Growth

acronym: FDLGG

summary:
Background:

Diffuse low-grade gliomas (DLGG) are slow-growing primary-cancer of the brain and spinal cord. They represent up to 15% of the developing tumors in those organs with fatal outcome for the patients because of their evolution. The reasons for this transformation towards more malignant tumors still remain ill defined. Previously, the research team in neuro oncology at Montpellier University Hospital found foci of tumor heterogeneity within 20 to 30 % of the patients developing a DLGG and published their results. The investigators assumed that those foci represent the early beginning of the transformation from a diffuse low-grade glioma to a glioblastoma, tumor with highly malignant cells and a life expectancy of two years in average for the patient.

Methods:

The investigators selected adult patients with no prior surgery nor neuro oncology treatment when enrolled. They presented a specific mutation for an enzyme of the metabolism named IDH1, standing for Isocitrate Dehydrogenase 1, found in 70% of DLGG. Patients were also selected because they presented foci of tumor heterogeneity. After obtaining their consent, the investigators studied by immunohistochemistry the pathways deregulated between the DLGG and the foci. The investigators also extracted RNAs, molecules expressing the life and metabolism of tumor cells, and compared them to know what genes were differentially expressed between the DLGG and the foci. All RNAs were tested for quality control prior to be processed further. The investigators then studied 8 patients with compliance with ethics, authorizations and institutional guidelines. Genes of interest were studied in vitro to assess their functions. The investigators found a barely described enzyme of the catabolism of the phosphoethanolamines and discovered a new anti-proliferative tumor-role for it.

•Discussion: The investigators first showed that foci have a higher percentage of p-STAT3+ cells which indicates STAT3 pathway activation in these cells. Phosphorylated STAT3 translocates to the cell nucleus to regulate many genes involved in proliferation, apoptosis and angiogenesis. As such, phosphorylation of STAT proteins, notably STAT3, is involved in the pathogenesis of many cancers, including GBM, by promoting cell cycle progression, stimulating angiogenesis, and impairing tumor immune surveillance.

The investigators found that ETNPPL RNA and protein are reduced in foci cells and absent in glioblastomas. This is consistent with glioma database analyses showing that ETNPLL expression is inversely correlated to STAT3 and MKI67 whose expression are higher in foci and glioblastomas. In addition, Kaplan-Meier analysis shows that patients with low expression of ETNPPL have lower overall survival These observations suggested that this enzyme may oppose glioma cells proliferation. The investigators demonstrated this hypothesis by overexpressing ETNPPL in 3 glioblastoma cell cultures. Two were sensitive to ETNPPL overexpression which reduced their growth while no effect was detected in Gli4 cells. These glioblastoma-derived cultures have different types of mutations.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Cross-cultural Adaptation and Validation of the French Version of the EXIT (EXperiences of Induction Tool) Self-questionnaire Assessing Women's Feelings About the Onset of Childbirth

acronym: EXIT

summary: The objective of the study is to cross-culturally adapt and validate the French version of the EXIT scale: an assessment tool on induction of labor.

lead_sponsor: University Hospital, Clermont-Ferrand


title: New Tools for Predicting Capillary Leak Shock During Dengue Fever

acronym: PrediDengue

summary: Evaluate the prognostic value of different methods (Osmometry / clinical-biological score) compared to the occurrence of capillary leak shock during dengue fever.

ReferenceCitation: Djossou F, Vesin G, Elenga N, Demar M, Epelboin L, Walter G, Abboud P, Le-Guen T, Rousset D, Moreau B, Mahamat A, Malvy D, Nacher M. A predictive score for hypotension in patients with confirmed dengue fever in Cayenne Hospital, French Guiana. Trans R Soc Trop Med Hyg. 2016 Dec 1;110(12):705-713. doi: 10.1093/trstmh/trx004.

lead_sponsor: Centre Hospitalier de Cayenne


title: Evolution of Body Connection and Identity Post-surgery: The Pancreas Cancer Case

summary: Evaluation of psychological impact of patients after pancreatectomy because of cancer diagnosis. Patients will be evaluated with questionnaires after and before intervention. 3 control groups will be used to compare de psychological impact.

intervention_type: Behavioral


title: Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia

summary:
Severe Acute Respiratory Syndrome (SARS) SARS-CoV-2, name of the Coronavirus Group of international Committee on taxonomy of viruses, is an emerging virus from the family of coronaviridae, responsible for the COVID-19 pandemic. This infection can progress to viral pneumonia, and in 3% of cases up to acute respiratory distress syndrome (ARDS) which conditions the prognosis of the disease.

Due to its unusual clinical presentation with a risk of sudden deterioration on the 8th day as a result of possible hyperinflammatory response, the respiratory impairment of COVID is unique and many questions remain unanswered concerning its evolution once the acute phase has passed. Knowledge of the evolution of pulmonary involvement, particularly in patients requiring hospitalization, can help reduce the morbidity linked to the persistent abnormalities identified by establishing early therapeutic management. It can also provide a better understanding of the mechanisms of pulmonary involvement in the acute phase. Current data regarding the acute phase of COVID-19 suggest that persistent abnormalities remain distant from this infection at all levels of the respiratory system: gas exchange, perfusion, ventilatory mechanics, and interstitial lung disease.

The main objective is to characterize persistent gas exchange anomalies 4 months after documented COVID-19 pneumonia, resulting in oxygen desaturation and requiring hospitalization.

lead_sponsor: University Hospital, Toulouse


title: COVID 19 Serology in Pulmonologists : Pneumo Sero Cov

acronym: Pneumoserocov

summary: Respiratory physicians are highly exposed workers to Covid-19 as they perform spirometry, endoscopy, and manage Covid-19 in first line for most of them. Moreover, none reported to have apply increased levels of protection for performing these acts in the most active period of viral circulation, until the lockdown. Whether they were most frequently immunized against SARS-CoV-2 at the end of the first wave than the general population is of utmost importance individually but also worldwide

time_perspective: Cross-Sectional


title: A 12-month Real Life Study of IBD Patients Under Stable Steroid Free Clinical and Biological Remission Switched From Adalimumab Originator Humira® to One of Its Biosimilar: Amgevita®,Hulio®,Hyrimoz® or Imraldi®.

acronym: Rhoneswitch

summary:
Biosimilars represent great potential in cost saving and reinvestment opportunities in healthcare. Biosimilars of adalimumab appear to be clinically equivalent to the reference product in patients with rheumatoid arthritis and psoriasis. No data are currently available in IBD patients. Real-life data are needed.

Minimizing the switch back is another clinical challenge in the current area of biosimilars. The primary objective of Rhoneswitch is to describe the magnitude of patient's switch back defined as a deterioration of symptoms without objective identification of disease activity, 12 months after the switch from ada originator Humira®.

The primary endpoint is to assess the percentage of patients who switch back to originator therapy Humira® 12 months after switching from ada Humira® to ada Bs: Amgevita® ,Hulio®, Hyrimoz® or Imraldi® in IBD patients without any objective markers of inflammation.

lead_sponsor: University Hospital, Grenoble


title: Retrospective Observational Study of Posterior Keratometry Measured by IOLMaster 700 in Patients With Keratoconus

summary:
Keratoconus is a progressive bilateral disease leading to an apical stromal thinning and an irregular astigmatism by a steepening of the cornea, causing visual impairment. The causes are not yet well known, but it seems to be linked to several comorbidities. Keratoconus is a rare and for a long-time asymptomatic condition and its diagnosis needs meticulous screening for the early stages. Detecting it as soon as possible is a goal as it could lead to earlier avoiding of contributing factors such as eye rubbing and earlier treatment if needed.

The gold standard for keratoconus screening and staging is computerized videotography. It gives information about anterior and posterior corneal bulging, steepening, and thinning. It can be completed by anterior segment optical coherence tomography, which can show corneal scarring. Since recently, some biometry devices can give some information about the posterior corneal keratometry trough swept source optical coherence tomography measures. The measurement of the total corneal power instead of an extrapolation lead to better precision in refractive results after cataract surgery in some cases. It also helped to increase our knowledge about posterior corneal astigmatism. In normal eyes, average posterior corneal astigmatism is 0.37 diopters and against the rule in 91 percent of eyes. There is a correlation between the magnitude of anterior and posterior astigmatism.

In keratoconus eyes, several studies have shown that there is an alignment between axes of the anterior and posterior corneal astigmatism. These studies have been performed on computerized videotopography devices.

The goal of this study was to confirm or deny previous observations about posterior astigmatism in keratoconus eyes, and to assess if the rotation of axis between anterior and posterior astigmatism measured by IOL Master 700® can be a good sign for detection of early stages and fruste keratoconus.


title: Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia : Prenatal Cephal

summary:
Congenital retrognathia, with or without Pierre Robin Sequence (PRS), is a rare anomaly which can be associated with chromosomal abnormalities. Respiratory and feeding consequences can be present at birth. After birth, the diagnosis of retrognathia is based on the clinical examination. Cephalometry can be used to complete the diagnosis. Several authors have proposed the use of objective quantitative ultrasound parameters for the antenatal screening of PRS. In our study, the investigators evaluated fetal cephalometry.

The aim First, the investigators studied the inter- and intra-observer reproducibility of cephalometry. Second, the investigators established reference values for antenatal cephalometry in normal fetuses. Third, the investigators compared the diagnostic performance of cephalometry and the other angles described in the literature for the diagnosis of retrognathia.


title: COLETTE : Study of the Pathophysiology of Status Epilepticus and Dysimmune Encephalitis and Identification of Valuable Biomarkers

acronym: COLETTE

summary: COLETTE is an interventional study for which blood, cerebrospinal fluid and post-mortem tissues are collected in patients with status epilepticus or epilepsy associated to dysimmune encephalitis as well as in control patients, to better understand the pathophysiology of these severe epileptic disorders.


title: Evaluation of the Effectiveness of the TOVERTAFEL System on Behavioral Disorders of People With Cognitive Disorders Hospitalized in Long-Term Care Units and in Reinforced Hosting Unit

acronym: TOVERTAFEL

summary:
The prevalence of behavioral disorders is high in patients living in an institutional environment or hospitalized in a long-term care unit. The consequences of these symptoms are not negligible with a faster cognitive decline and a significant impact on the life of the institution and of other patients when the disorders are pervasive and too difficult to manage for the healthcare teams.

Despite the daily attention paid to these disorders and their causes, especially the environmental ones, the teams are sometimes helpless, the teams are sometimes helpless today to fight against these symptoms, and their management thus constitutes a real challenge.

Non-drug interventions targeting this problem often require additional training, architectural installations (Snoezelen space) and / or are moderately effective. In order to offer a solution that can be used by everyone, that is transportable and based on new technologies, the TOVERTAFEL device was created.

These are interactive games projected onto a table using a ceiling projector. The light animations invite people to "play with the light" using arm or hand movements. These games stimulate residents' physical activity and encourage interactions between residents and with caregivers.

In this study, it is a question of evaluating the effectiveness of the TOVERTAFEL device on the frequent behavioral symptoms in dementia (agitation, ambulation, apathy, anxiety), the quality of life of the patients, as well as on psychotropic treatments.

primary_purpose: Supportive Care


title: Drug Hypersensitivity Reactions To Cephalosporins

acronym: CephALL

summary:
Background :

Although the hypersensitivity reactions to cephalosporins have been recently a more focused subject, studies on the cephalosporin as an allergen are significantly less frequent that those regarding penicillins. Most of the available data regards cephalosporin sensitization in patients previously allergic to penicillin. Like penicillins, cephalosporins represent one of the most prescribed classes of antibiotics. The diagnosis of cephalosporin hypersensitivity is based mainly on clinical history, skin tests (ST) and drug provocation tests (DPT). This succession of tests, performed in specialized services, allows to eliminate responsibility for the drug in many cases (80-85%). The drug allergy work-up also allows to identify profiles of allergy to cephalosporins, with different patterns of cross-reactivity.

Objective: To analyse the characteristics of patients studied in our Unit for suspicion of cephalosporin hypersensitivity.

Methods: This retrospective study will comprise all the patients who attended the allergy service of the UH of Montpellier from 1997 till 2018 with a clinical history evocative of cephalosporin drug hypersensitivity reaction (DHR), who underwent a drug allergy work up and who gave their consent to be included in the study . The Patients are selected from the Drug Allergy & Hypersensitivity Database (DAHD).


title: COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction

acronym: COLD-MI

summary: This study evaluates the benefit of colchicine on induced denervation after myocardial infarction. Patients who have suffered a documented De Novo myocardial infarction and completed a revascularization procedure will receive either colchicine on top of standard therapy, compared to standard therapy alone (1:1 allocation ratio). Colchicine 1mg (or 0.5mg) will be initiated within 48h after percutaneous revascularization and prescribed for one month.


title: Epidemiology of Injuries in Elite Badminton Players: a Prospective Study

acronym: BADINSEP

summary:
Objective: To determine the incidence and characteristics of injuries in elite badminton players over a competitive season.

Design: 12-months prospective cohort study Setting: The French National Institute of Sport, Expertise, and Performance (INSEP).

Participants: Twenty international elite badminton players Independent variables: The type, the location, the occurrence of the injury (match or training), the footwork type, the type of shot and the perceived fatigue were collected.

Main Outcome Measures: Injury incidence rates were calculated per 1000 hours of play (Hop).


title: Impact of Verticalization on Intracranial Hemodynamics Assessed by Continuous Transcranial Doppler Monitoring at the Acute Phase of Ischemic Stroke

acronym: STAND

summary:
Ischemic strokes account for more than 80% of strokes. Ischemic strokes are caused by the occlusion of an intracranial artery by a thrombus, responsible for tissue ischemia related to a decrease in local cerebral blood flow (CBS). Thus, the management of patients with Ischemic strokes is based on the preservation of an area that maintains sufficient intracranial hemodynamics (IH) and achieves the fastest possible recanalization. The impact of the patient's position (supine or seated position) on the IH in the event of narrowing or occlusion of an artery is poorly assessed but may be of particular importance. In practice, variations in blood flow according to the positioning of the patient's body can be measured using a transcranial Doppler. It is a simple, non-invasive and painless examination that provides the patient's bed with data on the intracerebral hemodynamic profile of patients.

This study was implemented because there are no studies known to us that evaluate the effect of verticalization on intracerebral hemodynamics based on the presence of upstream arterial stenosis or occlusion and other multimodal evaluation data in transcranial Doppler.

status: Terminated

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital: a Retrospective and Observational Study.

acronym: Perfogreffe

summary:
Liver transplantation enhances the prognosis of patients with cirrhoses or hepatocellular carcinoma. However some patients develop intestinal perforations for which the prognosis is poor.

The aim of the study is to evaluate the risk factors of intestinal perforations using a retrospective study scheme.

intervention_type: Procedure


title: Pharmacokinetics and Pharmacodynamics of rivAroxaban After Bariatric Surgery and in mORBid Obesity

acronym: ABSORB

summary:
Data on pharmacokinetics of rivaroxaban after bariatric surgery and in morbid obesity are sparse. The aim of this study is to assess the pharmacokinetic and pharmacodynamic parameters of rivaroxaban, used at a therapeutic anticoagulant dose, in patients with previous bariatric surgery, with sleeve gastrectomy or gastric bypass, and in morbid obese subjects.

Four groups of 16 subjects per group are studied: Morbid obese subjects / Subjects who have undergone gastric bypass surgery / Subjects who have undergone sleeve gastrectomy surgery / Non-operated control subjects matched for age and BMI with operated subjects.

All patients (obese, surgical patients, and controls) will receive rivaroxaban 20mg once daily during 8 days. Blood samples will be taken predose (Baseline) and 0.5, 1, 2, 3, 6, 9, 12 and 24h post rivaroxaban administration at day1 and day8. PK and PD parameters will be compared between groups in order to explore the impact of bariatric surgery, type of surgery and body mass index on the pharmacological profile of rivaroxaban.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Monitoring of Regional Lung Ventilation by Chest Electrical Impedance in the Course of Extubation

summary: The Electrical Impedance Tomography (EIT) is a non-invasive exam. This exam performed on the lung continuously produces cross-sectional images of lung function. It may be relevant in lung description.

primary_purpose: Other

lead_sponsor: BioSerenity

intervention_type: Device


title: A Phase 1 Dose-escalation Study Testing the Feasibility and the Tolerance of Infusion of a Specific Third Party Suicide Gene-transduced Anti-HLA-DPB1*0401 CD4+ T Cell Clone in HLA-DPB1*04:01 Positive Tumor Recipients Receiving an Allotransplant From a HLA-DPB1*04:01 Negative Donor.

acronym: CTL-DP 01

summary:
For several decades, allogeneic hematopoietic stem cell trans-plantation (allo-HSCT) has remained an important strategy in the management of patients with high-risk hematological malignancies. The acceptance of umbilical cord blood (UCBT) and haploidentical grafts (Haplo) as viable alternative donors for allo-HSCT has increased the options for patients with no matched donors and now ensures that a donor can be identified for virtually all patients. Relapsed disease is a principal threat to these patients and affects 30-50% of them. The therapeutic options for these relapsing patients are diverse but remain largely ineffective in altering their long-term outcomes. Therefore, pre-emptive treatment post allo-HSCT is considered.

MHC (major histocompatibility complex) class II molecules are a family of molecules normally found only on hematopoietic cells. cell-surface proteins are responsible for the regulation of the immune system in humans and are important in disease defense.

They are the major cause of organ transplant rejections. Different HLA-DPB1 alleles exist in the general population. HLA-DPB1*04:01 is the most frequent (70.5%) while HLA-DPB1*02:01 represents 32% and HLA-DPB1*03:01 20%. In allo-HSCT, the donor and the recipient may express different HLA-DPB1 molecules. HLA-DPB1 matching status has an impact on GVL (graft versus leukemia) and GVHD. In recipients of HSCT, a match for DPB1 is associated with a significantly increased risk of disease relapse, irrespective of the matching status of other HLA molecules.. Therefore, one could anticipate that a mismatched of HLA class II could induce a selective GVL reactivity without GVHD.

HLA-DP-expressing B cell and myeloid malignancies can be recognized and lysed by HLA-DP-specific T cells. The majority of leukemic cells (Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Chronic Lymphoid Leukemia) express HLA-DP. A T cell clone recognizing specifically HLA-DPB1*0401 has been developed as a permanent cell line This clone has been demonstrated to be able to kill HLA-DPB1*0401 positive leukemic cells. In addition, this clone harbors a special suicide gene allowing the destruction of the clone in presence of a specific anti-viral drug named ganciclovir.

We hypothesize that infusion of a third party suicide gene-transduced T cell clone directed against HLA-DPB1*401 might protect against possible relapse of hematological malignancies.

We propose to inject iv escalating dose of a third party clone recognizing HLA-DPB1*04:01, 4 to 5 months following transplantation (when immunosuppressive drugs have been discontinued) in patients HLA-DPB1*04:01 positive with a donor HLA-DPB1*04:01 negative to evaluate the feasibility, toxicity, benefits of this immune intervention.

intervention_type: Combination Product


title: Multimodal Modeling of the Knee Joint

acronym: KneeMod

summary: The trial will contribute to the development of an innovative algorithm that aims to simplify and improve preoperative knee surgical decision. This will be made by automatically extracting anatomical informations from different images acquired on the patient (scanner, MRI, radiography).


title: Effectiveness of Pain Neuroscience Education Compared to a Conventional Education for Patients With Chronic Low Back Pain : A Randomized Monocentric Trial.

acronym: EVAL-PNE

summary: The hypothesis is that pain biology education, combined with a rehabilitation program, reduces disability to 3 months, compared to conventional spinal physiology education.

lead_sponsor: University Hospital, Lille


title: Optimizing PD Patient's Health Pathways: Favoring Global, Patient Centered Care by a New Communication Aid Tool PARKINSUN

acronym: PARKINSUN

summary: PARKINSUN is a new communication aid tool, expected to favor global patient centered care for PD patients during consultation with GPs and neurologists. Two groups of patients will be randomized to use or not PARKINSUN when they consult their physicians every 3 months during 7 months.


title: Gallium68 Ventilation/Perfusion PET/CT for Pulmonary Embolism Diagnosis: a Diagnostic Accuracy Study vs CT Pulmonary Angiography

acronym: PETEP

summary: This study evaluates the diagnostic accuracy (sensitivity, specificity) of V/Q PET/CT for the diagnosis of pulmonary embolism (PE), using CT pulmonary angiography as a reference standard.


title: Identification of Reversible Cerebral Vasoconstriction Syndrome's Precipitating Factors. Triggers And Risk Factors to Develop a Reversible Cerebral Vasoconstriction Syndrome

acronym: TARDIS

summary:
This study will be the first to evaluate the role played by potential precipitating factors and risk factors in Reversible Cerebral Vasoconstriction Syndrome (RCVS) through of prospective selection of carefully characterised patients and controls. The impact of these factors on the prognosis will be evaluated through a follow-up assessment of patients.

Our study will include the formation of a clinicoradiological database and a biobank (plasma, cerebro-spinal fluid, DNA) which will be the tools of a future large multicentre study on RCVS.


title: Molecular and Organizational Changes in the Human Oral Mucosa During Aging

acronym: MMOBUCC

summary: The objective of this interventional with mucosa et saliva samples, monocentric, transversal and pilot study is to extract vibrational, thermal and dielectric markers obtained by Differential Scanning Calorimetry, Thermo-Stimulated Currents and Fourier Transform Infrared spectroscopy on oral mucosa and saliva samples collected from 66 patients divided in two groups (20-40 and 70-90 years old).


acronym: LIDA-ADJ

title: Hepatocellular Carcinoma Under 3 cm Treated by Percutaneous Tumor Destruction: Multicentric Phase 2 Test Evaluating the Impact of Adjuvant Chemotherapy by Intra-arterial Infusion of Idarubicin-lipiodol on the Hepatic Recurrence

summary: The aim of this study is to test whether the realization of 3 courses of intra-arterial chemotherapy of idarubicin-lipiodol without embolization, administered non-selectively in the hepatic artery, following the percutaneous tumour ablation of a hepatocellular carcinoma, could constitute an effective adjuvant treatment to reduce the rates of local and intrahepatic distant recurrence and thus improve the survival without hepatic progression.


title: Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma

acronym: SCLEROLF

summary:
Prospective monocentric study of patients with systemic sclerosis disease.

The primary outcome is to define the prevalence of olfactory disorders (hyposmia and anosmia) in systemic sclerosis disease.

The secondary outcomes are:

To assess the correlation of olfaction disorders with clinical and biological and factors related to systemic sclerosis patients.
To estimate the frequency of sinonasal disorders in patients with systemic sclerosis disease

ReferenceCitation: Amital H, Agmon-Levin N, Shoenfeld N, Arnson Y, Amital D, Langevitz P, Balbir Gurman A, Shoenfeld Y. Olfactory impairment in patients with the fibromyalgia syndrome and systemic sclerosis. Immunol Res. 2014 Dec;60(2-3):201-7. doi: 10.1007/s12026-014-8573-5.

ReferenceType: result

ReferenceCitation: Bombini MF, Peres FA, Lapa AT, Sinicato NA, Quental BR, Pincelli ÁSM, Amaral TN, Gomes CC, Del Rio AP, Marques-Neto JF, Costallat LTL, Fernandes PT, Cendes F, Rittner L, Appenzeller S. Olfactory function in systemic lupus erythematosus and systemic sclerosis. A longitudinal study and review of the literature. Autoimmun Rev. 2018 Apr;17(4):405-412. doi: 10.1016/j.autrev.2018.02.002. Epub 2018 Feb 11. Review.

family: Bombini

full_name: Mariana Freschi Bombini

given: Mariana Freschi

family: Peres

full_name: Fernando Augusto Peres

given: Fernando Augusto

family: Lapa

full_name: Aline Tamires Lapa

given: Aline Tamires

family: Sinicato

full_name: Nailú Angélica Sinicato

given: Nailú Angélica

family: Quental

full_name: Beatriz Ricato Quental

given: Beatriz Ricato

family: Pincelli

full_name: Ágatha de Souza Melo Pincelli

given: Ágatha de Souza Melo

family: Amaral

full_name: Tiago Nardi Amaral

given: Tiago Nardi

family: Gomes

full_name: Caroline Cristina Gomes

given: Caroline Cristina

family: del Rio

full_name: Ana Paula del Rio

given: Ana Paula

family: Marques-Neto

full_name: João Francisco Marques-Neto

given: João Francisco

family: Costallat

full_name: Lilian T.L. Costallat

given: Lilian T.L.

family: Fernandes

full_name: Paula Teixeira Fernandes

given: Paula Teixeira

family: Cendes

full_name: Fernando Cendes

given: Fernando

family: Rittner

full_name: Leticia Rittner

given: Leticia

family: Appenzeller

full_name: Simone Appenzeller

given: Simone

journal_name: Autoimmunity Reviews

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier


title: Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock

acronym: AMINO BESTDOSE

summary: Amikacin dose optimization is challenging in critically ill patients. The use of BestDose software algorithm-based drug optimization could help to achieve the recommended target concentrations (60-80 mg/L) after administration of the second dose of amikacin, associated with improved outcome. The study investigators hypothesize that 80% of patients undergoing drug dosing optimization using the BestDose software in the interventional group will reach the predefined PK/PD targets.


title: Impact of Routine Assessment of Health-Related Quality of Life Coupled With Therapeutic Information on Compliance With Endocrine Therapy in Patients With Non-metastatic Breast Cancer

acronym: COMPLIANCE

summary: Only 59% of women with breast cancer (BC) treated with Endocrine Therapy (ET) remain compliant one year upon initial prescription, despite its proven effectiveness in reducing recurrence and improving survival. Health-related quality of life (HRQoL) in BC has been widely studied and the positive effects of its routine evaluation on the improvement of communication between patients and medical staff and survival have been highlighted. Recently, a link between HRQoL and compliance with ET has been suggested, which would suggest a potential role for HRQoL assessment in improving compliance with ET. With the advent of digital technologies, electronic collection of HRQoL on a tablet is now possible. Since compliance is a multidimensional phenomenon, a multifaceted intervention is necessary to improve it. Thus, the investigators hypothesize that systematic HRQoL assessment (using a tablet, prior to each consultation, with delivery of scores to clinicians) coupled with therapeutic information could have an impact on 12-month compliance with ET in patients with non-metastatic BC.

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ReferenceCitation: Rascle N, Bruchon-Schweitzer M, Sarason IG. Short form of Sarason's Social Support Questionnaire: French adaptation and validation. Psychol Rep. 2005 Aug;97(1):195-202.

ReferenceCitation: Bruchon-Schweitzer M. Psychologie de la santé. Modèles, concepts et méthodes. 1er éd. Paris : Dunod. 2002A.

ReferenceCitation: Velikova G, Keding A, Harley C, Cocks K, Booth L, Smith AB, Wright P, Selby PJ, Brown JM. Patients report improvements in continuity of care when quality of life assessments are used routinely in oncology practice: secondary outcomes of a randomised controlled trial. Eur J Cancer. 2010 Sep;46(13):2381-8. doi: 10.1016/j.ejca.2010.04.030. Epub 2010 Jun 1.

ReferenceType: derived

ReferenceCitation: Mamguem Kamga A, Di Martino C, Anota A, Paget-Bailly S, Coutant C, Arveux P, Desmoulins I, Dabakuyo-Yonli TS. Impact of routine assessment of health-related quality of life coupled with therapeutic information on compliance with endocrine therapy in patients with non-metastatic breast cancer: protocol for a randomized controlled trial. Trials. 2020 Jun 16;21(1):527. doi: 10.1186/s13063-020-04397-w.

family: Mamguem Kamga

full_name: Ariane Mamguem Kamga

given: Ariane

family: Di Martino

full_name: Cyril Di Martino

given: Cyril

family: Anota

full_name: Amelie Anota

given: Amelie

family: Paget-Bailly

full_name: Sophie Paget-Bailly

given: Sophie

family: Coutant

full_name: Charles Coutant

given: Charles

family: Arveux

full_name: Patrick Arveux

given: Patrick

family: Desmoulins

full_name: Isabelle Desmoulins

given: Isabelle

family: Dabakuyo-Yonli

full_name: Tienhan Sandrine Dabakuyo-Yonli

given: Tienhan Sandrine

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)


title: Diagnosis and Management of Enhanced Myometrial Vascularity Associated With Retained Products of Conception: a Retrospectif Moncentric Study

acronym: EMV RPOC AVM

summary:
Background:

Hypervascularized products of conception remain a topic debated in terms of definitions (ultrasound criteria, need complement by angio MRI) and management. The different uterine vascular lesions are often confused. This is a recurrent problem and care are heterogeneous. The aim of the study is to evaluate the management of these entities in CHU of Montpellier and determine more homogeneous care. The investigators further aimed to evaluate clinical presentation, ultrasound criteria, complications and the gynaecological and obstetrical outcomes of patients •Methods: This study will be conducted in compliance of ethic comitee. The investigators will collect data from 64 individuals, aged 18 to 50, suffering from uterine vascular lesions associated or not with products of conception between 2013 and 2019. Caracterisitics of the population, ultrasound and angio MRI data will be collected. Management wll be described as expectative, surgery or embolization of uterine arteries and the success or not will be noted. The investigators will question patients on their gynaecologic and obstetrical outcomes by telephone.

•Discussion: The investigators aim to define and characterize the different lesions, establish ultrasound criteria that would guide treatments. Describe the current treatments and compare them in terms of efficiency and safety in order to establish a homogeneous treatment protocol in our center


title: Feasibility and Clinical Impact Study of Non Pharmacological Interventions Targeting the Subject's Empowerment Among Slackline, Mindfulness, Adapted Physical Activity, Self-hypnosis, Qi Gong Versus Usual Care in Management of Chronic Pain

acronym: ELISAD

summary: This feasability study aims to compare the 6-month success rate of a systematic proposal for non pharmacological interventions targeting the subject's empowerment among slackline, mindfulness, adapted physical activity, self-hypnosis, and Qi Gong versus usual care in the management of chronic pain.

ReferenceCitation: Shipton EA, Shipton EE, Shipton AJ. A Review of the Opioid Epidemic: What Do We Do About It? Pain Ther. 2018 Jun;7(1):23-36. doi: 10.1007/s40122-018-0096-7. Epub 2018 Apr 6. Review.

ReferenceCitation: Skelly AC, Chou R, Dettori JR, Turner JA, Friedly JL, Rundell SD, Fu R, Brodt ED, Wasson N, Winter C, Ferguson AJR. Noninvasive Nonpharmacological Treatment for Chronic Pain: A Systematic Review [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK519953/

ReferenceCitation: Devan H, Hale L, Hempel D, Saipe B, Perry MA. What Works and Does Not Work in a Self-Management Intervention for People With Chronic Pain? Qualitative Systematic Review and Meta-Synthesis. Phys Ther. 2018 May 1;98(5):381-397. doi: 10.1093/ptj/pzy029.

ReferenceCitation: Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, Hertz S, Raja SN, Rappaport BA, Rauschkolb C, Sampaio C. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009 Dec;146(3):238-244. doi: 10.1016/j.pain.2009.08.019. Review.

ReferenceCitation: Olsen MF, Bjerre E, Hansen MD, Tendal B, Hilden J, Hróbjartsson A. Minimum clinically important differences in chronic pain vary considerably by baseline pain and methodological factors: systematic review of empirical studies. J Clin Epidemiol. 2018 Sep;101:87-106.e2. doi: 10.1016/j.jclinepi.2018.05.007. Epub 2018 May 21. Review.


title: Effects of Tofacitinib on Body Composition, Bone Mineral Density and Bone Marrow Adiposity in Patients With Rheumatoid Arthritis: the TOFAT Project

acronym: TOFAT

summary:
Inflammatory rheumatic diseases (IRD), such as rheumatoid arthritis, are characterized by adverse changes in body composition. Lean mass and bone mineral density are usually reduced while adiposity (total fat mass, visceral adiposity…) is increased in comparison with healthy controls. Many factors may influence the body composition of those patients such as aging, Disease Modifying Anti-Rheumatic Drugs (DMARDs), nutrition and physical activity.

However, data on body composition and adverse changes under DMARDs in patients with rheumatoid arthritis (RA) are actually scarce. This is the case with tofacitinib (targeted synthetic DMARD or tsDMARD) while preliminary data let us think that this treatment may influence body composition and bone mineral density.

This study is going to be the first to focus on changes in body composition (fat mass and lean mass), bone mineral density and bone marrow adiposity under tofacitinib.

ReferenceCitation: Dodington DW, Desai HR, Woo M. JAK/STAT - Emerging Players in Metabolism. Trends Endocrinol Metab. 2018 Jan;29(1):55-65. doi: 10.1016/j.tem.2017.11.001. Epub 2017 Nov 27. Review.

ReferenceCitation: Fleischmann RM, Huizinga TW, Kavanaugh AF, Wilkinson B, Kwok K, DeMasi R, van Vollenhoven RF. Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis. RMD Open. 2016 Jul 26;2(2):e000262. doi: 10.1136/rmdopen-2016-000262. eCollection 2016.

ReferenceCitation: Tatsumi Y, Nakao YM, Masuda I, Higashiyama A, Takegami M, Nishimura K, Watanabe M, Ohkubo T, Okamura T, Miyamoto Y. Risk for metabolic diseases in normal weight individuals with visceral fat accumulation: a cross-sectional study in Japan. BMJ Open. 2017 Jan 16;7(1):e013831. doi: 10.1136/bmjopen-2016-013831.

ReferenceCitation: Book C, Karlsson MK, Akesson K, Jacobsson LT. Early rheumatoid arthritis and body composition. Rheumatology (Oxford). 2009 Sep;48(9):1128-32. doi: 10.1093/rheumatology/kep165. Epub 2009 Jul 13.

family: Book

full_name: C. Book

given: C.

family: Karlsson

full_name: M. K. Karlsson

given: M. K.

family: Akesson

full_name: K. Akesson

given: K.

family: Jacobsson

full_name: L. T. H. Jacobsson

given: L. T. H.

journal_name: Rheumatology

oa_host_type: publisher

evidence: open (via free pdf)

license_normalized: no license

ReferenceCitation: Haugeberg G, Uhlig T, Falch JA, Halse JI, Kvien TK. Bone mineral density and frequency of osteoporosis in female patients with rheumatoid arthritis: results from 394 patients in the Oslo County Rheumatoid Arthritis register. Arthritis Rheum. 2000 Mar;43(3):522-30.

ReferenceCitation: Toussirot É, Mourot L, Dehecq B, Wendling D, Grandclément É, Dumoulin G; CBT-506. TNFα blockade for inflammatory rheumatic diseases is associated with a significant gain in android fat mass and has varying effects on adipokines: a 2-year prospective study. Eur J Nutr. 2014 Apr;53(3):951-61. doi: 10.1007/s00394-013-0599-2. Epub 2013 Oct 31.

family: Toussirot

full_name: Éric Toussirot

given: Éric

family: Mourot

full_name: Laurent Mourot

given: Laurent

family: Dehecq

full_name: Barbara Dehecq

given: Barbara

family: Wendling

full_name: Daniel Wendling

given: Daniel

family: Grandclément

full_name: Émilie Grandclément

given: Émilie

family: Dumoulin

full_name: Gilles Dumoulin

given: Gilles

bso_classification: Biology (fond.)

journal_name: European Journal of Nutrition

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Marouen S, Barnetche T, Combe B, Morel J, Daïen CI. TNF inhibitors increase fat mass in inflammatory rheumatic disease: a systematic review with meta-analysis. Clin Exp Rheumatol. 2017 Mar-Apr;35(2):337-343. Epub 2016 Dec 13. Review.

ReferenceCitation: Engvall IL, Tengstrand B, Brismar K, Hafström I. Infliximab therapy increases body fat mass in early rheumatoid arthritis independently of changes in disease activity and levels of leptin and adiponectin: a randomised study over 21 months. Arthritis Res Ther. 2010;12(5):R197. doi: 10.1186/ar3169. Epub 2010 Oct 21.

family: Engvall

full_name: Inga-Lill Engvall

given: Inga-Lill

family: Tengstrand

full_name: Birgitta Tengstrand

given: Birgitta

family: Brismar

full_name: Kerstin Brismar

given: Kerstin

family: Hafström

full_name: Ingiäld Hafström

given: Ingiäld

ReferenceCitation: Tournadre A, Pereira B, Dutheil F, Giraud C, Courteix D, Sapin V, Frayssac T, Mathieu S, Malochet-Guinamand S, Soubrier M. Changes in body composition and metabolic profile during interleukin 6 inhibition in rheumatoid arthritis. J Cachexia Sarcopenia Muscle. 2017 Aug;8(4):639-646. doi: 10.1002/jcsm.12189. Epub 2017 Mar 18.

name: Rheumatology Department; CHU Clermont-Ferrand; 58 rue Montalembert, BP 69 63003 Clermont-Ferrand CEDEX France

name: UNH-UMR 1019, INRA; University Clermont Auvergne; 58 rue Montalembert, BP 321 63009 Clermont-Ferrand CEDEX France

name: Biostatistics Unit (DRCI); CHU Clermont-Ferrand; 58 rue Montalembert, BP 69 63003 Clermont-Ferrand CEDEX France

name: Department of Preventive and Occupational Medicine; CHU Clermont-Ferrand; 58 rue Montalembert, BP 69 63003 Clermont-Ferrand CEDEX France

name: Laboratory of Metabolic Adaptations to Exercise in Physiological and Pathological Conditions EA3533; University Clermont Auvergne, CNRS LaPSCo, Physiological and Psychosocial Stress; 24 Avenue des Landais 63171 Aubière France

name: Faculty of Health; Australian Catholic University; Melbourne Victoria Australia

name: Biochemistry and Molecular Biology Department; CHU Clermont-Ferrand; 58 rue Montalembert, BP 69 63003 Clermont-Ferrand CEDEX France

name: University Clermont Auvergne; EA7281, 28 Place Henri-Dunant 63001 Clermont-Ferrand France

journal_name: Journal of Cachexia, Sarcopenia and Muscle

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

repository_institution: Australian Catholic University - Research Bank

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

repositories:
HAL
PubMed Central
researchbank.acu.edu.au


title: Middle Ear Implant: Assessment of Satisfaction in the Medium Term

acronym: IOM

summary:
Currently, the data from the literature do not evaluate the use of the middle ear implant in implanted patients in the medium term (10 years and over) but only in the short term (1-5 years).

Based on the observation of the absence of these data, we considered it necessary to evaluate in the medium term the satisfaction of the patients carrying a middle ear implant and their rate of abandonment with a horizon of 10 to 20 years of apparatus.


title: Tracking Information Flow in the Brain: A Unified and General Framework for Dynamic Communication in Brain Networks

acronym: BRAINDYN

summary: The brain is composed of a set of areas specialized in specific computations whose outputs need to be transferred to other specialized areas for cognition to emerge. To account for context-dependent behaviors, the information must be flexibly routed through the fixed anatomy of the brain. The aim of this project is to test a general framework for this flexible communication between brain areas based on nested oscillations. The general idea is that internally-driven slow oscillations (<20Hertz) either set-up or prevent the communication between brain areas. Stimulus-driven gamma oscillations (>30Hertz), nested in the slow oscillations, can then be directed to task-relevant areas of the network. This multimodal, multi-scale approach uses magnetoencephalography using a 3-Dimensional (3D) printed individual head-cast system and transcranial stimulation in experiments manipulating visual processing, attention and memory to test core predictions of this framework. The theoretical approach and the methodological development used in this basic science study will provide the basis for future fundamental and clinical research.

location_facility: Centre de Recherche en Neuroscience de Lyon INSERM


title: CHOICE OF SUBJECTIVE OCULAR REFRACTION TECHNIQUE AND CORNEAL TOPOGRAPHY OF KERATOCONUS

acronym: RE-CON

summary:
Keratoconus is a rare evolving corneal ectasia that alters visual acuity. To improve spectacle-corrected visual acuity, various subjective refraction techniques can be used.

The subjective refraction techniques of keratoconus-carrying patients have never been studied.

The main hypothesis is that the most suitable subjective ocular refraction method varies with the corneal topography of the keratoconus.

The main objective is to define the most appropriate refractive technique(s) based on corneal topographies in order to provide keratoconus-affected patients with the best spectacle-corrected visual acuity.

ReferenceCitation: Metzger M, Navel V, Barrière JV, Kwiatkowski F, Hébraud J, Mulliez A, Béral L, Chiambaretta F, Dutheil F. Benefits of using corneal topography to choose subjective refraction technique in keratoconus (RE-CON): a prospective comparative crossover clinical study. Graefes Arch Clin Exp Ophthalmol. 2021 Aug 20. doi: 10.1007/s00417-021-05382-y. [Epub ahead of print]

family: Metzger

full_name: Margaux Metzger

given: Margaux

family: Navel

full_name: Valentin Navel

given: Valentin

family: Barrière

full_name: Jean-Vincent Barrière

given: Jean-Vincent

family: Kwiatkowski

full_name: Fabrice Kwiatkowski

given: Fabrice

family: Hébraud

full_name: Jérémy Hébraud

given: Jérémy

family: Mulliez

full_name: Aurélien Mulliez

given: Aurélien

family: Béral

full_name: Laurence Béral

given: Laurence

family: Chiambaretta

full_name: Frédéric Chiambaretta

given: Frédéric

family: Dutheil

full_name: Frédéric Dutheil

journal_name: Graefe's Archive for Clinical and Experimental Ophthalmology

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature


title: Concordance Between Body Temperature Measured Per Enteric Capsule and Auricular Temperature in Neutropenic Patients Hospitalized in Intensive Hematology Care Units

acronym: TEMPET

summary:
Connected medicine "2.0" is a major challenge that will lead in the near future to profound changes in medical practices. Our study is part of this technological transformation, which is already taking the form of multiple devices available to practitioners: connected pill dispensers, integrated monitoring and surveillance systems (telemedicine), connected sensors, etc.

However, a symptom as crucial and simple as body temperature has not been measured by real-time enteric capsule in a context of neutropenia. We therefore wish to study the concordance between the peripheral (tympanic) temperature and that measured by a capsule ingested in a cohort of patients hospitalized in the USIH. If the measurements are clinically reliable and truly allow anticipation of antimicrobial treatments, a medico-economic evaluation will be proposed between the two options in the context of USIH before its possible generalization.

lead_sponsor: Centre Henri Becquerel


title: Study of the Effectiveness of a Guided Compensatory Cognitive Remediation Program for Family Caregivers in Schizophrenia: a Randomized Pilot Study

acronym: CIRCUS

summary:
Cognitive impairments are extremely common in schizophrenia and strongly predict deficit in daily functioning, the poor managing medication and multiple hospitalizations. Cognitive remediation is recognized to have an impact on cognitive impairments by engaging preserved cognitive functions or by implementing environmental supports that sustain independent living.

Pr. Velligan (University of San Antonio) developed and tested a manualized intervention, called Cognitive Adaptation Training. In this program, trained mental health specialists implement compensatory technique such as environmental supports in the individual's living environment to live more independently and achieve greater self-sufficiency.

However, implementing this program needs a lot of professionals and time to maintain CAT effects. This type of intervention is not often done in community care and explains the large number of patients who are dependent on family members for daily living activities. Training family members in this form of intervention would be an appropriate way to resolve these issues. Families expressed a real interest in these types of home-support strategies that CAT offers. Recently, Pr. Kidd and Pr. Velligan developed a CAT version for families and created a manual accessible to people without any knowledge of cognitive deficit. This manual helps families to select specific cognitive-adaptative strategies with their relative to achieve targeted goals. Thism ethod has been translated in French.

The aim of this study was to examine whether Web-based family Cognitive Adaptation Training can improve functioning, medication adherence and negative symptoms for individuals with schizophrenia and reduce burden for family members.

A total of 60 Dyads consisting of one caregiver and one supported individual with schizophrenia will be randomized to either a Web-based family Cognitive Adaptation Training or an Internet-based control condition. Primary outcome measured will be the score on the life skills profile. Secondary outcomes will include the global score of the Zarit burden Interview, PANSS negative score, and medication adherence.

This type of intervention is expected to be developed in territorial area where professionals are not trained to cognitive remediation and therefore substantially lowers the barrier to the deployment of cognitive intervention with other psychosocial interventions for individual with schizophrenia and their caregivers.

location_facility: Service Universitaire de psychiatrie adulte


title: Systematic Screening and Identification of Psychoactive Substances Users in Young Adults (16 to 25 Years Old) Visiting the Emergency Department

acronym: DRUGS

summary:
Adolescence is a time for great physical and psychological change and it's often at that period of life that first use of psychoactive substances occurs. Although addiction is rare in teenagers, psychoactive substances abuse can have serious long-term health consequences on them. This is therefore a priority for all healthcare providers to identify early use and abuse of drugs in the youth's population.

The addictive process underlies environmental, genetic and individual causes. That is why it is somehow possible to identify individuals at risk based on some common sociological, cultural and environmental risk factors.

Due to the acute consequences of psychoactive substances abuses, Emergency Departments are main checkpoints for the screening of young drug users. Indeed, one patient out of five admitted in an Emergency Department shows a positive blood alcohol concentration regardless of the reason for their admission. This rate is twice as high as in the overall population. Hence, Emergency Departments are at the front-line for screening, caring, referral and transfer of psychoactive substances users. That is why the Emergency Department is the best place for this study.

In 2004, the special consultations of young consumers were founded in order to deal with these special cases where dependence is not yet established or installed and care has to be adapted to the age. Offering help to this age range represents a real challenge since only 20% of the teenagers come to visit this special consultations on their own initiative. The rest of teenagers are either obliged by their parents or sentenced by a court. The investigators assume that the repetition of care offered to the teenagers by repeated emergency admissions could trigger their own desire to overcome their drug use disorders and visit the Addictionology Department.


title: Is Short Antibiotherapy Duration After Drainage Suitable for Patients Admitted in Intensive Care Medicine With a Severe Acute Cholangitis?

acronym: CASCAD

summary:
Acute cholangitis (AC) occurs when biliary stenosis, due to various benign causes (often gallstones) or the presence of a tumour, leads to cholestasis and biliary infection. AC is a life-threatening infection if not diagnosed and treated in time, its mortality ranges from 1.4% to 5.2%. AC can be classified into different stages of severity depending on organ failure. A severity classification has been proposed by the Asian recommendations of Tokyo 2013: Grade I (Benin), Grade II (Moderate) and Grade III (Severe).

AC treatment includes endoscopic or percutaneous bile drainage in combination with systemic antibiotic treatment. It is currently recommended that patients with severe CA (Grade III) have biliary drainage within 24 hours, although it has not been shown to improve their survival. The emergence of antibiotic-resistant germs, which is a public health issue, calls for reasonable and considered use of antibiotics. Reducing the duration of antibiotic therapy is a fundamental measure of antimicrobial management and antibiotics sparing. 7 to 10 days of antibiotic treatment is common in the treatment of CA. A 14-day treatment is recommended in case of associated bacteremia. A recent study of 263 patients showed that reducing the duration of antibiotic therapy to less than 7 days in patients with CA associated with bacteremia with effective drainage does not increase the risk of recurrence or mortality at 30 days. However, this study was monocentric retrospective and compared groups that were unbalanced in terms of CA severity. The optimal duration of antibiotic therapy in the treatment of CA in critically ill patients hospitalized in intensive care remains poorly known.

The main purpose of this study is to compare short antibiotic therapy with long antibiotic therapy in terms of mortality in patients with AC admitted in intensive care unit (ICU).


title: Diagnostic Value of Antibodies Against Carbamylated Proteins in Psoriatic Arthritis.

acronym: CARPAPA

summary: Anti-carbamylated protein (anti-CarP) antibodies are present in approximately one-fourth of the patients who are seronegative for both rheumatoid factor and anti-citrullinated protein antibody and who may therefore have psoriatic arthritis. The investigators hypothesized that detection of anti-CarP antibodies in serum may be useful for diagnosis of psoriatic arthritis.

lead_sponsor: Association pour la Recherche Clinique et Immunologique


title: Feasibility Study of a Diary for Allogenic Hematopoietic Stem Cell Transplantation Patients and Families

acronym: JACintHE

summary: Allogenic hematopoietic stem cell transplantation is a specific time during hematological disease management for the patients, theirs relatives and the healthcare team. This heavy treatment is most of the time the last possible curative therapy and could cause many side effects such as infectious diseases and graft versus host reaction. The protective isolation is also a source of physical and psychological isolation. Published studies reported depressive syndrome, anxiety symptoms and post-traumatic stress disorders for patients and their families. Since 10 years ago, diaries are used in intensive care unit to limit these symptoms after a coma. In analogy, the diary for the patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long terms consequences. The investigators want to evaluate the psychological impact of a diary on the patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Endoarterial Treatment in Combination With Percutaneous Thermoablation for Medium-sized and Oligonodular Hepatocellular Carcinomas

summary:
Background: The association of transcatheter arterial chemotherapy infusion (TAC) with percutaneous ablation (PT) has been introduced as a method to increase the ablative zone. The aim of this study was to evaluate the efficacy of PT and TAC performed in a single session for HCCs between 30 and 50 mm or oligonodular up to 30 mm.

Methods: Thirty patients with a histologically proven HCC, uninodular between 30 and 50 mm or oligonodular (n≤3) up to 30 mm, treatment-naïve and non-metastatic, received combination treatment ("PT+TAC group"). A "control" group consisted of 34 patients with uninodular HCC up to 30 mm without any poor prognostic criteria treated with PT alone ("PT group").

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation of Electric Wheelchair Driving Performance in Simulator Compared to Driving in a Real-life Situation, in a Population of Regular Drivers With Neurological Disorders

summary:
The device that is the subject of this investigation is a solution for driving simulation of an electric wheelchair. It is intended to enable patients who are likely to acquire an electric wheelchair to train in a virtual environment, favorable to the safety of training, to its repetition, and to produce more varied, rich training environments and more tailored to specific and individualized needs. These solutions will make it easier to access real-world driving for patients who are currently experiencing learning difficulties.

It is expected that this investigation demonstrates the reproducibility of driving performance in electric wheelchair driving simulator compared to the real world.

lead_sponsor: Pôle Saint Hélier


title: Open-label, Phase 1, Single-dose Study to Evaluate the Pharmacokinetics of Elafibranor 120 mg in Healthy Elderly and Young Adults Volunteers

summary: In the elderly, pharmacokinetics is altered. Gastric juice pH is elevated which influences drug solubility and absorption. Drug distribution is decreased in the elderly because of decreased cardiac output, increased peripheral vascular resistance, diminished blood flow in the liver and the kidneys, reduced total amount of water in the body. Drug metabolism and biotransformation mainly take place in the liver and is often reduced. Drug elimination is altered very often because of reduced excretory (renal and hepatic) function. All these changes may lead to significant pharmacokinetic changes in geriatric population. A formal pharmacokinetic clinical study is being conducted in order to assess the need of dose adjustment in the elderly population.

lead_sponsor: Genfit


title: Transcutaneous Diaphragm Electrical StimuLAtion in Critically Ill Patients to Prevent Diaphragm Dysfunction

acronym: TESLA

summary: This study evaluates the effect of a transcutaneous electrical stimulation in critically ill patients compared to a sham electrical stimulation to decrease the incidence of diaphragm dysfunction before mechanical ventilation weaning.

lead_sponsor: Groupe Hospitalier du Havre


title: Development of a Global Scale Assessing Impairment in Cerebral Small Vessel Diseases

acronym: SMACS

summary:
In daily practice, several scales are used to evaluate patients with small vessel diseases of the brain (SVD). However, these scales exclude key symptoms such as apathy and mood disorders observed in SVD. Furthermore, the use of a combination of scales does not allow neither a very sensitive assessment of clinical changes, neither an overall assessment of a patient's outcome.

Moreover, there is no scale dedicated to cognitive, emotional and behavioural complaints in patients with SVD. These patients are evaluated with scales used in neurodegenerative diseases such as Alzheimer's disease and frontotemporal dementia. These are scales that have been developed in the elderly and they are not sensitive to minor complaints. It is needful to develop scales adapted to patients with SVD in order to understand the consequences of the disease symptoms on their daily life at inclusion and during follow-up.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: AngioCHIC : Interest of sFlt1/PlGF Ratio at Obstetric Emergencies

acronym: AngioCHIC

summary: In patients with suspected placental vascular disease who do not require hospitalization, the use of the sFlt-1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor)/ assay can most likely help teams to define the best possible management.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Retrospective Study of Causes Associated With Small Fiber Neuropathies.

acronym: EtioNPF

summary:
Small fiber neuropathy (SFN) is an injury of cutaneous nerve fibers, mainly by a decrease in their density within the cutaneous tissue. The symptomatology associated with this SFN is broad with symptoms that are essentially sensory, but also autonomic. The etiologies of SFN are numerous (diabetes, drug, infectious, immunological...) and clinically non-specific, justifying a broad etiological assessment. The appearance of staged skin biopsies in the SFN balance sheet has greatly helped to improve diagnosis.

Despite this, a significant part of SFN remains without associated etiology and is considered idiopathic.

As the distribution of the different causes of SFN remains a missing data to date, the completion of this cohort study by one of the SFN reference centres should make it possible to establish the prevalence of SFN causes over a large population.

Only patients with clinical symptoms that may be related to SFN and who have been sampled for SFN, positive or not, will be eligible for recruitment.

The result of the anatomopathological sampling will allow patients to be separated into two groups, with or without SFN.

The main judgement criteria will be the prevalence of etiologies associated with SFN: diabetes, medication, systemic lupus erythematosus, Gougerot-Sjögren syndrome, amylosis, dysthyroidism, alcoholism, vitamin B12 deficiency, HIV infection, hepatitis C, paraneoplastic syndrome, hereditary disease (Fabry disease, Friedreich ataxia,...), idiopathic, others.


title: A Cross-sectional Survey to Evaluate Prescribers' Knowledge and Understanding of Safety Messages Following Dengvaxia® Product Information Update

summary:
The primary objective of the study is to evaluate the effectiveness of additional risk minimization measures material by assessing the knowledge and understanding of healthcare professionals regarding the key safety messages provided in the material.

The secondary objective of the study is to evaluate if healthcare professionals know Dengvaxia product information, namely, age indication and contraindications.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi Pasteur, a Sanofi Company