title: Diagnostic Performance of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Pre-operative Lymph Node Assessment in Intermediate and High-risk Non-metastasic Prostate Cancer.

acronym: PREOP-PSMA

summary:
In France, prostate cancer is the most common cancer in men over 50 years of age (nearly 50,000 new cases per year) and is the second most common cause of cancer death in men (approximately 9,000 deaths per year). Although mortality has been declining since the end of the 1990s (about 7%/year), about 30 to 35% of them will have a biological recurrence.

Accurate assessment of local, regional and distant spread of the disease is therefore needed to design optimal personalised care for each patient, either curative or palliative.

Currently, in France, recommended disease assessment includes bone scintigraphy and Abdomino-Pelvic Magnetic Resonance Imaging. However, conventional imaging has limited performance with regard to lymph node extension.

Node dissection is the best way to assess node status. Currently, no imaging exam allows this level of accuracy.

Recently, molecular imaging has emerged as a promising tool to improve the initial extensional assessment of prostate cancer. Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein, specific to the prostate, which is over-expressed on the surface of prostate cancer cells.

Recent studies of PSMA PET/CT as part of the initial extension assessment of prostate cancer report superior diagnostic performance in terms of sensitivity and specificity compared to conventional tests, as well as an impact of PSMA PET/CT on patient management.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Etat BUCCO-dentaire de Patients Atteints de SCHIZophrénie et de Troubles Schizo-affectif Suivis au Centre Hospitalier de Charles Perrens

acronym: BUCCOSCHIZ

summary: The aim of the study is to describe the oral health status of patients suffering from schizophrenia and schizoaffective disorders in a psychiatric institute in France.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Denis F. [The oral health of patients in psychiatric institutions and related comorbidities]. Soins Psychiatr. 2014 Jan-Feb;(290):40-4. French.

ReferenceCitation: Curien R. & al; Evaluation de l'influence des psychotropes sur la santé bucco-dentaire chez une population de patients hospitalisés en secteur psychiatrique. Information Dentaire. 88 : (2006): 439-441

ReferenceCitation: Bertaud-Gounot V, Kovess-Masfety V, Perrus C, Trohel G, Richard F. Oral health status and treatment needs among psychiatric inpatients in Rennes, France: a cross-sectional study. BMC Psychiatry. 2013 Sep 21;13:227. doi: 10.1186/1471-244X-13-227.

ReferenceCitation: Catteau C, Blaizot A, Duhamel A, Delzenne A, Devillers A, Frimat P. [Dental status and related factors in an occupational health service in Northern France]. Sante Publique. 2013 Nov-Dec;25(6):747-55. French.

lead_sponsor: Centre Hospitalier Charles Perrens, Bordeaux

lead_sponsor_type: academique

status_simplified: Completed


title: Long-term Interventional Follow-up Study up to 4 Years of Age of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial and Comparison With an Untreated Cohort of Children With Prader-Willi Syndrome

summary:
This study is a prospective, multicentre, interventional cohort study in children with PWS over 4 years (no treatment administered). The duration of the preceding OTTB3 study is 26 weeks. An untreated cohort of children with PWS will be included at an age of 2 years and followed up until an age of 4 years.

Regarding the untreated cohort, children with PWS born in France and too old to be recruited in OTBB3 trial, principally those who were born within one year before the start of OTBB3 trial, will be offered to participate in this study. Infants born later who couldn't be included in OTBB3 study will be also offered to participate.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Other

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: University Hospital, Toulouse

location_facility: Centre de réfrence Prader-Willi, Hospital of infants

intervention_type: Other

status_simplified: Ongoing


title: Multicentric Evaluation of Rapid Diagnosis Tests for the Diagnosis of Imported Malaria.

acronym: TDR-PALU

summary: The annual number of cases of clinical malaria worldwide is estimated to be 300-500 million leading to 1.5 million deaths. Delayed care and frequent drug resistance of Plasmodium falciparum (Pf), the most frequent form of malaria, is responsible for these deaths. Each year, 5000-8000 travellers return to France with malaria, 4/5 from Africa and with Pf. Clinical features associated with a malaria crisis are poorly predictive and misdiagnosis can be easily made. Diagnosis of accurate malaria rely on microscopic examination of stained thin and thick blood films by a well trained microscopist. Few emergency wards are specialized for tropical diseases. For most of them, malaria is a rare disease and hours are lost before accurate microscopy can permit the decision

ReferenceType: result

ReferenceCitation: Musset L, Bouchaud O, Matheron S, Massias L, Le Bras J. Clinical atovaquone-proguanil resistance of Plasmodium falciparum associated with cytochrome b codon 268 mutations. Microbes Infect. 2006 Sep;8(11):2599-604. Epub 2006 Aug 10.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Device


title: Objective Assessment for Caregivers With Work-related Musculoskeletal Disorders of the Shoulder

acronym: AWMSD

summary: Work-related musculoskeletal disorders (WMSD) are a major public health problem both in France and internationally. Our clinical research project focuses on WMSD of the shoulder (WMSD-S), which account for 32% and 23% of these disorders in France and Europe, respectively. In order to prevent WMSD-S, the assessment and rehabilitation of workers' physical and functional capacities (PFC) (e.g. joint amplitude) may complement current interventions (e.g. ergonomics) in a novel manner. As a result, the objectives of this project would be to conduct a cohort study assessing the PFC of caregivers with WMSD-S compared to those of healthy subjects and a randomised, controlled, single-blind, multicentre clinical study assessing the relevance of a rehabilitation program for caregivers with WMSD-S working in a hospital setting. This project would foster the promotion of evidence-based physiotherapy and lead to the development of a interdisciplinary research team dedicated to rehabilitation.

ReferenceCitation: DGAFP. Guide pratique-Démarche de prévention des troubles musculo-squelettiques.2015; 1-65.

ReferenceCitation: DIRECCTE de Normandie. Plan santé au travail 2016-2020 Normandie. oct 2017.

ReferenceCitation: INRS. Troubles musculosquelettiques (TMS). INRS; 2015.

ReferenceCitation: Schneider et al. OSH in figures: Work-related musculoskeletal disorders in the EU. 2010.

ReferenceCitation: ARS Haute-Normandie. Prévenir durablement les Troubles Musculo-Squelettiques. 2013

ReferenceCitation: Akkas O, Lee CH, Hu YH, Harris Adamson C, Rempel D, Radwin RG. Measuring exertion time, duty cycle and hand activity level for industrial tasks using computer vision. Ergonomics. 2017 Dec;60(12):1730-1738. doi: 10.1080/00140139.2017.1346208. Epub 2017 Jul 6.

ReferenceCitation: Ghasemi MS, Hosseinzadeh P, Zamani F, Ahmadpoor H, Dehghan N. Ergonomic design and evaluation of a diagnostic ultrasound transducer holder. Int J Occup Saf Ergon. 2017 Dec;23(4):519-523. doi: 10.1080/10803548.2016.1216763. Epub 2016 Sep 7.

ReferenceCitation: Padula RS, Comper MLC, Sparer EH, Dennerlein JT. Job rotation designed to prevent musculoskeletal disorders and control risk in manufacturing industries: A systematic review. Appl Ergon. 2017 Jan;58:386-397. doi: 10.1016/j.apergo.2016.07.018. Epub 2016 Aug 9. Review.

ReferenceCitation: Pransky G, Robertson MM, Moon SD. Stress and work-related upper extremity disorders: implications for prevention and management. Am J Ind Med. 2002 May;41(5):443-55. Review.

ReferenceCitation: Gutenbrunner C, Meyer T, Melvin J, Stucki G. Towards a conceptual description of Physical and Rehabilitation Medicine. J Rehabil Med. 2011 Sep;43(9):760-4. doi: 10.2340/16501977-0866.

ReferenceCitation: van den Noort JC, Wiertsema SH, Hekman KMC, Schönhuth CP, Dekker J, Harlaar J. Reliability and precision of 3D wireless measurement of scapular kinematics. Med Biol Eng Comput. 2014 Nov;52(11):921-931. doi: 10.1007/s11517-014-1186-2. Epub 2014 Sep 6.

ReferenceCitation: Krause DA, Neuger MD, Lambert KA, Johnson AE, DeVinny HA, Hollman JH. Effects of examiner strength on reliability of hip-strength testing using a handheld dynamometer. J Sport Rehabil. 2014 Feb;23(1):56-64. doi: 10.1123/jsr.2012-0070. Epub 2013 Nov 14.

ReferenceCitation: De Baets L, van der Straaten R, Matheve T, Timmermans A. Shoulder assessment according to the international classification of functioning by means of inertial sensor technologies: A systematic review. Gait Posture. 2017 Sep;57:278-294. doi: 10.1016/j.gaitpost.2017.06.025. Epub 2017 Jun 27. Review.

ReferenceCitation: Seitz AL, Uhl TL. Reliability and minimal detectable change in scapulothoracic neuromuscular activity. J Electromyogr Kinesiol. 2012 Dec;22(6):968-74. doi: 10.1016/j.jelekin.2012.05.003. Epub 2012 Jun 8.

ReferenceCitation: Sivan M, O'Connor RJ, Makower S, Levesley M, Bhakta B. Systematic review of outcome measures used in the evaluation of robot-assisted upper limb exercise in stroke. J Rehabil Med. 2011 Feb;43(3):181-9. doi: 10.2340/16501977-0674. Review.

ReferenceCitation: Hefford C, Abbott JH, Arnold R, Baxter GD. The patient-specific functional scale: validity, reliability, and responsiveness in patients with upper extremity musculoskeletal problems. J Orthop Sports Phys Ther. 2012 Feb;42(2):56-65. doi: 10.2519/jospt.2012.3953. Epub 2012 Feb 1.

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.

ipd_sharing: No

ipd_sharing_description: The data collected will be anonymized, computerized and stored by Maxime GILLIAUX. Only the investigators (Mr GILLIAUX and Mrs Julie VAN NIEUWENHOVE) will have access to the anonymized data in order to carry out the statistical work of this research.

lead_sponsor: Hopital La Musse


title: Evaluation and Description of Mutual Influences Between Patient Training, Perception and Adoption of Home-Monitoring Technology

summary: Describe the mutual influences between trainings realized in implantation centers, medico-technical knowledges, technical implementation, perception, fears and appreciation felt by the patients during Home Monitoring implementation.

lead_sponsor: Biotronik France

lead_sponsor_type: industriel


type: Other Identifier

title: Evaluation of Fertility of Patients With a History of Postpartum Hemorrhage, Complicating Low-dose Delivery With Intrauterine Tamponade Treatment

acronym: FERTIBTIU

summary:
Today, few data are available on the patient's fertility following intrauterine tamponade balloon (BTIU) used for postpartum hemorrhage (PPH) after vaginal delivery (AVB). Several studies have concluded that there are no fertility disorders after conservative surgical treatment or embolization. BTIU is an essential treatment in the management of PPH. The aim was to evaluate post-BTIU fertility and the appearance of gynecological symptoms.

This is a bicentric retrospective study (Valenciennes, Lille, France), between 2012 and 2017. The data will be collected by telephone interview on fertility and various gynecological functional symptoms.

time_perspective: Retrospective

lead_sponsor: University Hospital, Lille


title: Emergency Management in a Dedicated Respiratory Unit of Patients With a Possible COVID-19 Infection (Unit "COVID Possible")

acronym: RECOP

summary:
This research aims to improve knowledge of the epidemiology of patients consulting in the COvid Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID19 affects France and impacts its health system. The reception of all intermediate patients will be on the Emergency Structures (SU). Indeed, the French healthcare system centralizes unscheduled urgent care on the ER. The aspecific respiratory symptomatology in "intermediate" patients indicates them all the more at an admission to SU or the diagnostic approach to respiratory difficulty may be carried out. It will be necessary to identify the diagnosis of the dyspneic patient and to define his virological status COVID before referring him to the appropriate units.

The investigatory propose an original strategy of dedicating entire care sectors to the care of patients admitted for dyspnea in our ER. These units will be named RECOP units.

This study would improve epidemiological knowledge of COVID-19 and ability to receive these patients within the SU.


title: Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy. Observational, Descriptive, Open-label, Multi-centric, Non-randomized Study

acronym: SoluWest

summary:
The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the dose to body weight and to limit waste of unused drug. The currently marketed vigabatrin (Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6 years) and 500 mg granules for oral solution sachets (for infants and children below 6 years). Sabril™ is not adapted for administration to infants when a fraction of the sachet is needed. Manual splitting of the sachet or lengthy and error-prone dilutions are often required.

This study is a descriptive, non-randomized, open label multi-centric acceptability study in infants and children affected with infantile spasms. The primary objective is to describe the adherence to the new formulation. Secondary objectives include:

evaluation of the palatability and user-friendliness of the new treatment,
evaluation of the pharmacokinetic parameters of the new formulation,
PK parameters,
evaluation of the tolerance,
measurement of taurine plasma levels. This study will recruit up to 40 patients with infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 23 clinical sites in France.

primary_purpose: Treatment

lead_sponsor: Orphelia Pharma

location_facility: Service de neurologie pédiatrique - Hôpital Necker Enfants Malades

location_facility: Service de neurologie pédiatrique - Hôpital de la Timone

location_facility: Service de neuropédiatrie - Hôpital de Clocheville

location_facility: Service de neuropédiatrie - CHU Pellegrin Enfants

location_facility: Service de neurologie pédiatrique - Hôpital Sud

location_facility: Service de neuropédiatrie - Hôpital Robert Debré

location_facility: Centre référent des épilepsies rares pédiatrique associé - Hôpital de Hautepierre

location_facility: Service de neurologie infantile - Hôpital Salengro

location_facility: Service de nuerologie pédiatrique - Hôpital Femme Mère Enfant

location_facility: Service de neuropédiatrie - Hôpital Purpan

intervention_type: Drug


title: Influenza Vaccination in Patients Living With HIV in the Northern Region: An Observational Monocentre Study of Blankets, Modalities, Drivers and Brakes

acronym: VACCIGRIPPE

summary: Anyone living with the Human Immunodeficiency Virus (HIV) has an indication for annual influenza vaccination. (Vaccination schedule and vaccination recommendations 2019). Influenza is a viral infection that has a significant impact on the health care system. However, vaccination coverage in France is still insufficient with regard to the objectives set at 75% by the WHO and the European Commission. For the 2019-2020 seasonal influenza vaccination campaign, flu vaccination by volunteer pharmacists has become possible throughout the country. Studies that have estimated vaccination coverage among HIV-positive populations are rare and show very low rates.

lead_sponsor: Tourcoing Hospital


title: Prospective Identification of Predictors of Neonatal Respiratory Distress for Newborns With Prenatally Diagnosed Congenital Lung Malformations : A Population-based, Nationally Representative Study

acronym: MALFPULM

summary:
This research focuses on lung malformations detected in fetuses during prenatal ultrasound exams. Pathogenic mechanisms of these rare malformations are poorly understood. Improved knowledge is needed, to give families better information, and to better standardize treatment decisions The main goal is to better predict neonatal complications associated with these malformations, by identifying key predictive markers during the fetal period.

To achieve this objective, it is planned to include 400 pregnant women with prenatal diagnosis of pulmonary malformation in 45 health centers in France. This is the largest study on this topic at the international level.


title: Psychological Vulnerabilities and Transgender Adolescents: A Descriptive Epidemiology Study

acronym: VATED

summary: The number of adolescents engaging in a transidentity journey has been increasing rapidly over the last decade. However, the knowledge of the medical world concerning the specificities of these adolescents is still too little in France. The objective of this study is to refine the knowledge of the different health care providers who are brought to meet these adolescents. This research proposes to study more specifically the register of psychological vulnerabilities: to cite only a few examplesThese include disorders such as depression, anxiety disorders and eating disorders, all of which cause suffering and difficulties in everyday life. A better understanding of the presence or absence and the distribution of these different types of vulnerabilities among transgender adolescents would allow, among other things, to promote their their screening by health care providers. This better screening would allow doctors to physicians to offer targeted treatment for these disorders in parallel with the transition process. transition process.

study_start_date_type: Anticipated

status: Not yet recruiting

intervention_type: Diagnostic Test


title: Evaluation of the Colonoscope With Vision to 330 ° (Full Spectrum Endoscopy) in the Detection of Colorectal Adenomas

acronym: FUSETM-Colon

summary: The coloscopy is considered as the gold standard for screening and resection of colorectal adenomas. However the literature reports that the rate of omitted adenoma is still high (24 to 41%). The development of the FUSE system (Endochoice, USA) allows a larger field of view with a projection onto 3 screens (330° vision). A pilot study and a randomized multicentre has demonstrated the feasibility with a significant improvement of the rate of detected adenomas. This first study in France concerning this technology has the objectives to demonstrate the feasibility in France, the safety and to compare the rate of detected adenomas with data of the literature.

ReferenceCitation: Gralnek IM, Segol O, Suissa A, Siersema PD, Carr-Locke DL, Halpern Z, Santo E, Domanov S. A prospective cohort study evaluating a novel colonoscopy platform featuring full-spectrum endoscopy. Endoscopy. 2013 Sep;45(9):697-702. doi: 10.1055/s-0033-1344395. Epub 2013 Aug 12.

ReferenceCitation: Gralnek IM, Siersema PD, Halpern Z, Segol O, Melhem A, Suissa A, Santo E, Sloyer A, Fenster J, Moons LM, Dik VK, D'Agostino RB Jr, Rex DK. Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre, randomised, tandem colonoscopy trial. Lancet Oncol. 2014 Mar;15(3):353-60. doi: 10.1016/S1470-2045(14)70020-8. Epub 2014 Feb 20.

ReferenceCitation: Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8.

ReferenceCitation: Rex DK, Rahmani EY, Haseman JH, Lemmel GT, Kaster S, Buckley JS. Relative sensitivity of colonoscopy and barium enema for detection of colorectal cancer in clinical practice. Gastroenterology. 1997 Jan;112(1):17-23.

ReferenceCitation: Siersema PD, Rastogi A, Leufkens AM, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, DeMarco DC. Retrograde-viewing device improves adenoma detection rate in colonoscopies for surveillance and diagnostic workup. World J Gastroenterol. 2012 Jul 14;18(26):3400-8. doi: 10.3748/wjg.v18.i26.3400.

lead_sponsor: Institut Paoli-Calmettes


title: French Observatory of Familial Hypercholesterolemia in Cardiology

acronym: FH Care

summary:
The Family Hypercholesterolemia remains poorly diagnosed disease with an outlet sometimes suboptimal care. However, the Family Hypercholesterolemia exposes patients concerned at increased cardiovascular risk.

The frequency of familial hypercholesterolemia in cardiologic is little studied and remains unknown, and there is little data on the profile of patients, diagnostic methods and management.

Main objectives:

Establish a monitoring patients with hypercholesterolemia Family cardiology in France
Characterize the Family hypercholesterolemia in cardiology, including assessing the frequency of the most severe forms, which are at higher cardiovascular risk.

status: Terminated

ReferenceCitation: Civeira F; International Panel on Management of Familial Hypercholesterolemia. Guidelines for the diagnosis and management of heterozygous familial hypercholesterolemia. Atherosclerosis. 2004 Mar;173(1):55-68. Review.

lead_sponsor: French Cardiology Society

status_simplified: Unknown


title: Care Pathway for Children With Autism Spectrum Disorder Included in the ELENA Cohort : Matching to the National Health Data System

acronym: ELENA-SNDS

summary:
Autism Spectrum Disorder (ASD) is lifelong neurodevelopmental disorder that affect social communication and interaction and includes limited and repetitive patterns of behavior (DSM 5). In France, national guidelines about practices recommends early and specific interventions but care pathway are not well described for ASD children. The national health insurance information system record demographic data, medical condition, and reimbursed drug over 98% of the French population. In addition, the ELENA cohort is a large cohort of children with ASD followed for 6 years. Data collected include clinical characteristics of children (IQ, severity of ASD...) and parents (educational level, professional status...).

The first objective of this project is to identify patterns of care trajectories using data from ELENA cohort matched to data from national health insurance information system. Secondary objectives are to examine the links between patterns of care trajectories and clinical characteristics, social environment of autistic children.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: The Medico-economic Impact and Quality of Life of the Small-fiber Neuropathy Associated by Using Validated Scales (SF36, DN4, PROFAD SSI, ESPRI)

acronym: SFINESS-QoLEco

summary:
BACKGROUND Sjögren's syndrome is an autoimmune disease whose prevalence is estimated between 200 and 500 patients per 100,000 persons in France (120 to 500,000 patients). It affects women (90%) between 40 and 60 years of age and main manifestations are generalized sicca syndrome (ocular, oral, cutaneous) and arthralgia. In 20% of cases, Sjögren's syndrome is associated with peripheral neuropathies, and the most common form is painful small fiber neuropathy (SFN). SFNs are mainly featured by neuropathic pain including burns (90%), numbness (87.5%), tingling (72.5%), electric shocks (70%) and tingling (82.5%) and also autonomic disorders (50 to 70%).

However, there are still important issues that deserve to be investigated by clinical and basic research. Among these issues, this study will focus on:

The impact of SFN on the quality of life of patients with Sjögren's syndrome.
The medico-economic impact of the SFN taking into account the repercussions on the quality of life, including professional life, usual care cost (analgesics, medical and paramedical consultations, hospitalizations or emergency).

EXPECTED RESULTS

Confirmation of the major impairment in the quality of life of patients with Sjogren-associated SFN
Analysis of correlations to highlight or not clinical or biological factors associated with quality of life impairment.
Evaluation of the cost attributed to the presence of an SFN in patients with Sjögren's syndrome and the pharmaco-economic interest of conventional therapeutic management (analgesic treatment, consultation pain) compared to the cost of more aggressive immunomodulatory treatments.

location_facility: Département de Médecine Interne - Hôpital Lariboisière


title: The circTeloDIAG: a New Approach of Liquid Biopsy for the Diagnosis and Follow-up of Patients With Glioma Tumor

acronym: circTeloDIAG

summary:
Gliomas represent the most frequent primary brain tumor, with 2,500 to 3,000 new cases per year in France. Their diagnosis, although highly complex, is essential for determining patient management. While grade I gliomas (infrequent) are curable by surgery or present a slow progression, grades II to IV require heavy treatment (surgery and radio-chemotherapy), and are associated with a prognosis ranging from 10-15 years for grade II to only 15 months for glioblastoma.

One of the key processes in glioma oncogenesis is the activation of a telomeric maintenance mechanism (TMM). Two TMMs ensure the maintenance of a telomere size compatible with intense cell proliferation (TERT mutation and ATRX loss).

Liquid biopsy is used for the routine diagnosis and monitoring of treatment efficacy of different cancers. To date, no routine clinical testing of liquid biopsies is available for gliomas.

The detection of glioma-specific oncogenic processes, by liquid biopsy, in peripheral blood (ctDNA) could improve diagnosis and follow-up and then avoid surgery for patients with suspected lesions.

Three oncogenic markers can be used to detect gliomas: IDH mutation, TERT mutation, and a marker correlated with ATRX loss on total blood cells.

We hypothesized that the circTeloDIAG will improve and accelerate the diagnostic/prognostic value of the actual classification and provide a new tool to manage patient response to treatment via liquid biopsy. It will combine detection of three markers in liquid biopsy, to produce a versatile tool for all types of gliomas.

Patients with suspected newly diagnosed or recurrent glioma will be included.

lead_sponsor: Hospices Civils de Lyon

location_facility: East Group Hospital, Hospices Civils de Lyon

intervention_type: Biological


title: Clinico-biological Collection of Subjects With Hyper Lipoprotein a in Reunion Island

acronym: COLLIPAR

summary:
Cardiovascular disease (CVD) is the second leading cause of death in France and the leading cause of death on Reunion Island. Some modifiable risk factors for cardiovascular diseases are well identified and can be easily modulated, in particular by hygiene and dietetic measures (tobacco, sedentary lifestyle). Other risk factors such as high blood pressure, diabetes or dyslipidemia can also be pharmacologically modulated. On the other hand, there is a cardiovascular risk factor that we do not know how to modulate: a high level of lipoprotein (a) (Lp (a)), whose regulation remains largely unknown.

High plasma levels of Lipoprotein (a) remain a major risk for the development of cardiovascular disease and its clinical complications, which no drug can currently reduce. Understanding the biological and genetic determinants modulating Lp (a) levels remains a major challenge for treating subjects with hyper Lp (a). Several individuals and possibly Reunion families have been detected as having abnormally high rates of apo (a)

Thanks to the link between cardiovascular clinical picture, Lp (a) concentration and other biological markers, the study should allow a better understanding of the mechanisms underlying the cardiovascular risk in order to offer advice. prevention and care of at-risk subjects screened; or even avenues for adapted genetic counseling (DNA sequencing).

At the genetic level, several hypotheses could be explored making it possible to link the expression of the apo (a) protein to the genotype, in particular the presence of mutations in the gene, in the promoter region, polymorphisms, or epistatic regulation.

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


ReferenceCitation: Blehaut H, Mircher C, Ravel A, Conte M, de Portzamparc V, Poret G, de Kermadec FH, Rethore MO, Sturtz FG. Effect of leucovorin (folinic acid) on the developmental quotient of children with Down's syndrome (trisomy 21) and influence of thyroid status. PLoS One. 2010 Jan 11;5(1):e8394. doi: 10.1371/journal.pone.0008394.

family: Blehaut

full_name: Henri Blehaut

given: Henri

sequence: first

family: Mircher

full_name: Clotilde Mircher

given: Clotilde

sequence: additional

family: Ravel

full_name: Aimé Ravel

given: Aimé

family: Conte

full_name: Martine Conte

given: Martine

family: de Portzamparc

full_name: Veronique de Portzamparc

given: Veronique

family: Poret

full_name: Gwendael Poret

given: Gwendael

family: Huon de Kermadec

full_name: Françoise Huon de Kermadec

given: Françoise

family: Rethore

full_name: Marie-Odile Rethore

given: Marie-Odile

family: Sturtz

full_name: Franck G. Sturtz

given: Franck G.

bso_classification: Biology (fond.)

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: PLoS ONE

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

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Effect of Leucovorin (Folinic Acid) on the Developmental Quotient of Children with Down's Syndrome (Trisomy 21) and Influence of Thyroid Status

ReferenceCitation: van Trotsenburg AS, Kempers MJ, Endert E, Tijssen JG, de Vijlder JJ, Vulsma T. Trisomy 21 causes persistent congenital hypothyroidism presumably of thyroidal origin. Thyroid. 2006 Jul;16(7):671-80.

ReferenceCitation: van Trotsenburg AS, Vulsma T, van Rozenburg-Marres SL, van Baar AL, Ridder JC, Heymans HS, Tijssen JG, de Vijlder JJ. The effect of thyroxine treatment started in the neonatal period on development and growth of two-year-old Down syndrome children: a randomized clinical trial. J Clin Endocrinol Metab. 2005 Jun;90(6):3304-11. Epub 2005 Mar 8.

ReferenceCitation: Ellis JM, Tan HK, Gilbert RE, Muller DP, Henley W, Moy R, Pumphrey R, Ani C, Davies S, Edwards V, Green H, Salt A, Logan S. Supplementation with antioxidants and folinic acid for children with Down's syndrome: randomised controlled trial. BMJ. 2008 Mar 15;336(7644):594-7. doi: 10.1136/bmj.39465.544028.AE. Epub 2008 Feb 21.

ReferenceType: derived

ReferenceCitation: Mircher C, Sacco S, Bouis C, Gallard J, Pichot A, Le Galloudec E, Cieuta C, Marey I, Greiner-Mahler O, Dorison N, Gambarini A, Stora S, Durand S, Polak M, Baruchel A, Schlumberger E, Dewailly J, Azar-Kolakez A, Guéant-Rodriguez RM, Guéant JL, Borderie D, Bonnefont-Rousselot D, Blondiaux E, Ravel A, Sturtz FG. Thyroid hormone and folinic acid in young children with Down syndrome: the phase 3 ACTHYF trial. Genet Med. 2020 Jan;22(1):44-52. doi: 10.1038/s41436-019-0597-8. Epub 2019 Jul 8.

family: Sacco

full_name: Silvia Sacco

given: Silvia

family: Bouis

full_name: Charles Bouis

given: Charles

family: Gallard

full_name: Jennifer Gallard

given: Jennifer

family: Pichot

title: Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children

summary:
Evaluation of the following in very young children with Down syndrome:

the efficacy of systematic treatment with L-thyroxine at controlled doses (clinically and by ultrasensitive thyreostimulating hormone (TSH) assay),
the efficacy of systematic folinic acid treatment at a dose of 1 mg/kg/o.i.d,
any interaction between these two treatments.


summary:
State of the question Over the past decade, the incidence of melanoma (MM) has steadily increased in France and in most developed countries. This increased incidence was concerned mainly MM thin while the incidence of MM thick that represent the true "killers", and mortality from MM remained stable or increased slightly over the same period. These epidemiological data and observations from everyday medical practice dermatologists suggest the existence of different growth patterns within MM. Indeed, some MM progressing slowly sometimes for decades before diagnosis but are thin at the time of resection. Conversely, others MM grow very quickly, resulting in thick tumors despite a diagnosis and resection sometimes very early. These fast growing MM (FGMM) probably contribute significantly to the relative mortality in MM, as improved screening failed to influence to this day.

Our team has already demonstrated that the growth kinetics of the MM was a prognostic factor of tumor aggressiveness regardless of the thickness of the tumor. Using the same method to calculate the growth rate, an Australian team recently studied the growth rate in a population of patients suffering from MM. In this population 1/3 of MM had a growth of more than 0.5 mm per month. Clinical aspects and FGMM of these risk factors were individuals (injuries symmetrical achromic and regular occurrence among about older and low-nevi). The European and Australian people are very different in particular regarding the prevention policy, these results can not be extrapolated to the French population.The main objective is to identify risk factors for FGMM in French propulation

status: Unknown status

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Behavioral


title: ESCAP-2020-CPHG: Treatment Strategies Follow-up Implemented During the First Three Years Following Primary Lung Cancer (PLC) Diagnosed in KBP-2020-CPHG Cohort Patients

summary:
The prognosis for primary lung cancer (PLC) is very limited. In France, patients diagnosed for PLC in 2010 and followed in Respiratory Medicine or Oncology department of a General Hospital Centre had a 5-year survival rate of 12.7% (vs 10% in 2000).

Over the last ten years, substantial improvements have been made both in terms of diagnostic (immunohistochemistry and molecular biology) and therapeutic. New treatments have been marketed and are now available in clinic.

New therapeutical strategies have been launched and have proved their efficacy in clinical studies or meta-analyses, generally increasing the survival rate of patients by a few months. However, little information still exists on the use and effectiveness of these molecules in clinical practice.

The CPHG proposes to complete the information collected during KPB-2020-CPHG study by the ESCAP-2020-CPHG study that is a follow-up of therapeutical strategies over the first 3 years of treatment. This study should improve knowledge of the PLC treatment management in General Hospital Centres.

location_facility: Collège des Pneumologues des Hôpitaux Généraux (CPHG) (General Hospital Pulmonologists College)


title: Identification of New Genetic Markers for the Risk of Recurrence of Venous Thromboembolism by Whole Genome Analysis: Case-control Study Nested in the MARTHA Cohort

acronym: MARTHARecidive

summary:
Venous thromboembolism (VTE) is a common and potentially fatal pathology in France. The risk of recurrence is around 5 to 7% per year. The identification of patients at risk of VTE and its prevention is a real health issue in particular. 50% of MTEV recurrences occur in the absence of a risk situation, suggesting the involvement of specific risk factors for MTEV recurrence that have not been identified to date.

In the last ten years, so-called "genome-whole" or "genome wide" association (GWAS) approaches have identified new genetic risk factors for the first episode of VTE. On the other hand, no study has focused on the predictive factors of recurrence.

The previous project, conducted from 2012 (NCT02904967), had as its main objective to identify new genes for susceptibility to MTEV recurrence by comparing cases of MTEV recurrence versus controls having had a single episode of MTEV. The MARTHA cohort (1,542 patients) is extremely valuable study material and is one of the few cohorts in the world with genome-wide data in the field of VTE. Follow-up could only be performed in 359 patients, 76 (21%) of whom presented with a new episode of VTE.

The objective of this project is to increase the number of patients for whom the investigators will have information on recurrence / non-recurrence of VTE, by querying national registries on the vital status of patients, and possible causes of death. .

These new data on the occurrence or not of a new thrombotic episode, will be confronted with the genetic data already available in all the patients in order to identify specific genetic risk factors and potentially predictive of the recurrence of MTEV.

location_facility: Assistance Publique Hôpitaux de Marseille


title: Experimental Study of Tongue/Palate Interactions Using Upper coMplete dEnture

acronym: EEXPLORE

summary: The project aims to assess the effect of a complete denture of new denture wearers on speech production using sensors placed inside a duplicate of the prosthesis according to the technique described in the PRESLA system. Secondly, it aims to assess the effect of a complete denture on swallowing for these new denture wearers. Thirdly it aims to describe a precise mapping of the mechanical pressures exerted by the tongue on the palate of complete denture user, been used in wearing denture, during speaking and swallowing. The experiments will take place in the department of treatments and dental consultations of the Hospices Civils de Lyon (Faculty of Odontology, Lyon, France).

location_facility: Service de Consultations et de Traitements Dentaires des Hospices Civils de Lyon


title: Evaluation of Relationship Between Hypersexuality and Psychostimulant Among Men Who Have Sex With Men

acronym: HYPERCHEM

summary:
Survey of fifty new psychoactive substances consumers in a context of MTM sexual intercourse.

Evaluation using an hetero-assessment questionnaire about the link between hypersexual disorder and the use of synthetic cathinone.

Evaluation on psychoactive drug addiction, the induced or pre-existing sexual practices and the medico-psycho-social consequences of those practices.


title: Adjunction of Hydroxychloroquine in Patients With a Metastatic Melanoma Who Are Resistant to BRAF and MEK Inhibitors : a Retrospective Case-control Study.

acronym: CHLORO-DATRAM

summary:
Patients with a BRAF mutated melanoma are usually treated in France by a first line of immunotherapy followed by a second line that combines a BRAF inhibitor (dabrafenib, vemurafenib, encorafenib) and a MEK inhibitor (trametinib, cobimetinib, binimetinib).

The combination dabrafenib/trametinib is initially very efficient but it is unfortunately limited because acquired resistances usually occur after a year of treatment. Patients who become resistant to dabrafenib/trametinib and immunotherapy, unfortunately do not have an approved effective treatment at their disposal. They usually receive a palliative chemotherapy by dacarbazine or fotemustine, and they have a mean overall survival that is less than three months.

Activation of autophagy in presence of BRAF and MEK inhibitors is a known mechanism of resistance to BRAF/MEK inhibitors. Hydroxychloroquine is an autophagy inhibitor and it has been suggested in vitro that it could decrease resistance to BRAF/MEK inhibitors.

Following the positive results in 2018 of a phase I/II study in the USA that showed the efficacy and the absence of toxicity of the association of Dabrafenib, Trametinib and hydroxychloroquine when used as a first line treatement, we proposed to our patients who had become resistant to the dabrafenib/trametinib combination, to pursue their treatment beyond progression and to receive in addition hydroxychloroquine.

This prescription was initiated in patients for whom no further therapeutic options were available, after validation by a multidisciplinary tumor board. All patients were informed that the combination dabrafenib/trametinib/hydroxychloroquine was not approved by a regulatory agency.


title: Clinic And Biologic Efficiency And Tolerance Of Oral Immunotherapy Protocol In Hazelnut Allergic Children

acronym: ENOIME

summary:
Prevalence of food allergy in the world has been inscreasing in recent years. Among nut allergy, hazelnut allergy is the most widespread in Europe and particularly in France. The current treatment for hazelnut allergy is based on eviction and wearing of an emergency kit with adrenaline auto-injector pens, to be used in the event of severe anaphylactic reaction. Oral immunotherapy (OIT) is a treatment that is now increasingly being offered as an alternatice to eviction. There are few published data concerning hazelnut OIT in Europe, where its consumption is nevertheless very high.

The main objective of our study is to evaluate the clinical efficacy of the hazelnut OIT protocol, implemented since 2015 in the pneumology and allergology-paediatric department of the Mother and Child Hospital in Bron, in hazelnut allergic children under 18 years old.

The secondary objectives will be to evaluate the biological efficacy and clinical tolerance of the protocol.

The study is retrospective and observational, and is based on the collection of medical data from patient records.

location_facility: Pneumology allergology-paediatric department of the Mother and Child Hospital


title: Study of SARS-CoV2 Virus (COVID-19) Seroprevalence in the Population of Creil Air Force Base (BA110)

acronym: EpiCovCreil

summary:
In mid-February 2020, within the Oise (France) cluster, a case of COVID-19 disease caused by a SARS-CoV2 infection was described among the personnel of the Creail Air Force Base (BA110). This resulted in the beginning of an epidemic controlled by epidemiological measures. One month later, containment measures were taken at the national level, measures that also applied to BA110 personnel. These personnel, exposed to both the initial phase of the epidemic and national protection measures, represent an extremely interesting population for understanding the epidemiological dynamics of the virus, particularly at a time when France is lifting the containment measures. It becomes extremely important to understand the levers of viral spread in order to adjust the health measures to be maintained as best as possible.

The main objective of this study is to determine the extent of virus diffusion in this highly circulating population, as evidenced by several identified cases of COVID-19.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Impact of Using Cumulative SUM (CUSUM) Control Chart in Maternity Department on Mother and Infant Health: a Cluster Randomized Trial

acronym: MATICUS

summary:
Hypothesis: Continuously monitor quality indicators with a specific method (CUSUM: Cumulative Sum) will increase the awareness of health care staff in maternity and permit rapid detection of a small dip in performance in order to enable prompt investigations and corrective measures when necessary , which decrease maternal and neonatal mortality and morbidity.

Objective: To assess the impact of Cumulative Sum (CUSUM) charts used as a maternity dashboard to decreases maternal and neonatal mortality and morbidity.

Design: Step-wedge cluster-randomized trial with prospective analyses of collected data.

Setting: ten Maternity departments in France. Population: Data from 60 000 women and infants could be collected over 2 year's period.

Method: Cumulative sum (CUSUM) charts were used to monitor the rate of quality indicators previously selected by Delphi method.

Main Outcome Measures: Composite outcome that considers multiple clinical events : mortality, adverse outcomes for women and newborn.

location_facility:
Robert Debré Hospital
Boulkedid


title: Performance of Different Application Regimens of ACTINICA® on Protection From UVR-induced Erythema After One Day of Sun Exposure in Fair-skinned Healthy Subjects.

summary:
Study objective To assess the performance of different application regimens of Actinica® on protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned healthy subjects (phototype I to III).

Study centers A total of 20 subjects will be enrolled in 1 site in France.

Methodology This will be a monocentre, randomised, controlled, investigator-blind, intra-individual comparative clinical investigation.

There will be a total of 6 visits for each subject. Each subject will participate for a period of maximum 35 days.

Study population Healthy subjects, male or female, at least 18-60 years old, with phototype I, II or III, not pre-treated/pre-protected skin, meeting specific inclusion/exclusion criteria.

The clinical investigation will be conducted in 2 parts.

Part 1 - SPF determination:

To determine the SPF of Actinica® with application of two different amounts (0.8 and 2 mg/cm2).

Part 2 - Sun exposure:

To assess the performance of the different application regimens of Actinica® on protection from UVR-induced erythema throughout 1 day of sun exposure.

design_allocation: Randomized

lead_sponsor: Galderma R&D


title: Effect of Bilateral Transversus Thoracis Muscle Plane Block on Postoperative Morphine Consumption in Patients Undergoing Elective On-pump Coronary Artery Bypass Graft Surgery: a Retrospective Study.

acronym: PARACABS

summary:
Coronary artery bypass graft surgery is the standard surgical treatment for coronary disease. However, there is no consensus on analgesic management in patients undergoing CABG.

The aim of the study is to evualuate efficacy of bilateral transversus thoracis muscle plane (TTMP) block combined with systemic analgesia, compared to systemic analgesia only, in patients undergoing elective on-pump CABG surgery.

Our main hypothesis is that a bilateral TTMP block performed after CABG surgery could reduce morphine consumption during the first 48 hours.

The investigators conducted an age, gender and type of surgery-matched retrospective cohort study in the Montpellier University Hospital (France).

intervention_type: Procedure


title: Medical Compression for Leg Ulcers in Patients With Peripheral Arterial Disease: A Practice Survey

acronym: COMPAD

summary: Real-life practice survey of vascular specialist in France caring for patients with a leg ulcer for which compression treatment would be indicated and arterial disease of the lower limbs


title: Impact of a Front-of-pack Nutrition Label on the Nutritional Quality of Purchases in Campus Cafeteria

summary: This study evaluates the impact of the introduction of a front-of-pack nutrition label on foods and beverages sold in a campus cafeteria in France on the nutritional quality of purchases.

lead_sponsor: University of Paris 13


title: Pharmaco-economical Study in Kidney Transplantation

acronym: EPHEGREN

summary:
The prevalence of renal acute rejection in transplantation is reduced thanks to the optimized use of immunosuppressive drugs. However, graft survival at ten years has not improved since then; this may be explained in part by the toxicity of these drugs, viral infections, and other comorbidities (diabetes, cardiovascular diseases …).

According to transplant center, strategies for the combination of immunosuppressive drugs are different, and probably involve a difference in the global cost of patient management. There is no recommendation in France to establish similar practices.

EPHEGREN is an observational, prospective, multicentric, pharmacoeconomic study for the renal transplant patients.

lead_sponsor: University Hospital, Limoges


title: Real-life Observatory of Efficacy and Resistance to Anti CMV Molecules in Stem Cell Recipients

acronym: NAViRe

summary:
Cytomegalovirus (CMV) is a ubiquitous herpesvirus that represent a major cause of morbidity in haematopoietic stem cell transplants (HSCT) recipients, mostly through reactivation of the recipient's virus.

If left untreated, 40 to 80% of patients will develop CMV infection, leading to CMV disease in 30 to 35 % patients, and associated with considerable morbi-mortality. Interstitial pneumonia is the most severe and specific manifestation, although CMV replication by itself has also indirect effects such as triggering graft versus host disease and increasing immunosuppression. The current burden of CMV infection increases by 25 to 30% the cost of the graft in France. This also includes the burden for refractory - infections, that represent up to 13% of recipients with CMV infection, including 3% of cases with virological resistance in France (data from the Reference Center cohorts).

Ganciclovir, or valganciclovir preemptive treatment, guided by CMV viral load follow-up allowed significant reduction of CMV disease to 2-6% but did not prevent CMV indirect effects. In addition, hematotoxicity can compromise post-transplant haematological reconstitution, thus preventing its use as prophylaxis in France. Foscarnet, iv-administered and nephrotoxic, remains less used. There is thus a high expectation from less toxic molecules for prophylaxis The development letermovir recently available for prophylaxis of CMV infection in high risk patients will modify the patients care and follow-up. This new molecule targeting CMV terminases (developed by Merck) was recently marketed in France (Jan 2020). However, the analysis of the letermovir phase III study and further publications show that the risk of emergence of resistance is low, but may occur in case of breakthrough and thus post AMM monitoring is required.

A "real-life" evaluation of these new molecules in terms of efficacy, emergence of resistance, tolerance and morbimortality related to CMV infection, is useful, to propose recommendations on management strategies, in particular for the most at-risk patients i.e. CMV-seropositive recipients. To this purpose, the National Reference Center in collaboration with the French Society for marrow graft and cell therapy (SFGMTC) set up a cohort of surveillance of allografted patients, receiving, in prevention or treatment, old and new molecules.

ReferenceCitation: Ljungman P, Boeckh M, Hirsch HH, Josephson F, Lundgren J, Nichols G, Pikis A, Razonable RR, Miller V, Griffiths PD; Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum. Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials. Clin Infect Dis. 2017 Jan 1;64(1):87-91. Epub 2016 Sep 28.

ReferenceCitation: Chemaly RF, Chou S, Einsele H, Griffiths P, Avery R, Razonable RR, Mullane KM, Kotton C, Lundgren J, Komatsu TE, Lischka P, Josephson F, Douglas CM, Umeh O, Miller V, Ljungman P; Resistant Definitions Working Group of the Cytomegalovirus Drug Development Forum. Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials. Clin Infect Dis. 2019 Apr 8;68(8):1420-1426. doi: 10.1093/cid/ciy696.

ReferenceCitation: Billat PA, Ossman T, Saint-Marcoux F, Essig M, Rerolle JP, Kamar N, Rostaing L, Kaminski H, Fabre G, Otyepka M, Woillard JB, Marquet P, Trouillas P, Picard N. Multidrug resistance-associated protein 4 (MRP4) controls ganciclovir intracellular accumulation and contributes to ganciclovir-induced neutropenia in renal transplant patients. Pharmacol Res. 2016 Sep;111:501-508. doi: 10.1016/j.phrs.2016.07.012. Epub 2016 Jul 9. Review.

ReferenceCitation: Marty FM, Ljungman P, Chemaly RF, Maertens J, Dadwal SS, Duarte RF, Haider S, Ullmann AJ, Katayama Y, Brown J, Mullane KM, Boeckh M, Blumberg EA, Einsele H, Snydman DR, Kanda Y, DiNubile MJ, Teal VL, Wan H, Murata Y, Kartsonis NA, Leavitt RY, Badshah C. Letermovir Prophylaxis for Cytomegalovirus in Hematopoietic-Cell Transplantation. N Engl J Med. 2017 Dec 21;377(25):2433-2444. doi: 10.1056/NEJMoa1706640. Epub 2017 Dec 6.

ReferenceCitation: Robin C, Hémery F, Dindorf C, Thillard J, Cabanne L, Redjoul R, Beckerich F, Rodriguez C, Pautas C, Toma A, Maury S, Durand-Zaleski I, Cordonnier C. Economic burden of preemptive treatment of CMV infection after allogeneic stem cell transplantation: a retrospective study of 208 consecutive patients. BMC Infect Dis. 2017 Dec 5;17(1):747. doi: 10.1186/s12879-017-2854-2.

ReferenceCitation: Billat PA, Woillard JB, Essig M, Sauvage FL, Picard N, Alain S, Neely M, Marquet P, Saint-Marcoux F. Plasma and intracellular exposure to ganciclovir in adult renal transplant recipients: is there an association with haematological toxicity? J Antimicrob Chemother. 2016 Feb;71(2):484-9. doi: 10.1093/jac/dkv342. Epub 2015 Nov 3.

family: Billat

full_name: Pierre-André Billat

given: Pierre-André

family: Woillard

full_name: Jean-Baptiste Woillard

given: Jean-Baptiste

family: Essig

full_name: Marie Essig

given: Marie

family: Sauvage

full_name: François-Ludovic Sauvage

given: François-Ludovic

family: Picard

full_name: Nicolas Picard

given: Nicolas

family: Alain

full_name: Sophie Alain

given: Sophie

family: Neely

full_name: Michael Neely

given: Michael

family: Marquet

full_name: Pierre Marquet

given: Pierre

family: Saint-Marcoux

full_name: Franck Saint-Marcoux

given: Franck

bso_classification: Medical research

journal_name: Journal of Antimicrobial Chemotherapy

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Kotton CN, Kumar D, Caliendo AM, Huprikar S, Chou S, Danziger-Isakov L, Humar A; The Transplantation Society International CMV Consensus Group. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation. 2018 Jun;102(6):900-931. doi: 10.1097/TP.0000000000002191. Review.

family: Kotton

full_name: Camille N. Kotton

given: Camille N.

family: Kumar

full_name: Deepali Kumar

given: Deepali

family: Caliendo

full_name: Angela M. Caliendo

given: Angela M.

family: Huprikar

full_name: Shirish Huprikar

given: Shirish

family: Chou

full_name: Sunwen Chou

given: Sunwen

family: Danziger-Isakov

full_name: Lara Danziger-Isakov

given: Lara

family: Humar

full_name: Atul Humar

given: Atul

journal_name: Transplantation

oa_colors: green hybrid

evidence: open (via free article)

repository_institution: University of Zurich - Zurich Open Repository and Archive

publisher: Ovid Technologies (Wolters Kluwer Health)


title: Etude Descriptive Retrospective de la Transfusion Plaquettaire Chez Des Patients Atteints d'hémopathie Maligne en Phase Palliative et Suivis au CHU de Besançon

summary:
Development of palliative care is less effective for patients with hematologic malignancies. Limited data is available for end of life care in this population, moreover with thrombocytopenic patients. Thrombopenia is a frequent complication, specific of bone marrow involvement in those diseases or its treatments. Yet, a few studies was interested in, whereas platelet transfusion is the only treatment indicated. As it represent a scarce, limited resource, the ethical principles are in conflict in this setting.

The purpose of this study was to describe retrospectively platelet transfusion in the six last few month of life of patients with hematologic malignancies at the CHU of Besançon (France) between 01/07/15 and 31/12/16.

ReferenceCitation: Höchsmann B, Moicean A, Risitano A, Ljungman P, Schrezenmeier H. Supportive care in severe and very severe aplastic anemia. Bone Marrow Transplant. 2013 Feb;48(2):168-73. doi: 10.1038/bmt.2012.220. Epub 2012 Dec 3. Review.

ReferenceCitation: Sherbeck JP, Boss RD. Ethical Questions about Platelet Transfusions at the End of Life. AMA J Ethics. 2016 Aug 1;18(8):764-70. doi: 10.1001/journalofethics.2016.18.8.ecas1-1608.

ReferenceCitation: Salacz ME, Lankiewicz MW, Weissman DE. Management of thrombocytopenia in bone marrow failure: a review. J Palliat Med. 2007 Feb;10(1):236-44. Review.

ReferenceCitation: Lassauniere JM, Bertolino M, Hunault M, Zittoun R, Verspieren P, Moh-Klaren J, Jaulmes D, Colombat P. Platelet transfusions in advanced hematological malignancies: a position paper. J Palliat Care. 1996 Spring;12(1):38-41.

ReferenceCitation: Boggs DR. Jehovah's Witnesses with leukemia. Hosp Pract (Off Ed). 1985 Mar 15;20(3):92, 94-5, 98 passim.

ReferenceCitation: Wang WS, Ma JD, Nelson SH, Revta C, Buckholz GT, Mulroney C, Roeland EJ. Transfusion practices at end of life for hematopoietic stem cell transplant patients. Support Care Cancer. 2018 Jun;26(6):1927-1931. doi: 10.1007/s00520-017-4023-y. Epub 2017 Dec 28.

family: Wang

full_name: Winnie S. Wang

given: Winnie S.

family: Ma

full_name: Joseph D. Ma

given: Joseph D.

family: Nelson

full_name: Sandahl H. Nelson

given: Sandahl H.

family: Revta

full_name: Carolyn Revta

given: Carolyn

family: Buckholz

full_name: Gary T. Buckholz

given: Gary T.

family: Mulroney

full_name: Carolyn Mulroney

family: Roeland

full_name: Eric J. Roeland

given: Eric J.

journal_name: Supportive Care in Cancer

oa_host_type: repository

version: acceptedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing_description: patient were dead during the period of recruitment. Characteristic of patient could be used for other purpose

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: SCOPYD Study: Development of a Predictive Clinical Score of Hypovitaminosis D

acronym: SCOPYD

summary:
Vitamin D has effects on many tissues, and hypovitaminosis D is frequent. In a French survey conducted among 1587 adults, vitamin D insufficiency (<30ng/ml) has been reported in 80% of subjects, including 43% with moderate deficiency (<20ng/ml) and 5% with severe deficiency (<10ng/ml).

Because of the possible consequences of hypovitaminosis D (osteomalacia in adults…), the number of vitamin D determination has increased ten-fold since 2005 in France, reaching 4.5 million € in 2011, and with it the costs for health insurance. However, there is currently no consensus on the strategy for detection, diagnosis and treatment of hypovitaminosis D.

We propose to develop a predictive clinical score of hypovitaminosis D based on the accurate assessment of solar exposure, vitamin D intakes and hypovitaminosis D risk factors collected through a self-administered questionnaire.


title: The French National Survey on Food Consumption of Children Under 3 Years of Age

summary: The Nutri-Bébé 2013 survey is an observational cross-sectional study aiming to update food consumption, practices and nutrient intakes in children under 3 years of age in metropolitan France.

time_perspective: Cross-Sectional

ipd_sharing_description: To be shared is the global report of results on each items (food practices, food consumption, nutrients intakes), according to age groups.

lead_sponsor: Secteur Français des Aliments de l'Enfance


title: Impact of a Front-of-pack Nutrition Label on the Nutritional Quality of Purchases in Campus University Restaurant

summary: This study evaluates the impact of the introduction of a front-of-pack nutrition label on foods and beverages sold in a campus university restaurant in France on the nutritional quality of purchases.


title: A French Prospective, Non-interventional Research ( NIR) of Nivolumab in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN) Progressing on or After a Platinum-based Therapy

acronym: ProNiHN

summary: A prospective real world evidence study of Nivolumab use in France in patient with recurrent or metastatic squamous cell carcinoma of the Head and Neck progressing on or after a platinum based therapy

lead_sponsor: Bristol-Myers Squibb


title: Investigator Centers Will Be All French Hematology Centers Performing Autologous Transplantation and Prescribing Mozobil in Hematopoietic Stem Cell Mobilization Willing to Participate In This Study

summary: The aim of this registry is to provide information, in day-to-day practice, on Plerixafor prescription modalities in France, over a 13-month period in order to address the health authorities' request.

lead_sponsor: Genzyme, a Sanofi Company


title: Identification of Predictive Markers for Testis Cancer in a Population of Men With High Risk

summary:
Testis cancer with germ cells is the most frequent cancer of young men and its incidence is in constant increase in many industrialized countries, as in France. An increased risk of developing testis cancer has been described in patients with testicular ectopia history and testicular cancer history (controlateral testicular cancer) and more recently suggested in a population of hypofertile men with altered spermatogenesis. To a better understanding of this risk, an attempt of characterization of this group of patients has been proposed in the present work.

The general objective of this project is to characterize morphological and molecular markers of hypofertility which could serve as predictive markers of testis malignant transformation.

In this project conducted in 3 establishments, the investigators propose:

To select a population of hypofertile patients exhibiting compatible clinical and morphological characters with a high risk of testis tumoral transformation (secretory azoospermia and/or a history of testicular ectopia. To determine the spermatogenic arrests on histological criteria (score of Jonhsen).
To study the expression of four proteins or family of proteins suspected of being involved in testis tumorogenesis such as: the Placenta Alkaline Phosphatase (PLAPE), cyclin A1, VASA and connexin (Cx) by immunohistochemistry and by real-time quantitative RT-PCR analysis real-time analyses.
To establish a possible correlation between the clinical data, spermatogenesis arrest and the expression of these biomarkers.

These approaches would allow to identify, in this population of hypofertile patients, subgroups of men who could develop tumours with germ cells, and subsequently to propose potential biomarkers for testis cancer. A more clinical observation of these subgroups will be also proposed.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease (ACTIV'AO)

acronym: ACTIV'AO

summary:
The prevalence of peripheral arterial disease is 12.2% in France. Intermittent claudication is the most common symtom of this disease. During physical exercise, such as walking, blood oxygen (O2) requirements increase. The development of atherosclerosis in the lower limbs, causes narrowing of the arteries and limits the increase in blood flow required for muscular effort. Patients then experience muscle pain, the intensity of which gradually increases until it forces them to stop. After stopping, the pain subsides and disappears in less than 10 minutes.

The location of the pain (calves and/or thighs and/or buttocks) is related to the location of the ischemia (distal in the calf, proximal in the thigh or buttock, or proximo-distal if several locations). This can have different consequences on the biomechanical parameters of walking and muscle activity. To date, the impact of this localization on physical capacity has never been studied.

These limitations are very disabling and impact the quality of life of patients.

In addition, poor lower limb performance is associated with higher mortality. Reducing symptomatology and improving functional abilities is therefore a major issue in patients with peripheral arterial disease. This can be achieved through the practice of an Adapted Physical Activity, an essential recommendation in the care of patients with peripheral arterial disease.

Our main hypothesis is that the physical activity rehabilitation protocol "Activ'AO" will improve the functional capacities of patients with peripheral arterial disease who have followed the program with the localization of ischemia with a greater consideration than in patients in the group following a "standard" APA protocol. Improvements in functional abilities (such as walking) will lead to improvements in quality of life.

lead_sponsor: Centre Hospitalier le Mans


title: Circadian & Homeostatic Synchronization Effect on Waking Mobility in Parkinson's Disease: a Feasibility Study

acronym: Synch Fit

summary:
Sleep benefit (SB) consists of a spontaneous, transient and inconsistent improvement of the mobility occurring on morning awakening in approximately 40% of Parkinson's disease (PD) patients, before taking the first morning dose of dopaminergic drugs.

The SB could represent a pathway for the development of new therapeutic strategies for motor symptoms in PD.

Being a seemingly unpredictable phenomenon and a great variability daily, inter- and intra-subject, the SB study requires multiple and repeated assessments of mobility for several days. An experimental home setting would be optimal for this purpose in terms of cost-effectiveness and patient acceptability.

In addition, since the extent and nature of SB have not been well characterized so far, and the magnitude of its variability is unknown, a reliable assessment method, independent of observers and situation, the SB is a requirement of further research in this area.

A recently developed technique combining machine learning algorithms with wireless portable sensors (accelerometers and gyroscopes) and software applications could be particularly promising for characterizing the complexity and multiplicity of SBs in. With this technique, repeated and multiple assessments of mobility can be performed in the homes of patients without the constant presence of a researcher.

This approach offers several advantages in terms of cost-effectiveness, feasibility and acceptability of study protocols by patients. It also improves the ecological validity of subjective and objective estimates of mobility in these patients.

The investigators chose to conduct this preliminary study on patients with PD rather than on healthy subjects, because SB is a phenomenon that has been described so far only in this population. Investigators also consider that the feasibility of the study will depend mainly on the patients' ability to move and the context of their own illness.

SB is a phenomenon induced by sleep. The propensity and timing of sleep depend on the coordinated interaction of the duration of the previous awakening (homeostatic process) and a circadian signal (circadian process). In order to better understand SB, it is necessary to study the reciprocal influences of the circadian and homeostatic process.

Investigators have devised a new paradigm to "shift" the circadian process phase around the homeostatic process, maintained under constant conditions, in order to observe the effect of the synchronism or desynchronization of these two processes on the awakening mobility of patients with an MP. This experimental approach was approved by Professor Aleksandar Videnovic (Harvard University School of Medicine, USA), opinion leader on circadian rhythmicity in the MP and scientific collaborator of this study.

As a first step, the investigators plan to implement a technology-assisted home-based methodology, to validate it in PD patients and to verify the logistic feasibility of this method-assisted approach in a small group of patients, in order to to be able to apply this paradigm in larger scientific projects.

status: Withdrawn

lead_sponsor: University Hospital Center of Martinique


title: Evaluation of Rupture of Galenic Practices at Home in a Population Aged 65 or Older

acronym: CRUSHAGE

summary:
Elderly people frequently take several medications and are exposed to iatrogenic risks.

The oral route is the preferred route of administration. The effectiveness and the safety of the drugs depend in particular on the modes of administration (frequency of the intake, respect of the doses and the galenic ...).

However, these modalities are very little known concerning the treatments intake at home in the elderly population.

In a health facility welcoming geriatric patients, the rupture of galenic is frequent and favored by swallowing disorders, dependence, the increase in age, the presence of cognitive disorders or psycho-behavioral disorders.

The consequences of the rupture of galenic are numerous, concern the patients but also the caregivers who administer the treatments.


title: Optic Neuritis Differential Diagnosis Study (ONDDS)

acronym: ONDDS

summary: Background: Optic neuritis is a frequent cause of vision loss encountered by ophthalmologists in the Caribbean. The diagnosis is made on clinical grounds. Optic neuritis can occur either in an isolated manner or, most often, as the first symptom of multiple sclerosis (MS) or neuromyelitisoptica (NMO). These 2 demyelinating disorders differ by many means, including treatment and prognosis. MS can cause severe long-term disability while NMO is a short-term sight- and life-threatening condition causing potential relapses, which may require plasma exchanges. Furthermore, disease-modifying therapies used in NMO are different from those used in MS, which can worsen the natural history of NMO. Early differential diagnosis of these diseases is thus crucial for preventing severe visual loss and disability.


title: Prospective, Non-randomized, Open-label and Multi-center Study With the Establishment of a Clinical-biological Database.

acronym: DEPLR

summary:
Colorectal cancer (CRC): is one of the most frequent cancers, with almost 42152 new cases estimated in France for 2012. There are 3 levels of risk of developing CRC: moderate, high or very high. At each level of risk, appropriate follow-up recommendations are made. Immunological tests for fecal occult blood tests have emerged in recent years and have rapidly become established as benchmark tests in Europe and then in France (OC Sensor test) as part of mass screening. In the case of a positive immunological test, a diagnostic colonoscopy must be systematically organized in order to characterize the possible recto-colic cause of the digestive bleeding thus observed.

Measurement of the DNA present in the circulating blood (circulating DNA or cfDNA): allowed a significant advance in the personalized management of cancers, as a non-invasive test capable of producing diagnostic, prognostic, theranostic, and of therapeutic follow-up type.

The aim of the work is to measure the cfDNA concentration in subjects undergoing colonoscopy because of a positive immunological fecal test.

primary_purpose: Screening

ReferenceCitation: Segnan N, Armaroli P, Bonelli L, Risio M, Sciallero S, Zappa M, Andreoni B, Arrigoni A, Bisanti L, Casella C, Crosta C, Falcini F, Ferrero F, Giacomin A, Giuliani O, Santarelli A, Visioli CB, Zanetti R, Atkin WS, Senore C; SCORE Working Group. Once-only sigmoidoscopy in colorectal cancer screening: follow-up findings of the Italian Randomized Controlled Trial--SCORE. J Natl Cancer Inst. 2011 Sep 7;103(17):1310-22. doi: 10.1093/jnci/djr284. Epub 2011 Aug 18. Erratum in: J Natl Cancer Inst. 2011 Dec 21;103(24):1903. Fracchia, M [added].

family: Segnan

full_name: N. Segnan

given: N.

family: Armaroli

full_name: P. Armaroli

given: P.

family: Bonelli

full_name: L. Bonelli

given: L.

family: Risio

full_name: M. Risio

given: M.

family: Sciallero

full_name: S. Sciallero

given: S.

family: Zappa

full_name: M. Zappa

family: Andreoni

full_name: B. Andreoni

given: B.

family: Arrigoni

full_name: A. Arrigoni

given: A.

family: Bisanti

full_name: L. Bisanti

family: Casella

full_name: C. Casella

given: C.

family: Crosta

full_name: C. Crosta

family: Falcini

full_name: F. Falcini

given: F.

family: Ferrero

full_name: F. Ferrero

family: Giacomin

full_name: A. Giacomin

family: Giuliani

full_name: O. Giuliani

given: O.

family: Santarelli

full_name: A. Santarelli

family: Visioli

full_name: C. B. Visioli

given: C. B.

family: Zanetti

full_name: R. Zanetti

given: R.

family: Atkin

full_name: W. S. Atkin

given: W. S.

family: Senore

full_name: C. Senore

journal_name: JNCI Journal of the National Cancer Institute

title: Once-Only Sigmoidoscopy in Colorectal Cancer Screening: Follow-up Findings of the Italian Randomized Controlled Trial--SCORE

ReferenceCitation: Schoen RE, Pinsky PF, Weissfeld JL, Yokochi LA, Church T, Laiyemo AO, Bresalier R, Andriole GL, Buys SS, Crawford ED, Fouad MN, Isaacs C, Johnson CC, Reding DJ, O'Brien B, Carrick DM, Wright P, Riley TL, Purdue MP, Izmirlian G, Kramer BS, Miller AB, Gohagan JK, Prorok PC, Berg CD; PLCO Project Team. Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. N Engl J Med. 2012 Jun 21;366(25):2345-57. doi: 10.1056/NEJMoa1114635. Epub 2012 May 21.

title: Colorectal-Cancer Incidence and Mortality with Screening Flexible Sigmoidoscopy

ReferenceCitation: Minozzi S, Armaroli P, Segnan N. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Principles of evidence assessment and methods for reaching recommendations. Endoscopy. 2012 Sep;44 Suppl 3:SE9-14. Epub 2012 Sep 25.

ReferenceCitation: US Preventive Services Task Force, Bibbins-Domingo K, Grossman DC, Curry SJ, Davidson KW, Epling JW Jr, García FAR, Gillman MW, Harper DM, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Owens DK, Phillips WR, Phipps MG, Pignone MP, Siu AL. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jun 21;315(23):2564-2575. doi: 10.1001/jama.2016.5989. Erratum in: JAMA. 2016 Aug 2;316(5):545. Erratum in: JAMA. 2017 Jun 6;317(21):2239.

name: Group Health Research Institute, Seattle, Washington

name: State University of New York Upstate Medical University, Syracuse

name: Pima County Department of Health, Tucson, Arizona

name: Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts

name: Fairfax Family Practice Residency, Fairfax, Virginia11Virginia Commonwealth University, Richmond

name: Veterans Affairs Palo Alto Health Care System, Palo Alto, California16Stanford University, Stanford, California

name: Brown University, Providence, Rhode Island

name: University of North Carolina, Chapel Hill

name: Mount Sinai School of Medicine, New York, New York21James J. Peters Veterans Affairs Medical Center, Bronx, New York

title: Screening for Colorectal Cancer

ReferenceCitation: Mouliere F, El Messaoudi S, Pang D, Dritschilo A, Thierry AR. Multi-marker analysis of circulating cell-free DNA toward personalized medicine for colorectal cancer. Mol Oncol. 2014 Jul;8(5):927-41. doi: 10.1016/j.molonc.2014.02.005. Epub 2014 Mar 24.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: ICM - Institut régional du Cancer Montpellier


title: Evaluation of the COVID-19 Infection Response in Patients Admitted to the Emergency Department for Dyspnea

acronym: EPRICOD

summary:
This research aims to improve our knowledge of the epidemiology of patients consulting in the COvid-19 Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID-19 affects France and impacts its health system. The reception of all intermediate patients will be on the Emergency Structures (SU). Indeed, the French healthcare system centralizes unscheduled urgent care on the ER. The aspecific respiratory symptomatology in "intermediate" patients indicates them all the more at an admission to SU or the diagnostic approach to respiratory difficulty may be carried out.

A central issue of this diagnostic strategy will be to be rapid, since the diagnosis will have to be made in the context of significant flows, with a need to quickly refer patients to the most suitable downstream service, while limiting the risk contamination of caregivers and vulnerable patients if a COVID-19 + patient is admitted to an unsuitable service. However, virological tests do not currently allow rapid results for COVID-19.

Research project of investigatory aims to develop a predictive model of the risk of being COVID-19 positive for patients admitted to the emergency room for acute dyspnea.

time_perspective: Other

lead_sponsor: University Hospital, Toulouse


title: French Cohort of HIV Associated Lymphomas

acronym: ANRS CO16

summary:
The incidence of lymphomas is increased among HIV infected patients. In 70 % of cases, those are Non Hodgkin's lymphomas (NHL) and Hodgkin lymphomas (HL) in 30% of cases. In France, their incidence is estimated to 100 cases per year (data from the "Base de données Hospitalière Française sur l'Infection à VIH" (FHDH)). The main mechanisms involved in lymphomagenesis are immune dysfunction, involvement of oncogenic viruses (Epstein-Barr (EBV) and HHV8) and molecular oncogenic events. A better understanding of these different pathways, give the possibility to design specific treatments. The treatment of these lymphomas is not standardized. A prospective study of patients with HIV associated lymphoid malignancies is an innovating tool to answer epidemiological, physiopathological and therapeutic questions. We propose a prospective multicentric study of these patients.

The main objectives of this prospective study are to:

evaluate the incidence, characterise clinically and histologically NHL and HL cases associated to HIV
perform an observational study of the treatment and outcome of these patients out of the context of clinical trials,
study the differentiation and activation of B-cell populations,
better understand the role of specific T cell responses in the control of EBV infection,
allow other biological studies from the ANRS group " Lymphome et VIH ".

The recruitment of 40 cases per year is expected. The length of inclusions is 7 years. The follow-up will be of 2 years. Clinical, pathological and biological data at diagnosis and during follow-up will be collected. This will allow characterizing the lymphoma, the HIV infection, the antitumoral treatments and the outcome of lymphoma. Biological samples will be centralized to collect cell, DNA, RNA, plasma, serum and tumour collections (Y.Taoufik, S Prevot* ). To better understand the EBV infection and lymphomagenesis in HIV infection, we propose to follow the viral load and the molecular characteristics of EBV in PBMC, plasma and tumour (P.Morand* , V.Boyer* ), to investigate the EBV-T cell responses (G.Carcelain) and the presence and reactivation of EBV in peripheral B cells (C.Amiel* , JC Nicolas) and in tumoral samples (M.Raphael* , I.Joab* ). The other mechanisms of lymphomagenesis in HIV infection will be studied by the analysis of the sub-populations of B-cells in terms of activation and differentiation (Y.Taoufik) and by the characterization of MSI tumours (A.Duval).

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Interest of Karate Kata Practice on the Self-esteem of Patients Living With HIV

acronym: KATACHRO

summary:
Since ancient times, physical and sports activity has been recognized as bringing many health benefits. Descriptive and interventional studies on physical activity are developing, demonstrating physical and psychological benefits for patients with various diseases.

Physical activity is effective in improving self-esteem in the general population. Good self-esteem allows for better autonomy to manage a chronic illness.

The benefit of physical activity in patients living with HIV has been the subject of several studies, notably outside France, and seems to improve the quality of life.

We hypothesize that sport, especially karate kata, could improve self-esteem in patients living with HIV, and represent another non-drug aid, in patients living with HIV.

primary_purpose: Supportive Care


lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronym: POOMA

type: EudraCT Number

source: euctr

title: Acute Non-severe Osteomyelitis in Children - Outpatient Management Strategy With Oral Antibiotic Therapy Compared to a Standard Strategy With Conventional Hospitalization and Intravenous Antibiotic Therapy: a Randomized Open-label Non-inferiority Study With Bayesian and Medical-economic Analyses.

summary:
The incidence of bone and joint infections (BJI) in children (osteomyelitis, septic arthritis and spondylodiscitis) is 22 per 100,000 children in France. Every year, 3,000 children are hospitalized for BJI, 46% of whom are hospitalized for osteomyelitis. The clinical pictures of BJI are varied: some are severe from the outset; others are non-severe, such as BJIs in Kingella kingae, which are most common in children between the ages of 6 months and 5 years. Currently, the management of children's BJI, regardless of their severity, involves initial hospitalization to start intravenous antibiotic therapy. This non-inferiority trial evaluates, in children with acute osteomyelitis with no severity criteria, less invasive outpatient management with an oral antibiotic treatment given at the outset compared to standard management.

Main objective : Demonstrate the non-inferiority of an ambulatory management strategy versus a standard strategy involving hospitalization on complete recovery without relapse at 6 months after an episode of acute osteomyelitis in children aged 1-4 years without severity criteria.

Primary endpoint: Complete cure without relapse at 6 months defined by the absence of clinical signs of osteomyelitis at 6 months AND the absence of secondary septic complications (septic arthritis, periosteal abscess) before the end of antibiotic therapy AND the absence of relapse or rehospitalization for osteomyelitis related to the initial infection. This criterion will be assessed blindly by an adjudication committee.

Randomized controlled trial of non inferiority, with active control, in open multi-center.

The control or experimental arm allocation (1:1 ratio) will be open-label of the physician, patient and parents. This is a PROBE study: The evaluation of the main judgment criterion will be carried out blindly by an adjudication committee.


title: Genetical, Multi-center, Prospective Study of Phenotyping and Genotyping of Patients Suffering From Congenital Amaurosis of Leber or From an Early Severe Retinal Dystrophy in the Aim of the Realisation of a Clinical Trial of Gene Therapy

summary: Retinal dystrophies are responsible for numerous cases of blindness, and there are no therapeutic possibilities today. Gene therapy is efficient in a dog model concerning dystrophy linked to a mutation of the rpe65 gene. If such a therapy is to be considered for humans, it is urgent to select, at a national level, patients suffering from dystrophy linked to a mutation of the rpe65 gene. The systematic correlation of phenotype/genotype is an anatomical-functional approach, but it also identifies patients who may be potentially included in a future gene therapy study. Indeed, identification of people with a mutation of rpe65 is still insufficient in France (compared to other European countries) because of a lack of systemic genotyping of retinal dystrophy.

lead_sponsor: Nantes University Hospital


title: Treatment of Chronic Active Antibody Mediated Rejection After Kidney Transplantation by Double-Filtration PlasmaPheresis (DFPP) or Plasma Exchange (PE).

acronym: DFPP

summary:
In France around 90,000 cases of end-stage chronic kidney disease patients treated either by dialysis (60%) or renal transplantation (just over 40%).

In terms of patient survival and quality of life and also economic reasons, the goal in France is to increase renal transplantation instead of patients on dialysis.

After renal transplant, two main causes of the graft loss after the first years are death of patient with functioning graft, and chronic AntiBody Mediated Rejection (ABMR).

Double Filtration PlasmaPheresis (DFPP) has never been evaluated for this indication.

DFPP makes it possible to treat larger volumes of plasma than plasma exchange, and essentially eliminates higher molecular weights molecules including immunoglobulins comprising DSA (donor-specific alloantibody) but also the C1q involved in the lesions of(ABMR). It is postulated that it will be more effective in treating ABMR than usual plasma exchanges.

A chronic ABMR is the result of the appearance de novo production of anti-Human Leucocyte Antigen antibodies (HLA) against one or more graft antigens (DSA: donor-specific alloantibody).These DSAs will lead to accelerated arteriosclerosis in the graft vessels, which will result in rapidly progressive renal failure, usually associated with a high rate of proteinuria.

Numerous studies have shown that up to 20% of renal transplant patients develop DSA within 5 years of renal transplantation.

Today, no treatment has been shown to be effective in the case of chronic ABMR: the basis of treatment is the reduction/elimination of DSA ( by apheresis for example) and the prevention of its re-synthesis B lymphocytes/plasma cells of the patient (with rituximab for example).

The investigators of this study propose in the context of the active ABMR demonstrated by renal biopsy to evaluate in combination with rituximab, a new apheresis technique double Plasma filtration (DFPP) instead of plasma Exchange.

ReferenceCitation: Eskandary F, Bond G, Kozakowski N, Regele H, Marinova L, Wahrmann M, Kikić Ž, Haslacher H, Rasoul-Rockenschaub S, Kaltenecker CC, König F, Hidalgo LG, Oberbauer R, Halloran PF, Böhmig GA. Diagnostic Contribution of Donor-Specific Antibody Characteristics to Uncover Late Silent Antibody-Mediated Rejection-Results of a Cross-Sectional Screening Study. Transplantation. 2017 Mar;101(3):631-641. doi: 10.1097/TP.0000000000001195.

family: Eskandary

full_name: Farsad Eskandary

given: Farsad

family: Bond

full_name: Gregor Bond

given: Gregor

family: Kozakowski

full_name: Nicolas Kozakowski

given: Nicolas

family: Regele

full_name: Heinz Regele

given: Heinz

family: Marinova

full_name: Lena Marinova

given: Lena

family: Wahrmann

full_name: Markus Wahrmann

given: Markus

family: Kikić

full_name: Željko Kikić

given: Željko

family: Haslacher

full_name: Helmuth Haslacher

given: Helmuth

family: Rasoul-Rockenschaub

full_name: Susanne Rasoul-Rockenschaub

given: Susanne

family: Kaltenecker

full_name: Christopher C. Kaltenecker

given: Christopher C.

family: König

full_name: Franz König

given: Franz

family: Hidalgo

full_name: Luis G. Hidalgo

given: Luis G.

family: Oberbauer

full_name: Rainer Oberbauer

given: Rainer

family: Halloran

full_name: Philip F. Halloran

given: Philip F.

family: Böhmig

full_name: Georg A. Böhmig

given: Georg A.

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Diagnostic Contribution of Donor-Specific Antibody Characteristics to Uncover Late Silent Antibody-Mediated Rejection—Results of a Cross-Sectional Screening Study

ReferenceCitation: Eskandary F, Wahrmann M, Mühlbacher J, Böhmig GA. Complement inhibition as potential new therapy for antibody-mediated rejection. Transpl Int. 2016 Apr;29(4):392-402. doi: 10.1111/tri.12706. Epub 2015 Nov 10. Review.

name: Division of Nephrology and Dialysis; Department of Medicine III; Medical University Vienna; Vienna Austria

name: Department of Surgery; Medical University Vienna; Vienna Austria

family: Mühlbacher

full_name: Jakob Mühlbacher

given: Jakob

journal_name: Transplant International

ReferenceCitation: Gatault P, Kamar N, Büchler M, Colosio C, Bertrand D, Durrbach A, Albano L, Rivalan J, Le Meur Y, Essig M, Bouvier N, Legendre C, Moulin B, Heng AE, Weestel PF, Sayegh J, Charpentier B, Rostaing L, Thervet E, Lebranchu Y. Reduction of Extended-Release Tacrolimus Dose in Low-Immunological-Risk Kidney Transplant Recipients Increases Risk of Rejection and Appearance of Donor-Specific Antibodies: A Randomized Study. Am J Transplant. 2017 May;17(5):1370-1379. doi: 10.1111/ajt.14109. Epub 2017 Jan 3.

name: EA4245 Dendritic Cells; Immunomodulation and Grafts; François-Rabelais University; Tours France

name: Department of Nephrology and Clinical Immunology; CHRU Tours; Tours France

name: Department of Nephrology and Organ Transplantation; CHU Rangueil; Toulouse France

name: INSERM U1043; IFR-BMT; CHU Purpan; Toulouse France

name: Université Paul Sabatier; Toulouse France

name: Department of Kidney Transplantation; CHU Reims; Reims France

name: Department of Kidney Transplantation; CHU Rouen; Rouen France

name: Department of Kidney Transplantation; Kremlin-Bicêtre Hospital; Villejuif France

name: Department of Kidney Transplantation; CHU Nice; Nice France

name: Department of Kidney Transplantation; CHU Rennes; Rennes France

name: Department of Kidney Transplantation; CHU Brest; Brest France

name: Department of Kidney Transplantation; CHU Limoges; Limoges France

name: Department of Kidney Transplantation; CHU Caen; Caen France

name: Department of Kidney Transplantation; Necker Hospital; Paris France

name: Department of Kidney Transplantation; CHRU Strasbourg; Strasbourg France

name: Department of Kidney Transplantation; CHU Clermont-Ferrand; Clermont-Ferrand France

name: Department of Kidney Transplantation; CHU Amiens; Amiens France

name: Department of Kidney Transplantation; CHU Angers; Angers France

name: Department of Kidney Transplantation; Georges-Pompidou Hospital; Paris France

ReferenceCitation: Loupy A, Haas M, Solez K, Racusen L, Glotz D, Seron D, Nankivell BJ, Colvin RB, Afrouzian M, Akalin E, Alachkar N, Bagnasco S, Becker JU, Cornell L, Drachenberg C, Dragun D, de Kort H, Gibson IW, Kraus ES, Lefaucheur C, Legendre C, Liapis H, Muthukumar T, Nickeleit V, Orandi B, Park W, Rabant M, Randhawa P, Reed EF, Roufosse C, Seshan SV, Sis B, Singh HK, Schinstock C, Tambur A, Zeevi A, Mengel M. The Banff 2015 Kidney Meeting Report: Current Challenges in Rejection Classification and Prospects for Adopting Molecular Pathology. Am J Transplant. 2017 Jan;17(1):28-41. doi: 10.1111/ajt.14107.

name: Paris Translational Research Center for Organ Transplantation INSERM U970 & Necker Hospital University Paris Descartes; Paris France

name: Department of Pathology & Laboratory Medicine; Cedars-Sinai Medical Center; Los Angeles CA

name: Department of Laboratory Medicine and Pathology; University of Alberta; Edmonton Canada

name: Department of Laboratory Medicine and Pathology; Johns Hopkins University School of Medicine; Baltimore MD

name: Paris Translational Research Center for Organ Transplantation & Department of Nephrology and Transplantation; Hopital Saint Louis; Université Paris VII and INSERM U 1160; Paris France

name: Nephrology Department; Hospital Vall d'Hebron; Autonomous University of Barcelona; Barcelona Spain

name: Department of Renal Medicine; Westmead Hospital; Sydney Australia

name: Department of Pathology; Massachusetts General Hospital; Harvard Medical School; Boston MA

name: Departments of Pathology & Internal Medicine; University of Texas Medical Branch; Galveston TX

name: Montefiore Medical Center; Albert Einstein College of Medicine; Bronx NY

name: Division of Nephrology; Department of Medicine; Johns Hopkins University School of Medicine; Baltimore MD

name: Institute of Pathology; University Hospital of Cologne; Cologne Germany

name: Department of Laboratory Medicine and Pathology; Mayo Clinic; Rochester MN

name: University of Maryland School of Medicine; Baltimore MD

name: Berlin Institute of Health and Department of Nephrology and Critical Care Medicine; Charité Universitätsmedizin; Berlin Germany

name: Department of Nephrology; Leiden University Medical Center; Leiden the Netherlands

name: Department of Pathology; University of Manitoba; Winnipeg Canada

name: Department of Pathology & Immunology; Washington University; St. Louis MO

name: Division of Nephrology and Hypertension; Department of Medicine; New York Presbyterian Hospital-Weill Cornell Medicine; New York NY

name: Department of Pathology and Laboratory Medicine; University of North Carolina; Chapel Hill NC

name: Division of Transplantation Pathology; The Thomas E Starzl Transplantation Institute; University of Pittsburgh; Pittsburgh PA

name: Department of Pathology and Laboratory Medicine; University of California; Los Angeles CA

name: Department of Cellular Pathology; Hammersmith Hospital; London UK

name: Department of Pathology; Weill Cornell Medicine; New York NY

name: Division of Nephrology; Mayo Clinic; Rochester MN

name: Comprehensive Transplant Center; Transplant Immunology Laboratory; Northwestern University; Chicago IL

name: University of Pittsburgh Medical Center; Pittsburgh PA

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

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

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

repositories: California Digital Library - eScholarship

ReferenceCitation: Hanafusa N, Kondo Y, Suzuki M, Nakao A, Noiri E, Fujita T. Double filtration plasmapheresis can decrease factor XIII Activity. Ther Apher Dial. 2007 Jun;11(3):165-70.


title: Sarcopenia in Axial and Peripheral Spondyloarthropathies

acronym: SASPAR

summary:
Spondylarthropathies (SpA) are among the most common chronic inflammatory rheumatisms in adults, responsible for a muscular loss or sarcopenia which can be very disabling, not much documented in the literature, and not yet studied in France. In addition, sarcopenia is associated with decreased physical activity and increased risk of falls and fractures. A better characterization of the determinants of this muscular loss will allow to better detect and take care of it.

The aim is to conduct the first French study on the prevalence and severity of sarcopenia in patients with spondyloarthropathies and to study the variables that may be associated with it. Finally, we propose to evaluate obesity related to sarcopenia in these patients and compare them to cases matched for age and sex (from OFELY / STRAMBO cohorts, Lyon, FRANCE).

This is a prospective interventional and monocentric study with minimal risks and constraints: patients will be included for one day for an evaluation of their sarcopenia by measuring their muscle strength, physical performance and body composition and recording of their socio-demographic and disease characteristics.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Rhumatologie - Hôpital Edouard Herriot


title: Prospective Study of Dysarthria, Swallowing Disorders and Respiratory in Parkinson's Disease

acronym: ProdDiGYPark

summary: The investigators prospectively enrolled 64 early PD patients (less than 3 years after the first symptom) in order to prospectively assess the natural history of non-dopaminergic symptoms.

lead_sponsor: University Hospital, Lille


title: A Randomized Placebo-Controlled Double Blind Trial Comparing Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture in Combination With Local Local 1% Xylocaine Anesthetic Versus Placebo in Order to Evaluate Pain Intensity During Bone Marrow Biopsy.

summary:
Bone marrow biopsy is a painful medical procedure often performed with local anesthetic.

Therefore a double-blind, randomized, controlled trial was carried out in 330 adult patients who where referred for bone marrow biopsy and aspiration. 164 were assigned to inhale an equimolar mixture of nitrous oxide and oxygen and 166 to inhale a placebo. Pain measurement used visual-analogue pain scales, which involve rating the intensity of pain on a horizontal ruler

primary_purpose: Prevention

lead_sponsor: Poitiers University Hospital


title: New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis

acronym: IRM-SLA

summary: Amyotrophic lateral sclerosis (ALS) is a disabling and rapidly progressive neurodegenerative disorder. There is no treatment that significantly slows progression. Our project aims to find new biomarkers in MRI at three levels: cerebral, medullary and muscular. These markers could allow an earlier diagnosis of the disease by showing more specific lesions of ALS and to quantify these lesions to measure the progression of the disease. This study will use advanced Magnetic Resonance Imaging (MRI) techniques High field (3T) and very high field (7T) MRI. Results from neurological and electrophysiological tests will be compared to the MRI. Subjects will be recruited from ALS center of Marseille, France. MRI will be done on ALS patients at baseline, at 3 month and at 6 month intervals.

lead_sponsor: Assistance Publique Hopitaux De Marseille