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].

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.

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. doi: 10.1055/s-0032-1309781. Epub 2012 Sep 25.

ReferenceCitation: US Preventive Services Task Force; Bibbins-Domingo K, Grossman DC, Curry SJ, Davidson KW, Epling JW Jr, Garcia 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. JAMA. 2017 Jun 6;317(21):2239.

publisher_dissemination: American Medical Association

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.

oa_colors: green hybrid

evidence: open (via page says Open Access)

license: unspecified-oa

license_normalized: unspecified-oa

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


type: Other Identifier

title: Identification of Genes and Pathogenesis Involved in Familial Thoracic Aortic Aneurysm (TAA)

acronym: TAA

summary:
The primary objectives of the study are

to assess the contribution of alteration of each known gene on non-syndromic TAA.
to map and identify unknown gene involved in the non-syndromic TAA.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Département de Génétique, Hôpital Bichat

lead_sponsor_type: academique

status_simplified: Completed


title: Absolute Quantification in Bone Scintigraphy: Phantom Evaluation and Clinical Application in Patients Undergoing Follow-up for Vertebral Fractures.

summary: While absolute quantification in 18F-FDG PET (Positon Emission Tomography) is widely used in clinical routine, absolute quantification in SPECT (Single Photon Emission Computed Tomography) is under development and its clinical interest remains to be demonstrated. Recent studies carried out on bone scan recordings show the potential interest of quantification indexes such as SUV (Standard Uptake Value).

time_perspective: Retrospective

ipd_sharing: No

lead_sponsor: Central Hospital, Nancy, France

location_facility:
CHRU of Nancy
CHU de Nancy - Hôpital Brabois
Chru Nancy

intervention_type: Device


title: Physical and Moral Benefits of Adapted Fencing in Patients With Invasive Breast Cancer: Pilot Study of a Randomized Trial

acronym: RIPOSTE

summary: Literature have shown the benefit of practicing regular physical activity during and after cancer treatment, particularly in terms of improving quality of life. The French Fencing Federation has thus developed an adapted physical activity program (Solution RIPOSTE) specially intended for patients with breast cancer. Adapted fencing sessions (saber) are thus offered to these patients in a perfectly secure context (i.e. compulsory medical-sports evaluation and trained fencing master). Since 2016, this RIPOSTE program has been implemented in several fencing halls in Lorraine. Our research project (controlled, randomized trial) aims to assess the impact of the practice of adapted fencing on the quality of life of patients, the functional capacities of the operated side (shoulder) and on the reduction of the sides effects of treatments. Our hypothesis is that such an adapted fencing program improves quality of life as well as functional abilities.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Omorou AY, Peiffert D, Rotonda C, Van Hoye A, Allado E, Hily O, Temperelli M, Chenuel B, Hornus-Dragne D, Poussel M. Adapted Fencing for Patients With Invasive Breast Cancer: The RIPOSTE Pilot Randomized Controlled Trial. Front Sports Act Living. 2022 Mar 29;4:786852. doi: 10.3389/fspor.2022.786852. eCollection 2022.

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 pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

location_facility:
Hia Legouest
Institut de Cancerologie de Lorraine
CHRU Nancy

intervention_type: Other

status_simplified: Unknown


type: Registry Identifier

title: Epidemiologic Study on Small-for-gestational-age Children (EPIPAGE2 Cohort Study) - Follow up at Five and a Half Years

summary:
Epipage 2 (epidemiologic study on small-for-gestational-age children) is a nationwide study implemented to improve our knowledge of the outcome of preterm children in France. This study was launched on March 28, 2011 and includes three groups of preterm children, all born before 35 weeks: extremely preterm infants (born between 22 and 26 completed weeks of gestation), very preterm children (born between 27 and 31 completed weeks) and moderately preterm children (born between 32 and 34 completed weeks).

These children are being studied from their birth up to the age of 12 years. At birth, data on maternal and infants' characteristics were collected from medical records. At one and two years, questionnaires sent to families and to physicians (at two years only) allowed to collect data about the children's life and health.

At five and a half years, medical and psychological assessments are specifically implemented for the study in order to evaluate motor and cognitive disorders in this population.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: Hôpital Saint Vincent de Paul - Groupement des Hôpitaux de l'Institut Catholique de Lille

location_facility: Hôpital Bel Air Thionville - CHR Metz Thionville


title: In Vivo Optimization Study of the Braindex Cerebral Tissue Oxygen Saturation (SctO2) Measurement Algorithm Compared to a Mixed Reference Value of Jugular Venous and Systemic Arterial Saturation During Proven Cerebral Autoregulation Loss

summary:
The objective of this clinical trial is to optimize Braindex brain tissue oxygen saturation (SctO2) measurement algorithm compared to a mixed reference value of jugular venous and systemic arterial saturation, during proven reproducible and standardized loss of brain autoregulation induced during transcatheter aortic valve replacement procedures. The main question it aims to answer is: assessing and improving the sensitivity/specificity of Braindex SctO2 measurements.

Study type: single-center, prospective, interventional, open-label, exploratory clinical trial.

Participant population/health status:

Patient, male or female, over 18 years of age
Patient scheduled for percutaneous femoral aortic valve replacement with aortic valve balloon deployment (Edwards Sapien valve) under simple sedation with Remifentanil (TIVA), with spontaneous ventilation.

The expected outcome of this research is to optimize in vivo the algorithm for calculating the SctO2 of the BRAINDEX sensor in surgical conditions, in a context of proven low cerebral flow, on a target population. It is expected, in the long run, a better quality of detection of the loss of cerebral auto-regulation leading to a faster and optimal correction, thus potentially limiting the risk of POCD, subcortical stroke and postoperative cognitive decline.

status: Recruiting

primary_purpose: Other

lead_sponsor: Braindex

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Cryoablation of Venous Vascular Malformations Located in Soft Tissues

acronym: CRYOMAV

summary: To now, two alternatives for the management of venous vascular malformations are recognized, appropriate to the location, size and patients: sclerosis and surgery. However, sclerosis is effective on symptoms in 80% of cases and excision removes the malformation completely or partially, but it is aggressive and recurrences are common.

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Cornelis F, Neuville A, Labreze C, Kind M, Bui B, Midy D, Palussiere J, Grenier N. Percutaneous cryotherapy of vascular malformation: initial experience. Cardiovasc Intervent Radiol. 2013 Jun;36(3):853-6. doi: 10.1007/s00270-012-0434-9. Epub 2012 Jun 22.

ReferenceCitation: Cornelis F, Havez M, Lippa N, Al-Ammari S, Verdier D, Carteret T, Amoretti N, Gangi A, Palussiere J, Hauger O, Grenier N. Radiologically guided percutaneous cryotherapy for soft tissue tumours: A promising treatment. Diagn Interv Imaging. 2013 Apr;94(4):364-70. doi: 10.1016/j.diii.2013.02.001. Epub 2013 Mar 11.

ReferenceCitation: Barza M, Pavan PR, Doft BH, Wisniewski SR, Wilson LA, Han DP, Kelsey SF. Evaluation of microbiological diagnostic techniques in postoperative endophthalmitis in the Endophthalmitis Vitrectomy Study. Arch Ophthalmol. 1997 Sep;115(9):1142-50. doi: 10.1001/archopht.1997.01100160312008.

lead_sponsor: University Hospital, Bordeaux


title: Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients After Acute Exacerbation With Monitoring the Quality of Support

summary: The hypothesis of this study is that any of 3 modalities of home non- invasive ventilation (NIV) compared to 'no NIV' (=hospital NIV) will reduce re-admission to hospital or death in COPD patients who remain persistently hypercapnic following an exacerbation requiring NIV.

ReferenceCitation: Rescue2-monitor group. Respiratory support in COPD patients after acute exacerbation with monitoring the quality of support (Rescue2-monitor): an open-label, prospective randomized, controlled, superiority clinical trial comparing hospital- versus home-based acute non-invasive ventilation for patients with hypercapnic chronic obstructive pulmonary disease. Trials. 2020 Oct 22;21(1):877. doi: 10.1186/s13063-020-04672-w. Erratum In: Trials. 2020 Nov 23;21(1):961.

publisher_dissemination: Springer-Nature

lead_sponsor: Clinact

sponsor_collaborators:
Clinact
Fondation du Souffle
Assistance Publique - Hôpitaux de Paris

location_facility: Groupe Hospitalier Pitié Salpêtrière-Charles Foix


title: Efficiency and Satisfaction With Telephone Consultation in Neuro-urology: Experience of the COVID-19 Pandemic

summary:
The COVID-19 pandemic has necessitated drastic measures in order to limit the spread of SARS-CoV-2. The stay home policies for the whole population and especially for frail patients and the express instruction to deprogram non-urgent consultations and interventions limited the clinic visits in neuro-urology department. In this context, telemedicine was seen as a pragmatic solution to provide follow-up care for our neurologic patients. Due to the delay in deploying telemedicine and the cognitive impairment of some of our patients, telephone consultation has been prioritized.

The COVID-19 pandemic might be an opportunity to review and refine our practices in neuro-urology. For the follow-up of selected patients, telephone consultations may be efficient and cost effective.

The aim of the study is to assess the efficiency and the satisfaction with telephone consultation for the physician and the patient.

The study was conducted in a neuro-urology department of a university hospital in France.

During the stay-home policies for the COVID-19 pandemic, all the scheduled medical visits were converted into telephone consultation. New patients weren't included.

For each teleconsultation, the physician assess the duration of the consultation, the number of tries to join the patient, the efficiency of the consultation, the difficulty to obtain relevant information due to the phone way of the consultation and the lack of physical examination.

On the next days, the patient was contacted by phone and was asked a) if he was satisfied of being phoned by the physician, b) if the teleconsultation was embarrassing, c) if he had enough time of teleconsultation d) if he got all the answers to his queries, e) if he would preferred to had a physical consultation f) to assessed the global satisfaction of the teleconsultation and g) if in the future, they may considered converting some clinic visits to teleconsultations.

The physician and the patient assessed whether this teleconsultation has replaced a physical visit.

The usual transport mode of the patient for a clinic visit and the need to take a day off for worker patients were recorded.

The primary aim was to assess the efficiency and the satisfaction of the telephone consultation. The primary outcome was the evaluation of the efficiency of the telephone consultation by the physician on a numerical 10-points scale. The secondary outcome was the evaluation of the satisfaction of the telephone consultation by the patient on a numerical 10-points scale.

Four hundred teleconsultations are scheduled for five physicians.

ipd_sharing: Undecided

lead_sponsor: Pierre and Marie Curie University

location_facility: Department of Neuro- Urology, Hôpital Tenon


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

intervention_type: Behavioral


title: Initialization of Methadone in Primary Care; a Randomized Intervention Research for Preventing HCV Transmission Practices. ANRS Methaville

acronym: Methaville

summary:
The rapid scale up of opioid substitution treatment (OST) for drug users mainly achieved through the possibility of prescribing buprenorphine in primary care has been successful in reducing HIV prevalence among drug users but still inadequate for reducing the spread of HCV. To date, methadone in France can only be initialised in drug centres but GPs can prescribe methadone after stabilisation of dosages.

This study was born as an answer to a request from the French Minister of Health that supports the initialisation of methadone in primary care in order to improve coverage by OST (now 70%) in drug users.

primary_purpose: Prevention

ReferenceCitation: Carrieri P, Vilotitch A, Nordmann S, Lions C, Michel L, Mora M, Morel A, Maradan G, Spire B, Roux P; Methaville Study Group. Decrease in self-reported offences and incarceration rates during methadone treatment: A comparison between patients switching from buprenorphine to methadone and maintenance treatment incident users (ANRS-Methaville trial). Int J Drug Policy. 2017 Jan;39:86-91. doi: 10.1016/j.drugpo.2016.08.005. Epub 2016 Oct 19.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Roux P, Lions C, Vilotitch A, Michel L, Mora M, Maradan G, Marcellin F, Spire B, Morel A, Carrieri PM; ANRS Methaville study group. Correlates of cocaine use during methadone treatment: implications for screening and clinical management (ANRS Methaville study). Harm Reduct J. 2016 Apr 5;13:12. doi: 10.1186/s12954-016-0100-7.

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

repository_institution: PubMed Central - Europe PMC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - TEL - Thèses en ligne

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

ReferenceCitation: Carrieri PM, Michel L, Lions C, Cohen J, Vray M, Mora M, Marcellin F, Spire B, Morel A, Roux P; Methaville Study Group. Methadone induction in primary care for opioid dependence: a pragmatic randomized trial (ANRS Methaville). PLoS One. 2014 Nov 13;9(11):e112328. doi: 10.1371/journal.pone.0112328. eCollection 2014.

repository_institution: Conservatoire national des arts et métiers - HAL CNAM

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université d'Artois

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

evidence: oa repository (semantic scholar lookup)

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

ReferenceCitation: Roux P, Lions C, Michel L, Mora M, Daulouede JP, Marcellin F, Spire B, Morel A, Carrieri PM; ANRS Methaville study group. Factors associated with HCV risk practices in methadone-maintained patients: the importance of considering the couple in prevention interventions. Subst Abuse Treat Prev Policy. 2014 Sep 10;9:37. doi: 10.1186/1747-597X-9-37.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

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

ReferenceCitation: Lions C, Carrieri MP, Michel L, Mora M, Marcellin F, Morel A, Spire B, Roux P; Methaville Study Group. Predictors of non-prescribed opioid use after one year of methadone treatment: an attributable-risk approach (ANRS-Methaville trial). Drug Alcohol Depend. 2014 Feb 1;135:1-8. doi: 10.1016/j.drugalcdep.2013.10.018. Epub 2013 Oct 31.

ReferenceCitation: Roux P, Michel L, Cohen J, Mora M, Morel A, Aubertin JF, Desenclos JC, Spire B, Carrieri PM; ANRS Methaville Study Group. Methadone induction in primary care (ANRS-Methaville): a phase III randomized intervention trial. BMC Public Health. 2012 Jun 28;12:488. doi: 10.1186/1471-2458-12-488.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis


title: A Prospective, Monocentric, Open, Non-controlled Study Evaluating the French Version of the CIQoL-35 Quality of Life Questionnaire in Adult Cochlear Implant Use

acronym: CIQoL

summary: The Cochlear Implant - Quality of Life (CIQoL) PROM is a quality-of-life assessment questionnaire for adults with cochlear implants. The CIQoL responds to an important need for a questionnaire that captures the benefits of cochlear implantation as perceived by patients and that can be used in clinical practice.

lead_sponsor: Oticon Medical

location_facility: Centre de Recherche en Audiologie adulte


title: Optimizing Drug Management of Patients Suffering From Rare Disease Through Medication Reconciliation: Proof of Concept in Pulmonary Hypertension

acronym: OPTICARE-HTP

summary: Pulmonary hypertension (PH) is a life threatening condition. In PH, pulmonary arterial hypertension (PAH) and chronic thrombo-embolic chronic pulmonary hypertension (CTEPH) are two rare diseases requiring specific and complex drug management. In France ,a part of these treatments ,only available in hospital pharmacies, are generally unknown from community health care professionals despite the high risk of drug-interactions and side effects. Anticipating medication errors at the begging of the disease is therefore important, and could be done through medication reconciliation.

status: Active, not recruiting

ipd_sharing_description: No sharing

collaborators: Agence Regionale de Sante d'Ile de France


title: Palliative Care Transfer Announcements: Qualitative Analysis of the Perspective of Physicians and Their Patients With Cancer

summary:
The course of care of a patient with a cancer whose evolution is pejorative, is marked by difficult announcements, called "bad news". In the palliative phase, prognostic announcements are at the forefront. Of these, the announcement of a transfer to the Palliative Care Unit has not been the subject of any specific studies to the best of our knowledge. It therefore seemed interesting to us to explore the stakes of this particular announcement, a source of upheaval for the doctor and the patient, by gathering the point of view of each one.

The objective of our study is to analyze the methods of announcing a transfer to the Palliative Care Unit and the perception of this announcement by the doctor and his patient with an incurable cancer.

time_perspective: Other

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service : Unité de soins d'Accompagnement de soins de Support et de soins Palliatifs (UnASP)


title: Efficacy of a Brief Alcohol Intervention for Non Dependant Alcohol-misusing Patients Undergoing a Scheduled Surgery: a Randomized Controlled Trial

acronym: ITBCHIR

summary:
Excessive alcohol consumption is a worldwide major public health problem. Brief interventions have shown to be an efficient treatment modality for problem drinkers, but have never been tested in scheduled surgery.

Patients will be recruited in various surgery units in 7 hospital in France. All patients attending a scheduled surgery will be screened during the visit with the anaesthesist by the Alcohol Use Disorders Identification Test (AUDIT). Patients aged 30-75 with an AUDIT between 7 and 12, corresponding to at risk or harmful use, will be proposed to enter a control study and randomized between a brief intervention by a trained nurse during the post-surgery hospitalisation and no intervention. Twelve months after the surgery, a research technician will interview by telephone patients and evaluate AUDIT and alcohol consumption of the last month.

status: Terminated

lead_sponsor: Rennes University Hospital

sponsor_collaborators:
Rennes University Hospital
Ministry of Health, France

location_facility: Unité d'Alcoologie et Hépatologie Générale, Département d'Anesthésie Réanimation- Hôpital de Pontchaillou


title: Evaluation of Hypophosphatemia as a Predictive Marker of Mortality During Sepsis in ICU

acronym: PORPOISE-REA

summary: Retrospective study in the 3 intensive care units of the Brest Teaching Hospital (France) during a 18-months period (June 2014 -December 2015) to study the independent association between hypophosphatemia and 90-day mortality.

ReferenceCitation: Padelli M, Aubron C, Huet O, Hery-Arnaud G, Vermeersch V, Hoffmann C, Bettacchioli E, Maguet H, Carre JL, Leven C. Is hypophosphataemia an independent predictor of mortality in critically ill patients with bloodstream infection? A multicenter retrospective cohort study. Aust Crit Care. 2021 Jan;34(1):47-54. doi: 10.1016/j.aucc.2020.05.001. Epub 2020 Jul 27.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

license: cc-by-nc

license_normalized: cc-by-nc

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

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

repositories_concat: HAL

unpaywall_oa_status: hybrid

lead_sponsor: University Hospital, Brest


title: Prospective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence

summary: Experimental and epidemiologic studies have suggested that aspirin intake reduces the risk for colorectal cancer. In the APACC study we randomly assigned 291 patients to daily Aspirin or Placebo for 4 years. However, the available data are not sufficient to serve as the basis for firm recommendations

ReferenceCitation: Benamouzig R, Deyra J, Martin A, Girard B, Jullian E, Piednoir B, Couturier D, Coste T, Little J, Chaussade S. Daily soluble aspirin and prevention of colorectal adenoma recurrence: one-year results of the APACC trial. Gastroenterology. 2003 Aug;125(2):328-36. doi: 10.1016/s0016-5085(03)00887-4.

ReferenceCitation: Benamouzig R, Uzzan B, Deyra J, Martin A, Girard B, Little J, Chaussade S; Association pour la Prevention par l'Aspirine du Cancer Colorectal Study Group (APACC). Prevention by daily soluble aspirin of colorectal adenoma recurrence: 4-year results of the APACC randomised trial. Gut. 2012 Feb;61(2):255-61. doi: 10.1136/gutjnl-2011-300113. Epub 2011 Sep 2. Erratum In: Gut. 2012 Mar;61(3):472.

collaborators: Société Nationale Française de Gastroentérologie

location_facility: Hôpital COCHIN Service d'Hépato-Gastro-Entérologie

intervention_type: Drug


title: Safety and Clinical Performance of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Abdominal Wall Reconstruction: an Observational Prospective Study.

summary:
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure, and to identify emerging risks in comparison to the clinical data related to other types of fixation material.

The present study will be a prospective multicentric non-randomized and noncontrolled trial involving 112 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.

lead_sponsor: Meccellis Biotech

location_facility: Groupe Hospitalier La Rochelle - Ré - Aunis

location_facility: CHU Montpellier, Hôpital Saint-Eloi, Pôle digestif, Service de Chirurgie Digestive B et Transplantation

location_facility: CHU Caen Normandie, Service de Chirurgie Digestive


title: Study of Diagnostic Performances of Dual Energy Imaging With Flat Detectors and Tomosynthesis in Identification of Loosening of Painful Hip Prosthesis

acronym: PLIDET

summary:
The purpose is to determine diagnostic performances of flat panel dual energy arthrography and arthro-tomosynthesis in identification of loosening of painful hip prosthesis, taking as reference the results of surgery performed 6 months after arthrography.

Secondary purposes are:

To describe the level of concordance of each technique with the indication for surgery
To study inter-technique concordance with kappa coefficient
To study the relationship between density differential between 2 acquisitions and grey level on subtraction, i.e. subtraction quality according to metal

primary_purpose: Diagnostic

location_facility:
SINCAL
CHU de Nancy

intervention_type: Procedure


title: Evaluation of Hypophosphatemia as a Predictor of Sepsis in Surgical Resuscitation Units.

summary: Retrospective study in the surgical intensive care unit of the Brest Teaching Hospital (France) during a 6-months period (January 2015 -May 2015) to study the independent association between hypophosphatemia and 28-day infection.


title: Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents: a Randomized Controlled Trial

summary:
The incidence of type 1 diabetes is increasing in France. A recent cross sectional study has shown that in France, only 15% of children and 26% of adults had HbA1c<7%. Adolescents seem to need particularly a better metabolic control.

Working Hypothesis:

We hypothesized that a stricter control of glycaemia by nurse-counselling could probably improve metabolic control in adolescents with type 1 diabetes.

Objectives:

To show that nurse-counselling may improve levels of patient satisfaction.

Methodology:

The main criterion is the patient acceptance of diabetes measured by an analogical visual scale rated from 0 (I cope very well with my diabetes, I cope very badly with my diabetes) to 10 cm. The scale will be measured every quarter within 12 months follow-up. We wish to improve patient's appreciation by 10 mm, near to "I cope very well with my diabetes".

This is a randomised parallel group study with 36 subjects in each group. During the follow-up, the "routine follow-up" group will continue its routine care. The "complementary follow-up" group will be called by nurses every 15 days and consult monthly. HbA1c is the secondary criterion and will be measured every 3 months.

The total study duration is 18 months including 6 months for the recruitment and 12 months for the patients follow-up

ReferenceCitation: Kassai B, Rabilloud M, Bernoux D, Michal C, Riche B, Ginhoux T, Laudy V, Terral D, Didier-Wright C, Maire V, Dumont C, Cottancin G, Plasse M, Jeannoel GP, Khoury J, Bony C, Lievre M, Drai J, Nicolino M. Management of adolescents with very poorly controlled type 1 diabetes by nurses: a parallel group randomized controlled trial. Trials. 2015 Sep 8;16:399. doi: 10.1186/s13063-015-0923-7.


title: Effects of a Series of Intensified Prevention Consultations on the Changes in Goals and Risk Factors in Hypertensive Patients at High Cardiovascular Risk

acronym: ESCAPE

summary:
Observational studies performed in France and abroad in hypertensive patients at high cardiovascular risk have shown a wide gap between the therapeutic targets reached in ambulatory patients and those set by guidelines. In primary prevention, in hypertensive patients at high cardiovascular risk (+ at least 2 risk factors), the gap is secondary to 1) the ignorance of the validated therapeutic targets and strategies, 2) the absence of global cardiovascular risk management, 3) the usual ambulatory medical practice, which is not adapted to a global cardiovascular prevention approach.

Objectives Principal. To demonstrate that a series of 5 specific prevention consultations over 2 years allows a greater number of hypertensive patients at high cardiovascular risk to reach the goals set by guidelines with no deterioration of their quality of life compared with no particular intervention.

Method Pragmatic, cluster-randomised controlled trial. At least 1904 high cardiovascular risk hypertensive patients will be included and followed up during two years by 268 teaching general practitioners from 23 regional teaching colleges. The regional teaching colleges will be randomised to avoid a contamination bias. The study will be coordinated by local coordinators at the college level.

Intervention In the intervention group, the investigators will have training, information, and feed back regarding the management of high risk hypertensive patients. The training will concern the targets to be reached, therapeutic strategies recommended by the AFSSAPS/HAS, and scientific data. The investigators will have an easy guide that can be used during consultations, and will be informed about tobacco withdrawal programs and education for improving diet, exercise and compliance.

In the control group, investigators will care for their patients as usual. End points Main: number of patients who reach all the therapeutic targets defined by the guidelines in the total study population, in the sub-group of patients with hypertension, but free of type-2 diabetes (T2D), and in the sub-group with hypertension and DT2.

Secondary: number of targets reached by the patients, changes in level of blood pressure, LDL-cholesterol, HbA1c, tobacco consumption, and use of aspirin if needed in the total population and its two subgroups, estimated cardiovascular risk, quality of life.

ReferenceCitation: Lebeau JP, Cadwallader JS, Vaillant-Roussel H, Pouchain D, Yaouanc V, Aubin-Auger I, Mercier A, Rusch E, Remmen R, Vermeire E, Hendrickx K. General practitioners' justifications for therapeutic inertia in cardiovascular prevention: an empirically grounded typology. BMJ Open. 2016 May 13;6(5):e010639. doi: 10.1136/bmjopen-2015-010639.

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

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

repositories:
HAL
PubMed Central
irua

repositories_concat: HAL;PubMed Central;irua

repositories_pmh: HAL europepmc.org irua

publisher_dissemination: British Medical Journal

ReferenceCitation: Pouchain D, Lievre M, Huas D, Lebeau JP, Renard V, Bruckert E, Girerd X, Boutitie F; French National College of Teachers in General Practice. Effects of a multifaceted intervention on cardiovascular risk factors in high-risk hypertensive patients: the ESCAPE trial, a pragmatic cluster randomized trial in general practice. Trials. 2013 Oct 1;14:318. doi: 10.1186/1745-6215-14-318.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

publisher_dissemination: Springer

lead_sponsor: Collège National des Généralistes Enseignants

collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility:
Service de Pharmacologie Clinique
French National College of GP Teatchers


acronym: CHIRPAN

summary: This data base has been set in order to gather medical and surgical information from patients who have undergone surgery for pancreatic cancer, at Institut Paoli Calmettes or Assistance Publique des Hôpitaux de Marseille, France.

lead_sponsor: Institut Paoli-Calmettes


title: Whole Blood Immune Cells Characterization in Critically Ill COVID-19 Patients: A Prospective Study

acronym: COVIDIMM

summary:
SARS-CoV-2 outbreak causes a spectrum of clinical patterns that varies from asymptomatic infection to mildly symptomatic manifestations and more-severe forms that need intensive care. Until now, the immune response to SARS-CoV-2 virus infection has been poorly reported to help decision for immune modulation therapies. As a consequence, trials have been designed to test both anti-inflammatory molecules as steroids or anti-bodies against IL-6, and others proposing to "boost" immunity with interferon beta based on similar inclusion criteria.

The immune response to infective agents including viruses may have a complex time evolution with early and late phases corresponding to different patterns, oscillating between pro-inflammation and immune-depression. The potential window to improve outcome in COVID-19 by therapeutic intervention aimed at a fine tuning between immune toxicity and immunodepression requires a longitudinal assessment during the course of illness, especially for the patients who develop acute respiratory failure. Immune monitoring of both innate and adaptive immunity would then be essential to appropriately design clinical trials.

The whole blood cells evaluation was recorded according to the time intervals between the onset of symptoms and the sampling after ICU admission. Patients' care was standardized, especially with regard to ventilation, sedation, and antimicrobial treatment.

In this study the investigators prospectively perform a longitudinal study of both innate and adaptive immunity on patients admitted to ICU for an COVID-19 related acute respiratory failure. The data will be analyzed in reference to the onset of initial symptoms and also to the admission in ICU.

The primary end point is the evolution of the characterization of monocytes and their subsets in term of number and expression of HLA-DR. A similar approach is used for lymphocytes and their subtypes with in addition, an ex vivo testing of their capabilities to be stimulated by SARS-CoV-2 viral proteins in term of TNFalpha, INFgamma, and IL1beta production.

The secondary end-point was to test the association with outcomes and other non-specific markers of inflammation as CRP (C reactive protein), PCT (procalcitonin), DDimers and ferritin.

ReferenceCitation: Tan L, Wang Q, Zhang D, Ding J, Huang Q, Tang YQ, Wang Q, Miao H. Lymphopenia predicts disease severity of COVID-19: a descriptive and predictive study. Signal Transduct Target Ther. 2020 Mar 27;5(1):33. doi: 10.1038/s41392-020-0148-4. No abstract available. Erratum In: Signal Transduct Target Ther. 2020 Apr 29;5(1):61.

ReferenceCitation: Payen D, Faivre V, Miatello J, Leentjens J, Brumpt C, Tissieres P, Dupuis C, Pickkers P, Lukaszewicz AC. Multicentric experience with interferon gamma therapy in sepsis induced immunosuppression. A case series. BMC Infect Dis. 2019 Nov 5;19(1):931. doi: 10.1186/s12879-019-4526-x.

ReferenceCitation: Ziegler-Heitbrock L, Ancuta P, Crowe S, Dalod M, Grau V, Hart DN, Leenen PJ, Liu YJ, MacPherson G, Randolph GJ, Scherberich J, Schmitz J, Shortman K, Sozzani S, Strobl H, Zembala M, Austyn JM, Lutz MB. Nomenclature of monocytes and dendritic cells in blood. Blood. 2010 Oct 21;116(16):e74-80. doi: 10.1182/blood-2010-02-258558. Epub 2010 Jul 13.

ReferenceCitation: Hotchkiss RS, Monneret G, Payen D. Sepsis-induced immunosuppression: from cellular dysfunctions to immunotherapy. Nat Rev Immunol. 2013 Dec;13(12):862-74. doi: 10.1038/nri3552. Epub 2013 Nov 15.

ReferenceCitation: Alattar R, Ibrahim TBH, Shaar SH, Abdalla S, Shukri K, Daghfal JN, Khatib MY, Aboukamar M, Abukhattab M, Alsoub HA, Almaslamani MA, Omrani AS. Tocilizumab for the treatment of severe coronavirus disease 2019. J Med Virol. 2020 Oct;92(10):2042-2049. doi: 10.1002/jmv.25964. Epub 2020 May 10.

ReferenceCitation: Payen D, Cravat M, Maadadi H, Didelot C, Prosic L, Dupuis C, Losser MR, De Carvalho Bittencourt M. A Longitudinal Study of Immune Cells in Severe COVID-19 Patients. Front Immunol. 2020 Oct 23;11:580250. doi: 10.3389/fimmu.2020.580250. eCollection 2020.


title: Multicentric Retrospective Evaluation of the Vesico-vaginal Fistula Repair by Robot Assisted Laparoscopy

acronym: FFVLARO

summary: Robot-assisted Vesico-Vaginal fistula (VVF) repair was described a few years ago as an alternative to the open approach to minimize the morbidity of this surgery. Very little series have reported the results of robotic VVF repair. The objective of this work was to evaluate the results of robotic VVF repair.

study_start_date_type: Anticipated


title: Creation of a Database of PET Digital Brain Exams, Adapted to a Population Aged 50 Years and Over, to Help in the Interpretation of Fluoro Desoxy Glucose (FDG) Labelled With Fluor 18 (18F-FDG) PET/CT (Computer Tomography) Exam

acronym: BASITEP

summary: This study evaluate the interest to create a new database of PET digital brain exams in population of 50 years and over of patients. Half of patients with no abnormal brain metabolism while the other half patients with Alzheimer's disease.

sponsor_collaborators:
Central Hospital, Nancy, France
GIE NANCYCLOTEP

intervention_type: Diagnostic Test


title: Études Observationnelles Des conséquences néonatales et pédiatriques de l'Infection à Virus Zika au Cours de la Grossesse Pendant l'épidémie Des départements français d'Amérique de l'année 2016

acronym: ZIKA-DFA-BB

summary:
The Zika epidemic has spread into the three French Overseas Departments in the Caribbean (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical data for the evaluation of potential complications due to having ZIKV infection during pregnancy.

This study is meant to collect, within usual care practices, clinical and paraclinical information (including imaging and laboratory results) as well as biological samples allowing the precise description of the consequences of ZIKV infection during pregnancy.

This study is the 2nd arm of a global research program in the 3 French Overseas Departments in the Caribbean. It is complementary to the first arm (ZIKA-DFA-FE) consisting in the follow-up of women in the French Overseas Departments who are pregnant during the Zika epidemic period.

The study population is made up of infants born during and up to 9 months after the end of the Zika epidemic period in the French Overseas Departments.

The data and biological specimens collected for this project will be done so through the recommended standard of care which has been put in place considering the ZIKV epidemic in the 3 French Overseas Departments, upholding existing recommendations (profession and/or recommendation from the public health authorities)

ReferenceCitation: Grant R, Flechelles O, Tressieres B, Dialo M, Elenga N, Mediamolle N, Mallard A, Hebert JC, Lachaume N, Couchy E, Hoen B, Fontanet A. In utero Zika virus exposure and neurodevelopment at 24 months in toddlers normocephalic at birth: a cohort study. BMC Med. 2021 Jan 21;19(1):12. doi: 10.1186/s12916-020-01888-0.

repository_institution: PubMed Central - Europe PMC

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

sponsor_collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: CH de l'Ouest Guyanais Franck Joly (CHOG)


title: In Utero Fetoscopic Repair Program for Sacral Myelomeningoceles and Mye-LDM

summary: The purpose of the study is to evaluate the feasibility and the maternal, fetal and postnatal outcomes of sacral myelomeningocele (MMC) and Myelic Limited Dorsal Myeloschisis (MyeLDM) fetoscopic repair at Trousseau Hospital (Paris, France).

location_facility: Service médecine foetale-Hôpital Trousseau

appel_a_projets: PHRCI

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: PRIUM 2

titre: Programme de réparation prénatale In Utero foetoscopique des Myéloméningocèles sacrées et myé-LDM

discipline_principale: autre

nom_porteur: GUILBAUD

prenom_porteur: Lucie


title: Smartphone Evaluation of Postoperative Pain Profiles Following General Surgery in Children : a French Multi Center Randomized Trial (AlgoDARPEF)

acronym: AlgoDARPEF

summary: Pain is common following surgery in children. Currently, no recent review of pain profiles at home has been performed on pediatric population in France following general surgery in children. The aim of this study is to evaluate the duration and severity of pain felt by children using a mobile phone application. All children operated in the different centers and leaving home will be included in the study. Children's pain scores will be measured using PPMP-SF scale (Postoperative Pain Measure for Parents Short Form). Data on prescribed and administered analgesia, nausea-vomiting, behavioral problems and parental satisfaction will be collected. The expected results are an inventory's objective observation of postoperative pain profiles at home following the different pediatric surgeries in France. The study will also highlight the different risk factors of postoperative pain (type of surgery, parental causes, reasons due to the child, medical causes).

ReferenceCitation: Walrave Y, Carles M, Evain JN, Ikonomoff T, Marie A, Ludot H, Bourdaud N, Kern D, Lejus-Bourdeau C, Orliaguet G, Rosello O, Ecoffey C, Savoldelli C, Perissier C, Delacquis M, Vare B, Donzeau D, Cousin C, Langlais E, Breaud J, Jonckheer K, Dadure C, De la Briere F; Association of French Pediatric Anaesthesia and Intensive Care Medicine (ADARPEF). A follow-up of pain reported by children undergoing outpatient surgery using a smartphone application: AlgoDARPEF multicenter descriptive prospective study. Pain. 2022 Nov 1;163(11):2224-2231. doi: 10.1097/j.pain.0000000000002620. Epub 2022 Mar 1.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Fondation Lenval

location_facility: Hôpitaaux Pédiatriques de Nice CHU-Lenval


title: Research for Genetic Factors Involved in the Individual Susceptibility to Develop a Valvulopathy During a Medicinal Exposure in the Benfluorex.

acronym: MEDIAGENE

summary:
More than 5 million persons in France exposed, in last years, to the taking of the Benfluorex.

Arisen, at certain patients, of a valvulopathy characterized by mitrals and/or aortic leaks Withdrawal of the French market: nov. 2009 Only a percentage limited by exposed patients developed a severe valvulopathy (1/1000), whereas on the contrary, many patients were exposed during years without developing the slightest anomaly.

The hypothesis is the existence of a particular genetic susceptibility at the patients having developed a valvulopathy continuation in the exposure in this medicine.

Existence of one varying genetics with strong effect. The purpose is to identify involved genetic factors.

sponsor_collaborators:
University Hospital, Brest
Ministry of Health, France

location_facility:
CHRU de Brest
Hôpital La Timone Marseille
Faculté de médecine Toulouse
Institut du Thorax Nantes
Hôpital Sud Amiens
CHU de la Côte de Nacre Caen
Hôpital Saint Philibert

intervention_type: Genetic


title: Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment

acronym: GIANT

summary: The objective of GIANT Study is to evaluate the clinical impact of genetic resistance to thienopyridine profile determination (CYP2C19 gene) and the clinical impact of compliance to an adjusted thienopyridine treatment on STEMI patients treated by primary PCI within the 24 hours following the first chest pain.

ReferenceCitation: Hulot JS, Chevalier B, Belle L, Cayla G, Khalife K, Funck F, Berthier R, Piot C, Tafflet M, Montalescot G; GIANT Investigators. Routine CYP2C19 Genotyping to Adjust Thienopyridine Treatment After Primary PCI for STEMI: Results of the GIANT Study. JACC Cardiovasc Interv. 2020 Mar 9;13(5):621-630. doi: 10.1016/j.jcin.2020.01.219.

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

version: submittedVersion

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

lead_sponsor: Biotronik France

collaborators: Allies in Cardiovascular Trials Initiatives and Organized

location_facility: Centre Hospitalier Universitaire Caremeau

location_facility: Centre Hospitalier de la Région Annecienne

location_facility: Centre Hospitalier Saint Joseph et Saint Luc


title: Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea in a Prospective Cohort of Subjects Aged 67 Years

acronym: SYNAPSE

summary:
The regulatory effects of the autonomic nervous system (ANS) concern almost all organs which permanently feed information back to this global biological vigilance system controlling allostasis. Heart rate fluctuations are highly dependent on ANS control, making the heart one of the best indicators of ANS activity.

Low ANS activity level is associated with severe cardiac and cerebral events, as well as to death from any cause in the general population. It is even associated with sleep apnea/hypopnea.

ReferenceCitation: Tsuji H, Venditti FJ Jr, Manders ES, Evans JC, Larson MG, Feldman CL, Levy D. Reduced heart rate variability and mortality risk in an elderly cohort. The Framingham Heart Study. Circulation. 1994 Aug;90(2):878-83. doi: 10.1161/01.cir.90.2.878.

ReferenceCitation: Pitson DJ, Stradling JR. Autonomic markers of arousal during sleep in patients undergoing investigation for obstructive sleep apnoea, their relationship to EEG arousals, respiratory events and subjective sleepiness. J Sleep Res. 1998 Mar;7(1):53-9. doi: 10.1046/j.1365-2869.1998.00092.x.

ReferenceCitation: Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.

ReferenceCitation: Lavie P, Lavie L, Herer P. All-cause mortality in males with sleep apnoea syndrome: declining mortality rates with age. Eur Respir J. 2005 Mar;25(3):514-20. doi: 10.1183/09031936.05.00051504.

ReferenceType: result

ReferenceCitation: Barthelemy JC, Pichot V, Dauphinot V, Celle S, Laurent B, Garcin A, Maudoux D, Kerleroux J, Lacour JR, Kossovsky M, Gaspoz JM, Roche F. Autonomic nervous system activity and decline as prognostic indicators of cardiovascular and cerebrovascular events: the 'PROOF' Study. Study design and population sample. Associations with sleep-related breathing disorders: the 'SYNAPSE' Study. Neuroepidemiology. 2007;29(1-2):18-28. doi: 10.1159/000108914.

ReferenceCitation: Celle S, Peyron R, Faillenot I, Pichot V, Alabdullah M, Gaspoz JM, Laurent B, Barthelemy JC, Roche F. Undiagnosed sleep-related breathing disorders are associated with focal brainstem atrophy in the elderly. Hum Brain Mapp. 2009 Jul;30(7):2090-7. doi: 10.1002/hbm.20650.

ReferenceCitation: Sforza E, Millasseau S, Hupin D, Barthelemy JC, Roche F. Arterial stiffness alteration and obstructive sleep apnea in an elderly cohort free of cardiovascular event history: the PROOF cohort study. Sleep Breath. 2019 Mar;23(1):201-208. doi: 10.1007/s11325-018-1683-x. Epub 2018 Jun 26.

ReferenceCitation: Monneret D, Barthelemy JC, Hupin D, Maudoux D, Celle S, Sforza E, Roche F. Serum lipid profile, sleep-disordered breathing and blood pressure in the elderly: a 10-year follow-up of the PROOF-SYNAPSE cohort. Sleep Med. 2017 Nov;39:14-22. doi: 10.1016/j.sleep.2017.07.028. Epub 2017 Sep 18.

ReferenceCitation: Saint Martin M, Labeix P, Garet M, Thomas T, Barthelemy JC, Collet P, Roche F, Sforza E. Does Subjective Sleep Affect Bone Mineral Density in Older People with Minimal Health Disorders? The PROOF Cohort. J Clin Sleep Med. 2016 Nov 15;12(11):1461-1469. doi: 10.5664/jcsm.6266.

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: American Academy of Sleep Medicine (AASM)

ReferenceCitation: Sforza E, Saint Martin M, Thomas T, Collet P, Garet M, Barthelemy JC, Roche F. Risk factors of osteoporosis in healthy elderly with unrecognized obstructive sleep apnea: role of physical activity. Sleep Med. 2016 Jun;22:25-32. doi: 10.1016/j.sleep.2016.04.010. Epub 2016 Jun 7.

ReferenceCitation: Sforza E, Saint Martin M, Barthelemy JC, Roche F. Mood disorders in healthy elderly with obstructive sleep apnea: a gender effect. Sleep Med. 2016 Mar;19:57-62. doi: 10.1016/j.sleep.2015.11.007. Epub 2015 Nov 25.

ReferenceCitation: Boutet C, Vassal F, Celle S, Schneider FC, Barthelemy JC, Laurent B, Barral FG, Roche F. Incidental findings on brain magnetic resonance imaging in the elderly:the PROOF study. Brain Imaging Behav. 2017 Feb;11(1):293-299. doi: 10.1007/s11682-016-9519-4.

ReferenceCitation: Sforza E, Celle S, Saint-Martin M, Barthelemy JC, Roche F. Hippocampus volume and subjective sleepiness in older people with sleep-disordered breathing: a preliminary report. J Sleep Res. 2016 Apr;25(2):190-3. doi: 10.1111/jsr.12367. Epub 2015 Dec 14.

publisher_dissemination: Wiley

ReferenceCitation: Sforza E, Pichot V, Martin MS, Barthelemy JC, Roche F. Prevalence and determinants of subjective sleepiness in healthy elderly with unrecognized obstructive sleep apnea. Sleep Med. 2015 Aug;16(8):981-6. doi: 10.1016/j.sleep.2015.03.010. Epub 2015 Apr 15.

ReferenceCitation: Sforza E, Sabri M, DaCosta A, Isaaz K, Barthelemy JC, Roche F. Echocardiographic Findings in Healthy Elderly People with Unrecognized Sleep Disordered Breathing. J Clin Sleep Med. 2015 Sep 15;11(9):975-80. doi: 10.5664/jcsm.5006.

ReferenceCitation: Saint Martin M, Roche F, Thomas-Anterion C, Barthelemy JC, Sforza E; PROgnostic OF cardiovascular and cerebrovascular events study group. Eight-year parallel change in baroreflex sensitivity and memory function in a sample of healthy older adults. J Am Geriatr Soc. 2015 Feb;63(2):270-5. doi: 10.1111/jgs.13252. Epub 2015 Feb 2.

oa_host_type: publisher

ReferenceCitation: Martin MS, Sforza E, Roche F, Barthelemy JC, Thomas-Anterion C; PROOF study group. Sleep breathing disorders and cognitive function in the elderly: an 8-year follow-up study. the proof-synapse cohort. Sleep. 2015 Feb 1;38(2):179-87. doi: 10.5665/sleep.4392.

ReferenceCitation: Sforza E, Saint Martin M, Barthelemy JC, Roche F. Association of self-reported sleep and hypertension in non-insomniac elderly subjects. J Clin Sleep Med. 2014 Sep 15;10(9):965-71. doi: 10.5664/jcsm.4026.

ReferenceCitation: Saint Martin M, Sforza E, Thomas-Anterion C, Barthelemy JC, Roche F; PROOF Study Group. Baroreflex sensitivity, vascular risk factors, and cognitive function in a healthy elderly population: the PROOF cohort. J Am Geriatr Soc. 2013 Dec;61(12):2096-2102. doi: 10.1111/jgs.12548. Epub 2013 Nov 26.

ReferenceCitation: Sforza E, Thomas T, Barthelemy JC, Collet P, Roche F. Obstructive sleep apnea is associated with preserved bone mineral density in healthy elderly subjects. Sleep. 2013 Oct 1;36(10):1509-15. doi: 10.5665/sleep.3046.

ReferenceCitation: Martin MS, Sforza E, Barthelemy JC, Thomas-Anterion C, Roche F. Sleep perception in non-insomniac healthy elderly: a 3-year longitudinal study. Rejuvenation Res. 2014 Feb;17(1):11-8. doi: 10.1089/rej.2013.1457.

ReferenceCitation: Chouchou F, Pichot V, Pepin JL, Tamisier R, Celle S, Maudoux D, Garcin A, Levy P, Barthelemy JC, Roche F; PROOF Study Group. Sympathetic overactivity due to sleep fragmentation is associated with elevated diurnal systolic blood pressure in healthy elderly subjects: the PROOF-SYNAPSE study. Eur Heart J. 2013 Jul;34(28):2122-31, 2131a. doi: 10.1093/eurheartj/eht208. Epub 2013 Jun 11.

ReferenceCitation: Degache F, Sforza E, Dauphinot V, Celle S, Garcin A, Collet P, Pichot V, Barthelemy JC, Roche F; PROOF Study Group. Relation of central fat mass to obstructive sleep apnea in the elderly. Sleep. 2013 Apr 1;36(4):501-7. doi: 10.5665/sleep.2532.

ReferenceCitation: Sforza E, Gauthier M, Crawford-Achour E, Pichot V, Maudoux D, Barthelemy JC, Roche F. A 3-year longitudinal study of sleep disordered breathing in the elderly. Eur Respir J. 2012 Sep;40(3):665-72. doi: 10.1183/09031936.00133011. Epub 2012 Mar 9.

ReferenceCitation: Tonnesen P, Lauri H, Perfekt R, Mann K, Batra A. Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial. Eur Respir J. 2012 Sep;40(3):548-54. doi: 10.1183/09031936.00155811. Epub 2012 Feb 9.

ReferenceCitation: Sforza E, Chouchou F, Pichot V, Barthelemy JC, Roche F. Heart rate increment in the diagnosis of obstructive sleep apnoea in an older population. Sleep Med. 2012 Jan;13(1):21-8. doi: 10.1016/j.sleep.2011.04.011. Epub 2011 Nov 21.

ReferenceCitation: Chouchou F, Sforza E, Celle S, Pichot V, Maudoux D, Garcin A, Barthelemy JC, Roche F; PROOF Study Group. Pulse transit time in screening sleep disordered breathing in an elderly population: the PROOF-SYNAPSE study. Sleep. 2011 Aug 1;34(8):1051-9. doi: 10.5665/SLEEP.1160.

ReferenceCitation: Sforza E, Chouchou F, Collet P, Pichot V, Barthelemy JC, Roche F. Sex differences in obstructive sleep apnoea in an elderly French population. Eur Respir J. 2011 May;37(5):1137-43. doi: 10.1183/09031936.00043210. Epub 2010 Sep 3.

ReferenceCitation: Sforza E, Roche F, Thomas-Anterion C, Kerleroux J, Beauchet O, Celle S, Maudoux D, Pichot V, Laurent B, Barthelemy JC. Cognitive function and sleep related breathing disorders in a healthy elderly population: the SYNAPSE study. Sleep. 2010 Apr;33(4):515-21. doi: 10.1093/sleep/33.4.515.

ReferenceCitation: Guillot M, Costes F, Sforza E, Maudoux D, Bertoletti L, Barthelemy JC, Roche F. Is tidal expiratory flow limitation predictive of sleep-related disorders in the elderly? Eur Respir J. 2010 Oct;36(4):842-8. doi: 10.1183/09031936.00078009. Epub 2010 Apr 8.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Prospective Evaluation of the Interest of a Systematic Biopsy for Hard-to-heal Leg Ulcers

acronym: ULCERE

summary: Primary aim of the study : to evaluate the prevalence of ulcerated cutaneous carcinoma or malignant degeneration, in leg ulcers, presumed of vascular origin and without evidence of healing despite 3 months of adequate treatmentSecondary aims of the study : to evaluate the interest of immunostainings for desmogleins 1-2 and p16 on biopsies to differentiate between pseudo epitheliomatous hyperplasia and squamous cell carcinoma ; and the prognosis of diagnosed carcinomas at 12 monthsStudy hypothesis : systematic biopsies of hard-to-heal leg ulcer may help to detect ulcerated carcinomas misdiagnosed as vascular ulcer or malignant degeneration of leg ulcer.

ReferenceCitation: Senet P, Combemale P, Debure C, Baudot N, Machet L, Aout M, Vicaut E, Lok C; Angio-Dermatology Group Of The French Society Of Dermatology. Malignancy and chronic leg ulcers: the value of systematic wound biopsies: a prospective, multicenter, cross-sectional study. Arch Dermatol. 2012 Jun;148(6):704-8. doi: 10.1001/archdermatol.2011.3362.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Société de Dermatologie Française


title: Gender Dysphoria in Children and Adolescents : Parents' Perspectives

acronym: GeDyPar

summary:
Gender dysphoria is defined as a persistent incongruence between an experienced gender and the assigned sex at birth Transgender and gender nonconforming persons desire to modify their appearance to be consistent with their self-identified gender identities. In non-binary people, contrary to binary transgender persons, self-identified gender identities do not fit the classical pattern male/female.

During the last decennium, an increase in the number of young subjects, especially children and adolescents, referred to gender identity centres has been observed. A new nosological entity "rapid-onset gender dysphoria in adolescents and young adults" has recently been described in the literature, whose etiology has not been well understood.

This growing demand of adolescents and young adults observed in the recent years is not well understood.

ipd_sharing_description: Not planned

lead_sponsor: Central Hospital, Nancy, France


title: New Clinical Outcome Measures to Remotely Evaluate Patients With FacioScapuloHumeral Muscular Dystrophy - PROGRESS FSHD

acronym: PROGRESS-FSHD

summary:
Facioscapulohumeral muscular dystrophy (FSHD) is one of the most common adult muscular dystrophy with an estimated prevalence range of 2-7 per 100,000. The disease is characterized by slowly progressive, asymmetric muscle weakness that starts with the face and scapular muscles. It causes significant lifetime morbidity, with up to 20% of patients eventually requiring full-time wheelchair use. However, there is a large degree of clinical variability in both disease progression and severity. This makes predicting an individual's disease course difficult and has made clinical trial design and the development of new therapeutic strategies challenging.

The disease is caused by the aberrant expression of a normally silenced gene, Double homeobox 4 (DUX4), which causes disease by a toxic gain-of-function. The emergence of the pathophysiologic model provided several possible therapeutic approaches to treat FSHD. However, as drugs move from preclinical testing into human trials, it is essential to validate clinical trial tools and methodologies to facilitate drug development from early phase studies through registration trials. Natural history studies are conducted to develop and validate new clinical outcome measures (COMs). A large international multicenter study is currently ongoing in order to validate COMs in ambulant FSHD patients (ReSolve, NCT03458832). Additionally, Nice University Hospital is conducting an ancillary study (CTRN FSHD France, NCT04038138) to evaluate muscle MRI, an additional emerging biomarker, to follow disease progression in the same patient population.

Nevertheless, these studies are focused on the development of COMs collected at the hospital. In this setting, several factors that may interfere with disease progression or patient quality of life are underestimated (daily exercise, daily pain or fatigue, the psychological impact of the disease, and falls…). Consequently, and given the context of the current pandemic, the interest of pharmaceutical companies, stakeholders, clinicians, and researchers in data collected in a cohort of FSHD patients at home is rapidly increasing. Consequently, a new battery of COMs adapted for the remote evaluation needs to be developed and/or validated. There are clear benefits to remote assessments. The ability to observe an individual perform functional mobility tasks and self-care in their natural environment is meaningful and invaluable.

The set-up of a reliable remote assessment will allow for ensuring drug home delivery, maintaining patients on trials, and collecting and analysing additional data to improve patient stratification in clinical trials and develop new approaches to assess the short-term and long-term efficacy of a given therapy. Remote assessment can also be the key to developing more efficient real-life studies, empowering patients and caregivers in the management of this disease, and more efficiently monitoring drug side effects or the socio-economic burden of the disease. The overall aim of the PROGRESS FSHD study is to experiment the feasibility of the remote evaluation in patients with FSHD, through the use of a patient-oriented mobile application (myFSHD app). The content of the application has been determined after extensive discussions with patients and patients' associations that have identified their unmet needs and based on preliminary results of the CTRN FSHD France project. The video-recorded exercises have been designed specifically to stress a particular body region. The myFSHD mobile application will be used by 70 FSHD1 patient during 12 months, at home and at the hospital, to administer patient-reported questionnaires on fatigue, pain, physical activity, sleep, quality of life, and socio-economic burden of the disease, as well as video of validated scores and scales. The collected data will help to:

Evaluate patients' adherence to the program
Evaluate the technical feasibility of remote evaluation
Assess the reliability of remote evaluation
Assess the robustness of new COMs compared to commonly used COMs
Evaluate the quality of life and socio-economic burden of the disease Overall, this study will provide digital tools adapted to monitor disease evolution remotely in FSHD patients. The patient-generated measures collected through connected digital tools (patient full-body motion videos collected through the myFSHD app) can be used to explain, influence, and/or predict disease-related outcomes

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHRU de Lille
CHU de Nice
Institut de Myologie


title: Observational Prospectif Monocentric Registry of Patients Suffering From VIE

acronym: REMOTEV

summary: Patients with an episode of VTE (DVT and / or PE) have a mortality rate of 16-21% at 1 year after diagnosis. Morbidity associated with VTE is marked by the risk of recurrence, estimated at 30% and estimated at 29% after 8 years of follow post-thrombotic syndrome. For a number of these patients, risk factors have been identified (congenital or acquired thrombophilia, cancer, postpartum, surgery, prolonged immobilization, etc..). In 25-50% of cases, the etiology remains unknown, justifying the need for well-conducted studies to determine other potential risk factors. In addition, the expansion of treatment options with the arrival on the market of new direct oral anticoagulants, allows comparative studies on the effectiveness and frequency of adverse events for each treatment.

location_facility: Service Des Maladies Vasculaires - Hta - Nhc


title: Evaluation of Urine Pregnancy Test, CHECK TOP Test, Compared to Transvaginal Ultrasound During Control Visit Post Drug Abortion (CHECK-TOP).

acronym: CHECK-TOP

summary:
According to a study of the DREES (Direction de la Recherche, des Etudes, de l'Evaluation et des Statistiques), in 2013, nearly 229 000 abortions were performed in France, an increasing number.

The success rate of drug abortion before 49 days of amenorrhea, defined by the National Health Autority as a complete abortion not requiring surgery, varies from 92 to 98% depending on the pregnancy term and the dose used.

The control visit is performed between the 14th day and the 21th day post abortion. Its role is to monitor the effectiveness of the method, to verify absence of complication and to better adapt contraception to prevent another unwanted pregnancy. The choice of the method is left to the physician's discretion: β-HCG dosage, pelvic or transvaginal ultrasound.

In the Orthogenic Departement of the Croix-Rousse Hospital Lyon, France, the method performed during the control visit is transvaginal ultrasound.

To simplify the monitoring of drug abortion, a urine pregnancy test would be an attractive alternative to transvaginal ultrasound: simplicity of use, speed, ease of interpretation and low cost.

The main objective of this study is to evaluate the diagnostic value of urine pregnancy test CHECK TOP compared to transvaginal ultrasound in monitoring the outcome of drug abortion during the control visit.

This is a monocentric observational study.

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


title: Utero-placental Vascularisation in Normal and Preeclamptic and Intra-uterine Growth Restriction Pregnancies: Third Trimester Quantification Using 3D Power Doppler With Comparison to Placental Vascular Morphology

acronym: EVUPA

summary:
Introduction

Preeclampsia (PE) and intra-uterine growth restriction (IUGR) are two major pregnancy complications related to chronic utero-placental hypoperfusion. Three-dimensional power Doppler (3DPD) angiography has been used for the evaluation of utero-placental vascularisation and three vascular indices have been calculated: the vascularisation index (VI), flow index (FI) and vascularisation-FI (VFI). However, several technical endpoints hinder the clinical use of 3DPD as physical characteristics and machine settings may affect 3DPD indices, and so its clinical significance is not yet clear.

Objectives

The primary objective is to better understand the clinical significance of 3DPD indices by evaluating the relationship between these indices and placental morphometry. Secondary objectives are (i) to determine the impact of machine settings and physical characteristics on 3DPD indices, and (ii) to evaluate physio-pathological placental vascularisation patterns.

Methods and analysis

This is a prospective controlled study. We expect to include 112 women: 84 with normal pregnancies and 28 with PE and/or IUGR (based on our former cohort study on 3DPD indices for PE and/or IUGR prediction (unpublished data)). Within 72 h before planned or semi-urgent caesarean section, utero-placental 3DPD images with five different machine settings will be acquired. Placentas will be collected and examined after surgery and stereological indices (volume density, surface density, length density) calculated. The 3DPD indices (VI, FI and VFI) of the placenta and adjacent myometrium will be calculated. Correlation between Doppler and morphological indices will be evaluated by Pearson or Spearman tests. Agreement between 3DPD indices and morphological indices will be assessed by Bland and Altman plots. The impact of Doppler settings and maternal characteristics on 3DPD indices will be evaluated with a multivariate linear regression model.

design_allocation: Non-Randomized

primary_purpose: Basic Science

ReferenceCitation: Duan J, Chabot-Lecoanet AC, Perdriolle-Galet E, Christov C, Hossu G, Cherifi A, Morel O. Utero-placental vascularisation in normal and preeclamptic and intra-uterine growth restriction pregnancies: third trimester quantification using 3D power Doppler with comparison to placental vascular morphology (EVUPA): a prospective controlled study. BMJ Open. 2016 Mar 31;6(3):e009909. doi: 10.1136/bmjopen-2015-009909.


title: Covid-19 in Patients With Chronic Inflammatory Rheumatism, Auto-immune or Auto-inflammatory Rare and Non-rare Diseases : a Retrospective Multicenter Observational Study

acronym: covid19 fai2r

summary:
Since December 2019, an international outbreak of respiratory illnesses caused by SARS-CoV-2 called covid-19 has become a global challenge. In France, while the first cases were reported in January, more than 20 000 cases were confirmed at end of March. Early estimations from epidemiological data seem to show that 18-20% of patients with confirmed covid-19 are admitted in an intensive care unit (ICU). Patients with chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases are susceptible to severe covid-19 (i.e ICU) due to the specific therapeutic management of their illness (corticosteroid, immunosuppressive and immunomodulatory drugs,..). No data are available for this particular population in France.

This retrospective multicentre observational study aims to evaluate the frequency of severe forms of covid-19 and risk factors associated with specific outcomes in covid-19 in patients with chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases.

ReferenceCitation: Truchetet ME, Drumez E, Barnetche T, Martin C, Devaux M, Goulenok T, Maria A, Schmidt J, Abdallah NA, Melki I, Hachulla E, Richez C. Outcome of COVID-19 in patients with rheumatic and inflammatory diseases treated with mycophenolic acid: data from the French RMD COVID-19 cohort. RMD Open. 2022 Sep;8(2):e002476. doi: 10.1136/rmdopen-2022-002476.

ReferenceCitation: Avouac J, Drumez E, Hachulla E, Seror R, Georgin-Lavialle S, El Mahou S, Pertuiset E, Pham T, Marotte H, Servettaz A, Domont F, Chazerain P, Devaux M, Claudepierre P, Langlois V, Mekinian A, Maria ATJ, Banneville B, Fautrel B, Pouchot J, Thomas T, Flipo RM, Richez C; FAI2R/SFR/SNFMI/SOFREMIP/CRI/IMIDIATE consortium and contributors; FAIR/SFR/SNFMI/SOFREMIP/CRI/IMIDIATE consortium and contributors. COVID-19 outcomes in patients with inflammatory rheumatic and musculoskeletal diseases treated with rituximab: a cohort study. Lancet Rheumatol. 2021 Jun;3(6):e419-e426. doi: 10.1016/S2665-9913(21)00059-X. Epub 2021 Mar 25.

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

ReferenceCitation: FAI2R /SFR/SNFMI/SOFREMIP/CRI/IMIDIATE consortium and contributors. Severity of COVID-19 and survival in patients with rheumatic and inflammatory diseases: data from the French RMD COVID-19 cohort of 694 patients. Ann Rheum Dis. 2021 Apr;80(4):527-538. doi: 10.1136/annrheumdis-2020-218310. Epub 2020 Dec 2.

evidence: open (via page says license)

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

lead_sponsor: University Hospital, Lille

collaborators: FAI²R (Auto-immune and auto-inflammatory rare diseases French network)


title: Using, Efficacity and Safety of Intranasal Fentanyl for the Treatment of Acute Severe Pain on the Pediatric Emergency Department of Mercy Hospital.

acronym: FENTANYLIN

summary: The treatment of acute severe pain in pediatric emergencies required a quick and effective therapeutic support. Actually in France, only peripheral venous access or oral therapies with onset of action are commonly used and only few treatments can be used to manage the acute severe pain in children. In June 2017, an intranasal fentanyl use protocol has been established in the pediatric emergency department of Mercy hospital-Metz. The intranasal fentanyl treatment has proved his effectiveness and safe condition in many countries since few years even though has not yet obtained a marketing authorization for use in children in France. In view of the information, parental permission was obtained before the intranasal administration. The efficacy and surveillance data in all patient records of children who benefited this analgesic protocol were retrospectively collected between June 2017 and August 2018. This retrospective study wants to describe the efficacy and safety of intranasal fentanyl on the pediatric emergency department.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: After Cancer in the Military: What Happens After Long-term Sick Leave

acronym: APCAM-CLDM

summary:
In recent decades, early diagnosis and improved treatment have led to increased survival for most people with cancer. This improved survival has led to more attention being paid to the quality of life of these people, and to their reintegration into social and professional life. In France, 3.8 million people are treated or in remission from cancer in 2017. Among the 400,000 new patients diagnosed with cancer each year in France, 160,000 (40%) are in professional activity.

Cancer treatments induce after-effects that can be felt several months or even years after the diagnosis and have an impact on life. In a study of patients in remission from cancer at 12 months after diagnosis, 47 to 53% of patients had changed jobs or stopped working. In another Finnish study, 26% of patients had decreased physical ability and 19% had decreased mental ability to work five years after cancer diagnosis.

In France, studies that have evaluated the impact of cancer on employment and the factors associated with return to work after cancer are still rare: the VICAN study showed that among people in work at the time of diagnosis, 20% were no longer working five years later.

With an estimated annual incidence of approximately 400 new cancers per year, the military population is also affected by cancer. Professional reintegration after cancer is of particular concern to the military. The specificity and requirements of the military condition can indeed make this reintegration more difficult. Regular or even intense physical activity is indeed essential but can be difficult after undergoing anti-cancer treatments. Moreover, external operations and many activities are conditioned by the obtaining of medical skills, which are sometimes incompatible with the state of health of patients recently treated for a neoplastic pathology. The studies previously carried out concerning the professional future after cancer do not seem to us to be transposable to the military population. To our knowledge, no study has evaluated occupational reintegration in military personnel after cancer.

The aim of this study is to evaluate the difficulties encountered during the post-cancer professional reintegration of military personnel in terms of fatigue, aptitude and advancement, in order to anticipate them and possibly remedy them. The identification of these difficulties will eventually allow to anticipate them and possibly to remedy them via an adapted post-cancer professional reintegration pathway.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Sainte-Anne


type: EudraCT Number

title: Activity and Safety of Regorafenib in Patients With Metastatic Soft Tissue Sarcoma Previously Treated With Anthracycline-based Chemotherapy : a Multinational, Randomized, Phase II, Placebo-controlled Trial

acronym: REGO-SARC

summary:
This is an international (France, Austria and Germany), randomized, double-blind, placebo-controlled, phase II study to evaluate the efficacy and safety of regorafenib in patients with histologically proven metastatic and/or unresectable Soft Tissue Sarcoma (STS) after failure or intolerance to doxorubicin (or other anthracycline).

Five cohorts will be defined:

Cohort A: Liposarcoma Cohort B: Leiomyosarcoma Cohort C: Synovial sarcoma Cohort D: other sarcomas (see Appendix C) Cohort E: Leiomyosarcoma, Synovial sarcoma and other sarcomas listed in Appendix C previously treated with pazopanib Approximately 226 patients who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to one of the treatment groups.

ReferenceCitation: Penel N, Mir O, Wallet J, Ray-Coquard I, Le Cesne A, Italiano A, Salas S, Delcambre C, Bompas E, Bertucci F, Saada-Bouzid E, Chaigneau L, Chevreau C, Brodowicz T, Decoupigny E, Vanseymortier M, Laroche L, Taieb S, Le Deley MC, Blay JY. A double-blind placebo-controlled randomized phase II trial assessing the activity and safety of regorafenib in non-adipocytic sarcoma patients previously treated with both chemotherapy and pazopanib. Eur J Cancer. 2020 Feb;126:45-55. doi: 10.1016/j.ejca.2019.12.001. Epub 2020 Jan 6.

ReferenceCitation: Longue M, Cabarrou B, Wallet J, Brodowicz T, Roche H, Boher JM, Delord JP, Penel N, Filleron T. The importance of jointly analyzing treatment administration and toxicity associated with targeted therapies: a case study of regorafenib in soft tissue sarcoma patients. Ann Oncol. 2018 Jul 1;29(7):1588-1593. doi: 10.1093/annonc/mdy168.

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

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

repositories:
HAL
LillOA (Lille Open Archive)

repositories_concat: HAL;LillOA (Lille Open Archive)

ReferenceCitation: Berry V, Basson L, Bogart E, Mir O, Blay JY, Italiano A, Bertucci F, Chevreau C, Clisant-Delaine S, Liegl-Antzager B, Tresch-Bruneel E, Wallet J, Taieb S, Decoupigny E, Le Cesne A, Brodowicz T, Penel N. REGOSARC: Regorafenib versus placebo in doxorubicin-refractory soft-tissue sarcoma-A quality-adjusted time without symptoms of progression or toxicity analysis. Cancer. 2017 Jun 15;123(12):2294-2302. doi: 10.1002/cncr.30661. Epub 2017 Mar 10.

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

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central

ReferenceCitation: Mir O, Brodowicz T, Italiano A, Wallet J, Blay JY, Bertucci F, Chevreau C, Piperno-Neumann S, Bompas E, Salas S, Perrin C, Delcambre C, Liegl-Atzwanger B, Toulmonde M, Dumont S, Ray-Coquard I, Clisant S, Taieb S, Guillemet C, Rios M, Collard O, Bozec L, Cupissol D, Saada-Bouzid E, Lemaignan C, Eisterer W, Isambert N, Chaigneau L, Cesne AL, Penel N. Safety and efficacy of regorafenib in patients with advanced soft tissue sarcoma (REGOSARC): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2016 Dec;17(12):1732-1742. doi: 10.1016/S1470-2045(16)30507-1. Epub 2016 Oct 14.

ReferenceCitation: Brodowicz T, Liegl-Atzwager B, Tresch E, Taieb S, Kramar A, Gruenwald V, Vanseymortier M, Clisant S, Blay JY, Le Cesne A, Penel N. Study protocol of REGOSARC trial: activity and safety of regorafenib in advanced soft tissue sarcoma: a multinational, randomized, placebo-controlled, phase II trial. BMC Cancer. 2015 Mar 14;15:127. doi: 10.1186/s12885-015-1143-y.

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Lille

location_facility: Institut de Cancérologie Lucien Neuwirth (ICL)

location_facility: Krankenhaus der Barmherzigen Schwestern Linz


title: Effects of Peri Operative Administration of Ketamine on Long Term Post Thoracotomy Pain

summary: We assessed the effects of the N Methyl aspartate receptor antagonist Ketamine on long-term post thoracotomy pain. We hypothesized that ketamine could prevent supersensitization of the central nervous system involved in this chronic neuropathic pain.

ReferenceCitation: Frappier J, Guenoun T, Journois D, Philippe H, Aka E, Cadi P, Silleran-Chassany J, Safran D. Airway management using the intubating laryngeal mask airway for the morbidly obese patient. Anesth Analg. 2003 May;96(5):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.

collaborators: Direction Régionale de la Recherche Clinique D'ILE DE FRANCE


title: Pathological Findings in Critically-ill Patients Who Died From SARS-CoV-2 Related Acute Respiratory Distress Syndrome

acronym: HISTOCOVID

summary: The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a new coronavirus discovered in December 2019 in Wuhan, China and currently responsible of a worldwide outbreak and the death of more than 55,000 patients in France. The more severe form of COVID-19 disease induces a pneumonia with profound hypoxemia which may require invasive mechanical ventilation. It is estimated that 5% of COVID-19 patients are admitted to the Intensive Care Unit (ICU) for management. Hospital mortality in patients who develop severe acute respiratory distress syndrome (ARDS) ranges between 40% and 60%. The investigators purpose to investigate the pathological findings of COVID-19 patients who died from ARDS in the ICU by doing post-mortem lung biopsies

ipd_sharing: Yes

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
National Research Agency, France

location_facility:
Hopital Lyon Sud
Nantes University Hospital
Hopital La Pitié Salpetrière APHP
CH Angoulême
CHU Nice
CHU Rennes
CH Ambroise Paré APHP
Hopital Georges Pompidou APHP
Hopital Saint-Louis APHP
CH Cahors
Marseille Hopital Nord APHM
Hopital Necker APHP
Hôpital Lyon Sud
CH Amiens
CH Troyes
CH Belfort
CH Melun
CHR Orléans
Hopital Saint-Antoine APHP
Hopital Louis Mourier APHP
GHEF Marne La Vallée
CHU Saint-Etienne
CHRU Tours
CH Annecy
Hopital Privé Claude Galien
Hopital Cochin APHP
Hopital Privé d'Antony
CH Poissy
CH Argenteuil
CHU Clermont-Ferrand
CH Versailles
Hopital Sainte Camille
Hopital Antoine Béclère APHP
CH Compiègne-Noyon
Angers University Hospital
CH Cergy Pontoise
CHD Vendée
CH Cholet
CH Vannes
CHU Bordeaux
CH Montélimar
CH Saint-Brieuc
CH Reims
Hopital Foch


title: Adult-onset Generalized Morphea : A Retrospective Multicenter Study

acronym: MORPHEA

summary: This study aimed to describe the demographical and clinical characteristics of a retrospective cohort of adult-onset GM and to investigate whether these findings differ between patients with an isomorphic and a symmetric pattern of lesion distribution.

location_facility: Service de dermatologie - Hôpital Civil de Strasbourg


title: Topical 0.01% Atropine for the Control of Fast Progressing Myopia

acronym: Myopie-STOP

summary:
Myopia prevalence has dramatically increased worldwide in recent years in the general population and among children. Progressive myopia increases gradually with growth until the age of 20-25 years. At the same time, there is a remarkable increase in the prevalence of severe myopia (more than -6 diopters). Severe myopia is associated with many complications, which can lead to blindness. There is thus an increase in the number of myopic patients in general, and severe myopic patients in particular.

The management of myopia and its complications is therefore a major public health issue.

All the means likely to slow the evolution of myopia (thus to limit the prevalence of strong myopia) must be developed to limit the consequences. 0.01% Atropine seems to be a drug with a great interest to slow down the progression of myopia.

The aim of the present study is to evaluate the efficacy at 1 year of 0.01% atropine (1 drop per day administered for 1 year) on the reduction of fast progressing myopia in children aged 4 to 12, compared to a control group (instillation of a placebo).


title: Volatil Organic Compounds in Exhaled Air and Sweat After Thoracic Surgery for Carcinological Resection

acronym: Onco-VOC

summary:
Bronchopulmonary cancer, with 39 000 new cases and 30 000 deaths per year, is a main issue in public health in France. It is the leading cause of cancer death in France. A lot of progress in medical care has been made, but surgery remains the most effective treatment, when it is still possible. The goal is to detect and manage the lung cancer as early as possible. Alongside screening strategies by annual thoracic scanner, new approaches with innovative technologies open up for cancer detection and therapeutic follow-up.

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

The composition of VOC in exhaled air and sweat is altered in patients with lung cancer. The VOC analysis and their variation could be used particularly in the follow-up of patients treated for lung cancer.

The purpose of this clinical research is to identify the VOCs related to lung cancers by comparing the VOC profiles in exhaled air and in sweat from patients diagnosed with localized lung cancer before and after resection surgery.

lead_sponsor: Hopital Foch


title: Evaluation of an Osteopathic Procedure in the Management of Pain in Palliative Care Patients in a Mobile Palliative Care Support Team (EMASP): Controlled, Randomized, Single-blind Study

acronym: OSTEOPAL

summary:
The culture of the palliative is anchored more and more in France. In 2009, nearly 9 out of 10 French people (89%) believe that palliative care can reduce the suffering of people at the end of their lives. Despite the rise of palliative care in France, their access is not homogeneous between regions. In 2010, it is estimated that 2 French out of 3 likely to receive palliative care could not access it. Palliative care remains essential at the end of the patient's life, as well as for the family and caregivers.

The French government has put in place three national palliative care development programs: 2002-2005, 2008-2012, 2015-2018. The last program has unlocked a budget of 190 million euros for their development. It has been estimated from Social Security reimbursements, that the costs per patient over their last years of life are 26,000 euros, for a total of 13.5 million euros.

One of the most important aspects of palliative care is the comfort of the patients as well as their feelings in the care.

In order to best meet the expectations of cancer patients, some offer early palliative care that is effective in improving both the quality of life of the patient and its life expectancy.

Osteopathy is a manual alternative medicine whose goal is to restore the lack of mobility of tissues. It can be used as a complementary treatment when a specific support is put in place. The purpose of this study is to examine the effectiveness of osteopathy in the reduction of pain in adult patients in palliative care.

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Evaluation of an Outpatient Protocol in Patients Operated for Laparoscopic Hysterectomy

acronym: HYSTECOE

summary:
Removal of the uterus, or hysterectomy, is a surgical operation that involves partial or total removal of the uterus. It can be done by vaginally, laparoscopically or laparotomically.

Since the first hysterectomy performed by laparoscopy in 1989, this approach has gained popularity to varying degrees depending on the countries. This technique allows a major surgical procedure to be performed by incisions of only a few millimeters, thus reducing parietal pain and visceral in addition to a cosmetic benefit.

Since 2013, more than 200 laparoscopic hysterectomies have been scheduled on an outpatient basis at the Clinique des Cèdres (France). The analysis of this retrospective series of approximately 200 patients would provide elements related to the practice of laparoscopic hysterectomy in ambulatory in France.

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity

acronym: METHACAN

summary:
Abuse of psychoactive substances is a behavior belonging to the field of risk behaviors that begins and takes place during adolescence. These risk behaviors are a major public health problem in France and worldwide.

Cannabis is the first illicit drug consumed by adolescents in France. His experimentation progresses rapidly between 11 and 17 years. The relationship between cannabis use and mental health has been shown by several studies. In particular Attention Deficit Hyperactivity Disorder (ADHD), characterized by attention deficit, impulsivity and disabling motor hyperactivity and beginning before 12 years of age (DSM-5), is a major risk factor for the consumption of cannabis. ADHD is a common condition (9% of children and 5% of adults), but often undiagnosed or untreated. It has been shown that the treatment of ADHD in childhood protects the consumption of psychoactive products during adolescence or adulthood. However, to our knowledge there is no study showing that treatment with methylphenidate in an ADHD patient - not treated - but already a cannabis user, was a positive prognostic factor in the decrease in cannabis use.

ReferenceCitation: Boesen K, Paludan-Muller AS, Gotzsche PC, Jorgensen KJ. Extended-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults. Cochrane Database Syst Rev. 2022 Feb 24;2(2):CD012857. doi: 10.1002/14651858.CD012857.pub2.

oa_host_type: repository

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repositories_concat: PubMed Central;sdu.dk

unpaywall_oa_status: green

acronyme: METHACAN

titre: Efficacité du Méthylphénidate forme retard pour réduire la consommation de cannabis chez des patients abuseurs ou dépendant du cannabis diagnostiqués TDAH.

nom_porteur: PEYRET

prenom_porteur: Emmanuelle


title: Study Of The Metabolic Parameters Of Uterine Muscle Cells In Cold Ischemia From Hysterectomies Programmed For Benign

summary:
To date, no transplant has allowed pregnancy from a donor in a state of brain death. One of the main reservations lies in the ischemic properties of the uterine graft between the sampling time and the grafting time.

Investigators propose to carry out a prospective monocentric study at the University Hospitals of Strasbourg in 2018/2019: the objective would be to study physiologically the time of ischemia of the uterine muscle The objective is to carry out a preparatory study on healthy uteri to study the ischemic properties of uterine muscle from living markers: study of mitochondrial respiration and free radical production on uterine muscle samples If the markers are reliable, they would then be used to measure the ischemia of whole uteri collected at the end of the multi-organ retrieval process from donors in a state of brain death and stored in tissue survival media.

lead_sponsor: University Hospital, Strasbourg, France


title: Cricopharyngeal Dysfunction in Adults: Diagnostic and Therapeutic Effects of Cricopharyngeal Botulinum Toxin (Botox) Injection

summary: The objective of the study, after reviewing the recent literature, is to corroborate the thesis of the authors considering the injection of botulinum toxin as a gesture that is both diagnostic and therapeutic in the disorders of the Upper Esophageal Sphincter and reinforce the results already published with a larger series of patients.

location_facility: Service ORL et chirurgie cervico-faciale


title: Preoperative CT Scan Analysis to Predict Perioperative Round Window Visibility Through the Posterior Tympanotoy in Cochlear Implant Surgery

summary:
It is difficult to predict the intraoperative visibility of the round window through the posterior Tympanostomy. In case of non-visualization, the surgeon may have to change operative technique during cochlear implant surgery.

The primary purpose of the study is to define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window. Define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window.

The secondary purpose is to validate the investigator's scanner reading protocol for a prospective study.

location_facility: Service D'Orl Et de Chirurgie Cervico-Faciale


title: PREDICTEURS ET IMPACT CLINIQUE DE LA THROMBOSE DU STENT APRES LES THROMBECTOMIES CEREBRALES POUR LES OCCLUSIONS EN TANDEM

acronym: DST-TANDEM

summary: The aim is to describe the rate of delayed stent thrombosis after endovascular management of consecutive tandem lesions, in a patient series with systematic follow-up of stent patency. In addition, Investigatros aim to research baseline patient characteristics that are associated with a higher risk of delayed stent thrombosis and to evaluate the clinical consequences of stent thrombosis

location_facility: Service de Neuroradiologie Interventionnelle


title: Coverage and Future of Children Referred by a Liberal Doctor's Letter to Pediatric Emergency in Strasbourg Teaching Hospital Compared With Children Who Are Coming by Themselves in 2017

summary:
Since 80's, admissions in Emergency medical services increase regularly. Children represents 30% of the patients in Emergency medical Service. Only 20% of admissions are hospitalized and only 3 % need emergency care. Consequences are team's exhaustion, a reduction of healthcare quality, a slowdown in emergency care.

Investigator decided to realize an epidemiologic prospective study in Emergency medical and surgical Pediatric Service in Strasbourg Teaching Hospital to compare coverage of children who are referred by a liberal doctor with children who are coming by themselves matched with age and complaint.

This study will analyze the relevance of complaints and decision-making factors for the liberal doctor to send children in Emergency Medical and Surgical Service. Investigator will talk about the importance of close collaboration between liberal doctor and hospital doctor, as well as patient's information about basic care service on nights and week-ends in order to decrease the number of emergency admission.

location_facility: Service D'Urgences Medico Chirurgicales Pediatriques


title: INTEREST OF INTRAVENOUS INJECTION OF GADOLINIUM IN EXPLORATION INTRA-LABYRINTHINE SCHWANNOMA IN MRI 3 TESLAS

summary: Evaluate the interest of gadolinium for the positive and topographic diagnosis of intra-labyrinthine schwannoma, comparing T1 sequence acquired after gadolinium injection to a sequence of fast imaging type employing steady state acquisition (FIESTA-C)


title: Breast MRI for Neaodjuvant Chemotherapy Response Prediction and Evaluation in Breast Cancer, With Focus on Background Parenchymal Enhancement

summary: The aim of this retrospective study is to evaluate the value of pre-treatment and post-treatment multimodality MRI study, including quantitative evaluation of background parenchymal enhancement, for response prediction and evaluation. This study will include 100 patients treated in a single institution between 2011 and 2016