title: Interest of Systematic Tracking of Dementia Cases in Nursing Homes: Analysing the Contribution of MultiDisciplinary Team Meeting (MDTM) in Alzheimer's Disease and Related Diseases

acronym: IDEM

summary:
Introduction: Epidemiological data show that in France only half of patients with Alzheimer disease are currently diagnosed in the general population. The absence of early diagnosis of dementia reduces the opportunities of patients to receive optimal care. One of the consequences of undiagnosed dementia is inadequate use of emergency care units.

The main objective: The main aim of this study is to evaluate the impact of a systematic case-finding procedure of dementia cases in nursing homes through a MDTM on the rate of hospitalization in emergency care units.

Secondary objectives:

To assess the impact of systematic tracking of dementia cases on the:

Quantity and quality of drug-prescription
Appropriateness of hospitalizations
Prevalence of neuropsychiatric symptoms
Dependency
Quality of life
Burden of nursing staff working conditions
Planning of specific therapeutic measures
Overall health care costs

ReferenceCitation: Rolland Y, Tavassoli N, de Souto Barreto P, Perrin A, Laffon de Mazieres C, Rapp T, Hermabessiere S, Tournay E, Vellas B, Andrieu S. Systematic Dementia Screening by Multidisciplinary Team Meetings in Nursing Homes for Reducing Emergency Department Transfers: The IDEM Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Feb 5;3(2):e200049. doi: 10.1001/jamanetworkopen.2020.0049.

publisher_dissemination: American Medical Association

lead_sponsor: University Hospital, Toulouse

location_facility: AP-HM Hôptal La Timone Service de Pédiatrie Mutidisciplinaire

location_facility: Ehpad Maison Retraite Orelia Ch St Gaudens

location_facility: AP-HP Hôpital Necker Enfants Malades Service d'endocrinologie pédiatrique - 149 route de Sèvres

location_facility: Ehpad Et. Public Gerontologie de Marines

location_facility: Ehpad Residence Borde Haute Promo-Accueil

location_facility: Ehpad Maison de Retraite Privee de Mazeres

location_facility: Ehpad Maison de Retraite Chic Tarbes Vic

location_facility: Ehpad Maison de Retraite Hl Ax Les Thermes

location_facility: Centre de Gerontologie Pompeyrie Chu Agen

location_facility: Ehpad Maison de Retraite "Les Charmilles"


title: Digital Phenotyping (Physical Activity, Heart Rate, Sleep) in Young Breast Cancer Patients Treated With Neoadjuvant Chemotherapy

acronym: NeoFit

summary: NeoFit is a prospective, national, multicenter, single-arm open-label study. It will include a total of 300 participants under the age of 70 years treated with neoadjuvant chemotherapy for BC. Participants will receive a Withing Steel HR activity tracker, which they will be asked to wear 24 h per day for 12 months. The principal assessments will be performed at baseline, at the end of neoadjuvant chemotherapy and at 12 months. The investigators will evaluate clinical (e.g. toxicity, efficacy of chemotherapy), lifestyle, quality of life, fatigue, and physical activity parameters. All questionnaires will be completed on a REDCap form, via a secure internet link.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Supportive Care

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Delrieu L, Hamy AS, Coussy F, Kassara A, Asselain B, Antero J, De Villele P, Dumas E, Forstmann N, Guerin J, Hotton J, Jouannaud C, Milder M, Leopold A, Sedeaud A, Soibinet P, Toussaint JF, Vercamer V, Laas E, Reyal F. Digital phenotyping in young breast cancer patients treated with neoadjuvant chemotherapy (the NeoFit Trial): protocol for a national, multicenter single-arm trial. BMC Cancer. 2022 May 4;22(1):493. doi: 10.1186/s12885-022-09608-y.

ipd_sharing: No

lead_sponsor: Institut Curie

location_facility:
Institut Jean Godinot
Institut Curie

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing


title: Effect of Opioid-free Anesthesia on Perioperative Period After Video-assisted Thoracoscopic Lobectomy: a Retrospective Study

acronym: VATOFA

summary:
No study has been conducted to demonstrate the feasibility and safety of an Opioid-Free Anesthesia (OFA) protocol compared to Opioid-Based Anesthesia (OBA) in thoracic surgery, at risk for intense post-operative pain, to improve patient care. The aim of the present study was to evaluate the effect of OFA on post-operative opioids consumption, pain and the post-operative period after lobectomy by Video-Assisted Thoracoscopy Surgery (VATS). systems.

Investigators perform a retrospective, single-center study in 2019. Patients were divided into two groups: OFA (with dexmedetomidine) or OBA (sufentanyl).

Investigators analyse the total postoperative opioid consumption in the 48 h after surgery. Investigators asses pain intensity in the 48 h after surgery, operative hemodynamic stability, Post-Operative Pain (POP) in Post-Anesthesia Care Unit (PACU) and POP on day 30.

All data are available in the medical record

Hypothesis: OFA can reduce post-operative opioids consumption, pain in lobectomy by video-assisted thoracoscopy surgery (VATS).

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of Anesthesiology and Intensive Care - Louis Pradel University Hospital - Hospices Civils, Lyon, France

intervention_type: Other

status_simplified: Completed


title: Organisation PERiopératoire de l'anesthésie et de la Chirurgie Ambulatoire

acronym: OPERA

summary: In France, there are no precise data regarding perioperative organization of medical structure and care management of ambulatory surgical patients. Particularly, data on management of pain, nausea and vomiting, as well as venous thromboembolic, prevention and treatment are needed, in several groups of patients.

time_perspective: Prospective

ReferenceCitation: Clergue F, Auroy Y, Pequignot F, Jougla E, Lienhart A, Laxenaire MC. [Anesthesia in France in 1996. Results of a study of the French Society of Anesthesia and Resuscitation]. Chirurgie. 1999 Apr;124(2):115-21. doi: 10.1016/s0001-4001(99)80053-1. No abstract available. French.

ReferenceCitation: Clergue F, Auroy Y, Pequignot F, Jougla E, Lienhart A, Laxenaire MC. French survey of anesthesia in 1996. Anesthesiology. 1999 Nov;91(5):1509-20. doi: 10.1097/00000542-199911000-00045.

ReferenceCitation: Lienhart A, Auroy Y, Clergue F, Laxenaire MC, Pequignot F, Jougla E. [Anesthetics and transfusion practices]. Ann Fr Anesth Reanim. 1998;17(11):1374-86. doi: 10.1016/s0750-7658(99)80050-1. No abstract available. French.

ReferenceType: derived

ReferenceCitation: Aubrun F, Ecoffey C, Benhamou D, Jouffroy L, Diemunsch P, Skaare K, Bosson JL, Albaladejo P. Perioperative pain and post-operative nausea and vomiting (PONV) management after day-case surgery: The SFAR-OPERA national study. Anaesth Crit Care Pain Med. 2019 Jun;38(3):223-229. doi: 10.1016/j.accpm.2018.08.004. Epub 2018 Oct 16.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via crossref license, author manuscript)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

evidence: open (author manuscript)

license_normalized: no license

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

host_type: repository

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

repository_normalized: HAL

version: submittedVersion

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

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

repositories_concat: HAL

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: University Hospital, Grenoble

collaborators: Société Française d'Anesthésie et de Réanimation

location_facility: Centre Hospitalier Bretagne Atlantique site de Vannes

location_facility: CH National d'Ophtalmologie - les quinze vingts

location_facility: Centre de Chirurgie Abulatoire des Hauts d'Avignon

location_facility: Clinique de Flandre - Coudekerque Branche

location_facility: Centre Hospitalier de Bretagne Sud site Bodelio

location_facility: Centre hospitalier Henri Mondor d'Aurillac

location_facility: Centre Hospitalier Saint-Cyr- Villeneuve sur Lot


type: Other Identifier

title: Host Responses in Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection

summary: Hepatitis E is a worldwide disease. It is the leading or second leading cause of acute hepatitis in adults in developing countries from sub-Saharan Africa or Southeast Asia, where it is hyperendemic and principally water-borne. In industrialised western countries, hepatitis E was until recently considered as imported from hyperendemic geographical areas, but is currently an emerging autochthonous infectious disease. A growing body of data from Europe, America, Australia, and Asia strongly indicate that pigs represent a major Hepatitis E Virus (HEV) reservoir and might be a source of zoonotic transmission to humans through direct or indirect exposure. Hepatitis E typically causes self-limited acute infection. However, the overall death rate is 1-4%, and it can reach 20% in pregnant women and might be still higher in patients with underlying chronic liver disease. To date, no preventive or curative treatment of hepatitis E is available.

design_allocation: Non-Randomized

ReferenceCitation: Moal V, Textoris J, Ben Amara A, Mehraj V, Berland Y, Colson P, Mege JL. Chronic hepatitis E virus infection is specifically associated with an interferon-related transcriptional program. J Infect Dis. 2013 Jan 1;207(1):125-32. doi: 10.1093/infdis/jis632. Epub 2012 Oct 16.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Study of the Coronary Microcirculation After Primary Angioplasty : Analysis of Absolute Coronary Blood Flow Rates and Resistance, Index of Microcirculatory Resistance and Comparison With Magnetic Resonance Imaging

acronym: NATHANAEL

summary:
In the management of acute myocardial infarction treated with primary angioplasty, despite effective epicardial clearance obtained in 95% of cases, microvascular obstruction (MVO) in the damaged territory concerns 50% of patients. The Index of Microvascular Resistance (IMR) allows early assessment of the microcirculatory state during the angioplasty procedure. A value of IMR>40 indicates MVO and is correlated with morbi-mortality. A new method for immediate evaluation of MVO using thermodilution with a new Rayflow® microcatheter has been described: it no longer allows the estimation but the measurements of absolute coronary resistance and coronary flow. We hypothesize that these measurements allows a better evaluation of the microcirculatory state after primary angioplasty, comparing to IMR.

The main objective is to study the diagnostic performance of Rayflow® to predict MVO - no reflow (NR) - in ST-Elevation Myocardial Infarction (STEMI) patients in order to determine an absolute coronary resistance threshold by thermodilution for early diagnosis of MVO.

The main secondary objectives will be to compare the different microcirculatory assessment parameters with each other, not indexed and indexed to the myocardial mass at risk (coronary resistance, IMR, CFR, Resistance Reserve Ratio) and to establish a link between high resistance or IMR and the occurrence of rhythm disorders at D1, D2 and D3.

primary_purpose: Diagnostic

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: APHP, Lariboisière Hospital, Cardiology Department

intervention_type: Diagnostic Test


title: Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers

acronym: Pre-QuantiPark

summary: Pre-QuantiPark is a pilot study to evaluate the reliability and responsiveness of ActiMyo measured activity in PD patients. The purpose of the study is to provide validation of the ActiMyo, an innovative home-recording device enabling use in clinical trials and as an innovative tool for PD patient care.

primary_purpose: Other

lead_sponsor: Institut de Myologie, France

location_facility: Service de Neurochirurgie, Hopital Henri Mondor

location_facility: Département des Maladies du Système Nerveux, GH Pitie Salpatriere

intervention_type: Drug

lead_sponsor_type: industriel


type: Registry Identifier

title: Clinical Characterisation Protocol for Severe Emerging Infections

acronym: FrenchCOVID

summary:
Infectious disease is the single biggest cause of death worldwide. New infectious agents, such as the SARS, MERS and other novel coronavirus, novel influenza viruses, viruses causing viral haemorrhagic fever (e.g. Ebola), and viruses that affect the central nervous system (CNS) such as TBEV & Nipah require investigation to understand pathogen biology and pathogenesis in the host. Even for known infections, resistance to antimicrobial therapies is widespread, and treatments to control potentially deleterious host responses are lacking.

In order to develop a mechanistic understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed, it is necessary to understand pathogen characteristics associated with virulence, the replication dynamics and in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of antimicrobial or host-directed therapies, the transmission dynamics, and factors underlying individual susceptibility.

The work proposed here may require sampling that will not immediately benefit the participants. It may also require analysis of the host genome, which may reveal other information about disease susceptibility or other aspects of health status.

ReferenceCitation: Garcia L, Woudenberg T, Rosado J, Dyer AH, Donnadieu F, Planas D, Bruel T, Schwartz O, Prazuck T, Velay A, Fafi-Kremer S, Batten I, Reddy C, Connolly E, McElheron M, Kennelly SP, Bourke NM, White MT, Pelleau S. Kinetics of the SARS-CoV-2 Antibody Avidity Response Following Infection and Vaccination. Viruses. 2022 Jul 8;14(7):1491. doi: 10.3390/v14071491.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: MDPI

ReferenceCitation: Gault N, Esposito-Farese M, Revest M, Inamo J, Cabie A, Polard E, Hulot JS, Ghosn J, Chirouze C, Deconinck L, Diehl JL, Poissy J, Epaulard O, Lefevre B, Piroth L, De Montmollin E, Oziol E, Etienne M, Laouenan C, Rossignol P, Costagliola D, Vidal-Petiot E; French-Covid cohort investigators, study group. Chronic use of renin-angiotensin-aldosterone system blockers and mortality in COVID-19: A multicenter prospective cohort and literature review. Fundam Clin Pharmacol. 2021 Dec;35(6):1141-1158. doi: 10.1111/fcp.12683. Epub 2021 May 16.

evidence: open (via free article)

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

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

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

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

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

ReferenceCitation: Buetti N, Wicky PH, Le Hingrat Q, Ruckly S, Mazzuchelli T, Loiodice A, Trimboli P, Forni Ogna V, de Montmollin E, Bernasconi E, Visseaux B, Timsit JF. SARS-CoV-2 detection in the lower respiratory tract of invasively ventilated ARDS patients. Crit Care. 2020 Oct 16;24(1):610. doi: 10.1186/s13054-020-03323-5.

ReferenceCitation: Bouadma L, Wiedemann A, Patrier J, Surenaud M, Wicky PH, Foucat E, Diehl JL, Hejblum BP, Sinnah F, de Montmollin E, Lacabaratz C, Thiebaut R, Timsit JF, Levy Y. Immune Alterations in a Patient with SARS-CoV-2-Related Acute Respiratory Distress Syndrome. J Clin Immunol. 2020 Nov;40(8):1082-1092. doi: 10.1007/s10875-020-00839-x. Epub 2020 Aug 22.

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

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

location_facility: CHU Toulouse IUCT Institut Universitaire de Cancer de Toulouse

location_facility: Centre hospitalier Intercommunal de Créteil

location_facility: Centre Hospitalier Régional Universitaire de Tours

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Centre hospitalier Louis Constant Fleming

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Assistance publique hopitaux de Marseille, hopital Nord

location_facility: Centre Hospitalier Universitaire de Rangueil

location_facility: Hopital d'instruction des armées Begin 69

location_facility: Grand Hopital de l'Est Francilien site Marne-la-Vallée


title: Vascular Risk Factors and Coronary Calcifications in Chronic Renal Failure Patients: Identification of Specific Factors Linked to Renal Failure Progression

acronym: Pre-HD

summary: The aim of this study is to appreciate the influence of renal failure progression on vasculopathy (coronary calcifications and left ventricular hypertrophy) and cardiovascular risk factors.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
Ministry of Health, France


title: Multicentre Study: Adherence to the Severe Trauma Patients Pathway in PACA Region

acronym: FILTRAUMA-PACA

summary:
Trauma patient management concerns more than 140,000 patients per year in France. PACA Regional Emergency Observatory (ORU) has issued recommendations to optimize the management of these trauma patients from pre-hospital phase to hospitalization first hours. Ideally, pre-hospital care should not exceed 60 minutes, from accident (first call to the SAMU) to trauma center arrival: the "golden hour" concept. Patients presenting at least one of the Vittel criteria are considered as severely traumatized and are classified according to 3 states of seriousness: unstable, critical and potentially serious. They are referred to trauma centers whose classification is based on their technical facilities, ranging from level 1 (maximum technical facilities) to level 3 (minimum technical facilities). Patients are referred according to their severity, distance from accident site, referral center and availability of each site. Initial hospital management recommends a whole body CT scan within 45 minutes for patients categorized as unstable or critical by pre-hospital doctor and 90 minutes for patients deemed potentially serious.

FILTRAUMA PACA study will analyze the impact of the different management sequences of severe trauma patients based on reliable temporal data because it is automatically incremented in databases and will seek to find a correlation with patient outcome (survival at 24 hours and 28 days).

The main hypothesis tested is that PACA ORU recommended delay respect during trauma patient initial management is correlated with vital prognosis in short (24 hours) and medium terms (28 days).

ReferenceCitation: Bege T, Pauly V, Orleans V, Boyer L, Leone M. Epidemiology of trauma in France: mortality and risk factors based on a national medico-administrative database. Anaesth Crit Care Pain Med. 2019 Oct;38(5):461-468. doi: 10.1016/j.accpm.2019.02.007. Epub 2019 Feb 23.

ReferenceCitation: Gauss T, Balandraud P, Frandon J, Abba J, Ageron FX, Albaladejo P, Arvieux C, Barbois S, Bijok B, Bobbia X, Charbit J, Cook F, David JS, Maurice GS, Duranteau J, Garrigue D, Gay E, Geeraerts T, Ghelfi J, Hamada S, Harrois A, Kobeiter H, Leone M, Levrat A, Mirek S, Nadji A, Paugam-Burtz C, Payen JF, Perbet S, Pirracchio R, Plenier I, Pottecher J, Rigal S, Riou B, Savary D, Secheresse T, Tazarourte K, Thony F, Tonetti J, Tresallet C, Wey PF, Picard J, Bouzat P; Groupe d'interet en traumatologie grave (GITE). Strategic proposal for a national trauma system in France. Anaesth Crit Care Pain Med. 2019 Apr;38(2):121-130. doi: 10.1016/j.accpm.2018.05.005. Epub 2018 May 29.

ReferenceCitation: Harmsen AM, Giannakopoulos GF, Moerbeek PR, Jansma EP, Bonjer HJ, Bloemers FW. The influence of prehospital time on trauma patients outcome: a systematic review. Injury. 2015 Apr;46(4):602-9. doi: 10.1016/j.injury.2015.01.008. Epub 2015 Jan 16.

ReferenceCitation: Ashburn NP, Hendley NW, Angi RM, Starnes AB, Nelson RD, McGinnis HD, Winslow JE, Cline DM, Hiestand BC, Stopyra JP. Prehospital Trauma Scene and Transport Times for Pediatric and Adult Patients. West J Emerg Med. 2020 Feb 21;21(2):455-462. doi: 10.5811/westjem.2019.11.44597.

ReferenceCitation: Mann NC, Mullins RJ, MacKenzie EJ, Jurkovich GJ, Mock CN. Systematic review of published evidence regarding trauma system effectiveness. J Trauma. 1999 Sep;47(3 Suppl):S25-33. doi: 10.1097/00005373-199909001-00007.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

location_facility: Centre Hospitalier d'Avignon Henri Duffaut

location_facility: Assistance Publique des Hôpitaux de Marseille


title: Effect of the Food Supplement LIMICOL on LDL Cholesterol and Muscle Function in Subjects Who Undergo a Program of Physical Training (Double-blind, Randomized, Placebo-controlled Study).

summary:
Cardiovascular disease (CVD), foremost among which ischemic heart disease and stroke, are the leading cause of mortality and morbidity in France. These diseases are multifactorial origin and even if it is not possible to act on risk markers such as age, sex, or heredity, risk factors like high cholesterol, smoking , hypertension, obesity, diabetes and physical inactivity, are the main target of prevention strategies. Dydlipidemias have a role in the formation of CVD in participating in the genesis of atherosclerosis. The cholesterol and LDL-cholesterol in particular is subject to oxidation process in plasma. The molecules of oxidized LDL-cholesterol, small and dense, easily penetrate the arterial endothelial wall and are greeted by macrophages. Following a succession of different processes including inflammation, atherosclerotic plaque is formed. The result is either an arteriopathy when the arterial lumen narrowing, or atherothrombosis in the event of plaque rupture. Given this pathophysiology, reduce blood lipids, including LDL-cholesterol and reducing oxidation and inflammation are interesting strategies in the context of cardiovascular prevention. Several scientific study showed that nutritional supplementation with some plant extracts such as artichokes, garlic, red yeast rice, or the sugar cane policosanol helps to reduce several cardiovascular risk factors including regulate concentrations of circulating lipids.

In this study, we hypothesize that the food supplement LIMICOL contributes to reducing LDL cholesterol in the context of care for patients (dietary measures and physical activity)

design_allocation: Randomized

lead_sponsor: Lescuyer Laboratory

collaborators: Clinique Médicale Cardio-Pneumologie de Durtol

location_facility: Service de médecine du sport et des explorations fonctionnelles, CHU G. Montpied

location_facility: Clermont Université, Université Blaise Pascal, EA 3533, Laboratoire des Adaptations Métaboliques à l'Exercice en Conditions Physiologiques et Pathologiques (AME2P), BP 10448

intervention_type: Dietary Supplement


lead_sponsor: Sierra Oncology LLC - a GSK company

summary:
MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic participants who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom (UK) and United States (US).

Participants must be symptomatic with a Myelofibrosis Symptom Assessment Form (MFSAF) version (v) 4.0 Total Symptom Score of >= 10 at screening, and be anemic with hemoglobin (Hgb) < 10 gram/deciliter (g/dL). For participants with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization.

Participants will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Participants randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the participants tolerates and continues to benefit from MMB.

Participants randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances: at the end of Week 24 if they complete the randomized treatment period; or at the end of Week 24 if they discontinue treatment with DAN but continue study assessments and do not receive prohibited medications including alternative active anti-MF therapy; or at any time during the randomized treatment period if they meet the protocol-defined criteria for radiographically confirmed symptomatic splenic progression. Participants randomized to receive DAN who are receiving clinical benefit at the end of Week 24 may choose to continue DAN therapy up to Week 48. The comparator treatment, DAN, is an approved medication in the US and in some other countries and is recommended by national guidelines as a treatment for anemia in MF.

ReferenceCitation: Gerds A, Verstovsek S, Vannucchi A, Al-Ali HK, Lavie D, Kuykendall A, Grosicki S, Iurlo A, Goh YT, Lazaroiu M, Egyed M, Fox ML, McLornan D, Perkins A, Yoon SS, Gupta V, Kiladjian JJ, Donahue R, Kawashima J, Mesa R. MPN-483 Thrombocytopenic Myelofibrosis (MF) Patients Previously Treated With a JAK Inhibitor in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM]. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S340. doi: 10.1016/S2152-2650(22)01464-1.

oa_host_type: closed

repositories_concat: closed

location_facility: University of Colorado Hospital Anschutz Cancer Pavilion

location_facility: American Institute of Research - Whittier

location_facility: Institut Hospital del Mar d'Investigacions Mèdiques

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

location_facility: The Catholic University of Korea Seoul Saint Mary's Hospital

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

location_facility: Washington University School of Medicine in Saint Louis

location_facility: Perth Radiological Clinic - Magnetic Resonance Centre

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: University Hospitals Cleveland Medical Center

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Queen Elizabeth II Health Sciences Centre - Halifax Infirmary

location_facility: Laboratul clinic MedLife-Policlinica de Diagnostic Rapid Brasov

location_facility: Klinika Hematologii Nowotworów Krwi i Transplantacji Szpiku

location_facility: Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire Nantes - Hôtel Dieu

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Centre Hosptitalier Universitaire Angers

location_facility: Columbia University Irving Medical Center - Presbyterian Hospital

location_facility: Spitalul Clinic Judetean De Urgenta Târgu Mureș

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Alessandria

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd

location_facility: Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo

location_facility: Hospital Center University Of Caen Normandie

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata

location_facility: Alvamed Zakład Specjalistycznej Opieki Zdrowotnej

location_facility: Ospedale Policlinico Giambattista Rossi Borgo Roma

location_facility: Presidio Ospedaliero Universitario Santa Maria della Misericordia

location_facility: Seoul National University Bundang Hospital

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet - Szent László Telephely

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hospital Universitario Central de Asturias

location_facility: Complejo Asistencial Universitario de Salamanca - Hospital Clínico

location_facility: National Specialized Hospital for Active Treatment of Haematologic Diseases

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Guy's and Saint Thomas' NHS Foundation Trust

location_facility: Sjællands Universitetshospital - Roskilde

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Northwest Oncology & Hematology - Rolling Meadows

location_facility: Research Institute of the McGill University Health Centre

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Cleveland Clinic - Richard E. Jacobs Health Center

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Uniwersyteckie Centrum Kliniczne w Gdańsku

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Markusovszky Egyetemi Oktatókórház Szombathely

location_facility: Centre Hospitalier Universitaire Amiens-Picardie - Site Sud

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: University Multiprofile Hospital For Active Treatment Aleksandrovska

location_facility: Centre Hospitalier Universitaire de Poitiers

title: A Randomized, Double-blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) Versus Danazol (DAN) in Symptomatic, Anemic Subjects With Primary Myelofibrosis (PMF), Post-polycythemia Vera (PV) Myelofibrosis, or Post-essential Thrombocythemia (ET) Myelofibrosis Who Were Previously Treated With JAK Inhibitor Therapy

primary_purpose: Treatment

source: euctr

location_country:
Germany
Poland
New Zealand
Australia
Czechia
Canada
France
Hungary
Denmark
United States
Romania
Belgium
Italy
United Kingdom
Singapore
Sweden
Austria
Korea, Republic of
Spain
Taiwan
Bulgaria
Israel


title: Dressing: Comparison of 3-day and 7-day Catheter Dressing Frequency and Efficacy of Antiseptic Impregnated Dressing in Preventing Catheter-related Infection in ICU

acronym: DRESSING

summary: The purpose of this study is to determine whether a catheter dressing every 7th day is not inferior to a catheter dressing every 3 days and if Chlorhexidine impregnated sponges are effective in preventing catheter-related infections in ICUs.

primary_purpose: Prevention

ReferenceCitation: Buetti N, Ruckly S, Schwebel C, Mimoz O, Souweine B, Lucet JC, Timsit JF. Chlorhexidine-impregnated sponge versus chlorhexidine gel dressing for short-term intravascular catheters: which one is better? Crit Care. 2020 Jul 23;24(1):458. doi: 10.1186/s13054-020-03174-0.

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

publisher_dissemination: Springer-Nature

ReferenceCitation: Timsit JF, Bouadma L, Mimoz O, Parienti JJ, Garrouste-Orgeas M, Alfandari S, Plantefeve G, Bronchard R, Troche G, Gauzit R, Antona M, Canet E, Bohe J, Herrault MC, Schwebel C, Ruckly S, Souweine B, Lucet JC. Jugular versus femoral short-term catheterization and risk of infection in intensive care unit patients. Causal analysis of two randomized trials. Am J Respir Crit Care Med. 2013 Nov 15;188(10):1232-9. doi: 10.1164/rccm.201303-0460OC.

publisher_dissemination: American Thoracic Society

ReferenceCitation: Timsit JF, Bouadma L, Ruckly S, Schwebel C, Garrouste-Orgeas M, Bronchard R, Calvino-Gunther S, Laupland K, Adrie C, Thuong M, Herault MC, Pease S, Arrault X, Lucet JC. Dressing disruption is a major risk factor for catheter-related infections. Crit Care Med. 2012 Jun;40(6):1707-14. doi: 10.1097/CCM.0b013e31824e0d46.

ReferenceCitation: Schwebel C, Lucet JC, Vesin A, Arrault X, Calvino-Gunther S, Bouadma L, Timsit JF. Economic evaluation of chlorhexidine-impregnated sponges for preventing catheter-related infections in critically ill adults in the Dressing Study. Crit Care Med. 2012 Jan;40(1):11-7. doi: 10.1097/CCM.0b013e31822f0604.

ReferenceCitation: Timsit JF, Schwebel C, Bouadma L, Geffroy A, Garrouste-Orgeas M, Pease S, Herault MC, Haouache H, Calvino-Gunther S, Gestin B, Armand-Lefevre L, Leflon V, Chaplain C, Benali A, Francais A, Adrie C, Zahar JR, Thuong M, Arrault X, Croize J, Lucet JC; Dressing Study Group. Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults: a randomized controlled trial. JAMA. 2009 Mar 25;301(12):1231-41. doi: 10.1001/jama.2009.376.

sponsor_collaborators:
University Hospital, Grenoble
Ministry of Health, France

location_facility: grenoble university hospital (medical ICU and surgical ICU)

location_facility: University hospital Bichat Claude Bernard


title: Study of Geriatric Patients Aged 75 Years or Older Treated and Cured for Localized Prostate Cancer: Case-control Study

acronym: PROGE

summary:
This is a multicenter pilot study, proposed for cases and controls 3 departments in France.

Cases are cured patients who have had prostate cancer for at least 10 years. Cookies are healthy subjects selected by lottery on voter list.

Volunteer subjects (cases and controls) are offered a consultation and assessment with an geriatrician.

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre François BACLESSE
CHIC
Clinique Claude BERNARD
Hopitaux universitaires de Strasbourg
CHRU


title: The Developmental Origins of Endometriosis

acronym: ENDOHaD

summary:
Introduction:

Endometriosis is a common pathology affecting one in 10 women, characterized by the ectopic development of endometrium, which can cause pain and/or infertility. This pathology is primarily determined by hereditary factors, but it is also susceptible to environmental influences, such as the age of the onset of menstruation or exposure to chemical substances that modify the endocrine system. Recent studies have highlighted that endometriosis is more common in women with relatively short ano-genital distances (AGD), and that sensitivity to pain is closely linked to adult levels of testosterone (T) or oxytocin (OT).

Aim:

The main objective is to compare the anogenital distance (AGD) between two groups of women: one with stage III or IV endometriosis (ENDO +) and another group without endometriosis confirmed by laparoscopy (ENDO -).

The secondary objectives are to compare various factors between the 2 groups :

Basal testosterone levels in blood.
Variations in blood testosterone levels before and after a video stimulating empathy.
Basal oxytocin levels in saliva.
Variations in oxytocin levels in saliva before and after an empathy-stimulating video.
Pelvic pain, between D2 and D5 after the start of the menstrual cycle.

For the ENDO + group only:

Evaluate patients' quality of life, between D2 and D5 after the start of the menstrual cycle.
Correlate pain experienced over the last 4 weeks with hormonal markers (AGD, T, OT).

Methods:

Participants in the ENDO+ group will fill in a questionnaire assessing the impact of pain experienced over the past 4 weeks on their quality of life. D0 is defined as the day when participants experience a menstrual bleed before 10 am. All participants will return for project-specific hospital appointment between D2 and D5 after the start of their menstrual cycle to measure T, Sex Hormone-Binding Globulin (SHBG) and OT.

During this consultation, the following samples will be taken:

10mL blood sample
2mL saliva sample

Both samples will be taken at t0 (before watching the video) and t1 (20 minutes after watching the video).

study_start_date_type: Anticipated

collaborators: Centre National de la Recherche Scientifique, France

collaborators: Fondation pour la Recherche sur l'Endométriose


title: Identification of Key Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais, Normandy and Picardy Regions

acronym: FRISC

summary:
Kidney transplantation is now the treatment of choice for end-stage renal disease (ESRD). Between 2800 and 3000 kidney transplants are performed each year in France and more than 33 000 patients are living with a functioning graft.

Preventing allograft rejection requires the use of immunosuppressive therapy, the intensity decreases as the distance from the day of transplantation. Unfortunately, treatment favors certain complications, including infectious and neoplastic. These represent a major cause of mortality in these patients. If the frequency of skin cancer is greatly increased in this population, that of solid tumors remains a concern. Approximately 20% of patients develop cancer after 10 years of graft , half non- skin cancers, the main risk factor is immunosuppressive therapy .

The aim of the study is to evaluate, in a large population of patients treated in 4 regions ( the Nord-Pas de Calais, the Upper and Lower Normandy and Picardy) risk factors (in particular the nature of the immunosuppressive treatment) of developing a neoplastic complication, skin cancers and solid tumors, after renal transplantation.

status: Unknown status

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU CAEN
Chu Rouen
Chru Lille
CHU Amiens

status_simplified: Unknown


title: Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation

acronym: Stim-Endom

summary:
6-10% of women of childbearing age suffer from endometriosis, which is mainly manifested by dysmenorrhea, non-menstrual pelvic pain and dyspareunia. Several treatment strategies, including surgical ones, are proposed but they are sometimes insufficient because endometriosis-related pain is frequently accompanied by sensitization. Endometriosis surgery, when indicated, is therefore changeably effective, even though the lesions have been completely resected. Patients therefore consult Pain Units seeking for the effective treatment as the pain persist even after surgical management of endometriosis.

Vagus nerve stimulation is a non-invasive technique that includes an anti-inflammatory effect and a modulation of neurotransmitter production (adrenaline, norepinephrine; serotonin, acetylcholine). Yuan and Silberstein published a general review on the technique. Migraine and depression are one of the selected indications. In addition, Napadow et al. published favourable results in a short series of patients with chronic pelvic pain. The Investigators of this study have treated some patients with this technique with a result deemed satisfactory which leads to propose a randomized study to confirm this impression.

lead_sponsor: Hopital Foch

location_facility:
Hopital Saint Joseph
CHI Poissy-St-Germain
Hopital Foch


title: Toi Même: a Mobile System for Measuring Bipolar Illness Activity - Feasibility Study

summary:
Bipolar disorder is a severe psychiatric illness with chronic course and it is associated with high risk of relapse and hospitalisation, and many patients do not recover to their previous psychosocial functioning. Major reasons for poor outcomes are delayed intervention for prodromal mood and behavioural symptoms as well as incomplete treatment responses. Current diagnostic approaches used to assess mood symptoms rely on symptom-based categories, which lack sensitivity to detect subtle mood and behavioural changes. Therefore, the ability to better characterizing bipolar patients may allow to detect possible differences in the illness activity.

On the other hand, there is a growing interest in the potential use of mobile technologies such as mobile apps, smartphone and internet in psychiatric care. Some projects have been testing the potential benefits of mobile apps to assess and treat individuals at-risk or suffering from mood and bipolar disorders, using online signs and symptoms monitoring, yet to the investigators knowledge, none of them have integrated a dimensional approach in a smartphone app to assess mood and behavioural alterations and bipolar illness activity, including subjective and objective data (e.g. physical activity, social activity, etc.).

In this feasibility study the investigators will evaluate the potential relevance of Toi Même app to self-monitoring mood and behavioural changes in bipolar patients with different mood phases compared to the gold-standard mood rating tools used in clinical practice. All patients will be followed for 3 months, with outcome assessments after 2 weeks, after 1 month, 2 months and after 3 months.

status: Terminated

ReferenceCitation: Dargel AA, Mosconi E, Masson M, Plaze M, Taieb F, Von Platen C, Buivan TP, Pouleriguen G, Sanchez M, Fournier S, Lledo PM, Henry C. Toi Meme, a Mobile Health Platform for Measuring Bipolar Illness Activity: Protocol for a Feasibility Study. JMIR Res Protoc. 2020 Aug 18;9(8):e18818. doi: 10.2196/18818.

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

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

publisher_dissemination: JMIR Publications

lead_sponsor: Institut Pasteur

location_facility: Nightingale Hospitals Paris - Clinique du Château

location_facility: Centre Thérapeutique et Preventif de Jour - Troubles Bipolaires (Clinique Bellevue)


title: Interest in Studying Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma : Exploratory Study

acronym: FibroRect

summary: Single center interventional study to explore activity of fibroblasts in the tumor and away in the healthy rectal tissue.

ipd_sharing: Yes

ipd_sharing_description: Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.

location_facility:
Institut Curie - Hôpital René Huguenin
INSTITUT CURIE - Site Paris
Institut Curie


title: Early Postoperative Recurrence in Crohn's Disease: Predictors of Research Targeting the Constitutional Mutation of IRGM

summary: Crohn's disease is a disease of complex etiology, multifactorial and still poorly understood. This disease, due to its morbidity and mortality, poses a significant public health problem in France. Apart from the involvement of bacterial factors and those involving the permeability of the epithelial barrier, it is now well recognized that several factors are associated with genetic predisposition in some of these patients. Among these factors, the Nod2 mutations were first identified. Studies concerning the presence of these mutations and the severity of disease results were sometimes conflicting. Very recently, new interesting mutations in genes involved in autophagy were found with greater frequency in patients with Crohn's disease. These mutations observed in Atg16 and IRGM genes. It has been particularly shown on large patient cohorts,the IRGM polymorphism was associated with a progressive disease, with histological severity scores. One of the severity criteria of Crohn's disease is the early recurrence observed in some patients after surgical resection of the injured segment. Predictive factors for such recurrence after surgery are not known or not.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Nice
CHU de Montpellier
AP-HM
CHU de Grenoble


title: Development and Validation of a Predictive Score for Surgical Site Infections (SSI): a Prospective Preoperative Trial in Major Digestive Surgery

acronym: SPRED

summary:
More than 8 millions surgical interventions are carried out each year in France. Postoperative complications, in particular infectious, can occur in 10 to 60% of cases and are the cause of postoperative revision in 30% of cases, an increase in mortality, length of stay, readmissions and lead to significant additional socio-economic costs. Currently, improvements in surgical practices have not reduced the incidence of surgical site complications. In this context, the development of predictive scores for the risk of post-operative complication becomes urgent in order to implement new interventions (pre-habilitation) or to modify surgical decisions (timing, approach) in order to reduce the risk of complications before surgery. Several recent studies highlights the importance of the immune response in postoperative prognosis. In particular, an imbalance between the adaptive and innate response involving MDSCs has been demonstrated in patients with postoperative complications.Thanks to new techniques for analyzing the immune system, in-depth analysis of the immune system before surgery is a very promising approach aimed at identifying predictive biomarkers of postoperative prognosis.

Our team has developed and patented a multivariate model integrating mass cytometry data, proteomics and clinical data collected before surgery to accurately predict the occurrence of a surgical site complication (AUC = 0.94, p<10e-7) in a monocentric cohort of 43 patients to major abdominal surgery (Stanford University).

The objective of the present study is to generalize and validate this preoperative predictive score of infectious complications of the surgical site in the 30 days following major digestive surgery on a larger workforce within a multicenter cohort and to validate this score at using a machine learning method.

ReferenceCitation: Storesund A, Haugen AS, Hjortas M, Nortvedt MW, Flaatten H, Eide GE, Boermeester MA, Sevdalis N, Softeland E. Accuracy of surgical complication rate estimation using ICD-10 codes. Br J Surg. 2019 Feb;106(3):236-244. doi: 10.1002/bjs.10985. Epub 2018 Sep 18.

ReferenceCitation: Hawn MT, Vick CC, Richman J, Holman W, Deierhoi RJ, Graham LA, Henderson WG, Itani KM. Surgical site infection prevention: time to move beyond the surgical care improvement program. Ann Surg. 2011 Sep;254(3):494-9; discussion 499-501. doi: 10.1097/SLA.0b013e31822c6929.

ReferenceCitation: Gaudilliere B, Angst MS, Hotchkiss RS. Deep Immune Profiling in Trauma and Sepsis: Flow Is the Way to Go! Crit Care Med. 2017 Sep;45(9):1577-1578. doi: 10.1097/CCM.0000000000002594. No abstract available.

ReferenceCitation: Zhu X, Herrera G, Ochoa JB. Immunosupression and infection after major surgery: a nutritional deficiency. Crit Care Clin. 2010 Jul;26(3):491-500, ix. doi: 10.1016/j.ccc.2010.04.004.

ReferenceCitation: Gaudilliere B, Fragiadakis GK, Bruggner RV, Nicolau M, Finck R, Tingle M, Silva J, Ganio EA, Yeh CG, Maloney WJ, Huddleston JI, Goodman SB, Davis MM, Bendall SC, Fantl WJ, Angst MS, Nolan GP. Clinical recovery from surgery correlates with single-cell immune signatures. Sci Transl Med. 2014 Sep 24;6(255):255ra131. doi: 10.1126/scitranslmed.3009701.

location_facility:
Saint Joseph Hospital
La pitiè Salpâtrière Hospital
FOCH Hospital
Saint Antoine Hospital

intervention_type: Biological


title: PAncreas Borderline and Locally Advanced Snapshot Study

acronym: PALASS

summary: The project's objective is to carry out prospectively, in France, for one year, a descriptive registry study in the management of patients with borderline or locally advanced pancreatic adenocarcinoma, and to collect both the patient's demographic characteristics, but also the therapeutic regimens applied, the types of surgeries performed and the outcome of the patients after surgery, and at three months of follow up (preoperative data, complications's post surgery, quality of the resection, etc.)

status: Not yet recruiting

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU Toulouse
CHU Nice
CHU Rennes
CHU Lille
CHU Tours
CHU Amiens
CHU clermont-ferrand
APHP Hopital Beaujon
CHU Dijon
CHU Rouen
APHP Hopital Paul Brousse
CHU Nancy
APHM
CHU Nantes
CHU Montpellier
CHU Reims
Institut Paoli-Calmettes d'Unicancer
CHU Strasbourg
APHP Hopital Cochin
CHU Besançon
Hospices Civils de Lyon
CHU Bordeaux
APHP Hopital de la Pitié-Salpétrière


title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 on Cerebrospinal Fluid Biomarkers in 36 Patients With Progressive Supranuclear Palsy

summary: A phase 2 study to assess tolerability, safety, pharmacokinetics and effect of AZP2006 at different doses versus placebo on cerebrospinal fluid biomarkers in 36 patients with progressive supranuclear palsy. The patient study duration is 29 weeks including a washout period.

status: Active, not recruiting

lead_sponsor: AlzProtect SAS

location_facility: Hôpital de la Fondation Adolphe de Rothschild

location_facility: Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix


title: Evaluation of the Involvement of the Intestinal Microbiota and Choline Deficiency in the Severity of Chronic Liver Disease Explored by Analyzing Collection of Biological Samples

acronym: MICRONACH

summary:
Chronic liver diseases are common and the two main causes in France are NAFLD (No Alcoholic Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease).

Because of the importance of the current global obesity, NAFLD has become very common and it is estimated that its prevalence in the general population reaches 20-30%.

NAFLD (No Alcoholic Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease) includes a broad spectrum of liver damage, ranging from simple steatosis isolated (infiltration of fat in the liver), in hepatic inflammation, fibrosis (abnormally high accumulation of extracellular components in the functional liver tissue) and finally cirrhosis and its complications.

Choline deficiency (essential nutrient generally classified as Class B vitamins) has been associated with liver damage each characterizing NAFLD and ALD. The amount of choline in the body depends in particular on food intake and degradation of choline by the intestinal microbiota.

NAFLD and ALD are complex pathologies resulting from the interaction of environmental / nutritional factors and a genetic background. It therefore appears now necessary to study the influence of the relationship between genetic predisposition, environmental factors, and gut microbiota metabolism of choline on the severity of liver injury observed in NAFLD and ALD.

If the interaction of these three elements (the host genetics - environmental factors - and intestinal microbiota metabolic choline) has an influence on the severity of the lesions of NAFLD and ALD direct application may be of bring a food supplement choline in patients at risk (mutation of the PEMT gene (phosphatidylethanolamine N-methyltransferase), postmenopausal women, microbiota profile for increased degradation of dietary choline) to restore the amount of choline in the body and thus to avoid a worsening of the ALD or NAFLD and progression to cirrhosis.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
CHU Rennes
CHU Toulouse
CHU Nantes
CHU Angers


title: Treatment of Mature B-cell Lymphoma/Leukaemia A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study

summary: This is an international trial conducted by three cooperative groups: SFOP (France, Belgium, Netherlands), CCG (USA, Canada, Australia), and UKCCSG (UK and Ireland). Children with mature B-cell lymphoma/leukaemia are stratified into three different risk groups (A, B, C) and receive treatment of progressive intensity. Randomized trials in the 2 biggest groups (B and C) test whether "reduced" therapy is equivalent to standard intensive therapy (LMB-89 B and C) in terms of event free survival. The reason for the modification is to reduce the long term toxicity which includes cardiotoxicity, impaired fertility and secondary malignancy. In group B, the modifications of treatment consists of a reduction of cyclophosphamide in COPADM2 and/or the elimination of COPADM3. In group C, the modification consists in a reduction of the doses in the CYVE courses and the elimination of the last 3 courses of maintenance treatment

ReferenceCitation: Frazer JK, Li KJ, Galardy PJ, Perkins SL, Auperin A, Anderson JR, Pinkerton R, Buxton A, Gross TG, Michon J, Leverger G, Weinstein HJ, Harrison L, Shiramizu B, Barth MJ, Goldman SC, Patte C, Cairo MS. Excellent outcomes in children and adolescents with CNS+ Burkitt lymphoma or other mature B-NHL using only intrathecal and systemic chemoimmunotherapy: results from FAB/LMB96 and COG ANHL01P1. Br J Haematol. 2019 Apr;185(2):374-377. doi: 10.1111/bjh.15520. Epub 2018 Aug 16. No abstract available.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
United States
United Kingdom
France

location_facility: Morgan Stanley Childrens Hospital of New York Presbyterian


title: Investigation of Tumour Spectrum, Penetrance and Clinical Utility of Germline Mutations in New Breast and Ovarian Cancer Susceptibility Genes.

acronym: TUMOSPEC

summary: TUMOSPEC is a national family study designed to measure the relative and absolute risk of cancer for carriers of deleterious mutations to these "new" breast cancer (BC) susceptibility genes. Index cases will be enrolled consecutively from patients attending an appointment at one of the Unicancer centres, with no other inclusion criteria, and offered a BRCA1/2 analysis as part of their care plan. A panel of 24 TUMOSPEC genes, chosen in advance by a steering committee, will be tested as the same time as the BRCA1/2 genes, at one of the usual BRCA1/2 analysis laboratories belonging to the same network and participating in the study. If a mutation is found, the index cases will be asked to invite their first and second degree family members and their cousins to take part in the study, regardless of whether they have cancer. Saliva samples will be then taken and used for a targeted analysis of the familial abnormality. Each participant will also complete an epidemiological questionnaire in order to gather information about his/her medical history and any exposure to various risk factors. All medical and genotype data will be centralised at the Genetic Epidemiology Research Platform (PIGE, INSERM). The cumulative mutation frequency for all genes is estimated at 10%. Penetrance will be analysed using methods designed to minimise selection bias. The expression spectrum of the mutations will also be described. For genes where the number of mutated families is too low, the data may be contributed to international consortia. The main project will be preceded by a two-year feasibility study, using the same inclusion criteria and logistic circuits. It is this pilot study to which the current funding application relates.

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

lead_sponsor: UNICANCER

collaborators: Gustave Roussy, Cancer Campus, Grand Paris

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

location_facility:
Gustave Roussy
Institut Curie - PIGE


acronym: GROWTH

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

summary:
Intrauterine growth restriction (IUGR) is correlated to an abnormal placenta development, with an alteration of the maternal-fetal circulation, coagulation troubles, and apparition of placental infarcts. IUGR represents the third cause of perinatal mortality in France, and is associated to an important morbidity. For birth-weights < 10th percentile of the gestational age, the neonatal death risk is doubled, compared to abnormal weights. In 35% of cases, IUGR is of vascular origin and is included in the broader framework of placental vascular pathology (PVP).

Up to now, studies have focused on the primary or secondary prevention of PVP. Few studies have evaluated the treatment of constituted vascular IUGR. Currently, the management of vascular IUGR is mainly based on active surveillance, or termination of pregnancy. Pathological findings suggest that placental pro-thrombotic phenomena play a role in the constitution of vascular IUGR. Since aspirin is not effective in reducing this type of event, a randomized, open-label study conducted in China compared 14-day treatment with low-molecular-weight heparin (LMWH) versus Dan-Shen (a product not used in France) after diagnosis of IUGR. This trial, including 73 patients, showed a significant improvement in average growth kinetics in the LMWH group. The mean birth weight was 2877 g in the heparin group and 2492 g in the Dan-Shen group (p <0.0001). However, no data were provided concerning the number of newborns with a birth weight <10th percentile, i.e. the risk of morbidity and mortality, or complications occurring. Due to the lack of reliable data, LMWH are not included in the currently recommended therapeutic strategy for vascular IUGR.

The studies in IUGR reported to date mainly focused on primary or secondary prevention in women at risk of PVP, assessing the value of aspirin, which showed only a modest effect. No effective therapeutic strategy is available to treat patients with constituted vascular IUGR, a situation where LMWH should be more effective than antiplatelets given the vascular context.

location_facility:
Chu Saint Etienne
Chu Grenoble
Chru Brest
HFME - Lyon Est
Hopital Croix Rousse Lyon
Chu Clermont-Ferrand
Ch Roanne
Ch Lyon Sud Pierre Benite

title: Low-molecular-weight Heparin in Constituted Vascular Intrauterine Growth Restriction. Randomized Multicenter Trial

type: EudraCT Number


title: Hypertensive Pregnant Women Monitored by Teletransmitted Self-measurements of Blood Pressure

acronym: FETH

summary: The occurrence of arterial hypertension (AH) during pregnancy is a major cause of fetal, neonatal and maternal morbidity and mortality in western countries. It is estimated that about 10% of pregnancies are complicated by AH (80 000 women / year in France). It is therefore essential to diagnose AH with certainty in order to set-up appropriate care and follow its evolution.

ReferenceCitation: Ashworth DC, Maule SP, Stewart F, Nathan HL, Shennan AH, Chappell LC. Setting and techniques for monitoring blood pressure during pregnancy. Cochrane Database Syst Rev. 2020 Jul 23;8(8):CD012739. doi: 10.1002/14651858.CD012739.pub2.

oa_host_type: repository

unpaywall_oa_status: green

lead_sponsor: Rennes University Hospital

location_facility:
CHU Tours
CH St-Malo
CHU Caen
CHU Lille
Hôpital Cochin (APHP)


title: Improvement of Social Adaptation After Pre-operative Cognitive Remediation in Parkinson's Patients Profiting From a Bilateral Subthalamic Stimulation

summary:
Main objective:

To assess the impact of a structured program of preoperative cognitive remediation on postoperative social adaptation in patients suffering from Parkinson's disease profiting from bilateral subthalamic nucleus stimulation.

Secondary objectives:

To assess in the same patients the impact of structured program of preoperative cognitive remediation on quality of life, mood, anxiety, apathy and psychologic, social and professional functioning depending on psychiatric symptomatology after intervention.

lead_sponsor: Central Hospital, Nancy, France

location_facility:
CHU Clermont Ferrand
CHRU Strasbourg
CHU de Nancy

intervention_type: Procedure


title: Prospective Study of Neutrophil Gelatinase Associated Lipocalin (NGAL)as a Biomarker of Mineralocorticoid Receiver Activity in Human: Proof of Concept.

summary: Aldosterone and its target the mineralocorticoid receptor are implied in development of cardiovascular disease such as arterial high blood pressure or cardiac failure. Serum aldosterone level is insufficient to know if the mineralocorticoid receptor is activated or not. The aim of this study is to identify biomarkers of mineralocorticoid receptor activity. The first "candidate biomarker" is Neutrophil gelatinase-associated lipocalin (NGAL) or "lipocalin" which being measured in blood or in the urine. According to scientific knowledge's evolution, others biomarkers could be tested later thanks to the blood or urinary samples taken during study.

location_facility: Unit of arterial high blood pressure of the Georges Pompidou Hospital


title: Effect of Enterally Administered Probiotics in Mechanically Ventilated Patients: Double-Blind, Prospective Randomized Study Versus Placebo

summary: The objective of this study is to assess the effects of a daily enteral supplementation with probiotics within a population of critically ill, mechanically ventilated patients. Especially, the effects of probiotics on mortality rate in intensive care medicine will be analysed.

location_facility: Hopital Central, Service de Reanimation Medicale


title: The VEPRO Trial: A Cross-Over Randomised Controlled Trial Comparing 2 Corrective Lenses for Patients With Presbyopia

acronym: VEPRO

summary: The VEPRO trial is a cross-over randomised controlled trial comparing 2 corrective lenses for patients with presbyopia. The aim of the study is to compare the effectiveness of two corrective lenses: an old generation (Varilux Comfort Orma Crizal) and a new generation (Varilux Panamic Orma Crizal) of corrective lenses prescribed in presbyopia.

ReferenceCitation: Boutron I, Touizer C, Pitrou I, Roy C, Ravaud P. The VEPRO trial: a cross-over randomised controlled trial comparing 2 progressive lenses for patients with presbyopia. Trials. 2008 Sep 19;9:54. doi: 10.1186/1745-6215-9-54.

lead_sponsor: Santéclair

location_facility: INSERM, U738, Paris, France ; Université Paris 7 Denis Diderot, UFR de Médecine, Paris, France ; AP-HP, Hôpital Bichat, Département d'Epidémiologie, Biostatistique et Recherche Clinique


title: Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults. Phase 2 Trial

summary: DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in human. The purpose of this study is to determine if DHEA is effective in the treatment of respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease (COPD) on exercise capacity and haemodynamic variables. Patients will receive after randomisation either 25 mg/day or 200mg/day oral DHEA over a one-year period. Evaluation concerns clinical parameters, echocardiography and right catheterization after and before treatment. Primary end-point is the six-minute walk test. This is a prospective double blind, randomised, placebo controlled study which will be realized in four university hospitals in France : Bordeaux, Strasbourg, Toulouse and Limoges.

lead_sponsor: University Hospital, Bordeaux

location_facility:
University Hospital, Bordeaux
CHU de Toulouse
CHU de Strasbourg
CHU de Limoges


title: Cardiovascular Risk Prevention Among Night Workers

acronym: Heart-Of-Night

summary:
With around 15 to 20% of workforce engaging in nightshift work in modern society for obvious economic and social reasons, the consequences of night work on cardiovascular risks are substantial. Compared to day workers, it was reported higher risks of cardiovascular diseases (estimated at 40%) and of metabolic syndrome (1.5 times) in shift workers. The occurrence of metabolic syndrome increases the risk to develop high blood pressure, diabetes and cardiovascular events. Because some characteristics of night work are potentially modifiable, some preventive strategies could be applied to reduce its adverse effects. For shift workers, some recent guidelines (High Health Authority, 2012 & 2016) and fruitful literature propose to develop regular assessments of cardiovascular risk factors and occupational activities, and stress the need to expand preventive strategies. Moreover, some recent French laws provide an opportunity to implement preventive interventions and specific monitoring through the occupational physicians network. However, whether the concept is defined, the exact content, method and the potential benefits are unknown. The investigator assume that individual advice related to collective countermeasures referenced on guidelines (applied on worksite within plant) could lead a better improvement on incidence of metabolic syndrome compared to those that benefit only individual advice.

Main objective:

To measure the benefit from implementation of individual and collective prevention (dispensed in worksites within plants) on metabolic syndrome compared to strategy relying only on individual prevention among night workers, over 2 years' follow-up. The secondary objectives of the study are to evaluate in both groups:

Observance of different types of preventive strategies
Impact of observance of preventive advice on metabolic syndrome in shift workers and on each component of metabolic syndrome
Determinants which promote the up-take of preventive strategies among night workers
The countermeasures which could be applied and effective within company 5) Medico-economic assessment is planned from an ancillary study.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Toulouse

collaborators: assistance of the French National Health Insurance Fund for Employees (CNAMTS)

collaborators: French Directorate General of Health (DGS)

collaborators: French National Institute for Prevention and Education in Health (INPES)

collaborators: French Inter-Departemental Agency for the Fight against Drugs and Addictive Behaviors (Mildeca)

collaborators: French Social Security Scheme for Liberal Professionals (RSI)

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

location_facility: Toulouse University Hospital (CHU de Toulouse)


title: A Monocentric Study Evaluating Pupillometry as an Objective Measurement for Cochlear Implant (CI) Fittings

acronym: PupillOM

summary: This trial is a monocentric, prospective and controlled study of the pupil response to detect hearing threshold and comfortable loudness of normal-hearing (NH) and CI-subjects.

primary_purpose: Basic Science

ReferenceCitation: Wang J, Puel JL. Presbycusis: An Update on Cochlear Mechanisms and Therapies. J Clin Med. 2020 Jan 14;9(1):218. doi: 10.3390/jcm9010218.

ReferenceCitation: Vaerenberg B, Smits C, De Ceulaer G, Zir E, Harman S, Jaspers N, Tam Y, Dillon M, Wesarg T, Martin-Bonniot D, Gartner L, Cozma S, Kosaner J, Prentiss S, Sasidharan P, Briaire JJ, Bradley J, Debruyne J, Hollow R, Patadia R, Mens L, Veekmans K, Greisiger R, Harboun-Cohen E, Borel S, Tavora-Vieira D, Mancini P, Cullington H, Ng AH, Walkowiak A, Shapiro WH, Govaerts PJ. Cochlear implant programming: a global survey on the state of the art. ScientificWorldJournal. 2014 Feb 4;2014:501738. doi: 10.1155/2014/501738. eCollection 2014.

ReferenceCitation: Legris E, Galvin J, Mofid Y, Aguillon-Hernandez N, Roux S, Aoustin JM, Gomot M, Bakhos D. Relationship between Behavioral and Objective Measures of Sound Intensity in Normal-Hearing Listeners and Hearing-Aid Users: A Pilot Study. Brain Sci. 2022 Mar 15;12(3):392. doi: 10.3390/brainsci12030392.

ReferenceCitation: Versfeld NJ, Lie S, Kramer SE, Zekveld AA. Informational masking with speech-on-speech intelligibility: Pupil response and time-course of learning. J Acoust Soc Am. 2021 Apr;149(4):2353. doi: 10.1121/10.0003952.

ReferenceCitation: Dingemanse G, Goedegebure A. Listening Effort in Cochlear Implant Users: The Effect of Speech Intelligibility, Noise Reduction Processing, and Working Memory Capacity on the Pupil Dilation Response. J Speech Lang Hear Res. 2022 Jan 12;65(1):392-404. doi: 10.1044/2021_JSLHR-21-00230. Epub 2021 Dec 13.

ReferenceCitation: Bala ADS, Whitchurch EA, Takahashi TT. Human Auditory Detection and Discrimination Measured with the Pupil Dilation Response. J Assoc Res Otolaryngol. 2020 Feb;21(1):43-59. doi: 10.1007/s10162-019-00739-x. Epub 2019 Dec 2.

ReferenceCitation: Jackson IR, Sirois S. But that's possible! Infants, pupils, and impossible events. Infant Behav Dev. 2022 May;67:101710. doi: 10.1016/j.infbeh.2022.101710. Epub 2022 Mar 17.

ReferenceCitation: Kaldy Z, Blaser E. Putting effort into infant cognition. Curr Dir Psychol Sci. 2020 Apr;29(2):180-185. doi: 10.1177/0963721420903015. Epub 2020 Feb 27.

ReferenceCitation: Russo FY, Hoen M, Karoui C, Demarcy T, Ardoint M, Tuset MP, De Seta D, Sterkers O, Lahlou G, Mosnier I. Pupillometry Assessment of Speech Recognition and Listening Experience in Adult Cochlear Implant Patients. Front Neurosci. 2020 Nov 6;14:556675. doi: 10.3389/fnins.2020.556675. eCollection 2020.

ReferenceCitation: Schramm D, Chen J, Morris DP, Shoman N, Philippon D, Caye-Thomasen P, Hoen M, Karoui C, Laplante-Levesque A, Gnansia D. Clinical efficiency and safety of the oticon medical neuro cochlear implant system: a multicenter prospective longitudinal study. Expert Rev Med Devices. 2020 Sep;17(9):959-967. doi: 10.1080/17434440.2020.1814741. Epub 2020 Oct 3.

ReferenceCitation: Sulas E, Hasan PY, Zhang Y, Patou F. Streamlining experiment design in cognitive hearing science using OpenSesame. Behav Res Methods. 2023 Jun;55(4):1965-1979. doi: 10.3758/s13428-022-01886-5. Epub 2022 Jul 6.

ReferenceCitation: Winn MB, Wendt D, Koelewijn T, Kuchinsky SE. Best Practices and Advice for Using Pupillometry to Measure Listening Effort: An Introduction for Those Who Want to Get Started. Trends Hear. 2018 Jan-Dec;22:2331216518800869. doi: 10.1177/2331216518800869.

lead_sponsor: Oticon Medical

location_facility: Centre de Recherche en Audiologie adulte GH Pitié-Salpêtrière, APHP Sorbonne Université, Unité Fonctionnelle Implants auditifs et Explorations Fonctionnelles, 52 Bd Vincent Auriol, 75013 Paris, France


acronym: GENKYST

summary: Genkyst is a regional cohort involving up to nephrologists working in private and public nephrology centers in the West of France. It registers clinical and molecular genetic data of all consenting patients with ADPKD from this area.

lead_sponsor: University Hospital, Brest

location_facility: Centre Nephrologie et Dialyse d Armorique


title: Evaluation of Insulin Therapy by Multiwave Bolus Based on the Lipid and Protein Content in Addition to the Carbohydrates Content Compared to Insulin Therapy Based Only on the Carbohydrates Content in type1 Diabetes Treated by Insulin Pump

summary:
The aim of the study is to evaluate the effect of insulin therapy when the bolus dose of insulin is calculated on the basis of protein and fat content in food intake, in addition to that of carbohydrates in T1D patients treated by insulin pump. The study is planned to recruit 150 patients with type1 diabetes already practicing functional insulin therapy based on carbohydrate counting in meals. We will therefore study the effect on continuous glucose measured by subcutaneous sensor, of meal bolus adjustments by comparing two groups of T1D patients:

Groupe A takes into account the lipid and protein content in addition to the carbohydrate content
Group B takes into account the carbohydrate content only At randomization, all patients receive dietary and adjustment of bolus doses instructions according to the randomization group. They have to apply these instructions for 3 months. At the end of 3 months, the study groups will be under glucose monitoring during two weeks in the Outpatient Clinic but returns to the investigational site in hospital to download data from the continuous measurement of glucose. In addition, we propose a period of extension similar to that of the main period, namely 3 months of application of dietetic and adaptation of bolus doses instructions and 2 weeks of continuous measurement of glucose.

During each 2 weeks period will be assessed specific glucose parameters in the post-prandial period over 4hours (glycemic sensor values in the glucose range between 70-140 mg / dl, glycemic sensor values in the glucose range between 140 -180 mg /dl and > 180 mg /dl) after taking each meal during the 13 days of Glucose Continuous Measurement (GCM), average daily glucose per meal, average blood glucose over the 13-day period after each meal.

sponsor_collaborators:
Central Hospital, Nancy, France
Central Hospital, Reims, France
Central Hospital, Toulouse, France
Central Hospital, Strasbourg, France
Central Hospital, Besançon, France
Central Hospital, Dijon, France

location_facility: Service d'Endocrinologie-Métabolisme et Diabétologie-Nutrition

location_facility: Service d'Endocrinologie, Diabétologie et Nutrition

location_facility: Structure d'Endocrinologie, Diabète et Nutrition

location_facility: Service de diabétologie, maladies métaboliques et nutrition

location_facility: Service d'endocrinologie et maladies métaboliques

location_facility: Service Endocrinologie Diabète Nutrition

appel_a_projets: PHRCI

region: Grand Est

nom_etablissement: CHRU DE NANCY

type_etablissement: CH

titre: Evaluation d'une insulinothérapie fonctionnelle par bolus alternatif chez des adultes diabétiques de type 1 traités par pompe à insuline sur une période de 14 semaines, suivie par une période d'extension optionnelle de 3 mois évaluant l'adhésion des patients à ces nouvelles modalités de délivrance des bolus d'insuline.

discipline_principale: autre

nom_porteur: GUERCI

prenom_porteur: Bruno


title: Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device

acronym: VPASH

summary:
Sleep Apnea Syndrome (SAS) is a common pathology affecting between 4 and 8% of the general population. It aggravates morbidity and cardio-metabolic mortality and is responsible for accidents related to vigilance disorders. It is estimated that 80%% of SAS cases are not diagnosed and therefore not treated. It is however impracticable to propose a diagnostic test of polygraphy (PG) or polysomnography (PSG) to every patient because of the cost and insufficient availability of these exams. It would therefore be useful to carry out a screening test before directing the patient to a complete test.

Several simplified polygraph systems with 2 or 3 channels have been proposed (nasal cannula, oximetry, heart rate) but they generally record only one night and remain intrusive enough to perturb the sleep.

The Withings HWA09 is a wrist-worn watch, which allows screening of SAS from four signals: movement, heart rate, breathing rate and blood oxygen saturation (SpO2). The objective of the present study is to validate the diagnostic performance of the Withings HWA09 for the detection of SAS compared to PSG.

lead_sponsor: Withings

location_country: Belgium France

location_facility:
Antoine Béclère Hospital
St Pierre Hospital


title: Light Therapy for Chronic Insomnia in General Practice: a Randomized Double Blind Study

acronym: Insolux

summary:
Sleep disorders, especially insomnia
Attention deficits (or disorders), daytime somnolence and drug dependence
The goal is to evaluate whether light therapy could be used as an efficient alternative treatment with direct application in general practice

lead_sponsor: University Hospital, Strasbourg, France

location_facility:
University of Nantes
CHU Reims
Hôpitaux Universitaires de Strasbourg

appel_a_projets: PHRCN

nom_etablissement: HOPITAUX UNIVERSITAIRES DE STRASBOURG

acronyme: INSOLUX

titre: Luminothérapie dans l'insomnie chronique en population de médecine générale : étude randomisée en double aveugle

discipline_principale: general medicine

nom_porteur: CHAMBE

prenom_porteur: Juliette


title: Evaluation of the Renal Congestion, Perfusion and Function Before and After Diuretic Treatment in the ICU

acronym: ECHOFURO

summary:
Renal congestion is a pathological state that can lead to acute kidney failure. Furosemide is known to lower renal congestion by its diuretic effect.

The aim of this trial is to study the reversibility of kidney congestion under diuretic therapy and assess through echodoppler parameters if it can improve renal perfusion and function in congestive ICU patients.

It could in fine lead to a better identification of patients that could benefit from diuretic therapy in the ICU.

location_facility: Les Hôpitaux Universitaires de Strasbourg


title: Assistance in Neurosurgery by Extemporaneous Analysis of Magnetic Resonance of the Metabolic Content in Excised Tissues (ExtempoRMN)

acronym: ExtempoRMN

summary:
The main ambition of this project is to develop, and provide the medical community, an innovative method to analyze extemporaneously, during a neurosurgery operation, excised tissues. This method is based on the analysis of the metabolic profile of excised tissues by the technique of High-Resolution Magic-Angle Spinning (HR-MAS) Nuclear Magnetic Resonance (NMR) spectroscopy. Indeed HRMAS NMR method can provide in a sufficiently short time lapse (currently about 30 minutes but within our project a time lapse of 15 min or even less is ultimately intended), medical information that can complement those obtained by classic histological examination.

Primary purpose:

The main objective of this study is to determine the sensitivity of HRMAS NMR spectroscopy in detecting residual tumor infiltration at the brain resection cavity. The investigators aim to determine the relevance of the metabolic analysis compared to histological analysis during a neurosurgery operation. This involves analyzing excised tissue samples, obtained from the operating rooms of Strasbourg University Hospitals, and Colmar Hospital Center, with no return to neurosurgeon for surgery.

Secondary purposes:

The secondary objectives of the protocol are to investigate the metabolome of different types of brain tumors, in order to find prognostic and diagnostic markers. It consists in detecting metabolomic factors of bad prognosis, and potential marker of good prognosis such as the IDH mutation.

location_facility: Service de Biophysique et de Médecine Nucléaire, Hôpital de Hautepierre


title: Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses

summary:
Patellofemoral pain syndrome is one of the most common musculoskeletal disorders. It is defined as an anterior knee pain. Its origin is a conflict during patellar tracking, due to patellofemoral malalignment and soft tissue overload.

A few recent studies seem to show a benefit of prefabricated feet orthoses in patellofemoral pain syndrome, alone or in association with rehabilitation. However, no one has analyzed the outcome of morpho-specific foot orthoses in a prospective randomized study.

The purpose of this prospective randomized study is to compare clinical outcomes in daily living and in sports activities, between morpho-specific and placebo foot orthoses.

Morpho-specific foot orthoses are designed according to the patient's morphotype. They are intended to correct structural defects of the hindfoot, midfoot and forefoot, in the aim to correct abnormal overload during patellofemoral tracking.

location_facility: Service de Chirurgie Orthopédique - Hôpital CCOM - Hôpitaux Universitaires de Strasbourg


title: Clinical Evaluation of Daptomycin Bone Penetration

acronym: DAPTO-HUS

summary: Bone and joint infections are commonly due to Gram-positive bacteria. Treatment of these infections is difficult because of the need of prolonged duration of antimicrobial agents in combination with surgical procedure. Moreover, in recent years, a growing resistance pattern to various antimicrobial agents has been observed for Gram-positive bacteria. Consequently, there is an urgent need for new drugs with high bone penetration for the treatment of those infections. The investigators hypothesized that daptomycin allow to achieve high concentrations in bone compartments.

location_facility: Plateau Technique de Microbiologie - Hôpitaux Universitaires de Strasbourg - 1, rue Koeberlé

location_facility: Service d'Orthopédie - Hôpital Centre de Chirurgie Orthopédie et de la Main (CCOM) - Hôpitaux Universitaires de Strasbourg - 10 av Achille Baumann -

location_facility: Service des maladies infectieuses et tropicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg


title: Beneficial Effects of Exercise Training on Physical Capacity in Type 2 Diabetics: Improvement in Skeletal Muscle Energetic Capacity, Endothelial Dysfunction and Glycemic Control

summary: The aim of this study is to evaluate the improvement in skeletal muscle energetic capacity, endothelial dysfunction and glycemic control induced by physical training in 20 sedentary patients with a type 2 diabetes.The protocol consists in a physical training program with 3 sessions of 30 minutes per week during six consecutive weeks. A skeletal muscle biopsy, a cardiac and humeral artery ultrasounds, a glycemic and tensional holters will be performed before and at the end of the physical training program.

location_facility: Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg

location_facility: Médecine Interne et Nutrition, Hôpital Civil, Hôpitaux universitaires de Strasbourg

location_facility: Service de Physiologie et d'Explorations Fonctionnelles, Nouvel Hôpital Civil, Hôpitaux universitaires de Strasbourg

intervention_type: Behavioral


title: MRI Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri

summary: To evaluate the diagnosis value of MRI and positon emission tomography (PET) scan for studying macrophagic infiltration and other brain modification in multiple sclerosis (MS) patients treated with Natalizumab (Tysabri).

sponsor_collaborators:
University Hospital, Strasbourg, France
Biogen

location_facility: Service de Médecine Nucléaire, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Radiologie 2, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Neurologie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg


title: Prevention of Graft Reinfection After Liver Transplantation for HCV Related End-stage Liver Disease . Study of Humoral Anti-HCV Response

summary: End stage HCV-related cirrhosis has become a major indication for liver transplantation (LT). Unfortunately, recurrence of HCV infection on the liver graft occurs in almost all patients following transplantation and causes a persistent infection that leads to chronic hepatitis and cirrhosis in a significant proportion of patients. To date there is no effective way to prevent HCV reinfection of the liver graft in the early phase after transplantation. . Early passive immunotherapy with neutralizing antibodies against HCV should be considered for preventing reinfection of liver transplanted patients associated with HCV. This approach is well established in the case of patients undergoing liver transplantation for chronic hepatitis B virus infection. Our purpose is to produce neutralizing monoclonal antibodies to prevent reinfection of the liver graft.

location_facility: Service d'Hématologie et Oncologie - Hôpital de Hautepierre

location_facility: Service de Chirurgie Générale et Transplantation Multiorganes - Hôpital de Hautepierre

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


title: Effects of Oral Chronic L-Arginine Supplementation on Exercise and Renal Function of Heart Transplant Recipients

summary:
exercise capacities are still altered after heart transplantation partly due to peripheral endothelial dysfunction
cyclosporin-induced renal dysfunction may be due to renal endothelial dysfunction and can be reversed in an animal model by L-arginine supplementation
to determine the potential beneficial effect of L-arginine supplementation on exercise capacity and renal function of heart transplant recipients

location_facility: Service des Explorations Fonctionnelles Respiratoires et de l'Exercice


acronym: CORTI-Covid

lead_sponsor: Hospices Civils de Lyon

summary:
Infection with the SARS-Cov-2 virus, responsible of severe acute respiratory distress syndrome (SARS), is an emerging infectious disease called Covid-19 and declared as pandemic by the World Health Organization on March 11, 2020. This pandemic is responsible of significant mortality. In France, several thousand patients are hospitalized in intensive care units, and their number continues to increase. Mortality during Covid-19 is mainly linked to acute respiratory distress syndrome, which frequency is estimated in France to occur in 6% of infected patients. Comorbidities such as cardiovascular conditions, obesity and diabetes increase susceptibility to severe forms of Covid-19 and associated mortality. Therapeutic management has three components: symptomatic management, including supplementary oxygen therapy and in case of respiratory distress mechanical ventilation; the antiviral approach; and immunomodulation, aiming at reducing inflammation associated with viral infection, which is considered to take part in severe presentations of the disease.

During Covid-19 viral pneumonia related to SARS-COv-2, there is a significant release of pro-inflammatory cytokines in the acute phase of viral infection, which could participate in viral pneumonia lesions. In children with less mature immune system than adults, SARS-Cov-2 infection is less severe. The current prevailing assumption is that severe forms of Covid-19 may not only be related to high viral replication, but also to an excessive inflammatory response favoring acute lung injury and stimulating infection.

The investigators hypothesize that early control of the excessive inflammatory response may help reducing the risk of acute respiratory distress syndrome.

The investigators will evaluate the benefit, safety and tolerability of corticosteroid therapy to reduce the rate of subjects hospitalized for Covid-19 viral pneumonia who experience clinical worsening with a need of high-flow supplemental oxygen supplementation or transfer in intensive care units for respiratory support.

location_facility: Hôpital Pneumologique et Cardiovasculaire Louis Pradel

title: Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection


title: Caregiver Serological Monitoring Extended Secondarily to Patients With the SARS-CoV-2 Coronavirus

summary:
Hospital mortality attributed to SARS-CoV-2 in France increased daily by 28% in the week before confinement. The week following this decision, the daily increase was 30%. During the week of the second week of confinement, it started a decline of 19% estimated over the last 5 days, reaching the cumulative number of 2606 deaths on 29/3 (site https://www.eficiens.com/coronavirus- personal statistics / and calculation).

The diagnosis of viral carriage by RT-PCR is reserved for symptomatic cases among caregivers, due to the shortage of available tests and the cumbersome implementation. The carrier diagnosis is the benchmark, on which are implemented the therapeutic strategies and established the national statistics. It can present false negatives, linked to a research too early or too late in relation to the infection, or to a technical defect of the nasal swab sample. Caregivers on the front line in patient care, in hospitals or in the city, have only partial access to this diagnostic test, depending on the existence of symptoms. The implementation of a systematic serological screening, planned by the government and which cannot be based only on the search for the virus, will make it possible to inform the caregivers presenting symptoms or not, of their serological status, and therefore of their degree immunity or, on the contrary, susceptibility to infectious contacts. It should therefore be very voluntarily requested. On the occasion of this screening, the constitution of the COVID-3S cohort will make it possible to verify the degree of contamination in an asymptomatic population, information which is sorely lacking for the estimation of the immune coverage of the population. The implementation of the Covid-3S study will be based on the work of the National Reference Center of Pr B Lina, from the COVID-SER cohort, for the selection of the most efficient test (s). It seems useful to initiate the constitution of this cohort as soon as possible in relation to the evolution of the epidemic. Pending receipt of official recommendations, the lack of knowledge of the performance of serological tests means that it should be applied first to health professionals, better able to appreciate its limits, for the initial period before determining a validated serological screening strategy. Once the strategy has been specified, the gradual expansion of screening to the patient population will provide a more representative basis for the construction of epidemiological models for evaluating strategies.

location_facility:
CHU de Saint Etienne
CHU de Grenoble - Hôpital Nord
Hôpital Henry Gabrielle
Hôpital de la Croix Rousse


title: Stress Thallium-201/Rest Technetium-99m Sequential Dual Isotope High-Speed Myocardial Perfusion Imaging Validation Versus Invasive Coronary Angiography

acronym: CameraCZT

summary: The new cadmium-zinc-telluride (CZT) technology is a powerful tool for cardiac nuclear medicine. The increased photon counting sensitivity of camera can be used to explore novel protocols like dual isotope (rapid stress Tl-201/rest Tc-99m protocol for use with high-speed SPECT MPI). The use of dual isotope imaging is very interesting because this imaging combines the use of thallium-201 with technetium-99m agents permitting optimal image resolution and simultaneous assessment of viability, all with an exam duration of approximately 20 minutes. However, no study compares stress thallium-201/rest technetium-99m sequential dual isotope high-speed myocardial perfusion imaging versus invasive coronary angiography. The investigators report here the first validation of high-speed protocol with dual isotope for myocardial perfusion imaging using invasive coronary angiography as the standard of reference.

ReferenceCitation: Barone-Rochette G, Leclere M, Calizzano A, Vautrin E, Celine GC, Broisat A, Ghezzi C, Baguet JP, Machecourt J, Vanzetto G, Fagret D. Stress thallium-201/rest technetium-99m sequential dual-isotope high-speed myocardial perfusion imaging validation versus invasive coronary angiography. J Nucl Cardiol. 2015 Jun;22(3):513-22. doi: 10.1007/s12350-014-0016-0. Epub 2014 Nov 8.

publisher_dissemination: Springer

lead_sponsor: University Hospital, Grenoble


title: Treatment of Bullous Pemphigoid With Avdoralimab (IPH5401), an Anti-C5aR1 Monoclonal Antibody

acronym: IPH

summary:
The development of Auto Immune bullous Diseases (AIBD) results from a complex interaction between innate and adaptive immune systems. Bullous pemphigoid (BP), the most frequently encountered AIBD, predominantly affects elderly patients above 70 with an estimated incidence of 21.7 new cases/million/year in France.Interestingly, coversin, an anti-C5a and -leukotriene B4 small molecule, is currently used in a phase IIA clinical trial in BP patients (NCT04035733). However, although overall C5-blocking drugs are potentially interesting, they are likely to interfere with C5a-C5aR2-axis activation as well, a pathway that has recently proved protective in BP 12. The main objective is to investigate the clinical efficacy of an anti-C5aR1 antibody in addition to superpotent topical steroids compared to superpotent topical steroids alone in BP patients at 3 months.It is a case-controlled, randomized, open-labelled, and multicenter phase II clinical trial. Four Dermatologic French centers (Nice, Marseille Nord, Marseille Timone and Montpellier university hospitals) specialized in the in the care of BP patients will be participating in the study. It is expected that forty subjects will be included in this trial.

Conversely, a more targeted inhibition of C5a-C5aR1 axis might be more effective in BP, sparing the potentially protective effect of C5a-C5aR2 interaction.

Avdoralimab (IPH5401), a specific anti-C5aR1 monoclonal antibody, has already been credited of a good safety profile in the treatment of solid tumors and rheumatoid arthritis. The investigators hypothesize that avdoralimab might be a safe and effective treatment in BP patients

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
APHM, Timone
CHU Montpellier, Dermatologie
APHM, Hôpital Nord
CHU de Nice- Dermatologie


title: Determinants and Consequences of the Transition to Adulthood Among Adolescents With Haemophilia - TRANSHEMO

acronym: TRANSHEMO

summary:
Severe haemophilia is a rare disease characterized by spontaneous bleedings from early childhood, which may lead to various complications especially in joints. Due to advances in medical care and more specifically in the development of prophylactic strategies by the application of clotting factor concentrates, life expectancy of persons with severe haemophilia has significantly increased over the last decades. This progress requires a long-term follow-up, including into adulthood. The adherence to a regular clinical follow-up and to a prophylactic treatment then depends on how successful patients' transition from childhood to adulthood has been as this process involves a transfer of responsibility from parents to patients concerning the management of their health. Beyond the issue of patients' adherence, a suboptimal transition may also impair quality of life and the entry into adulthood, especially at the social, emotional and professional levels. Only a few studies have been conducted to identify the specific needs and difficulties young persons with severe haemophilia experience during their transition from childhood to adulthood, and none of these studies has been carried out in France where the features of the health care system are very specific.

Therefore, this study aims to address the issue of transition into adulthood among young persons with severe haemophilia in France. This study will focus not only on the facilitators and barriers of the access to health care but also, from a more global perspective, on all the specific concerns and difficulties they may experience as they grow into adulthood which may impair their long-term health related quality of life as well as their personal empowerment. This study will also allow to identify some of the socio- cognitive, emotional, and familial determinants of a good transition into adulthood.

ReferenceCitation: Resseguier N, Rosso-Delsemme N, Beltran Anzola A, Baumstarck K, Milien V, Ardillon L, Bayart S, Berger C, Bertrand MA, Biron-Andreani C, Borel-Derlon A, Castet S, Chamouni P, Claeyssens Donadel S, De Raucourt E, Desprez D, Falaise C, Frotscher B, Gay V, Goudemand J, Gruel Y, Guillet B, Harroche A, Hassoun A, Huguenin Y, Lambert T, Lebreton A, Lienhart A, Martin M, Meunier S, Monpoux F, Mourey G, Negrier C, Nguyen P, Nyombe P, Oudot C, Pan-Petesch B, Polack B, Rafowicz A, Rauch A, Rivaud D, Schneider P, Spiegel A, Stoven C, Tardy B, Trossaert M, Valentin JB, Vanderbecken S, Volot F, Voyer-Ebrard A, Wibaut B, Leroy T, Sannie T, Chambost H, Auquier P. Determinants of adherence and consequences of the transition from adolescence to adulthood among young people with severe haemophilia (TRANSHEMO): study protocol for a multicentric French national observational cross-sectional study. BMJ Open. 2018 Jul 25;8(7):e022409. doi: 10.1136/bmjopen-2018-022409.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

publisher_dissemination: British Medical Journal

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille Hôpital de la Timone

appel_a_projets: PREPS

region: Provence-Alpes-Côte d'Azur

nom_etablissement: APHM DIRECTION GENERALE

type_etablissement: CHUR

acronyme: TRANSHEMO

titre: Déterminants et conséquences de la transition vers l'âge adulte pour les adolescents atteints d'hémophilie.

discipline_principale: organisation des soins

nom_porteur: RESSEGUIER

prenom_porteur: Noémie