title: Evaluation of a Strategy Guided by Imaging Versus Systematic Coronary Angiography in Elderly Patients With Ischemia: a Multicentric Randomized Non Inferiority Trial.

acronym: EVAOLD

summary:
The WHO predicts that cardiovascular morbi-mortality will increase by 120-137% within 20 years due to the aging population. Myocardial infarction without ST segment elevation (NSTEMI) is the most common form of infarction. However, its treatment among elderly patients remains a challenging question.

Indeed, the risk benefit balance of revascularization remains unclear, and complications related to revascularization are more frequent in the elderly, including MI, heart failure, stroke, renal failure and bleeding according to National Cardiovascular Network data.The last randomized controlled trial "After Eighty Study", showed a reduction of major cardio-cerebrovascular events (MACCEs) in NSTEMI patients with an invasive strategy (systematic coronary angiography - CA) compared to a conservative strategy (medical treatment alone). Nevertheless, this study presented several limitations of which a major one was the lack of a definition of frailty at inclusion. Moreover, the "After Eighty Study" has shown that percutaneous revascularization in the invasive arm was only performed for 1 in 2 patients showing an inadequacy in the strategy for selecting candidates for revascularization.

Consequently, despite European Society of Cardiology (ESC) guidelines, the management of NSTEMI in elderly patients is not yet evidence based, and current recommendations do not provide any clear clinical decision rule indicating one strategy over another.

For fragile patients, an alternative strategy consists of selecting candidates for a guided CA according to the extent of myocardial ischemia, identified by non-invasive imaging. Single-photon emission computed tomography or dobutamine stress echocardiograms are currently the reference methods with well-defined interpretation of ischemia. According to our experience, this strategy avoids CA for one third of patients and improves the rate of revascularization.

The aim of our study is to compare 1-year morbidity and mortality in NSTEMI patients over 80 years, assigned to guided versus systematic-CA. Our hypothesis is that the guided strategy will not be inferior on MACE rates at 1 year, and will be cost-effective by reducing iatrogenic complications.

ReferenceCitation: Batchelor WB, Anstrom KJ, Muhlbaier LH, Grosswald R, Weintraub WS, O'Neill WW, Peterson ED. Contemporary outcome trends in the elderly undergoing percutaneous coronary interventions: results in 7,472 octogenarians. National Cardiovascular Network Collaboration. J Am Coll Cardiol. 2000 Sep;36(3):723-30.

ReferenceCitation: Bauer T, Koeth O, Jünger C, Heer T, Wienbergen H, Gitt A, Zahn R, Senges J, Zeymer U; Acute Coronary Syndromes Registry (ACOS) Investigators. Effect of an invasive strategy on in-hospital outcome in elderly patients with non-ST-elevation myocardial infarction. Eur Heart J. 2007 Dec;28(23):2873-8. Epub 2007 Nov 2.

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ReferenceCitation: Alexander KP, Anstrom KJ, Muhlbaier LH, Grosswald RD, Smith PK, Jones RH, Peterson ED. Outcomes of cardiac surgery in patients > or = 80 years: results from the National Cardiovascular Network. J Am Coll Cardiol. 2000 Mar 1;35(3):731-8.

ReferenceCitation: Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators, Freij A, Thorsén M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.

ReferenceCitation: Wallentin L, Lagerqvist B, Husted S, Kontny F, Ståhle E, Swahn E. Outcome at 1 year after an invasive compared with a non-invasive strategy in unstable coronary-artery disease: the FRISC II invasive randomised trial. FRISC II Investigators. Fast Revascularisation during Instability in Coronary artery disease. Lancet. 2000 Jul 1;356(9223):9-16.

ReferenceCitation: Lagerqvist B, Husted S, Kontny F, Ståhle E, Swahn E, Wallentin L; Fast Revascularisation during InStability in Coronary artery disease (FRISC-II) Investigators. 5-year outcomes in the FRISC-II randomised trial of an invasive versus a non-invasive strategy in non-ST-elevation acute coronary syndrome: a follow-up study. Lancet. 2006 Sep 16;368(9540):998-1004.

ReferenceCitation: Fox KA, Clayton TC, Damman P, Pocock SJ, de Winter RJ, Tijssen JG, Lagerqvist B, Wallentin L; FIR Collaboration. Long-term outcome of a routine versus selective invasive strategy in patients with non-ST-segment elevation acute coronary syndrome a meta-analysis of individual patient data. J Am Coll Cardiol. 2010 Jun 1;55(22):2435-45. doi: 10.1016/j.jacc.2010.03.007. Epub 2010 Mar 30. Review.

ReferenceCitation: Savonitto S, Cavallini C, Petronio AS, Murena E, Antonicelli R, Sacco A, Steffenino G, Bonechi F, Mossuti E, Manari A, Tolaro S, Toso A, Daniotti A, Piscione F, Morici N, Cesana BM, Jori MC, De Servi S; Italian Elderly ACS Trial Investigators. Early aggressive versus initially conservative treatment in elderly patients with non-ST-segment elevation acute coronary syndrome: a randomized controlled trial. JACC Cardiovasc Interv. 2012 Sep;5(9):906-16. doi: 10.1016/j.jcin.2012.06.008.

ReferenceCitation: Tegn N, Abdelnoor M, Aaberge L, Endresen K, Smith P, Aakhus S, Gjertsen E, Dahl-Hofseth O, Ranhoff AH, Gullestad L, Bendz B; After Eighty study investigators. Invasive versus conservative strategy in patients aged 80 years or older with non-ST-elevation myocardial infarction or unstable angina pectoris (After Eighty study): an open-label randomised controlled trial. Lancet. 2016 Mar 12;387(10023):1057-1065. doi: 10.1016/S0140-6736(15)01166-6. Epub 2016 Jan 13.

ReferenceCitation: Afilalo J, Alexander KP, Mack MJ, Maurer MS, Green P, Allen LA, Popma JJ, Ferrucci L, Forman DE. Frailty assessment in the cardiovascular care of older adults. J Am Coll Cardiol. 2014 Mar 4;63(8):747-62. doi: 10.1016/j.jacc.2013.09.070. Epub 2013 Nov 27. Review.

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ReferenceCitation: Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. J Am Coll Cardiol. 2007 Nov 27;50(22):2173-95.

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ReferenceCitation: Lakatos E, Lan KK. A comparison of sample size methods for the logrank statistic. Stat Med. 1992 Jan 30;11(2):179-91.

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location_facility:
University Hospital Grenoble
Clinique Mutualiste


type: Other Identifier

title: Chair Rise Tests for a Simplified Evaluation of Functional Response After a Rehabilitation Program in Patients COPD.

summary:
Improvement in the functional functioning and dyspnea of COPD patients after a rehabilitation program (RHB) is assessed by exercise tests and questionnaires difficult to replicate outside specialized centers.

In order to monitor the eventual decline of patients in the course of their RHB management, Chair Rise Tests (3CRT-1CRT-5STS) and short questionnaires were developed (CAT-DIRECT). The goal of this prospective, multicenter, real-life study is to compare the change in several functional function tests and questionnaires of quality of life and dyspnea related to daily activities. In addition, MCIDs of the 3CRT and the DIRECT questionnaire (Disability Related to COPS Tool) were specified.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Lévesque J, Antoniadis A, Li PZ, Herengt F, Brosson C, Grosbois JM, Bernady A, Bender A, Favre M, Guerder A, Surpas P, Similowski T, Aguilaniu B. Minimal clinically important difference of 3-minute chair rise test and the DIRECT questionnaire after pulmonary rehabilitation in COPD patients. Int J Chron Obstruct Pulmon Dis. 2019 Jan 22;14:261-269. doi: 10.2147/COPD.S187567. eCollection 2019.

lead_sponsor: University Hospital, Lille

location_facility:
Hôpital Calmette, CHRU
Centre Hospitalier Universitaire

intervention_type: Diagnostic Test

lead_sponsor_type: academique

status_simplified: Completed


title: Prognostic Factors and the Impact of Various Management of Acute Myeloid Leukemia in Real Life Condition at Toulouse and Bordeaux University Hospital

acronym: LAM-BDD

summary: The treatment of older patients with acute myeloid leukemia that is secondary to previous myelodysplastic syndrome, myeloproliferative neoplasm, or prior cytotoxic exposure remains unsatisfactory. We compared patients treated with intensive chemotherapy or azacitidine within two centres.

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital Bordeaux
University Hospital Toulouse

intervention_type: Drug

status_simplified: Ongoing


title: Feasibility of a Cytokine Expression Profile in Immune Cells as an Orientation Tool in Therapeutic Decisions for Auto-inflammatory and Auto-immune Diseases

acronym: IL-MAI

summary: This study will assess the feasibility of using cytokine expression profiles in blood samples as a method for evaluating rheumatoid polyarthritis

design_allocation: Non-Randomized

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU Nimes
CHU de Montpellier

intervention_type: Procedure


title: Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma and Analysis of Associated Factors.

acronym: SCLERO-PID

summary: Diffuse infiltrating pneumonia (DIP) is a severe complication of systemic sclerosis and one of the leading cause of death in this condition. The main objective of this study is to prospectively describe the evolution of DIP overtime and to find prognosis factors.

status: Recruiting

time_perspective: Prospective

enrollment_type: Anticipated

location_facility:
AH-HP, Hôpital Saint Antoine
Hôpital Claude Huriez, CHU

intervention_type: Other


title: Effects of Dapagliflozin on Lipoprotein Kinetics in Patients With Type 2 Diabetes

acronym: Cinétique DAPA

summary:
This study will make it possible to better understand the mechanisms responsible for the increase in bad cholesterol levels observed in patients with type 2 diabetes treated with Dapagliflozin, an antidiabetic treatment made by Astrazeneca.

The information will:

reveal what is not working properly
make it possible to choose the most appropriate treatments against cholesterol to compensate for this impaired functioning

This biomedical research will take place at the University Hospitals of DIJON and NANTES.

28 patients will take part: 20 patients will be given Dapagliflozin and 8 patients will be given the placebo.
The study treatment will be randomised: patients will be given either Dapagliflozin or the placebo. The treatment duration is 6 months.
Moreover, during the inclusion visit and at the end of the study (6 months after the start of treatment), a kinetics study, to follow the production and elimination of cholesterol, will be conducted. This will involve administering amino acids that have been specifically synthesised for this purpose.
Participation in the study will last 6 months and include 4 protocol visits.

status: Unknown status

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU Dijon Bourgogne
CHU de Nantes

status_simplified: Unknown


title: Assessment of the Reproducibility of the 3 Minutes Sit-to-stand Test in Patients With Idiopathic Pulmonary Fibrosis (IPF)

summary:
This study is designed to evaluate the reproductibility and the performance of the 3 minutes sit-to-stand test in patients with idiopathic pulmonary fibrosis.

To do this, the investigators are recruiting 40 patients with idiopathic pulmonary fibrosis in 2 centers (Grenoble university hospital and Lyon university hospital).

Patients had to achieve an effort test on a cycle ergometer. 2 visits are planned in the hospital. During each visit, patients will perform a 3 minutes sit-to-stand test, a 1 minute sit-to-stand test and a 6 minutes walk test. During the second visit, patients will also perform a 3 minutes sit-to-stand test with measurement of oxygen uptake.

The investigators will then analyse the results by comparing numbers of cycle, functional response and symptoms during the 3 minutes sit-to-stand test of the 2 visits. The investigators will also compare the functional response obtained during the 3 minutes sit-to-stand test, the 1 minute sit-to-stand test and the 6 minutes walk test.

Finally, the investigators will compare the maximal values of oxygen uptake, respiration rate and expired volume obtained during the 3 minutes sit-to-stand test to the effort test on cycle ergometer.

ReferenceType: result

ReferenceCitation: King TE Jr, Pardo A, Selman M. Idiopathic pulmonary fibrosis. Lancet. 2011 Dec 3;378(9807):1949-61. doi: 10.1016/S0140-6736(11)60052-4. Epub 2011 Jun 28. Review.

ReferenceCitation: Cottin V, Crestani B, Valeyre D, Wallaert B, Cadranel J, Dalphin JC, Delaval P, Israel-Biet D, Kessler R, Reynaud-Gaubert M, Cordier JF, Aguilaniu B, Bouquillon B, Carré P, Danel C, Faivre JB, Ferreti G, Just N, Kouzan S, Lebargy F, Marchand Adam S, Philippe B, Prévot G, Stach B, Thivolet-Béjui F; French National Reference and Competence Centers for Rare Diseases; Societe de Pneumologies de Langue Francaise. [French practical guidelines for the diagnosis and management of idiopathic pulmonary fibrosis. From the National Reference and the Competence centers for rare diseases and the Société de Pneumologie de Langue Française]. Rev Mal Respir. 2013 Dec;30(10):879-902. doi: 10.1016/j.rmr.2013.09.007. Epub 2013 Oct 25. French. Erratum in: Rev Mal Respir. 2014 Feb;31(2):194-5.

ReferenceCitation: Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Müller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schünemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.

ReferenceCitation: Nalysnyk L, Cid-Ruzafa J, Rotella P, Esser D. Incidence and prevalence of idiopathic pulmonary fibrosis: review of the literature. Eur Respir Rev. 2012 Dec 1;21(126):355-61. doi: 10.1183/09059180.00002512. Review.

ReferenceCitation: Huang XF, Gao F, Xue ZQ, Wang Y, Xu GW. [Multifactorial analysis of survival in breast cancer]. Zhonghua Zhong Liu Za Zhi. 1988 Mar;10(2):117-9. Chinese.

ReferenceCitation: du Bois RM, Weycker D, Albera C, Bradford WZ, Costabel U, Kartashov A, Lancaster L, Noble PW, Sahn SA, Szwarcberg J, Thomeer M, Valeyre D, King TE Jr. Six-minute-walk test in idiopathic pulmonary fibrosis: test validation and minimal clinically important difference. Am J Respir Crit Care Med. 2011 May 1;183(9):1231-7. doi: 10.1164/rccm.201007-1179OC. Epub 2010 Dec 3.

ReferenceCitation: Nathan SD, du Bois RM, Albera C, Bradford WZ, Costabel U, Kartashov A, Noble PW, Sahn SA, Valeyre D, Weycker D, King TE Jr. Validation of test performance characteristics and minimal clinically important difference of the 6-minute walk test in patients with idiopathic pulmonary fibrosis. Respir Med. 2015 Jul;109(7):914-22. doi: 10.1016/j.rmed.2015.04.008. Epub 2015 Apr 24.

ReferenceCitation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.

ReferenceCitation: Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9.

ReferenceCitation: Buatois S, Miljkovic D, Manckoundia P, Gueguen R, Miget P, Vançon G, Perrin P, Benetos A. Five times sit to stand test is a predictor of recurrent falls in healthy community-living subjects aged 65 and older. J Am Geriatr Soc. 2008 Aug;56(8):1575-7. doi: 10.1111/j.1532-5415.2008.01777.x.

ReferenceCitation: Macfarlane DJ, Chou KL, Cheng YH, Chi I. Validity and normative data for thirty-second chair stand test in elderly community-dwelling Hong Kong Chinese. Am J Hum Biol. 2006 May-Jun;18(3):418-21.

ReferenceCitation: Hill CJ, Denehy L, Holland AE, McDonald CF. Measurement of functional activity in chronic obstructive pulmonary disease: the grocery shelving task. J Cardiopulm Rehabil Prev. 2008 Nov-Dec;28(6):402-9. doi: 10.1097/HCR.0b013e31818c3c65.

ReferenceCitation: Perrault H, Baril J, Henophy S, Rycroft A, Bourbeau J, Maltais F. Paced-walk and step tests to assess exertional dyspnea in COPD. COPD. 2009 Oct;6(5):330-9.

ReferenceCitation: Brodin E, Ljungman S, Sunnerhagen KS. Rising from a chair: a simple screening test for physical function in predialysis patients. Scand J Urol Nephrol. 2008;42(3):293-300. doi: 10.1080/00365590701797556.

ReferenceCitation: Ozalevli S, Ozden A, Itil O, Akkoclu A. Comparison of the Sit-to-Stand Test with 6 min walk test in patients with chronic obstructive pulmonary disease. Respir Med. 2007 Feb;101(2):286-93. Epub 2006 Jun 27.

ReferenceCitation: Craig CP, Reynolds SL, Airhart JW, Staab EV. Alterations in immune responses by attenuated Venezuelan equine encephalitis vaccine. I. Adjuvant effect of VEE virus infection in guinea pigs. J Immunol. 1969 May;102(5):1220-7.

ReferenceCitation: Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. Review.

ReferenceCitation: Passing H, Bablok. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem. 1983 Nov;21(11):709-20.

ReferenceCitation: Carstensen B. Comparing methods of measurement: Extending the LoA by regression. Stat Med. 2010 Feb 10;29(3):401-10. doi: 10.1002/sim.3769.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Grenoble

location_facility:
CHU Grenoble Alpes
Groupement Hospitalier Est


title: Contribution of the ENT Surgeon's Clinical Evaluation to the Contouring of Target Volumes and Organs Eligible for Radiotherapy in Head and Neck Cancers

acronym: CONTOUR

summary: Radiotherapy (RT), surgery and chemotherapy (CT) are treatments for head and neck cancers, used alone or in combination. Conformal RT with Intensity Modulation (IMRT) is currently the reference technique. IMRT requires a precise definition of the target volumes to be treated and the anatomical structures to be protected from irradiation. Most studies of head and neck cancers published in the literature demonstrate the variability in the contouring of the target volumes between radiotherapists. This may have an impact on dosimetry. To date, no studies have evaluated the impact of the ENT surgeon's evaluation in volumes contouring. The aim of this study is to compare the volumes determined by the radiotherapists alone and those determined jointly by the radiotherapists and the ENT surgeon.

time_perspective: Cross-Sectional

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild

lead_sponsor_type: industriel


title: Correlation Between Tissue and Plasmatic EGFR in CBNPC With EGFR Mutation or Predictive Factor of EGFR Mutation

acronym: CONCORDE

summary: Condorde main objective is to evaluate the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed on ctDNA after liquid biopsy. EGFR status will be assessed by real time PCR (rtPCR), digital PCR (dPCR) and Next Generation Sequencing (NGS) in patients with chemotherapy naive lung carcinoma.

status: Terminated

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Oscar Lambret
CHRU Lille

intervention_type: Biological


title: Genomic Screening for Hereditary Erythrocytosis and Related Diseases

acronym: GENRED

summary:
Unexplained polycythemias are rare diseases, and therefore, the collection of data inherent to these diseases will not only improve their characterisation, but also allow stratification according to the risks and the course of the disease. The objective of this project is to constitute a database on the disease which will allow us to better understand it and in due course improve its management.

The GENRED project thus bears uniquely on the collection of information, which will be gathered throughout the usual management of patients for this type of disease.

location_facility:
CHU Dijon Bourgogne
CHU de NANTES


title: Impact of Preoperative Martial Deficiency on the Level of Blood Transfusion in Programmed Cardiac Surgery (CARMATS)

acronym: CARMATS

summary: Observational study.

lead_sponsor: Rennes University Hospital

location_facility:
Rennes University Hospital
Brest University Hospital


title: Impact of Early Enteral vs. Parenteral Nutrition on Risk of Gastric-Content Aspiration in Patients Requiring Mechanical Ventilation and Catecholamines: an Ancillary Study of the NUTRIREA2 Trial (NCT01802099)

summary: To evaluate the impact of enteral nutrition on microaspiration of gastric content and pharyngeal secretions

primary_purpose: Prevention

ReferenceCitation: Nseir S, Le Gouge A, Lascarrou JB, Lacherade JC, Jaillette E, Mira JP, Mercier E, Declercq PL, Sirodot M, Piton G, Tinturier F, Coupez E, Gaudry S, Djibré M, Thevenin D, Pasco J, Balduyck M, Zerimech F, Reignier J. Impact of nutrition route on microaspiration in critically ill patients with shock: a planned ancillary study of the NUTRIREA-2 trial. Crit Care. 2019 Apr 5;23(1):111. doi: 10.1186/s13054-019-2403-z.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
CHU Tours
CHU Saint Louis
CHU Lille
CHU Louis Mourier
Centre hospitalier d'Annecy
CHU Amiens


title: Preliminary Feasibility Study of Rehabilitation by Robot "Coach" of Chronic Low Back Pain Patient

acronym: RCOOL

summary:
The objective of KERAAL technological project is to create a new intelligent robot which allows a humanoid robot to record then to show and to follow the progress of rehabilitation sessions proposed by a physiotherapist to a patient, the latter being able to practice without the physiotherapist. The final objective is to stimulate and increase the overseen time of rehabilitation. Poppy robot was chosen as it is able to realize all kind of movements notably movements of the spine with 5 degrees of freedom associated to the several levels of the spine. It will allow to address the population included in the protocol. RCOOL study tries to validate this prototype device as tool of rehabilitation.

The main objective is the feasibility of the supervision by a humanoid robot of a succession of rehabilitation exercises.

RCOOL study is a randomized clinical trial checked under single-blind condition to compare two rehabilitation strategies, one with exercises executed by the patients and supervised by Poppy and the other one with usual rehabilitation protocol.

primary_purpose: Device Feasibility

lead_sponsor: University Hospital, Brest

location_facility: Fondation ILDYS - Service de MPR de l'appareil locomoteur de PERHARIDY


title: Combined Therapy of Hypnosis Kinesitherapy and MEOPA in Patients With Regional Painful Syndrome Complex

acronym: ProHKM-SDRC

summary: Relation between hypnosis and MEOPA on algodystrophy.

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Oerlemans HM, Oostendorp RA, de Boo T, Perez RS, Goris RJ. Signs and symptoms in complex regional pain syndrome type I/reflex sympathetic dystrophy: judgment of the physician versus objective measurement. Clin J Pain. 1999 Sep;15(3):224-32.

location_facility:
University Hospital of Toulouse
Croix du Sud


acronym: Inter-B-NHL ritux 2010

title: Intergroup Trial for Children or Adolescents With B-Cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase II Trial of DA-EPOCH-Rituximab in PMLBL

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

type: EudraCT Number

source: euctr

ReferenceCitation: Burke GAA, Minard-Colin V, Aupérin A, Alexander S, Pillon M, Delgado R, Zsíros J, Uyttebroeck A, Dartigues P, Miles RR, Kazanowska B, Chiang AK, Haouy S, Bollard CM, Csoka M, Wheatley K, Barkauskas DA, Adamson PC, Vassal G, Patte C, Gross TG. Dose-Adjusted Etoposide, Doxorubicin, and Cyclophosphamide With Vincristine and Prednisone Plus Rituximab Therapy in Children and Adolescents With Primary Mediastinal B-Cell Lymphoma: A Multicenter Phase II Trial. J Clin Oncol. 2021 Nov 20;39(33):3716-3724. doi: 10.1200/JCO.21.00920. Epub 2021 Sep 27.

location_country:
Poland
Spain
Italy
United Kingdom
Canada
Hungary
France
Belgium
Netherlands

location_facility: Children Oncology Group Operations centres

location_facility: 2nd Dept. of Pediatrics Semmelweis Univ.

location_facility: Associazione Italiana di Ematologia ed Oncologia Pediatrica

location_facility: Sociedad Española de Hematología y Oncología Pediátricas

summary: Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children and adolescent with primary mediastinal large B cell lymphoma in terms of event free survival.


title: A Randomized, Phase 3 Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment of Patients With Pancreatic Adenocarcinoma

summary: This is an open-label, multicenter, randomized, Phase 3 study in patients with ductal adenocarcinoma of the pancreas who have failed only one prior line of systemic anti-cancer therapy for advanced pancreatic cancer and have measurable disease.

lead_sponsor: ERYtech Pharma

location_country:
United States
United Kingdom
France

location_facility: University of California Davis Medical Center

location_facility: University of Minnesota Health Clinics and Surgery Center


title: Constitution of a Biological Cohort Following Bone Marrow Sampling From MDS or AML Patients and Age-matched Healthy Donors (COSMOS)

acronym: COSMOS

summary: It is of clinical significance to better characterize the intrinsic defects harbored by mesenchymal stromal cells (MSC) in Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) context, as compared to physiological conditions. Such research initiative aims to dissect the cross-talk between malignant hematopoietic stem cells (HSC) and their bone marrow (BM) partners in crime, further prospecting for innovative stromal-directed strategies for the treatment of Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


acronym: SAVE-VEMED

title: A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Primary Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility

lead_sponsor: Sanofi

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Romania
Russian Federation
Austria
Australia
India
Mexico
Canada
Hungary
Germany
Latvia
Estonia
New Zealand
Czech Republic
Korea, Republic of
France
Netherlands

location_facility: sanofi-aventis Australia & New Zealand administrative office

summary:
The primary objective was to compare the efficacy of once daily [q.d] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the primary prevention of Venous Thromboembolic Events [VTE] in patients hospitalized for acute medical illness.

The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.


title: Morphologic Study of the Intersegmental Plane After Fully Thoracoscopic Segmentectomy

summary: The objective of this study is to determine whether stapling adversely affects the pulmonary parenchyma and the vascularisation of the adjacent segments. The aim of our work is to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy, 3 or 6 months post-surgery. the investigator will assess venous drainage and the arterial vascularisation of the remaining segments, possible modifications of the adjacent parenchyma and whether there is a defect of pleuro-pulmonary adhesion (residual pneumothorax).

primary_purpose: Other

lead_sponsor: Institut Mutualiste Montsouris

location_facility:
Institut mutualiste montsouris
Institut Mutualiste montsouris


title: Phase II Study of Iberdomide (Cc220) Maintenance After Autologous Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients

summary: This is a phase II study to evaluate the efficacy and safety of different doses of iberdomide continuous therapy as maintenancetreatment after transplant.

lead_sponsor: European Myeloma Network

location_country: Netherlands France Italy Greece

location_facility: Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens

location_facility: CHU Hôtel-Dieu, 1, place Alexis Ricordeau, 44093 NANTES Cedex 1, FRANCE

location_facility: Vrije Universiteit Medical Center (VUMC)

location_facility: Ospedale Generale Regionale-Divisione di Ematologia e Centro Trapianto Midollo Osseo


title: Pilot Study: Characterization of the Immune Phenotype of Patients Allergic to Wasp Venom or Penicillin

acronym: WasPenIP

summary: Severity of allergic reactions are highly variable from one individual to another, they can range from absent to life threatening. Allergic manifestations and specifically those of anaphylactic reactions are generally attributed to an IgE-dependent activation of mast cells and/or basophils followed by the release of histamine. Recently however evidence accumulated that other pathways might similarly contribute or even trigger anaphylaxis. Moreover, while the variance in human populations is an important subject to scientific research, medical practices and public health policies typically take a 'one for all' approach to disease management and drug development. Indeed, individual heterogeneity in the immune response can have a big impact on the likelihood to respond to therapy. Because of the complexity of immune responses in the individual and within the population, it has not been possible thus far to define the parameters (genetic or environmental) that define the immune system of allergic patients and its natural occurring variability. Thanks to the efforts that have been made in the framework of the Labex "Milieu Intérieur" study genetic, immunological and environmental factors have been identified that can be linked to the heterogeneity of immune responses in healthy individuals. By comparing these already available data from healthy individuals to a novel cohort of patients with defined severe allergic manifestations, we will be able to identify for the first time immunological and environmental parameters that are common to patients with severe allergies and identify those parameters that distinguish allergic patients from the healthy donor cohort. This analysis will thus open new perspectives on deregulated immune pathways in allergic patients allowing to orient future treatment approaches. Furthermore, comparing immune responses before and after allergen-specific immunotherapy will help understanding, which changes in immune responses are causal to a successful treatment. Importantly, this analysis will shed light on the individual differences that may predict the outcome of treatment approaches and propose novel markers of its success.

primary_purpose: Basic Science

lead_sponsor: Institut Pasteur

location_facility:
Service de Pneumologie Hôpital Bichat
Hôpital Saint Joseph


title: A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions

summary: The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

ReferenceCitation: Morice MC. XIENCE V SPIRIT WOMEN clinical trial: characterization of the female population undergoing stent implantation. Womens Health (Lond). 2008 Sep;4(5):439-43. doi: 10.2217/17455057.4.5.439.

ReferenceCitation: Franzone A, Zaugg S, Piccolo R, Modena MG, Mikhail GW, Ferré JM, Strasser R, Grinfeld L, Heg D, Jüni P, Windecker S, Morice MC. A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study. PLoS One. 2017 Aug 10;12(8):e0182632. doi: 10.1371/journal.pone.0182632. eCollection 2017.

lead_sponsor: Abbott Medical Devices

location_country: Denmark Poland Brazil Spain Italy Austria Latvia Netherlands Argentina Switzerland Hungary France Belgium Norway Germany

location_facility: Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Latvian Center of Cardiology, P. Stradina University Hospital

location_facility: Instituto Cardiovascular de Buenos Aires-ICBA

location_facility: Kardiologische Klinik Herz- und Diabeteszentrum

location_facility: Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud

location_facility: Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II

location_facility: Technische Universität Dresden, Medizinische Klinik II - Kardiologie

location_facility: Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia

location_facility: Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO

location_facility: Hosital Italiano de Buenos Aires - Cardiologia

location_facility: Semmelweis University, Department of Cardiovascular Surgery

intervention_type: Device


title: Comparison of the Variability of Hepatic Load Quantification in Iron and Fat Estimated by MRI at 1.5 and 3 Tesla

acronym: HEMOCOMPARE

summary: The study proposes to compare the results of two examinations at 1.5 and 3 Tesla obtained on the same day on a series of 80 patients.

location_facility: Hôpital St Vincent du Groupement des Hôpitaux de l'Institut Catholique de Lille


title: A Prospective, Randomized, Open, Multicentric Study Intended to Evaluate the Efficacy and Tolerability of Sequential Treatment Based on Rabbit Anti-T-lymphocyte Serum, of Mycophenolate Mofetil and of Cyclosporin, Without Concomitant Corticosteroids, After a First Cadaveric Renal Transplant

summary: The trial is planned as a multicentric, randomized, prospective, open study in accordance with a 1/1 plan, on parallel groups and 2 arms of treatment. A total of 200 patients with chronic renal insufficiency, included in the French national waiting list of the Establishment Français des Greffes [French Transplants Institution] and receiving a first renal transplant will be included, after signed agreement, in this study. All the patients will receive organs taken from brain-dead subjects. The patients will be given immunosuppressant treatment based on rabbit anti-T lymphocyte serum, CellCeptÒ and NeoralÒ cyclosporin. One group of 100 randomised patients will be given standard corticosteroid therapy as well during the first six months following the transplant. This group will be compared with a second group of 100 randomised patients who will be given a single dose of corticosteroids. The main aim of this study is to evaluate the number of acute rejection episodes in patients given a first renal transplant and subjected to an immunosuppressant protocol not containing corticosteroids. The hypothesis which is proposed is that, in the absence of corticosteroids and/or calcineurin inhibitors (i.e. cyclosporin and tacrolimus), antilymphocyte serum results in a certain state of "tolerance" in respect of the allograft. The second objective concerns the beneficial effect which the absence of corticosteroids may have on short- and long-term postoperative morbidity and mortality. One may in fact assume that the absence of corticosteroids will result in an extension of the transplant patient's life expectancy as a result of the reduction in cardiovascular complications. Cardiovascular complications are the most frequent cause of death after a renal transplant.

ReferenceCitation: Cantarovich D, Rostaing L, Kamar N, Saint-Hillier Y, Ducloux D, Mourad G, Garrigue V, Wolf P, Ellero B, Cassuto E, Albano L, Soulillou JP; FRANCIA Study Trial Investigators Group. Corticosteroid avoidance in adult kidney transplant recipients under rabbit anti-T-lymphocyte globulin, mycophenolate mofetil and delayed cyclosporine microemulsion introduction. Transpl Int. 2010 Mar 1;23(3):313-24. doi: 10.1111/j.1432-2277.2009.00971.x. Epub 2009 Oct 19.

lead_sponsor: Nantes University Hospital

location_facility:
Nice Universitary Hospital
Besançon Universitary Hospital
Strasbourg Universitary Hospital
Montpellier Universitary Hospital
Nantes University Hospital


title: Characteristics of the Intestinal Microbiota in Patients With Cancer (Catalogue-Onco)

acronym: Catalogue-Onco

summary:
In order to understand how the intestinal microbiota plays a role in the effectiveness of an anti-cancer treatment by an immune control point inhibitor, this study aims to constitute a catalog of microbial genes of a patient with cancer. This catalog will help to characterize the intestinal microbiota of cancer patients and to be able to use this catalog as a reference tool for screening the microbiota of patients treated with immune control point inhibitors. To produce this catalog, five types of cancer were selected: non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma, breast cancer and prostate cancer.

The metagenomic analysis of a group of five different types of cancers introduces a lot of heterogeneity which is favorable to the richness of a catalog. For non-small cell lung cancer treated with immune control point inhibitors, two stool collections will be performed per patient (one stool collection before setting up an immune control point inhibitor and one collection after one month of being inhibited Of immune control point) to assess the impact of the immune control point inhibitor on the microbiota (pilot study). For this study, two stool collection tubes containing different preservative solutions will be used (one RNAlater tube and one DMSO-EDTA tube for Dimethylsulfoxide-Ethylene diamine tetraacetic acid).

In parallel, we will also collect samples of serum and plasma to evaluate, in a second step, protein markers in circulating blood.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
Hopital Universitaire Paul Brousse
Centre Georges-François Leclerc


title: Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies

acronym: TMF-Allo

summary:
The aim of this study is to assess the Fecal Microbiota Transplantation (FMT) efficacy in the prevention of allogeneic hematopoietic stem cell transplantation (allo-HSCT) complications and particularly Graft versus Host Disease (GvHD).

The hypothesis of this study is that allogeneic FMT may improve outcomes of these patients.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens Picardie - Site Sud

location_facility: Service d'hématologie clinique, département de greffe de moelle CHU Nice

location_facility: Service d'Hématologie Adultes Hôpital Necker

location_facility: Service d'Hématologie Centre Hospitalier Lyon Sud

location_facility: Service des Maladies du sang Hôpital HURIEZ, CHRU de Lille

location_facility: Hématologie clinique Institut de Cancérologie de la Loire

location_facility: Service d'Hématologie Clinique CHU Nantes

location_facility: Service d'hématologie greffe Hôpital St Louis

location_facility: Hématologie clinique et thérapie cellulaire Hôpital Haut-Lévèque

location_facility: Plateforme d'Investigation Clinique / Centre d'Investigation Clinique - Inserm 1405, CHU Gabriel Montpied Clermont-Ferrand

location_facility: Service d'Hématologie clinique Hôpital Pitié-Salpêtrière

location_facility: Service de thérapie cellulaire et l'hématologie clinique adulte CHU Limoges

location_facility: Service d'Hématologie et de Médecine interne Hôpital Brabois CHRU Nancy

location_facility: Service de thérapie Cellulaire et d'Hématologie Clinique Adulte CHU Estaing - Clermont-Ferrand


title: Proteomic Analysis of Amniotic Fluid in the Case of Diaphragmatic Hernia: Search for Prognostic Expression Profiles

acronym: pro-CDH

summary:
Congenital diaphragmatic hernia (CDH) is a severe congenital malformation, related to a developmental defect of the diaphragm. The incidence of CDH is approximated at 1 in 3,000 live births. Although advances in surgery and neonatal intensive care have improved the prognosis, mortality remains high, around 30-50% related to severe lung hypoplasia and persistent pulmonary hypertension. Prenatal evaluation with observed/expected Lung over Head Ratio (o/e LHR), liver position and total lung volume measured by magnetic resonance, have been shown to correlate with neonatal mortality . However, the preponderant factor of persistent pulmonary hypertension remains difficult to predict prenatally. In patients with isolated diaphragmatic hernia (without associated malformations or karyotype abnormalities), prognosis is evaluated indirectly on pulmonary development from pulmonary volume measurements. Apart from the most caricatural cases with extremely good or very pejorative values, for a large proportion of fetuses with diaphragmatic dome hernia the prognosis remains uncertain.

The aim of the proposal is to investigate whether the analysis of the proteom of the amniotic fluid of the fetuses with CDH could give information of a prognostic character. The objective of the study is to identify, from the proteomic profile of the amniotic fluid of mothers whose fetus has CDH, prognostic markers candidates for death at 2 months of the infant. The first step is to carry out an exploratory and non-interventional study on a small sample (n = 10) of the target population. This is a preliminary step before considering, if the results are encouraging, a large-scale study from a biological collection to determine candidate proteins (new biomarkers) which relative expression levels could be used as surrogate marker of pulmonary hypoplasia.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU de Dijon
CHU de Besançon


title: Recording Facial and Vocal Emotional Productions in Children With Autism as Part of the JEMImE Project

summary:
The purpose of the JEMImE project is to create a serious game to help children with Autism and Pervasive Developmental Disorder (PDD) develop facial and vocal emotions in context.

The objective of this study is to record facial and vocal emotional productions in children with autism and PDD in order to create an algorithm for the recognition of facial emotional expressions implemented in the serious game JEMImE.

lead_sponsor: Fondation Lenval

location_facility: Fondation Lenval Hôpitaux Pédiatriques de Nice CHU-LENVAL


title: Feasibility of DNA Analysis From Isolated Cardiomyocytes in the Molecular Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy/Dysplasia

summary: The main objective of this study is to assess if it is possible, at the end of endocardial voltage mapping, to accurately collect intact cardiomyocytes and to isolate high quality DNA allowing molecular testing of selected genes involved in arrhythmogenic right ventricular cardiomyopathy/dysplasia.

lead_sponsor: University Hospital, Toulouse

location_facility: University Hospital Toulouse - Cardiology Department


title: Repetitive Transcranial Magnetic Stimulation Efficacy for Major Resistant Depression Compared or Associated With Venlafaxine : a Multicentric Study.

summary: The purpose of this study is to assess the efficacy of add-on therapy with repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of major depressive disorders compared to venlafaxine only (the optimal medication) and to rTMS only.

ReferenceCitation: Brunelin J, Jalenques I, Trojak B, Attal J, Szekely D, Gay A, Januel D, Haffen E, Schott-Pethelaz AM, Brault C; STEP Group, Poulet E. The efficacy and safety of low frequency repetitive transcranial magnetic stimulation for treatment-resistant depression: the results from a large multicenter French RCT. Brain Stimul. 2014 Nov-Dec;7(6):855-63. doi: 10.1016/j.brs.2014.07.040. Epub 2014 Aug 7.

lead_sponsor: Club rTMS et Psychiatrie

location_country: France Monaco

location_facility: C.H.U. de Grenoble, Hôpital sud - Département de Psychiatrie

location_facility: EPS de Ville Evrard - Unité de Saint-Denis

location_facility: C.H.U. Dijon, Hôpital Général - Service de Psychiatrie et d'Addictologie

location_facility: Hôpital Sainte Anne - Service Hospitalo-Universitaire de Santé Mentale et de Thérapeutique

location_facility: C.H.U. Saint-Jacques - Service de Psychiatrie de l'Adulte

location_facility: C.H. Le Vinatier - EA 4166, UCB Lyon 1 - Department of Psychiatry - Service du Pr d'AMATO

location_facility: C.H.U. Gabriel Montpied - Service de Psychiatrie et Psychologie Médicale - CMP A

location_facility: C.H.U. Charles Nicolle - Service Hospitalo-Universitaire de Psychiatrie


title: An Open-label, Phase II Study to Explore the Safety and Efficacy of Imatinib With Chemotherapy in Pediatric Patients With Ph+ / BCR-ABL+ Acute Lymphoblastic Leukemia (Ph+ALL)

acronym: ESPHALL

summary: The purpose of this study is to determine whether Imatinib is safe and effective in association with intensive treatment of Ph+ALL in children.

ReferenceCitation: Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0.

ReferenceCitation: Biondi A, Gandemer V, De Lorenzo P, Cario G, Campbell M, Castor A, Pieters R, Baruchel A, Vora A, Leoni V, Stary J, Escherich G, Li CK, Cazzaniga G, Cavé H, Bradtke J, Conter V, Saha V, Schrappe M, Grazia Valsecchi M. Imatinib treatment of paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia (EsPhALL2010): a prospective, intergroup, open-label, single-arm clinical trial. Lancet Haematol. 2018 Dec;5(12):e641-e652. doi: 10.1016/S2352-3026(18)30173-X.

ReferenceCitation: Biondi A, Schrappe M, De Lorenzo P, Castor A, Lucchini G, Gandemer V, Pieters R, Stary J, Escherich G, Campbell M, Li CK, Vora A, Aricò M, Röttgers S, Saha V, Valsecchi MG. Imatinib after induction for treatment of children and adolescents with Philadelphia-chromosome-positive acute lymphoblastic leukaemia (EsPhALL): a randomised, open-label, intergroup study. Lancet Oncol. 2012 Sep;13(9):936-45. doi: 10.1016/S1470-2045(12)70377-7. Epub 2012 Aug 14.

lead_sponsor: Rennes University Hospital

location_facility: Hématologie, Oncologie pédiatrique-CHU Saint Etienne

location_facility: Hémato-Oncologie et Thérapie Cellulaire Pédiatrique - Hôtel Dieu

location_facility: Service d'Immuno Hémato Oncologie Pédiatrique - Hôpital Charles Nicolle

location_facility: Hématologie oncologie pédiatrique-CHU Caen

location_facility: Hématologie Pédiatrique - Hôpital Trousseau

location_facility: Hémato-Oncologie Pédiatrique - Hôpital d'Enfants

location_facility: Service hématologie pédiatrique Hôpital Saint-Jacques

location_facility: Service d'hématologie pédiatrique - Hôpital Sud

location_facility: Service d'hémato-oncologie - Hôpital des Enfants Pellegrin

location_facility: Hôpital DEBROUSSE Institut d'hématologie et d'oncologie pédiatrique


title: Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection

acronym: Bio-Prost

summary:
In this study, we aim to evaluate the feasibility of anti-PSMA labelling to detect post-operative prostatic tissues by two ex vivo fluorescence techniques. We will evaluate the feasibility and detection of anti-PSMA labelling by:

/ the FEMTO-ST institute medical device,
/ the confocal microscope that will be used to measure fluorescence spectra of biological samples.

lead_sponsor: University Hospital, Grenoble

location_facility: Grenoble Alpes University Hospital - Urology department


title: Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia (VAP): an Ancillary Study of the DEMETER Trial (NCT02515617)

summary:
Many studies provide evidence for the benefit of lower respiratory tract surveillance, mostly by culture of endotracheal secretions, to predict bacterial pathogens (especially multi-drugs resistant pathogens) involved in VAP. The DEMETER study (NCT02515617) assessing the medico-economical impact of the subglottic secretions drainage (SSD) provides the opportunity to evaluate the accuracy of the subglottic secretions culture surveillance to predict pathogens involved in VAP (in comparison with the concomitant endotracheal secretions surveillance). These subglottic and tracheal secretions culture surveillance will be masked to the investigators of the DEMETER Study.

This ancillary study will be performed in 14 centers participating to the DEMETER study

ReferenceCitation: Brusselaers N, Labeau S, Vogelaers D, Blot S. Value of lower respiratory tract surveillance cultures to predict bacterial pathogens in ventilator-associated pneumonia: systematic review and diagnostic test accuracy meta-analysis. Intensive Care Med. 2013 Mar;39(3):365-75. doi: 10.1007/s00134-012-2759-x. Epub 2012 Nov 28. Review.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_country: France Belgium

location_facility: CHU La Réunion, site de Saint Denis de la Réunion

location_facility: Centre Hospitalier Intercommunal des Portes de l'Oise


title: Is Variation of Plasmatic Protein Concentration During Continuous Renal Replacement Therapy Predictive of Hypovolemia in Intensive Care Unit?

summary: The aim of the study is to analyze if blood protein concentration variation during continuous renal replacement therapy (CRRT) with fluid removal can predict a decrease of 15 % of cardiac index in intensive care unit (ICU) patients. Blood protein concentration, clinical data describing hemodynamic status (providing data from Pulsion medical system PiCCO2 ® monitoring), including preload dependency evaluation with passive leg raising, are collected at different times: before initiation of fluid removal, and after the first episode of hypotension or one hour after initiation of fluid removal.

ReferenceCitation: Lamia B, Ochagavia A, Monnet X, Chemla D, Richard C, Teboul JL. Echocardiographic prediction of volume responsiveness in critically ill patients with spontaneously breathing activity. Intensive Care Med. 2007 Jul;33(7):1125-1132. doi: 10.1007/s00134-007-0646-7. Epub 2007 May 17.

ReferenceCitation: Monnet X, Marik P, Teboul JL. Passive leg raising for predicting fluid responsiveness: a systematic review and meta-analysis. Intensive Care Med. 2016 Dec;42(12):1935-1947. doi: 10.1007/s00134-015-4134-1. Epub 2016 Jan 29. Review.

ReferenceCitation: Monnet X, Cipriani F, Camous L, Sentenac P, Dres M, Krastinova E, Anguel N, Richard C, Teboul JL. The passive leg raising test to guide fluid removal in critically ill patients. Ann Intensive Care. 2016 Dec;6(1):46. doi: 10.1186/s13613-016-0149-1. Epub 2016 May 20.

ReferenceCitation: Bitker L, Bayle F, Yonis H, Gobert F, Leray V, Taponnier R, Debord S, Stoian-Cividjian A, Guérin C, Richard JC. Prevalence and risk factors of hypotension associated with preload-dependence during intermittent hemodialysis in critically ill patients. Crit Care. 2016 Feb 23;20:44. doi: 10.1186/s13054-016-1227-3.

lead_sponsor: Hopital Louis Pradel

location_facility:
Matthias Jacquet-Lagreze
Hôpital Cardiologique Louis Pradel


title: Observational, Longitudinal, Prospective, French, Multicentre Study Conducted on Adult and Paediatric Patients Treated With Micafungin in Prophylaxis and Followed Over a 3 Months' Period in Routine Medical Practice

acronym: OLYMPE

summary: The purpose of this observational study is to describe the actual conditions of prescription of micafungin in antifungal prophylaxis in French haematological and onco-haematological units. The efficacy and the safety outcomes will be described.

ipd_sharing_description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

lead_sponsor: Astellas Pharma S.A.S.


title: Safety Acceptability and Benefits of Tracking Cardiac Pacemakers by Carelink Express

acronym: SAFECARE

summary: Follow-up strategy for patients implanted with a pacemaker.

lead_sponsor: University Hospital, Brest

location_facility:
CH Lorient
CHRU Brest


title: Prospective, Randomized, Double-blind, Placebo-controlled Study on Parallel Groups Evaluating the Efficacy and Safety of Cranberry (Vaccinium Macrocarpon) in Prevention of Urinary Tract Infections in Multiple Sclerosis Patients.

acronym: CANNEBERGE

summary: Bladder dysfunction occurs at some time in most patients with multiple sclerosis and these patients are prone to have recurrent urinary tract infections. Cranberry has been traditionally used for the treatment and prophylaxis of urinary tract infections but there is no reliable randomized controlled trial demonstrating evidence of cranberry's utility in this disease. The aim of our study is to assess the efficacy and safety of cranberry in the prophylaxis of urinary tract infections in patients with multiple sclerosis with a prospective randomized, double-blind and placebo-controlled clinical trial.

ReferenceCitation: Gallien P, Amarenco G, Benoit N, Bonniaud V, Donzé C, Kerdraon J, de Seze M, Denys P, Renault A, Naudet F, Reymann JM. Cranberry versus placebo in the prevention of urinary infections in multiple sclerosis: a multicenter, randomized, placebo-controlled, double-blind trial. Mult Scler. 2014 Aug;20(9):1252-9. doi: 10.1177/1352458513517592. Epub 2014 Jan 8.

location_facility: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE

location_facility: Médecine Physique et Réadaptation - Groupe Hospitalier de l'institut Catholique de Lille - Hôpital Saint Philibert

location_facility: Unité de Médecine Physique et Réadaptation - CHU Jean Minjoz

location_facility: Service de Médecine Physique et Réadaptation - Hôpital Raymond Poincaré

location_facility: Service de médecine physique et réadapation Hopital de Rangueil

location_facility: Centre de Médecine Physique et Réadaptation Notre Dame de Lourdes

location_facility: Rééducation Neurologique et Explorations Périnéales - Hôpital Rothschild

location_facility: Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou

location_facility: Consultations maladies infectieuses et tropicales, Hôpital Raymond Poincaré

location_facility: Service de Médecine Physique et Réadaptation - Hôpital Pellegrin


title: Continuation of the Exploration of the Standing Seated Passage of the Hemiplegic for the Realization of a New Transport Device

summary:
This is a study for a new mechanical transport device adapted to the hemiplegic patients.

Healthy volunteers :

After explaining the protocol and presenting the movement laboratory, the subjects are equipped with reflective markers on the 4 limbs, the trunk and the head. The subjects are installed on a seat positioned in front of 2 force platforms installed on the ground. The seat is equipped with a force platform.

Phase 1 :

After being seated, the subject realizes :

3 seat to stand and stand to seat without assistance
3 seat to stand and stand to seat using a handle located in front of it (handle equipped with a 6-axis force sensor)
3 seat to stand and stand to seat using the experimental device This phase will last 45minutes (mn) (30mn of equipment and 15mn of sitting passengers standing)

Phase 2:

After being seated, the subject performs a course comprising:

A standing pass from sitting on a chair
A straight line movement
A succession of left and right turns
An upward and downward travel of less than 1%.
Standard doorway
Standing on the toilet
A sitting pass from the toilet
One way to a bed
A sitting pass on the bed
A passenger seat sitting upright from the bed
A return to the starting point
A sitting pass on the starting chair Each stage is timed. A subjective analysis of each step is done by a lickert scale on the perceived comfort and safety.

This phase 2 will last 30mn (15mn of course and 15mn of questions).

Hemiplegic subjects :

At each session, the subject is examined by a physician who evaluates the motor control (Fugl Meyer scale), the equilibrium (Berg scale) and the spatial hemineglect (Bergego scale).

Phase 1 is performed except the 3 seat to stand and stand to seat without assistance which are impossible.

Phase 2 is performed. An evaluation of the device over 4 hours is carried out for each subject in therapeutic apartment in simulated living conditions. The validation in living lab is carried out by an ergonomist and by a questionnaire on the comfort and safety of the various steps identified by the ergonomist.

location_facility: Centre de rééducation fonctionnelle de KERPAPE


title: TREg Activation in the Treatment of the PELADE (Alopecia Areata). Double Blind Randomized Placebo Controlled Comparative Study Using Low Doses of IL2

acronym: TreatPelade

summary:
In a prospective pilot study the investigators showed that low doses of IL2 could be beneficial for severe AA inducing a long lasting regrowth in 4 out of the 5 patients treated.

The objective of this study is to compare the long term efficacy of low doses of IL2 versus placebo in a multicenter prospective randomized double blind study.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHI St Raphael Fréjus - Dermatologie
CHU de Nice - dermatologie
CHU de Nimes - Dermatologie
AP-HM - La timone - Dermatologie
CHU Montpellier - Dermatologie
AP-HP St Louis - Dermatologie


title: Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation

acronym: UniTEP

summary: Our main objective is to study how the extent of reorganization of the central auditory system is related to the binaural integration in cochlear implanted subjects with asymmetric hearing loss. Subjects with asymmetric hearing loss treated with a cochlear implant and a control group of normal hearing subjects will perform two tests for binaural integration (speech recognition in noise and spatial localization) and two tasks of non-linguistic sounds perception.

ReferenceCitation: Deggouj N, Gersdorff M, Garin P, Castelein S, Gérard JM. Today's indications for cochlear implantation. B-ENT. 2007;3(1):9-14. Review.

ReferenceCitation: Devocht EM, Dees G, Arts RA, Smits JJ, George EL, van Hoof M, Stokroos RJ. Revisiting Place-Pitch Match in CI Recipients Using 3D Imaging Analysis. Ann Otol Rhinol Laryngol. 2016 May;125(5):378-84. doi: 10.1177/0003489415616130. Epub 2015 Dec 1.

ReferenceCitation: Shannon RV, Zeng FG, Kamath V, Wygonski J, Ekelid M. Speech recognition with primarily temporal cues. Science. 1995 Oct 13;270(5234):303-4.

ReferenceCitation: Fu QJ, Shannon RV, Wang X. Effects of noise and spectral resolution on vowel and consonant recognition: acoustic and electric hearing. J Acoust Soc Am. 1998 Dec;104(6):3586-96.

ReferenceCitation: Munson B, Nelson PB. Phonetic identification in quiet and in noise by listeners with cochlear implants. J Acoust Soc Am. 2005 Oct;118(4):2607-17.

ReferenceCitation: Rouger J, Lagleyre S, Fraysse B, Deneve S, Deguine O, Barone P. Evidence that cochlear-implanted deaf patients are better multisensory integrators. Proc Natl Acad Sci U S A. 2007 Apr 24;104(17):7295-300. Epub 2007 Apr 2.

ReferenceCitation: Rouger J, Fraysse B, Deguine O, Barone P. McGurk effects in cochlear-implanted deaf subjects. Brain Res. 2008 Jan 10;1188:87-99. Epub 2007 Oct 26.

ReferenceCitation: Marx M, James C, Foxton J, Capber A, Fraysse B, Barone P, Deguine O. Speech prosody perception in cochlear implant users with and without residual hearing. Ear Hear. 2015 Mar-Apr;36(2):239-48. doi: 10.1097/AUD.0000000000000105.

ReferenceCitation: Strelnikov K, Rouger J, Demonet JF, Lagleyre S, Fraysse B, Deguine O, Barone P. Does brain activity at rest reflect adaptive strategies? Evidence from speech processing after cochlear implantation. Cereb Cortex. 2010 May;20(5):1217-22. doi: 10.1093/cercor/bhp183. Epub 2009 Oct 5.

ReferenceCitation: Strelnikov K, Rouger J, Lagleyre S, Fraysse B, Démonet JF, Déguine O, Barone P. Increased audiovisual integration in cochlear-implanted deaf patients: independent components analysis of longitudinal positron emission tomography data. Eur J Neurosci. 2015 Mar;41(5):677-85. doi: 10.1111/ejn.12827.

ReferenceCitation: Strelnikov K, Rouger J, Demonet JF, Lagleyre S, Fraysse B, Deguine O, Barone P. Visual activity predicts auditory recovery from deafness after adult cochlear implantation. Brain. 2013 Dec;136(Pt 12):3682-95. doi: 10.1093/brain/awt274. Epub 2013 Oct 17.

ReferenceCitation: Rouger J, Lagleyre S, Démonet JF, Fraysse B, Deguine O, Barone P. Evolution of crossmodal reorganization of the voice area in cochlear-implanted deaf patients. Hum Brain Mapp. 2012 Aug;33(8):1929-40. doi: 10.1002/hbm.21331. Epub 2011 May 6.

ReferenceCitation: Giraud AL, Truy E, Frackowiak RS, Grégoire MC, Pujol JF, Collet L. Differential recruitment of the speech processing system in healthy subjects and rehabilitated cochlear implant patients. Brain. 2000 Jul;123 ( Pt 7):1391-402.

ReferenceCitation: Giraud AL, Price CJ, Graham JM, Truy E, Frackowiak RS. Cross-modal plasticity underpins language recovery after cochlear implantation. Neuron. 2001 Jun;30(3):657-63.

ReferenceCitation: Vannson N, James C, Fraysse B, Strelnikov K, Barone P, Deguine O, Marx M. Quality of life and auditory performance in adults with asymmetric hearing loss. Audiol Neurootol. 2015;20 Suppl 1:38-43. doi: 10.1159/000380746. Epub 2015 May 19.

ReferenceCitation: Scheffler K, Bilecen D, Schmid N, Tschopp K, Seelig J. Auditory cortical responses in hearing subjects and unilateral deaf patients as detected by functional magnetic resonance imaging. Cereb Cortex. 1998 Mar;8(2):156-63.

ReferenceCitation: Ponton CW, Vasama JP, Tremblay K, Khosla D, Kwong B, Don M. Plasticity in the adult human central auditory system: evidence from late-onset profound unilateral deafness. Hear Res. 2001 Apr;154(1-2):32-44.

ReferenceCitation: Massida Z, Belin P, James C, Rouger J, Fraysse B, Barone P, Deguine O. Voice discrimination in cochlear-implanted deaf subjects. Hear Res. 2011 May;275(1-2):120-9. doi: 10.1016/j.heares.2010.12.010. Epub 2010 Dec 16.

ReferenceCitation: Guerreiro MJ, Erfort MV, Henssler J, Putzar L, Röder B. Increased visual cortical thickness in sight-recovery individuals. Hum Brain Mapp. 2015 Dec;36(12):5265-74. doi: 10.1002/hbm.23009. Epub 2015 Sep 29.

ReferenceCitation: Collett E, Marx M, Gaillard P, Roby B, Fraysse B, Deguine O, Barone P. Categorization of common sounds by cochlear implanted and normal hearing adults. Hear Res. 2016 May;335:207-219. doi: 10.1016/j.heares.2016.03.007. Epub 2016 Apr 2.

ReferenceCitation: Strelnikov K, Rouger J, Lagleyre S, Fraysse B, Deguine O, Barone P. Improvement in speech-reading ability by auditory training: Evidence from gender differences in normally hearing, deaf and cochlear implanted subjects. Neuropsychologia. 2009 Mar;47(4):972-9. doi: 10.1016/j.neuropsychologia.2008.10.017. Epub 2008 Oct 30.

location_facility:
CERCO
CHU de Toulouse - Hôpital Purpan


title: Brain-computer Interface in the Diagnosis of Disorders of Consciousness

acronym: AWAKE

summary:
The objective of this study is to show that the measurement of auditory and vibro-tactile evoked potentials, or the recording of the EEG signal during a motor imaging task, can be used in routine clinical situations to explore the state of consciousness of subjects in Non-responsive Awakening (or Chronic Vegetative State) or in Minimal Consciousness (or relational state) after a severe brain injury.

Assumptions :

Correlation between patient response rates obtained with the brain-machine interface and their clinical consciousness score (Coma Recovery Scale Revised score)
Differentiation of the parameters of the evoked potentials P300 between patients in a vegetative state and those in a state of minimal consciousness

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Clinique Fontfroide
CHU de Montpellier
Hôpital d'Uzès
CHU de Nîmes


title: Impact of Interictal Electroencephalographic Abnormalities on the Stability of Attention in the Epilepsies in Adults and Children

acronym: COGNIT-AIC

summary:
Cognitive disorders are a major problem in patients with epilepsy. One hypothesis is that the anomalies EEGs (AIC) may be responsible for short periods of attentional fluctuations causing a reduction of intellectual efficiency of patients. In this project, we propose to evaluate the impact of AIC on cognitive performance, specifically on attentional performance (central parameter of cognitive functioning) through the use of a computerized cognitive test (called STABILO, detailed below after) to measure, with good temporal sampling, the level of attentional engagement of patients in relation to their EEG activity.

The originality of this study lies in the synchronization of two examinations usually made independently (EEG and psychometric testing), respecting a precise temporal coupling. The aim is to provide clinicians with a tool to assess very quickly attentional fluctuations in epileptic patients, and to assess the potential impact of AIC on the occurrence of these changes, with possible therapeutic implications (treatment of AIC and / or specific treatment of attention deficit disorder).

The main objective of this study is to assess whether the presence of AIC EEG can induce a weakening of attentional performance.

location_facility:
HCL
University Hospital Grenoble


title: National Oesophageal and Gastric Carcinomas Data Base Construction: the FREGAT (French EsoGastric Tumours) Data Base

acronym: FREGAT

summary: This retrospective study aims at evaluating the outcomes of gastrointestinal stromal tumor after surgery.

ReferenceCitation: Mariette C, Renaud F, Piessen G, Gele P, Copin MC, Leteurtre E, Delaeter C, Dib M, Clisant S, Harter V, Bonnetain F, Duhamel A, Christophe V, Adenis A; Fregat Working Group. The FREGAT biobank: a clinico-biological database dedicated to esophageal and gastric cancers. BMC Cancer. 2018 Feb 6;18(1):139. doi: 10.1186/s12885-018-3991-8.

lead_sponsor: University Hospital, Lille

location_facility: Hopital Estaing - Chu63 - Clermont Ferrand

location_facility: Hospices Civils de Lyon (Pierre Bénite,Edouard Herriot, La Croix Rousse)


title: Assessment of Perioperative Morbidity in Gyneco-oncology According to the Surgical Approach : Coelioscopy Versus Robot-assisted Coelioscopy

acronym: ROBO-GYN

summary: The purpose of this study is to compare perioperative morbidity of coelioscopy versus robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.

ReferenceCitation: Narducci F, Bogart E, Hebert T, Gauthier T, Collinet P, Classe JM, Lecuru F, Delest A, Motton S, Conri V, Ferrer C, Marchal F, Ferron G, Probst A, Thery J, Le Deley MC, Lefebvre D, Francon D, Leblanc E, Lambaudie E. Severe perioperative morbidity after robot-assisted versus conventional laparoscopy in gynecologic oncology: Results of the randomized ROBOGYN-1004 trial. Gynecol Oncol. 2020 Aug;158(2):382-389. doi: 10.1016/j.ygyno.2020.05.010. Epub 2020 May 25.

lead_sponsor: Centre Oscar Lambret

location_facility: Institut de Cancérologie de l'Ouest Site René Gauducheau


title: A Phase II Multicentric Trial to Assess Efficacy and Toxicity of Imatinib in Adult Patients With Metastatic Ocular Melanoma

acronym: O-Mel-Inib

summary: The scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic ocular melanoma patients.

location_facility: Centre Hospitalier Regional Universitaire


title: SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0

acronym: SBRT-NSCLC

summary:
The purpose of this study is to evaluate local disease control after 2 years in patients with non-metastatic, non-operated non-small-cell lung cancer treated by radiotherapy.

Eligible patients will be recruited and registered consecutively (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 4 years.

The number of patients required in this multicentric prospective study is 120:

20 patients in the SBRT-1 arm (cyberknife),
80 patients in the SBRT-2 arm (linear accelerator-based)
20 patients in the conformational radiotherapy arm.

This is a prospective, multicentric, non comparative and non randomized study.

ReferenceCitation: Noel G, Bollet MA, Noel S, Feuvret L, Boisserie G, Tep B, Delattre JY, Baillet F, Ambroise Valery C, Cornu P, Mazeron JJ. Linac stereotactic radiosurgery: an effective and safe treatment for elderly patients with brain metastases. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1555-61. Epub 2005 Jul 18.

ReferenceCitation: Kaplan EL., MP. Nonparametric estimation from incomplete observations. 1958. J Am Stat Assoc 1958; 53:457-481

ReferenceCitation: Pommier P. Modélisation spatiale et médico-économique des thérapeutiques innovantes : à propos du projet français ETOILE d'hadronthérapie par ions carbone. Thèse de Science en économie de la santé ; juin 2005

ReferenceCitation: Pommier P, Ndiaga Gueye N, Buron C, Meyroneinc S. Modélisation du coût de l'innovation thérapeutique pour l'aide à la décision. Application à la radiothérapie par ions carbone (projet ETOILE). Santé et systémique 2007 ; 10 : 217-31

ReferenceCitation: Evaluation de la radiothérapie fractionnée en condition stéréotaxiques des métastases cérébrales, STIC 2005

ReferenceCitation: Tschung Sibley G. Radiotherapy for patient with medically inoperable stage I non-small cell lung cancer smaller doses and higher doses - a review. Cancer 2003;41:1-11

ReferenceCitation: Timmerman R, Papiez L, McGarry R, Likes L, DesRosiers C, Frost S, Williams M. Extracranial stereotactic radioablation: results of a phase I study in medically inoperable stage I non-small cell lung cancer. Chest. 2003 Nov;124(5):1946-55.

ReferenceCitation: McGarry RC, Papiez L, Williams M, Whitford T, Timmerman RD. Stereotactic body radiation therapy of early-stage non-small-cell lung carcinoma: phase I study. Int J Radiat Oncol Biol Phys. 2005 Nov 15;63(4):1010-5. Epub 2005 Aug 22.

ReferenceCitation: Whyte RI, Crownover R, Murphy MJ, Martin DP, Rice TW, DeCamp MM Jr, Rodebaugh R, Weinhous MS, Le QT. Stereotactic radiosurgery for lung tumors: preliminary report of a phase I trial. Ann Thorac Surg. 2003 Apr;75(4):1097-101.

ReferenceCitation: Xia T, Li H, Sun Q, Wang Y, Fan N, Yu Y, Li P, Chang JY. Promising clinical outcome of stereotactic body radiation therapy for patients with inoperable Stage I/II non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):117-25. Epub 2006 Jun 9.

ReferenceCitation: Nagata Y, Takayama K, Matsuo Y, Norihisa Y, Mizowaki T, Sakamoto T, Sakamoto M, Mitsumori M, Shibuya K, Araki N, Yano S, Hiraoka M. Clinical outcomes of a phase I/II study of 48 Gy of stereotactic body radiotherapy in 4 fractions for primary lung cancer using a stereotactic body frame. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1427-31. Epub 2005 Sep 19.

ReferenceCitation: Onishi H, Araki T, Shirato H, Nagata Y, Hiraoka M, Gomi K, Yamashita T, Niibe Y, Karasawa K, Hayakawa K, Takai Y, Kimura T, Hirokawa Y, Takeda A, Ouchi A, Hareyama M, Kokubo M, Hara R, Itami J, Yamada K. Stereotactic hypofractionated high-dose irradiation for stage I nonsmall cell lung carcinoma: clinical outcomes in 245 subjects in a Japanese multiinstitutional study. Cancer. 2004 Oct 1;101(7):1623-31.

ReferenceCitation: Hof H, Herfarth KK, Münter M, Hoess A, Motsch J, Wannenmacher M, Debus J J. Stereotactic single-dose radiotherapy of stage I non-small-cell lung cancer (NSCLC). Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):335-41.

ReferenceCitation: Uematsu M, Shioda A, Suda A, Fukui T, Ozeki Y, Hama Y, Wong JR, Kusano S. Computed tomography-guided frameless stereotactic radiotherapy for stage I non-small cell lung cancer: a 5-year experience. Int J Radiat Oncol Biol Phys. 2001 Nov 1;51(3):666-70.

ReferenceCitation: Fukumoto S, Shirato H, Shimzu S, Ogura S, Onimaru R, Kitamura K, Yamazaki K, Miyasaka K, Nishimura M, Dosaka-Akita H. Small-volume image-guided radiotherapy using hypofractionated, coplanar, and noncoplanar multiple fields for patients with inoperable Stage I nonsmall cell lung carcinomas. Cancer. 2002 Oct 1;95(7):1546-53.

ReferenceCitation: Lax I, Blomgren H, Näslund I, Svanström R. Stereotactic radiotherapy of malignancies in the abdomen. Methodological aspects. Acta Oncol. 1994;33(6):677-83.

ReferenceCitation: Blomgren H, Lax I, Näslund I, Svanström R. Stereotactic high dose fraction radiation therapy of extracranial tumors using an accelerator. Clinical experience of the first thirty-one patients. Acta Oncol. 1995;34(6):861-70.

ReferenceCitation: Schemper M, Smith TL. A note on quantifying follow-up in studies of failure time. Control Clin Trials. 1996 Aug;17(4):343-6.

ReferenceCitation: Krol AD, Aussems P, Noordijk EM, Hermans J, Leer JW. Local irradiation alone for peripheral stage I lung cancer: could we omit the elective regional nodal irradiation? Int J Radiat Oncol Biol Phys. 1996 Jan 15;34(2):297-302. Review.

ReferenceCitation: Gauden SJ, Tripcony L. The curative treatment by radiation therapy alone of Stage I non-small cell lung cancer in a geriatric population. Lung Cancer. 2001 Apr;32(1):71-9.

ReferenceCitation: Morita K, Fuwa N, Suzuki Y, Nishio M, Sakai K, Tamaki Y, Niibe H, Chujo M, Wada S, Sugawara T, Kita M. Radical radiotherapy for medically inoperable non-small cell lung cancer in clinical stage I: a retrospective analysis of 149 patients. Radiother Oncol. 1997 Jan;42(1):31-6.

ReferenceCitation: Sirzén F, Kjellén E, Sörenson S, Cavallin-Ståhl E. A systematic overview of radiation therapy effects in non-small cell lung cancer. Acta Oncol. 2003;42(5-6):493-515. Review.

ReferenceCitation: Bradley JD, Wahab S, Lockett MA, Perez CA, Purdy JA. Elective nodal failures are uncommon in medically inoperable patients with Stage I non-small-cell lung carcinoma treated with limited radiotherapy fields. Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):342-7.

lead_sponsor: Centre Leon Berard

location_facility:
Centre Val d'Aurelle Paul Lamarque
Centre René Gauducheau
Centre Alexis Vautrin
Centre Georges François Leclerc
Centre Antoine Lacassagne
Centre Oscar Lambret
Hôpital Tenon
CHLS
Centre Leon Berard

intervention_type: Radiation


acronym: ROPISIO

title: Study of the Analgesic Effect of the Perineal Infiltration of Ropivacaine 0.75% Versus Placebo in Post-episiotomy Perineal Pain: a Randomized, Double-blind Study

ReferenceCitation: Cardaillac C, Ploteau S, Le Thuaut A, Dochez V, Winer N, Ducarme G. Ropivacaine 75 mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women - the ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trials. Trials. 2020 Jun 12;21(1):522. doi: 10.1186/s13063-020-04423-x.

location_facility:
Centre Hospitalier Universitaire Nantes
Centre Hospitalier Departemental Vendee

summary:
Episiotomy is a common obstetric gesture (20 to 30% of deliveries by the low route). In postpartum, perineal pains associated with episiotomy are common, about 70% on D7 and persistent 13% at 5 months. Most studies of obstetrical analgesia have focussed on pain during labor or following a caesarean section. The perineal pain associated with the realization of an episiotomy has been much less studied and often undervalued.

Local ropivacaine has shown its effectiveness in the reduction of postoperative pain in many indications (wall surgery, hemorrhoidectomy, infiltration of trocar scars during laparoscopy). This product has the advantage of being well tolerated, easy access and administration. Three recent studies compared the post-episiotomy analgesic efficacy of local ropivacaine versus lidocaine versus placebo and lidocaine versus no infiltration. Two of these studies showed statistically significant results. However, they focused on the results at 24 and 48 hours and did not evaluate the analgesic efficacy in the medium and long term.


title: ESCORT-HU : European Sickle Cell Disease Cohort - Hydroxyurea

acronym: ESCORT-HU

summary: In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in patients with Sickle Cell Disease.

ReferenceCitation: de Montalembert M, Voskaridou E, Oevermann L, Cannas G, Habibi A, Loko G, Joseph L, Colombatti R, Bartolucci P, Brousse V, Galactéros F; All ESCORT HU Investigators. Real-Life experience with hydroxyurea in patients with sickle cell disease: Results from the prospective ESCORT-HU cohort study. Am J Hematol. 2021 Oct 1;96(10):1223-1231. doi: 10.1002/ajh.26286. Epub 2021 Jul 23.

lead_sponsor: ADDMEDICA SASA

location_country:
Greece
Italy
Guadeloupe
Martinique
France
French Guiana
Germany

location_facility: Azienda Ospedaliera-University of Padova

location_facility: Centre Hospitalier Intercommunal André Grégoire

location_facility: Hôpital Louis Mourier; service de pédiatrie

location_facility: Hôpital Necker; maladies infectieuses et tropicales

location_facility: Centre Hospitalier Robert Ballanger, pédiatrie et néonatalogie

location_facility: Hôpital Robert Debré, immunologie-hématologie pédiatrique

location_facility: Centre Hospitalier Delafontaine, médecine interne

location_facility: Institut Universitaire du cancer; médecine interne

location_facility: Institut d'Hématologie et d'Oncologie Pédiatrique

location_facility: Hôpital de la Conception, médecine interne

location_facility: Centre Hospitalier de Gonesse, pédiatrie

location_facility: Centre hospitalier intercommunal de Créteil

location_facility: Azienda Ospedaliera Universitaria Integrata (AOUI Verona)

location_facility: Centre Hospitalier de Gonesse, médecine interne

location_facility: Hôpital Necker enfants, maladies infectieuses et tropicales

location_facility: Hôpital Henri Mondor, centre de la Drépanocytose

location_facility: Centre Hospitalier Delafontaine, pédiatrie


title: Analysis of the Most Common Major Intraoperative Complications During Video-assisted Thoracoscopic Surgery (VATS) Anatomical Resections - On Behalf of MITIG-ESTS

summary: This study investigates the most common major complications that result in unplanned additional surgery in patients undergoing vats anatomical resections. Several high-volume European centres participate. The purpose is to quantify these major complications, discuss the steps that can be taken to prevent these events, how they can be dealt with, be it by vats or conversion

lead_sponsor: University Hospital, Gasthuisberg

location_country: Denmark Poland Spain Italy Austria Netherlands Switzerland France Germany

location_facility: Karol Marcinkowski University of Med Sciences, Department of Thoracic Surgery

location_facility: Division of Thoracic Surgery, Ospedali Riuniti Ancona

location_facility: Department of Visceral, Transplant and Thoracic Surgery, Innsbruck University Hospital

location_facility: Department of Cardiothoracic Surgery, Rigshospitalet

location_facility: Thoracic Department, Institut Mutualiste Montsouris


title: adaptatiVe Endovascular Strategy to the CloT MRI in Large Intracranial Vessel Occlusion

acronym: VECTOR

summary:
In the VECTOR trial, the aim is to analyze, in case of SVS+ occlusions, a first line Embotrap II added to CA combined strategy compare to CA alone strategy.

Many practitioners are convinced that a first line strategy with CA alone is easy, safe, rapid and efficient. Maybe, after two, three, four ... passes and with the secondary help of a combined strategy, a high rate of eTICI 2b/3 could be reached with a CA first line strategy. But this could go with a higher number of passes, a waste of time and a suboptimal angiographic results (eTICI 2b) due to distal emboli, especially in case of friable, non-well organized, red blood cell rich (RBC) i.e. SVS + thrombi (25-28). This could, be related to worst clinical outcome at 3 months. VECTOR asks a relevant question: Do the invetigators have to add the use of an Embotrap II or III to the CA, from the first passes, in case of SVS+ clots?

lead_sponsor: Nantes University Hospital

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Contribution of a Semantic Therapy on a Tactile Tablet in the Alzheimer's Disease, Early and Late Onset

acronym: SemantiMATT

summary:
Lexical semantic disorders are described in Alzheimer's disease, and their incidence in everyday life is important to the extent that these disorders affect expression and comprehension.

Providing a tactile tablet stimulation, independent and complementary to speech therapy, could help to maintain certain abilities and reinforce the feeling of autonomy of the patients.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Pitié-Salpêtriere
APHP - Pitié-Salpêtrière Hospital


title: A Randomized, Multicenter, Phase III Trial Comparing Induction CT With Docetaxel, Cisplatin and 5-FU (TPF) Followed by Concurrent CT-RT to Concurrent CT Alone, in Nasopharyngeal Cancers Staged as T2b, T3, T4 and/or With Lymph Node Involvement (>N1)

summary: This is a randomized, multicenter, phase III trial comparing induction chemotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy to concurrent chemoradiotherapy alone, in nasopharyngeal cancers staged as T2b, T3, T4 and/or with lymph node involvement (≥ N1. The main end point is the event free survival.

ReferenceCitation: Tao Y, Aupérin A, Graff P, Lapeyre M, Grégoire V, Maingon P, Geoffrois L, Verrelle P, Calais G, Gery B, Martin L, Alfonsi M, Deprez P, Bardet E, Pignon T, Rives M, Sire C, Bourhis J. Very accelerated radiotherapy or concurrent chemoradiotherapy for N3 head and neck squamous cell carcinoma: Pooled analysis of two GORTEC randomized trials. Oral Oncol. 2017 Aug;71:61-66. doi: 10.1016/j.oraloncology.2017.06.002. Epub 2017 Jun 9.

ReferenceCitation: Bourhis J, Sire C, Graff P, Grégoire V, Maingon P, Calais G, Gery B, Martin L, Alfonsi M, Desprez P, Pignon T, Bardet E, Rives M, Geoffrois L, Daly-Schveitzer N, Sen S, Tuchais C, Dupuis O, Guerif S, Lapeyre M, Favrel V, Hamoir M, Lusinchi A, Temam S, Pinna A, Tao YG, Blanchard P, Aupérin A. Concomitant chemoradiotherapy versus acceleration of radiotherapy with or without concomitant chemotherapy in locally advanced head and neck carcinoma (GORTEC 99-02): an open-label phase 3 randomised trial. Lancet Oncol. 2012 Feb;13(2):145-53. doi: 10.1016/S1470-2045(11)70346-1. Epub 2012 Jan 18.

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_country: Morocco France Tunisia Romania

location_facility:
Hôpital Habib Bourguiba
University of Casablanca
University of Cluj
Hôpital de la Pitié-Salpétrière
Institut Gustave Roussy


title: Molecular Signature From Tumor to Lymph Nodes: How to Identify the Right Candidate for IIIA-N2 Lung Cancer Surgery?

summary:
Mediastinal lymph node (LN) involvement (N2) in non-small cell lung cancer (NSCLC) concerns 15% of resectable tumors and is associated with a poor prognosis and an overall survival reaching 9 to 49%. Literature fails to provide any definitive consensus regarding the management of these patients, except for the platinum-based doublet chemotherapy. The N2 involvement remains a matter of debate because of its not yet well-classified heterogeneity. Regarding anatomy, the Mountain and Dresler's regional LN classification for lung cancer staging remains the reference. Different studies classified IIIA-N2 disease into 4 groups, in addition to the skip-N2 phenomenon: minimal-N2, N2 single station, N2 multiple stations, and bulky-N2. Other subgroups were recently proposed for the 8th edition of the TNM: N2a1 - single station skip, N2a2 - single station non-skip, N2b - multiple stations.

The French National Cancer Institute (INCa) proposed guidelines, but in case of cN2 staging without mediastinal infiltration, guidelines remained imprecise ("resectability should be discussed for each case") and suggested surgery first, or induction chemotherapy, or concomitant chemoradiation.

Thus, optimal management of cIIIA-N2 remains controversial but complete tumor resection can be related to long-term survival in some patients, including 10 years after surgery [1]. In this situation, the identification of markers that will help select IIIA-N2 patients who will benefit from surgical resection is mandatory.

ReferenceCitation: Altman DG, McShane LM, Sauerbrei W, Taube SE. Reporting recommendations for tumor marker prognostic studies (REMARK): explanation and elaboration. BMC Med. 2012 May 29;10:51. doi: 10.1186/1741-7015-10-51.

ReferenceCitation: Legras A, Mordant P, Arame A, Foucault C, Dujon A, Le Pimpec Barthes F, Riquet M. Long-term survival of patients with pN2 lung cancer according to the pattern of lymphatic spread. Ann Thorac Surg. 2014 Apr;97(4):1156-62. doi: 10.1016/j.athoracsur.2013.12.047. Epub 2014 Feb 26.

ReferenceCitation: Lin IF, Chang WP, Liao YN. Shrinkage methods enhanced the accuracy of parameter estimation using Cox models with small number of events. J Clin Epidemiol. 2013 Jul;66(7):743-51. doi: 10.1016/j.jclinepi.2013.02.002. Epub 2013 Apr 6.

ReferenceCitation: Pécuchet N, Rozenholc Y, Zonta E, Pietrasz D, Didelot A, Combe P, Gibault L, Bachet JB, Taly V, Fabre E, Blons H, Laurent-Puig P. Analysis of Base-Position Error Rate of Next-Generation Sequencing to Detect Tumor Mutations in Circulating DNA. Clin Chem. 2016 Nov;62(11):1492-1503. Epub 2016 Sep 13.

ReferenceCitation: Peduzzi P, Concato J, Feinstein AR, Holford TR. Importance of events per independent variable in proportional hazards regression analysis. II. Accuracy and precision of regression estimates. J Clin Epidemiol. 1995 Dec;48(12):1503-10.

ReferenceCitation: Tapak L, Saidijam M, Sadeghifar M, Poorolajal J, Mahjub H. Competing risks data analysis with high-dimensional covariates: an application in bladder cancer. Genomics Proteomics Bioinformatics. 2015 Jun;13(3):169-76. doi: 10.1016/j.gpb.2015.04.001. Epub 2015 Apr 20.

ReferenceCitation: Um SW, Joung JG, Lee H, Kim H, Kim KT, Park J, Hayes DN, Park WY. Molecular Evolution Patterns in Metastatic Lymph Nodes Reflect the Differential Treatment Response of Advanced Primary Lung Cancer. Cancer Res. 2016 Nov 15;76(22):6568-6576. doi: 10.1158/0008-5472.CAN-16-0873. Epub 2016 Sep 13.

ReferenceCitation: Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007 Mar 15;165(6):710-8. Epub 2006 Dec 20.

ipd_sharing: Yes

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.

location_facility: Hôpital du Haut-Lévêque, CHU de Bordeaux


title: Can we Define a Clinical Score for Predicting of Hypofibrinogenemia in Severe Trauma

summary: In this retrospective and prospective study, the aim is to determine a score for predicting a fibrinogen <1.5g/L (corresponding to European threshold of Directors recommendations of fibrinogen concentrates)

lead_sponsor: Hospices Civils de Lyon

location_facility:
CHLS, Hospices Civils de Lyon
HEH - Hospices Civils de Lyon


title: Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents

acronym: STELLASUPERA

summary:
Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal lesions. This technique tends to extend to lesions for which the gold standard remains until now the open surgery treatment (lesions TASC C and D).

The primary objective of the study was to evaluate the clinical efficacy at 12 months of the SuperA stent (Abbott) in the treatment of long de novo atherosclerotic lesions TASC C and D in patients with symptomatic peripheral arterial disease. The secondary objectives are to evaluate the clinical effectiveness of the SuperA stent at 24 months, according to clinical, morphological and haemodynamic criteria, the possible influence of calcifications and the quality of life of patients.

The SuperA stent treatment is not specifically provided for by the Protocol but is carried out within the framework of the care. This study is an observationnal study.

location_facility:
Nantes CHU
CHD Vendée