title: Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus (Relais Oral Dans le Traitement Des Endocardites à Streptocoques Multi-sensibles)

summary:
Infective endocarditis (IE) is a serious infection with a significant burden for patients and hospitals (in France, median length of hospital stay = 43 days), partly due to the long duration of intravenous (IV) antibacterial treatment recommended by international guidelines, between 4 and 6 weeks in most situations.

A recent survey of practices regarding the management of IE in France showed that a switch from IV to oral antibiotics is feasible, when patients with left-sided Streptococcus-Enterococcus IE are stable after an initial course of IV antibiotic treatment, with or without valvular surgery.

These practices have not been associated with unfavourable outcome, while significantly reducing the duration and cost of hospitalization, the risk of nosocomial infection, and patients' discomfort.

There has been no randomized controlled trial (RCT) in the field of IE over the last 20 years; current guidelines are mostly based on expert advice, in vitro studies, animal experiments, or clinical studies performed before the 90's.

The RODEO 2 project is an unprecedented opportunity to bring back evidence-based medicine in the field of IE.

Most experts acknowledge that the pharmacological PK/PD characteristics of antibiotics such as amoxicillin allow a high level of efficacy in the treatment of IE when orally administrated after an IV period of induction.

It's needed to conduct RCTs that clearly demonstrate the clinical non-inferiority of this strategy for streptococci, and enterococci IE with a benefit regarding costs.

The RODEO 2 project corresponds to one pragmatic trial assessing the impact of a switch strategy, making it a comparative effectiveness trial that should be able to feed the next revision of IE international guidelines and to change practices in IE management.

ReferenceCitation: Lemaignen A, Bernard L, Tattevin P, Bru JP, Duval X, Hoen B, Brunet-Houdard S, Mainardi JL, Caille A; RODEO (Relais Oral Dans le traitement des Endocardites à staphylocoques ou streptOcoques) and AEPEI (Association pour l'Etude et la Prévention de l'Endocardite Infectieuse) study groups. Oral switch versus standard intravenous antibiotic therapy in left-sided endocarditis due to susceptible staphylococci, streptococci or enterococci (RODEO): a protocol for two open-label randomised controlled trials. BMJ Open. 2020 Jul 14;10(7):e033540. doi: 10.1136/bmjopen-2019-033540.

ipd_sharing_description:
There are no plans to grant public access to the full protocol, participant-level data or statistical code. Data from the RODEO trials is stored by the promotor of the trial. Data and the personal identifiers are stored separately and a special permit is required for access to the data. Data can be available on request for academic researchers when it have been analysed and published. Qualified researchers can ask for data sharing by the first author LB after the study finalization.

Open Access This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work noncommercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http:// creativecommons.org/licenses/by-nc/4.0/

lead_sponsor: University Hospital, Tours

location_facility: Service de court séjour gériatrique - EMG, Centre hospitalier d'Alès

location_facility: Service des maladies infectieuses, Centre Hospitalier du Pays d'Aix

location_facility: Département d'infectiologie, Complexe Bocage, Hôpital d'enfants, CHU de Dijon

location_facility: APHP BICETRE - Service des maladies infectieuses et tropicales

location_facility: Service de Maladies Infectieuses et tropicales, Hôpital Dupuytren, CHU de Limoges

location_facility: CHU St Etienne - Service des maladies infectieuses et tropicales

location_facility: Service des Maladies infectieuses et Tropicales, Hôpital Jean Minjoz, CHU de Besançon

location_facility: Service de Microbiologie, Hôpital Européen Georges Pompidou, APHP

location_facility: Service de Maladies infectieuses et tropicales, et pathologie VIH, Hôpital A Mignot, CH de Versailles

location_facility: Service de médecine interne, Hôpital Ambroise Paré, APHP

location_facility: Service des Maladie infectieuses et tropicales, Hôpital d'instruction des armées Bégin

location_facility: APHP Henri-Mondor - Service des maladies infectieuses et tropicales

location_facility: Service des Maladies Infectieuses et Tropicales, Hôpital Carémeau, CHU de Nîmes

location_facility: Infectiologie, médecine interne et médecine des voyages, CH d'Annecy

location_facility: Service de médecine post-urgence, infectiologie, Site de la Roche sur Yon, CHD Vendée

location_facility: Service de maladies infectieuses, parasitaires et tropicales, Hôpital Bichat, APHP

location_facility: CHU Toulouse (Rangueil) Service de Cardiologie

location_facility: Service de médecine aigue spécifique, Hôpital Raymond Poincaré, APHP

location_facility: Service des maladies infectieuses et tropicales, Hôpital G. Montpied, CHU de Clermont-Ferrand

location_facility: Service de Médecine interne, maladies infectieuses, immunologie clinique, Hôpital R. Debré, CHU de Reims

location_facility: Service de Réanimation médicale, Hôpital St André, CHU de Bordeaux

location_facility: Service de Médecine interne et maladies infectieuses, Hôpital Bretonneau, CHU de Tours

location_facility: Service des Maladies infectieuses et tropicales, CH Le Mans

location_facility: Service des Maladies infectieuses et tropicales, CH de Perpignan

location_facility: Service de Pathologies infectieuses et tropicales, Hôpital Nord, CHU d'Amiens

location_facility: Service des Maladies infectieuses, CH de Niort

location_facility: Service des Maladies infectieuses et tropicales, Hôpital de Purpan, CHU de Toulouse

location_facility: Unité médicale d'infectiologie, Hôpital Huriez, CHU de Lille

location_facility: Service de Maladies infectieuses et tropicales, Hôpitaux de Brabois, CHU de Nancy

location_facility: Consultation de Médecine Interne, maladies infectieuses et tropicales, CH intercommunal de Villeneuve St Georges

location_facility: Service Maladies Infectieuses et tropicales, Hôpital Côte de Nacre, CHU de Caen

location_facility: Service de Maladies infectieuses, Hôpital Gui de CHauliac, CHU de Montpellier

location_facility: Service de Maladies infectieuses et tropicales, Hôpital Hôtel Dieu, CHU Nantes

location_facility: Service de Médecine infectieuse, Hôpital Nord Michallon, CHU de Grenoble

location_facility: Service de Maladies infectieuses et tropicales médecine interne, CH Métropole Savoie

location_facility: Service de Maladies infectieuses et tropicales, Hôpital de la Source, CHR Orléans

location_facility: Institut Mutualiste Montsouris - Service de médecine interne

location_facility: Service de Médecine interne, maladies infectieuses et tropicales, CHU de Poitiers

location_facility: Service de maladies infectieuses et tropicales, Hôpital Necker, APHP

location_facility: CHU ANGERS - Service des maladies infectieuses et tropicales

location_facility: Service de Cardiologie, Hôpitall Louis Pradel, Hôpitaux Est, Hospices Civils de Lyon

location_facility: Service de Médecine interne polyvalente et neurologique CH de Douai

location_facility: CH PAU - Service de Médecine interne et Maladies infectieuses

location_facility: Service de Maladies infectieuses, Hôpital de la Cavale Blanche, CHU Brest

location_facility: Service des maladies infectieuses et réanimation médicale, Hôpital Pontchaillou, CHU de Rennes

location_facility: Service Universitaire des Maladies Infectieuses et du voyageur, CH de Tourcoing

location_facility: Service des Maladies infectieuses et tropicales, Hôpital Charles Nicolle, CHU de Rouen

location_facility: Service de maladies infectieuses et tropicales, Hôpital Avicenne, APHP

location_facility: Service des maladies respiratoires et infectieuses, CH de St Malo

location_facility: Service d'Infectiologie, Hôpital de l'Archet, CHU de Nice


title: Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Staphylococcus (Relais Oral Dans le Traitement Des Endocardites à Staphylocoques Multi-sensibles)

summary:
Infective endocarditis (IE) is a serious infection with a significant burden for patients and hospitals (in France, median length of hospital stay = 43 days), partly due to the long duration of intravenous (IV) antibacterial treatment recommended by international guidelines, between 4 and 6 weeks in most situations.

A recent survey of practices regarding the management of IE in France showed that a switch from IV to oral antibiotics is feasible, when patients with left-sided Staphylococcus IE are stable after an initial course of IV antibiotic treatment, with or without valvular surgery.

These practices have not been associated with unfavourable outcome, while significantly reducing the duration and cost of hospitalization, the risk of nosocomial infection, and patients' discomfort.

There has been no randomized controlled trial (RCT) in the field of IE over the last 20 years; current guidelines are mostly based on expert advice, in vitro studies, animal experiments, or clinical studies performed before the 90's.

The RODEO 1 project is an unprecedented opportunity to bring back evidence-based medicine in the field of IE.

Most experts acknowledge that the pharmacological PK/PD characteristics of antibiotics such as fluoroquinolones and rifampicin allow a high level of efficacy in the treatment of IE when orally administrated after an IV period of induction.

It's needed to conduct RCTs that clearly demonstrate the clinical non-inferiority of this strategy for multisusceptible staphylococci with a benefit regarding costs.

The RODEO 1 project corresponds to one pragmatic trial assessing the impact of a switch strategy, making it a comparative effectiveness trial that should be able to feed the next revision of IE international guidelines and to change practices in IE management.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ipd_sharing: Yes

location_facility: Service de court séjour gériatrique - EMG, Centre hospitalier d'Alès

location_facility: Département d'infectiologie, Complexe Bocage, Hôpital d'enfants, CHU de Dijon

location_facility: APHP BICETRE - Service des maladies infectieuses et tropicales

location_facility: Service de Maladies Infectieuses et tropicales, Hôpital Dupuytren, CHU de Limoges

location_facility: CHU St Etienne - Service des maladies infectieuses et tropicales

location_facility: Service des Maladies infectieuses et Tropicales, Hôpital Jean Minjoz, CHU de Besançon

location_facility: Service de Maladies infectieuses, Hôpital de la Cavale Blanche

location_facility: Service de Microbiologie, Hôpital Européen Georges Pompidou, APHP

location_facility: Service des Maladie infectieuses et tropicales, Hôpital d'instruction des armées Bégin

location_facility: Service de Médecine interne, Hôpital Ambroise Paré, APHP

location_facility: APHP Henri-Mondor - Service des maladies infectieuses et tropicales

location_facility: Service des Maladies Infectieuses et Tropicales, Hôpital Carémeau, CHU de Nîmes

location_facility: Service de Maladies infectieuses, parasitaires et tropicales, Hôpital Bichat, APHP

location_facility: Service de Maladies infectieuses et tropicales, Hôpital Necker, APHP

location_facility: CHU Toulouse (Rangueil) Service de Cardiologie

location_facility: Service des maladies infectieuses et tropicales, Hôpital G. Montpied, CHU de Clermont-Ferrand

location_facility: Service de Médecine aigue spécifique, Hôpital Raymond Poincaré, APHP

location_facility: Service de Maladies infectieuses et tropicales, médecine interne, CH de Chambéry

location_facility: Service de Médecine interne, maladies infectieuses, immunologie clinique, Hôpital R. Debré, CHU de Reims

location_facility: Service de Réanimation médicale, Hôpital St André, CHU de Bordeaux

location_facility: Service de Maladies infectieuses et tropicales, et pathologie VIH

location_facility: Service de Médecine interne et maladies infectieuses, Hôpital Bretonneau, CHU de Tours

location_facility: Service des Maladies infectieuses et tropicales, CH Le Mans

location_facility: Service des Maladies infectieuses et tropicales, CH de Perpignan

location_facility: Service de Pathologies infectieuses et tropicales, Hôpital Nord, CHU d'Amiens

location_facility: Service des Maladies infectieuses, CH de Niort

location_facility: Service des Maladies infectieuses et tropicales, Hôpital de Purpan, CHU de Toulouse

location_facility: Unité médicale d'infectiologie, Hôpital Huriez, CHU de Lille

location_facility: Service de Maladies infectieuses et tropicales, Hôpitaux de Brabois, CHU de Nancy

location_facility: Consultation de Médecine Interne, maladies infectieuses et tropicales, CH intercommunal de Villeneuve St Georges

location_facility: Service Maladies Infectieuses et tropicales, Hôpital Côte de Nacre, CHU de Caen

location_facility: Service de Médecine post-urgence, infectiologie, Site de la Roche sur Yon, CHD Vendée

location_facility: Service de Maladies infectieuses, Hôpital Gui de CHauliac, CHU de Montpellier

location_facility: Service de Maladies infectieuses et tropicales, Hôpital Avicenne, APHP

location_facility: Service de Maladies infectieuses et tropicales, Hôpital Hôtel Dieu, CHU Nantes

location_facility: Service de Médecine infectieuse, Hôpital Nord Michallon, CHU de Grenoble

location_facility: Service des Maladies infectieuses, Centre Hospitalier du Pays d'Aix

location_facility: Infectiologie, médecine interne et médecine des voyages, CH d'Annecy

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


title: Zephyr Etude Post-Inscription (French Registry)

summary: The objective of this Registry is to provide ongoing safety and effectiveness assessment of the Zephyr Valve treatment of adult patients with Chronic Obstructive Pulmonary Disease (COPD) Grade III and Grade IV in order to support the renewal of the inscription of the Zephyr Valve on the list LPPR (Art 165-1) in France.

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Criner GJ, Sue R, Wright S, Dransfield M, Rivas-Perez H, Wiese T, Sciurba FC, Shah PL, Wahidi MM, de Oliveira HG, Morrissey B, Cardoso PFG, Hays S, Majid A, Pastis N Jr, Kopas L, Vollenweider M, McFadden PM, Machuzak M, Hsia DW, Sung A, Jarad N, Kornaszewska M, Hazelrigg S, Krishna G, Armstrong B, Shargill NS, Slebos DJ; LIBERATE Study Group. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE). Am J Respir Crit Care Med. 2018 Nov 1;198(9):1151-1164. doi: 10.1164/rccm.201803-0590OC.

ReferenceCitation: Kemp SV, Slebos DJ, Kirk A, Kornaszewska M, Carron K, Ek L, Broman G, Hillerdal G, Mal H, Pison C, Briault A, Downer N, Darwiche K, Rao J, Hübner RH, Ruwwe-Glosenkamp C, Trosini-Desert V, Eberhardt R, Herth FJ, Derom E, Malfait T, Shah PL, Garner JL, Ten Hacken NH, Fallouh H, Leroy S, Marquette CH; TRANSFORM Study Team *. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM). Am J Respir Crit Care Med. 2017 Dec 15;196(12):1535-1543. doi: 10.1164/rccm.201707-1327OC.

ReferenceCitation: Valipour A, Slebos DJ, Herth F, Darwiche K, Wagner M, Ficker JH, Petermann C, Hubner RH, Stanzel F, Eberhardt R; IMPACT Study Team. Endobronchial Valve Therapy in Patients with Homogeneous Emphysema. Results from the IMPACT Study. Am J Respir Crit Care Med. 2016 Nov 1;194(9):1073-1082.

ReferenceCitation: Klooster K, ten Hacken NH, Hartman JE, Kerstjens HA, van Rikxoort EM, Slebos DJ. Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation. N Engl J Med. 2015 Dec 10;373(24):2325-35. doi: 10.1056/NEJMoa1507807.

ReferenceCitation: Klooster K, Hartman JE, Ten Hacken NH, Slebos DJ. One-Year Follow-Up after Endobronchial Valve Treatment in Patients with Emphysema without Collateral Ventilation Treated in the STELVIO Trial. Respiration. 2017;93(2):112-121. doi: 10.1159/000453529. Epub 2016 Dec 15.

ipd_sharing: Undecided

lead_sponsor: Pulmonx Corporation

location_facility:
Hôpital La Cavale Blanche
Hôpital Calmette
Hôpital Charles Nicolle
Hôpital Nord
Hôpital Arnaud de Villeneuve
Hôpital Cochin
Nouvel Hôpital Civil
Hôpital Larrey
Hôpital François Mitterrand
Hôpital Bichat
Hôpital Dupuytren

intervention_type: Device

lead_sponsor_type: industriel


title: HEMOTOL: Effects of New Dialysis On-line Monitoring Devices on Hemodynamic Stability During Intermittent Hemodialysis in Critically Ill Patients With Acute Kidney Injury : a Prospective Randomized Study.

acronym: HEMOTOL

summary: The purpose of this randomized controlled study is to compare the effects of different new dialysis on-line monitoring devices on hemodynamic stability during intermittent hemodialysis in critically ill patients with acute kidney injury.

status: Completed

study_completion_date_type: Actual

ReferenceCitation: du Cheyron D, Terzi N, Seguin A, Valette X, Prevost F, Ramakers M, Daubin C, Charbonneau P, Parienti JJ. Use of online blood volume and blood temperature monitoring during haemodialysis in critically ill patients with acute kidney injury: a single-centre randomized controlled trial. Nephrol Dial Transplant. 2013 Feb;28(2):430-7. doi: 10.1093/ndt/gfs124. Epub 2012 Apr 25.

lead_sponsor: University Hospital, Caen

location_facility: Service de Réanimation Médicale - CHU de Caen

status_simplified: Completed


title: Evaluation of a New Customized Removable Device With Rocker Sole for Plantar Off-Loading "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients

acronym: ORTHODIAB

summary:
Multi-center trial, randomized in 2 parallel groups, open label, with a blinded adjudication committee (PROBE methodology), comparing "Orthèse Diabète" with "conventional" removable devices in terms of healing of ulcers.

- Primary objective: Evaluate the efficiency of "Orthèse Diabète" compared to "conventional" removable devices, in terms of the proportion of diabetic patients whose principal ulcer will heal completely at 3 months.

enrollment_type: Actual

ReferenceCitation: Malgrange D. [Physiopathology of the diabetic foot]. Rev Med Interne. 2008 Sep;29 Suppl 2:S231-7. doi: 10.1016/S0248-8663(08)73950-X. Review. French.

ReferenceCitation: Cavanagh PR, Lipsky BA, Bradbury AW, Botek G. Treatment for diabetic foot ulcers. Lancet. 2005 Nov 12;366(9498):1725-35. Review.

ReferenceCitation: Ramsey SD, Newton K, Blough D, McCulloch DK, Sandhu N, Reiber GE, Wagner EH. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999 Mar;22(3):382-7.

ReferenceCitation: Muller IS, de Grauw WJ, van Gerwen WH, Bartelink ML, van Den Hoogen HJ, Rutten GE. Foot ulceration and lower limb amputation in type 2 diabetic patients in dutch primary health care. Diabetes Care. 2002 Mar;25(3):570-4.

ReferenceCitation: Detournay B, Cros S, Charbonnel B, Grimaldi A, Liard F, Cogneau J, Fagnani F, Eschwège E. Managing type 2 diabetes in France: the ECODIA survey. Diabetes Metab. 2000 Nov;26(5):363-9.

ReferenceCitation: Detournay B, Raccah D, Cadilhac M, Eschwège E. Epidemiology and costs of diabetes treated with insulin in France. Diabetes Metab. 2005 Jun;31(3 Pt 2):3-18.

ReferenceCitation: Malgrange D, Richard JL, Leymarie F; French Working Group On The Diabetic Foot. Screening diabetic patients at risk for foot ulceration. A multi-centre hospital-based study in France. Diabetes Metab. 2003 Jun;29(3):261-8.

ReferenceCitation: Apelqvist J, Larsson J, Agardh CD. Long-term prognosis for diabetic patients with foot ulcers. J Intern Med. 1993 Jun;233(6):485-91.

ReferenceCitation: Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet. 2005 Nov 12;366(9498):1719-24. Review.

ReferenceCitation: Moxey PW, Hofman D, Hinchliffe RJ, Jones K, Thompson MM, Holt PJ. Epidemiological study of lower limb amputation in England between 2003 and 2008. Br J Surg. 2010 Sep;97(9):1348-53. doi: 10.1002/bjs.7092.

ReferenceCitation: Resnick HE, Carter EA, Sosenko JM, Henly SJ, Fabsitz RR, Ness FK, Welty TK, Lee ET, Howard BV; Strong Heart Study. Incidence of lower-extremity amputation in American Indians: the Strong Heart Study. Diabetes Care. 2004 Aug;27(8):1885-91.

ReferenceCitation: Fosse S, Hartemann-Heurtier A, Jacqueminet S, Ha Van G, Grimaldi A, Fagot-Campagna A. Incidence and characteristics of lower limb amputations in people with diabetes. Diabet Med. 2009 Apr;26(4):391-6. doi: 10.1111/j.1464-5491.2009.02698.x.

ReferenceCitation: Potier L, François M, Dardari D, Feron M, Belhatem N, Nobecourt-Dupuy E, Dolz M, Bordier L, Ducloux R, Chibani A, Eveno DF, Crea Avila T, Sultan A, Baillet-Blanco L, Rigalleau V, Gand E, Saulnier PJ, Velho G, Roussel R, Pellenc Q, Dupré JC, Malgrange D, Marre M, Mohammedi K; ORTHODIAB study group. Comparison of a new versus standard removable offloading device in patients with neuropathic diabetic foot ulcers: a French national, multicentre, open-label randomized, controlled trial. BMJ Open Diabetes Res Care. 2020 May;8(1). pii: e000954. doi: 10.1136/bmjdrc-2019-000954.

ReferenceCitation: Mohammedi K, Potier L, François M, Dardari D, Feron M, Nobecourt-Dupuy E, Dolz M, Ducloux R, Chibani A, Eveno DF, Crea Avila T, Sultan A, Baillet-Blanco L, Rigalleau V, Velho G, Tubach F, Roussel R, Dupré JC, Malgrange D, Marre M. The evaluation of off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) randomized controlled trial: study design and rational. J Foot Ankle Res. 2016 Aug 22;9(1):34. doi: 10.1186/s13047-016-0163-4. eCollection 2016.

lead_sponsor: Proteor Group


title: Epidemiology and Clinical Characteristics of Non-Tuberculous Mycobacteria Infections in Cystic Fibrosis Patients.

acronym: CIMENT

summary:
An increase in the prevalence of infections due to non-tuberculous mycobacteria (NTM) is observed in many countries and recent data suggest the circulation of dominant clones with a possibility of human-to-human contamination. The hypothesis is made that these infections are also increasing in France and that dominant NTM clones are circulating. The last French study carried out in 2004 already showed prevalences of up to 10% in certain French regions. It is essential to know the prevalence 8 years later, taking advantage of the new recommendations for the management of patients and samples, which will homogenize practices on French territory.

No data are currently available in France on the prevalence of positive serological responses in cystic fibrosis patients. Serological analyzes of the sera collected during this study will enable us to evaluate the performance of serology in mycobacterial culture and to identify patients with no positive respiratory specimen in culture but with positive serology indicating potential contact with a mycobacterium. The establishment of a serological follow-up of these patients will allow to correlate this result with a clinical evolution and / or the detection of NTM in subsequent samples. Serology is an innovative aspect of the CIMENT study.

study_start_date_type: Anticipated

status: Unknown status

ReferenceCitation: Qvist T, Gilljam M, Jönsson B, Taylor-Robinson D, Jensen-Fangel S, Wang M, Svahn A, Kötz K, Hansson L, Hollsing A, Hansen CR, Finstad PL, Pressler T, Høiby N, Katzenstein TL; Scandinavian Cystic Fibrosis Study Consortium (SCFSC). Epidemiology of nontuberculous mycobacteria among patients with cystic fibrosis in Scandinavia. J Cyst Fibros. 2015 Jan;14(1):46-52. doi: 10.1016/j.jcf.2014.08.002. Epub 2014 Aug 30.

ReferenceCitation: Albrecht C, Ringshausen F, Ott S, Wagner D, Rademacher J, Schneider M, Welte T, Pletz MW. Should all adult cystic fibrosis patients with repeated nontuberculous mycobacteria cultures receive specific treatment? A 10-year case-control study. Eur Respir J. 2016 May;47(5):1575-7. doi: 10.1183/13993003.01239-2015. Epub 2016 Feb 4.

ReferenceCitation: Griffith DE, Aksamit T, Brown-Elliott BA, Catanzaro A, Daley C, Gordin F, Holland SM, Horsburgh R, Huitt G, Iademarco MF, Iseman M, Olivier K, Ruoss S, von Reyn CF, Wallace RJ Jr, Winthrop K; ATS Mycobacterial Diseases Subcommittee; American Thoracic Society; Infectious Disease Society of America. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007 Feb 15;175(4):367-416. Review. Erratum in: Am J Respir Crit Care Med. 2007 Apr 1;175(7):744-5. Dosage error in article text.

ReferenceCitation: Martiniano SL, Sontag MK, Daley CL, Nick JA, Sagel SD. Clinical significance of a first positive nontuberculous mycobacteria culture in cystic fibrosis. Ann Am Thorac Soc. 2014 Jan;11(1):36-44. doi: 10.1513/AnnalsATS.201309-310OC.

ReferenceCitation: Floto RA, Olivier KN, Saiman L, Daley CL, Herrmann JL, Nick JA, Noone PG, Bilton D, Corris P, Gibson RL, Hempstead SE, Koetz K, Sabadosa KA, Sermet-Gaudelus I, Smyth AR, van Ingen J, Wallace RJ, Winthrop KL, Marshall BC, Haworth CS. US Cystic Fibrosis Foundation and European Cystic Fibrosis Society consensus recommendations for the management of non-tuberculous mycobacteria in individuals with cystic fibrosis: executive summary. Thorax. 2016 Jan;71(1):88-90. doi: 10.1136/thoraxjnl-2015-207983.

ReferenceCitation: Jeong BH, Kim SY, Jeon K, Lee SY, Shin SJ, Koh WJ. Serodiagnosis of Mycobacterium avium complex and Mycobacterium abscessus complex pulmonary disease by use of IgA antibodies to glycopeptidolipid core antigen. J Clin Microbiol. 2013 Aug;51(8):2747-9. doi: 10.1128/JCM.00702-13. Epub 2013 Jun 5.

ReferenceCitation: Qvist T, Taylor-Robinson D, Waldmann E, Olesen HV, Hansen CR, Mathiesen IH, Høiby N, Katzenstein TL, Smyth RL, Diggle PJ, Pressler T. Comparing the harmful effects of nontuberculous mycobacteria and Gram negative bacteria on lung function in patients with cystic fibrosis. J Cyst Fibros. 2016 May;15(3):380-5. doi: 10.1016/j.jcf.2015.09.007. Epub 2015 Oct 9.

ReferenceCitation: Qvist T, Pressler T, Taylor-Robinson D, Katzenstein TL, Høiby N. Serodiagnosis of Mycobacterium abscessus complex infection in cystic fibrosis. Eur Respir J. 2015 Sep;46(3):707-16. doi: 10.1183/09031936.00011815. Epub 2015 Apr 30.

lead_sponsor: University Hospital, Brest

location_facility:
CHU Tours
CHR Sud Réunion
CHIC Créteil
CHU Lille
CHU Bordeaux
CHU Rouen
CHU Toulouse
CHU Grenoble
Centre de Perharidy
CHU Côte de Nacre
CHRU Brest
AP-HP Hôpital Cochin
AP-HP Hôpital Foch
CHU Amiens

intervention_type: Other

status_simplified: Unknown


title: Self-help Program for Hypnotics Withdrawal in Chronic Insomniac Patients: A Randomized Controlled Clinical Trial

acronym: PROPERSOM

summary:
Persistent insomnia has a high prevalence in French general population affecting between 15.8 % and 19 % of adults. In France, the disease is mainly managed by general practitioners (GP) who usually proposed intermediate half-life benzodiazepines and Z-drugs in first-line treatment. French Health authorities recommend restricting the consumption of both hypnotics to no more than 4 weeks, considering their potential adverse effects (memory impairment, altered sleep physiology, motor-vehicle crash), and the risk of tolerance and dependence. However, it appears that a majority of patients become chronic users. Therefore, discontinuation of benzodiazepines/Z-drugs is recommended, but it may appear as a challenge due to withdrawal symptoms and psychological factors (anticipatory anxiety, fear of rebound insomnia).

Numerous studies have shown that programs based on Cognitive-Behavioural Therapy (CBT) principles improve sleep and daily life quality leading to hypnotic taper and maintain of hypnotic abstinence in insomniac patients. Cognitive-Behavioural Therapy (CBT) is based on 4 components: sleep restriction, stimulus control, cognitive therapy and sleep hygiene education. This therapy is dependent on a therapeutic alliance between practitioner and patient. Unfortunately, there are an insufficient number of trained CBT experts especially in France.

The implementation of an internet-delivered self-help program based on time-in-bed restriction and stimulus control may be an issue within the context of general practice.

Online programs based on CBT principles have been proved to be effective in improving the sleep and daytime functioning in this population, but the studies were realized in small patients groups.

Investigators hypothesis is that a simple and internet-delivered short-term program based on sleep restriction therapy and stimulus control (following to a GP consultation) may facilitate hypnotics discontinuation (benzodiazepines/Z-drugs) in patient with insomnia disorder still reporting sleep complaints in comparison with a tapering alone (no access to the self-help program).

primary_purpose: Supportive Care

ipd_sharing_description: Patient could request investigator an access to IPD according to French regulation (act No. 78-17 of 6 January 1978 on data processing, data files and individual liberties, amended by act No. 2004-801 of 6 August 2004).

lead_sponsor: University Hospital, Bordeaux

location_facility:
APHP Hôtel-Dieu de Paris
CHU de Bordeaux
CHRU de Lille
CHU de Montpellier
AP-HP Hôpital Pitié-Salpétrière
APHP Hôpital Raymond Poincaré


type: Other Grant/Funding Number

type: Other Identifier

title: Pressure Therapy in the Treatment of Upper Arm of Cerebral Palsy Children

acronym: PROPENSIX

summary: The purpose of this study is to assess the efficacy of a 6 months upper arm proprioceptive pressure therapy on Assisting Hand Assessment ("AHA") performance in Cerebral Palsy (CP). To perform this study, 80 CP patients aged of 5 to 10 years old will be included in a multicentric, double blind, prospective parallel-group randomized study. Treatment will be a pressure therapy using a LYCRA® compressive sleeve initially used in burn therapy. Primary outcome is to increase of 60% of AHA performance. The secondary outcome are to increase Quality of Upper Extremity Skill Test (QUEST), quality of life and improve Somatosensory Evoked Potentials (SEP).

ReferenceCitation: Gerard A, Toussaint-Thorin M, Mohammad Y, Letellier G, Fritot S, Masson S, Duhamel A, Donskoff C, Zagame Y, Beghin L, Gottrand L. PROPENSIX: pressure garment therapy using compressive dynamic Lycra(®) sleeve to improve bi-manual performance in unilateral cerebral palsy: a multicenter randomized controlled trial protocol. Trials. 2022 Feb 5;23(1):117. doi: 10.1186/s13063-022-06041-1.

ipd_sharing: No

lead_sponsor: University Hospital, Lille

location_facility: Service d'Education et de Soins Spécialisés à domicile_APF de Creil

location_facility: Centre de Soins de Suite et de Réadaptation Pédiatrique Spécialisé_Centre Paul Dottin


title: Anti-Angiotensin II Type 1 Receptor Antibodies and Kidney Transplant Outcomes

summary:
Incompatibility between non-genetically identical donors and recipients has been increasingly recognized as the main contributing factor to solid allograft rejection and failure, through the triggering of donor-specific responses mediated by T- and B-lymphocytes. The Human Leucocyte Antigen (HLA) system has been identified as the main target of donor-specific responses, especially through the production by the recipient of antibodies directed toward non-self donor HLA molecules expressed on the allograft endothelium. As a consequence, in organ transplantation, the current approach to immunological risk stratification, patient monitoring and rejection diagnosis is based on biomarkers derived from the HLA system. However, this approach does not provide a sufficient accuracy for the risk stratification and the diagnosis of immunological complications in solid organ transplantation, which still remain the dominant cause of allograft failure.

A recent body of evidence supports that specific non-HLA antigens expressed on the allograft endothelium may be relevant to allograft rejection, suggesting that a new strategy to transplant diagnostic testing at a non-HLA level would help to overcome the limitations of the current HLA-based approach to immunological assessment of transplant recipients. Among antibodies to non-HLA endothelial antigens, angiotensin II type 1 receptor activating antibodies have been the most widely reported antibodies to associate with the occurrence of allograft rejection, dysfunction and loss, even if their independent role, with respect to the presence of concomitant anti-HLA antibodies, has not been demonstrated.

time_perspective: Retrospective

lead_sponsor: Paris Translational Research Center for Organ Transplantation

location_facility: Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France

location_facility: Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France


title: Post-market Study for At-home Evaluation of Near Visual Acuity With OdySight, a Smartphone Based Medical Application in Comparison to a Standardized Method (TIL002)

summary: OdySight is a mobile application allowing self-testing of visual parameters including near visual acuity and communication of the data to an online dashboard to patient's doctors. TIL-002 post-market clinical trial objective is to evaluate the near visual acuity at home, measured with OdySight application in comparison to the standardized methods. The clinical trial is intended to prove that OdySight can provide relevant data and participate in the remote monitoring of subject vision.

lead_sponsor: Tilak Healthcare

location_facility: Institut Ophtalmologique de l'Ouest Clinique Jules Verne

location_facility: Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts


title: Effectiveness of an Exercise Re-training Program on Dyspnea in Patients After Acute Respiratory Distress Syndrome Secondary to Severe COVID-19 Pneumonia in Post-ICU

acronym: RECOVER

summary:
Dyspnea is defined by a subjective sensation of respiratory discomfort, the intensity of which varies according to the terrain, the anamnesis and the cause. Resuscitation is associated with many causes of dyspnea, including initial distress, mechanical ventilation, or after-effects following the pathology and its management.

Respiratory distress is the most severe form of impaired lung function. It is the first cause of hospitalization in intensive care. This distress, indicative of the failure of the respiratory system, is always severe and potentially fatal. It therefore constitutes an absolute therapeutic emergency. Dyspnea is often the revealing symptom of the condition and the urgency surrounding its management is an additional factor of concern for the patient. As a result, dyspnea is a pejorative element associated with severity or even death.

status: Active, not recruiting

ReferenceCitation: Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.

ReferenceCitation: Bailey PH. The dyspnea-anxiety-dyspnea cycle--COPD patients' stories of breathlessness: "It's scary /when you can't breathe". Qual Health Res. 2004 Jul;14(6):760-78.

ReferenceCitation: Ek K, Andershed B, Sahlberg-Blom E, Ternestedt BM. "The unpredictable death"-The last year of life for patients with advanced COPD: Relatives' stories. Palliat Support Care. 2015 Oct;13(5):1213-22. doi: 10.1017/S1478951514001151. Epub 2014 Oct 15.

ReferenceCitation: Davidson AC; British Thoracic Society Guideline Group For The Ventilatory Management of Acute Hypercapnic Respiratory Failure in Adults. Managing acute hypercapnic respiratory failure in adults: where do we need to get to? Thorax. 2016 Apr;71(4):297-8. doi: 10.1136/thoraxjnl-2016-208281. Erratum in: Thorax. 2016 Jun;71(6):492.

ReferenceCitation: Erratum: 'British Thoracic Society Guideline Group For The Ventilatory Management of Acute Hypercapnic Respiratory Failure in Adults. Managing acute hypercapnic respiratory failure in adults: where do we need to get to?'. Thorax. 2016 Jun;71(6):492. doi: 10.1136/thoraxjnl-2016-208281corr1.

ReferenceCitation: Howell MD, Davis AM. Management of ARDS in Adults. JAMA. 2018 Feb 20;319(7):711-712. doi: 10.1001/jama.2018.0307.

ReferenceCitation: Gloeckl R, Marinov B, Pitta F. Practical recommendations for exercise training in patients with COPD. Eur Respir Rev. 2013 Jun 1;22(128):178-86. doi: 10.1183/09059180.00000513. Review.

ReferenceCitation: Lacasse Y, Martin S, Lasserson TJ, Goldstein RS. Meta-analysis of respiratory rehabilitation in chronic obstructive pulmonary disease. A Cochrane systematic review. Eura Medicophys. 2007 Dec;43(4):475-85. Review.

ReferenceCitation: Schmidt M, Banzett RB, Raux M, Morélot-Panzini C, Dangers L, Similowski T, Demoule A. Unrecognized suffering in the ICU: addressing dyspnea in mechanically ventilated patients. Intensive Care Med. 2014 Jan;40(1):1-10. doi: 10.1007/s00134-013-3117-3. Epub 2013 Oct 17. Review.

ReferenceCitation: Rose L, Nonoyama M, Rezaie S, Fraser I. Psychological wellbeing, health related quality of life and memories of intensive care and a specialised weaning centre reported by survivors of prolonged mechanical ventilation. Intensive Crit Care Nurs. 2014 Jun;30(3):145-51. doi: 10.1016/j.iccn.2013.11.002. Epub 2013 Dec 3.

ReferenceCitation: Hough CL, Steinberg KP, Taylor Thompson B, Rubenfeld GD, Hudson LD. Intensive care unit-acquired neuromyopathy and corticosteroids in survivors of persistent ARDS. Intensive Care Med. 2009 Jan;35(1):63-8. doi: 10.1007/s00134-008-1304-4. Epub 2008 Oct 23.

ReferenceCitation: Kramer CL. Intensive Care Unit-Acquired Weakness. Neurol Clin. 2017 Nov;35(4):723-736. doi: 10.1016/j.ncl.2017.06.008. Review.

ReferenceCitation: Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.

ReferenceCitation: Schmidt M, Demoule A, Polito A, Porchet R, Aboab J, Siami S, Morelot-Panzini C, Similowski T, Sharshar T. Dyspnea in mechanically ventilated critically ill patients. Crit Care Med. 2011 Sep;39(9):2059-65. doi: 10.1097/CCM.0b013e31821e8779.

ReferenceCitation: Binks AP, Desjardin S, Riker R. ICU Clinicians Underestimate Breathing Discomfort in Ventilated Subjects. Respir Care. 2017 Feb;62(2):150-155. doi: 10.4187/respcare.04927. Epub 2016 Dec 13.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility:
Groupe Hospitalier Paris Saint Joseph
Centre Hospitalier Victor Dupouy
Hôpital Cochin


title: CORIMUNO19-ECU: Trial Evaluating Efficacy and Safety of Eculizumab (Soliris) in Patients With COVID-19 Infection, Nested in the CORIMUNO-19 Cohort

summary: The overall objective of the study is to determine the therapeutic effect and tolerance of Eculizumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Eculizumab is a terminal complement inhibitor that has been investigated for more than 10 years in numerous complement-mediated diseases. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Eculizumab administration to patients enrolled in the CORIMUNO-19 cohort. Eculizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Eculizumab will receive standard of care. Outcomes of Eculizumab-treated patients will be compared with outcomes of standard of care-treated patients as well as with outcomes of patients treated with other immune modulators.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
saint Louis
Saint Louis
Réanimation médicale

intervention_type: Drug


title: Prospective Multicentric Study of Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients

acronym: OPTIREG

summary:
Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality. However, one-third of patients are non-responders. Among factors associated with non-response, suboptimal electrical settings of the device, i.e. inadequate pacing vector selection and atrioventricular (AV) delay, is an important cause.

The aim of the study is to investigate whether the optimization of CRT settings (pacing vector and AV delay) results in improved clinical and echocardiographic outcomes in a non-responder CRT population after 6 months of therapy.

status: Terminated

lead_sponsor: CMC Ambroise Paré

location_facility:
CMC Ambroise Paré
GHEM Eaubonne
CHU de Poitiers


title: Efficacy of Antibiotic Short Course for Bloodstream Infections in Acute Myeloid Leukemia Patients With Febrile Neutropenia: a Retrospective Comparative Study

summary: There is no specific recommendation about antimicrobial treatment length for documented infections in chemotherapy induced febrile neutropenia. The aim of this study was to compare long versus short antibiotic course for bloodstream infection treatment in acute myeloid leukemia patients during febrile neutropenia. This monocentric retrospective comparative study included all consecutive bloodstream infection episodes among acute myeloid leukemia patients with febrile neutropenia for 3 years (2017-2019). Episodes were classified regarding the length of antibiotic treatment, considered as short course if the treatment lasted ≤7 days, except for nonfermenting bacteria and Staphylococcus aureus or lugdunensis for which the threshold was ≤10 days and ≤14 days, respectively. The primary outcome was the number of bloodstream infection relapses in both groups within 30 days of antibiotic discontinuation.

lead_sponsor: Poitiers University Hospital


title: Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

acronym: PROFIDYS

summary: This trial is intended to test the efficacy of an oral bisphosphonate (risedronate) to decrease bone pain and improve radiological aspect in fibrous dysplasia of bone.

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

location_country: Germany France Netherlands Belgium

location_facility:
Hopital Cochin
Cliniques Universitaires Saint Luc
Hopital E Herriot
Hospital Benjamin Franklin
Leids Universitair Medisch Centrum
Hopital Lariboisiere
Cologne Clinical Centre
Heildeberg Clinical Centre


title: Feasibility and Performances of Spleen Stiffness Measurement as Surrogate Marker for Oesophageal Varices in Cirrhotic Patients.

summary:
FibroScan® (Echosens, Paris, France) is an active non implantable medical device marketed in Europe since December 2003 and is currently used in many countries. FibroScan® is an ultrasound-based vibration-controlled transient elastography (VCTE™) device dedicated to liver stiffness measurement (LSM).

Several clinical studies have shown the accuracy of LSM by FibroScan® to predict liver fibrosis.

Some other studies have already shown the good correlation between LSM, assessed by FibroScan® based on VCTE™ technology, and the presence of portal hypertension (PHT).

PHT is a clinical condition characterized by a high blood pressure in the portal vein and its tributaries and it is defined as a gradient between portal and systemic blood pressure > 6 mmHg.

The development of oesophageal varices (OV) in cirrhotic patients, as well as their potential bleeding, represent one of the most severe and life-threatening complication of cirrhosis.

Upper endoscopy is the best diagnostic tool for detecting the presence of OV, gastric varices or congestive gastropathy, for estimating the grade of OV and for the recognition of the presence of red color signs and wale marks or other indicators of high risk for bleeding.

However these two methods are quite invasive and associated with some risks; at the same time, not all cirrhotic patients present OV at endoscopic screening.

The aim of this study is the validation of SSM, assessed by a FibroScan® with acquisition parameters and algorithm optimized for SSM, as surrogate noninvasive marker for the presence of OV in liver cirrhosis patients.

primary_purpose: Diagnostic

ReferenceCitation: Stefanescu H, Marasco G, Calès P, Fraquelli M, Rosselli M, Ganne-Carriè N, de Ledinghen V, Ravaioli F, Colecchia A, Rusu C, Andreone P, Mazzella G, Festi D. A novel spleen-dedicated stiffness measurement by FibroScan® improves the screening of high-risk oesophageal varices. Liver Int. 2020 Jan;40(1):175-185. doi: 10.1111/liv.14228. Epub 2019 Sep 11.

lead_sponsor: Echosens

location_country:
France
Romania
United Kingdom
Italy

location_facility: Department of Clinical Medicine, Policlinico S. Orsola Malpighi

location_facility: Hôpital Jean Verdier, Service Hépato-gastroentérologie

location_facility: Hôpital Haut-Lévêque, Service Hépato-gastroentérologie et Oncologie digestive

location_facility: Seconda Divisione di Gastroenterologia Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico,

location_facility: Iuliu Hatieganu University of Medicine and Pharmacy


type: EudraCT Number

title: Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder

summary: The purpose of this study will be to demonstrate improvement of the T regulatory cells (Treg) response, under add on low-dose Interleukin 2 (ld-IL2) in patients with bipolar disorders experiencing a depressive relapse


title: Development and Validation of Indicators on the Appropriateness of Oral Anticoagulant Prescriptions in Adult Medicine Automated From the Hospital Information System (PACHA Study).

acronym: PACHA

summary: This research focuses on the development and validation of indicators on the appropriateness of oral anticoagulant prescriptions. The investigators want to propose transferable tools to other healthcare institutions to allow automated construction of indicators as part of a structured approach to improve future practices. The main objective of the study is to develop indicators on the appropriateness of oral anticoagulant prescriptions in adult medicine automated from the hospital information system and to assess their criterion validity.

ReferenceType: result

ReferenceCitation: Petit-Monéger A, Thiessard F, Noize P, Berdaï D, Jouhet V, Saillour-Glénisson F, Salmi LR; PACHA research group. Definition of indicators of the appropriateness of oral anticoagulant prescriptions in hospitalized adults: Literature review and consensus (PACHA study). Arch Cardiovasc Dis. 2018 Mar;111(3):155-171. doi: 10.1016/j.acvd.2017.05.005. Epub 2017 Sep 21. Review.

ReferenceCitation: Petit-Monéger A, Thiessard F, Jouhet V, Noize P, Berdaï D, Kret M, Sitta R, Salmi LR, Saillour-Glénisson F; PACHA research group. Development and validation of hospital information system-generated indicators of the appropriateness of oral anticoagulant prescriptions in hospitalised adults: the PACHA study protocol. BMJ Open. 2017 Aug 31;7(8):e016488. doi: 10.1136/bmjopen-2017-016488.

location_facility: Hôpital européen Georges-Pompidou - Département d'informatique Hospitalière

location_facility: CHU de Rennes - Service d'information médicale

location_facility: Service d'Information Médicale, Unité d'Informatique et d'Archivistique Médicale (UIAM)


title: Evaluation of an 3D Imaging Intensifier Coupled to a Navigation Station in the Surgery of the Spine and Pelvis

acronym: FLUORONAV

summary: The purpose of this study is to demonstrate an optimization of the establishment of orthopedic implants in surgery of the spine and pelvic ring by combining 3D fluoroscopy and navigation system versus conventional method involving anatomical landmarks and 2D fluoroscopy.

lead_sponsor: AdministrateurCIC

location_facility: Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France


title: "ShearWave" Elastography Interest in the Management of Thyroid Nodules

acronym: SWETHY

summary: Define an ultrasound/elastography benignity criteria in strategy management of a patient population carries one or more thyroid nodules.

design_allocation: Non-Randomized


title: Study to Establish Patient-Matched Population Norms for the MS-COG

summary: The primary objective of the study is to develop MS patient-matched healthy population norms for the Multiple Sclerosis Cognition Assessment Battery (MS-COG) that are representative of the United States (US), France, and Italy.

lead_sponsor: Biogen

location_country:
United States
Italy
France

location_facility:
Research site
Research Site


title: Improving the Participation Rate in ColoRectal Cancer Screening by Training General Practitioners in Motivational Interviewing

acronym: AMDepCCR

summary:
Colorectal cancer is the 2nd leading cause of cancer mortality in France. However this cancer is preventable in the majority of cases by early detection of adenomas.

In France, there is organized colorectal cancer screening, which relies on general practitioners (GPs). Tests delivered by GPs are performed in 89% of cases. However, GPs do not systematically offer the test, for time management and communication reasons. Patients expect their GPs to offer the test and to focus on their expectations. A previous study conducted on GPs showed that training in communication and motivational interviewing increases the number of tests performed by 12.2%.

In order to facilitate the promotion of screening, the investigators would like to develop a training programme for GPs focusing on the application of Motivational Interviewing (MI) techniques to the promotion of colorectal cancer screening.

Motivational Interviewing is a directive, client-centered counseling style for eliciting behavior change by helping clients to explore and resolve ambivalence.

This study is a multicenter trial in general medicine. In this randomized trial the 902 subjects will be included prospectively by the general practitioners (GP) participating in the study.

As a first step, general practitioners who have never participated in Motivational Interviewing training will be recruited and split into 2 groups by randomization, an intervention group and a control group. The interventional group will then undergo a 3 times 2-day training in Motivational Interviewing.

In a second step, the patients will be included by those GP and a self-questionnaire will be send at the inclusion and after 6, 12 and 24 months. The evaluation of the number of tests performed and the analyse of the Health Belief Model (HBM) self-questionnaire will be carried out.

At 24 months, there will be an evaluation of the denial motivation questionnaire for patients who have not participated in organized colorectal cancer screening.

ReferenceCitation: Aujoulat P, Le Goff D, Dany A, Robaskiewick M, Nousbaum JB, Derrienic J, Cariou M, Guillou M, Le Reste JY. Improvement of participation rate in colorectal cancer (CRC) screening by training general practitioners in motivational interviewing (AmDepCCR). Trials. 2022 Feb 14;23(1):144. doi: 10.1186/s13063-022-06056-8.

ipd_sharing_description: All collected data that underlie results in a publication

location_facility:
Dr VELLY
Dr KERVELLA
Dr BLANCHARD
Dr KERFRIDEN KERHOAS
Dr DESNOT
Dr GRALL
Dr POINOT
Dr BODIN
Dr PREVOT
Dr LE GRIGNOU
Dr LE FLOCH
Dr PETIT
Dr HENRY
Dr PERRIER
Dr DENIEL
Dr ATTENCOURT
Dr COLLETER
Dr GASNIER
Dr AOUDIA
Dr VIALA
Dr LUCAS
Dr KERGASTEL
Dr VERBEQUE MORVAN
Dr DROGOU
Dr BOUTERAON
Dr PITMAN
Dr MAGADUR
Dr BARAIS
Dr LOPIN
Dr AUTRET
Dr TREBAOL
Dr PETTON-HILI
Dr CHAPOIX
Dr DAOUDAL
Dr COGNEAU
Dr CRENN-CORVEZ
Dr COROLLER
Dr BEURTON-COURAUD
Dr COUTURIER
Dr MUNCK
Dr LEFEVRE
Dr BECK-ROBERT
Dr LE BOURHIS
Dr ABALAIN
Dr BAUTA
Dr NICOLAS
Dr MONFORT
Dr MAILLEUCHET
Dr DE LA SOUDIERE
Dr PIPET-PENIN
Dr BARCELO
Dr OLIVIER
Dr JOLIVET COUTURE

intervention_type: Behavioral


title: Prevalence of Right Ventricular Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases and Its Impact on Outcomes

acronym: DVD

summary: Observational study in patients with chronic respiratory diseases (chronic obstructive pulmonary diseases, bronchiectasis, interstitial lung diseases, neuromuscular diseases, obesity-hypoventilation syndrome...) admitted in intensive care unit for acute respiratory failure. The main objective is to determine the prevalence of right ventricular (RV) dysfunction in this population and to analyze the impact of such a complication on outcomes (survival at day-28, duration of non-invasive or mechanical ventilation, duration of hospital stay). RV function will be assessed by echocardiography at admission, after 3 days and at discharge. Plasma NT-proBNP and troponin levels will be collected.

lead_sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

location_facility: Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière Paris, France


title: Feasibility and Validity of an Observational Scale as a Surrogate of Dyspnea in Non-communicating Patients in the Intensive Care Unit (ICU): DYS-NOC

acronym: DYS-NOC

summary:
Background : Dyspnea is common and severely impact mechanically ventilated patients outcomes in intensive care unit (ICU). Recognize, measure and treat dyspnea have become current major therapeutic challenge. Its measurement involves a self-assessment by the patient, and by definition, a certain level of communication. Consequently, a large proportion of the ICU-population (non-communicating) misses its evaluation and potential benefits associated with its control. In other hand, electrophysiological markers that help to detect and quantify dyspnea regardless of the patient's cooperation, has been developed and validated as dyspnea surrogate, namely: 1) the electromyographic (EMG) activity of extra diaphragmatic inspiratory muscles and 2) the premotor inspiratory potentials (PIP) detected on the electroencephalogram (EEG). Because of its complex implementation in daily practice the research team has developed alternatively a behavioral score called IC-RDOS that provides reliable dyspnea assessment also without patient participation. Validated in conscious patients, it has not been yet validated in non-communicating patients.

Hypothesis : The IC-RDOS is valid for non-communicating ventilated patients and allows a simple and reliable assessment of dyspnea in this specific population.

Objective : To validate the IC-RDOS in non-communicating ICU patients under mechanical ventilation, using comparison with the tools validated for reliable measure of dyspnea in non-communicating patients (EMG, EEG).

Patients and Methods: In 40 patients will be collected simultaneously IC-RDOS, PIP (EEG) and electromyographic activity of three extra diaphragmatic inspiratory muscles (scalene, parasternal and Alae nasi) before and after intervention therapy aiming at reduce dyspnea (ventilator settings or pharmacological intervention), initiated by the clinician in charge of the patient.

Expected results : Observe a strong positive correlation between the IC-RDOS and electrophysiological markers (amplitude of the electromyogram and presence and magnitude of PIP). Observe a correlation between changes in the IC-RDOS and the electrophysiological markers after therapeutic interventions.

Optimizing patient comfort is a prominent concern in the ICU. By optimizing the detection and quantification of dyspnea in non-communicating patients, this study should ultimately improve the management and "the better living" of ventilated patients in intensive care

ReferenceCitation: Lansing RW, Gracely RH, Banzett RB. The multiple dimensions of dyspnea: review and hypotheses. Respir Physiol Neurobiol. 2009 May 30;167(1):53-60. doi: 10.1016/j.resp.2008.07.012. Epub 2008 Jul 25. Review.

ReferenceCitation: Cherniack NS, Altose MD. Mechanisms of dyspnea. Clin Chest Med. 1987 Jun;8(2):207-14. Review.

ReferenceCitation: Morélot-Panzini C, Demoule A, Straus C, Zelter M, Derenne JP, Willer JC, Similowski T. Dyspnea as a noxious sensation: inspiratory threshold loading may trigger diffuse noxious inhibitory controls in humans. J Neurophysiol. 2007 Feb;97(2):1396-404. Epub 2006 Jul 26.

ReferenceCitation: HAMMOND EC. SOME PRELIMINARY FINDINGS ON PHYSICAL COMPLAINTS FROM A PROSPECTIVE STUDY OF 1,064,004 MEN AND WOMEN. Am J Public Health Nations Health. 1964 Jan;54:11-23.

ReferenceCitation: Kessler R, Partridge MR, Miravitlles M, Cazzola M, Vogelmeier C, Leynaud D, Ostinelli J. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J. 2011 Feb;37(2):264-72. doi: 10.1183/09031936.00051110. Epub 2010 Nov 29.

ReferenceCitation: Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. Epub 2007 May 16. Review.

ReferenceCitation: Nishimura K, Izumi T, Tsukino M, Oga T. Dyspnea is a better predictor of 5-year survival than airway obstruction in patients with COPD. Chest. 2002 May;121(5):1434-40.

ReferenceCitation: Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12.

ReferenceCitation: Esteban C, Quintana JM, Aburto M, Moraza J, Egurrola M, Pérez-Izquierdo J, Aizpiri S, Aguirre U, Capelastegui A. Impact of changes in physical activity on health-related quality of life among patients with COPD. Eur Respir J. 2010 Aug;36(2):292-300. doi: 10.1183/09031936.00021409. Epub 2010 Jan 14.

ReferenceCitation: Wilson PR. Clinical practice guideline: acute pain management. Clin J Pain. 1992 Sep;8(3):187-8.

ReferenceCitation: Pochard F, Lanore JJ, Bellivier F, Ferrand I, Mira JP, Belghith M, Brunet F, Dhainaut JF. Subjective psychological status of severely ill patients discharged from mechanical ventilation. Clin Intensive Care. 1995;6(2):57-61.

ReferenceCitation: de Miranda S, Pochard F, Chaize M, Megarbane B, Cuvelier A, Bele N, Gonzalez-Bermejo J, Aboab J, Lautrette A, Lemiale V, Roche N, Thirion M, Chevret S, Schlemmer B, Similowski T, Azoulay E. Postintensive care unit psychological burden in patients with chronic obstructive pulmonary disease and informal caregivers: A multicenter study. Crit Care Med. 2011 Jan;39(1):112-8. doi: 10.1097/CCM.0b013e3181feb824.

ReferenceCitation: Pennock BE, Crawshaw L, Maher T, Price T, Kaplan PD. Distressful events in the ICU as perceived by patients recovering from coronary artery bypass surgery. Heart Lung. 1994 Jul-Aug;23(4):323-7.

ReferenceCitation: van de Leur JP, van der Schans CP, Loef BG, Deelman BG, Geertzen JH, Zwaveling JH. Discomfort and factual recollection in intensive care unit patients. Crit Care. 2004 Dec;8(6):R467-73. Epub 2004 Oct 28.

ReferenceCitation: Rotondi AJ, Chelluri L, Sirio C, Mendelsohn A, Schulz R, Belle S, Im K, Donahoe M, Pinsky MR. Patients' recollections of stressful experiences while receiving prolonged mechanical ventilation in an intensive care unit. Crit Care Med. 2002 Apr;30(4):746-52.

ReferenceCitation: Cuthbertson BH, Hull A, Strachan M, Scott J. Post-traumatic stress disorder after critical illness requiring general intensive care. Intensive Care Med. 2004 Mar;30(3):450-5. Epub 2003 Sep 5.

ReferenceCitation: Campbell ML, Templin T, Walch J. A Respiratory Distress Observation Scale for patients unable to self-report dyspnea. J Palliat Med. 2010 Mar;13(3):285-90. doi: 10.1089/jpm.2009.0229.

ReferenceCitation: Campbell ML. Respiratory distress: a model of responses and behaviors to an asphyxial threat for patients who are unable to self-report. Heart Lung. 2008 Jan-Feb;37(1):54-60. doi: 10.1016/j.hrtlng.2007.05.007.

ReferenceCitation: Persichini R, Gay F, Schmidt M, Mayaux J, Demoule A, Morélot-Panzini C, Similowski T. Diagnostic Accuracy of Respiratory Distress Observation Scales as Surrogates of Dyspnea Self-report in Intensive Care Unit Patients. Anesthesiology. 2015 Oct;123(4):830-7. doi: 10.1097/ALN.0000000000000805.

ReferenceCitation: Hug F, Raux M, Morelot-Panzini C, Similowski T. Surface EMG to assess and quantify upper airway dilators activity during non-invasive ventilation. Respir Physiol Neurobiol. 2011 Sep 15;178(2):341-5. doi: 10.1016/j.resp.2011.06.007. Epub 2011 Jun 15.

ReferenceCitation: Ward ME, Corbeil C, Gibbons W, Newman S, Macklem PT. Optimization of respiratory muscle relaxation during mechanical ventilation. Anesthesiology. 1988 Jul;69(1):29-35.

ReferenceCitation: Parthasarathy S, Jubran A, Laghi F, Tobin MJ. Sternomastoid, rib cage, and expiratory muscle activity during weaning failure. J Appl Physiol (1985). 2007 Jul;103(1):140-7. Epub 2007 Mar 29.

ReferenceCitation: Schmidt M, Chiti L, Hug F, Demoule A, Similowski T. Surface electromyogram of inspiratory muscles: a possible routine monitoring tool in the intensive care unit. Br J Anaesth. 2011 Jun;106(6):913-4. doi: 10.1093/bja/aer141.

ReferenceCitation: Schmidt M, Kindler F, Gottfried SB, Raux M, Hug F, Similowski T, Demoule A. Dyspnea and surface inspiratory electromyograms in mechanically ventilated patients. Intensive Care Med. 2013 Aug;39(8):1368-76. doi: 10.1007/s00134-013-2910-3. Epub 2013 Apr 11.

ReferenceCitation: Raux M, Straus C, Redolfi S, Morelot-Panzini C, Couturier A, Hug F, Similowski T. Electroencephalographic evidence for pre-motor cortex activation during inspiratory loading in humans. J Physiol. 2007 Jan 15;578(Pt 2):569-78. Epub 2006 Nov 16.

ReferenceCitation: Raux M, Ray P, Prella M, Duguet A, Demoule A, Similowski T. Cerebral cortex activation during experimentally induced ventilator fighting in normal humans receiving noninvasive mechanical ventilation. Anesthesiology. 2007 Nov;107(5):746-55.


title: Rapid Detection of Rifampin and Isoniazid Resistance by PCR Before Tuberculosis (TB) Treatment Initiation: a National Multicenter Randomized Clinical Trial

acronym: FAST-TB

summary:
French guidelines currently recommend to initiate a 4-drug containing regimen associating isoniazid (INH or H), rifampicin (RIFor RMP or R), pyrazinamide (PZA or Z) and ethambutol (EMB or E) pending the results of drug susceptibility testing (DST). The rationale behind routine use of EMB is to prevent the emergence of resistance to rifampicin (RMP), in case of primary resistance to INH. Hence, early detection of resistance to INH and RIF using molecular testing in Mycobacterium tuberculosis could allow early adaptation of antituberculosis treatment: i) start with a 3-drug containing regimen (i.e. INH, RIF, and PZA); ii) early enforcement of treatment when resistance is suspected, pending in depth susceptibility testings.

the duration of treatment is 6 months or 12 months.

location_facility:
Bichat hospital
Bichat Claude Bernard Hospital


title: Observational and Transversal Study of Patients Treated in "Real Life"Conditions With Adaptive Servo-Ventilation

acronym: OTRLASV

summary: Adaptive Servo-Ventilation (ASV) treatment is routinely prescribed in France. In order to be reimbursed according to the French Social Security rules, the patient treated with an ASV needs to be examined each year. In this observational transversal single-visit study, the investigators aim to describe the clinical characteristics of patients treated with ASV and the associated device settings.

ReferenceCitation: Jaffuel D, Philippe C, Rabec C, Mallet JP, Georges M, Redolfi S, Palot A, Suehs CM, Nogue E, Molinari N, Bourdin A. What is the remaining status of adaptive servo-ventilation? The results of a real-life multicenter study (OTRLASV-study) : Adaptive servo-ventilation in real-life conditions. Respir Res. 2019 Oct 29;20(1):235. doi: 10.1186/s12931-019-1221-9.

ReferenceCitation: Jaffuel D, Rabec C, Philippe C, Mallet JP, Georges M, Redolfi S, Palot A, Suehs CM, Nogue E, Molinari N, Bourdin A. Patterns of adaptive servo-ventilation settings in a real-life multicenter study: pay attention to volume! : Adaptive servo-ventilation settings in real-life conditions. Respir Res. 2020 Sep 21;21(1):243. doi: 10.1186/s12931-020-01509-7.

ReferenceCitation: Jaffuel D, Mallet JP, Combes N, Palot A, Rabec C, Molinari N, Jaber S, Bourdin A. [Adaptive servo-ventilation after the SERVE-HF study: The swan song?]. Rev Mal Respir. 2016 Sep;33(7):641-4. doi: 10.1016/j.rmr.2016.04.001. Epub 2016 May 5. French.

lead_sponsor: University Hospital, Montpellier

location_facility: Arnaud de Villeneuve University Hospital


title: Test of Ventricular Stimulation as Immediate Predictor of Hypovolemia After Cardiac Surgery: Non-randomized Open Label Trial.

acronym: TESTI

summary: The purpose of the study is to validate a ventricular pacing test as a predictor of preload dependency in post cardiac surgery patients.

intervention_type: Diagnostic Test


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

primary_purpose: Prevention

ReferenceCitation: Rolland Y, Tavassoli N, de Souto Barreto P, Perrin A, Laffon de Mazières C, Rapp T, Hermabessière 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.

lead_sponsor: University Hospital, Toulouse

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 "Les Charmilles"

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 Retraite Orelia Ch St Gaudens

location_facility: Ehpad Maison de Retraite Privee de Mazeres

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


title: Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA in the Administered Rt-PA

acronym: OPHELIE

summary: intravenous rt-PA is effective to reduce the risk of death or dependency after ischaemic stroke. This effect is due to an early recanalization secondary to the lysis of the clot. However this effect may be counterbalanced by the increased risk of bleeding and also the neurotoxicity of rt-PA, which has been shown in animals to depend on the ratio single chain (sc) / double chain (tc) in the rt-PA administered. The main objective of OPHELIE is to determine whether the functional outcome after treatment by iv rt-PA depends on the ratio sc-rtPA / tc-rtPA. Secondary objectives were to identify the influence on the risk of brain haemorrhage, and the influence of the cognitive state (OPHELIE-COG substudy).

ReferenceCitation: Caparros F, Kuchcinski G, Drelon A, Casolla B, Moulin S, Dequatre-Ponchelle N, Henon H, Cordonnier C, Pruvo JP, Leys D. Use of MRI to predict symptomatic haemorrhagic transformation after thrombolysis for cerebral ischaemia. J Neurol Neurosurg Psychiatry. 2020 Apr;91(4):402-410. doi: 10.1136/jnnp-2019-321904. Epub 2020 Feb 3.

ReferenceCitation: Leys D, Hommet Y, Jacquet C, Moulin S, Sibon I, Mas JL, Moulin T, Giroud M, Sagnier S, Cordonnier C, Medeiros de Bustos E, Turc G, Ronzière T, Bejot Y, Detante O, Ouk T, Mendyk AM, Favrole P, Zuber M, Triquenot-Bagan A, Ozkul-Wermester O, Montoro FM, Lamy C, Faivre A, Lebouvier L, Potey C, Poli M, Hénon H, Renou P, Dequatre-Ponchelle N, Bodenant M, Debruxelles S, Rossi C, Bordet R, Vivien D; OPHELIE investigators and the STROKAVENIR network. Proportion of single-chain recombinant tissue plasminogen activator and outcome after stroke. Neurology. 2016 Dec 6;87(23):2416-2426. Epub 2016 Nov 4.


title: Impact of Early and Intensive Bimanual Stimulation on the Evolution of Bimanual Function in Infants With Clinical Findings Suggesting Unilateral Cerebral Palsy (BB-BIM)

acronym: BB-BIM

summary: The aim of this study is to measure the impact of early bimanual stimulation in babies with clinical signs of underuse of one hand. The observation focuses on the developmental curve of hands use. The intervention is provided by the family environment and takes place in the child's familiar surroundings.

lead_sponsor: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

location_facility: Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues


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.

ReferenceCitation: Clergue F, Auroy Y, Péquignot 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. French.

ReferenceCitation: Clergue F, Auroy Y, Péquignot F, Jougla E, Lienhart A, Laxenaire MC. French survey of anesthesia in 1996. Anesthesiology. 1999 Nov;91(5):1509-20.

ReferenceCitation: Lienhart A, Auroy Y, Clergue F, Laxenaire MC, Péquignot F, Jougla E. [Anesthetics and transfusion practices]. Ann Fr Anesth Reanim. 1998;17(11):1374-86. French.

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.

lead_sponsor: University Hospital, Grenoble

location_facility: CH National d'Ophtalmologie - les quinze vingts

location_facility: Centre hospitalier Henri Mondor d'Aurillac

location_facility: Centre Hospitalier Saint-Cyr- Villeneuve sur Lot

location_facility: Centre de Chirurgie Abulatoire des Hauts d'Avignon

location_facility: Centre Hospitalier Bretagne Atlantique site de Vannes

location_facility: Clinique de Flandre - Coudekerque Branche

location_facility: Centre Hospitalier de Bretagne Sud site Bodelio


title: Observational Study of Iron Metabolism in Anemia in ICU and Post-Operative Patients, Role of Hepcidin

acronym: FAIRe

summary: Anemia in intensive care and post-operative patients is due to both blood loss (leading to iron loss) and inflammation.


title: Patient Empowerment for Major Surgery Preparation @ Home: Multimodal Prehabilitation in Major Elective Surgery

acronym: Paprika

summary: Non-randomized monocentric open cohort study vs historical comparative group testing the efficacy of a multimodal prehabilitation program (based on physical activity, nutritional support and mental preparation) for unfit patients based on nutrition, physical activity and mental preparation in reducing postoperative complications in elective major surgery

ReferenceCitation: Barberan-Garcia A, Ubré M, Roca J, Lacy AM, Burgos F, Risco R, Momblán D, Balust J, Blanco I, Martínez-Pallí G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.

ReferenceCitation: Barberan-Garcia A, Ubre M, Pascual-Argente N, Risco R, Faner J, Balust J, Lacy AM, Puig-Junoy J, Roca J, Martinez-Palli G. Post-discharge impact and cost-consequence analysis of prehabilitation in high-risk patients undergoing major abdominal surgery: secondary results from a randomised controlled trial. Br J Anaesth. 2019 Oct;123(4):450-456. doi: 10.1016/j.bja.2019.05.032. Epub 2019 Jun 25.

ipd_sharing_description: Anonymised data will be shared with Barcelona, Köln and Gdansk: all collected IPD

location_facility: Centre Hospitalier Universitaire Grenoble Alpes


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).

lead_sponsor: Hospices Civils de Lyon

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


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: Département des Maladies du Système Nerveux, GH Pitie Salpatriere

location_facility: Service de Neurochirurgie, Hopital Henri Mondor


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). pii: 1491. doi: 10.3390/v14071491.

ReferenceCitation: Gault N, Esposito-Farèse M, Revest M, Inamo J, Cabié A, Polard É, Hulot JS, Ghosn J, Chirouze C, Deconinck L, Diehl JL, Poissy J, Epaulard O, Lefèvre B, Piroth L, De Montmollin E, Oziol E, Etienne M, Laouénan 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.

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, Surénaud M, Wicky PH, Foucat E, Diehl JL, Hejblum BP, Sinnah F, de Montmollin E, Lacabaratz C, Thiébaut R, Timsit JF, Lévy 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.

location_facility: Hopital d'instruction des armées Begin 69

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre hospitalier Intercommunal de Créteil

location_facility: CHU Toulouse IUCT Institut Universitaire de Cancer de Toulouse

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Centre Hospitalier Universitaire de Rangueil

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

location_facility: Centre Hospitalier Régional Universitaire de Tours

location_facility: Assistance publique hopitaux de Marseille, hopital Nord

location_facility: Centre hospitalier Louis Constant Fleming


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.

location_facility: APHP, Lariboisière Hospital, Cardiology Department


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.

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: French Long Term Registry With Longitudinal Follow up of PDGFRA D842V-GIST Patients Treated With Avapritinib : AVapritinib Real-life observatTORy

summary:
GIST are rare mesenchymal tumors of the gastrointestinal tract characterized by somatic mutations in the gene encoding the KIT (85%) or the PDGFRα (8%) protein. Treatment of localized forms relies on adequate surgery without tumor spillage and sometimes systemic treatment with imatinib according to risk of relapse defined by localization, tumor size and mitotic count, as well as mutational status. More than 40% of cases may recur and metastasize. Advanced and relapsing forms are currently treated with oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR such as imatinib (standard treatment), sunitinib (2nd line) and regorafenib (3rd line). Nevertheless, imatinib has little or no activity in patients harboring the D842V mutation in the exon 18 of PDGFRα (20% of gastric GIST, 6% of all GIST patients). Consequently, other therapeutic alternatives are needed.

Results from the phase I single-arm NAVIGATOR study show that avapritinib has significant efficacy in GIST patients with PDGFRα D842V mutation (ORR = 86 %). In France, an authorization for temporary use (ATUc) starting on September 21st, 2020 has been granted by the National Agency for Safety of Medicines and Health Products (ANSM). It allows the early availability of avapritinib in France while waiting for Market Authorization Approval (AMM). This ATUc will be accompanied by a protocol of therapeutic use and collection of information (PUT) that describes the frequency of patient visits.

The objective of this real-life registry is to perform a long-term longitudinal follow up of PDGFRA D842V-mutated GIST patients treated with avapritinib and to collect effectiveness and safety data. It will be implemented in parallel to the ATUc until June 2023.

Data from the electronic health record (EHR) will be collected. Moreover, as per the ANSM's requirements, quality of life and cognitive function will be investigated using FACT-G, FACT-Cog and MoCA questionnaires.

Undesirable effects will be collected as well. Follow-up is envisioned for a minimum of 2 years.

lead_sponsor: Centre Leon Berard

location_facility:
Centre Geroges François Leclerc
CHU Robert Debré
Insitut Bergonié
CHRU Besançon
Centre Léon Bérard
Institut Gustave Roussy


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

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 subjects 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, UK, and US.

Subjects must be symptomatic with a MFSAF v4.0 Total Symptom Score of ≥ 10 at screening, and be anemic with Hgb < 10 g/dL. For subjects 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.

Subjects will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Subjects 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 subject tolerates and continues to benefit from MMB.

Subjects 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.

Subjects 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.

lead_sponsor: Sierra Oncology, Inc.

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

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd

location_facility: Laboratul clinic MedLife-Policlinica de Diagnostic Rapid Brasov

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

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

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

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

location_facility: Sjællands Universitetshospital - Roskilde

location_facility: The University of Texas MD Anderson Cancer Center

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

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: Centre Hosptitalier Universitaire Angers

location_facility: Queen Elizabeth II Health Sciences Centre - Halifax Infirmary

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

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Centre Hospitalier Universitaire Nantes - Hôtel Dieu

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Ospedale Policlinico Giambattista Rossi Borgo Roma

location_facility: Centre Hospitalier Universitaire Amiens-Picardie - Site Sud

location_facility: Uniwersyteckie Centrum Kliniczne w Gdańsku

location_facility: Institut Hospital del Mar d'Investigacions Mèdiques

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

location_facility: National Specialized Hospital for Active Treatment of Haematologic Diseases

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: University Multiprofile Hospital For Active Treatment Aleksandrovska

location_facility: Spitalul Clinic Judetean De Urgenta Târgu Mureș

location_facility: Markusovszky Egyetemi Oktatókórház Szombathely

location_facility: Columbia University Irving Medical Center - Presbyterian Hospital

location_facility: Klinika Hematologii Nowotworów Krwi i Transplantacji Szpiku

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata

location_facility: Perth Radiological Clinic - Magnetic Resonance Centre

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

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

location_facility: University Hospitals Cleveland Medical Center

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

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

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo

location_facility: University of Colorado Hospital Anschutz Cancer Pavilion

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Presidio Ospedaliero Universitario Santa Maria della Misericordia

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

location_facility: Cleveland Clinic - Richard E. Jacobs Health Center

location_facility: Seoul National University Bundang Hospital

location_facility: Washington University School of Medicine in Saint Louis

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Complejo Asistencial Universitario de Salamanca - Hospital Clínico

location_facility: University Hospitals Bristol NHS Foundation Trust

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

location_facility: Northwest Oncology & Hematology - Rolling Meadows

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

location_facility: Alvamed Zakład Specjalistycznej Opieki Zdrowotnej

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: Hospital Universitario Central de Asturias

location_facility: American Institute of Research - Whittier

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

location_facility: Hospital Center University Of Caen Normandie

location_facility: Research Institute of the McGill University Health Centre

location_facility: University College London Hospitals NHS Foundation Trust


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).

status: Not yet recruiting

ReferenceCitation: Bège 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'intérêt 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. Review.

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. Review.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Assistance Publique des Hôpitaux de Marseille

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

location_facility: Centre Hospitalier d'Avignon Henri Duffaut


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