title: Impact of a Transitional Care Program Involving an Advanced Practice Nurse on 30-Day Hospital Readmissions for Elderly Patients Discharged From a Short Stay Geriatric Ward (PROUST Study)

acronym: PROUST

summary: In France, it has be estimated that the hospital readmission rate within 30 days of patients aged 75 or older is 14% (IC95% [12.0-16.7]), nearly a quarter being avoidable. There is evidence that interventions "bridging" the transition from hospital to home involving a dedicated professional (usually nurses) would be most effective in reducing the risk of readmission, but the level of evidence of current studies is low. Our study aims to assess the impact of a program of transitional care from hospital to home for people of 75 years old or more admitted to acute care.

primary_purpose: Health Services Research

ReferenceCitation: Occelli P, Touzet S, Rabilloud M, Ganne C, Poupon Bourdy S, Galamand B, Debray M, Dartiguepeyrou A, Chuzeville M, Comte B, Turkie B, Tardy M, Luiggi JS, Jacquet-Francillon T, Gilbert T, Bonnefoy M. Impact of a transition nurse program on the prevention of thirty-day hospital readmissions of elderly patients discharged from short-stay units: study protocol of the PROUST stepped-wedge cluster randomised trial. BMC Geriatr. 2016 Mar 3;16:57. doi: 10.1186/s12877-016-0233-2.

family: Occelli

full_name: Pauline Occelli

given: Pauline

family: Touzet

full_name: Sandrine Touzet

given: Sandrine

family: Rabilloud

full_name: Muriel Rabilloud

given: Muriel

family: Ganne

full_name: Christell Ganne

given: Christell

family: Poupon Bourdy

full_name: Stéphanie Poupon Bourdy

given: Stéphanie

family: Galamand

full_name: Béatrice Galamand

given: Béatrice

family: Debray

full_name: Matthieu Debray

given: Matthieu

family: Dartiguepeyrou

full_name: André Dartiguepeyrou

given: André

family: Chuzeville

full_name: Michel Chuzeville

given: Michel

family: Comte

full_name: Brigitte Comte

given: Brigitte

family: Turkie

full_name: Basile Turkie

given: Basile

family: Tardy

full_name: Magali Tardy

given: Magali

family: Luiggi

full_name: Jean-Stéphane Luiggi

given: Jean-Stéphane

family: Jacquet-Francillon

full_name: Thierry Jacquet-Francillon

given: Thierry

family: Gilbert

full_name: Thomas Gilbert

given: Thomas

family: Bonnefoy

full_name: Marc Bonnefoy

given: Marc

journal_name: BMC Geriatrics

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

location_facility:
CHG Annecy
Centre Hospitalier Alpes Léman
CH Bourg-en-Bresse
Hôpital Édouard Herriot
Centre Hospitalier Lyon Sud
CH Saint-Chamond
CH Villefranche
Clinique des portes du sud
CH Gériatrique des Monts d'Or


type: EudraCT Number

title: Could Positon Emission Tomography With Radiolabelled 3'-Deoxy-3'-(18)F-Fluoro-L-Thymidine be a Theranostic Tool During Erlotinib Treatment in Non-small Cell Lung Cancer Patients ?

acronym: FLT-THERA

summary:
In France, lung cancer is the leading cause of death induced by cancer. Therapeutic advances have been made in therapy of unresectable non-small cell lung cancer (NSCLC) with tyrosine kinase receptor inhibitors blocking the Epidermal Growth Factor Receptor (EGFR), as erlotinib.

This drug usually does not induce rapid shrinking of NSCLC tumour explaining why RECIST criteria are less reliable with erlotinib than cytotoxic drugs after 8 weeks of treatment.

Among patients with unresectable NSCLC, 3'-deoxy-3'-18F-fluoro-L-thymidine (18F-FLT) and 18F-2-18F-fluoro-2-deoxy-D-glucose (18F- FDG) Positron Emission Tomography (PET) has identified early responding patients and with better progression-free survival in erlotinib first line and in the second or third line.

To date, none medico-economic study has been conducted to determine if this strategy will be cost-effective.

The purpose of this study is to confirm that an early metabolic imaging with 18 F-FLT and 18FFDG PET could have theranostic issue by identifying at the fourteenth day of erlotinib (second line or more) the subjects that do not respond to erlotinib, i.e. 6 weeks prior to the morphological evaluation based on the new RECIST 1.1, that is typically done at week 8 of erlotinib treatment.

A health economics ancillary study will be achieved. Indeed, recent therapeutic improvements, in particular targeted therapies in NSCLC, have improved quality of life and life expectancy, but have also induce an important increase of the health costs. According to studies, the mean cost of the treatments of NSCLC has been increased by a factor 3 during the 10 last years. More efficient strategies that would permit to stop early with objective endpoints, expensive therapies is a main achievement in thoracic oncology.

The potential clinical impacts of this work are 1) to stop early erlotinib in non-responders and replace another treatment before a deterioration in their physical status, 2) reduce the risk of side effects and costs of unnecessary treatment and 3) to propose a customization treatment after the first line therapy.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Vesselle H, Grierson J, Muzi M, Pugsley JM, Schmidt RA, Rabinowitz P, Peterson LM, Vallières E, Wood DE. In vivo validation of 3'deoxy-3'-[(18)F]fluorothymidine ([(18)F]FLT) as a proliferation imaging tracer in humans: correlation of [(18)F]FLT uptake by positron emission tomography with Ki-67 immunohistochemistry and flow cytometry in human lung tumors. Clin Cancer Res. 2002 Nov;8(11):3315-23.

ReferenceCitation: Aouba A, Pequignot F, Le Toullec A, Jougla E. Les causes médicales de décès en France en 2004 et leur évolution 1980-2004. Bul Epidémiol Hebd 2007;35-36:308-14.

ReferenceCitation: Ferlay J, Parkin DM, Steliarova-Foucher E. Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer. 2010 Mar;46(4):765-81. doi: 10.1016/j.ejca.2009.12.014. Epub 2010 Jan 29.

ReferenceCitation: Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.

ReferenceCitation: Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009 Sep 3;361(10):947-57. doi: 10.1056/NEJMoa0810699. Epub 2009 Aug 19.

ReferenceCitation: Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, Palmero R, Garcia-Gomez R, Pallares C, Sanchez JM, Porta R, Cobo M, Garrido P, Longo F, Moran T, Insa A, De Marinis F, Corre R, Bover I, Illiano A, Dansin E, de Castro J, Milella M, Reguart N, Altavilla G, Jimenez U, Provencio M, Moreno MA, Terrasa J, Muñoz-Langa J, Valdivia J, Isla D, Domine M, Molinier O, Mazieres J, Baize N, Garcia-Campelo R, Robinet G, Rodriguez-Abreu D, Lopez-Vivanco G, Gebbia V, Ferrera-Delgado L, Bombaron P, Bernabe R, Bearz A, Artal A, Cortesi E, Rolfo C, Sanchez-Ronco M, Drozdowskyj A, Queralt C, de Aguirre I, Ramirez JL, Sanchez JJ, Molina MA, Taron M, Paz-Ares L; Spanish Lung Cancer Group in collaboration with Groupe Français de Pneumo-Cancérologie and Associazione Italiana Oncologia Toracica. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012 Mar;13(3):239-46. doi: 10.1016/S1470-2045(11)70393-X. Epub 2012 Jan 26.

family: Rosell

full_name: Rafael Rosell

given: Rafael

sequence: first

family: Carcereny

full_name: Enric Carcereny

given: Enric

sequence: additional

family: Gervais

full_name: Radj Gervais

given: Radj

family: Vergnenegre

full_name: Alain Vergnenegre

given: Alain

family: Massuti

full_name: Bartomeu Massuti

given: Bartomeu

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

family: Palmero

full_name: Ramon Palmero

given: Ramon

family: Garcia-Gomez

full_name: Ramon Garcia-Gomez

family: Pallares

full_name: Cinta Pallares

given: Cinta

family: Sanchez

full_name: Jose Miguel Sanchez

given: Jose Miguel

family: Porta

full_name: Rut Porta

given: Rut

family: Cobo

full_name: Manuel Cobo

given: Manuel

family: Garrido

full_name: Pilar Garrido

given: Pilar

family: Longo

full_name: Flavia Longo

given: Flavia

family: Moran

full_name: Teresa Moran

given: Teresa

family: Insa

full_name: Amelia Insa

given: Amelia

family: De Marinis

full_name: Filippo De Marinis

given: Filippo

family: Corre

full_name: Romain Corre

given: Romain

family: Bover

full_name: Isabel Bover

given: Isabel

family: Illiano

full_name: Alfonso Illiano

given: Alfonso

family: Dansin

full_name: Eric Dansin

given: Eric

family: de Castro

full_name: Javier de Castro

given: Javier

ReferenceCitation: Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabárbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32.

ReferenceCitation: Chouaid C, Moser A, Coudray-Omnès C, Vergnenègre A. [Economic impact of second- and third-line erlotinib treatment of non small-cell lung cancer]. Rev Mal Respir. 2008 Nov;25(9):1096-103. French.

ReferenceCitation: Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer. 1981 Jan 1;47(1):207-14.

ReferenceCitation: Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16.

ReferenceCitation: Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

ReferenceCitation: Shankar LK, Hoffman JM, Bacharach S, Graham MM, Karp J, Lammertsma AA, Larson S, Mankoff DA, Siegel BA, Van den Abbeele A, Yap J, Sullivan D; National Cancer Institute. Consensus recommendations for the use of 18F-FDG PET as an indicator of therapeutic response in patients in National Cancer Institute Trials. J Nucl Med. 2006 Jun;47(6):1059-66.

ReferenceCitation: Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors. J Nucl Med. 2009 May;50 Suppl 1:122S-50S. doi: 10.2967/jnumed.108.057307. Review.

ReferenceCitation: Dittmann H, Dohmen BM, Kehlbach R, Bartusek G, Pritzkow M, Sarbia M, Bares R. Early changes in [18F]FLT uptake after chemotherapy: an experimental study. Eur J Nucl Med Mol Imaging. 2002 Nov;29(11):1462-9. Epub 2002 Sep 6.

ReferenceCitation: Barthel H, Perumal M, Latigo J, He Q, Brady F, Luthra SK, Price PM, Aboagye EO. The uptake of 3'-deoxy-3'-[18F]fluorothymidine into L5178Y tumours in vivo is dependent on thymidine kinase 1 protein levels. Eur J Nucl Med Mol Imaging. 2005 Mar;32(3):257-63. Epub 2004 Sep 4.

ReferenceCitation: Oyama N, Ponde DE, Dence C, Kim J, Tai YC, Welch MJ. Monitoring of therapy in androgen-dependent prostate tumor model by measuring tumor proliferation. J Nucl Med. 2004 Mar;45(3):519-25.

ReferenceCitation: Sugiyama M, Sakahara H, Sato K, Harada N, Fukumoto D, Kakiuchi T, Hirano T, Kohno E, Tsukada H. Evaluation of 3'-deoxy-3'-18F-fluorothymidine for monitoring tumor response to radiotherapy and photodynamic therapy in mice. J Nucl Med. 2004 Oct;45(10):1754-8.

ReferenceCitation: Graf N, Herrmann K, den Hollander J, Fend F, Schuster T, Wester HJ, Senekowitsch-Schmidtke R, zum Büschenfelde CM, Peschel C, Schwaiger M, Dechow T, Buck AK. Imaging proliferation to monitor early response of lymphoma to cytotoxic treatment. Mol Imaging Biol. 2008 Nov-Dec;10(6):349-55. doi: 10.1007/s11307-008-0162-3. Epub 2008 Aug 14.

ReferenceCitation: Jensen MM, Erichsen KD, Björkling F, Madsen J, Jensen PB, Højgaard L, Sehested M, Kjær A. Early detection of response to experimental chemotherapeutic Top216 with [18F]FLT and [18F]FDG PET in human ovary cancer xenografts in mice. PLoS One. 2010 Sep 24;5(9):e12965. doi: 10.1371/journal.pone.0012965.

ReferenceCitation: Leyton J, Latigo JR, Perumal M, Dhaliwal H, He Q, Aboagye EO. Early detection of tumor response to chemotherapy by 3'-deoxy-3'-[18F]fluorothymidine positron emission tomography: the effect of cisplatin on a fibrosarcoma tumor model in vivo. Cancer Res. 2005 May 15;65(10):4202-10.

ReferenceCitation: Apisarnthanarax S, Alauddin MM, Mourtada F, Ariga H, Raju U, Mawlawi O, Han D, Bornmann WG, Ajani JA, Milas L, Gelovani JG, Chao KS. Early detection of chemoradioresponse in esophageal carcinoma by 3'-deoxy-3'-3H-fluorothymidine using preclinical tumor models. Clin Cancer Res. 2006 Aug 1;12(15):4590-7.

ReferenceCitation: Molthoff CF, Klabbers BM, Berkhof J, Felten JT, van Gelder M, Windhorst AD, Slotman BJ, Lammertsma AA. Monitoring response to radiotherapy in human squamous cell cancer bearing nude mice: comparison of 2'-deoxy-2'-[18F]fluoro-D-glucose (FDG) and 3'-[18F]fluoro-3'-deoxythymidine (FLT). Mol Imaging Biol. 2007 Nov-Dec;9(6):340-7.

ReferenceCitation: Atkinson DM, Clarke MJ, Mladek AC, Carlson BL, Trump DP, Jacobson MS, Kemp BJ, Lowe VJ, Sarkaria JN. Using fluorodeoxythymidine to monitor anti-EGFR inhibitor therapy in squamous cell carcinoma xenografts. Head Neck. 2008 Jun;30(6):790-9. doi: 10.1002/hed.20770.

ReferenceCitation: Ullrich RT, Zander T, Neumaier B, Koker M, Shimamura T, Waerzeggers Y, Borgman CL, Tawadros S, Li H, Sos ML, Backes H, Shapiro GI, Wolf J, Jacobs AH, Thomas RK, Winkeler A. Early detection of erlotinib treatment response in NSCLC by 3'-deoxy-3'-[F]-fluoro-L-thymidine ([F]FLT) positron emission tomography (PET). PLoS One. 2008;3(12):e3908. doi: 10.1371/journal.pone.0003908. Epub 2008 Dec 12.

ReferenceCitation: Wei LH, Su H, Hildebrandt IJ, Phelps ME, Czernin J, Weber WA. Changes in tumor metabolism as readout for Mammalian target of rapamycin kinase inhibition by rapamycin in glioblastoma. Clin Cancer Res. 2008 Jun 1;14(11):3416-26. doi: 10.1158/1078-0432.CCR-07-1824.

ReferenceCitation: Brepoels L, Stroobants S, Verhoef G, De Groot T, Mortelmans L, De Wolf-Peeters C. (18)F-FDG and (18)F-FLT uptake early after cyclophosphamide and mTOR inhibition in an experimental lymphoma model. J Nucl Med. 2009 Jul;50(7):1102-9. doi: 10.2967/jnumed.109.062208. Epub 2009 Jun 12.

ReferenceCitation: Buck AK, Kratochwil C, Glatting G, Juweid M, Bommer M, Tepsic D, Vogg AT, Mattfeldt T, Neumaier B, Möller P, Reske SN. Early assessment of therapy response in malignant lymphoma with the thymidine analogue [18F]FLT. Eur J Nucl Med Mol Imaging. 2007 Nov;34(11):1775-82. Epub 2007 May 31.

ReferenceCitation: McKinley ET, Ayers GD, Smith RA, Saleh SA, Zhao P, Washington MK, Coffey RJ, Manning HC. Limits of [18F]-FLT PET as a biomarker of proliferation in oncology. PLoS One. 2013;8(3):e58938. doi: 10.1371/journal.pone.0058938. Epub 2013 Mar 15.

ReferenceCitation: Lawrence J, Vanderhoek M, Barbee D, Jeraj R, Tumas DB, Vail DM. Use of 3'-deoxy-3'-[18F]fluorothymidine PET/CT for evaluating response to cytotoxic chemotherapy in dogs with non-Hodgkin's lymphoma. Vet Radiol Ultrasound. 2009 Nov-Dec;50(6):660-8.

ReferenceCitation: Sohn HJ, Yang YJ, Ryu JS, Oh SJ, Im KC, Moon DH, Lee DH, Suh C, Lee JS, Kim SW. [18F]Fluorothymidine positron emission tomography before and 7 days after gefitinib treatment predicts response in patients with advanced adenocarcinoma of the lung. Clin Cancer Res. 2008 Nov 15;14(22):7423-9. doi: 10.1158/1078-0432.CCR-08-0312.

ReferenceCitation: Zander T, Scheffler M, Nogova L, Kobe C, Engel-Riedel W, Hellmich M, Papachristou I, Toepelt K, Draube A, Heukamp L, Buettner R, Ko YD, Ullrich RT, Smit E, Boellaard R, Lammertsma AA, Hallek M, Jacobs AH, Schlesinger A, Schulte K, Querings S, Stoelben E, Neumaier B, Thomas RK, Dietlein M, Wolf J. Early prediction of nonprogression in advanced non-small-cell lung cancer treated with erlotinib by using [(18)F]fluorodeoxyglucose and [(18)F]fluorothymidine positron emission tomography. J Clin Oncol. 2011 May 1;29(13):1701-8. doi: 10.1200/JCO.2010.32.4939. Epub 2011 Mar 21.

ReferenceCitation: Mileshkin L, Hicks RJ, Hughes BG, Mitchell PL, Charu V, Gitlitz BJ, Macfarlane D, Solomon B, Amler LC, Yu W, Pirzkall A, Fine BM. Changes in 18F-fluorodeoxyglucose and 18F-fluorodeoxythymidine positron emission tomography imaging in patients with non-small cell lung cancer treated with erlotinib. Clin Cancer Res. 2011 May 15;17(10):3304-15. doi: 10.1158/1078-0432.CCR-10-2763. Epub 2011 Mar 1.

ReferenceCitation: Benz MR, Herrmann K, Walter F, Garon EB, Reckamp KL, Figlin R, Phelps ME, Weber WA, Czernin J, Allen-Auerbach MS. (18)F-FDG PET/CT for monitoring treatment responses to the epidermal growth factor receptor inhibitor erlotinib. J Nucl Med. 2011 Nov;52(11):1684-1689. doi: 10.2967/jnumed.111.095257.

ReferenceCitation: Girard N, Sima CS, Jackman DM, Sequist LV, Chen H, Yang JC, Ji H, Waltman B, Rosell R, Taron M, Zakowski MF, Ladanyi M, Riely G, Pao W. Nomogram to predict the presence of EGFR activating mutation in lung adenocarcinoma. Eur Respir J. 2012 Feb;39(2):366-72. doi: 10.1183/09031936.00010111. Epub 2011 Jul 20.

ReferenceCitation: Garassino MC, Martelli O, Broggini M, Farina G, Veronese S, Rulli E, Bianchi F, Bettini A, Longo F, Moscetti L, Tomirotti M, Marabese M, Ganzinelli M, Lauricella C, Labianca R, Floriani I, Giaccone G, Torri V, Scanni A, Marsoni S; TAILOR trialists. Erlotinib versus docetaxel as second-line treatment of patients with advanced non-small-cell lung cancer and wild-type EGFR tumours (TAILOR): a randomised controlled trial. Lancet Oncol. 2013 Sep;14(10):981-8. doi: 10.1016/S1470-2045(13)70310-3. Epub 2013 Jul 22.

ReferenceCitation: Bouchet F, Geworski L, Knoop BO, Ferrer L, Barriolo-Riedinger A, Millardet C, Fourcade M, Martineau A, Belly-Poinsignon A, Djoumessi F, Tendero K, Keros L, Montoya F, Mesleard C, Martin AL, Lacoeuille F, Couturier O. Calibration test of PET scanners in a multi-centre clinical trial on breast cancer therapy monitoring using 18F-FLT. PLoS One. 2013;8(3):e58152. doi: 10.1371/journal.pone.0058152. Epub 2013 Mar 13.

ReferenceCitation: Laffon E, Bardiès M, Barbet J, Marthan R. Calculating an estimate of tissue integrated activity in 18F-FDG PET imaging using one SUV value. EJNMMI Res. 2013 Apr 5;3(1):26. doi: 10.1186/2191-219X-3-26.

ReferenceCitation: Kahraman D, Scheffler M, Zander T, Nogova L, Lammertsma AA, Boellaard R, Neumaier B, Ullrich RT, Holstein A, Dietlein M, Wolf J, Kobe C. Quantitative analysis of response to treatment with erlotinib in advanced non-small cell lung cancer using 18F-FDG and 3'-deoxy-3'-18F-fluorothymidine PET. J Nucl Med. 2011 Dec;52(12):1871-7. doi: 10.2967/jnumed.111.094458. Epub 2011 Nov 7.

location_facility:
University Hospital, Bordeaux
University Hospital, Toulouse
University Hospital, Nancy
Army Hospital, Percy
University Hospital, Rouen
University Hospital, Tours
University Hospital, Angers
Hospital, Créteil


type: Other Identifier

title: The EUropean TRAnsplantation and INnovation Consortium for Risk Stratification in Kidney Transplant Patients

acronym: EU-TRAIN

summary: Main objective: To design a precision risk stratification system that predicts individual risk of rejection

study_start_date_type: Actual

status: Active, not recruiting

study_type: Observational

time_perspective: Prospective

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_country: Germany France Switzerland Spain

location_facility:
Hôpital Necker
Hospital La Charité
Hopital Saint Louis
Hôpitaux Universitaires de Genève
Hospital La Charité Campus Virchow
Hospital Bellvitge
CHU Nantes
Hôpital du Kremlin Bicêtre
Hospital Vall d'Hebron

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


title: Multicenter Observatory to Assess the Yukon Choice PC & the Yukon Chrome PC Sirolimus Eluting Bioabsorbable Polymer Stents Systems in Routine Clinical Practice

acronym: YuChooSeR

summary:
The TRANSLUMINA GmbH YuChooSeR Observatory is a prospective, multicentric post-marketing observatory designed to evaluate large scale safety and reliability of the Yukon Choice PC and the Yukon Chrome PC stents systems use in routine, clinical practice.

This based observatory will enroll 2000 patients from 14 to 30 sites in France.

status: Recruiting

ipd_sharing: No

lead_sponsor: Translumina GmbH

location_facility:
Clinique Axium
Centre Hospitalier Haguenau
Clinique Saint Hilaire
Hopital A. Schweitzer - Ghca
Clinique Pasteur
Centre Hospitalier Sud Francilien
Polyclinique Saint-Laurent

intervention_type: Device

lead_sponsor_type: industriel


title: Dimensional and Developmental Approach to Psychotic Episodes in Children and Adolescents: Impact on Clinical Management

acronym: PSYDEV

summary: Five collaborating sites in France will study the broad spectrum of schizophrenia in children and adolescents. Patients will be studied with diagnostic interviews, developmental histories, dimensional clinical ratings, comprehensive cognitive assessments, neuroimaging and DNA (copy number variant) analyses (in families and patients who agree), and follow-up of course of illness, cognitive status and treatment response to specific antipsychotic drugs. The goal of the study is to test a prior hypothesis about clinical subgroups in this population and to test whether these subgroups predict antipsychotic medication response.

primary_purpose: Other

ipd_sharing: Undecided

location_facility:
CHU de Rouvray
CHRU de Lille
CHU de Nice
Fondation Vallée, Gentilly
Pitié Salpétrière
CHU de Rouen

intervention_type: Other


title: Severity of the New UK SARS-Cov2 Variant in COVID-19 Infection

acronym: SEVASAR

summary: The COVID-19 epidemic has now raged for more than a year with more than 100 million identified cases and nearly 2.5 million deaths worldwide. Since November 2020, we have been witnessing the emergence of viral variants in different regions of the world. This expected genetic drift of the virus, but somewhat abrupt since November, raises questions concerning the characteristics of transmissibility, pathogenicity, sensitivity to possible treatments, and escape from natural or vaccine immunity. The objective of this study is to find out whether the new variants of SARS-CoV-2 are associated with particular clinical forms. The results of this research will provide elements to determine whether the new variants of SARS-CoV-2 are associated with more severe clinical forms.

time_perspective: Other

lead_sponsor: ANRS, Emerging Infectious Diseases

location_country: Martinique France

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Centre Hospitalier Châteaubriant Nozay Pouancé


title: A Prospective Randomized Phase II Study Assess the Schema of Retreatment With Lutathera® ([177LU]LU-DOTA-TATE) in Patients With New Progression of Intestinal Well-differenciated Neuroendocrine Tumor

acronym: ReLUTH

summary: In France, since the reimbursement of Lutathera®, this treatment is allowed for retreatment if patients still fulfill the criteria of its indication and 4 news cycles could be proposed. However, clinical practices are heterogeneous regarding the number of new cycles and most teams perform only two additional cycles (every 8 weeks). Therefore, the coordinator propose to evaluate the efficacy of two additional cycle of Lutathera® versus active surveillance in patients already retreated with two cycles Lutathera® for a new progression of intestinal neuroendocrine tumor and who previously received the 4 cycles of treatment with a clinical benefit.

study_start_date_type: Anticipated

status: Not yet recruiting

design_allocation: Randomized

primary_purpose: Treatment

ReferenceCitation: Yao JC, Hassan M, Phan A, Dagohoy C, Leary C, Mares JE, Abdalla EK, Fleming JB, Vauthey JN, Rashid A, Evans DB. One hundred years after "carcinoid": epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States. J Clin Oncol. 2008 Jun 20;26(18):3063-72. doi: 10.1200/JCO.2007.15.4377. Review.

ReferenceCitation: Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, Mittra E, Kunz PL, Kulke MH, Jacene H, Bushnell D, O'Dorisio TM, Baum RP, Kulkarni HR, Caplin M, Lebtahi R, Hobday T, Delpassand E, Van Cutsem E, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Öberg K, Lopera Sierra M, Santoro P, Thevenet T, Erion JL, Ruszniewski P, Kwekkeboom D, Krenning E; NETTER-1 Trial Investigators. Phase 3 Trial of (177)Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med. 2017 Jan 12;376(2):125-135. doi: 10.1056/NEJMoa1607427.

family: Strosberg

full_name: Jonathan Strosberg

given: Jonathan

family: El-Haddad

full_name: Ghassan El-Haddad

given: Ghassan

family: Wolin

full_name: Edward Wolin

given: Edward

family: Hendifar

full_name: Andrew Hendifar

given: Andrew

family: Yao

full_name: James Yao

given: James

family: Chasen

full_name: Beth Chasen

given: Beth

family: Mittra

full_name: Erik Mittra

given: Erik

family: Kunz

full_name: Pamela L. Kunz

given: Pamela L.

family: Kulke

full_name: Matthew H. Kulke

given: Matthew H.

family: Jacene

full_name: Heather Jacene

given: Heather

family: Bushnell

full_name: David Bushnell

given: David

family: O’Dorisio

full_name: Thomas M. O’Dorisio

given: Thomas M.

family: Baum

full_name: Richard P. Baum

given: Richard P.

family: Kulkarni

full_name: Harshad R. Kulkarni

given: Harshad R.

family: Caplin

full_name: Martyn Caplin

given: Martyn

family: Lebtahi

full_name: Rachida Lebtahi

given: Rachida

family: Hobday

full_name: Timothy Hobday

given: Timothy

family: Delpassand

full_name: Ebrahim Delpassand

given: Ebrahim

family: Van Cutsem

full_name: Eric Van Cutsem

family: Benson

full_name: Al Benson

given: Al

family: Srirajaskanthan

full_name: Rajaventhan Srirajaskanthan

given: Rajaventhan

family: Pavel

full_name: Marianne Pavel

given: Marianne

family: Mora

full_name: Jaime Mora

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

title: Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors

ReferenceCitation: Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum RP, Kunz P, Hobday T, Hendifar A, Oberg K, Sierra ML, Thevenet T, Margalet I, Ruszniewski P, Krenning E; NETTER-1 Study Group. Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With (177)Lu-Dotatate in the Phase III NETTER-1 Trial. J Clin Oncol. 2018 Sep 1;36(25):2578-2584. doi: 10.1200/JCO.2018.78.5865. Epub 2018 Jun 7.

name: Jonathan Strosberg, Moffitt Cancer Center, Tampa, FL; Edward Wolin, Montefiore Einstein Center for Cancer Care, Bronx, NY; Beth Chasen, University of Texas MD Anderson Cancer Center, Houston, TX; Matthew Kulke, Dana-Farber Cancer Institute, Boston, MA; David Bushnell, University of Iowa, Iowa City, IA; Martyn Caplin, Royal Free Hospital, London, United Kingdom; Richard P. Baum, Zentralklinik, Bad Berka, Germany; Pamela Kunz, Stanford University Medical Center, Stanford; Andrew Hendifar, Cedars Sinai...

publisher: American Society of Clinical Oncology (ASCO)

title: Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 Trial

ReferenceCitation: Rudisile S, Gosewisch A, Wenter V, Unterrainer M, Böning G, Gildehaus FJ, Fendler WP, Auernhammer CJ, Spitzweg C, Bartenstein P, Todica A, Ilhan H. Salvage PRRT with (177)Lu-DOTA-octreotate in extensively pretreated patients with metastatic neuroendocrine tumor (NET): dosimetry, toxicity, efficacy, and survival. BMC Cancer. 2019 Aug 8;19(1):788. doi: 10.1186/s12885-019-6000-y.

ReferenceCitation: Vaughan E, Machta J, Walker M, Toumpanakis C, Caplin M, Navalkissoor S. Retreatment with peptide receptor radionuclide therapy in patients with progressing neuroendocrine tumours: efficacy and prognostic factors for response. Br J Radiol. 2018 Nov;91(1091):20180041. doi: 10.1259/bjr.20180041. Epub 2018 Mar 20.

ReferenceCitation: Yordanova A, Mayer K, Brossart P, Gonzalez-Carmona MA, Strassburg CP, Essler M, Ahmadzadehfar H. Safety of multiple repeated cycles of (177)Lu-octreotate in patients with recurrent neuroendocrine tumour. Eur J Nucl Med Mol Imaging. 2017 Jul;44(7):1207-1214. doi: 10.1007/s00259-017-3652-1. Epub 2017 Mar 1.

ReferenceCitation: Sabet A, Haslerud T, Pape UF, Sabet A, Ahmadzadehfar H, Grünwald F, Guhlke S, Biersack HJ, Ezziddin S. Outcome and toxicity of salvage therapy with 177Lu-octreotate in patients with metastatic gastroenteropancreatic neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 2014 Feb;41(2):205-10. doi: 10.1007/s00259-013-2547-z. Epub 2013 Sep 13.

ReferenceCitation: van Essen M, Krenning EP, Kam BL, de Herder WW, Feelders RA, Kwekkeboom DJ. Salvage therapy with (177)Lu-octreotate in patients with bronchial and gastroenteropancreatic neuroendocrine tumors. J Nucl Med. 2010 Mar;51(3):383-90. doi: 10.2967/jnumed.109.068957. Epub 2010 Feb 11.

ReferenceCitation: Gleisner KS, Brolin G, Sundlöv A, Mjekiqi E, Östlund K, Tennvall J, Larsson E. Long-Term Retention of 177Lu/177mLu-DOTATATE in Patients Investigated by γ-Spectrometry and γ-Camera Imaging. J Nucl Med. 2015 Jul;56(7):976-84. doi: 10.2967/jnumed.115.155390. Epub 2015 May 21.

ReferenceCitation: Sundlöv A, Sjögreen-Gleisner K, Svensson J, Ljungberg M, Olsson T, Bernhardt P, Tennvall J. Individualised (177)Lu-DOTATATE treatment of neuroendocrine tumours based on kidney dosimetry. Eur J Nucl Med Mol Imaging. 2017 Aug;44(9):1480-1489. doi: 10.1007/s00259-017-3678-4. Epub 2017 Mar 22.

ReferenceCitation: Del Prete M, Buteau FA, Arsenault F, Saighi N, Bouchard LO, Beaulieu A, Beauregard JM. Personalized (177)Lu-octreotate peptide receptor radionuclide therapy of neuroendocrine tumours: initial results from the P-PRRT trial. Eur J Nucl Med Mol Imaging. 2019 Mar;46(3):728-742. doi: 10.1007/s00259-018-4209-7. Epub 2018 Nov 30.

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

location_facility:
CHRU Lille
Centre Antoine Lacassagne
Hôpital Haut-Lévêque
Hospices civils de LYON - GHE
Institut de Cancérologie de l'Ouest
CHRU Morvan
Centre Jean Perrin
Hôpital de la Timone
Hôpital Cochin
IUCT Oncopole
ICM Val d'Aurelle
CHU Nantes
CHRU Nancy Brabois
Institut Bergonié
Hôpital Pitié Salpétrière
Institut Gustave Roussy
CHU Grenoble Alpes (CHUGA)
Centre léon bérard


title: Changes in Body Core Temperature During a 25-km Open Water Race in Elite Swimmers: Identifying Predictors for Hypothermia and Dropouts

summary: Open water swimming is a swimming discipline which takes place in outdoor water such as open oceans, lakes, and rivers. Elite swimmers are exposed to hypothermia when swimming in cold water, especially in long duration races, such as the 25-km race. The objective of this study is to evaluate the change in body core temperature in swimmers with continuous temperature monitoring during a 25-km race. The secondary objective is to identify the predictors of hypothermia and hypothermia-related drop-out.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: University Hospital, Caen

status_simplified: Completed


title: Continuous Deep Sedation Until Death Following a Decision to Limit or Stop Treatment in Intensive Care and in Continuous Surveillance Units

acronym: SPCMD-REA

summary: This research is a descriptive observational study conducted in multicenter (intensive care and continuing care units) in France. All data collected is part of the patient record. The main objective is to describe the end-of-life sedative practices following a decision to limit or stop therapy in intensive care unit and continuing care unit.

time_perspective: Retrospective

lead_sponsor: Société Française d'Anesthésie et de Réanimation

location_facility: Hôpital d'Instruction des Armées Sainte Anne

location_facility: Hôpital Pitié-Salpêtrière - Réa neuro chir

location_facility: CHU MONTPELLIER - Hôpital Arnaud de Villeneuve

location_facility: CHU Clermont-Ferrand - Site de Gabriel Montpied - Neuroréanimation

location_facility: CHU de Rennes - Réanimation chirurgicale

location_facility: Groupe hospitalier de la région de Mulhouse et Sud-Alsace _ GHRMSA Mulhouse

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: CHU Clermont-Ferrand - Site de Gabriel Montpied - Réa médico chir

location_facility: Centre Hospitalier Bretagne Atlantique de Vannes

location_facility: Hôpital Pitié-Salpêtrière - Réanimation Polyvalente

location_facility: Centre Hospitalier de Laon - Réanimation Polyvalente

location_facility: CHU Rouen - Réanimation cardiaque chirurgicale

location_facility: CHU Rangueil - Toulouse - Réanimation de Néphrologie et Transplantation

location_facility: Centre Hospitalier territorial de Nouméa en Nouvelle Calédonie

location_facility: CHU de Montpellier - Hopital Gui de Chauliac - Réa médicale

location_facility: CHRU de Lille - service de déchocage et de soins intensifs - Urgence

location_facility: Hôpital Privé Gériatrique Les Sources- Nice


title: Frequency of Hypoglycemia in Patients With Type 2 Diabetes Under Insulin Therapy Older Than 75 Years in Real Life

acronym: HYPOAGE

summary:
Diabetes is a chronic and progressive disease that affects nearly 3.5 million people in France.

Currently the investigators are seeing an aging of the population explained by the increase in life expectancy and thus an increasing incidence of diabetes in the elderly. However, the frequency of hypoglycemia in older vulnerable patients remains poorly characterized

status: Terminated

lead_sponsor: Nantes University Hospital

location_facility:
Hôpital Sud Francilien
CHU de Nantes
CHRU de Lille
CHU d'Angers
CH d'Ancenis
CHU de Poitiers
CHU de Toulouse

status_simplified: Unknown


title: Efficacy of a Polyamine-free Diet Associated or Not With Ketamine on Early and Late Hyperalgesia After Breast Cancer Surgery

acronym: PoLyDOL

summary: After surgery, sensitization and hyperexcitability of central nervous system result in acute and long lasting postoperative pain. It has been shown that N-methyl-D-aspartate (NMDA) receptors antagonist (such as ketamine) prevent this adverse neuroplasticity and potentiate analgesic drugs efficacy. Polyamines (putrescine, spermidine, spermine) are essential components of cells functioning and are also known as allosteric modulators of NMDA receptors. In animal studies, polyamine-free diet has confirmed these antinociceptive properties. This research aims at evaluating anti hyperalgesic properties of polyamine-free diet in women operated on breast cancer versus kétamine

lead_sponsor: University Hospital, Bordeaux

location_facility: département d'anesthésie-réanimation 3, hôpital Pellegrin

location_facility: APHParis Hôpital Pitié Salpétrière - Dépt. d'anesthésie réanimation

location_facility: CLCC-Institut Bergonie, service d'anesthésie réanimation, 229 cours de l'Argonne

intervention_type: Drug


title: Évaluation de la Congestion en Hospitalisation de Jour Pour un Bilan d'Insuffisance Cardiaque Chronique. CHF-COV (Chronic Heart Failure - COngestion eValuation)

acronym: CHF-COV

summary:
Heart failure (HF) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. Congestion is the main source of symptoms and the leading cause of hospitalization for HF. Furthermore, congestive signs identified in asymptomatic patients are associated with the risk of developing symptomatic HF. The literature supports a multi-modality / integrative evaluation of congestion, combining clinical examination, laboratory results and ultrasound evaluation.

The main objective of the CHF-COV study is to identify congestion markers (clinical, biological and ultrasound) in day hospitalization for chronic HF monitoring that are associated with the risk of all-cause death or hospitalization for acute HF within 24 months after day hospitalization.

primary_purpose: Diagnostic

lead_sponsor: Pr. Nicolas GIRERD


title: Role of 18FDG PET in the Evaluation of Early Response to Maintenance Treatment With Bevacizumab or Pemetrexed in Advanced Non-small-cell Lung Cancer

acronym: CALMETTE

summary:
Non small cell lung cancer is the first cause of cancer related death in France and is becoming an increasing health problem in developing countries.

Recently for patient with no progression disease after first line chemotherapy, new therapies were validated in maintenance (bevacizumab) or switch maintenance treatment (erlotinib, pemetrexed) with improved survival.

Until now, determination of efficiency of treatment is only based on morphological response (RECIST) and remains inappropriate to such cytostatic drugs for which there is no anatomical lesion modification.

Nuclear Medicine and especially 18-FDG Positron Emission Tomography (PET) offers a biologically relevant tool for assessment of tumour response therapies.

The assumption of the study is that FDG PET would allow to earlier detect a lack of response, thereafter, to modify an ineffective treatment. Indeed, nowadays the treatment is maintained up to evidence of progression disease.

However, despite the increasing use of FDG PET for predicting therapeutic response, there are no validated criteria for judging response of maintenance therapy in non-small cell lung cancer.

It seems necessary to determine standardized criteria response, earlier during the course of maintenance therapy in patient with non small cell lung cancer.

The final aim is to optimize survival by an adapted metabolic imaging guided therapy.

lead_sponsor: Centre Henri Becquerel

location_facility: Centre hospitalier intercommunal Elbeuf Louviers


title: Evaluation of the Benefit at 6 Months of a 3 Weeks Spa Treatment in the Type 2 Diabetic Patient. Multicenter Randomized Therapeutic Trial

summary:
Diabetes mellitus is a metabolic disorder characterized by chronic hyperglycemia due to deficiency in either insulin secretion, insulin action, or both. There are different types of diabetes. The most common nowadays is type 2 diabetes, characterized by insulin resistance and a relative deficiency of insulin secretion, either of which may dominate to a varying degree. This form of diabetes occurs mainly in mature adults but can also occur at a younger age, or even during adolescence.

According to estimates, the number of diabetic subjects in the world increased from 153 million in 1980 to 347 million in 2008. In France, the prevalence of diabetes treated increased from 2.6% to 4.4% between 2000 and 2009, reaching nearly 3 million people. Type 2 diabetes accounts for 92% of cases of diabetes treated, and its share continues to increase due to a relative stability of type 1 diabetes and a steady increase in type 2 diabetes (5.4% per year). The aging of the population, the increase in obesity and the lack of physical activity contribute to the development of type 2 diabetes. According to the Entred study conducted in France between 2001 and 2007, four out of five type 2 diabetic patients were either overweight (39%) or obese (41%).

In the long term, unbalanced diabetes exposes to macro-vascular complications such as myocardial infarction and stroke, and microvascular complications affecting the peripheral nervous system, kidneys, retina may result in amputation of the lower limb, renal failure and blindness, respectively. As a result, the risk of death for diabetics is at least twice as high as for non-diabetics.

However, a good control of the disease by a lifestyle adaptation (lifestyle and dietary measures, physical activity) with good medical care, and possibly pharmacological, can avoid or significantly reduce the risk of complications. The purpose of dietary and lifestyle measures is to reduce hyperglycaemia and to control the weight of the patient. The implementation of effective dietary measures is a necessary prerequisite for the medication treatment of glycemic control and their application should be continued throughout the course of treatment. The treatment of other cardiovascular risk factors and complications of diabetes is also essential for the management of the diabetic patient.

The HAS (Haute Autorité de Santé : High Authority of Health) in its latest recommendations for a drug strategy for glycemic control of type 2 diabetes emphasizes that the short-term goal of decreasing hyperglycemia is the improvement of symptoms (thirst, polyuria, asthenia, weight loss and fuzziness visual) and the prevention of acute complications (infectious and hyperosmolar coma). The longer-term goal is the prevention of chronic microvascular complications (retinopathy, nephropathy and neuropathy), macrovascular (myocardial infarction, stroke, and peripheral arterial occlusive disease) and decreased mortality. The HAS notes, however, that HbA1c as a criterion for substituting morbidity and mortality endpoints in type 2 diabetes is not sufficiently supported in the scientific literature.

Be that as it may, HAS recommends individualizing the goal of glycemic control according to the profile of the patient and in particular to mobilize the recommended therapeutic means to reach the HbA1c target, in particular the dietary and hygiene measures. The data in the literature do not allow to define a lower limit for the HbA1c target. For most type 2 diabetic patients, an HbA1c target of less than or equal to 7% is recommended.

A target of 6.5% is recommended for newly diagnosed patients with no history of cardiovascular disease and a life expectancy of more than 15 years, as well as for women during pregnancy. An HbA1c target of 8% or less is recommended for patients with proven severe comorbidity and / or limited life expectancy (<5 years), or with advanced or long-lasting macrovascular complications diabetes (> 10 years) and for whom the target of 7% is difficult to achieve because drug intensification causes severe hypoglycaemia, or with a history of macrovascular complication considered as advanced, or with severe chronic renal insufficiency or (stages 4 and 5), as well as for the so-called frail elderly. For elderly people who are "sick", the priority is to avoid acute complications due to diabetes (dehydration, hyperosmolar coma) and hypoglycaemia; Pre-meal capillary glucose values of between 1 and 2 g / l and / or an HbA1c level of less than 9% are recommended. There are many molecules available on the pharmaceutical market to treat this disease (biguanides, hypoglycemic sulfonamides, DPP-4 inhibitors, GLP-1 analogues, alpha-glucosidase inhibitors, insulin, etc.). It is important to choose, depending on the clinical profile of the patient, the molecule (s) to be combined in order to achieve the glycated hemoglobin targets set by health organizations.

ReferenceCitation: Danaei G, Finucane MM, Lu Y, Singh GM, Cowan MJ, Paciorek CJ, Lin JK, Farzadfar F, Khang YH, Stevens GA, Rao M, Ali MK, Riley LM, Robinson CA, Ezzati M; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Blood Glucose). National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2·7 million participants. Lancet. 2011 Jul 2;378(9785):31-40. doi: 10.1016/S0140-6736(11)60679-X. Epub 2011 Jun 24. Review.

ReferenceCitation: Ampudia-Blasco FJ, Benhamou PY, Charpentier G, Consoli A, Diamant M, Gallwitz B, Khunti K, Mathieu C, Ridderstråle M, Seufert J, Tack C, Vilsbøll T, Phan TM, Stoevelaar H. A decision support tool for appropriate glucose-lowering therapy in patients with type 2 diabetes. Diabetes Technol Ther. 2015 Mar;17(3):194-202. doi: 10.1089/dia.2014.0260. Epub 2014 Oct 27.

ReferenceCitation: Debaty I, Halimi S, Quesada JL, Baudrant M, Allenet B, Benhamou PY. A prospective study of quality of life in 77 type 1 diabetic patients 12 months after a hospital therapeutic educational programme. Diabetes Metab. 2008 Nov;34(5):507-13. doi: 10.1016/j.diabet.2008.03.007. Epub 2008 Sep 30.

ReferenceCitation: Bradley C, Todd C, Gorton T, Symonds E, Martin A, Plowright R. The development of an individualized questionnaire measure of perceived impact of diabetes on quality of life: the ADDQoL. Qual Life Res. 1999;8(1-2):79-91.

ReferenceCitation: Forestier R, Desfour H, Tessier JM, Françon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.

family: Forestier

full_name: R. Forestier

given: R.

family: Desfour

full_name: H. Desfour

given: H.

family: Tessier

full_name: J.-M. Tessier

family: Francon

full_name: A. Francon

given: A.

family: Foote

full_name: A. M. Foote

given: A. M.

family: Genty

full_name: C. Genty

given: C.

family: Rolland

full_name: C. Rolland

family: Roques

full_name: C.-F. Roques

family: Bosson

full_name: J.-L. Bosson

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of the Rheumatic Diseases

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

version: submittedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Hanh T, Serog P, Fauconnier J, Batailler P, Mercier F, Roques CF, Blin P. One-year effectiveness of a 3-week balneotherapy program for the treatment of overweight or obesity. Evid Based Complement Alternat Med. 2012;2012:150839. doi: 10.1155/2012/150839. Epub 2012 Dec 24.

ReferenceCitation: Gin H, Demeaux JL, Grelaud A, Grolleau A, Droz-Perroteau C, Robinson P, Lassalle R, Abouelfath A, Boisseau M, Toussaint C, Moore N. Observation of the long-term effects of lifestyle intervention during balneotherapy in metabolic syndrome. Therapie. 2013 May-Jun;68(3):163-7. doi: 10.2515/therapie/2013025. Epub 2013 Jul 26.

lead_sponsor: Association Francaise pour la Recherche Thermale

location_facility:
CLERGEOT Annie
ROUSSEL Ludivine
WATERLOT
PARADIS Sabrina
SOUDET Simon
PENFORNIS Alfred
BETRY Cécile
DAOUDI
ODDOU Christel


title: High-flow Nasal Therapy for Early Management of Hypercapnic Respiratory Failure Due to Acute Cardiogenic Pulmonary Edema in the ED: a Prospective Observational Study

acronym: preopticap

summary: High flow nasal therapy (HFNT) has not been well evaluated for treating hypercapnia The purpose of this study is to determine whether high flow nasal therapy (HFNT) can decrease hypercapnia and improve respiratory distress parameters in Emergency Department patients with acute hypercapnic respiratory failure related to cardiogenic pulmonary edema and to compare its efficacy to that of non invasive ventilation.

ReferenceType: derived

ReferenceCitation: Marjanovic N, Flacher A, Drouet L, Gouhinec AL, Said H, Vigneau JF, Chollet B, Lefebvre S, Sebbane M. High-Flow Nasal Cannula in Early Emergency Department Management of Acute Hypercapnic Respiratory Failure Due to Cardiogenic Pulmonary Edema. Respir Care. 2020 Sep;65(9):1241-1249. doi: 10.4187/respcare.07278. Epub 2020 Apr 14.

family: Marjanovic

full_name: Nicolas Marjanovic

given: Nicolas

family: Flacher

full_name: Alexandre Flacher

given: Alexandre

family: Drouet

full_name: Loïc Drouet

given: Loïc

family: Gouhinec

full_name: Aude Le Gouhinec

given: Aude Le

family: Said

full_name: Hakim Said

given: Hakim

family: Vigneau

full_name: Jean-François Vigneau

given: Jean-François

family: Chollet

full_name: Barbara Chollet

given: Barbara

family: Lefebvre

full_name: Sophie Lefebvre

given: Sophie

family: Sebbane

full_name: Mustapha Sebbane

given: Mustapha

journal_name: Respiratory Care

publisher: Daedalus Enterprises

publisher_dissemination: Daedalus Enterprises

publisher_group: Daedalus Enterprises

publisher_normalized: Daedalus Enterprises

lead_sponsor: University Hospital, Montpellier


title: Contamination and Transmission of the SARS-CoV-2 Virus in Exposed, Confined and Community-based Infants: A Cross-sectional, Multicentre, Interventional Seroprevalence Study

acronym: COVIDOCRECHE

summary: According to epidemiological models, the seroprevalence of SARS-CoV-2 infection in Île-de-France as of 11 May was between 10 and 15%. Preliminary data on the number of professionals evicted from nurseries on suspicion of COVID-19 (on clinical grounds) seem to be of the same order of magnitude, but need to be confirmed by a biological technique. Children would be susceptible to infection but often asymptomatic.

ReferenceCitation: Lachassinne E, de Pontual L, Caseris M, Lorrot M, Guilluy C, Naud A, Dommergues MA, Pinquier D, Wannepain E, Hausherr E, Jung C, Gajdos V, Cohen R, Zahar JR, Brichler S, Basmaci R, Boelle PY, Bloch-Queyrat C, Aupiais C; COVIDOCRECHE collaborators. SARS-CoV-2 transmission among children and staff in daycare centres during a nationwide lockdown in France: a cross-sectional, multicentre, seroprevalence study. Lancet Child Adolesc Health. 2021 Apr;5(4):256-264. doi: 10.1016/S2352-4642(21)00024-9. Epub 2021 Feb 8.

family: Lachassinne

full_name: Eric Lachassinne

given: Eric

family: de Pontual

full_name: Loïc de Pontual

family: Caseris

full_name: Marion Caseris

given: Marion

family: Lorrot

full_name: Mathie Lorrot

given: Mathie

family: Guilluy

full_name: Carole Guilluy

given: Carole

family: Naud

full_name: Aurélie Naud

given: Aurélie

family: Dommergues

full_name: Marie-Aliette Dommergues

given: Marie-Aliette

family: Pinquier

full_name: Didier Pinquier

given: Didier

family: Wannepain

full_name: Evelyne Wannepain

given: Evelyne

family: Hausherr

full_name: Elisabeth Hausherr

given: Elisabeth

family: Jung

full_name: Camille Jung

given: Camille

family: Gajdos

full_name: Vincent Gajdos

given: Vincent

family: Cohen

full_name: Robert Cohen

given: Robert

family: Zahar

full_name: Jean-Ralph Zahar

given: Jean-Ralph

family: Brichler

full_name: Ségolène Brichler

given: Ségolène

family: Basmaci

full_name: Romain Basmaci

given: Romain

family: Boelle

full_name: Pierre-Yves Boelle

given: Pierre-Yves

family: Bloch-Queyrat

full_name: Coralie Bloch-Queyrat

given: Coralie

family: Aupiais

full_name: Camille Aupiais

family: Charbonnier

full_name: Lorelei Charbonnier

given: Lorelei

family: Chosidow

full_name: Anais Chosidow

given: Anais

family: Hentgen

full_name: Véronique Hentgen

given: Véronique

family: Lescano

full_name: Oscar Lescano

given: Oscar

location_facility: Hôpital Jean Verdier - Service de Pédiatrie


title: Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Ancillary Study

summary: Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree. By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, postcare, and rehabilitation units, etc…). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves. The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.

lead_sponsor: Physio-Assist

location_facility: Nice University-Affiliated Hospital : Pneumo-pediatric department

location_facility: Grenoble University Hospital : pneumo-pediatric department

location_facility: Nice University-Affiliated Hospital : Pneumology department

location_facility: Grenoble University-Affiliated Hospital : Pneumology department


type: Registry Identifier

title: Study of Immune Tolerance and Capacity for Wound Healing of Patients With Recessive Dystrophic Epidermolysis Bullosa (RDEB)

acronym: RDEB

summary:
Recessive Dystrophic Epidermolysis Bullosa (RDEB) is one of the most severe rare inherited skin disorders affecting children and adults. Current medical care protocols for RDEB patients are limited to palliative procedures to treat blistering and erosive lesions, wounds, and severe local and systemic complications such as fusion and contracture of the digits, skin cancer, esophageal stricture, severe anemia, infections, malnutrition and growth retardation. However, current medical treatments still cannot prevent the recurrence of the lesions arising from defective expression of type VII collagen (COL7A1), the main constituent of anchoring fibrils which form essential structures for dermal-epidermal adherence.

The purpose of this study is to investigate the capacity of keratinocytes and fibroblasts to repair skin wounds in patients suffering from Recessive Dystrophic Epidermolysis Bullosa (RDEB).

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

location_country:
United Kingdom
France

location_facility: Inserm U781 Service de Génétique Necker Hospital for sick children

location_facility: Service de dermatologie Necker Hospital for sick children

location_facility: Guy's and ST Thomas NHS Foundation trust/Guy's Hospital


title: Effectiveness of Ustekinumab in Patients Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases in a Real-world Setting

acronym: TENOR

summary: The purpose of this study is to assess the effectiveness of ustekinumab on extra-intestinal manifestations (EIMs) and immune-mediated inflammatory diseases (IMIDs) associated with inflammatory bowel disease (IBD) (both Crohn's Disease [CD] and Ulcerative Colitis [UC]).

lead_sponsor: Janssen Cilag S.A.S.


title: Prospective, Multicenter, Non-interventional Study to Characterize Profile of Patient With Psoriatic Arthritis Depending on Whether Their Disease is Managed by a Dermatologist or by a Rheumatologist, and Starting Ustekinumab

summary: The primary purpose of this study is to describe the Psoriatic Arthritis (PsA) participant profiles depending on whether their disease is managed by a dermatologist or by a rheumatologist in routine practice.


title: Innate Immunity During Community Acquired Pneumonia: A Translational Approach

acronym: ImPACT

summary:
Community acquired pneumonia (CAP) is a major cause of morbidity and mortality worldwide. Despite recent improvement in acute management (specifically for administration of antibiotics) many severe presentations of pneumonia worsen, progressing to Acute Respiratory Distress Syndrome (ARDS), a clinical entity with 40% hospital mortality.

Dysregulation of immune response is thought to be largely implicated in severe pneumonia progressing to ARDS. Notably, experimental studies have recently suggested the implication of non-conventional T lymphocytes and innate cells in this immunopathology. However, no data are available in Humans in clinical settings.

This study aims to explore the role of non-conventional T cells in pneumonia and ARDS, in participants. For this purpose, 100 participants admitted to Intensive Care Unit (ICU) with a diagnosis of CAP will be included, and 50 "control" participants with no pneumonia nor shock. Presence and functionality of non-conventional T cells and innate cells will be explored using flow-cytometry and ex-vivo stimulation, alongside with cytokines productions. These analyses are conducted in the blood, and, for invasively ventilated participants, in tracheal aspirates or broncho-alveolar fluids if available. For each participants included, the analyses are conducted at different time-points during ICU stay: inclusion, day 3, day 8 and day 15. Moreover, participants with ARDS, for whom a post-ICU follow-up program is normally established after discharge, will have blood analysis from blood samples taken during the follow-up visit up to 8 months after inclusion.

Immunophenotypage and functionality of non-conventional T cells and innate cells will be compared to clinical parameters and their evolution, between "CAP" participants and "Control" participants", and for each participants, according to the different time-point of analysis, in order to better understand dynamic of innate immunity during pneumonia and ARDS.

lead_sponsor: University Hospital, Tours

location_facility: University Hospitakl of TOURS Département of Pneumonia

location_facility: University Hospital -Bretonneau - Intensive Care

location_facility: University Hospital of Tours; INSERM CIC 1415


title: An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of M-M-R™II Manufactured With Recombinant Human Albumin (rHA) and VARIVAX® When Administered Concomitantly by Intramuscular (IM) Route or Subcutaneous (SC) Route at Two Separate Injection Sites in Healthy Subjects 12 to 18 Months of Age

summary:
Primary objective:

To compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of age using separate injection sites, a single dose of M-M-RTMII administered by IM route is as immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates to measles, mumps and rubella at 42 days following the vaccination.

AND/OR

To compare if, when given concomitantly with M-M-RTMII by the same route at 12-18 months of age using separate injection sites, a single dose of VARIVAX® administered by IM route is as immunogenic as a single dose of VARIVAX® administered by SC route in terms of response rate to varicella at 42 days following the vaccination

Secondary objectives:

To summarise the antibody titres to measles, mumps, rubella and varicella at 42 days following the vaccination in children immunised with M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC,
To evaluate the safety profiles of M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC.

ReferenceCitation: Gillet Y, Habermehl P, Thomas S, Eymin C, Fiquet A. Immunogenicity and safety of concomitant administration of a measles, mumps and rubella vaccine (M-M-RvaxPro) and a varicella vaccine (VARIVAX) by intramuscular or subcutaneous routes at separate injection sites: a randomised clinical trial. BMC Med. 2009 Apr 14;7:16. doi: 10.1186/1741-7015-7-16.

family: Gillet

full_name: Yves Gillet

given: Yves

family: Habermehl

full_name: Pirmin Habermehl

given: Pirmin

family: Thomas

full_name: Stéphane Thomas

given: Stéphane

family: Eymin

full_name: Cécile Eymin

given: Cécile

family: Fiquet

full_name: Anne Fiquet

given: Anne

currency_apc_doaj: GBP

journal_name: BMC Medicine

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Immunogenicity and safety of concomitant administration of a measles, mumps and rubella vaccine (M-M-RvaxPro®) and a varicella vaccine (VARIVAX®) by intramuscular or subcutaneous routes at separate injection sites: a randomised clinical trial

lead_sponsor: Merck Sharp & Dohme Corp.

location_country: Germany France

intervention_type: Biological


title: Impact of Combination of Clopidogrel With Aspirin on Postoperative Bleeding and Platelets Functions in Coronary Surgical Patients Treated Prophylactically With Tranexamic Acid: the ICARE Study.

acronym: ICARE

summary:
Aims Aspirin combined with clopidogrel is the treatment of choice for acute coronary syndromes. Although the maintenance of aspirin until surgery does not affect postoperative bleeding after coronary artery bypass graft (CABG) surgery, the latter may be dramatically increased when clopidogrel is continued over a period of 5 days preoperatively. Methods and results: This prospective observational study will include 136 consecutive patients scheduled for first-time CABG. Postoperative bleeding and blood transfusion requirements will be compared (non inferiority)between patients pretreated during a period of 5 days prior surgery by either aspirin alone or combined with clopidogrel. Tranexamic acid will be systematically used in all these patients considered as high risk for bleeding.

In concusion, this study has to to test the hypothesis that with tranexamic acid also, bleeding in the aspirin + clopidogrel group is not 25% more important than in the aspirin alone group after CABG surgery, according to the previous study using aprotinin.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere


title: Evaluation of Informal Opinions of the Infectious Disease Specialist Referent for the Good Use of AnTiBiotics in General Medicine

acronym: AIRBUS-ATB

summary:
The increase in bacterial resistance and the overuse of antibiotics have led health authorities to propose incentives for the proper use of antibiotics. Among these measures, the introduction of referring physicians for antibiotic therapy and tele-advisory devices for infectious diseases have shown positive effects on antibiotic prescriptions in hospitals. Today, an increase is observed in the consumption of antibiotics linked to ambulatory prescriptions.

The objective of the project is to deploy tele-advice devices for general practitioners and to evaluate the effects on ambulatory antibiotic dispensing.

AIRBUS-ATB is a prospective, multi-center, population-based, interrupted time-series observational study with a control group with 12 points before and 24 points after the deployment of the intervention in voluntary territories.

ReferenceCitation: Gennai S, François P, Sellier E, Vittoz JP, Hincky-Vitrat V, Pavese P. Prospective study of telephone calls to a hotline for infectious disease consultation: analysis of 7,863 solicited consultations over a 1-year period. Eur J Clin Microbiol Infect Dis. 2011 Apr;30(4):509-14. doi: 10.1007/s10096-010-1111-z. Epub 2010 Nov 11.

ReferenceCitation: Sellier E, Labarère J, Gennai S, Bal G, François P, Pavese P. Compliance with recommendations and clinical outcomes for formal and informal infectious disease specialist consultations. Eur J Clin Microbiol Infect Dis. 2011 Jul;30(7):887-94. doi: 10.1007/s10096-011-1172-7. Epub 2011 Feb 11.

ReferenceCitation: Bal G, Sellier E, Gennai S, Caillis M, François P, Pavese P. Infectious disease specialist telephone consultations requested by general practitioners. Scand J Infect Dis. 2011 Dec;43(11-12):912-7. doi: 10.3109/00365548.2011.598874. Epub 2011 Aug 26.

ReferenceCitation: Lesprit P, Landelle C, Brun-Buisson C. Unsolicited post-prescription antibiotic review in surgical and medical wards: factors associated with counselling and physicians' compliance. Eur J Clin Microbiol Infect Dis. 2013 Feb;32(2):227-35. doi: 10.1007/s10096-012-1734-3. Epub 2012 Aug 24.

ReferenceCitation: Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.

ReferenceCitation: Bernal JL, Cummins S, Gasparrini A. Interrupted time series regression for the evaluation of public health interventions: a tutorial. Int J Epidemiol. 2017 Feb 1;46(1):348-355. doi: 10.1093/ije/dyw098. Erratum in: Int J Epidemiol. 2020 Aug 1;49(4):1414.

ReferenceCitation: Pavese P, Sellier E, Laborde L, Gennai S, Stahl JP, François P. Requesting physicians' experiences regarding infectious disease consultations. BMC Infect Dis. 2011 Mar 14;11:62. doi: 10.1186/1471-2334-11-62.

ReferenceCitation: Borowsky SJ. What do we really need to know about consultation and referral? J Gen Intern Med. 1998 Jul;13(7):497-8.

ReferenceCitation: Keating NL, Zaslavsky AM, Ayanian JZ. Physicians' experiences and beliefs regarding informal consultation. JAMA. 1998 Sep 9;280(10):900-4.

lead_sponsor: University Hospital, Grenoble

location_facility:
MIIT Lyon
CH Annecy Genevois
Hospices civils de Lyon
CH Métropole Savoie
CHU de Nice
CHU Saint Etienne
CHU Clermont-Ferrand
Cochin, APHP
CH Notre Dame de la Miséricorde
CH de Melun
CHU Rennes
Chu de Grenoble Alpes
Olivier.rogeaux@ch-metropole_savoie.fr


title: An Open-Label, Multicenter, Phase III Study to Assess the Impact of Transient Androgenic Deprivation With Enantone LP 11.25 Mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer

summary: The purpose of this study is to assess two treatment strategies (leuprorelin treatment and active surveillance without androgen deprivation) for indolent prostate cancer and to compare their therapeutic benefit for management of patients with low-risk, localized prostate cancer.

lead_sponsor: Takeda

location_facility:
Tenon Hospital Paris France
Ouzid, Paris La Défense,


title: Pharmacological, Clinical and Statistical Assessment of a New Tool Available for Pharmacodependence Report Evaluation

summary: In France, the Afssaps is the body in charge of the evaluation of pharmacodependance. In order to fulfil its mission, the Afssaps has created a network of 11 Centres for Evaluation and Information on Pharmacodependance (CEIP), coordinated by the Drugs and Psychotropics Unit. Pharmacodependence notifications issued by professionals are collected by each Centre which evaluates them. Nantes' CEIP created an original tool to harmonize case reporting and make it possible to homogeneously evaluate the seriousness of pharmacodependence cases as each CEIP had his own way of analysing his cases. The aim of this study is to assess this tool.

ReferenceCitation: Victorri-Vigneau C, Hardouin JB, Rousselet M, Gerardin M, Guerlais M, Guillou M, Bronnec M, Sébille V, Jolliet P; French Addictovigilance Network. Multicentre study for validation of the French addictovigilance network reports assessment tool. Br J Clin Pharmacol. 2016 Oct;82(4):1030-9. doi: 10.1111/bcp.13044. Epub 2016 Jul 28.

name: Pharmacology Department; Nantes University Hospital, Institute of Biology, Hôtel Dieu; 9, Quai Moncousu 44093 Nantes Cedex 01 France

name: EA 4275 Biostatistics, Pharmacoepidemiology and Subjective Measures in Health, UFR Pharmaceutical Sciences; 1 rue Gaston Veil BP 53508, 44035 Nantes cedex 1 France

family: Victorri-Vigneau

full_name: Caroline Victorri-Vigneau

given: Caroline

family: Hardouin

full_name: Jean Benoit Hardouin

given: Jean Benoit

name: Addictology Department; Nantes University Hospital, Bâtiment Louis Philippe; Hôpital St Jacques, 85 rue Saint-Jacques 44093 Nantes Cedex 1 France

family: Rousselet

full_name: Morgane Rousselet

given: Morgane

family: Gerardin

full_name: Marie Gerardin

given: Marie

family: Guerlais

full_name: Marylène Guerlais

given: Marylène

family: Guillou

full_name: Morgane Guillou

family: Bronnec

full_name: Marie Bronnec

family: Sébille

full_name: Véronique Sébille

family: Jolliet

full_name: Pascale Jolliet

given: Pascale

journal_name: British Journal of Clinical Pharmacology

evidence: open (via free article)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

location_facility: Centre Antipoison - Centre de Pharmacovigilance


title: Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Device REMEEX® in the Treatment of Male Stress Urinary Incontinence

acronym: Remeex

summary: We wish to set up a multicentric prospective observational study across France to collate data on the efficacy and tolerance of the Male REMEEX® device in patients with moderate stress urinary incontinence following radical prostatectomy. Patient satisfaction, improvement in quality of life, side effects and complications will also be studied, as will the ease of use of the device from the point of view of the surgeon. A long-term follow-up of 5 years will be conducted.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU Strasbourg
CHU Toulouse
CHU Nimes
CHU de Dijon
CHU de Limoges
Hôpital Foch
CHU Nice
CHU Nancy
APHP Hôpital Henry Mondor
CHU de Besançon


title: Pneumonia Due to Stenotrophomonas Maltophilia in Intensive Care Units: a Multicentre Retrospective Study

acronym: RETROSTENO

summary:
Pneumonia is a major cause of ICU admission, or may complicate ICU course. Among the causative pathogens, Stenotrophomonas Maltophilia is a rare pathogen, but affects usually patients with chronic pulmonary co-morbidities, or with long duration of mechanical ventilation and multiples treatment with broad spectrum antimicrobial therapy. However, there are only a paucity of data regarding epidemiology, impact and outcome of Pneumonia due to Stenotrophomonas Maltophilia in critically ill patients.

Primary objective was to study factors associated with mortality in case of Pneumonia due to Stenotrophomonas Maltophilia. Secondary objectives were to describe factors associated with morbidity of Pneumonia due to Stenotrophomonas Maltophilia (duration of mechanical ventilation, ICU length of stay), and to report the characteristics of critically ill patients presenting Pneumonia due to Stenotrophomonas Maltophilia.

ReferenceCitation: Guerci P, Bellut H, Mokhtari M, Gaudefroy J, Mongardon N, Charpentier C, Louis G, Tashk P, Dubost C, Ledochowski S, Kimmoun A, Godet T, Pottecher J, Lalot JM, Novy E, Hajage D, Bouglé A; AZUREA research network. Outcomes of Stenotrophomonas maltophilia hospital-acquired pneumonia in intensive care unit: a nationwide retrospective study. Crit Care. 2019 Nov 21;23(1):371. doi: 10.1186/s13054-019-2649-5.

family: Guerci

full_name: Philippe Guerci

given: Philippe

family: Bellut

full_name: Hugo Bellut

given: Hugo

family: Mokhtari

full_name: Mokhtar Mokhtari

given: Mokhtar

family: Gaudefroy

full_name: Julie Gaudefroy

given: Julie

family: Mongardon

full_name: Nicolas Mongardon

given: Nicolas

family: Charpentier

full_name: Claire Charpentier

given: Claire

family: Louis

full_name: Guillaume Louis

given: Guillaume

family: Tashk

full_name: Parvine Tashk

given: Parvine

family: Dubost

full_name: Clément Dubost

given: Clément

family: Ledochowski

full_name: Stanislas Ledochowski

given: Stanislas

family: Kimmoun

full_name: Antoine Kimmoun

given: Antoine

family: Godet

full_name: Thomas Godet

given: Thomas

family: Pottecher

full_name: Julien Pottecher

given: Julien

family: Lalot

full_name: Jean-Marc Lalot

given: Jean-Marc

family: Novy

full_name: Emmanuel Novy

given: Emmanuel

family: Hajage

full_name: David Hajage

given: David

family: Bouglé

full_name: Adrien Bouglé

given: Adrien

journal_name: Critical Care

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

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

location_facility: Department of Anesthesiology and Critical Care Medicine, University Hospital of NANCY

location_facility: Réanimation Polyvalente CHR Metz-Thionville

location_facility: Anesthesiology and Critical Care Medicine, Groupe Hospitalier Pitié-Salpêtrière

location_facility: Department of Anesthesiology and Critical Care Medicine, University Hospital of Strasbourg


title: Non Interventional Study on the Follow-up, by Specialists, of Short Children Born Small for Gestational Age and Treated With SAIZEN®- SEPAGE Study

acronym: SEPAGE

summary: This one-arm, multi-centric, non-randomized, observational, open label, prospective study was designed to study short subjects born SGA, by pediatricians, endocrinologists or physicians in private, mixed private and hospital practice treated with Saizen.

lead_sponsor: Merck KGaA, Darmstadt, Germany


title: EMDR Pre-treatment Yoga for Complex Trauma Randomized Controlled Comparative Study

acronym: YOGA-EMDR

summary: Yoga practice has shown benefits in treating multiple physical or mental disorders (Barnes, Bloom, & Nahin, 2008; Khalsa, 2004; Ross, Friedmann, Bevans, & Thomas, 2013) and has recently been evaluated for PTSD. We identified six randomized controlled studies measuring the effect of yoga in women (mostly) who experienced childhood violence (see table). With the exception of one pilot study (Dick, Niles, Street, Dimartino, & Mitchell, 2014; Mitchell et al., 2014), all studies show a significant reduction in PTSD symptoms compared to the pre-treatment period and compared to the control group (waiting list group). In particular, it was shown that this reduction in symptomatology was comparable to that of other commonly practiced psychotherapies, such as the exposure techniques of Behavioural and Cognitive Therapies or EMDR, and comparable to pharmacological treatments (Van Der Kolk et al., 2014). Prolonged yoga therapy would also significantly improve dissociative symptoms (Price et al., 2017). However, all these studies tested the effect of yoga therapy in isolation, without associating it with conventional and recommended treatments for trauma. However, given the fields of action of the yoga listed above, we think that it could be the ideal tool to prepare (in the pre-treatment phase) the work on traumatic memory. We believe that the combination of yoga therapy and EMDR would work in synergy to reduce complex PTSD and achieve a higher success rate than these individual approaches. In this work, we will use a yoga technique adapted to the treatment of psycho-trauma called "trauma sensitive yoga" (Emerson, 2015).

lead_sponsor: Januel

location_facility: Center for Psychotherapy and Psychotraumatology


title: Risk of Bleeding and Anticoagulation in Atrial Fibrillation: What Predictive Criterion Used?

acronym: PREDIC-AGE

summary:
Atrial fibrillation (AF) is a rhythmic cardiac activity disorder disturbing hemodynamic blood flow. It is a public health problem with 600,000 to 1 million people involved in France which 2/3 are aged over 75 years. a FA untreated exposes the patient to a significant risk of embolism responsible for a rate stroke (stroke) ischemic estimated at 85%. The anticoagulant standard treatment helps prevent the occurrence of this complication.

However, oral anticoagulation also exposes patients to an increased risk of bleeding. The bleeding risk can be assessed using scales: several being proposed (HEMORR2HAGES, HAS-BLED, ATRIA and scores Shireman and Charlson ...).

moreover, in geriatric hospital care, every patient has a "standardized geriatric assessment" to assess and quantify functional capacity, autonomy, cognitive abilities, nutritional status, psychological state and its environment social.

Thus, the objective of the investigators study was to determine the frequency of each item of each bleeding risk assessment score and geriatric assessment in patients 80 and older hospitalized geriatric ward in the department and with anticoagulant.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CH de FEURS
CHU de SAINT-ETIENNE
CH de SAINT-CHAMOND
CH de FIRMINY
CH de ROANNE


title: Association Between Blood Fibrocytes During an Exacerbation and Lung Function Decline in Patients With Early Stage Chronic Obstructive Pulmonary Disease (COPD) in Primary Care

acronym: FIBRO-COPD

summary: This study aims to estimate the association between blood fibrocytes measured during a suspected exacerbation and 3-year decline forced expiratory volume in one second (FEV1), in patients with Chronic obstructive pulmonary disease (COPD) in primary care, with a history of smoking, independently of the number of exacerbations and of tobacco or occupational exposure.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Cabinet médical
Cabinet Médical

intervention_type: Diagnostic Test


lead_sponsor: LEO Pharma

source: euctr

title: Calcipotriol Plus Hydrocortisone in Paediatric Patients (Aged 6 to 17 Years) With Psoriasis Vulgaris on the Face and on the Intertriginous Areas

summary: An international, multi-centre, prospective, randomised, double-blind, active-controlled, 2-arm, parallel group, 8-week, phase 3 clinical study in paediatric patients (aged 6 to 17 years) with psoriasis vulgaris on the face and on the intertriginous areas


title: Maintenance of Occupational Therapy for Patients With Alzheimer: A Pragmatic Randomized Trial

acronym: MaTheoAlz

summary: France put a massive effort for improving dementia care through a national Alzheimer plan in 2008 and this effort was confirmed by the next government (Neurodegenerative Diseases Plan 2014-2019). Some new care models and interventions have been implemented such as Alzheimer specialized teams offering occupational therapy. The teams intervene at home with medical prescription. A recent pilot study demonstrated that occupational therapy has the potential to bring clinical benefits for both dementia patients and their caregivers. Nevertheless, occupational therapy has been designed as a short-term intervention and the end of intervention is challenging for therapists and patients. We aim to test the clinical and economic efficacy of maintaining occupational therapy over supplementary 4 months in a pragmatic randomized controlled trial.

primary_purpose: Supportive Care

ReferenceCitation: Pimouguet C, Le Goff M, Wittwer J, Dartigues JF, Helmer C. Benefits of Occupational Therapy in Dementia Patients: Findings from a Real-World Observational Study. J Alzheimers Dis. 2017;56(2):509-517. doi: 10.3233/JAD-160820.

ReferenceCitation: Pimouguet C, Sitta R, Wittwer J, Hayes N, Petit-Monéger A, Dartigues JF, Helmer C. Maintenance of occupational therapy (OT) for dementia: protocol of a multi-center, randomized controlled and pragmatic trial. BMC Geriatr. 2019 Feb 6;19(1):35. doi: 10.1186/s12877-019-1046-x.

family: Pimouguet

full_name: Clément Pimouguet

family: Sitta

full_name: Rémi Sitta

given: Rémi

family: Wittwer

full_name: Jérôme Wittwer

given: Jérôme

family: Hayes

full_name: Nathalie Hayes

given: Nathalie

family: Petit-Monéger

full_name: Aurélie Petit-Monéger

given: Aurélie

family: Dartigues

full_name: Jean-François Dartigues

given: Jean-François

family: Helmer

full_name: Catherine Helmer

given: Catherine

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repositories_institution:
PubMed Central - Europe PMC
Universite de Bordeaux - Oskar-Bordeaux

location_facility:
SSIAD Hauts de garonne
Vie Santé Merignac
AMSADHG
SSIAD du bassin d'Arcachon
Equipe Espard
Castelsanté
Aapam-Ssiad
SESAME

intervention_type: Behavioral


lead_sponsor: Laboratoire Innotech International

location_country: Slovakia Serbia France Czechia

acronym: PRISM

location_facility: MARICIC GATOVA PERCEVAL TURKOVA

title: Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis International, Multicentre, Randomised, Double-blind, Parallel Group Study, Comparative Versus Miconazole

summary:
POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated for the local treatment of vaginitis due to sensitive germs and treatment of non specific vaginitis of adults. POLYGYNAX® has been marketed in France since 1969.

Nevertheless, despite the well established use of POLYGYNAX®, there is no clinical study supporting the interest of the combination of antifungal and antibiotics agents versus antifungal agent alone.

The aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole in the treatment of women experiencing symptoms of infectious vaginitis.


title: Impact of Bronchial Drainage by the Medical Device Simeox® on Function and Respiratory Symptoms Compared to Manual Autogenous Drainage Physiotherapy in Adult Cystic Fibrosis Patients

acronym: MUCOSIM

summary: The main objective of the study is to evaluate the short-term effects of the airway clearance technique by the medical device Simeox (Physio Assist, France) versus Autogenic Drainage, on the pulmonary function of adult patients with stable cystic fibrosis. To analyse these effects, the investigators used forced oscillation technique measured by TremoFlo™ C-100 Airwave Oscillometry System™ (THORASYS Thoracic Medical Systems Inc. Montreal, Quebec, Canada) with an evaluation of the perceived clinical benefits.

lead_sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

location_facility: Soins de Suite Nutritionnels et Respiratoires -Fondation IDLYS


title: Neuro-feedback Therapy for Treating Tinnitus : Efficacy Pilot Study on a Targeted Population

acronym: TNTA

summary: Neuro-feedback for treating tinnitus seem to be a promising approach to help people suffering from chronic tinnitus. The past studies on this approach suffered interindividual variability in their results. The investigators' current hypothesis is that the variability of the results is the consequences of two possible flaws: lack of appropriate patient selection and lack of support of the patient during the therapy. This study is aimed at testing these hypotheses.

ReferenceCitation: Crocetti A, Forti S, Del Bo L. Neurofeedback for subjective tinnitus patients. Auris Nasus Larynx. 2011 Dec;38(6):735-8. doi: 10.1016/j.anl.2011.02.003. Epub 2011 May 17.

ReferenceCitation: Dohrmann K, Weisz N, Schlee W, Hartmann T, Elbert T. Neurofeedback for treating tinnitus. Prog Brain Res. 2007;166:473-85. Review.

ReferenceCitation: Hartmann T, Lorenz I, Müller N, Langguth B, Weisz N. The effects of neurofeedback on oscillatory processes related to tinnitus. Brain Topogr. 2014 Jan;27(1):149-57. doi: 10.1007/s10548-013-0295-9. Epub 2013 May 23.

ReferenceCitation: Guillard R, Fraysse MJ, Simeon R, Cervoni T, Schmutz J, Piedfort B, Ferat V, Congedo M, Londero A. A portable neurofeedback device for treating chronic subjective tinnitus: Feasibility and results of a pilot study. Prog Brain Res. 2021;260:167-185. doi: 10.1016/bs.pbr.2020.08.001. Epub 2020 Oct 14.

family: Guillard

full_name: Robin Guillard

given: Robin

family: Fraysse

full_name: Marie-Josée Fraysse

given: Marie-Josée

family: Simeon

full_name: Renaud Simeon

given: Renaud

family: Cervoni

full_name: Thomas Cervoni

family: Schmutz

full_name: Jonathan Schmutz

given: Jonathan

family: Piedfort

full_name: Bastien Piedfort

given: Bastien

family: Ferat

full_name: Victor Ferat

given: Victor

family: Congedo

full_name: Marco Congedo

given: Marco

family: Londero

full_name: Alain Londero

given: Alain

genre: book-chapter

genre_raw: book-chapter

journal_name: Tinnitus - An Interdisciplinary Approach Towards Individualized Treatment: From Heterogeneity to Personalized Medicine

publisher: Elsevier

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Zeta Technologies

location_facility:
Audika Research Center
Purpan University hospital


title: Comparison of the Analgesic Effect Between the Motor Cortex Stimulation (tDCS and rTMS) and the Trans-spinal Stimulation (tsDCS ) in the Algoneurodystrophy of Members. A Randomised Clinical Trial. tDCS : Transcranial Direct-current Stimulation rTMS : Repetitive Transcranial Magnetic Stimulation tsDCS : Transcutaneous Spinal Direct Current Stimulation

acronym: ALGOSTIM

summary: The purpose of this study is to compare the analgesic effectiveness of two motor cortex neurostimulations (tDCS and rTMS) and the trans-spinal neurostimulation (tsDCS ) in the algoneurodystrophy.

ReferenceCitation: Lefaucheur JP, Drouot X, Ménard-Lefaucheur I, Keravel Y, Nguyen JP. Motor cortex rTMS restores defective intracortical inhibition in chronic neuropathic pain. Neurology. 2006 Nov 14;67(9):1568-74.

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location_facility: Service de Physiologie - Explorations Fonctionnelles, Hôpital Henri Mondor

location_facility: Centre de la douleur, CHU Grenoble Alpes


title: ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD

summary:
Intensive Care Unit (ICU) admission for acute exacerbation of chronic obstructive lung disease (COLD) is a major cause of morbidity and mortality in such patients. Although bacterial of mortality in such patients. Although bacterial and or viral infections are considered as the major precipitating factor, the antibiotic strategy in this setting is unclear. The absence of overt infection remains controversial, and has not been adequately studied in patients admitted to the ICU. To assess the benefit ( or lack thereof ) of routine early systemic antibiotic therapy in patients with COLD admitted to the ICU.

The primary objective of the essay is to evaluate the effectiveness of the precocious antibiotic therapy on the length of the respiratory symptoms with the admitted patients in polyvalent medical intensive care of chronic obstructive lung disease ( COLD )

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Assistance Publique-Hopitaux de Paris
Hopital Henri Mondor


title: Evaluation de la Congestion en Hospitalisation de Jour Pour un Bilan d'Insuffisance Cardiaque Chronique à Fraction d'éjection altérée ou modérément altérée CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)

acronym: CHF-COVReduced

summary:
Heart failure (HF) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. Congestion is the main source of symptoms and the leading cause of hospitalization for HF. Furthermore, congestive signs identified in asymptomatic patients are associated with the risk of developing symptomatic HF. The literature supports a multi-modality / integrative evaluation of congestion, combining clinical examination, laboratory results and ultrasound evaluation.

The main objective of the CHF-COVReduced study is to identify congestion markers (clinical, biological and ultrasound) in day hospitalization for the monitoring of chronic HF with reduced left ventricular ejection fraction that are associated with the risk of all-cause death, hospitalization for acute HF or IV diuretics injection in a day hospital.

lead_sponsor: Pr. Nicolas GIRERD