title: Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour : a Randomised Controlled Trial in Primary Care.

acronym: PIL

summary: To assess the impact of four Patient Information Leaflets (PIL) on patient behaviour in primary care.

primary_purpose: Supportive Care

ReferenceCitation: Stewart M, Brown JB, Donner A, McWhinney IR, Oates J, Weston WW, Jordan J. The impact of patient-centered care on outcomes. J Fam Pract. 2000 Sep;49(9):796-804.

ReferenceCitation: Kitching JB. Patient information leaflets--the state of the art. J R Soc Med. 1990 May;83(5):298-300. doi: 10.1177/014107689008300506. No abstract available.

ReferenceCitation: Kenny T, Wilson RG, Purves IN, Clark J Sr, Newton LD, Newton DP, Moseley DV. A PIL for every ill? Patient information leaflets (PILs): a review of past, present and future use. Fam Pract. 1998 Oct;15(5):471-9. doi: 10.1093/fampra/15.5.471.

ReferenceCitation: Little P, Griffin S, Kelly J, Dickson N, Sadler C. Effect of educational leaflets and questions on knowledge of contraception in women taking the combined contraceptive pill: randomised controlled trial. BMJ. 1998 Jun 27;316(7149):1948-52. doi: 10.1136/bmj.316.7149.1948.

ReferenceCitation: Little P, Dorward M, Warner G, Moore M, Stephens K, Senior J, Kendrick T. Randomised controlled trial of effect of leaflets to empower patients in consultations in primary care. BMJ. 2004 Feb 21;328(7437):441. doi: 10.1136/bmj.37999.716157.44. Epub 2004 Feb 13.

ReferenceCitation: Coudeyre E, Givron P, Vanbiervliet W, Benaim C, Herisson C, Pelissier J, Poiraudeau S. [The role of an information booklet or oral information about back pain in reducing disability and fear-avoidance beliefs among patients with subacute and chronic low back pain. A randomized controlled trial in a rehabilitation unit]. Ann Readapt Med Phys. 2006 Nov;49(8):600-8. doi: 10.1016/j.annrmp.2006.05.003. Epub 2006 May 26. French.

ReferenceCitation: Coudeyre E, Poiraudeau S, Revel M, Kahan A, Drape JL, Ravaud P. Beneficial effects of information leaflets before spinal steroid injection. Joint Bone Spine. 2002 Dec;69(6):597-603. doi: 10.1016/s1297-319x(02)00457-8.

ReferenceCitation: McIntosh A, Shaw CF. Barriers to patient information provision in primary care: patients' and general practitioners' experiences and expectations of information for low back pain. Health Expect. 2003 Mar;6(1):19-29. doi: 10.1046/j.1369-6513.2003.00197.x.

ReferenceCitation: Watkins CJ, Papacosta AO, Chinn S, Martin J. A randomized controlled trial of an information booklet for hypertensive patients in general practice. J R Coll Gen Pract. 1987 Dec;37(305):548-50.

ReferenceCitation: Roberts L, Little P, Chapman J, Cantrell T, Pickering R, Langridge J. The back home trial: general practitioner-supported leaflets may change back pain behavior. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1821-8. doi: 10.1097/00007632-200209010-00002.

ReferenceCitation: Johnson LK, Edelman A, Jensen J. Patient satisfaction and the impact of written material about postpartum contraceptive decisions. Am J Obstet Gynecol. 2003 May;188(5):1202-4. doi: 10.1067/mob.2003.308.

ReferenceCitation: Mancini J, Nogues C, Adenis C, Berthet P, Bonadona V, Chompret A, Coupier I, Eisinger F, Fricker JP, Gauthier-Villars M, Lasset C, Lortholary A, N'Guyen TD, Vennin P, Sobol H, Stoppa-Lyonnet D, Julian-Reynier C. Impact of an information booklet on satisfaction and decision-making about BRCA genetic testing. Eur J Cancer. 2006 May;42(7):871-81. doi: 10.1016/j.ejca.2005.10.029. Epub 2006 Mar 23.

ReferenceCitation: Al-Asfour A, Andersson L. The effect of a leaflet given to parents for first aid measures after tooth avulsion. Dent Traumatol. 2008 Oct;24(5):515-21. doi: 10.1111/j.1600-9657.2008.00651.x.

ReferenceCitation: Carre PC, Roche N, Neukirch F, Radeau T, Perez T, Terrioux P, Ostinelli J, Pouchain D, Huchon G. The effect of an information leaflet upon knowledge and awareness of COPD in potential sufferers. A randomized controlled study. Respiration. 2008;76(1):53-60. doi: 10.1159/000115947. Epub 2008 Feb 5.

ReferenceCitation: Scala D, Cozzolino S, D'Amato G, Cocco G, Sena A, Martucci P, Ferraro E, Mancini AA. Sharing knowledge is the key to success in a patient-physician relationship: how to produce a patient information leaflet on COPD. Monaldi Arch Chest Dis. 2008 Jun;69(2):50-4. doi: 10.4081/monaldi.2008.395.

ReferenceCitation: Vetto JT, Dubois PM, Vetto IP. The impact of distribution of a patient-education pamphlet in a multidisciplinary breast clinic. J Cancer Educ. 1996 Fall;11(3):148-52. doi: 10.1080/08858199609528418.

ReferenceCitation: Leichtnam-Dugarin L, Carretier J, Delavigne V, Brusco S, Hoarau H, Philip T, Fervers B; Comite d'Organisation des Standards, Options et Recommentations SAVOIR; Federation Nationale des Centres de lutte contre le cancer; Ligue contre le Cancer; Federation Hospitaliere de France; Federation Nationale de Cancerologie des CHRU; Federation Francaise de Cancerologie. [The SOR SAVOIR Patient, a project of patient information and education]. Cancer Radiother. 2003 Jun;7(3):210-2. doi: 10.1016/s1278-3218(03)00037-4. No abstract available. French.

ReferenceCitation: Roland M, Dixon M. Randomized controlled trial of an educational booklet for patients presenting with back pain in general practice. J R Coll Gen Pract. 1989 Jun;39(323):244-6.

ReferenceCitation: Macfarlane JT, Holmes WF, Macfarlane RM. Reducing reconsultations for acute lower respiratory tract illness with an information leaflet: a randomized controlled study of patients in primary care. Br J Gen Pract. 1997 Nov;47(424):719-22.

ReferenceCitation: Macfarlane J, Holmes W, Gard P, Thornhill D, Macfarlane R, Hubbard R. Reducing antibiotic use for acute bronchitis in primary care: blinded, randomised controlled trial of patient information leaflet. BMJ. 2002 Jan 12;324(7329):91-4. doi: 10.1136/bmj.324.7329.91.

ReferenceCitation: Vuorma S, Rissanen P, Aalto AM, Hurskainen R, Kujansuu E, Teperi J. Impact of patient information booklet on treatment decision--a randomized trial among women with heavy menstruation. Health Expect. 2003 Dec;6(4):290-7. doi: 10.1046/j.1369-7625.2003.00225.x.

ReferenceCitation: Dedianne MC, Hauzanneau P, Labarere J, Moreau A. Relation médecin-malade en soins primaires: qu'attendent les patients? Investigation par la méthode qualitative des focus groups. La revue du praticien Médecine générale. 2003;17 (612):653-6.

ReferenceCitation: Paul F, Jones MC, Hendry C, Adair PM. The quality of written information for parents regarding the management of a febrile convulsion: a randomized controlled trial. J Clin Nurs. 2007 Dec;16(12):2308-22. doi: 10.1111/j.1365-2702.2007.02019.x.

ReferenceCitation: Sustersic M, Voorhoeve M, Menuret H, Baudrant M, Meneau A, Bosson JL. Fiches d'information pour les patients: quel intérêt? L'étude EDIMAP. La Revue de la médecine générale. 2010;276:332-9.

ReferenceCitation: Francis NA, Butler CC, Hood K, Simpson S, Wood F, Nuttall J. Effect of using an interactive booklet about childhood respiratory tract infections in primary care consultations on reconsulting and antibiotic prescribing: a cluster randomised controlled trial. BMJ. 2009 Jul 29;339:b2885. doi: 10.1136/bmj.b2885.

ReferenceCitation: Lerman C, Ross E, Boyce A, Gorchov PM, McLaughlin R, Rimer B, Engstrom P. The impact of mailing psychoeducational materials to women with abnormal mammograms. Am J Public Health. 1992 May;82(5):729-30. doi: 10.2105/ajph.82.5.729.

ReferenceCitation: Sustersic M, Meneau A, Dremont R, Paris A, Laborde L, Bosson JL. [Developing patient information sheets in general practice. Proposal for a methodology]. Rev Prat. 2008 Dec 15;58(19 Suppl):17-24. French.

ReferenceCitation: Sustersic M, Meneau A, Dremont R, Bosson JL. Fiches d'information patient: quelle méthodologie? La revue du praticien Médecine générale. 2007;790:1167-8.

ReferenceCitation: Sustersic M, Meneau A, Drémont R, Paris A, Laborde L, Bosson JL. Elaboration d'un outil d'aide à l'éducation du patient pas la réalisation de 125 fiches d'information et de conseil concernant des motifs de consultation les plus fréquents en médecin générale. Université Joseph Fourier, faculté de médecine de Grenoble. juillet 2007.

lead_sponsor: University Hospital, Grenoble

location_facility:
University Hospital Grenoble
General practitioner office


title: Phase 2 Multicenter Study to Assess the Safety and Efficacy of BKM120 as Monotherapy in Treatment of Initial or Recurrent Metastatic Endometrial Cancer After 1st Line Therapy in Patients Who Cannot Undergo Local Surgery and/or Radiotherapy

acronym: ENDOPIK

summary:
This study is to determine the clinical efficacy of BKM120 as monotherapy in the treatment of initial or recurrent metastatic endometrial cancer after first line radio chemotherapy.

Clinical efficacy will be determined by the non-progression rate at 3 or 2 months depending on the group of patients. The primary endpoint is the non-progression rate at 3 months (12 weeks) for the patient group whose disease is painless (low grade tumor = stratum 1) and the non-progression rate at 2 months (8 weeks) for the group of patients with an aggressive disease (high grade tumor = stratum 2).

Disease progression is defined by the RECIST 1.1 criteria

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Group Hospitalier Mutualiste de Grenoble

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase Ib/II Study of Escalating Doses of Revlimid in Association With R-CHOP (R2-CHOP) in the Treatment of B-cell Lymphoma

summary: The purpose of the study is to assess the efficacy of the association of Lenalidomide (Revlimid) and R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, vincristine and Prednisone) in a population of patients with follicular lymphoma as measured by the response rate at the end of treatment.

ReferenceType: derived

ReferenceCitation: Tilly H, Morschhauser F, Casasnovas O, Molina TJ, Feugier P, Gouill SL, Haioun C, Tournilhac O, Bouabdallah R, Gabarre J, Lamy T, Cabecadas J, Becker S, Jardin F, Mounier N, Salles G; Lymphoma Study Association. Lenalidomide in combination with R-CHOP (R2-CHOP) as first-line treatment of patients with high tumour burden follicular lymphoma: a single-arm, open-label, phase 2 study. Lancet Haematol. 2018 Sep;5(9):e403-e410. doi: 10.1016/S2352-3026(18)30131-5.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ipd_sharing: No

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility:
Centre Léon Bérard
CHU de Poitiers
Institut Curie
Hôpital Necker
Centre Henri BECQUEREL
Hôpital Saint Eloi
Institut Gustave Roussy
Hôpital Robert Debré
Chu Lyon Sud
CHU de NANTES
Hôpital Pontchaillou
Hôpital St Louis
Hôpital René Huguenin
Chru Lille
Institut Paoli Calmettes
Institut Bergonié
CHU Estaing
Hôpital Saint Antoine
Hôpital Henri Mondor
Hôpital Notre Dame de Bon Secours
Chu Brabois
CHU de DIJON
Hôpital de la Pitié Salpétrière
Polyclinique Bordeaux Nord Aquitaine


title: Evaluation of Glucocorticoid Sparing Effect in Patients Receiving RoActemra® for Rheumatoid Arthritis in Real Life.

summary: This observational study will evaluate the glucocorticoid sparing effect after 12 months of treatment with RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 12 months after the initiation of treatment with RoActemra/Actemra from patients who had been on treatment with >5 mg prednisone or equivalent for at least 3 months .

study_type: Observational

time_perspective: Prospective

lead_sponsor: Hoffmann-La Roche


title: Observatoire Prospectif, Longitudinal Dans la Prise en Charge Thérapeutique de La Rectocolite Hémorragique légère à Modérée

acronym: OPTIMUM

summary: The primary objective of this study is to confirm the long-term efficacy (remission and maintenance in remission) of current validated treatments. Each patient will be followed during 3 years in this non-interventional trial.

lead_sponsor: Ferring Pharmaceuticals

location_facility: Groupe Hospitalier Mutualiste Les Portes du Sud

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Centre Hospitalier de Tourcoing-Hôpital DRON

location_facility: Groupe Hospitalier Mutualiste "Les Portes du Sud"

location_facility: CH de Bourg-en Bresse Hopital de Fleyriart (Viriat)

location_facility: Centre Hospitalier du Haut Anjou Hospital St Julien


title: Randomized Phase III Trial Evaluating the Impact of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer

summary: GYNECO 02 hypothesis is that hysterectomy reduces the possibility of local or loco-regional relapse, especially in patient with a reduced metastatic risk and who received a local chemoradiation therapy with an increase of radiotherapy doses (45 grays).

status: Terminated

design_allocation: Randomized

lead_sponsor: UNICANCER

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Centre Hospitalier Régional Universitaire Hôpital Nord

location_facility: Centre Hospitalier Universitaire Jean Bernard

location_facility: Centre Universitaire Hospitalier- Hôpital Sud

location_facility: Centre Hospitalier Universitaire - Hôpital Arnaud de Villeneuve

location_facility: Clinique Sainte Thérèse de l'enfant Jésus

location_facility: Centre Hospitalier Régional Universitaire La Timone

intervention_type: Procedure

status_simplified: Unknown


title: National Evaluation of the Adherence to Recommendations of VTE Treatment in Cancer Patients

acronym: CARMEN

summary: Treatment of venous thromboembolism in cancer patients is specific and has been validated in trials that favor the use of LMWH (Low Molecular Weight Heparin) instead of VKA (Vitamin K Antagonist) treatment during 6 months. International recommendations have diffused this option.It is necessary to evaluate the compliance of physicians to this treatment by measuring the number of patients with cancer treated with long term use of LMWH.

ReferenceType: background

ReferenceCitation: Khorana AA, Francis CW, Culakova E, Kuderer NM, Lyman GH. Frequency, risk factors, and trends for venous thromboembolism among hospitalized cancer patients. Cancer. 2007 Nov 15;110(10):2339-46. doi: 10.1002/cncr.23062.

ReferenceCitation: Levitan N, Dowlati A, Remick SC, Tahsildar HI, Sivinski LD, Beyth R, Rimm AA. Rates of initial and recurrent thromboembolic disease among patients with malignancy versus those without malignancy. Risk analysis using Medicare claims data. Medicine (Baltimore). 1999 Sep;78(5):285-91. doi: 10.1097/00005792-199909000-00001.

ReferenceCitation: Khorana AA, Francis CW, Culakova E, Lyman GH. Risk factors for chemotherapy-associated venous thromboembolism in a prospective observational study. Cancer. 2005 Dec 15;104(12):2822-9. doi: 10.1002/cncr.21496.

ReferenceCitation: Blom JW, Vanderschoot JP, Oostindier MJ, Osanto S, van der Meer FJ, Rosendaal FR. Incidence of venous thrombosis in a large cohort of 66,329 cancer patients: results of a record linkage study. J Thromb Haemost. 2006 Mar;4(3):529-35. doi: 10.1111/j.1538-7836.2006.01804.x.

ReferenceCitation: Chew HK, Wun T, Harvey D, Zhou H, White RH. Incidence of venous thromboembolism and its effect on survival among patients with common cancers. Arch Intern Med. 2006 Feb 27;166(4):458-64. doi: 10.1001/archinte.166.4.458.

ReferenceCitation: Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15. doi: 10.1001/archinte.160.6.809.

ReferenceCitation: Lee AY, Levine MN, Butler G, Webb C, Costantini L, Gu C, Julian JA. Incidence, risk factors, and outcomes of catheter-related thrombosis in adult patients with cancer. J Clin Oncol. 2006 Mar 20;24(9):1404-8. doi: 10.1200/JCO.2005.03.5600.

lead_sponsor: Floralis

collaborators: Centre Hospitalier Universitaire, Amiens

collaborators: Groupe Francophone Thrombose et Cancer (GFTC)

location_facility: Centre Hospitalier Mutualiste Site Etienne Dolet

location_facility: Centre Régional de Lutte Contre le Cancer Val d'Aurelle

location_facility: Centre Hospitalier de Villefranche sur Saône

location_facility: Centre de Lutte contre le Cancer (Centre René Gauducheau)


title: Patients Presenting With Acute STEMI Treated With Primary PCI : Comparison of the Impact of the MIMI Approach With a Conventional Strategy of Immediate Stenting

acronym: MIMI

summary: In the setting of primary Percutaneous Coronary Intervention (PCI), the investigators hypothesize that a 24-48 hour delay strategy of stenting after successful thrombus aspiration and establishment of Thrombolysis In Myocardial Infarction (TIMI)-3 flow with optimal antithrombotic therapy may decrease the risk of MicroVascular Obstruction (MVO) as assessed by Cardiac Magnetic Resonance Imaging (CMRI).

ReferenceCitation: Bovill EG, Terrin ML, Stump DC, Berke AD, Frederick M, Collen D, Feit F, Gore JM, Hillis LD, Lambrew CT, et al. Hemorrhagic events during therapy with recombinant tissue-type plasminogen activator, heparin, and aspirin for acute myocardial infarction. Results of the Thrombolysis in Myocardial Infarction (TIMI), Phase II Trial. Ann Intern Med. 1991 Aug 15;115(4):256-65. doi: 10.7326/0003-4819-115-4-256.

ReferenceCitation: Brodie BR, Stuckey TD, Hansen C, VerSteeg DS, Muncy DB, Moore S, Gupta N, Downey WE. Relation between electrocardiographic ST-segment resolution and early and late outcomes after primary percutaneous coronary intervention for acute myocardial infarction. Am J Cardiol. 2005 Feb 1;95(3):343-8. doi: 10.1016/j.amjcard.2004.09.031.

ReferenceCitation: Bruder O, Breuckmann F, Jensen C, Jochims M, Naber CK, Barkhausen J, Erbel R, Sabin GV; Herzinfarktverbund Essen. Prognostic impact of contrast-enhanced CMR early after acute ST segment elevation myocardial infarction (STEMI) in a regional STEMI network: results of the "Herzinfarktverbund Essen". Herz. 2008 Mar;33(2):136-42. doi: 10.1007/s00059-008-3102-8.

ReferenceCitation: Hombach V, Grebe O, Merkle N, Waldenmaier S, Hoher M, Kochs M, Wohrle J, Kestler HA. Sequelae of acute myocardial infarction regarding cardiac structure and function and their prognostic significance as assessed by magnetic resonance imaging. Eur Heart J. 2005 Mar;26(6):549-57. doi: 10.1093/eurheartj/ehi147. Epub 2005 Feb 15.

ReferenceCitation: Isaaz K, Robin C, Cerisier A, Lamaud M, Richard L, Da Costa A, Sabry MH, Gerenton C, Blanc JL. A new approach of primary angioplasty for ST-elevation acute myocardial infarction based on minimalist immediate mechanical intervention. Coron Artery Dis. 2006 May;17(3):261-9. doi: 10.1097/00019501-200605000-00010.

ReferenceCitation: Kushner FG, Hand M, Smith SC Jr, King SB 3rd, Anderson JL, Antman EM, Bailey SR, Bates ER, Blankenship JC, Casey DE Jr, Green LA, Hochman JS, Jacobs AK, Krumholz HM, Morrison DA, Ornato JP, Pearle DL, Peterson ED, Sloan MA, Whitlow PL, Williams DO; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2009 Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction (updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (updating the 2005 Guideline and 2007 Focused Update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2009 Dec 1;120(22):2271-306. doi: 10.1161/CIRCULATIONAHA.109.192663. Epub 2009 Nov 18. No abstract available. Erratum In: Circulation. 2010 Mar 30;121(12):e257. Dosage error in article text.

ReferenceCitation: Meneveau N, Seronde MF, Descotes-Genon V, Dutheil J, Chopard R, Ecarnot F, Briand F, Bernard Y, Schiele F, Bassand JP. Immediate versus delayed angioplasty in infarct-related arteries with TIMI III flow and ST segment recovery: a matched comparison in acute myocardial infarction patients. Clin Res Cardiol. 2009 Apr;98(4):257-64. doi: 10.1007/s00392-009-0756-z. Epub 2009 Feb 9.

ReferenceCitation: Nijveldt R, Beek AM, Hirsch A, Stoel MG, Hofman MB, Umans VA, Algra PR, Twisk JW, van Rossum AC. Functional recovery after acute myocardial infarction: comparison between angiography, electrocardiography, and cardiovascular magnetic resonance measures of microvascular injury. J Am Coll Cardiol. 2008 Jul 15;52(3):181-9. doi: 10.1016/j.jacc.2008.04.006.

ReferenceCitation: Sardella G, Mancone M, Bucciarelli-Ducci C, Agati L, Scardala R, Carbone I, Francone M, Di Roma A, Benedetti G, Conti G, Fedele F. Thrombus aspiration during primary percutaneous coronary intervention improves myocardial reperfusion and reduces infarct size: the EXPIRA (thrombectomy with export catheter in infarct-related artery during primary percutaneous coronary intervention) prospective, randomized trial. J Am Coll Cardiol. 2009 Jan 27;53(4):309-15. doi: 10.1016/j.jacc.2008.10.017.

ReferenceCitation: Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. doi: 10.1016/j.jacc.2007.04.059. Epub 2007 Jul 30.

ReferenceCitation: Svilaas T, Vlaar PJ, van der Horst IC, Diercks GF, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Thrombus aspiration during primary percutaneous coronary intervention. N Engl J Med. 2008 Feb 7;358(6):557-67. doi: 10.1056/NEJMoa0706416.

ReferenceCitation: Thiele H, Schindler K, Friedenberger J, Eitel I, Furnau G, Grebe E, Erbs S, Linke A, Mobius-Winkler S, Kivelitz D, Schuler G. Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the randomized Leipzig immediate percutaneous coronary intervention abciximab IV versus IC in ST-elevation myocardial infarction trial. Circulation. 2008 Jul 1;118(1):49-57. doi: 10.1161/CIRCULATIONAHA.107.747642. Epub 2008 Jun 16.

ReferenceCitation: Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12. No abstract available.

ReferenceCitation: Wu KC, Zerhouni EA, Judd RM, Lugo-Olivieri CH, Barouch LA, Schulman SP, Blumenthal RS, Lima JA. Prognostic significance of microvascular obstruction by magnetic resonance imaging in patients with acute myocardial infarction. Circulation. 1998 Mar 3;97(8):765-72. doi: 10.1161/01.cir.97.8.765.

ReferenceCitation: Belle L, Motreff P, Mangin L, Range G, Marcaggi X, Marie A, Ferrier N, Dubreuil O, Zemour G, Souteyrand G, Caussin C, Amabile N, Isaaz K, Dauphin R, Koning R, Robin C, Faurie B, Bonello L, Champin S, Delhaye C, Cuilleret F, Mewton N, Genty C, Viallon M, Bosson JL, Croisille P; MIMI Investigators*. Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study. Circ Cardiovasc Interv. 2016 Mar;9(3):e003388. doi: 10.1161/CIRCINTERVENTIONS.115.003388.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Centre Hospitalier Annecy Genevois

sponsor_collaborators:
Centre Hospitalier Annecy Genevois
University Hospital, Grenoble

location_facility:
CHRA
CHU Croix Rousse
Clinique de Courlancy
CHU
Clinique Mutualiste
CH
CHI
Ch Bastia
Clinique St Hilaire
Clinique Convert
CHU Nord
Hopital Privé
CH St Luc St Joseph
Clinique du Tonkin
Clinique St Gatien
Clinique Marie Lannelongue

lead_sponsor_type: academique


title: A Multi-center, Randomized, Double Blind, Dose Escalation Safety Study of MP4CO in Clinically Stable Adult Sickle Cell Patients

summary:
Sickle Cell Anemia is caused by an inherited hemoglobin disorder. Healthy red blood cells are discoid and can deform and move through small blood vessels to carry oxygen to all parts of the body. In sickle cell disease, as red blood cells circulate and oxygen is released in the circulatory system, the deoxygenated abnormal hemoglobin S can begin to polymerize. When this occurs, the red blood cells can become sticky and elongated. These sickled red blood cells are less flexible and will obstruct small blood vessels and block normal red blood cells from traveling through the circulatory system, which limits oxygen delivery to tissues and organs. This is known as a "sickle crisis".

Patients suffering from a sickle crisis experience severe pain and are at risk of stroke, heart attack or even death. By lowering the level of oxygen pressure at which sickling occurs and opening the vasculature and rapidly delivering oxygen directly to ischemic tissues, the addition of MP4CO to existing treatment protocols may alleviate pain associated with a sickle cell crisis, abort a crisis and/or potentially reduce the duration of a crisis. This could mean less time in the hospital and an improved quality of life for patients with sickle cell anemia.

lead_sponsor: Sangart

location_country:
United Kingdom
Jamaica
Lebanon
France

location_facility: Sickle Cell Unit, University of West Indies


title: Phase III Study of Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation

acronym: RITUX-ERAH

summary: Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a composite "TREATMENT FAILURE"

lead_sponsor: University Hospital, Tours

sponsor_collaborators:
University Hospital, Tours
Roche Pharma AG

location_facility:
Hospital Necker
Hospital Calmette
Hospital Pellegrin
Hospital Milétrie Jean Bernard
Hospital Gabriel Montpied
Hospital Hôtel Dieu
Hospital Conception
Hospital Bretonneau
Hospital Sud
Hospital Maison Blanche
Hospital Bicêtre
Hospital Bois-Guillaume
Hospital Edouard Herriot
Hospital Lapeyronie
Hospital Saint Louis
Hospital Civil
Hospital Pitié-Salpêtrière
Hospital Lyon Sud
Hospital Henri Mondor
Hospital Dupuytren
Hospital Tenon
Hospital Nord
Hospital
Hospital Bocage
Hospital Pasteur
Hospital Saint-Jacques


title: Randomized Open Non Comparative Multicenter Phase II Study of Sequential Erlotinib With Docetaxel Versus Docetaxel Alone in Second Line of Treatment in Patients With Non Small Cell Lung Cancer After Failure of First Line Chemotherapy

acronym: TARSEQ

summary:
This 2 arms study will compare the efficacy and safety of treatment with sequential erlotinib plus docetaxel therapy versus docetaxel alone as second line treatment in patients with recurrent non-small cell lung cancer. Patients will be randomized to receive in group 1(experimental arm): docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16 and group 2 (control arm): docetaxel :75 mg/m² IV day 1 every 3 weeks.

The anticipated time on study treatment is until disease progression. Target sample size is 156.

The main of this study is to determine the relevance of the association sequential erlotinib and docetaxel in terms of progression-free survival .

lead_sponsor: University Hospital, Limoges

sponsor_collaborators:
University Hospital, Limoges
Hoffmann-La Roche

location_facility: Service de Pneumologie, Hôpital Pontchailloux

location_facility: Service de Pneumologie, Hôpital de la Croix Rousse

location_facility: Département de Pathologie Respiratoire du CHU de Limoges

location_facility: Service de Pneumologie ; Centre hospitalier

location_facility: Service de pneumologie; Centre Hospitalier d'Annecy

location_facility: Service de Pneumologie - Hôpital St Antoine, Paris

location_facility: Service de Pneumologie-Allergologie; Centre Hospitalier Général

location_facility: Service de Pneumologie; Hôpital Bois Guillaume

location_facility: Hôpital Charles Nicolle, Service de Pneumologie

location_facility: Service de Pneumologie-Neurologie ; Centre Hospitalier F. Quesnay

location_facility: Clinique Pneumologique; Hôpital Charles Nicolle

location_facility: Service de Pneumologie; Centre Hospitalier

location_facility: Département des Maladies Respiratoires ; Hôpital Sainte Marguerite


acronym: EORTC protocol 26083

lead_sponsor: Bristol-Myers Squibb

summary: To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma

sponsor_collaborators: European Organisation for Research and Treatment of Cancer - EORTC

title: Randomized Phase II of Lomustine Versus Lomustine-Dasatinib in Patients With Recurrent Glioblastoma

type: Other Identifier

type: EudraCT Number

source: euctr

location_country: Italy Netherlands Switzerland France


title: A Phase I Study to Determine the Pharmacokinetic Profile, Safety and Tolerability of a Single Dose (50IU/kg) of KW-3357 in Subjects With Congenital Antithrombin Deficiency.

summary: The aim of this study is to determine the pharmacokinetics, safety and tolerability of KW-3357 in asymptomatic subjects with congenital antithrombin deficiency.

design_allocation: Non-Randomized

enrollment_type: Anticipated

lead_sponsor: Kyowa Hakko Kirin UK, Ltd.

location_country:
Germany
Italy
France
United Kingdom
Sweden


title: Evaluation of the Validity of a New Index Provided by the PiCCO2 Device for Predicting Fluid Responsiveness in Critically Ill Patients

acronym: FRI

summary:
Fluid therapy is an important part of the management of patients with hemodynamic instability in the intensive care unit. By increasing cardiac preload, it aims at elevating cardiac output (CO) and thus restoring hemodynamic conditions in patients who are preload responsive. By contrast, volume administration can be deleterious in terms of pulmonary edema formation or other manifestations or fluid overload, especially in patients who are not preload responsive. Functional dynamic parameters that use heart-lung interactions, such as pulse pressure variation (PPV) and stroke volume variation (SVV) are considered accurate predictors of preload responsiveness in patients receiving fully controlled mechanical ventilation.

However, in cases of spontaneous breathing activity where heart-lung interaction indices fail to predict fluid responsiveness, one needs parameters able to reliably predict the hemodynamic response of fluid administration.

A new index that could indicate fluid responsiveness, so-called the fluid responsiveness index (FRI), has been elaborated. The advantage is that it could be used in patients who are not in control mechanical ventilation as well as in patients who are fully adapted to mechanical ventilation.

The FRI is based upon the analysis of continuous arterial and continuous central venous pressure. The FRI is determined by the relation of cardiac and respiratory activity; both are evaluated by means of power spectrum analysis of the pressures recorded.

The aim of this study is to test the value of the FRI to predict the hemodynamic response to fluid infusion in patients with hemodynamic instability not receiving fully controlled mechanical ventilation.

status: Unknown status

lead_sponsor: Bicetre Hospital

location_country: Germany Israel Spain France

location_facility: Unidad de cuidados intensivos, Fundacion Jimenez Diaz

location_facility: Department of Anesthesiology and Intensive Care Sheba Medical Centre


type: Registry Identifier

title: ORM Narval Mandibular Repositioning Device in the Second-line Treatment of Severe OSAH

acronym: ORCADES

summary: The purpose of this study is to evaluate the long-term efficacy, tolerance and compliance of ORM Narval Mandibular Repositioning Device (MRD) as a second-line treatment for patients with severe Obstructive Sleep Apnea Hypopnea (OSAH) syndrome who refuse or are intolerant to Continuous Positive Airway Pressure (CPAP) treatment.

study_start_date_type: Actual

ReferenceType: result

ReferenceCitation: Vecchierini MF, Attali V, Collet JM, d'Ortho MP, El Chater P, Kerbrat JB, Leger D, Monaca C, Monteyrol PJ, Morin L, Mullens E, Pigearias B, Meurice JC; ORCADES investigators. A custom-made mandibular repositioning device for obstructive sleep apnoea-hypopnoea syndrome: the ORCADES study. Sleep Med. 2016 Mar;19:131-40. doi: 10.1016/j.sleep.2015.05.020. Epub 2015 Jun 29.

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

ReferenceCitation: Attali V, Vecchierini MF, Collet JM, d'Ortho MP, Goutorbe F, Kerbrat JB, Leger D, Lavergne F, Monaca C, Monteyrol PJ, Morin L, Mullens E, Pigearias B, Martin F, Tordjman F, Khemliche H, Lerousseau L, Meurice JC; ORCADES investigators. Efficacy and tolerability of a custom-made Narval mandibular repositioning device for the treatment of obstructive sleep apnea: ORCADES study 2-year follow-up data. Sleep Med. 2019 Nov;63:64-74. doi: 10.1016/j.sleep.2019.04.021. Epub 2019 Jun 12.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

evidence: open (author manuscript)

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

host_type: repository

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

repository_normalized: HAL

version: submittedVersion

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

repositories_concat: HAL

ReferenceCitation: Vecchierini MF, Attali V, Collet JM, d'Ortho MP, Goutorbe F, Kerbrat JB, Leger D, Lavergne F, Monaca C, Monteyrol PJ, Morin L, Mullens E, Pigearias B, Martin F, Khemliche H, Lerousseau L, Meurice JC; ORCADES investigators; Abedipour D, Allard-Redon A, Aranda A, Attali V, Bavozet F, Becu M, Beruben W, Bessard J, Bonafe I, Boukhana M, Chabrol B, Chatte G, Lebret C, Collet JM, Coste O, Dumont N, Durand-Amat S, D'ortho MP, Elbaum JM, De Santerre OG, Goutorbes F, Grandjean T, Guyot W, Hammer D, Havasi C, Huet P, Kerbrat JB, Khemliche H, Koltes C, Leger D, Lacassagne L, Laur X, Lerousseau L, Liard O, Loisel C, Longuet M, Mallart A, Martin F, Merle Beral F, Meurice JC, Mokhtari Z, Monaca C, Monteyrol PJ, Muir JF, Mullens E, Muller D, Paoli C, Petit FX, Pigearias B, Pradines M, Prigent A, Putterman G, Rey M, Samama M, Tamisier R, Tiberge M, Tison C, Tordjman F, Triolet B, Vacher C, Vecchierini MF, Verain A. Sex differences in mandibular repositioning device therapy effectiveness in patients with obstructive sleep apnea syndrome. Sleep Breath. 2019 Sep;23(3):837-848. doi: 10.1007/s11325-018-1766-8. Epub 2018 Dec 22.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

publisher_dissemination: Springer-Nature

lead_sponsor: ResMed

location_facility: Centre Médical Plateau de Haye / cabinet médical / cabinet dentaire

location_facility: CHRU Rennes / polyclinique St Laurent / cabinet dentaire

location_facility: Maison de la Mutualité / polyclinique de l'Atlantique

location_facility: CHRU Montpellier / Clinique Beau Soleil / Faculté d'Odontologie / cabinet dentaire

location_facility: Polyclinique du Tondu / cabinet dentaire

location_facility: Fondation Bon Sauveur / cabinet médical / cabinet dentaire

location_facility: CH Compiègne Senlis / cabinets dentaires

intervention_type: Device


title: Complications Associated With Promontofixation for Pelvic Organ Prolapse: a Randomized Trial Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures

acronym: RoboLaps

summary:
The primary objective of this study is to compare 30-day complication rates associated with promontofixation for pelvic organ prolapse performed via a robot-assisted laparoscopic technique versus a non-robot-assisted laparoscopic technique. Secondary objectives include comparing technical data, anatomical correction, prolapse recurrence, incontinence, quality of life and medico-economic data between the two techniques.

The patient diary did not allow the collection of sufficiently precise data to meet the secondary medico-economic objective of the study. Access to data from the National Health Data System (SDNS), which was not available at the time of the initial drafting of this protocol, now makes it possible to obtain a complete picture of patients' health care consumption. We propose, therefore, to extract data from the SNIIRAM via the SNDS (matching of patients' NIR to their health care consumption) in order to retrieve and accurately estimate the cost of follow-up.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHU de Lyon - Centre Hospitalier Lyon Sud

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly

location_facility: APHP - Groupe Hospitalier Pitié-Salpetrière


acronym: LUDIC

lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study is to evaluate the proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA) at 6 months in current medical practice.

title: An Open-label, Multicenter, Phase IV Study of the Efficacy and Safety of Ranibizumab 0.5mg in Diabetic Patients Presenting a Visual Impairment Due to Macular Edema in Current Medical Practice


title: A Phase III Study Comparing the Efficacy of the Combination of Doxorubicin and the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF to Doxorubicin Alone as First-line Therapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma

acronym: FIBROSARC

summary:
The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in advanced or metastatic soft-tissue sarcoma patients.

In the study, 102 patients will be randomized in a 1:1 ratio to receive doxorubicin treatment (Arm 1) or L19TNF treatment in combination with doxorubicin (Arm 2).

The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin (Arm 2) given for unresectable or metastatic soft tissue sarcoma improves efficacy measured as progression free survival, as compared to doxorubicin alone (Arm 1).

status: Recruiting

study_completion_date_type: Anticipated

lead_sponsor: Philogen S.p.A.

location_country: Germany Italy Poland Spain France

location_facility: Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie Warszawa

location_facility: Bologna University, Chemotherapy Unit, IRCCS Istituto Ortopedico Rizzoli, Department of DIMES

location_facility: Universitätsmedizin der J.-G. Universität Mainz

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: IRCCS Fondazione del Piemonte per l'Oncologia Istituto per la Ricerca e la Cura del Cancro di Candiolo

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Hospital Universitario Virgen de la Arrixaca

status_simplified: Ongoing


title: Metacognition in Semantic Dementia: Comparison With Alzheimer's Disease

acronym: META-DEM

summary: This study aims at exploring patients' ability to monitor their own memory performance depending on their primary deficit and the type of memory involved in the criterion task. The goal is to evaluate if semantic dementia (SD) and Alzheimer's disease (AD) differently affect patients' awareness of their memory abilities.

lead_sponsor: University Hospital, Grenoble

location_country: Switzerland France

location_facility:
CHU Vaudois
CHU Angers
CHU Rennes
CHU Bordeaux
Hôpitaux Civils Colmar
Chu Grenoble Alpes
Hôpital Neurologique de Lyon

intervention_type: Other


title: Evaluation De L'Observance Globale Et De La Duree De Traitement Par Zomacton® Avec Le Stylo Transjecteur Zomajet® Etude Pharmaco-Epidemiologique Observationnelle Longitudinale Prospective

acronym: ZOMAJET

summary:
The purpose of this strictly observational, prospective, longitudinal study is to evaluate with sufficient precision the rate of overall treatment compliance from one year to 3 years of follow-up of the patients.

Somatotropin is indicated in the long-term treatment of children with growth retardation related to a deficiency in secretion of growth hormone and in the long-term treatment of growth retardation related to Turner's syndrome confirmed by chromosomal analysis. These are the two indications of Zomacton® 4 mg and 10 mg injection solution.

The use of the Zomajet® needle-free device (Zomajet® 2 Vision, reserved for the administration of Zomacton® 4 mg or of the Zomajet® Vision X needle-free device, reserved for the administration of Zomacton® 10 mg), allows the product to be administered by percutaneous transjection (needle-free) and can be used by the child directly or by the family after an initial training.

In April 2004, the CEPP (Commission for the Evaluation of Products and Services) requested a follow-up of the cohort of patients using the Zomajet® 2 Vision system measuring the compliance and duration of use of the device.

The number of patients initiated on Zomacton treatment using the Zomajet® needle-free device is estimated to 30. Over a period of inclusion of 3 years, we therefore estimate that 90 patients will be treated. In the cohort studied the patients will be followed-up for 1 year at least and for 3 years at the maximum.

The rate of treatment compliance will be evaluated according to the ratio of the actual duration of administration over the total duration recommended by the physician during the observation period.


title: A Phase I/II Study of the Efficacy and Safety of an Intensified Schedule of Azacitidine (Vidaza®) in Intermediate-2 and High Risk MDS Patients

summary: A phase I/II study of the efficacy and safety of an intensified schedule of Azacitidine (Vidaza®) in intermediate-2 and high risk MDS patients.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Hopital Saint Louis - AP-HP, Hematology Dpt

location_facility: CHU Albert Michallon - Service d'Hématologie Clinique

location_facility: Hopital Purpan Service d'Hématologie Clinique


title: A Phase I-II Study of the Efficacy and Safety of Idarubicin Combined to Azacitidine in Int-2 or High Risk Myelodysplastic Syndromes

summary:
Patients will receive escalating doses of ldarubicin combined to Azacitidine given at the FDA/EMEA approved Schedule and dosing.

For the Phase I study :

Determine the safety and tolerance of escalating doses of Idarubicin combined to Azacitidine in patients with INT-2 or higher risk MDS.

For the phase II study:

Primary: Evaluate rate and duration of response (according to IWG 2006 criteria and IWG 2000 criteria) to the combination of Idarubicin and Azacitidine in patients with INT-2 or higher risk MDS

location_country: Tunisia France

location_facility: Hôpital Saint Louis - Hématologie Séniors

location_facility: Hôpital saint louis - Hématologie Clinique


title: Understanding the Long-Term Management of Organic Acidemia Patients With CARBAGLU®: A Mixed Methods Approach

acronym: PROTECT

summary: This is a prospective mixed-design study focused on the long-term management of propionic aciduria (PA) and methylmalonic aciduria (MMA) with N-carbamylglutamate (NCG) maintenance therapy. Treatment characteristics, clinical outcomes, and healthcare utilization data of patients diagnosed PA or MMA treated >6 months therapy with NCG are collected at baseline, 12 months, 18 months, 36 months and 54 months. Qualitative interviews with adult patients and caregivers are conducted >6 months after study enrollment to gain a better understanding of the disease burden and the treatment burden of patients and their families.

ReferenceCitation: Burlina A, Bettocchi I, Biasucci G, Bordugo A, Gasperini S, La Spina L, Maines E, Meli C, Menni F, Paci S, Procopio E, Rossi A, Rubert L, Spada M, Tubili F, Tummolo A. Long-term use of carglumic acid in methylmalonic aciduria, propionic aciduria and isovaleric aciduria in Italy: a qualitative survey. Eur Rev Med Pharmacol Sci. 2022 Jul;26(14):5136-5143. doi: 10.26355/eurrev_202207_29302.

ReferenceCitation: Alfadhel M, Nashabat M, Saleh M, Elamin M, Alfares A, Al Othaim A, Umair M, Ahmed H, Ababneh F, Al Mutairi F, Eyaid W, Alswaid A, Alohali L, Faqeih E, Almannai M, Aljeraisy M, Albdah B, Hussein MA, Rahbeeni Z, Alasmari A. Long-term effectiveness of carglumic acid in patients with propionic acidemia (PA) and methylmalonic acidemia (MMA): a randomized clinical trial. Orphanet J Rare Dis. 2021 Oct 11;16(1):422. doi: 10.1186/s13023-021-02032-8.

ReferenceCitation: Kido J, Matsumoto S, Nakamura K. Carglumic Acid Contributes to a Favorable Clinical Course in a Case of Severe Propionic Acidemia. Case Rep Pediatr. 2020 Mar 9;2020:4709548. doi: 10.1155/2020/4709548. eCollection 2020.

ReferenceCitation: Kiykim E, Oguz O, Duman C, Zubarioglu T, Cansever MS, Zeybek ACA. Long-term N-carbamylglutamate treatment of hyperammonemia in patients with classic organic acidemias. Mol Genet Metab Rep. 2021 Jan 30;26:100715. doi: 10.1016/j.ymgmr.2021.100715. eCollection 2021 Mar.

ReferenceCitation: Tummolo A, Melpignano L, Carella A, Di Mauro AM, Piccinno E, Vendemiale M, Ortolani F, Fedele S, Masciopinto M, Papadia F. Long-term continuous N-carbamylglutamate treatment in frequently decompensated propionic acidemia: a case report. J Med Case Rep. 2018 Apr 22;12(1):103. doi: 10.1186/s13256-018-1631-1.

ReferenceCitation: Burlina A, Cazzorla C, Zanonato E, Viggiano E, Fasan I, Polo G. Clinical experience with N-carbamylglutamate in a single-centre cohort of patients with propionic and methylmalonic aciduria. Mol Genet Metab Rep. 2016 Jul 13;8:34-40. doi: 10.1016/j.ymgmr.2016.06.007. eCollection 2016 Sep.

lead_sponsor: Recordati Rare Diseases

location_country:
Germany
Italy
Norway
United Kingdom
Sweden
Spain
France

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Guy's and St. Thomas' Hospital NHS Foundation Trust

location_facility: Hopital Des Enfants, CHU de Bordeaux-GH Pellegrin

location_facility: Sheffield Children's Hospital NHS Foundation Trust

location_facility: Klinikum Bremen Mitte, Prof. Hess Kinderklinik

location_facility: San Paola Hospital, ASST Santi Paolo e Carlo

location_facility: Azienda Ospedaliera Universitaria Federico II


title: SHAMAL: A Multicentre, Randomised, Open-Label, Parallel-Group, Active-Controlled, Phase IV Study to Assess the Reduction of Daily Maintenance ICS/LABA Treatment Towards Anti-Inflammatory Reliever Treatment in Patients With Severe Eosinophilic Asthma Treated With Benralizumab

summary: This is a multicentre, randomised, open-label, parallel-group, active-controlled, phase IV study to assess the reduction of daily Symbicort® maintenance to anti-inflammatory reliever treatment only in participants with severe eosinophilic asthma on Fasenra® treatment, while maintaining asthma control.

ReferenceCitation: Butler CA, Heaney LG. Fractional exhaled nitric oxide and asthma treatment adherence. Curr Opin Allergy Clin Immunol. 2021 Feb 1;21(1):59-64. doi: 10.1097/ACI.0000000000000704.

ipd_sharing: Undecided

lead_sponsor: AstraZeneca

location_country:
Germany
Italy
United Kingdom
France


title: Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz Sirolimus-eluting Coronary Stent System in the Treatment of All-comer Patients With Coronary Artery Disease

summary: This is a prospective, multicenter, open-label, single-arm registry. The primary objective of this registry is to confirm the results of the Supraflex Cruz stent in real life all-comer patients (800 patients as in the Supraflex arm of the TALENT trial) and demonstrate that the Supraflex Cruz stent is not inferior to the BioFreedom stent in High Bleeding Risk (HBR) patients (400 patients) with respect to device oriented composite endpoint (DOCE) at 12 months. All patients will be followed up to 12 months after the index procedure.

lead_sponsor: Sahajanand Medical Technologies Limited

collaborators: Cardiovascular European Research Center (CERC)

location_country: Germany Switzerland France

location_facility: Heart and Diabetes Center Nordrhine Westfalia

location_facility: Städtische Kliniken Neuss, Lukaskrankenhaus

location_facility: Herzzentrum Dresden - Universitätklinikum an der TU Dresden


title: Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell Adults.

acronym: DREPSUFINDOL

summary: The analgesic treatment for vaso-occlusive crisis (VOC) in sickle-cell patients is an emergency. The reference treatment is morphine, which requires a venous way sometimes difficult to obtain in these patients. Sufentanil intranasal has been shown to be effective in traumatology. The objective is to evaluate, in VOC, the efficacy of intranasal sufentanil relayed by morphine IV compared to the usual protocol, Equimolar Mixture of Oxygen-Nitrous Oxide (EMONO) relayed by morphine intravenous (IV).

lead_sponsor: University Hospital, Bordeaux

location_country:
Guadeloupe
French Guiana
France

location_facility:
Hôpital Rangueil
CHU Pointe à Pitre
Gonesse Hospital
Hôpital Louis Mourier
Hôpital Edouard Herriot
CH de Cayenne
Hopital Pellegrin
Hôpital Charles Nicolle

appel_a_projets: PHRCI

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

type_etablissement: CH

acronyme: DREPSUFINDOL

titre: EFFICACITE DU SUFENTANIL INTRANASAL POUR L'ANALGESIE DES CRISES VASOOCCLUSIVES DE L'ADULTE DREPANOCYTAIRE.

discipline_principale: drépanocytose , douleur aigue , crise vaso-occlusive , opiacé

nom_porteur: GALINSKI

prenom_porteur: Michel


lead_sponsor: Gilead Sciences

summary: The primary objective of this study is to evaluate the efficacy of bulevirtide combination with pegylated interferon in participants with chronic hepatitis delta (CHD).

location_facility: "Matei Bals" National Institute of Infectious Diseases, Hospital department

location_facility: Specialized clinical Infectious diseases Hospital

location_facility: N.V.Sklifosovsky Scientific Research Institute of Emergency care of the Moscow Healthcare Department

location_facility: CH Pitié-Salpétrière - Hépato-Gastroentérologie

location_facility: "Matei Bals" National Institute of Infectious Diseases,Clinical Trials department

location_facility: Hôpital Cochin - Unité d'Hépatologie Pavillon Achard

location_facility: "Victor Babes" Centre of Diagnostic and Treatment

location_facility: Moscow Regional Scientific and Research Clinical Institute

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Federal Budget Institute of Science "Central Research Institute for Epidemiology" of Federal Service on Consumers Rights Protection and Human Well-Being Surveillance

location_facility: Hôpital Saint Joseph Hépato-Gastroentérologie

location_facility: Dr. V. Babes Clinical Hospital of Infectious and Tropical Diseases

location_facility: Infectious Clinical Hospital "T. Ciorba", Department 5 / Medical University Department of Infectious Diseases

location_facility: Infectious Clinical Hospital "T. Ciorba", Department 4 / Medical University Department of Infectious Diseases

location_facility: State Budgetary Educational Institution of Higher Professional Education "South Ural State Medical University" of the Ministry of Healthcare of the Russian Federation

location_facility: Hôpital Beaujon-Pavillon Abrami -Sce Hépatologie

location_facility: Federal State Budgetary Institution National Research Medical Center for Phthisiopulmonology and Infectious Diseases of the Ministry of Health of the Russian Federation

title: A Multicenter, Open-label, Randomized Phase 2b Clinical Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Patients With Chronic Hepatitis Delta

location_country:
Romania
Moldova, Republic of
Russian Federation
France


title: HighLife™ Transcatheter Mitral Valve Replacement System for Severe Mitral Regurgitation in Patients at High Surgical Risk

summary: Multicenter feasibility study of the HighLife™ TMVR system.

status: Active, not recruiting

ReferenceCitation: Lange R, Piazza N. HighLife transcatheter mitral valve replacement. EuroIntervention. 2016 Sep 18;12(Y):Y81-3. doi: 10.4244/EIJV12SYA22. No abstract available.

ReferenceCitation: Stone GW, Adams DH, Abraham WT, Kappetein AP, Genereux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: A Consensus Document From the Mitral Valve Academic Research Consortium. J Am Coll Cardiol. 2015 Jul 21;66(3):308-321. doi: 10.1016/j.jacc.2015.05.049.

ReferenceCitation: Barbanti M, Piazza N, Mangiafico S, Buithieu J, Bleiziffer S, Ronsivalle G, Scandura S, Giuffrida A, Popolo Rubbio A, Mazzamuto M, Sgroi C, Lange R, Tamburino C. Transcatheter Mitral Valve Implantation Using the HighLife System. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1662-1670. doi: 10.1016/j.jcin.2017.06.046.

lead_sponsor: HighLife SAS

collaborators:
MedPass International
ICON plc

sponsor_collaborators:
HighLife SAS
MedPass International
ICON plc

location_country: Germany France

location_facility: Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: Universitäres Herzzentrum Hamburg GmbH (UHZ)


title: Efficacy of Clarithromycin or Moxifloxacin Containing Regimen in 6 Months Sputum Conversion of Mycobacterium Xenopi

acronym: CAMOMY

summary: The purpose of this study is to determine the 6-months sputum conversion rate with a clarithromycin or moxifloxacin containing regimen in patients with a M. xenopi pulmonary infection.

ReferenceCitation: TIMPE A, RUNYON EH. The relationship of atypical acid-fast bacteria to human disease; a preliminary report. J Lab Clin Med. 1954 Aug;44(2):202-9. No abstract available.

ReferenceCitation: RUNYON EH. Anonymous mycobacteria in pulmonary disease. Med Clin North Am. 1959 Jan;43(1):273-90. doi: 10.1016/s0025-7125(16)34193-1. No abstract available.

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. doi: 10.1164/rccm.200604-571ST. No abstract available. Erratum In: Am J Respir Crit Care Med. 2007 Apr 1;175(7):744-5. Dosage error in article text.

ReferenceCitation: Falkinham JO 3rd. Nontuberculous mycobacteria in the environment. Clin Chest Med. 2002 Sep;23(3):529-51. doi: 10.1016/s0272-5231(02)00014-x.

ReferenceCitation: von Reyn CF, Waddell RD, Eaton T, Arbeit RD, Maslow JN, Barber TW, Brindle RJ, Gilks CF, Lumio J, Lahdevirta J, et al. Isolation of Mycobacterium avium complex from water in the United States, Finland, Zaire, and Kenya. J Clin Microbiol. 1993 Dec;31(12):3227-30. doi: 10.1128/jcm.31.12.3227-3230.1993.

ReferenceCitation: Smith MJ, Citron KM. Clinical review of pulmonary disease caused by Mycobacterium xenopi. Thorax. 1983 May;38(5):373-7. doi: 10.1136/thx.38.5.373.

ReferenceCitation: Banks J, Hunter AM, Campbell IA, Jenkins PA, Smith AP. Pulmonary infection with mycobacterium xenopi: review of treatment and response. Thorax. 1984 May;39(5):376-82. doi: 10.1136/thx.39.5.376.

ReferenceCitation: American Thoracic Society. Diagnosis standards and classification of tuberculosis and other mycobacterial diseases. New York: American Lung Association, 1974:25

ReferenceCitation: Diagnosis and treatment of disease caused by nontuberculous mycobacteria. Am Rev Respir Dis. 1990 Oct;142(4):940-53. doi: 10.1164/ajrccm/142.4.940. No abstract available. Erratum In: Am Rev Respir Dis 1991 Jan;143(1):204.

ReferenceCitation: Diagnosis and treatment of disease caused by nontuberculous mycobacteria. This official statement of the American Thoracic Society was approved by the Board of Directors, March 1997. Medical Section of the American Lung Association. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 2):S1-25. doi: 10.1164/ajrccm.156.2.atsstatement.

ReferenceCitation: Subcommittee OT. Management of opportunist mycobacterial infections: Joint Tuberculosis Committee Guidelines 1999. Subcommittee of the Joint Tuberculosis Committee of the British Thoracic Society. Thorax. 2000 Mar;55(3):210-8. doi: 10.1136/thorax.55.3.210. No abstract available.

ReferenceCitation: Dailloux M, Abalain ML, Laurain C, Lebrun L, Loos-Ayav C, Lozniewski A, Maugein J; French Mycobacteria Study Group. Respiratory infections associated with nontuberculous mycobacteria in non-HIV patients. Eur Respir J. 2006 Dec;28(6):1211-5. doi: 10.1183/09031936.00063806.

ReferenceCitation: Jenkins PA, Campbell IA; Research Committee of The British Thoracic Society. Pulmonary disease caused by Mycobacterium xenopi in HIV-negative patients: five year follow-up of patients receiving standardised treatment. Respir Med. 2003 Apr;97(4):439-44. doi: 10.1053/rmed.2002.1444.

ReferenceCitation: Baugnee PE, Pouthier F, Delaunois L. [Pulmonary mycobacteriosis due to Mycobacterium xenopi" in-vitro sensitivity to classical antitubercular agents and clinical development]. Acta Clin Belg. 1996;51(1):19-27. French.

ReferenceCitation: Martin-Casabona N, Bahrmand AR, Bennedsen J, Thomsen VO, Curcio M, Fauville-Dufaux M, Feldman K, Havelkova M, Katila ML, Koksalan K, Pereira MF, Rodrigues F, Pfyffer GE, Portaels F, Urgell JR, Rusch-Gerdes S, Tortoli E, Vincent V, Watt B; Spanish Group for Non-Tuberculosis Mycobacteria. Non-tuberculous mycobacteria: patterns of isolation. A multi-country retrospective survey. Int J Tuberc Lung Dis. 2004 Oct;8(10):1186-93.

ReferenceCitation: Yates MD, Pozniak A, Uttley AH, Clarke R, Grange JM. Isolation of environmental mycobacteria from clinical specimens in south-east England: 1973-1993. Int J Tuberc Lung Dis. 1997 Feb;1(1):75-80.

ReferenceCitation: Andrejak C, Lescure FX, Douadi Y, Laurans G, Smail A, Duhaut P, Jounieaux V, Schmit JL. Non-tuberculous mycobacteria pulmonary infection: management and follow-up of 31 infected patients. J Infect. 2007 Jul;55(1):34-40. doi: 10.1016/j.jinf.2007.01.008. Epub 2007 Mar 13.

ReferenceCitation: Andrejak C, Lescure FX, Pukenyte E, Douadi Y, Yazdanpanah Y, Laurans G, Schmit JL, Jounieaux V; Xenopi Group. Mycobacterium xenopi pulmonary infections: a multicentric retrospective study of 136 cases in north-east France. Thorax. 2009 Apr;64(4):291-6. doi: 10.1136/thx.2008.096842. Epub 2008 Dec 3.

ReferenceCitation: Costrini AM, Mahler DA, Gross WM, Hawkins JE, Yesner R, D'Esopo ND. Clinical and roentgenographic features of nosocomial pulmonary disease due to Mycobacterium xenopi. Am Rev Respir Dis. 1981 Jan;123(1):104-9. doi: 10.1164/arrd.1981.123.1.104.

ReferenceCitation: Andrejak C, Thomsen VO, Johansen IS, Riis A, Benfield TL, Duhaut P, Sorensen HT, Lescure FX, Thomsen RW. Nontuberculous pulmonary mycobacteriosis in Denmark: incidence and prognostic factors. Am J Respir Crit Care Med. 2010 Mar 1;181(5):514-21. doi: 10.1164/rccm.200905-0778OC. Epub 2009 Dec 10.

ReferenceCitation: Dautzenberg B, Papillon F, Lepitre M, Truffot-Pernod C, Chauvin JP. Mycobacterium xenopi infections treated with clarithromycine-containing regimens. Annual meeting, 33rd Interscience Conference on Antimicrobial Agents and Chemotherapy.

ReferenceCitation: Alfandari S. Recommandations du C-CLIN Paris Nord pour le diagnostic et le traitement des infections ostéo-articulaires à Mycobacterium xenopi. Med Mal Infect 28 :231-234, 1998.

ReferenceCitation: Klemens SP, Cynamon MH. Activities of azithromycin and clarithromycin against nontuberculous mycobacteria in beige mice. Antimicrob Agents Chemother. 1994 Jul;38(7):1455-9. doi: 10.1128/AAC.38.7.1455.

ReferenceCitation: Lounis N, Truffot-Pernot C, Bentoucha A, Robert J, Ji B, Grosset J. Efficacies of clarithromycin regimens against Mycobacterium xenopi in mice. Antimicrob Agents Chemother. 2001 Nov;45(11):3229-30. doi: 10.1128/AAC.45.11.3229-3230.2001.

ReferenceCitation: Jenkins PA, Campbell IA, Banks J, Gelder CM, Prescott RJ, Smith AP. Clarithromycin vs ciprofloxacin as adjuncts to rifampicin and ethambutol in treating opportunist mycobacterial lung diseases and an assessment of Mycobacterium vaccae immunotherapy. Thorax. 2008 Jul;63(7):627-34. doi: 10.1136/thx.2007.087999. Epub 2008 Feb 4. Erratum In: Thorax. 2008 Sep;63(9):844.

ReferenceCitation: Varadi RG, Marras TK. Pulmonary Mycobacterium xenopi infection in non-HIV-infected patients: a systematic review. Int J Tuberc Lung Dis. 2009 Oct;13(10):1210-8.

ReferenceCitation: Wallace RJ Jr, Brown BA, Griffith DE, Girard WM, Murphy DT. Clarithromycin regimens for pulmonary Mycobacterium avium complex. The first 50 patients. Am J Respir Crit Care Med. 1996 Jun;153(6 Pt 1):1766-72. doi: 10.1164/ajrccm.153.6.8665032.

ReferenceCitation: Dautzenberg B, Piperno D, Diot P, Truffot-Pernot C, Chauvin JP. Clarithromycin in the treatment of Mycobacterium avium lung infections in patients without AIDS. Clarithromycin Study Group of France. Chest. 1995 Apr;107(4):1035-40. doi: 10.1378/chest.107.4.1035.

ReferenceCitation: Griffith DE, Brown BA, Cegielski P, Murphy DT, Wallace RJ Jr. Early results (at 6 months) with intermittent clarithromycin-including regimens for lung disease due to Mycobacterium avium complex. Clin Infect Dis. 2000 Feb;30(2):288-92. doi: 10.1086/313644.

ReferenceCitation: Griffith DE, Brown BA, Girard WM, Murphy DT, Wallace RJ Jr. Azithromycin activity against Mycobacterium avium complex lung disease in patients who were not infected with human immunodeficiency virus. Clin Infect Dis. 1996 Nov;23(5):983-9. doi: 10.1093/clinids/23.5.983.

ReferenceCitation: Tanaka E, Kimoto T, Tsuyuguchi K, Watanabe I, Matsumoto H, Niimi A, Suzuki K, Murayama T, Amitani R, Kuze F. Effect of clarithromycin regimen for Mycobacterium avium complex pulmonary disease. Am J Respir Crit Care Med. 1999 Sep;160(3):866-72. doi: 10.1164/ajrccm.160.3.9811086.

ReferenceCitation: Dauendorffer JN, Laurain C, Weber M, Dailloux M. In vitro sensitivity of Mycobacterium xenopi to five antibiotics. Pathol Biol (Paris). 2002 Dec;50(10):591-4. doi: 10.1016/s0369-8114(02)00360-7.

ReferenceCitation: Berlin OG, Young LS, Floyd-Reising SA, Bruckner DA. Comparative in vitro activity of the new macrolide A-56268 against mycobacteria. Eur J Clin Microbiol. 1987 Aug;6(4):486-7. doi: 10.1007/BF02013117. No abstract available.

ReferenceCitation: Fraschini F, Scaglione F, Pintucci G, Maccarinelli G, Dugnani S, Demartini G. The diffusion of clarithromycin and roxithromycin into nasal mucosa, tonsil and lung in humans. J Antimicrob Chemother. 1991 Feb;27 Suppl A:61-5. doi: 10.1093/jac/27.suppl_a.61.

ReferenceCitation: Wallace RJ Jr, Brown BA, Griffith DE. Drug intolerance to high-dose clarithromycin among elderly patients. Diagn Microbiol Infect Dis. 1993 Mar-Apr;16(3):215-21. doi: 10.1016/0732-8893(93)90112-k.

ReferenceCitation: Gillespie SH, Billington O. Activity of moxifloxacin against mycobacteria. J Antimicrob Chemother. 1999 Sep;44(3):393-5. doi: 10.1093/jac/44.3.393.

ReferenceCitation: Alcaide F, Calatayud L, Santin M, Martin R. Comparative in vitro activities of linezolid, telithromycin, clarithromycin, levofloxacin, moxifloxacin, and four conventional antimycobacterial drugs against Mycobacterium kansasii. Antimicrob Agents Chemother. 2004 Dec;48(12):4562-5. doi: 10.1128/AAC.48.12.4562-4565.2004.

ReferenceCitation: Rodriguez Diaz JC, Lopez M, Ruiz M, Royo G. In vitro activity of new fluoroquinolones and linezolid against non-tuberculous mycobacteria. Int J Antimicrob Agents. 2003 Jun;21(6):585-8. doi: 10.1016/s0924-8579(03)00048-7.

ReferenceCitation: Gosling RD, Uiso LO, Sam NE, Bongard E, Kanduma EG, Nyindo M, Morris RW, Gillespie SH. The bactericidal activity of moxifloxacin in patients with pulmonary tuberculosis. Am J Respir Crit Care Med. 2003 Dec 1;168(11):1342-5. doi: 10.1164/rccm.200305-682OC. Epub 2003 Aug 13.

ReferenceCitation: Bermudez LE, Kolonoski P, Petrofsky M, Wu M, Inderlied CB, Young LS. Mefloquine, moxifloxacin, and ethambutol are a triple-drug alternative to macrolide-containing regimens for treatment of Mycobacterium avium disease. J Infect Dis. 2003 Jun 15;187(12):1977-80. doi: 10.1086/375352. Epub 2003 Jun 4.

ReferenceCitation: Bermudez LE, Inderlied CB, Kolonoski P, Petrofsky M, Aralar P, Wu M, Young LS. Activity of moxifloxacin by itself and in combination with ethambutol, rifabutin, and azithromycin in vitro and in vivo against Mycobacterium avium. Antimicrob Agents Chemother. 2001 Jan;45(1):217-22. doi: 10.1128/AAC.45.1.217-222.2001.

ReferenceCitation: Veziris N, Truffot-Pernot C, Aubry A, Jarlier V, Lounis N. Fluoroquinolone-containing third-line regimen against Mycobacterium tuberculosis in vivo. Antimicrob Agents Chemother. 2003 Oct;47(10):3117-22. doi: 10.1128/AAC.47.10.3117-3122.2003.

ReferenceCitation: Valerio G, Bracciale P, Manisco V, Quitadamo M, Legari G, Bellanova S. Long-term tolerance and effectiveness of moxifloxacin therapy for tuberculosis: preliminary results. J Chemother. 2003 Feb;15(1):66-70. doi: 10.1179/joc.2003.15.1.66.

ReferenceCitation: Moadebi S, Harder CK, Fitzgerald MJ, Elwood KR, Marra F. Fluoroquinolones for the treatment of pulmonary tuberculosis. Drugs. 2007;67(14):2077-99. doi: 10.2165/00003495-200767140-00007.

ReferenceCitation: Shandil RK, Jayaram R, Kaur P, Gaonkar S, Suresh BL, Mahesh BN, Jayashree R, Nandi V, Bharath S, Balasubramanian V. Moxifloxacin, ofloxacin, sparfloxacin, and ciprofloxacin against Mycobacterium tuberculosis: evaluation of in vitro and pharmacodynamic indices that best predict in vivo efficacy. Antimicrob Agents Chemother. 2007 Feb;51(2):576-82. doi: 10.1128/AAC.00414-06. Epub 2006 Dec 4.

ReferenceCitation: Teeter JG, Bleecker ER. Relationship between airway obstruction and respiratory symptoms in adult asthmatics. Chest. 1998 Feb;113(2):272-7. doi: 10.1378/chest.113.2.272.

ReferenceCitation: Begaud B, Evreux JC, Jouglard J, Lagier G. [Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France]. Therapie. 1985 Mar-Apr;40(2):111-8. No abstract available. French.

ReferenceCitation: Rhodes VA, McDaniel RW. The Index of Nausea, Vomiting, and Retching: a new format of the lndex of Nausea and Vomiting. Oncol Nurs Forum. 1999 Jun;26(5):889-94.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: CHU Montpellier Hôpital Arnaud de Villeneuve

location_facility: Assistance Publique Hôpitaux de Paris, hôpital TENON

location_facility: Assistance Publique Hôpitaux de Marseille

location_facility: Assistance Publique Hôpitaux de Paris Hôpital Bicetre

location_facility: Assistance Publique Hôpitaux de Paris Hôpital Saint Antoine

location_facility: Assistance Publique Hôpitaux de Paris CHU Avicenne

location_facility: Assistance Publique Hôpitaux de Paris Hôpital BICHAT

location_facility: Assistance Publique Hôpitaux de Paris Hôpital Saint Louis

location_facility: Centre National de Reference Des Mycobactéries

location_facility: CHU Clermont Ferrand Hôpital Gabriel Mont pied


type: Other Grant/Funding Number

title: Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?

summary: The purpose of this study is to estimate the sensibility at the growth hormone in vivo at the children presenting a Prader-Willi syndrome (SPW) in comparison with children presenting a deficit in growth hormone (GHD).

ReferenceCitation: Cadoudal T, Buleon M, Sengenes C, Diene G, Desneulin F, Molinas C, Eddiry S, Conte-Auriol F, Daviaud D, Martin PG, Bouloumie A, Salles JP, Tauber M, Valet P. Impairment of adipose tissue in Prader-Willi syndrome rescued by growth hormone treatment. Int J Obes (Lond). 2014 Sep;38(9):1234-40. doi: 10.1038/ijo.2014.3. Epub 2014 Jan 10.

publisher_dissemination: Springer

ReferenceCitation: Eddiry S, Diene G, Molinas C, Salles J, Auriol FC, Gennero I, Bieth E, Skryabin BV, Rozhdestvensky TS, Burnett LC, Leibel RL, Tauber M, Salles JP. SNORD116 and growth hormone therapy impact IGFBP7 in Prader-Willi syndrome. Genet Med. 2021 Sep;23(9):1664-1672. doi: 10.1038/s41436-021-01185-y. Epub 2021 May 26.

ReferenceCitation: Bieth E, Eddiry S, Gaston V, Lorenzini F, Buffet A, Conte Auriol F, Molinas C, Cailley D, Rooryck C, Arveiler B, Cavaille J, Salles JP, Tauber M. Highly restricted deletion of the SNORD116 region is implicated in Prader-Willi Syndrome. Eur J Hum Genet. 2015 Feb;23(2):252-5. doi: 10.1038/ejhg.2014.103. Epub 2014 Jun 11.

lead_sponsor: University Hospital, Toulouse

location_facility: CHU Lyon Hôpital Debrousse service Pédiatrie

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

location_facility: CHU Nice Hôpital Archet 2 - 151 route Saint Antoine de Ginestière

location_facility: CHU Reims Service de Pédiatrie - 47, rue Cognacq-Jay

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

location_facility: CHU La Rochelle Service de Pédiatrie - Rue du Dr Schweitzer

location_facility: CHU Saint-Etienne Hôpital Nord Service de Pédiatrie

location_facility: CHU Brest Département de Pédiatrie - 5, ave Foch

location_facility: CHU Montpellier Hôpital Arnaud de Villeneuve - 371 ave du doyen Gaston Giraud

location_facility: CHU Poitiers Service de Pédiatrie - Rue de la Miléterie

location_facility: CHU Toulouse Hôpital des Enfants Service d'endocrinologie - 330 ave de Grande Bretagne

location_facility: CHRU Tours Centre de Pédiatrie Gatien de Clocheville

location_facility: CHU Bordeaux Hôpital Pellegrin Service endocrinologie de l'enfant - Place Amélie Raba Léon

location_facility: CHU Amiens Hôpital Nord Service Pédiatrie - Place Victor Pauchet

location_facility: CHU Limoges Hôpital Mère Enfant Service Pédiatrie - 8, ave du Larrey

location_facility: CHU Grenoble Service de pédiatrie - BP 217

location_facility: CHU Dijon Service de pédiatrie - 2, Bd Maréchal de lattre de Tassigny

location_facility: CHU Besançon Hôpital Saint Jacques - 2 Place Saint Jacques

location_facility: CHU Nantes Hôpital Mère Enfant Service de Pédiatrie

location_facility: CHU Rouen Hôpital Nicolle - 1, rue de Germont

location_facility: CHU Strasbourg Hôpital Haute-Pierre - Avenue Molière

location_facility: CHRU Lille Hôpital Jeanne de Flandre service de Pédiatrie

location_facility: CHU Lorient Hôpital du Scorff Pôle Femme Mère Enfant - Rue Guiguen


acronym: CHIVA

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

summary: This is a phase II, multicenter, non-randomized, open-label study evaluating the combination of pemetrexed plus carboplatin in HIV-positive patients with lung cancer.

ReferenceCitation: Lavole A, Chouaid C, Baudrin L, Wislez M, Raguin G, Pialoux G, Girard PM, Milleron B, Cadranel J. Effect of highly active antiretroviral therapy on survival of HIV infected patients with non-small-cell lung cancer. Lung Cancer. 2009 Sep;65(3):345-50. doi: 10.1016/j.lungcan.2008.11.018. Epub 2009 Jan 9.

ReferenceCitation: Lavole A, Greillier L, Mazieres J, Monnet I, Kiakouama-Maleka L, Quantin X, Spano JP, Lena H, Fraisse P, Janicot H, Audigier-Valette C, Langlais A, Morin F, Makinson A, Cadranel J; French Cooperative Thoracic Intergroup (IFCT). First-line carboplatin plus pemetrexed with pemetrexed maintenance in HIV-positive patients with advanced non-squamous non-small cell lung cancer: the phase II IFCT-1001 CHIVA trial. Eur Respir J. 2020 Aug 27;56(2):1902066. doi: 10.1183/13993003.02066-2019. Print 2020 Aug.

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

publisher_dissemination: European Respiratory Society

location_facility: Centre François Magendie - hôpital du Haut-Lévèque

title: Phase II Trial Evaluating the Efficacy and Safety of Carboplatin Plus Pemetrexed in Human Immunodeficiency Virus Positive (HIV+) Patients With Stage III (Not Amenable to Radiation or Inoperable) or Stage IV Nonsquamous Non Small Cell Lung Cancer


title: Prospective, Multicentre, Observational Study

acronym: TCD

summary: Patients with mild to moderate traumatic brain injury (TBI) are at risk for secondary neurological deterioration. Their outcome within the first week after injury could be predicted by clinical signs, brain CT scan and transcranial doppler (TCD) on admission to the emergency room. The investigators aim to evaluate the diagnostic performance of TCD to screen patients presented with mild to moderate TBI and mild lesions on CT scan, i.e., Trauma Coma Data Bank, TCDB classification II. The principal outcome measure is the negative predictive value of TCD.

ReferenceCitation: Thornhill S, Teasdale GM, Murray GD, McEwen J, Roy CW, Penny KI. Disability in young people and adults one year after head injury: prospective cohort study. BMJ. 2000 Jun 17;320(7250):1631-5. doi: 10.1136/bmj.320.7250.1631.

ReferenceCitation: Davis DP, Kene M, Vilke GM, Sise MJ, Kennedy F, Eastman AB, Velky T, Hoyt DB. Head-injured patients who "talk and die": the San Diego perspective. J Trauma. 2007 Feb;62(2):277-81. doi: 10.1097/TA.0b013e31802ef4a3.

ReferenceCitation: Livingston DH, Lavery RF, Passannante MR, Skurnick JH, Baker S, Fabian TC, Fry DE, Malangoni MA. Emergency department discharge of patients with a negative cranial computed tomography scan after minimal head injury. Ann Surg. 2000 Jul;232(1):126-32. doi: 10.1097/00000658-200007000-00018.

ReferenceCitation: Marshall LF, Marshall SB, Klauber MR, van Berkum Clark M, Eisenberg HM, Jane JA, et al. A new classification of head injury based on computerized tomography. J Neurosurg 1991; 75: S14-S20.

ReferenceCitation: Wardlaw JM, Easton VJ, Statham P. Which CT features help predict outcome after head injury? J Neurol Neurosurg Psychiatry. 2002 Feb;72(2):188-92; discussion 151. doi: 10.1136/jnnp.72.2.188.

ReferenceCitation: Sifri ZC, Homnick AT, Vaynman A, Lavery R, Liao W, Mohr A, Hauser CJ, Manniker A, Livingston D. A prospective evaluation of the value of repeat cranial computed tomography in patients with minimal head injury and an intracranial bleed. J Trauma. 2006 Oct;61(4):862-7. doi: 10.1097/01.ta.0000224225.54982.90.

ReferenceCitation: af Geijerstam JL, Oredsson S, Britton M; OCTOPUS Study Investigators. Medical outcome after immediate computed tomography or admission for observation in patients with mild head injury: randomised controlled trial. BMJ. 2006 Sep 2;333(7566):465. doi: 10.1136/bmj.38918.669317.4F. Epub 2006 Aug 8.

ReferenceCitation: Stein SC, Burnett MG, Glick HA. Indications for CT scanning in mild traumatic brain injury: A cost-effectiveness study. J Trauma. 2006 Sep;61(3):558-66. doi: 10.1097/01.ta.0000233766.60315.5e. Erratum In: J Trauma. 2007 May;62(5):1309.

ReferenceCitation: White H, Venkatesh B. Applications of transcranial Doppler in the ICU: a review. Intensive Care Med. 2006 Jul;32(7):981-94. doi: 10.1007/s00134-006-0173-y. Epub 2006 May 10.

ReferenceCitation: McQuire JC, Sutcliffe JC, Coats TJ. Early changes in middle cerebral artery blood flow velocity after head injury. J Neurosurg. 1998 Oct;89(4):526-32. doi: 10.3171/jns.1998.89.4.0526.

ReferenceCitation: Jaffres P, Brun J, Declety P, Bosson JL, Fauvage B, Schleiermacher A, Kaddour A, Anglade D, Jacquot C, Payen JF. Transcranial Doppler to detect on admission patients at risk for neurological deterioration following mild and moderate brain trauma. Intensive Care Med. 2005 Jun;31(6):785-90. doi: 10.1007/s00134-005-2630-4. Epub 2005 Apr 16.

collaborators: CIC Clinical Investigation Centre Grenoble

location_facility:
Hopitaux Du Pays Du Mont Blanc
Ch Belley
CHU Lyon
Chu Nimes
Ch Voiron
CH Nantes
Ch Cannes
Ch Grasse
CHU Pierre Benite
Ch Saint Julien En Genevois
Ch Briancon
Ch Chambery
Chu Edouard Herriot
CHRA Annecy
CHU Grenoble
CHU
Ch Thonon Les Bains
CH Valence
Ch Saint Jean de Maurienne


summary: The goal of this multicentric prospective randomized controlled clinical and economic study is to investigate the effectiveness and cost-utility of long-term continuous intraduodenal infusion of levodopa ( DUODOPA), compared to best medical treatment, on advanced and severe form of Parkinson's disease.

lead_sponsor: Poitiers University Hospital

location_facility:
Chu Saint Etienne
Chu de Marseille
Chu de Toulouse
CH d'Aix en Provence
Chu de Poitiers
Ch La Pitie Salpetriere
Chu Bordeaux
Chu de Rennes
Chu de Lyon
Chu Clermont-Ferrand
Chu Amiens
Chu de Nimes
Chu de Nantes
Chu Lille
Chu de Nice
Ch Saint Antoine
Chu de Rouen
Hôpital Henri Mondor
Chu de Limoges
Chu de Strasbourg


lead_sponsor: Novo Nordisk A/S

summary: This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.

ReferenceCitation: Heise T, Tack CJ, Cuddihy R, Davidson J, Gouet D, Liebl A, Romero E, Mersebach H, Dykiel P, Jorde R. A new-generation ultra-long-acting basal insulin with a bolus boost compared with insulin glargine in insulin-naive people with type 2 diabetes: a randomized, controlled trial. Diabetes Care. 2011 Mar;34(3):669-74. doi: 10.2337/dc10-1905. Epub 2011 Feb 1.

ReferenceCitation: Ma Z, Parkner T, Christiansen JS, Laursen T. IDegAsp: a novel soluble insulin analogs combination. Expert Opin Biol Ther. 2012 Nov;12(11):1533-40. doi: 10.1517/14712598.2012.722203. Epub 2012 Sep 4.

ReferenceCitation: Liebl A, Davidson J, Mersebach H, Dykiel P, Tack CJ, Heise T. A novel insulin combination of insulin degludec and insulin aspart achieves a more stable overnight glucose profile than insulin glargine: results from continuous glucose monitoring in a proof-of-concept trial. J Diabetes Sci Technol. 2013 Sep 1;7(5):1328-36. doi: 10.1177/193229681300700524.

publisher_dissemination: SAGE Publications

title: A 16 Week Randomised, Open Labelled, 3 Armed, Parallel Group, Treat-to-target Trial Comparing Once Daily Injection of SIAC 30 (B), SIAC 45 (B) and Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment

location_country: Germany Norway Romania Spain France


intervention_type: Biological

lead_sponsor: GlaxoSmithKline

summary: In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64 years.

title: Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza Vaccine GSK1247446A With Various Formulations in Subjects Aged 18-64 Years

primary_purpose: Prevention

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country: Germany Spain France

ipd_sharing: Yes


title: Multicentric Prospective, Randomised, Controlled Clinical Study on Clinical Efficacy and Tolerability of Urinary FSH (Fostimon® , IBSA) Versus r-FSH (Gonal-F®, Serono) in ICSI.

summary: Purpose of the study is the comparative evaluation of the clinical efficacy and of the general tolerability of two different subcutaneous FSH preparations (Fostimon® IBSA Vs Gonal-F® Serono) when administered in patients undergoing ICSI

ReferenceCitation: GEMZELL CA, DICZFALUSY E, TILLINGER G. Clinical effect of human pituitary follicle-stimulating hormone (FSH). J Clin Endocrinol Metab. 1958 Dec;18(12):1333-48. doi: 10.1210/jcem-18-12-1333. No abstract available.

ReferenceCitation: Thompson CR, Hansen LM. Pergonal (menotropins): a summary of clinical experience in the induction of ovulation and pregnancy. Fertil Steril. 1970 Dec;21(12):844-53. doi: 10.1016/s0015-0282(16)37925-0. No abstract available.

ReferenceCitation: Oelsner G, Serr DM, Mashiach S, Blankstein J, Snyder M, Lunenfeld B. The study of induction of ovulation with menotropins: analysis of results of 1897 treatment cycles. Fertil Steril. 1978 Nov;30(5):538-44. doi: 10.1016/s0015-0282(16)43634-4. No abstract available.

ReferenceCitation: Schwartz M, Jewelewicz R, Dyrenfurth I, Tropper P, Vande Wiele RL. The use of human menopausal and chorionic gonadotropins for induction of ovulation. Sixteen years' experience at the Sloane Hospital for Women. Am J Obstet Gynecol. 1980 Dec 1;138(7 Pt 1):801-7. doi: 10.1016/s0002-9378(16)32740-5.

ReferenceCitation: Notation AD, Tagatz GE, Steffes MW. Serum 17beta-estradiol. Index of follicular maturation during gonadotropin therapy. Obstet Gynecol. 1978 Feb;51(2):204-9.

ReferenceCitation: Dore PC, Rice C, Killick S. Human gonadotrophin preparations. May cause allergic reaction. BMJ. 1994 Jun 4;308(6942):1509. doi: 10.1136/bmj.308.6942.1509b. No abstract available.

ReferenceCitation: Howles CM, Loumaye E, Giroud D, Luyet G. Multiple follicular development and ovarian steroidogenesis following subcutaneous administration of a highly purified urinary FSH preparation in pituitary desensitized women undergoing IVF: a multicentre European phase III study. Hum Reprod. 1994 Mar;9(3):424-30. doi: 10.1093/oxfordjournals.humrep.a138522.

ReferenceCitation: Wikland M, Borg J, Hamberger L, Svalander P. Simplification of IVF: minimal monitoring and the use of subcutaneous highly purified FSH administration for ovulation induction. Hum Reprod. 1994 Aug;9(8):1430-6. doi: 10.1093/oxfordjournals.humrep.a138724.

ReferenceCitation: Daya S, Gunby J. Recombinant versus urinary follicle stimulating hormone for ovarian stimulation in assisted reproduction. Hum Reprod. 1999 Sep;14(9):2207-15. doi: 10.1093/humrep/14.9.2207.

ReferenceCitation: Remorgida V, Venturini PL, Anserini P, Lanera P, De Cecco L. Administration of pure follicle-stimulating hormone during gonadotropin-releasing hormone agonist therapy in patients with clomiphene-resistant polycystic ovarian disease: hormonal evaluations and clinical perspectives. Am J Obstet Gynecol. 1989 Jan;160(1):108-13. doi: 10.1016/0002-9378(89)90099-9.

ReferenceCitation: Hackeloer BJ, Fleming R, Robinson HP, Adam AH, Coutts JR. Correlation of ultrasonic and endocrinologic assessment of human follicular development. Am J Obstet Gynecol. 1979 Sep 1;135(1):122-8.

ReferenceCitation: Venturoli S, Paradisi R, Fabbri R, Magrini O, Porcu E, Flamigni C. Comparison between human urinary follicle-stimulating hormone and human menopausal gonadotropin treatment in polycystic ovary. Obstet Gynecol. 1984 Jan;63(1):6-11.

ReferenceCitation: Mendelson EB, Bohm-Velez M, Joseph N, Neiman HL. Gynecologic imaging: comparison of transabdominal and transvaginal sonography. Radiology. 1988 Feb;166(2):321-4. doi: 10.1148/radiology.166.2.3275976.

ReferenceCitation: Fleischer AC. Transabdominal and transvaginal sonography of ovarian masses. Clin Obstet Gynecol. 1991 Jun;34(2):433-42. doi: 10.1097/00003081-199106000-00027.

ReferenceCitation: Wang CF, Gemzell C. The use of human gonadotropins for the induction of ovulation in women with polycystic ovarian disease. Fertil Steril. 1980 May;33(5):479-86. doi: 10.1016/s0015-0282(16)44711-4.

lead_sponsor: IBSA Institut Biochimique SA

location_country: Hungary France

location_facility:
Hôpital Tenon
Semmelweis Medical School
Hôpital Jeanne de Flandre
Hôpital Américain
Hôpital Edouard Herriot
Institut de Médecine de la Reproduction
Private Consulting


title: Multicenter, Dose Response, Randomized, Double Blind, Parallel, Placebo Controlled Clinical Trial to Evaluate the Efficacy and the Safety of Subcutaneous CDP870 in Subjects Suffering From Moderate-to-severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy and/or Phototherapy and/or Photochemotherapy

summary: A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo, administered during 12 weeks, to patients suffering from moderate to severe chronic plaque psoriasis, extended by a 12 to 24 week follow-up.

ReferenceCitation: Ortonne JP, Tasset C, Reich K. Efficacy of certolizumab pegol, a PEGylated Fab' fragment of an anti-alpha monoclonal antibody, in patients previously exposed to biologicals: preliminary results of a randomised, placebo-controlled, phase II clinical trial in psoriasis. J.Eur.Acad.Dermatol.Venereol. 22[Suppl 1], 2007. Vienna, 16th Congress of the European Academy of Dermatology and Venereology (EADV), May 16-20, 2007.

ReferenceCitation: Ortonne JP, Sterry W, Tasset C, Reich K. Safety and efficacy of subcutaneous certolizumab pegol, a new anti-TNF-alpha monoclonal antibody, in patients with moderate-to-severe chronic plaque psoriasis: preliminary results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 56[Suppl 2], AB6. 2007. Washington, DC, 65th Annual Meeting of the American Academy of Dermatology (AAAD), February 2-7, 2007.

ReferenceCitation: Reich K, Tasset C, Ortonne J. Efficacy and safety of certolizumab pegol, in patients with chronic plaque psoriasis: preliminary results of a randomized, double-blind, placebo-controlled trial. Ann.Rheum.Dis. 66[Suppl 2], 251. 2007. Barcelona, Annual European Congress of Rheumatology EULAR 2007, June 13-16, 2007.

ReferenceCitation: Ortonne JP, Sterry W, Tasset C, Reich K. Certolizumab pegol, the first pegylated anti-TNF alpha, is effective and well tolerated in patients with moderate-to-severe chronic plaque psoriasis: preliminary data from a phase II study. J.Eur.Acad.Dermatol.Venereol. 21[Suppl 1], 26. 2007. Rhodes, Greece, 15th Congress of the European Academy of Dermatology and Venereology (EADV), October 4-8, 2006.

ReferenceCitation: Ortonne JP, Sterry W, Coteur G, Keininger DL, Reich K. Improved health-related quality of life in psoriasis patients following 10 weeks' treatment with certolizumab pegol: data from a Phase II study. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.

ReferenceCitation: Reich K, Sterry W, Tasset C, Terpstra I, Ortonne JP. Efficacy and time to relapse with certolizumab pegol, the first pegylated anti-TNF alpha agent, in patients with moderate-to-severe chronic plaque psoriasis: Phase II study results. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.

ReferenceCitation: Ortonne JP, Reich K, Sterry W, Terpstra I. Safety and efficacy (PASI 90 and global evaluation) of subcutaneous certolizumab pegol in patients with moderate to severe chronic plaque psoriasis: Results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 58[Suppl 2], AB4. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.

ReferenceCitation: Ortonne JP, Reich K, Keininger DL. Certolizumab pegol improved health-related quality of life in patients with psoriasis: Data from a phase II study. J.Am.Acad.Dermatol. 58[Suppl 2], AB121. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.

ReferenceCitation: Reich K, Ortonne JP, Gottlieb AB, Terpstra IJ, Coteur G, Tasset C, Mease P. Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension. Br J Dermatol. 2012 Jul;167(1):180-90. doi: 10.1111/j.1365-2133.2012.10941.x. Epub 2012 Jun 11.

lead_sponsor: UCB Pharma


title: A Single Arm, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness

summary: A Single Arm, Pivotal, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: CorNeat Vision Ltd.

location_country: Israel Canada Netherlands France

location_facility:
Rabin Medical Center - Beilinson
University of British Columbia
CHU de Montpellier
UHN - University Health Network
Hopital Fondation Adolphe de Rothschild
Amsterdam UMC - Location AMC


title: A Two Part, Randomized, Participant and Investigator-blinded, 2-arm, Parallel-design, Placebo-controlled Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles on Tendon Regeneration in Patients With Achilles Tendinopathy

summary: The purpose of this study is to measure local and systemic safety and tolerability as well as improvement of Achilles tendon mechanical properties after a single peritendon injection of NGI226 MP in comparison to placebo MP in patients with mid-portion Achilles tendinopathy.

lead_sponsor: Novartis Pharmaceuticals

location_country:
United States
United Kingdom
Germany
France


title: A Confirmatory, Multi-centre, Randomised, Open Label, Controlled Study Confirming Performance of a Single-use Intermittent Micro-holes Zone Catheter in a Population of Adult Male Intermittent Catheter Users.

summary: A multi-centre, randomised, controlled crossover design. The total study duration for the individual subject was approximately 9 weeks, consisting of four site visits and two 4-week test periods at home. Visits 0 and 1 could be performed on the same day. For visit 2 and 3, catheterisations were performed in a hospital setting for bladder emptying assessment and collection of urine samples (the latter only in Denmark). Visit 1 and 2 were followed by a home-use test period, followed by visit 3 which terminated the study.

lead_sponsor: Coloplast A/S

location_country:
Germany
Denmark
United Kingdom
France

location_facility:
Hopital Claude Huriez
Hôpital Tenon
Illingworth Research Group
Artimed
Sanos Clinic
Rigshospitalet


title: National Study of Prevalence of Creatinine Phosphokinase (CPK) Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases (TKI)

summary: This study describes the elevation of CPK in patient treated for solid tumors by TKI

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Léon Bérard
Centre René Huguenin
Hôpital Edouard Herriot
CHU Limoges
Centre Eugène Marquis
Institut Curie
Hôpital Tenon - APHP
Hôpital Saint-Louis - APHP
Centre Oscar Lambret
CHU Robert Debré
Institut Gustave Roussy
Institut Jean Godinot
Hôpital Henri Mondor - APHP
Centre Jean Perrin
Centre Alexis Vautrin
Hôpital Jean Minjoz
Centre Antoine Lacassagne
Institut Claudius Régaud
Centre Val d'Aurelle
Centre Paul Papin
Centre François Baclesse
Institut Paoli Calmettes
Institut Bergonié
Institut de Cancérologie de la Loire
Hôpital Cochin - APHP
CHU Bordeaux
Centre Henri Becquerel


title: Open-Label Multicenter 2-Arm Phase I Study of RO5429083 With Dose-Escalation and Extension Cohorts, and Imaging Cohorts With RO5429083 and 89Zr-labeled RO5429083, in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors

summary: This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously at escalating doses. In Part B, patients will receive 89Zr-labelled RO5429083 in Cycles 1 and/or 2, followed by RO5429083. For all patients there will be an option to continue treatment with RO5429083 until disease progression or unacceptable toxicity occurs.

lead_sponsor: Hoffmann-La Roche

location_country:
United States
Netherlands
France


title: EPO906 Phase I 6-arm Trial to Optimize Administration Exploring Single Dose Bolus and Continuous Infusion Over 1 or 5 Days Every 3 or 4 Weeks in Patients With Pretreated Advanced Colon Cancer With Nutritional Support Treatment and Intensive Management of Diarrhea

summary: This study is exploring different administration schedules (short versus prolonged infusion) to optimize the safety and efficacy profile of EPO906A (patupilone) in patients with pretreated advanced colon cancer.

location_country:
Czechia
Spain
United Kingdom
France


title: Cost-effectiveness of New Surgical Treatments for Haemorrhoidal Disease - Randomized Controlled Trial Comparing Transanal Doppler-guided Arterial Ligation With Mucopexy and Stapled Haemorrhoidopexy (Longo's Technique)

acronym: LIGALONGO

summary: This multicentre RCT aims to compare two surgical treatments of haemorrhoidal disease: doppler-guided arterial ligation with mucopexy (DGALM) and stapled haemorrhoidopexy according to Longo (SH). The hypothesis of the trial is that the DGALM is at a lesser risk and is more cost-effective than SH. With a large number of patients managed in more than 20 centres, we aim to demonstrate that DGALM has a lower morbidity than SH when treating haemorrhoidal disease. At a lower postoperative risk and a lower risk of sequelae, the DGALM would demonstrate to be cost-effective for health care system and attractive for patients.

ReferenceCitation: Woaye-Hune P, Hardouin JB, Lehur PA, Meurette G, Vanier A. Practical issues encountered while determining Minimal Clinically Important Difference in Patient-Reported Outcomes. Health Qual Life Outcomes. 2020 May 27;18(1):156. doi: 10.1186/s12955-020-01398-w.

oa_colors: green gold

evidence: oa journal (via doaj)

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

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

ReferenceCitation: Venara A, Podevin J, Godeberge P, Redon Y, Barussaud ML, Sielezneff I, Queralto M, Bourbao C, Chiffoleau A, Lehur PA; LigaLongo Study Group. A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy. Int J Colorectal Dis. 2018 Oct;33(10):1479-1483. doi: 10.1007/s00384-018-3093-8. Epub 2018 May 28.

lead_sponsor: Nantes University Hospital

location_facility: Marseille University Hospital "Hôpital Nord"

location_facility: Lille University Hospital "Claude Huriez"

location_facility: Marseille University Hospital "La Timone"


title: Phase IIb, Randomized, Double-blind, Placebo-controlled Study in Parallel Groups Assessing the Efficacy and Safety of Two Doses of SOM3355 in Patients Suffering From Huntington's Disease With Choreic Movements

summary: Phase IIb, randomized, double-blind, placebo-controlled study in parallel groups assessing the efficacy and safety of two doses of SOM3355 in patients suffering from Huntington's Disease with choreic movements.

lead_sponsor: SOM Innovation Biotech SA

location_country:
Germany
Italy
Poland
United Kingdom
Switzerland
Spain
France

location_facility: Cambridge University Hospitals NHS Foundation Trust Addenbrooke's Hospital

location_facility: IRCCS Istituto delle Scienze Neurologiche di Bologna

location_facility: Krakowska Akademia Neurologii Sp. z o.o.

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Indywidualna Praktyka Lekarska Daniel Zielonka

location_facility: NIHR Wellcome Trust Manchester Clinical Research Facility

location_facility: Azienda Ospedaliera Universitaria Federico II


title: A Phase 4, Multi-centre, Randomized, Evaluator-blinded, Active-controlled Study to Determine the Incidence of Squamous Cell Carcinoma and Evaluate the Long-term Safety of Tirbanibulin 10 mg/g Ointment and Diclofenac Sodium 3% Gel for the Treatment of Adult Patients With Actinic Keratosis on the Face or Scalp

summary: The purpose of the study is to evaluate the incidence of biopsy confirmed invasive squamous cell carcinoma (SCC) in the selected treatment field (TF) after administration of topical tirbanibulin 10 milligram (mg)/gram (g) ointment or diclofenac sodium 3 percent (%) gel over the 3-year study period.

lead_sponsor: Almirall, S.A.

location_country:
Germany
Italy
Poland
United Kingdom
Spain
France

location_facility:
Almirall Investigational Site 26
Almirall Investigational Site 709
Almirall Investigational Site 503
Almirall Investigational Site 307
Almirall Investigational Site 502
Almirall Investigational Site 508
Almirall Investigational Site 303
Almirall Investigational Site 207
Almirall Investigational Site 703
Almirall Investigational Site 401
Almirall Investigational Site 706
Almirall Investigational Site 704
Almirall Investigation Site 104
Almirall Investigational Site 205
Almirall Investigational Site 209
Almirall Investigational Site 106
Almirall Investigational Site 206
Almirall Investigational Site 701
Almirall Investigational Site 505
Almirall Investigation Site 202
Almirall Investigational Site 504
Almirall Investigational Site 308
Almirall Investigation Site 102
Almirall Investigational Site 310
Almirall Investigational Site 403
Almirall Investigational Site 27
Almirall Investigational Site 304
Almirall Investigational Site 408
Almirall Investigational Site 301
Almirall Investigational Site 204
Almirall Investigational Site 306
Almirall Investigational Site 506
Almirall Investigational Site 507
Almirall Investigational Site 509
Almirall Investigational Site 708
Almirall Investigational Site 208
Almirall Investigation Site 103
Almirall Investigational Site 309
Almirall Investigational Site 101
Almirall Investigational Site 501
Almirall Investigational Site 407
Almirall Investigational Site 402
Almirall Investigational Site 302
Almirall Investigational Site 210
Almirall Investigational Site 305
Almirall Investigation Site 201