acronym: TASTE

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

summary:
Our hypothesis is that patients receiving therapy based on their baseline tumor ERCC1 levels and EGFR mutations would attain better disease free survival rates than patients in the control arm receiving noncustomized therapy. Using this selective approach, patients with stage II and IIIA non N2 NSCLC in the genotypic arm with low ERCC1 levels will receive cisplatin plus pemetrexed, and those with high ERCC1 levels will not receive cisplatin-based chemotherapy. If they harbor EGRF mutations they will be treated with erlotinib.

The study will be restricted to non-squamous NSCLC for two mains reasons. First, this will enrich the EGFR mutation rate that is awaited to be higher in these tumors than in squamous cell carcinoma. Second, permetrexed cisplatin combination has a promising efficacy and favorable toxicity profile and is of potential interest in the adjuvant setting of resected non-squamous NSCLC.

ReferenceCitation: Wislez M, Barlesi F, Besse B, Mazieres J, Merle P, Cadranel J, Audigier-Valette C, Moro-Sibilot D, Gautier-Felizot L, Goupil F, Renault A, Quoix E, Souquet PJ, Madroszyck A, Corre R, Perol D, Morin F, Zalcman G, Soria JC. Customized adjuvant phase II trial in patients with non-small-cell lung cancer: IFCT-0801 TASTE. J Clin Oncol. 2014 Apr 20;32(12):1256-61. doi: 10.1200/JCO.2013.53.1525. Epub 2014 Mar 17.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_facility: Lyon - Hôpital Louis Pradel (Pneumologie)

title: Randomized Phase II/III Adjuvant Trial Evaluating Feasibility of Standard (A) vs. Customized Treatment (B) in Stage II or Stage IIIA Non-N2, Non-squamous Non Small Cell Lung Cancer (NSCLC).


type: Other Identifier

title: Comparison of Two Different Treatment Strategies in Patients With Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy

summary:
This study investigates two different approaches to the change in antidepressant treatment when an initial treatment is not effective: early intervention or delayed intervention.

Two hypothesis will be tested:

that time to confirmed response is shorter in the early intervention strategy vs. delayed intervention strategy
that the time to confirmed remission is shorter in the early intervention strategy compared to delayed intervention strategy.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Romera I, Perez V, Menchon JM, Schacht A, Papen R, Neuhauser D, Abbar M, Svanborg P, Gilaberte I. Early switch strategy in patients with major depressive disorder: a double-blind, randomized study. J Clin Psychopharmacol. 2012 Aug;32(4):479-86. doi: 10.1097/JCP.0b013e31825d9958.

lead_sponsor: Eli Lilly and Company

location_country: Slovenia Italy Hungary Denmark Romania Sweden Netherlands Spain Greece Turkey France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Sensitivity of Echography in Arthritis

acronym: SEA

summary:
It has been reported recently that the detection of synovitis by ultrasonography was more sensitive than clinical examination (Wakefield et al. Ann Rheum Dis).

An OMERACT and EULAR working party recently produced guidelines on the best way to record and score quantitatively synovitis of the small joints of the hands and feet (Wakefield R, D'Agostino MA).

It has also been presumed recently that ultrasonography was more sensitive to changes than clinical examination after anti-TNF treatment (Ref. Taylor et al). If this better sensitivity to change were to be confirmed, ultrasonography would be preferred to clinical examination in studies evaluating new treatments.

In everyday practice, better intrinsic validity of the evaluation of synovitis by ultrasonography would lead to widespread use of this technique in the diagnosis and treatment of rheumatoid arthritis patients.

Objective of this study is to compare the sensitivity to change in synovitis score according to the monitoring method used (clinical examination versus ultrasonography).

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

ReferenceCitation: Cheung PP, Mari K, Devauchelle-Pensec V, Jousse-Joulin S, D'Agostino MA, Chales G, Gaudin P, Mariette X, Saraux A, Dougados M. Predictive value of tender joints compared to synovitis for structural damage in rheumatoid arthritis. RMD Open. 2016 Mar 17;2(1):e000205. doi: 10.1136/rmdopen-2015-000205. eCollection 2016.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central;publicatt.unicatt.it

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

lead_sponsor: Association de Recherche Clinique en Rhumatologie

location_country: Belgium France

location_facility:
Hôpital Ambroise Paré
Hôpital Cochin
CHU de RENNES - Hôpital Sud
CHU de la Cavale Blanche
Hôpital de la Pitié
CHU-Brugmann
CHU Nancy-Brabois
Hôpital Bicêtre
CHU Côte de Nacre
CHU A. Michallon

intervention_type: Device

status_simplified: Unknown


title: Demonstrate the Lot-to-lot Consistency of 3 Consecutive Production Lots of an Adjuvanted Influenza Vaccine Candidate and Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate Versus Fluarix™ Administered Intramuscularly in Elderly

summary: The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.

primary_purpose: Prevention

ipd_sharing: Yes

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.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Norway
United Kingdom
Greece
Estonia
Russian Federation
France

intervention_type: Biological


title: Randomized Study of ACVBP Versus ACVBP Plus Rituximab in Previously Untreated Patients Aged From 18 to 65 Years With Low-risk Localized Diffuse Large B-cell Lymphoma (Age-adjusted IPI = 0)

summary: This study is a multicentric randomized trial evaluating the efficacy of the combination R-ACVBP in patients 18 to 65 years with low risk localized diffuse large B-cell lymphoma.

study_start_date_type: Actual

status: Terminated

ReferenceType: background

ReferenceCitation: Reyes F, Lepage E, Ganem G, Molina TJ, Brice P, Coiffier B, Morel P, Ferme C, Bosly A, Lederlin P, Laurent G, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte (GELA). ACVBP versus CHOP plus radiotherapy for localized aggressive lymphoma. N Engl J Med. 2005 Mar 24;352(12):1197-205. doi: 10.1056/NEJMoa042040.

ReferenceCitation: Miller TP, Dahlberg S, Cassady JR, Adelstein DJ, Spier CM, Grogan TM, LeBlanc M, Carlin S, Chase E, Fisher RI. Chemotherapy alone compared with chemotherapy plus radiotherapy for localized intermediate- and high-grade non-Hodgkin's lymphoma. N Engl J Med. 1998 Jul 2;339(1):21-6. doi: 10.1056/NEJM199807023390104.

ReferenceCitation: Feugier P, Van Hoof A, Sebban C, Solal-Celigny P, Bouabdallah R, Ferme C, Christian B, Lepage E, Tilly H, Morschhauser F, Gaulard P, Salles G, Bosly A, Gisselbrecht C, Reyes F, Coiffier B. Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2005 Jun 20;23(18):4117-26. doi: 10.1200/JCO.2005.09.131. Epub 2005 May 2.

ReferenceCitation: Tilly H, Lepage E, Coiffier B, Blanc M, Herbrecht R, Bosly A, Attal M, Fillet G, Guettier C, Molina TJ, Gisselbrecht C, Reyes F; Groupe d'Etude des Lymphomes de l'Adulte. Intensive conventional chemotherapy (ACVBP regimen) compared with standard CHOP for poor-prognosis aggressive non-Hodgkin lymphoma. Blood. 2003 Dec 15;102(13):4284-9. doi: 10.1182/blood-2003-02-0542. Epub 2003 Aug 14.

ReferenceCitation: Copie-Bergman C, Cuilliere-Dartigues P, Baia M, Briere J, Delarue R, Canioni D, Salles G, Parrens M, Belhadj K, Fabiani B, Recher C, Petrella T, Ketterer N, Peyrade F, Haioun C, Nagel I, Siebert R, Jardin F, Leroy K, Jais JP, Tilly H, Molina TJ, Gaulard P. MYC-IG rearrangements are negative predictors of survival in DLBCL patients treated with immunochemotherapy: a GELA/LYSA study. Blood. 2015 Nov 26;126(22):2466-74. doi: 10.1182/blood-2015-05-647602. Epub 2015 Sep 15.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

ipd_sharing: No

lead_sponsor: Lymphoma Study Association

sponsor_collaborators:
Lymphoma Study Association
Amgen

location_country: Switzerland Belgium France

location_facility: Groupe d'Etude des Lymphomes de l'adulte

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud

location_facility: Centre Pluridisciplinaire d'Oncologie, CHUV


title: Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients Aged From 18 to 59 Years With Diffuse Large B-cell Lymphoma and a Age-adjusted IPI of 1.

summary: This study is a multicentric randomized trial evaluating the efficacy of the combination ACVBP+rituximab compared to the combination of CHOP+rituximab in patients aged from 18 to 59 years with diffuse large B-cell lymphoma and one factor of the age-adjusted international prognostic index (IPI).

ReferenceCitation: Dumontet C, Mounier N, Munck JN, Bosly A, Morschauser F, Simon D, Marit G, Casasnovas O, Reman O, Molina T, Reyes F, Coiffier B. Factors predictive of early death in patients receiving high-dose CHOP (ACVB regimen) for aggressive non-Hodgkin's lymphoma: a GELA study. Br J Haematol. 2002 Jul;118(1):210-7. doi: 10.1046/j.1365-2141.2002.03565.x.

ReferenceCitation: Ghesquieres H, Larrabee BR, Haioun C, Link BK, Verney A, Slager SL, Ketterer N, Ansell SM, Delarue R, Maurer MJ, Fitoussi O, Habermann TM, Peyrade F, Dogan A, Molina TJ, Novak AJ, Tilly H, Cerhan JR, Salles G. FCGR3A/2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts. Hematol Oncol. 2017 Dec;35(4):447-455. doi: 10.1002/hon.2305. Epub 2016 Jun 10.

oa_host_type: repository

version: acceptedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Molina TJ, Canioni D, Copie-Bergman C, Recher C, Briere J, Haioun C, Berger F, Ferme C, Copin MC, Casasnovas O, Thieblemont C, Petrella T, Leroy K, Salles G, Fabiani B, Morschauser F, Mounier N, Coiffier B, Jardin F, Gaulard P, Jais JP, Tilly H. Young patients with non-germinal center B-cell-like diffuse large B-cell lymphoma benefit from intensified chemotherapy with ACVBP plus rituximab compared with CHOP plus rituximab: analysis of data from the Groupe d'Etudes des Lymphomes de l'Adulte/lymphoma study association phase III trial LNH 03-2B. J Clin Oncol. 2014 Dec 10;32(35):3996-4003. doi: 10.1200/JCO.2013.54.9493. Epub 2014 Nov 10.

ReferenceCitation: Recher C, Coiffier B, Haioun C, Molina TJ, Ferme C, Casasnovas O, Thieblemont C, Bosly A, Laurent G, Morschhauser F, Ghesquieres H, Jardin F, Bologna S, Fruchart C, Corront B, Gabarre J, Bonnet C, Janvier M, Canioni D, Jais JP, Salles G, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte. Intensified chemotherapy with ACVBP plus rituximab versus standard CHOP plus rituximab for the treatment of diffuse large B-cell lymphoma (LNH03-2B): an open-label randomised phase 3 trial. Lancet. 2011 Nov 26;378(9806):1858-67. doi: 10.1016/S0140-6736(11)61040-4.

location_facility: Groupe d'étude des lymphomes de l'adulte


title: Phase II Study of Gemcitabine Plus Oxaliplatin in Patients With Locally Advanced or Metastatic Pancreatic Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine and oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer.

ReferenceCitation: Huguet F, Andre T, Hammel P, Artru P, Balosso J, Selle F, Deniaud-Alexandre E, Ruszniewski P, Touboul E, Labianca R, de Gramont A, Louvet C. Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol. 2007 Jan 20;25(3):326-31. doi: 10.1200/JCO.2006.07.5663.

ReferenceType: result

ReferenceCitation: Afchain P, Chibaudel B, Lledo G, Selle F, Bengrine-Lefevre L, Nguyen S, Paitel JF, Mineur L, Artru P, Andre T, Louvet C. First-line simplified GEMOX (S-GemOx) versus classical GEMOX in metastatic pancreatic cancer (MPA): results of a GERCOR randomized phase II study. Bull Cancer. 2009 May;96(5):E18-22. doi: 10.1684/bdc.2009.0871. Epub 2009 May 12.

ReferenceCitation: Louvet C, Andre T, Lledo G, Hammel P, Bleiberg H, Bouleuc C, Gamelin E, Flesch M, Cvitkovic E, de Gramont A. Gemcitabine combined with oxaliplatin in advanced pancreatic adenocarcinoma: final results of a GERCOR multicenter phase II study. J Clin Oncol. 2002 Mar 15;20(6):1512-8. doi: 10.1200/JCO.2002.20.6.1512.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Polyclinique De Courlancy
Clinique Saint Jean
Centre Hospitalier Victor Dupouy
Institut Jules Bordet
Hopital Beaujon
Hopital Drevon
American Hospital of Paris
Hopital Tenon
Hopital Saint Antoine
Centre Paul Papin


title: Marshall Ethanolization, Pulmonary Vein Isolation and Line Completion for Ablation of Persistent Atrial Fibrillation

acronym: MARSHALL-PLAN

summary: In ablation strategy for persistent Atrial Fibrillation (PsAF), ablation limited to Pulmonary Vein (PV) isolation is the most straightforward approach but the result give only 50% of arrhythmia free follow-up. Substrate modification strategies have failed to demonstrate their superiority with variable reported success rate. The Marshall network is a highly arrhythmogenic structure that has not been incorporated in current ablation strategies. The investigators sought to investigate a new ablation strategy that target systematically the vein of Marshall by ethanol infusion. This step is integrated in a new ablation strategy consisting in a global anatomical substrate based ablation including PV isolation and left atrial linear ablation (Marshall-Plan).

status: Recruiting

lead_sponsor: University Hospital, Bordeaux

location_facility:
Clermont-Ferrand University Hospital
Ambroise Paré Hospital
AZ Sint Jan Brugge
Clinique Saint Augustin
Centre Cardiologique du Nord
Clinique Pasteur
Bordeaux University Hospital
Les Franciscaines Hospital
Toulouse University Hospirtal

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing

appel_a_projets: PHRCN

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

type_etablissement: CH

acronyme: Marshall-PLAN

titre: Étude multicentrique prospective évaluant l'intérêt d'une stratégie d'ablation de la fibrillation atriale ciblant le substrat anatomique et incluant une alcoolisation systématique de la veine de Marshall.

discipline_principale: cardiologie

nom_porteur: DERVAL

prenom_porteur: Nicolas


title: A Randomised, Controlled, Open-label, French Multicenter Parallel Group Study to Compare the Maintenance of Haemoglobin Level With Once Monthly Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) Versus Epoetin Beta or Darbepoetin Alfa in Patients With Chronic Kidney Disease on Haemodialysis

summary: This 2 arm study will compare the hemoglobin maintenance with once monthly methoxy polyethylene glycol-epoetin beta (Mircera) administration versus epoetin beta or darbepoetin alfa in participants with chronic kidney disease on hemodialysis. Participants will be randomized to receive either monthly intravenous (IV) or subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (at a starting dose of 120 or 200 micrograms, calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered), or standard therapy (IV or SC epoetin beta once, twice or thrice weekly, or IV or SC darbepoetin alfa once a week or twice a week).

ReferenceCitation: Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.

oa_colors: green hybrid

evidence: open (via page says license)

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

lead_sponsor: Hoffmann-La Roche


title: An Open Label Study to Assess the Rate of Pathological Complete Response in Patients With Primary Inflammatory HER2-positive Breast Cancer Treated With Avastin + Herceptin Based Chemotherapy

summary: This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

ReferenceCitation: Pierga JY, Petit T, Delozier T, Ferrero JM, Campone M, Gligorov J, Lerebours F, Roche H, Bachelot T, Charafe-Jauffret E, Pavlyuk M, Kraemer S, Bidard FC, Viens P. Neoadjuvant bevacizumab, trastuzumab, and chemotherapy for primary inflammatory HER2-positive breast cancer (BEVERLY-2): an open-label, single-arm phase 2 study. Lancet Oncol. 2012 Apr;13(4):375-84. doi: 10.1016/S1470-2045(12)70049-9. Epub 2012 Feb 28.


title: Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in ICD Patients

summary: The purpose of this study is to report the incidence of ventricular arrhythmias correlated to the SAS and to focus on the interest of diagnosing Sleep-disorders breathing in ICD patients. This diagnosis will be assessed by an ambulatory nasal pressure recording with portable multi-channel recorder associated to a complete SAS related symptoms questionnaire.This clinical trial will be the first step to gather information about the suspected sleep relation between ventricular arrhythmias and Sleep breathing disorders, in order to improve the management and treatment of such arrhythmias in next generation of defibrillators which will integrate a minute ventilation sensor able to monitor breathing.

lead_sponsor: LivaNova

location_country: Germany Italy Greece France

location_facility:
CHU - Hopital Michallon
CHR Notre Dame de Bonsecours
CHRU Brabois
Prof. Frey Praxis Starnberg
Hopital cardiologique
CHRU Hopital Trousseau
Universitatsklinikum Hamburg Eppendorf
Clinique Saint gatien
Herz-Kreislauf-Klinik Bevensen AG
Policlinico San Donato
Hopital Saint Joseph et saint Luc
Casa di Cura Montevergine
CHU Hopital la Milétrie
CHRU Hopital de la cavale blanche
Osp. Civile
Instituto di Cura
Nouvelle Clinique Nantaise
CHU Dupuytren
Ospedale Mellini
CH Montpellier
Onassis Cardiac Surgery Center
CHU Charles Nicolle
Clinique Bizet
Clinique Pasteur
CHR Cardiologie A
Hopital Nord
CH Pau
CHU
Hospitale civile Guglielmo da Saliceto
Policlinico de Modenna


title: Survey on Time to Lipid-lowering Drug Implementation on Dyslipidemic Patients in General Practice.

acronym: PRYSME

summary: The purpose of this observational study is to describe the time to lipid-lowering drug implementation in the management of dyslipidemic patients, according to the cardiovascular risk level.

study_type: Observational

time_perspective: Cross-Sectional

lead_sponsor: AstraZeneca


title: Comparison and Description of Coronary Patients Management With or Without Heart Failure in Cardiology Consulting

acronym: COMPAR

summary: The purpose of this observational study is to compare frequency of attainment control goals through the more represented cardiovascular factor risk, dyslipidemia, among coronary patients with or without heart failure in cardiology consulting.


title: National Prospective Survey on Women With a Diagnosis of Infiltrative Breast Cancer

acronym: CSI

summary: The purpose of this observational study is to describe radiological, clinical and histological characteristics of women with infiltrative breast cancer.

time_perspective: Prospective


title: Evaluation of the Impact of Abdominal Fat on GERD Severity and GERD Frequency in General Practice

acronym: LINEA

summary: The purpose of this observational study is to assess the impact of abdominal fat on severity and frequency of GERD symptoms .


title: Profile of Hypertensive Patients Seen in Hospital Outpatient's Department

acronym: PROPHYL HO

summary: To evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics, health care management) of hypertensive patients seen in hospital out patient's department by a cardiologist or a nephrologists.


title: Profile of Hypertensive Patients Seen in Private Cardiology Consultation

acronym: Prophyl C

summary: To evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics, health care management) of hypertensive patients seen in private cardiology consultation by holding account of type of exercise of the cardiologist (private exclusive or mixed hospital and private).


acronym: LIBER

lead_sponsor: UNICANCER

summary:
RATIONALE: Letrozole may prevent breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation.

PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in preventing breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation.

ReferenceCitation: Pujol P, Lasset C, Berthet P, Dugast C, Delaloge S, Fricker JP, Tennevet I, Chabbert-Buffet N, This P, Baudry K, Lemonnier J, Roca L, Mijonnet S, Gesta P, Chiesa J, Dreyfus H, Vennin P, Delnatte C, Bignon YJ, Lortholary A, Prieur F, Gladieff L, Lesur A, Clough KB, Nogues C, Martin AL; French Federation of Cancer Centres (FNCLCC). Uptake of a randomized breast cancer prevention trial comparing letrozole to placebo in BRCA1/2 mutations carriers: the LIBER trial. Fam Cancer. 2012 Mar;11(1):77-84. doi: 10.1007/s10689-011-9484-4.

ReferenceCitation: Pujol P, Mijonnet S, Karen S, et al.: Breast cancer prevention by letrozole in post menopausal BRCA1/2 mutations carriers: The Onco-03/LIBER trial. [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-1048, 2009.

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

status: Active, not recruiting

title: Prevention of Breast Cancer by Letrozole in Post-menopausal Women Carrying a BRCA1/BRCA2 Mutation

type: EudraCT Number

source: euctr

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


acronym: NON APPLICABLE

summary:
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as triptorelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving triptorelin and radiation therapy soon after surgery or later after surgery is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying giving triptorelin and radiation therapy soon after surgery to see how well it works compared with giving them later after surgery in treating patients who have undergone surgery for intermediate-risk stage III or stage IV prostate cancer.

ReferenceCitation: Sargos P, Chabaud S, Latorzeff I, Magne N, Benyoucef A, Supiot S, Pasquier D, Abdiche MS, Gilliot O, Graff-Cailleaud P, Silva M, Bergerot P, Baumann P, Belkacemi Y, Azria D, Brihoum M, Soulie M, Richaud P. Adjuvant radiotherapy versus early salvage radiotherapy plus short-term androgen deprivation therapy in men with localised prostate cancer after radical prostatectomy (GETUG-AFU 17): a randomised, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1341-1352. doi: 10.1016/S1470-2045(20)30454-X.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

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

repository_normalized: HAL

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

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

repositories_concat: HAL

publisher_dissemination: Elsevier

ReferenceCitation: Campillo-Gimenez B, Buscail C, Zekri O, Laguerre B, Le Prise E, De Crevoisier R, Cuggia M. Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials. Trials. 2015 Jan 16;16:15. doi: 10.1186/s13063-014-0535-7.

license: cc-by

license_normalized: cc-by

sponsor_collaborators: UNICANCER Ipsen

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

location_facility: Centre Hospitalier Universitaire Henri Mondor

title: Randomized, Multicenter Study Comparing the Immediate Adjuvant Radiotherapy Associate With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) vs Delayed Radiotherapy Until Biochemical Relapse Associated With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) in Patients With Operable Prostate Cancer pT3 R1 pN0 or pNx at Intermediate Risk.


acronym: MAPS

summary: Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.

ReferenceCitation: Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Riviere F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-1414. doi: 10.1016/S0140-6736(15)01238-6. Epub 2015 Dec 21. Erratum In: Lancet. 2016 Apr 2;387(10026):e24.

oa_host_type: closed

ReferenceCitation: Brosseau S, Danel C, Scherpereel A, Mazieres J, Lantuejoul S, Margery J, Greillier L, Audigier-Valette C, Gounant V, Antoine M, Moro-Sibilot D, Rouquette I, Molinier O, Corre R, Monnet I, Langlais A, Morin F, Bergot E, Zalcman G, Levallet G. Shorter Survival in Malignant Pleural Mesothelioma Patients With High PD-L1 Expression Associated With Sarcomatoid or Biphasic Histology Subtype: A Series of 214 Cases From the Bio-MAPS Cohort. Clin Lung Cancer. 2019 Sep;20(5):e564-e575. doi: 10.1016/j.cllc.2019.04.010. Epub 2019 May 13.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

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

ReferenceCitation: Ribi K, Luo W, Colleoni M, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Di Lauro V, Gomez HL, Ruhstaller T, Abdi E, Biganzoli L, Muller B, Barbeaux A, Graas MP, Rabaglio M, Francis PA, Foukakis T, Pagani O, Graiff C, Vorobiof D, Maibach R, Di Leo A, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J; SOLE Investigators. Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial. Br J Cancer. 2019 May;120(10):959-967. doi: 10.1038/s41416-019-0435-4. Epub 2019 Apr 10. Erratum In: Br J Cancer. 2020 Jan 16;:

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

version: submittedVersion

repositories_concat: LIRIAS (KU Leuven);PubMed Central;University of Melbourne - Minerva Access

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

sponsor_collaborators: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Boujan sur Libron - Polyclinique Saint-Privat

title: A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM)

ipd_sharing: Undecided

collaborators:
University Hospital, Caen
Groupe Francais De Pneumo-Cancerologie


title: Azithromycin (Zithromax®) 5 Days Versus Amoxicillin-Clavulanic Acid (Augmentin®): Multicentre, Randomised, Open-Label Study To Compare The Clinical Efficacy And Safety Of Azithromycin With Those Of Amoxicillin-Clavulanic Acid In Patients Presenting With An Exacerbation Of Chronic Bronchitis

summary: This study compared the clinical efficacy and safety of azithromycin with that of amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with an exacerbation of chronic bronchitis.

lead_sponsor: Pfizer


title: Multicenter, Open, Randomized Comparative Trial To Compare Bacteriological And Clinical Efficacy Of Azithromycin Versus Amoxicillin In Children With Streptococcus Tonsillitis

summary: The primary objective was to compare the bacteriological efficacy at Day 10 of azithromycin pediatric suspension (20 mg/kg/day once daily for 3 consecutive days) versus amoxicillin pediatric suspension (50 mg/kg/day in 2 doses for 6 consecutive days) in children aged 3-15 years with Group A streptococcal acute pharyngitis/tonsillitis. Secondary objectives were assessments of bacteriological efficacy at Day 30 and clinical efficacy at Day 10 and Day 30.


acronym: PHERGain

lead_sponsor: MedSIR

summary:
The study assess the early metabolic effects of neoadjuvant treatment with trastuzumab and pertuzumab (± endocrine therapy) on the primary tumor and axillary lymph nodes and their predictive value for pathologic complete response (pCR) in the breast and axilla.

And also assess 3-year invasive disease-free survival (iDFS) in patients with HER2-positive (HER: human epidermal receptor) breast cancer treated with neoadjuvant trastuzumab and pertuzumab (± endocrine therapy) using a FDG-PET response-adapted strategy.

ReferenceCitation: Perez-Garcia JM, Gebhart G, Borrego MR, Schmid P, Marme F, Prat A, Dalenc F, Kerrou K, Colleoni M, Braga S, Malfettone A, Sampayo-Cordero M, Cortes J, Llombart-Cussac A. Trastuzumab and pertuzumab without chemotherapy in early-stage HER2+ breast cancer: a plain language summary of the PHERGain study. Future Oncol. 2022 Oct;18(33):3677-3688. doi: 10.2217/fon-2022-0663. Epub 2022 Oct 27.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

publisher_dissemination: Future Science Ltd

ReferenceCitation: Perez-Garcia JM, Gebhart G, Ruiz Borrego M, Stradella A, Bermejo B, Schmid P, Marme F, Escriva-de-Romani S, Calvo L, Ribelles N, Martinez N, Albacar C, Prat A, Dalenc F, Kerrou K, Colleoni M, Afonso N, Di Cosimo S, Sampayo-Cordero M, Malfettone A, Cortes J, Llombart-Cussac A; PHERGain steering committee and trial investigators. Chemotherapy de-escalation using an 18F-FDG-PET-based pathological response-adapted strategy in patients with HER2-positive early breast cancer (PHERGain): a multicentre, randomised, open-label, non-comparative, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):858-871. doi: 10.1016/S1470-2045(21)00122-4. Epub 2021 May 18.

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Clinical of Nuclear Medicine Technical University Munich

location_facility: Centro Hospitalaer de Tras-os-Montes e Alto Douro

location_facility: Hospital Clínic Universitari de Valencia

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Hospital General Universitari de Valencia

location_facility: Städtisches Klinikum "St. Georg" Leipzig

title: Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive (Human Epidermal Receptor) Breast Cancer: FDG-PET Response-adapted Strategy. The PHERGain Study

location_country:
Germany
Italy
Portugal
United Kingdom
Belgium
Spain
France


title: Evaluation of the Technique of Axillary Sentinel Lymph Node (SLN) Detection in Breast Cancers > 2 cm

summary:
The purpose of this study is to evaluate the quality criteria of the SLN detection technique in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters (rate of false negatives, rate of detection).

Eligible patients will only be registered (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 25 months (24 months for patient inclusion + 1 month for reception of results). The maximum participation duration of each patient is 1 month.

The number of patients required in this multicentric and prospective study is 240 (16 participating centers).

ReferenceCitation: Bonadonna G, Valagussa P, Moliterni A, Zambetti M, Brambilla C. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N Engl J Med. 1995 Apr 6;332(14):901-6. doi: 10.1056/NEJM199504063321401.

ReferenceCitation: Ivens D, Hoe AL, Podd TJ, Hamilton CR, Taylor I, Royle GT. Assessment of morbidity from complete axillary dissection. Br J Cancer. 1992 Jul;66(1):136-8. doi: 10.1038/bjc.1992.230.

ReferenceCitation: Ververs JM, Roumen RM, Vingerhoets AJ, Vreugdenhil G, Coebergh JW, Crommelin MA, Luiten EJ, Repelaer van Driel OJ, Schijven M, Wissing JC, Voogd AC. Risk, severity and predictors of physical and psychological morbidity after axillary lymph node dissection for breast cancer. Eur J Cancer. 2001 May;37(8):991-9. doi: 10.1016/s0959-8049(01)00067-3.

ReferenceCitation: Kissin MW, Querci della Rovere G, Easton D, Westbury G. Risk of lymphoedema following the treatment of breast cancer. Br J Surg. 1986 Jul;73(7):580-4. doi: 10.1002/bjs.1800730723.

ReferenceCitation: Giuliano AE, Kirgan DM, Guenther JM, Morton DL. Lymphatic mapping and sentinel lymphadenectomy for breast cancer. Ann Surg. 1994 Sep;220(3):391-8; discussion 398-401. doi: 10.1097/00000658-199409000-00015.

ReferenceCitation: Krag DN, Weaver DL, Alex JC, Fairbank JT. Surgical resection and radiolocalization of the sentinel lymph node in breast cancer using a gamma probe. Surg Oncol. 1993 Dec;2(6):335-9; discussion 340. doi: 10.1016/0960-7404(93)90064-6.

ReferenceCitation: Glass EC, Essner R, Giuliano AE. Sentinel node localization in breast cancer. Semin Nucl Med. 1999 Jan;29(1):57-68. doi: 10.1016/s0001-2998(99)80030-0.

ReferenceCitation: Turner RR, Ollila DW, Krasne DL, Giuliano AE. Histopathologic validation of the sentinel lymph node hypothesis for breast carcinoma. Ann Surg. 1997 Sep;226(3):271-6; discussion 276-8. doi: 10.1097/00000658-199709000-00006.

ReferenceCitation: McMasters KM, Tuttle TM, Carlson DJ, Brown CM, Noyes RD, Glaser RL, Vennekotter DJ, Turk PS, Tate PS, Sardi A, Cerrito PB, Edwards MJ. Sentinel lymph node biopsy for breast cancer: a suitable alternative to routine axillary dissection in multi-institutional practice when optimal technique is used. J Clin Oncol. 2000 Jul;18(13):2560-6. doi: 10.1200/JCO.2000.18.13.2560.

ReferenceCitation: Weaver DL, Krag DN, Ashikaga T, Harlow SP, O'Connell M. Pathologic analysis of sentinel and nonsentinel lymph nodes in breast carcinoma: a multicenter study. Cancer. 2000 Mar 1;88(5):1099-107.

ReferenceCitation: Tafra L, McMasters KM, Whitworth P, Edwards MJ. Credentialing issues with sentinel lymph node staging for breast cancer. Am J Surg. 2000 Oct;180(4):268-73. doi: 10.1016/s0002-9610(00)00466-9.

ReferenceCitation: McMasters KM, Wong SL, Chao C, Woo C, Tuttle TM, Noyes RD, Carlson DJ, Laidley AL, McGlothin TQ, Ley PB, Brown CM, Glaser RL, Pennington RE, Turk PS, Simpson D, Edwards MJ; University of Louisville Breast Cancer Study Group. Defining the optimal surgeon experience for breast cancer sentinel lymph node biopsy: a model for implementation of new surgical techniques. Ann Surg. 2001 Sep;234(3):292-9; discussion 299-300. doi: 10.1097/00000658-200109000-00003.

ReferenceCitation: Orr RK, Hoehn JL, Col NF. The learning curve for sentinel node biopsy in breast cancer: practical considerations. Arch Surg. 1999 Jul;134(7):764-7. doi: 10.1001/archsurg.134.7.764.

ReferenceCitation: Bedrosian I, Reynolds C, Mick R, Callans LS, Grant CS, Donohue JH, Farley DR, Heller R, Conant E, Orel SG, Lawton T, Fraker DL, Czerniecki BJ. Accuracy of sentinel lymph node biopsy in patients with large primary breast tumors. Cancer. 2000 Jun 1;88(11):2540-5. doi: 10.1002/1097-0142(20000601)88:113.0.co;2-a.

ReferenceCitation: Chung MH, Ye W, Giuliano AE. Role for sentinel lymph node dissection in the management of large (> or = 5 cm) invasive breast cancer. Ann Surg Oncol. 2001 Oct;8(9):688-92. doi: 10.1007/s10434-001-0688-y.

ReferenceCitation: Lelievre L, Houvenaeghel G, Buttarelli M, Brenot-Rossi I, Huiart L, Tallet A, Tarpin C, Jacquemier J. Value of the sentinel lymph node procedure in patients with large size breast cancer. Ann Surg Oncol. 2007 Feb;14(2):621-6. doi: 10.1245/s10434-006-9232-4. Epub 2006 Nov 12.

ReferenceCitation: Schwartz GF, Giuliano AE, Veronesi U; Consensus Conference Committee. Proceedings of the consensus conference on the role of sentinel lymph node biopsy in carcinoma of the breast, April 19-22, 2001, Philadelphia, Pennsylvania. Cancer. 2002 May 15;94(10):2542-51. doi: 10.1002/cncr.10539. No abstract available.

ReferenceCitation: Lyman GH, Giuliano AE, Somerfield MR, Benson AB 3rd, Bodurka DC, Burstein HJ, Cochran AJ, Cody HS 3rd, Edge SB, Galper S, Hayman JA, Kim TY, Perkins CL, Podoloff DA, Sivasubramaniam VH, Turner RR, Wahl R, Weaver DL, Wolff AC, Winer EP; American Society of Clinical Oncology. American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer. J Clin Oncol. 2005 Oct 20;23(30):7703-20. doi: 10.1200/JCO.2005.08.001. Epub 2005 Sep 12.

ReferenceCitation: Edwards M, Giuliano A, Reintgen D, Tafra L. Consensus statement on guidelines for performance of sentinel lymph node biopsy for breast cancer. Am Soc Breast Surg Q. Press Release, 1998 ;Fall :3

lead_sponsor: Centre Leon Berard

sponsor_collaborators:
Centre Leon Berard
PHRC 2007: financial support

location_facility:
Clinique des 2 Caps
Centre Léon Bérard
Centre René Huguenin
Centre Eugène Marquis
CH Calais
Centre Henri Becquerel
CHRU Saint Etienne
CH Arrondissement Montreuil sur Mer
Centre Oscar Lambret
Centre Alexis Vautrin
CMCO
Clinique Pasteur
Institut Claudius Régaud
Centre Val d'Aurelle
Centre Paul Papin
Institut Paoli Calmettes
Institut Bergonié
Clinique des Acacias
CH Boulogne sur Mer
Hôtel Dieu
Centre Hospitalier Lyon Sud
Centre René Gauducheau

intervention_type: Other


title: Randomized Multicenter Phase III Study in Patients With Locally Advanced Adenocarcinoma of the Pancreas: Gemcitabine With or Without Chemoradiotherapy and With or Without Erlotinib. Intergroup Study

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which regimen of chemotherapy with or without erlotinib and/or radiation therapy is most effective in treating pancreatic cancer.

PURPOSE: This randomized phase III trial is studying giving gemcitabine together with or without capecitabine and/or radiation therapy to see how well it works compared with giving gemcitabine together with or without erlotinib in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

ReferenceCitation: Hammel P, Huguet F, van Laethem JL, Goldstein D, Glimelius B, Artru P, Borbath I, Bouche O, Shannon J, Andre T, Mineur L, Chibaudel B, Bonnetain F, Louvet C; LAP07 Trial Group. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib: The LAP07 Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1844-53. doi: 10.1001/jama.2016.4324.

publisher_dissemination: American Medical Association

sponsor_collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Radiotherapie Oncologie Moyenne Garonne

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Centre Hospitalier General de Mont de Marsan

location_facility: C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

location_facility: Centre Hospitalier Universitaire de Bicetre


title: Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Subjects With Type IIa and IIb Hypercholesterolaemia

acronym: CAP-Chol

summary: The purpose of this study is to evaluate the efficacy and safety of Rosuvastatin 5 mg as an hypercholesterolemia treatment comparatively at 2 other statins: Pravastatin 40 mg and Atorvastatin 10 mg. Treatment efficacy will be evaluated by the percentage of LDL-C variation after 8 weeks of treatment.


title: Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients With Chronic Failure of Intensive Insulin Therapy and Conventional Care. The TELEDIAB-1 STUDY

summary:
TELEDIAB-1 is a national, multicenter, controlled, randomised trial. The Primary objective of the TELEDIAB-1 study is to demonstrate that the PDA-FIT system (PDA-Phone and/or telemonitoring) is able to improve metabolic control of chronically uncontrolled type 1 diabetic patients, despite intensive insulin therapy (multiple daily injections with basal-bolus insulin or insulin pump), as compared with conventional care.

Main judgment criteria: comparison of HbA1c means between the 3 groups at 6 months

ReferenceCitation: Charpentier G, Benhamou PY, Dardari D, Clergeot A, Franc S, Schaepelynck-Belicar P, Catargi B, Melki V, Chaillous L, Farret A, Bosson JL, Penfornis A; TeleDiab Study Group. The Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support improves HbA1c in poorly controlled type 1 diabetic patients: a 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study). Diabetes Care. 2011 Mar;34(3):533-9. doi: 10.2337/dc10-1259. Epub 2011 Jan 25.

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility: Centre Hospitalier de Belfort Montbéliard


title: Chemotherapy With FOLFIRI Plus Bevacizumab (AvastinR) in Patients With Metastatic Colorectal Cancer Bearing Genotype UGT1A1*1/UGT1A1*1 or UGT1A1*1/UGT1A1*1/UGT1A1*28: Prospective, Phase II, Multicenter Study

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with bevacizumab and to see how well it works in treating patients with metastatic colorectal cancer.

ReferenceCitation: Manfredi S, Bouche O, Rougier P, Dahan L, Loriot MA, Aparicio T, Etienne PL, Lafargue JP, Lecaille C, Legoux JL, Le Malicot K, Maillard E, Lecomte T, Khemissa F, Breysacher G, Michel P, Mitry E, Bedenne L. High-Dose FOLFIRI plus Bevacizumab in the Treatment of Metastatic Colorectal Cancer Patients with Two Different UGT1A1 Genotypes: FFCD 0504 Study. Mol Cancer Ther. 2015 Dec;14(12):2782-8. doi: 10.1158/1535-7163.MCT-15-0293. Epub 2015 Oct 22.

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Centre Hospitalier General Lucien Hussel

location_facility: Centre Hospitalier de Chalons-en-Champagne


title: Open Label, Randomized, Multicenter Phase II Study of a Combination of Torisel® (Temsirolimus) and Avastin® (Bevacizumab) Versus Sutent® (Sunitinib) and Versus a Combination of Avastin® (Bevacizumab) and Roféron® (Interferon Alpha-2a) in First-line Treatment of Patients With Metastatic Renal Cell Carcinoma.

acronym: TORAVA

summary:
The TORAVA trial is designed to evaluate the progression-free rate at 48 weeks of a combination of Torisel® and Avastin® given at first-line treatment in patients with metastatic renal cancer.

Eligible patients will be randomly assigned, in a 2:1:1 ratio, to either Avastin® + Torisel®, or Sutent® or IFN+Avastin®.

ReferenceCitation: Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. doi: 10.1056/NEJMoa060655. Erratum In: N Engl J Med. 2007 Jul 12;357(2):203.

ReferenceCitation: Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115-24. doi: 10.1056/NEJMoa065044.

ReferenceCitation: Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, Staroslawska E, Sosman J, McDermott D, Bodrogi I, Kovacevic Z, Lesovoy V, Schmidt-Wolf IG, Barbarash O, Gokmen E, O'Toole T, Lustgarten S, Moore L, Motzer RJ; Global ARCC Trial. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007 May 31;356(22):2271-81. doi: 10.1056/NEJMoa066838.

ReferenceCitation: Negrier S, Gravis G, Perol D, Chevreau C, Delva R, Bay JO, Blanc E, Ferlay C, Geoffrois L, Rolland F, Legouffe E, Sevin E, Laguerre B, Escudier B. Temsirolimus and bevacizumab, or sunitinib, or interferon alfa and bevacizumab for patients with advanced renal cell carcinoma (TORAVA): a randomised phase 2 trial. Lancet Oncol. 2011 Jul;12(7):673-80. doi: 10.1016/S1470-2045(11)70124-3. Epub 2011 Jun 12.

ReferenceCitation: Polena H, Creuzet J, Dufies M, Sidibe A, Khalil-Mgharbel A, Salomon A, Deroux A, Quesada JL, Roelants C, Filhol O, Cochet C, Blanc E, Ferlay-Segura C, Borchiellini D, Ferrero JM, Escudier B, Negrier S, Pages G, Vilgrain I. The tyrosine-kinase inhibitor sunitinib targets vascular endothelial (VE)-cadherin: a marker of response to antitumoural treatment in metastatic renal cell carcinoma. Br J Cancer. 2018 May;118(9):1179-1188. doi: 10.1038/s41416-018-0054-5. Epub 2018 Mar 22.

location_facility: Centre Hospitalier Universiariare Lyon, Hôpital Lyon Sud

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hôpital St André

location_facility: Centre Hospitalier Universitaire de Lille - Hôpital Claude Huriez

location_facility: Centre Hospilier Universitaire de Poitiers

location_facility: Centre Hospitalier Universitaire DUPUTRYEN

location_facility: Clinique Valdegour-Centre médical Oncogard


title: Pharmaco-epidemiological Description of the Patient Population Treated With Aptivus Under Market Conditions, Safety & Efficacy

summary: To obtain information on clinical practices for patients treated by Aptivus in real life

lead_sponsor: Boehringer Ingelheim

location_facility: 1182.127.3301 Boehringer Ingelheim Investigational Site


title: A Randomised, Multicentre, Single-Blind, Phase IV Study, of the Efficacy, Safety, and Acceptability of Moviprep® Versus Colopeg® in Colonoscopy Preparation.

acronym: NORMO

summary:
Primary:

- To demonstrate the superiority of Moviprep® versus Colopeg® in gut cleansing prior to colonoscopy.

Secondary:

To assess the safety of Moviprep® versus Colopeg®.
To assess acceptability of Moviprep® versus Colopeg®.

ReferenceCitation: Bitoun A, Ponchon T, Barthet M, Coffin B, Dugue C, Halphen M; Norcol Group. Results of a prospective randomised multicentre controlled trial comparing a new 2-L ascorbic acid plus polyethylene glycol and electrolyte solution vs. sodium phosphate solution in patients undergoing elective colonoscopy. Aliment Pharmacol Ther. 2006 Dec;24(11-12):1631-42. doi: 10.1111/j.1365-2036.2006.03167.x. Epub 2006 Nov 10.

lead_sponsor: Norgine

collaborators: International Clinical Trials Association

location_facility: Service de Gastroentérologie, HOPITAL DE L'ARCHET

location_facility: Service de Gastroentérologie du Pr. MARTEAU, HÔPITAL LARIBOISIERE

location_facility: Service de Gastro-Entérologie, HÔPITAL GEORGES POMPIDOU

location_facility: Service d'Hépato-Gastroentérologie, CHRU NANCY, HOPITAL DE BRABOIS

location_facility: Service de Gastroentérologie,CENTRE HOSPITALIER d'AVIGNON

location_facility: Service de Gastro-Entérologie, HOPITAL TROUSSEAU CHRU de Tours

location_facility: Service des Maladies de l'Appareil Digestif, Centre Hospitalier Régional et Universitaire

location_facility: Centre Des Maladies Du Foie Et de L'Appareil Digestif

location_facility: Service de Gastroentérologie du Dr. Chousterman, HOPITAL INTERCOMMUNAL

location_facility: Service de Gastroentérologie du Pr. LEREBOURS, HOPITAL CHARLES NICOLLE


acronym: DECAPUB

lead_sponsor: Ipsen

summary: The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the delay of premature onset of puberty in girls less than 9 years and boys less than 10 years. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after injection with triptorelin 11.25 mg.

location_facility:
Hôpital du Bocage
Hôpital St-Vincent de Paul
Hôpital des Enfants
Hôpital de la Gespe
Medical Centre
Hôpital Saint-Jacques
Hôpital Archet 2
American Memorial Hospital
Hôpital Flaubert
Hôpital Jeanne de Flandre
Hôpital Necker - Enfants Malades
Hôpital Debrousse
Hôpital de la Timone Enfants
Hôpital Trousseau
Hôpital Hotel-Dieu (CHU)
Hôpital Charles Nicolle
Hôpital Hautepierre
Hôpital Robert Debré

title: Phase III, Multicentre, Non-comparative, Open and Single Stage Study to Assess the Efficacy and Safety of Pamoate of Triptorelin 11.25 MG in Children With Precocious Puberty

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.


title: An Open Label Study to Evaluate the Safety of NeoRecormon in the Treatment of Anemia in Patients With Chronic Hepatitis C Who Are Treated With Pegylated Interferon + Ribavirin Combination Therapy

summary: This single arm study will assess the safety of NeoRecormon in the correction of anemia in patients with chronic hepatitis C who are being treated with Pegylated interferon + ribavirin combination therapy. Patients will receive NeoRecormon at a starting dose of 30,000 IU s.c. which will be adjusted as required to maintain a target Hb of 11-13g/dL. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.


title: A Double-blind, Double-dummy, Randomized, Parallel Groups Study to Assess the Efficacy, Safety and Tolerability of Switching Patients With Early Parkinson's Disease (PD) From Pramipexole IR to Pramipexole ER or Pramipexole IR

summary:
The objectives of this trial conducted in early Parkinson's disease (PD) patients are:

To assess if patients with early Parkinson's disease (PD) can be successfully switched (overnight switching) from Pramipexole (PPX) Immediate Release (IR) to Pramipexole Extended Release (ER). A successful switch at a specific visit is defined as no worsening of the Unified Parkinsons Disease Rating Scale (UPDRS) parts II+III score by more than 15% from baseline and no drug-related adverse events leading to withdrawal;
To establish if this successful switch can be obtained with or without dose-adaptation;
To provide information about the conversion ratio (mg:mg) from Pramipexole IR to Pramipexole ER.

location_country: Germany Netherlands France

location_facility: 248.636.49001 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3303C Boehringer Ingelheim Investigational Site

location_facility: 248.636.3305A Boehringer Ingelheim Investigational Site

location_facility: 248.636.31006 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3302B Boehringer Ingelheim Investigational Site

location_facility: 248.636.49007 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3302A Boehringer Ingelheim Investigational Site

location_facility: 248.636.3313A Boehringer Ingelheim Investigational Site

location_facility: 248.636.3309B Boehringer Ingelheim Investigational Site

location_facility: 248.636.31001 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3308C Boehringer Ingelheim Investigational Site

location_facility: 248.636.31002 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3308D Boehringer Ingelheim Investigational Site

location_facility: 248.636.49004 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3311A Boehringer Ingelheim Investigational Site

location_facility: 248.636.3303B Boehringer Ingelheim Investigational Site

location_facility: 248.636.31003 Boehringer Ingelheim Investigational Site

location_facility: 248.636.31004 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3303A Boehringer Ingelheim Investigational Site

location_facility: 248.636.49003 Boehringer Ingelheim Investigational Site

location_facility: 248.636.49008 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3304A Boehringer Ingelheim Investigational Site

location_facility: 248.636.31005 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3308E Boehringer Ingelheim Investigational Site

location_facility: 248.636.3312B Boehringer Ingelheim Investigational Site

location_facility: 248.636.49002 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3312A Boehringer Ingelheim Investigational Site

location_facility: 248.636.3307C Boehringer Ingelheim Investigational Site

location_facility: 248.636.49006 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3301A Boehringer Ingelheim Investigational Site

location_facility: 248.636.49005 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3305B Boehringer Ingelheim Investigational Site

location_facility: 248.636.3301D Boehringer Ingelheim Investigational Site

location_facility: 248.636.3301B Boehringer Ingelheim Investigational Site

location_facility: 248.636.3306B Boehringer Ingelheim Investigational Site

location_facility: 248.636.3308B Boehringer Ingelheim Investigational Site


acronym: PROPICE

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

summary:
Fondaparinux is an antithrombotic agent having already received a regulatory approval by the European Authorities in venous thromboembolic event prevention after major orthopaedic surgery, as total hip replacement (THR), total knee replacement (TKR), hip fracture (HF). The bleeding risk associated with this prescription is highly related to renal function evaluated by creatinin clearance (CrCl). In order to reduce the bleeding risk, it has been proposed to prescribe fondaparinux 1.5 mg/day in patients with a CrCl between 20 and 50ml/mn instead of 2.5mg/day (European MMA). In the meantime, this approval is essentially based on simulated pharmakinetic data without any support of clinical data.

prospective, multicentre, open-label study evaluating the safety profile of fondaparinux 1.5 mg/day, subcutaneously administered, in patients with a renal impairment defined by a CrCl between 20 and 30 ml/min and undergoing a major orthopaedic surgery.

location_facility:
MARTIN
BEGOU Gérard
LETOURNEAU Bernard
LANGERON Olivier
SCHOEFFLER Pierre
GARANGER Thierry
BARRE Jeanne
GAERTNER Elisabeth
COUVRET Claude
THERY Philippe
LIGNOT Sophie
SZTARCK François
PEGOIX Michel
PERON Alain
MAZUIRE Elisabeth
BONNEMAISON Julie
CHAMBON Françoise
TISSIER Dominique
BAYLOT Denis
CHEVALEREAUD Erick
BELLOUCIF Sadek
RIPART Jacques
CAPDEVILLA Xavier
AUSSET Sylvain
CHARRET Françoise
FUZIER Régis
LEMANISSIER Denis
RABUEL Christophe
DUVERGER Daniel

title: Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux,in Venous Thromboembolic Events Prevention in Patients With Renal Impairment and Undergoing a Major Orthopaedic Surgery. PROPICE Study


title: Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease

acronym: RAPID

summary: Pluricentric randomized study comparing two therapeutic strategies at beginning of Crohn's disease: early immunosuppressants (prescription within the six first months following diagnosis) vs. conventional strategy (immunosuppressants given only in case of steroid failure, in a selected group of patients being at high risk of disabling course. The hypothesis is that immunosuppressants given early may improve the disease course during the 3 following years in this subset of patients.

ReferenceCitation: Beaugerie L, Seksik P, Nion-Larmurier I, Gendre JP, Cosnes J. Predictors of Crohn's disease. Gastroenterology. 2006 Mar;130(3):650-6. doi: 10.1053/j.gastro.2005.12.019.

ReferenceCitation: Cosnes J, Nion-Larmurier I, Beaugerie L, Afchain P, Tiret E, Gendre JP. Impact of the increasing use of immunosuppressants in Crohn's disease on the need for intestinal surgery. Gut. 2005 Feb;54(2):237-41. doi: 10.1136/gut.2004.045294. Erratum In: Gut. 2005 May;54(5):734.

ReferenceCitation: Cosnes J, Bourrier A, Laharie D, Nahon S, Bouhnik Y, Carbonnel F, Allez M, Dupas JL, Reimund JM, Savoye G, Jouet P, Moreau J, Mary JY, Colombel JF; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Early administration of azathioprine vs conventional management of Crohn's Disease: a randomized controlled trial. Gastroenterology. 2013 Oct;145(4):758-65.e2; quiz e14-5. doi: 10.1053/j.gastro.2013.04.048. Epub 2013 Apr 30.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

collaborators: Société Nationale Française de Gastroentérologie

location_facility:
Hopital Lariboisiere
Hopital Beaujon
CHU CAEN
Hopital Bichat
Ch Le Raincy Montfermeil
Institut Mutualiste Montsouris (Imm)
Chu Nantes
Chu Clermont-Ferrand
CHU LYON
Hopital Cochin
Hopital Georges Pompidou
CHU NICE
Chu Amiens
Chu Toulouse
Hopital Bicetre
Chu Strasbourg
Hopital Louis Mourrier
Chu Besancon
Chru Lille
Chu Rouen
Hopital Saint Louis
Chu Marseille - Hopital Nord
Chu Reims
Chu Tours
Hopital St Antoine
Hopital Haut Leveque


title: A Randomized, Open-label Study to Investigate the Impact of Bone Marker Feedback on Persistence to Once Monthly Oral Bonviva (Ibandronate) Treatment for Post-menopausal Osteoporosis.

summary: This 2 arm study will assess the impact of bone marker feedback, using blood sampling and communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. The study will also assess safety, quality of life and patient satisfaction. All patients will receive Bonviva 150mg po monthly, and will be randomized into the bio-feedback or no bio-feedback study arms. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

ReferenceCitation: Roux C, Giraudeau B, Rouanet S, Dubourg G, Perrodeau E, Ravaud P. Monitoring of bone turnover markers does not improve persistence with ibandronate treatment. Joint Bone Spine. 2012 Jul;79(4):389-92. doi: 10.1016/j.jbspin.2011.05.001. Epub 2011 Jun 23.

sponsor_collaborators:
Hoffmann-La Roche
GlaxoSmithKline


title: An Open-label, Multicenter Study in Male Pediatric Patients With Cerebral X-linked Adrenoleukodystrophy (Cald) to Assess the Effects of MIN-102 Treatment on Disease Progression Prior to Human Stem Cell Transplant (HSCT)

acronym: NEXUS

summary: An Open-Label, multicenter study in male pediatric patients with cerebral x-linked adrenoleukodystrophy (cald) to assess the effects of MIN-102 treatment on disease progression prior to human stem cell transplant (HSCT)

lead_sponsor: Minoryx Therapeutics, S.L.

location_country: Argentina Spain Germany France

location_facility: Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik für Kinder- und Jugendmedizin


title: Phase II of Sunitinib (SUTENT®) in First Line for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma - SUPAP

summary:
RATIONALE: Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works as first-line therapy in treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer.

ReferenceCitation: Cabarrou B, Boher JM, Bogart E, Tresch-Bruneel E, Penel N, Ravaud A, Escudier B, Mahier Ait-Oukhatar C, Delord JP, Roche H, Filleron T. How to report toxicity associated with targeted therapies? Ann Oncol. 2016 Aug;27(8):1633-8. doi: 10.1093/annonc/mdw218. Epub 2016 May 23.

evidence: open (via crossref license)

ReferenceCitation: Ravaud A, Oudard S, De Fromont M, Chevreau C, Gravis G, Zanetta S, Theodore C, Jimenez M, Sevin E, Laguerre B, Rolland F, Ouali M, Culine S, Escudier B. First-line treatment with sunitinib for type 1 and type 2 locally advanced or metastatic papillary renal cell carcinoma: a phase II study (SUPAP) by the French Genitourinary Group (GETUG)dagger. Ann Oncol. 2015 Jun;26(6):1123-1128. doi: 10.1093/annonc/mdv149. Epub 2015 Mar 23.

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

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

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours


title: Characterization of T-Cell Response in Subjects Previously Treated With JNJ-54861911 (Atabecestat)

summary: The purpose of this study is to determine T-cell mediated inflammatory immune response in some participants previously exposed to atabecestat.

primary_purpose: Other

lead_sponsor: Janssen Research & Development, LLC

location_country: Germany France Belgium Spain Sweden

location_facility: CTC North GmbH & Co. KGim Spectrum am UKE


lead_sponsor: Swedish Orphan Biovitrum

summary: Macrophage Activation Syndrome (MAS) is a rare, life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD). Emapalumab is a monoclonal antibody neutralizing interferon-gamma (IFN-gamma), a key cytokine which contributes to the inflammation and tissue damage seen in MAS. The purpose of this study is to assess the safety, tolerability and efficacy of emapalumab in sJIA or AOSD participants developing MAS, presenting an inadequate response to high dose glucocorticoid treatment.

location_facility: Great Ormond Street Hospital for Children

location_facility: Hôpital Necker-Enfants Malades, Unité d'Immunologie-hématologie et Rhumatologie pédiatriques

title: A Pilot, Open-label, Single Arm, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFNγ) Monoclonal Antibody, in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH)

location_country:
Italy
United Kingdom
United States
Spain
France


title: Study of Positron Emission Tomography With 3'-Deoxy-3'-[18F] Fluoro-thymidine ([18F]-FLT) for the Evaluation of Response to Neoadjuvant Chemotherapy for Cancers of the Breast

summary:
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using 3'-deoxy-3'-(18F) fluorothymidine, may be effective in assessing the response to chemotherapy before surgery in treating locally advanced breast cancer.

PURPOSE: This clinical trial is studying how well positron emission tomography using 3'-deoxy-3'-(18F) fluorothymidine works in treating women with locally advanced cancer in one breast who are receiving chemotherapy.

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Centre Hospitalier Regional et Universitaire d'Angers


title: A Randomized, Open Label Study to Evaluate the Effect of Doxycycline on Tarceva-induced Skin Rash in Patients With Non-small Cell Lung Cancer After Failure of First Line Chemotherapy

summary: This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with non-small cell lung cancer who have failed first-line chemotherapy for advanced disease. Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated time on study treatment is until disease progression or intolerable toxicity, and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche


title: A Randomized, Double-blind Study of the Efficacy of Intravenous Bonviva in the Relief of Pain After Recent Vertebral Osteoporotic Fracture in Osteoporotic Patients.

summary: This 2 arm study will assess the efficacy and safety of intravenous Bonviva in patients with osteoporosis experiencing pain after recent vertebral osteoporotic fracture. Patients will be randomized to receive either Bonviva (3mg i.v. bolus injection) or placebo. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.


type: Other Grant/Funding Number

title: Specific Care and Assistance Plan for Alzheimer's Disease: Impact Study on Disease Progression and Management Modalities

acronym: PLASA

summary:
The main objective of this work is to assess the feasibility and efficacy of a specific Care and Assistance Plan for Alzheimer's disease (PLASA). The main outcome measure selected is incapacity in carrying out the basic activities of daily living, evaluated by the ADCS-ADL scale .

The PLASA was developed by a working group appointed by the Direction Générale de la Santé as part of the government programme of action on Alzheimer's disease (October 2001, Ministère de l'Emploi et de la Solidarité).

primary_purpose: Supportive Care

ReferenceCitation: Callahan CM, Boustani MA, Unverzagt FW, Austrom MG, Damush TM, Perkins AJ, Fultz BA, Hui SL, Counsell SR, Hendrie HC. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA. 2006 May 10;295(18):2148-57. doi: 10.1001/jama.295.18.2148.

ReferenceCitation: Teri L, Gibbons LE, McCurry SM, Logsdon RG, Buchner DM, Barlow WE, Kukull WA, LaCroix AZ, McCormick W, Larson EB. Exercise plus behavioral management in patients with Alzheimer disease: a randomized controlled trial. JAMA. 2003 Oct 15;290(15):2015-22. doi: 10.1001/jama.290.15.2015.

ReferenceCitation: Teri L, Logsdon RG, McCurry SM. Nonpharmacologic treatment of behavioral disturbance in dementia. Med Clin North Am. 2002 May;86(3):641-56, viii. doi: 10.1016/s0025-7125(02)00006-8.

ReferenceCitation: Vickrey BG, Mittman BS, Connor KI, Pearson ML, Della Penna RD, Ganiats TG, Demonte RW Jr, Chodosh J, Cui X, Vassar S, Duan N, Lee M. The effect of a disease management intervention on quality and outcomes of dementia care: a randomized, controlled trial. Ann Intern Med. 2006 Nov 21;145(10):713-26. doi: 10.7326/0003-4819-145-10-200611210-00004.

ReferenceCitation: Nourhashemi F, Andrieu S, Gillette-Guyonnet S, Giraudeau B, Cantet C, Coley N, Vellas B; PLASA Group. Effectiveness of a specific care plan in patients with Alzheimer's disease: cluster randomised trial (PLASA study). BMJ. 2010 Jun 3;340:c2466. doi: 10.1136/bmj.c2466.

ReferenceCitation: Nourhashemi F, Gillette-Guyonnet S, Andrieu S, Rolland Y, Ousset PJ, Vellas B; PLASA group. A randomized trial of the impact of a specific care plan in 1120 Alzheimer's patients (PLASA Study) over a two-year period: design and baseline data. J Nutr Health Aging. 2008 Apr;12(4):263-71. doi: 10.1007/BF02982632.

lead_sponsor: University Hospital, Toulouse

location_facility: University Hospital, Hôpital Xavier Arnozan

location_facility: University Hospital BROCA - La Rochefoucauld

location_facility: Hospital Center Notre Dame du Bon Secours


title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma

acronym: DYNAMO + R

summary: A study to evaluate the safety and efficacy of duvelisib administered in combination with rituximab vs placebo in combination with rituximab in patients with previously treated CD20-positive follicular lymphoma who are not suitable candidates for chemotherapy.

lead_sponsor: SecuraBio

location_country: Italy Australia Poland France


title: TRANSLINK: A Prospective, Multi-center, Multi-national, Non Randomized, Open, Study to Defining the Role of Xeno-directed and Immune Events (SVD) in Patients Receiving Animal-derived Bioprosthetic Heart Valves.

acronym: TRANSLINK

summary: Cardiac valve disorders are widely spread in the general population and represents the third most frequent cardiovascular illness after coronary disease and arterial hypertension. In this context, aortic valve stenosis (the central pathology in this project) is the most common form of valve disease. Cardiac valve replacement is in the vast majority of cases the first line therapy for degenerative heart-valve diseases. These are represented by mechanical and bioprosthetic valve (BHV). In the vast majority of cases, BHV are derived from animals and from a biological standpoint are classified as xenografts. BHV are severely penalised by a premature structural damage, with ultimate valve failure occurring around 10 years after surgery in 5 to 30% of cases, depending on the type of BHV used. Several factors [including dyslipidaemia, gender, valve position] may contribute to the ultimate failure of the BHV and there has been increasing evidence recently of a substantial immune reaction elicited by the implanted BHV. This immune response is still poorly understood. It may lead to adverse immune reactions and this will be thoroughly investigated by the TRANSLINK team. In this light, the TRANSLINK project aims to provide the necessary data to demonstrate beyond any reasonable doubt the central role of the anti-BHV immune response in the premature failure of BHV and to provide efficient strategies to enable safe implantation of BHV valves in currently unsuitable candidates

primary_purpose: Health Services Research

lead_sponsor: Nantes University Hospital

location_country: Italy Canada Spain France

location_facility: University of Padova Medical School, Italy

location_facility: University Hospital of Bellvitge, Barcelona, Spain

location_facility: University Hospital Vall d'Hebron, Barcelona, Spain


title: International, Multicenter, Non-interventional, Prospective, Longitudinal Study to Investigate the Effectiveness of Botulinum Toxin A (Dysport®) Injections in Patients Suffering From Post-stroke Arm Spasticity With Respect to Early, Medium or Late Start of Treatment.

acronym: EARLYBIRD

summary:
Botulinum toxin A (BoNT-A) is effective and safe in alleviating post-stroke spasticity and reducing the burden of associated symptoms.

The hypothesis for this non-interventional study in arm spasticity (AS-NIS early BIRD) is no significant difference between naïve and pre-treated patients. The patients will be divided in sub-groups according to the time interval between occurrence of stroke and start of treatment (early, medium and late start of treatment according to the first and third quartiles time distribution). It is hypothesized that the "early" start of treatment group will have a reduced modified Ashworth scale (MAS) on the elbow and wrist flexors when compared to the "late" start of treatment group.

location_country: Germany Netherlands Austria Switzerland France


title: A Phase I, Open-label, Multi-center, Dose Escalation Study of Oral CGM097, a p53/HDM2-interaction Inhibitor, in Adult Patients With Selected Advanced Solid Tumors

summary: This is a first in human phase I study of single agent CGM097 in patients with advanced solid tumors who have progressed despite standard therapy or for whom no standard therapy exists. The tumor must be characterized by p53wt status. The study consists of a dose escalation part where patients will receive escalating doses of CGM097, and a dose expansion part in which patients are given CGM097 at the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D). Each dose escalation step will be decided based on the recommendation from an adaptive Bayesian logistic regression model (BLRM).

ReferenceCitation: Bauer S, Demetri GD, Halilovic E, Dummer R, Meille C, Tan DSW, Guerreiro N, Jullion A, Ferretti S, Jeay S, Van Bree L, Hourcade-Potelleret F, Wuerthner JU, Fabre C, Cassier PA. Pharmacokinetic-pharmacodynamic guided optimisation of dose and schedule of CGM097, an HDM2 inhibitor, in preclinical and clinical studies. Br J Cancer. 2021 Aug;125(5):687-698. doi: 10.1038/s41416-021-01444-4. Epub 2021 Jun 17.

repository_institution: University of Zurich - Zurich Open Repository and Archive

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Singapore
Switzerland
United States
France

location_facility:
Novartis Investigative Site
Dana Farber Cancer Institute SC (2)


title: Evaluation of the CHOndromodulating Effect of DIAcerein in Osteoarthritis of the Hip. ECHODIAH.

acronym: ECHODIAH

summary:
We carried out a 3 years, randomized, double-blind, placebo-controlled, multicenter clinical trial in patients with hip osteoarthritis in order to:

evaluate the ability of diacerein, an interleukin-1β inhibitor, to slow the progressive decrease in joint space width observed in patients with hip osteoarthritis
to investigate the potential structure-modifying effect of diacerein in patients with hip osteoarthritis

This study compare also after ten years the percentage of patients in each treatment group who require a hip replacement surgery

ReferenceCitation: Dougados M, Nguyen M, Berdah L, Mazieres B, Vignon E, Lequesne M; ECHODIAH Investigators Study Group. Evaluation of the structure-modifying effects of diacerein in hip osteoarthritis: ECHODIAH, a three-year, placebo-controlled trial. Evaluation of the Chondromodulating Effect of Diacerein in OA of the Hip. Arthritis Rheum. 2001 Nov;44(11):2539-47. doi: 10.1002/1529-0131(200111)44:113.0.co;2-t.

lead_sponsor: Laboratoires NEGMA

location_facility: Hôpital Cochin, clinique de rhumatologie


title: An Open Label Study to Evaluate the Effect of Avastin in Association With Chemotherapy on Progression-free Survival in Patients With Progressive Advanced/Metastatic Well-differentiated Digestive Endocrine Tumors of the Gastrointestinal Tract

summary: This 2 arm study will assess the efficacy and safety of two systemic treatments including Avastin in patients with previously-untreated progressive locally advanced/metastatic well-differentiated digestive endocrine tumors. Patients with duodeno-pancreatic tumors (arm 1) will be treated with 5FU/streptozotocin iv (5FU 400mg/m2/d D1 to D5;streptozotocin 500mg/m2/d/iv D1 to D5;D1=D42) every 6 weeks, plus Avastin 7.5mg/kg iv every 3 weeks. Patients with gastrointestinal tract tumors (arm 2) will be treated with Xeloda 1000mg/m2 po bid D1 to D14 plus Avastin 7.5mg/kg iv D1=D21 every 3 weeks. The patients will be treated with chemotherapy for a minimum of 6 months, unless there is tumor progression and/or unacceptable toxicity. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is <100 individuals.


acronym: REVAXIS® versus DT Polio® as a second booster in 6 year-old children

lead_sponsor: Sanofi Pasteur, a Sanofi Company

summary:
Primary objective:

To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second booster to healthy 6 year-old children .

Secondary objectives:

Additional immunogenicity assessments.
To describe the safety profile of a single dose of REVAXIS® or DT-Polio®

ReferenceCitation: Gajdos V, Soubeyrand B, Vidor E, Richard P, Boyer J, Sadorge C, Fiquet A. Immunogenicity and safety of combined adsorbed low-dose diphtheria, tetanus and inactivated poliovirus vaccine (REVAXIS ((R))) versus combined diphtheria, tetanus and inactivated poliovirus vaccine (DT Polio ((R))) given as a booster dose at 6 years of age. Hum Vaccin. 2011 May;7(5):549-56. doi: 10.4161/hv.7.5.14982. Epub 2011 May 1.

title: Comparison of the Immunogenicity and Safety of a Combined Adsorbed Low Dose Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (REVAXIS®) With a Combined Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (DT Polio®) When Given as a Booster Dose at 6 Years of Age


title: A Phase II Study of Maintenance With Azacitidine in MDS Patients Achieving Complete or Partial Remission (CR or PR) After Intensive Chemotherapy

summary:
A phase II multicentre trial of maintenance with Azacitidine in MDS patients achieving complete or partial remission (CR or PR) after intensive chemoterapy.

The primary objective is response duration (MDS or AML)

lead_sponsor: Groupe Francophone des Myelodysplasies

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Celgene Corporation

location_facility:
Hopital Purpan
Hopital Saint Antoine
Hopital Edouard Herriot
CHU d'Amiens
Hopital Jean-Bernard
Hopital Archet
CHRU Hurriez
CHU Brabois
CHU de Dijon
Hopital Paoli Calmette
Hopital Cochin
CHRU de Reims
CHU Angers
Hopital Hotel Dieu
CH d'Avignon
CH Versailles
CHU Pontchaillou
CHRU de Limoges
CHU Albert Michallon
Hopital Hautepierre
Hopital Saint Louis
CHU de Caen
Hopital d'Instruction des Armées Percy
Hopital Henri Mondor
Hopital Haut Leveque


title: A Randomised, Double-blind, Placebo-controlled, Multiple-dose, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Lu AA24493 in Patients With Acute Ischemic Stroke

summary: The primary purpose of the study is to determine whether carbamylated erythropoietin (CEPO) dosed once daily for 5 days is a safe treatment for patients who have suffered an acute ischemic stroke.

lead_sponsor: H. Lundbeck A/S

location_country:
Finland
United Kingdom
Singapore
Netherlands
France


acronym: EURTAC

lead_sponsor: Spanish Lung Cancer Group

summary: A Phase III, multicenter, open-label, randomized trial of Erlotinib (Tarceva®) versus chemotherapy in patients with advanced NSCLC with mutations in the Tyrosine Kinase (TK) domain of the EGFR.

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

ReferenceCitation: Karachaliou N, Mayo-de las Casas C, Queralt C, de Aguirre I, Melloni B, Cardenal F, Garcia-Gomez R, Massuti B, Sanchez JM, Porta R, Ponce-Aix S, Moran T, Carcereny E, Felip E, Bover I, Insa A, Reguart N, Isla D, Vergnenegre A, de Marinis F, Gervais R, Corre R, Paz-Ares L, Morales-Espinosa D, Viteri S, Drozdowskyj A, Jordana-Ariza N, Ramirez-Serrano JL, Molina-Vila MA, Rosell R; Spanish Lung Cancer Group. Association of EGFR L858R Mutation in Circulating Free DNA With Survival in the EURTAC Trial. JAMA Oncol. 2015 May;1(2):149-57. doi: 10.1001/jamaoncol.2014.257.

ReferenceCitation: Karachaliou N, Gimenez-Capitan A, Drozdowskyj A, Viteri S, Moran T, Carcereny E, Massuti B, Vergnenegre A, de Marinis F, Molina MA, Teixido C, Rosell R. ROR1 as a novel therapeutic target for EGFR-mutant non-small-cell lung cancer patients with the EGFR T790M mutation. Transl Lung Cancer Res. 2014 Jun;3(3):122-30. doi: 10.3978/j.issn.2218-6751.2014.03.02.

ReferenceCitation: Costa C, Molina MA, Drozdowskyj A, Gimenez-Capitan A, Bertran-Alamillo J, Karachaliou N, Gervais R, Massuti B, Wei J, Moran T, Majem M, Felip E, Carcereny E, Garcia-Campelo R, Viteri S, Taron M, Ono M, Giannikopoulos P, Bivona T, Rosell R. The impact of EGFR T790M mutations and BIM mRNA expression on outcome in patients with EGFR-mutant NSCLC treated with erlotinib or chemotherapy in the randomized phase III EURTAC trial. Clin Cancer Res. 2014 Apr 1;20(7):2001-10. doi: 10.1158/1078-0432.CCR-13-2233. Epub 2014 Feb 3.

evidence: oa repository (via page says license)

location_facility: Centre Hospitalier de La Région D'Annecy

location_facility: Università di Roma "La Sapienza" Az.Policlinico Umb.I°

location_facility: Centre Hospitalier Universitaire D'Angers

title: Phase III, Multicenter, Open-label, Randomized Trial of Tarceva® vs Chemotherapy in Patients With Advanced NSCLC With Mutations in the TK Domain of the EGFR

location_country: Italy Spain France


title: Study Multicentric, Randomised, in Duplicate Blind Person of the Impact of a Per Operatory Strategy of Optimization of the Cardiac Output on the Forecast of the Old Subjects Operated for Fracture of the Upper End of the Femur " FRACTALE "

acronym: FRACTALE

summary: The aim of this study is to assess whether intra-operative fluid supplementation (to improve tissue perfusion) can reduce the incidence of postoperative complications in elderly patients with hip fracture.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators:
Fresenius Kabi
GAMIDA

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Fresenius Kabi
GAMIDA

location_facility: Centre Hospitalier Universitaire de La Cote de Nacre

location_facility: Centre Hospitalier Universitaire de Poitiers


title: A Phase II Study of Darbepoetin Alpha in Myelodysplastic Syndromes (MSD)

summary: This is an evaluation of the effectiveness of darbepoetin alpha in treating anemia of MDS patients with an International Prognostic Scoring System (IPSS) score of low or intermediate 1.

ReferenceCitation: Kelaidi C, Beyne-Rauzy O, Braun T, Sapena R, Cougoul P, Ades L, Pillard F, Lamberto C, Charniot JC, Guerci A, Choufi B, Stamatoullas A, Slama B, De Renzis B, Ame S, Damaj G, Boyer F, Chaury MP, Legros L, Cheze S, Testu A, Gyan E, Bene MC, Rose C, Dreyfus F, Fenaux P. High response rate and improved exercise capacity and quality of life with a new regimen of darbepoetin alfa with or without filgrastim in lower-risk myelodysplastic syndromes: a phase II study by the GFM. Ann Hematol. 2013 May;92(5):621-31. doi: 10.1007/s00277-013-1686-4. Epub 2013 Jan 29. Erratum In: Ann Hematol. 2013 May;92(5):633. Lambert, Christine [corrected to Lamberto, C].

publisher_dissemination: Springer

location_facility:
Hopital Bretonneau
Hopital Purpan
Hopital Saint Antoine
Hopital Edouard Herriot
CHU de Brest - Hopital Morvan
CHU d'Amiens
Hopital Jean-Bernard
CHRU Hurriez
CHU de Dijon
Hopital Paoli Calmette
CHU d'Angers
Hopital Cochin
Hopital Percy
CHU d'Avignon
Hopital Hotel Dieu
CHRU Limoges
CHU Pontchaillou
CHU Nancy-Brabois
Hopital Henri Becquerel
Hopital St Louis
CH de la Cote Basque
CHU Albert Michallon
Hopital Hautepierre
CHU de Caen
CHU Robert Debre
Hopital Henri Mondor
CHU Archet


title: Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis: Comparison of Infusion Every 6 Weeks Versus Infusion on Demand

summary: Continuous treatment with the anti-tumor necrosis factor alpha monoclonal antibody infliximab is efficacious in ankylosing spondylitis (AS), whereas treatment discontinuation results in disease relapse, with variable delay. Objective of this study was to compare efficacy between a continuous treatment with infliximab, and a treatment adapted to symptoms recurrence. Addition of methotrexate (MTX)to infliximab was also tested.

ReferenceCitation: Fautrel B, Benhamou M, Breban M, Roy C, Lenoir C, Trape G, Baleydier A, Ravaud P, Dougados M. Cost effectiveness of two therapeutic regimens of infliximab in ankylosing spondylitis: economic evaluation within a randomised controlled trial. Ann Rheum Dis. 2010 Feb;69(2):424-7. doi: 10.1136/ard.2008.103887. Epub 2009 Sep 9.

ReferenceCitation: Breban M, Ravaud P, Claudepierre P, Baron G, Henry YD, Hudry C, Euller-Ziegler L, Pham T, Solau-Gervais E, Chary-Valckenaere I, Marcelli C, Perdriger A, Le Loet X, Wendling D, Fautrel B, Fournie B, Combe B, Gaudin P, Jousse S, Mariette X, Baleydier A, Trape G, Dougados M; French Ankylosing Spondylitis Infliximab Network. Maintenance of infliximab treatment in ankylosing spondylitis: results of a one-year randomized controlled trial comparing systematic versus on-demand treatment. Arthritis Rheum. 2008 Jan;58(1):88-97. doi: 10.1002/art.23167.

lead_sponsor: Association de Recherche Clinique en Rhumatologie

location_facility:
Hôpital Ambroise Paré
Hôpital Avicenne
Hôpital Gilles de Corbeil
CHU de Poitiers
Hôpital Pellegrin
Hôpital de la Conception
CHU Hôpital Trousseau
CHU A. Michallon
CHU Amiens
Centre Hospitalier Saint Philibert
CHU Saint-Etienne
Hôpital de la Pitié
Hôpital Bicêtre
Hôpital de Purpan
CHU Dupuytren
Groupe Hospitalier du Havre
Hôpital Cochin
CHU - Hôpital de Bois Guillaume
CHU Hautepierre
CHU Nancy-Brabois
CHU l'Archet 1
CHU Hôpital Minjoz
CHU Côte de Nacre
Hôpital Henri Mondor
CHRU Hôpital Roger Salengro
CH St Joseph - St Luc
Hôpital Porte Madeleine
CHU de la Cavale Blanche
Hôpital Général
CHU - Hôpital Sud
Hôpital Lapeyronie


title: Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid

summary:
The purpose of this study is

To evaluate the efficacy of association of Erythropoetin (Neorecormon) and ATRA in patients with low risk myelodysplastic syndromes
To evaluate the tolerance of this treatment

location_facility:
CHU Edouard Herriot
Hopital Saint Antoine
CHU d'Amiens
CHU Brabois
CH de la cote Basque
CHU Bretoneau
Chu Purpan
CHU d'Angers
CHU Dijon
Hopital Necker
Hopital Percy
CHU d'Avignon
Hopital Hotel Dieu
Institut Paoli Calmette
CHRU Limoges
Hopital Avicenne
Hopital Henri Becquerel
CHU Albert Michallon
CH de Cournouaille
Hopital Hautepierre
CHU de Caen
CHU Robert Debre
HOPITAL Cochin
CHU Archet


title: A Double-blind, Randomised, Controlled, Multi-centre Safety Study of a Refrigerator-stable Formulation of VARIVAX® in Healthy 12 to 15 Month-old Infants.

summary:
Primary objective:

To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-vaccination.

Secondary objectives: NA

ReferenceCitation: Ferrera G, Gajdos V, Thomas S, Tran C, Fiquet A. Safety of a refrigerator-stable varicella vaccine (VARIVAX) in healthy 12- to 15-month-old children: A randomized, double-blind, cross-over study. Hum Vaccin. 2009 Jul;5(7):455-60. doi: 10.4161/hv.8269. Epub 2009 Jul 23.

lead_sponsor: Merck Sharp & Dohme LLC

location_country: Italy France


title: Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis.

summary: Cortico-dependence is frequent in giant cell arteritis patients, and no drugs has proved its ability to prevent corticodependence. Hydrocychloroquine is a well tolerated immunomodulatory drug that may have a corticosteroid sparing potential according to immuno-pharmacological and clinical data. We have designed a multcentric double blind versus placebo randomized controled trial to assess the corticosteroid sparing effect of hydroxychloroquine in non complicated giant cell arteritis.

ReferenceCitation: Jover JA, Hernandez-Garcia C, Morado IC, Vargas E, Banares A, Fernandez-Gutierrez B. Combined treatment of giant-cell arteritis with methotrexate and prednisone. a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2001 Jan 16;134(2):106-14. doi: 10.7326/0003-4819-134-2-200101160-00010.

ReferenceCitation: Chevalet P, Barrier JH, Pottier P, Magadur-Joly G, Pottier MA, Hamidou M, Planchon B, El Kouri D, Connan L, Dupond JL, De Wazieres B, Dien G, Duhamel E, Grosbois B, Jego P, Le Strat A, Capdeville J, Letellier P, Agron L. A randomized, multicenter, controlled trial using intravenous pulses of methylprednisolone in the initial treatment of simple forms of giant cell arteritis: a one year followup study of 164 patients. J Rheumatol. 2000 Jun;27(6):1484-91.

ReferenceCitation: Mazlumzadeh M, Hunder GG, Easley KA, Calamia KT, Matteson EL, Griffing WL, Younge BR, Weyand CM, Goronzy JJ. Treatment of giant cell arteritis using induction therapy with high-dose glucocorticoids: a double-blind, placebo-controlled, randomized prospective clinical trial. Arthritis Rheum. 2006 Oct;54(10):3310-8. doi: 10.1002/art.22163.

ReferenceCitation: Le Guennec P, Dromer C, Sixou L, Marc V, Coustals P, Fournie B. [Treatment of Horton disease. Value of synthetic antimalarials. Apropos of a retrospective study of 36 patients]. Rev Rhum Ed Fr. 1994;61(7-8):485-90. French.

ReferenceCitation: David-Chausse J, Dehais J, Leman A. [Results of a regional survey on the treatment of rhizomelic pseudopolyarthritis and temporal arteritis. Apropos of 242 cases treated by various modalities with synthetic antimalarials, corticoids and non-steroidal anti-inflammatory agents]. Rev Rhum Mal Osteoartic. 1983 Jul-Sep;50(8-9):563-71. French.

ReferenceCitation: Hoffman GS, Cid MC, Hellmann DB, Guillevin L, Stone JH, Schousboe J, Cohen P, Calabrese LH, Dickler H, Merkel PA, Fortin P, Flynn JA, Locker GA, Easley KA, Schned E, Hunder GG, Sneller MC, Tuggle C, Swanson H, Hernandez-Rodriguez J, Lopez-Soto A, Bork D, Hoffman DB, Kalunian K, Klashman D, Wilke WS, Scheetz RJ, Mandell BF, Fessler BJ, Kosmorsky G, Prayson R, Luqmani RA, Nuki G, McRorie E, Sherrer Y, Baca S, Walsh B, Ferland D, Soubrier M, Choi HK, Gross W, Segal AM, Ludivico C, Puechal X; International Network for the Study of Systemic Vasculitides. A multicenter, randomized, double-blind, placebo-controlled trial of adjuvant methotrexate treatment for giant cell arteritis. Arthritis Rheum. 2002 May;46(5):1309-18. doi: 10.1002/art.10262.

location_facility:
Hospital
University Hospital Toulouse
Hospital Béziers
University Hospital Dijon
University Hospital Dupuytren
Saint Louis Hospital
University Hospital Saint Antoine
Hospital Suresnes
Hospital Auch
University Hospital Bretonneau
University Hospital Bichat
University Hospital
University Hospital Besançon
Hospital Avignon
University Hospital Côte de Nacre


title: An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study to Determine the Pharmacokinetics, Safety and Tolerability of Olaparib Following a Single Oral 300 mg Dose to Patients With Advanced Solid Tumours and Normal Hepatic Function or Mild or Moderate Hepatic Impairment

summary: This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow patients with mild or moderate hepatic impairment or normal hepatic function continued access to olaparib after the PK phase and will provide additional safety data.

lead_sponsor: AstraZeneca

location_country:
United Kingdom
Netherlands
Korea, Republic of
Czechia
France


title: Randomised, Double-blind, Placebo-controlled, Dose-ranging Phase II Study of APD421 for the Prevention of Post-operative Nausea and Vomiting

summary: To assess the efficacy and safety of different doses of APD421 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.

ReferenceCitation: Kranke P, Eberhart L, Motsch J, Chassard D, Wallenborn J, Diemunsch P, Liu N, Keh D, Bouaziz H, Bergis M, Fox G, Gan TJ. I.V. APD421 (amisulpride) prevents postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled, multicentre trial. Br J Anaesth. 2013 Dec;111(6):938-45. doi: 10.1093/bja/aet251. Epub 2013 Jul 19.

lead_sponsor: Acacia Pharma Ltd

location_country:
United States
Germany
France

location_facility:
Hôpital FOCH
HELIOS Klinikum Aue
Hôpital Huriez
Hautepierre Hospital
Philipps University
Klinikum Ludwigshafen
University Hospitals of Würzburg
Charité - Universitätsmedizin
Universität Heidelberg
Duke University Medical Center
Hôpital mère enfant
University Hospital


title: Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

summary: To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

ReferenceCitation: McDiarmid J, Ruiz JB, Lee D, Lippert S, Hartisch C, Havlickova B. Results from a pooled analysis of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the pharmacologic reduction of excess submental fat. Aesthetic Plast Surg. 2014 Oct;38(5):849-60. doi: 10.1007/s00266-014-0364-9. Epub 2014 Jul 2.

lead_sponsor: Kythera Biopharmaceuticals

sponsor_collaborators:
Kythera Biopharmaceuticals
Bayer

location_country:
Germany
United Kingdom
Belgium
Spain
France