acronym: REMITTER

lead_sponsor: Novartis

summary:
This study is designed to provide efficacy and safety data for ACZ885 (a fully human anti-interleukin-1beta (anti-IL-1beta) monoclonal antibody) administered as an injection subcutaneously (s.c.) in patients with Muckle-Wells Syndrome.

Part I is an 8-week open-label, active treatment period to identify ACZ885 responders.

Part II is a double-blind, placebo-controlled period to assess primarily the efficacy of ACZ885 compared to placebo.

Part III is an open-label, active treatment period where patients will receive ACZ885 every 8 weeks after withdrawal or completion of Part II.

ReferenceCitation: Kone-Paut I, Lachmann HJ, Kuemmerle-Deschner JB, Hachulla E, Leslie KS, Mouy R, Ferreira A, Lheritier K, Patel N, Preiss R, Hawkins PN; Canakinumab in CAPS Study Group. Sustained remission of symptoms and improved health-related quality of life in patients with cryopyrin-associated periodic syndrome treated with canakinumab: results of a double-blind placebo-controlled randomized withdrawal study. Arthritis Res Ther. 2011;13(6):R202. doi: 10.1186/ar3535. Epub 2011 Dec 9.

ReferenceCitation: Lachmann HJ, Kone-Paut I, Kuemmerle-Deschner JB, Leslie KS, Hachulla E, Quartier P, Gitton X, Widmer A, Patel N, Hawkins PN; Canakinumab in CAPS Study Group. Use of canakinumab in the cryopyrin-associated periodic syndrome. N Engl J Med. 2009 Jun 4;360(23):2416-25. doi: 10.1056/NEJMoa0810787.

location_facility:
Novartis Investigational Site
Novartis Investigative Site

title: A Three-part,Multicenter Study,With a Randomized,Double-blind,Placebo Controlled,Withdrawal Design in Part II to Assess Efficacy,Safety,and Tolerability of ACZ885(Anti-interleukin-1beta Monoclonal Antibody)in Patients With Muckle-Wells Syndrome

location_country:
Germany
India
United Kingdom
United States
Spain
France


title: Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients With Chronic Low Back Pain

summary:
The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition.

Whether duloxetine once daily can help patients with Chronic Low Back Pain.

Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Williamson OD, Schroer M, Ruff DD, Ahl J, Margherita A, Sagman D, Wohlreich MM. Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials. Clin Ther. 2014 Apr 1;36(4):544-51. doi: 10.1016/j.clinthera.2014.02.009. Epub 2014 Mar 17.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Skljarevski V, Zhang S, Chappell AS, Walker DJ, Murray I, Backonja M. Maintenance of effect of duloxetine in patients with chronic low back pain: a 41-week uncontrolled, dose-blinded study. Pain Med. 2010 May;11(5):648-57. doi: 10.1111/j.1526-4637.2010.00836.x. Epub 2010 Apr 13.

ReferenceCitation: Skljarevski V, Desaiah D, Liu-Seifert H, Zhang Q, Chappell AS, Detke MJ, Iyengar S, Atkinson JH, Backonja M. Efficacy and safety of duloxetine in patients with chronic low back pain. Spine (Phila Pa 1976). 2010 Jun 1;35(13):E578-85. doi: 10.1097/BRS.0b013e3181d3cef6.

lead_sponsor: Eli Lilly and Company

location_country: Germany Brazil Netherlands Mexico 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 p

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


acronym: ADPKD

lead_sponsor: Novartis Pharmaceuticals

summary: This study will assess whether everolimus (RAD001) is effective in preventing cyst and kidney expansion as well as worsening of renal function in patients with ADPKD and whether the application of 5 mg/day everolimus as monotherapy is safe and well tolerated.

ReferenceCitation: Walz G, Budde K, Mannaa M, Nurnberger J, Wanner C, Sommerer C, Kunzendorf U, Banas B, Horl WH, Obermuller N, Arns W, Pavenstadt H, Gaedeke J, Buchert M, May C, Gschaidmeier H, Kramer S, Eckardt KU. Everolimus in patients with autosomal dominant polycystic kidney disease. N Engl J Med. 2010 Aug 26;363(9):830-40. doi: 10.1056/NEJMoa1003491. Epub 2010 Jun 26. Erratum In: N Engl J Med. 2010 Nov 11;363(20):1977. N Engl J Med. 2010 Sep 16;363(12):1190.

title: A Multicenter, Randomized, Placebo-controlled, Double-blind Study on the Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease (ESRD) in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

source: euctr

location_country: Germany Austria France


title: Phase III, Multicentre, Open Study to Assess the Efficacy and Safety Profiles of the Co-administration of Lanreotide Autogel 120 mg (Administered Via Deep Subcutaneous Injections Every 28 Days) and Pegvisomant 40 to 120 mg Per Week (Administered Via Subcutaneous Route Once or Twice a Week) in Acromegalic Patients Failing to Respond to Lanreotide Autogel 120 mg Alone

summary: The main aim of this study is to assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period.

ReferenceType: result

ReferenceCitation: van der Lely AJ, Bernabeu I, Cap J, Caron P, Colao A, Marek J, Neggers S, Birman P. Coadministration of lanreotide Autogel and pegvisomant normalizes IGF1 levels and is well tolerated in patients with acromegaly partially controlled by somatostatin analogs alone. Eur J Endocrinol. 2011 Mar;164(3):325-33. doi: 10.1530/EJE-10-0867. Epub 2010 Dec 10.

ipd_sharing: Yes

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.

lead_sponsor: Ipsen

location_country:
Germany
Italy
United Kingdom
Denmark
Sweden
Netherlands
Spain
Greece
Czechia
France

location_facility: Groupe Hospitalier Henri Mondor- Albert Chenevier

location_facility: Klinikum Johann Wolfgang Goethe-Universität

location_facility: Christie Hospital and Holt Radium Institute

location_facility: Hospital Clínico Universitario de Santiago de Compostela


title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial To Study The Efficacy And The Safety Of The Early Administration Of Somatostatin (Ucb) 12 Mg/24 H IV Infusion And Two IV Boluses Of 250 Mcg During 72 Hours In The Treatment Of Subjects With Acute Severe Upper Gastrointestinal Bleeding (UGIB) With Suspicion Of Peptic Ulcer Bleeding [The PUB Study]

summary: To assess the efficacy and safety of the early administration of somatostatin in infusion during 72 hours plus 2 boluses, compared to placebo in the control of acute severe UGIB with suspicion of PUB.

lead_sponsor: UCB Pharma

location_country: Poland Hungary Belgium Spain Greece France


title: A Multicenter, Open-label Phase I/II Trial to Evaluate the Safety and Activity of CPC-P501 Protein Formulated With the Adjuvant AS15 as First-line Treatment in Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSA

summary: Patients with hormone-sensitive prostate cancer and rising PSA, after primary tumor treatment, will be treated with the P501-AS15 vaccine as out-patients. The maximum dose will be 16 vaccinations, given over a period of approximately one year. Thereafter, the patients' long-term safety and PSA status will be followed over a period of approximately 11 months.

study_start_date_type: Actual

design_allocation: Non-Randomized

primary_purpose: Prevention

lead_sponsor: GlaxoSmithKline

location_country: Belgium France

intervention_type: Biological


summary: Definition: Patients with bladder cancer will be participating in this study for the treatment of abnormal cells in the bladder that have returned after initial treatment OR have moved to a new site in the body.

location_country: Finland Germany France

location_facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.

location_facility: "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician."


title: "Baricitinib for Treating Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype, an International Phase II/Phase III, Randomized, Controlled Trial - TREAT-HAP Study.

acronym: TREAT-HAP

summary: The goal of this clinical trial is to determine the safety (phase II), then efficacy (phase III) of baricitinib plus standard of care (SOC) as compared to SOC alone for the treatment of hospital-acquired pneumonia in patients with a pro-inflammatory profile.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Nantes University Hospital

location_country: Spain Netherlands Belgium France

location_facility:
CHU la Pitié-Salpétrière
CHU de Poitiers
CHU de Rennes
St-Luc Clinics
CHU de Nancy
CHU Pitié-Salpétrière
CHU de Beaujon
CHU de Nantes
CHU Angers
CH La Roche sur Yon
Groupe Jolimont
Hospital del Mar
Clinique Saint-Pierre
Hospital Clinic
University Medical Center Utrecht
CHU Clermont-Ferrand
CHU de Brest
University Hospital of UCL Namur
CHU de Marseille
Ghent University Hospital
CHU de Caen
Hospital Vall d'Hebron
CHU de Clermont-Ferrand
CHU de Limoges

lead_sponsor_type: academique

status_simplified: Ongoing


title: A Randomized Phase II Trial Evaluating Ibrutinib Plus CD20 Ab and Venetoclax in Patients With Untreated Mantle Cell Lymphoma

summary:
The OASIS II trial is a multicentre, open label, randomized phase II trial. We will compare the efficacy of Ibrutinib/anti-CD20 Ab versus Ibrutinib/anti-CD20 Ab/Venetoclax given as fixed duration combinations in newly diagnosed Mantle Cell Lymphoma (MCL) patients (≥ 18 years and < 80 years of age).

Treatment duration of Ibrutinib and Venetoclax will be a maximum of two years. Patients will be treated with CD20 Ab for 3.5 years.

The primary aim is to assess MRD status at 6 months in both arms.

status: Recruiting

ipd_sharing: No

lead_sponsor: The Lymphoma Academic Research Organisation

collaborators: Institute of Cancer Research, United Kingdom

location_country:
United Kingdom
Belgium
France

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: Chu de Bordeaux - Hopital Haut-Leveque - Centre Francois Magendie

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: Universite Catholique de Louvain Mont Godinne

location_facility: CH de Bretagne Atlantique - Hopital CHUBERT

location_facility: Universite Libre de Bruxelles - Hopital ERASME


acronym: ANITA

lead_sponsor: Grupo Español de Investigación en Cáncer de Ovario

summary:
Atezolizumab in this study is expected to have a positive benefit-risk profile for the treatment of patients with platinum-sensitive relapse of ovarian cancer. Of interest, atezolizumab is being investigated also in combination with platinum-based doublet chemotherapy in second line (2L)/ third line (3L) platinum-sensitive recurrent ovarian cancer patients in ATALANTE (NCT02891824), which also includes bevacizumab in the combination. The study is proceeding as expected after >100 patients enrolled and under independent Data Monitoring Committee (IDMC) supervision.

Platinum-containing therapy is considered the treatment of choice for patients with platinum-sensitive relapse. However the duration of response and the prolongation of the progression free interval with chemotherapy are usually brief, among other because these chemotherapy regimens cannot be continued until progression as they are associated with neurological, renal and hematological toxicity and cannot generally be tolerated for more than about 6 to 9 cycles.

Niraparib received FDA approval in March 2017 as maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Recently, the European Medicines Agency (EMA) has also approved niraparib as maintenance monotherapy. Despite the progress brought about by niraparib, there is a need for a more effective treatment to extend the progression free interval in this patient population. The combination with immune checkpoint inhibitors such as anti-death protein 1 (anti-PD1) or anti-death protein ligand 1 (anti-PD-L1) has a compelling rationale to this aim, especially under the light of the emerging clinical data of this combination.

The use of atezolizumab concurrent to platinum-containing chemotherapy followed by niraparib as maintenance therapy after completion of chemotherapy, as per normal clinical practice, may provide further benefit to patients in terms of prolonging the progression free interval and increasing the interval between lines of chemotherapy, hence delaying further hospitalization and the cumulative toxicities associated with chemotherapy. Additionally, preliminary studies with atezolizumab suggest an acceptable tolerability profile for long term clinical use in recurrent ovarian cancer patients and other indications.

ReferenceCitation: Gonzalez Martin A, Sanchez Lorenzo L, Colombo N, dePont Christensen R, Heitz F, Meirovitz M, Selle F, van Gorp T, Alvarez N, Sanchez J, Marques C. A phase III, randomized, double blinded trial of platinum based chemotherapy with or without atezolizumab followed by niraparib maintenance with or without atezolizumab in patients with recurrent ovarian, tubal, or peritoneal cancer and platinum treatment free interval of more than 6 months: ENGOT-Ov41/GEICO 69-O/ANITA Trial. Int J Gynecol Cancer. 2021 Apr;31(4):617-622. doi: 10.1136/ijgc-2020-001633. Epub 2020 Dec 14.

publisher_dissemination: British Medical Journal

location_facility: ONCOGARD - Institut de Cancérologie du Gard

location_facility: Complejo Hospitalario Regional de Málaga

location_facility: Complejo Hospitalario Universitario de A Coruña

location_facility: Mammazentrum Hamburg am Krankenhaus Jerusalem

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Institut Curie - Hôpital René Huguenin- SAINT CLOUD

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: AO Città della Salute e della Scienza- Ospedale Sant'Anna

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Institut Curie - Hopital Claudius Régaud

location_facility: Groupe Hospitalier Diaconesses-Croix Saint Simon

status: Active, not recruiting

title: A Phase III Randomized, Double-blinded Trial of Platinum-based Chemotherapy With or Without Atezolizumab Followed by Niraparib Maintenance With or Without Atezolizumab in Patients With Recurrent Ovarian, Tubal or Peritoneal Cancer and Platinum Treatment-free Interval (TFIp) >6 Months

type: EudraCT Number

type: Other Identifier

location_country: Germany Italy Belgium Spain France

collaborators:
Hoffmann-La Roche
GlaxoSmithKline
AGO Study Group
Belgian Gynaecological Oncology Group
ARCAGY/ GINECO GROUP
Israeli Society of Gynecologic Oncology
MaNGO
Apices Soluciones S.L.


title: Setting up a Pediatric Cohort for Inflammatory Rheumatic Diseases

acronym: JIR-cohorte

summary: The investigators created a cohort of patients with juvenile inflammatory rheumatisms with the purpose to follow them prospectively, and investigate the tolerance and efficacy of immunosuppresive and biological agents.

status: Enrolling by invitation

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Pouletty M, Borocco C, Ouldali N, Caseris M, Basmaci R, Lachaume N, Bensaid P, Pichard S, Kouider H, Morelle G, Craiu I, Pondarre C, Deho A, Maroni A, Oualha M, Amoura Z, Haroche J, Chommeloux J, Bajolle F, Beyler C, Bonacorsi S, Carcelain G, Kone-Paut I, Bader-Meunier B, Faye A, Meinzer U, Galeotti C, Melki I. Paediatric multisystem inflammatory syndrome temporally associated with SARS-CoV-2 mimicking Kawasaki disease (Kawa-COVID-19): a multicentre cohort. Ann Rheum Dis. 2020 Aug;79(8):999-1006. doi: 10.1136/annrheumdis-2020-217960. Epub 2020 Jun 11.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

lead_sponsor: Michaël Hofer

sponsor_collaborators:
Michaël Hofer
Hospices Civils de Lyon
Versailles Hospital
Tenon Hospital, Paris
Bicetre Hospital
University of Lausanne Hospitals
University Hospital Muenster
Fondation Rhumatismes-Enfants-Suisse

location_country: Germany Switzerland Belgium Morocco France

location_facility: Klinik für Rheumatologie und internistische Rehabilitation

location_facility: Ospedale Regionale di Bellinzona e valli

status_simplified: Unknown


type: Registry Identifier

title: Low-molecular-weight Heparin to Prevent Recurrent VTE in Pregnancy: a Randomized Controlled Trial of Two Doses

acronym: Highlow

summary:
This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy.

Patients enter the study and will be randomized as soon as a home test confirms pregnancy. LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months postpartum. Patients will be recruited by their treating physician, either an obstetrician or internist.

ReferenceType: background

ReferenceCitation: Greer IA. Thrombosis in pregnancy: maternal and fetal issues. Lancet. 1999 Apr 10;353(9160):1258-65. doi: 10.1016/S0140-6736(98)10265-9.

ReferenceCitation: Pabinger I, Grafenhofer H, Kyrle PA, Quehenberger P, Mannhalter C, Lechner K, Kaider A. Temporary increase in the risk for recurrence during pregnancy in women with a history of venous thromboembolism. Blood. 2002 Aug 1;100(3):1060-2. doi: 10.1182/blood-2002-01-0149.

ReferenceCitation: White RH, Chan WS, Zhou H, Ginsberg JS. Recurrent venous thromboembolism after pregnancy-associated versus unprovoked thromboembolism. Thromb Haemost. 2008 Aug;100(2):246-52.

ReferenceCitation: Bates SM, Greer IA, Middeldorp S, Veenstra DL, Prabulos AM, Vandvik PO. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e691S-e736S. doi: 10.1378/chest.11-2300.

ReferenceCitation: Greer IA, Nelson-Piercy C. Low-molecular-weight heparins for thromboprophylaxis and treatment of venous thromboembolism in pregnancy: a systematic review of safety and efficacy. Blood. 2005 Jul 15;106(2):401-7. doi: 10.1182/blood-2005-02-0626. Epub 2005 Apr 5.

ReferenceCitation: Tooher R, Gates S, Dowswell T, Davis LJ. Prophylaxis for venous thromboembolic disease in pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2010 May 12;(5):CD001689. doi: 10.1002/14651858.CD001689.pub2.

ReferenceCitation: Sanson BJ, Lensing AW, Prins MH, Ginsberg JS, Barkagan ZS, Lavenne-Pardonge E, Brenner B, Dulitzky M, Nielsen JD, Boda Z, Turi S, Mac Gillavry MR, Hamulyak K, Theunissen IM, Hunt BJ, Buller HR. Safety of low-molecular-weight heparin in pregnancy: a systematic review. Thromb Haemost. 1999 May;81(5):668-72.

ReferenceCitation: Lepercq J, Conard J, Borel-Derlon A, Darmon JY, Boudignat O, Francoual C, Priollet P, Cohen C, Yvelin N, Schved JF, Tournaire M, Borg JY. Venous thromboembolism during pregnancy: a retrospective study of enoxaparin safety in 624 pregnancies. BJOG. 2001 Nov;108(11):1134-40. doi: 10.1111/j.1471-0528.2003.00272.x.

ReferenceCitation: Pabinger I, Grafenhofer H, Kaider A, Kyrle PA, Quehenberger P, Mannhalter C, Lechner K. Risk of pregnancy-associated recurrent venous thromboembolism in women with a history of venous thrombosis. J Thromb Haemost. 2005 May;3(5):949-54. doi: 10.1111/j.1538-7836.2005.01307.x.

ReferenceCitation: Roeters van Lennep JE, Meijer E, Klumper FJ, Middeldorp JM, Bloemenkamp KW, Middeldorp S. Prophylaxis with low-dose low-molecular-weight heparin during pregnancy and postpartum: is it effective? J Thromb Haemost. 2011 Mar;9(3):473-80. doi: 10.1111/j.1538-7836.2011.04186.x.

ReferenceCitation: Lindqvist PG, Bremme K, Hellgren M; Working Group on Hemostatic Disorders (Hem-ARG), Swedish Society of Obstetrics and Gynecology. Efficacy of obstetric thromboprophylaxis and long-term risk of recurrence of venous thromboembolism. Acta Obstet Gynecol Scand. 2011 Jun;90(6):648-53. doi: 10.1111/j.1600-0412.2011.01098.x. Epub 2011 Apr 15.

ReferenceCitation: Roshani S, Cohn DM, Stehouwer AC, Wolf H, van der Post JA, Buller HR, Kamphuisen PW, Middeldorp S. Incidence of postpartum haemorrhage in women receiving therapeutic doses of low-molecular-weight heparin: results of a retrospective cohort study. BMJ Open. 2011 Nov 14;1(2):e000257. doi: 10.1136/bmjopen-2011-000257. Print 2011.

ReferenceCitation: Kaandorp SP, Goddijn M, van der Post JA, Hutten BA, Verhoeve HR, Hamulyak K, Mol BW, Folkeringa N, Nahuis M, Papatsonis DN, Buller HR, van der Veen F, Middeldorp S. Aspirin plus heparin or aspirin alone in women with recurrent miscarriage. N Engl J Med. 2010 Apr 29;362(17):1586-96. doi: 10.1056/NEJMoa1000641. Epub 2010 Mar 24.

ReferenceCitation: Bistervels IM, Buchmuller A, Wiegers HMG, Ni Ainle F, Tardy B, Donnelly J, Verhamme P, Jacobsen AF, Hansen AT, Rodger MA, DeSancho MT, Shmakov RG, van Es N, Prins MH, Chauleur C, Middeldorp S; Highlow Block writing committee; Highlow Investigators. Intermediate-dose versus low-dose low-molecular-weight heparin in pregnant and post-partum women with a history of venous thromboembolism (Highlow study): an open-label, multicentre, randomised, controlled trial. Lancet. 2022 Nov 19;400(10365):1777-1787. doi: 10.1016/S0140-6736(22)02128-6. Epub 2022 Oct 28.

oa_host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Oslo - Duo Research Archive

version: acceptedVersion

repository_institution: Erasmus University Rotterdam - EUR Research Repository

version: submittedVersion

unpaywall_oa_status: green

ReferenceCitation: Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.

publisher_dissemination: Wiley

ReferenceCitation: Middeldorp S. New studies of low-molecular-weight heparin in pregnancy. Thromb Res. 2015 Feb;135 Suppl 1:S26-9. doi: 10.1016/S0049-3848(15)50436-2. Epub 2015 Feb 9.

ReferenceCitation: Bleker SM, Coppens M, Middeldorp S. Sex, thrombosis and inherited thrombophilia. Blood Rev. 2014 May;28(3):123-33. doi: 10.1016/j.blre.2014.03.005. Epub 2014 Apr 1.

lead_sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

collaborators: Netherlands Organisation for Scientific Research

collaborators: CHU of Saint Etienne: French Ministry of Health Grant (sponsor of the French part of the study)

collaborators: Rotunda Hospital: Definitive Interventions and Feasibility Awards (DIFA) 2017 (sponsor of the Irish part of the study))

location_country:
Ireland
Norway
Denmark
Netherlands
Belgium
United States
Spain
Canada
Russian Federation
France

location_facility: Federal State Institution "Research Center for Obstetrics, Gynecology and Perinatology"

location_facility: Weill Cornell Medicine | NewYork-Presbyterian

appel_a_projets: PHRCN

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU DE SAINT-ETIENNE

type_etablissement: CH

acronyme: HIGHLOW

titre: Prévention secondaire de maladie veineuse thrombo-embolique pendant la grossesse par héparine de bas poids moléculaire: étude randomisée de deux doses

discipline_principale: médecine vasculaire

nom_porteur: CHAULEUR

prenom_porteur: Céline


title: Epidemiological Study to Describe Non-small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Europe. Lung

acronym: EPICLIN

summary: To provide accurate and reliable information regarding NSCLC clinical management across European countries in order to detect unmet medical needs of this disease in terms of: patient and hospital characteristics; diagnostic and treatment approaches: initial and subsequent, follow-up patterns in clinical management; outcomes: symptoms, death, functionality, quality of life; use of resources and burden on patients and health care systems.

ReferenceCitation: Vergnenegre A, Carrato A, Thomas M, Jernigan C, Medina J, Cruciani G. Real-world healthcare resource utilization in a European non-small cell lung cancer population: the EPICLIN-Lung study. Curr Med Res Opin. 2014 Mar;30(3):463-70. doi: 10.1185/03007995.2013.860373. Epub 2013 Nov 18.

publisher_dissemination: Informa

ReferenceCitation: Carrato A, Vergnenegre A, Thomas M, McBride K, Medina J, Cruciani G. Clinical management patterns and treatment outcomes in patients with non-small cell lung cancer (NSCLC) across Europe: EPICLIN-Lung study. Curr Med Res Opin. 2014 Mar;30(3):447-61. doi: 10.1185/03007995.2013.860372. Epub 2013 Nov 18.

lead_sponsor: AstraZeneca

location_country: Germany Italy Portugal Belgium Spain Greece Turkey France


title: A Randomized, Multicenter Open Label Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis

acronym: CYSIF

summary:
PHASE: IV

TYPE OF STUDY: With direct benefit.

DESCRIPTIVE: Multicenter, randomized, open label study.

INCLUSION CRITERIA: Steroid-refractory ulcerative colitis.

OBJECTIVES: To compare the efficacy of cyclosporine with infliximab in steroid- refractory attacks of ulcerative colitis.

STUDY TREATMENTS:Cyclosporine 2mg/kg/day intravenous(IV)for 7days then Neoral 4mg/kg/day orally for 3 months. Infliximab 5mg/kg at Weeks 0, 2 and 6.

NUMBER OF PATIENTS: 50 patients in each group i.e. a total of 100 patients.

INCLUSION PERIOD: 24 months.

STUDY DURATION: 27 months.

MAIN EVALUATION CRITERIA:

Clinical response at D7 according to the Lichtiger Index score AND Clinical Remission at D98 according to the Mayo Disease Activity Index score

SECONDARY EVALUATION CRITERIA:

Clinical remission at D98 (according to the Mayo Disease Activity Index score) Endoscopic response Colectomy rate Tolerance

ReferenceCitation: EDWARDS FC, TRUELOVE SC. THE COURSE AND PROGNOSIS OF ULCERATIVE COLITIS. Gut. 1963 Dec;4(4):299-315. doi: 10.1136/gut.4.4.299.

ReferenceCitation: Truelove SC, Willoughby CP, Lee EG, Kettlewell MG. Further experience in the treatment of severe attacks of ulcerative colitis. Lancet. 1978 Nov 18;2(8099):1086-8. doi: 10.1016/s0140-6736(78)91816-0.

ReferenceCitation: D'Haens G, Lemmens L, Geboes K, Vandeputte L, Van Acker F, Mortelmans L, Peeters M, Vermeire S, Penninckx F, Nevens F, Hiele M, Rutgeerts P. Intravenous cyclosporine versus intravenous corticosteroids as single therapy for severe attacks of ulcerative colitis. Gastroenterology. 2001 May;120(6):1323-9. doi: 10.1053/gast.2001.23983.

ReferenceCitation: Lichtiger S, Present DH, Kornbluth A, Gelernt I, Bauer J, Galler G, Michelassi F, Hanauer S. Cyclosporine in severe ulcerative colitis refractory to steroid therapy. N Engl J Med. 1994 Jun 30;330(26):1841-5. doi: 10.1056/NEJM199406303302601.

ReferenceCitation: Van Assche G, D'Haens G, Noman M, Vermeire S, Hiele M, Asnong K, Arts J, D'Hoore A, Penninckx F, Rutgeerts P. Randomized, double-blind comparison of 4 mg/kg versus 2 mg/kg intravenous cyclosporine in severe ulcerative colitis. Gastroenterology. 2003 Oct;125(4):1025-31. doi: 10.1016/s0016-5085(03)01214-9.

ReferenceCitation: Arts J, D'Haens G, Zeegers M, Van Assche G, Hiele M, D'Hoore A, Penninckx F, Vermeire S, Rutgeerts P. Long-term outcome of treatment with intravenous cyclosporin in patients with severe ulcerative colitis. Inflamm Bowel Dis. 2004 Mar;10(2):73-8. doi: 10.1097/00054725-200403000-00002.

ReferenceCitation: Actis GC, Bresso F, Astegiano M, Demarchi B, Sapone N, Boscaglia C, Rizzetto M. Safety and efficacy of azathioprine in the maintenance of ciclosporin-induced remission of ulcerative colitis. Aliment Pharmacol Ther. 2001 Sep;15(9):1307-11. doi: 10.1046/j.1365-2036.2001.01019.x.

ReferenceCitation: Cohen RD, Stein R, Hanauer SB. Intravenous cyclosporin in ulcerative colitis: a five-year experience. Am J Gastroenterol. 1999 Jun;94(6):1587-92. doi: 10.1111/j.1572-0241.1999.01149.x.

ReferenceCitation: Ardizzone S, Maconi G, Russo A, Imbesi V, Colombo E, Bianchi Porro G. Randomised controlled trial of azathioprine and 5-aminosalicylic acid for treatment of steroid dependent ulcerative colitis. Gut. 2006 Jan;55(1):47-53. doi: 10.1136/gut.2005.068809. Epub 2005 Jun 21.

ReferenceCitation: Shibolet O, Regushevskaya E, Brezis M, Soares-Weiser K. Cyclosporine A for induction of remission in severe ulcerative colitis. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD004277. doi: 10.1002/14651858.CD004277.pub2.

ReferenceCitation: Jarnerot G, Hertervig E, Friis-Liby I, Blomquist L, Karlen P, Granno C, Vilien M, Strom M, Danielsson A, Verbaan H, Hellstrom PM, Magnuson A, Curman B. Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: a randomized, placebo-controlled study. Gastroenterology. 2005 Jun;128(7):1805-11. doi: 10.1053/j.gastro.2005.03.003.

ReferenceCitation: Su C, Salzberg BA, Lewis JD, Deren JJ, Kornbluth A, Katzka DA, Stein RB, Adler DR, Lichtenstein GR. Efficacy of anti-tumor necrosis factor therapy in patients with ulcerative colitis. Am J Gastroenterol. 2002 Oct;97(10):2577-84. doi: 10.1111/j.1572-0241.2002.06026.x.

ReferenceCitation: Gornet JM, Couve S, Hassani Z, Delchier JC, Marteau P, Cosnes J, Bouhnik Y, Dupas JL, Modigliani R, Taillard F, Lemann M. Infliximab for refractory ulcerative colitis or indeterminate colitis: an open-label multicentre study. Aliment Pharmacol Ther. 2003 Jul 15;18(2):175-81. doi: 10.1046/j.1365-2036.2003.01686.x.

ReferenceCitation: Kohn A, Prantera C, Pera A, Cosintino R, Sostegni R, Daperno M. Infliximab in the treatment of severe ulcerative colitis: a follow-up study. Eur Rev Med Pharmacol Sci. 2004 Sep-Oct;8(5):235-7.

ReferenceCitation: Eidelwein AP, Cuffari C, Abadom V, Oliva-Hemker M. Infliximab efficacy in pediatric ulcerative colitis. Inflamm Bowel Dis. 2005 Mar;11(3):213-8. doi: 10.1097/01.mib.0000160803.44449.a5.

ReferenceCitation: Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. doi: 10.1056/NEJMoa050516. Erratum In: N Engl J Med. 2006 May 18;354(20):2200.

ReferenceCitation: Laharie D, Bourreille A, Branche J, Allez M, Bouhnik Y, Filippi J, Zerbib F, Savoye G, Vuitton L, Moreau J, Amiot A, Cosnes J, Ricart E, Dewit O, Lopez-Sanroman A, Fumery M, Carbonnel F, Bommelaer G, Coffin B, Roblin X, van Assche G, Esteve M, Farkkila M, Gisbert JP, Marteau P, Nahon S, de Vos M, Lambert J, Mary JY, Louis E; Groupe d'Etudes Therapeutiques des Affections Inflammatoires Digestives. Long-term outcome of patients with steroid-refractory acute severe UC treated with ciclosporin or infliximab. Gut. 2018 Feb;67(2):237-243. doi: 10.1136/gutjnl-2016-313060. Epub 2017 Jan 4.

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

ReferenceCitation: Laharie D, Bourreille A, Branche J, Allez M, Bouhnik Y, Filippi J, Zerbib F, Savoye G, Nachury M, Moreau J, Delchier JC, Cosnes J, Ricart E, Dewit O, Lopez-Sanroman A, Dupas JL, Carbonnel F, Bommelaer G, Coffin B, Roblin X, Van Assche G, Esteve M, Farkkila M, Gisbert JP, Marteau P, Nahon S, de Vos M, Franchimont D, Mary JY, Colombel JF, Lemann M; Groupe d'Etudes Therapeutiques des Affections Inflammatoires Digestives. Ciclosporin versus infliximab in patients with severe ulcerative colitis refractory to intravenous steroids: a parallel, open-label randomised controlled trial. Lancet. 2012 Dec 1;380(9857):1909-15. doi: 10.1016/S0140-6736(12)61084-8. Epub 2012 Oct 10.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_country: Finland Italy Belgium Spain France

location_facility:
Chu Saint Etienne
Hopital Lariboisiere
Hopital Beaujon
Hospital Mutua de Terressa
CHU CAEN
Hopital Bichat
Chu Nancy
Chu Rennes
Hospital de la Princesa
Ch Le Raincy Montfermeil
Institut Mutualiste Montsouris (Imm)
Chu Nantes
Istituto Clinico Humanitas
Chu Clermont-Ferrand
CHU LYON
Ch Avignon
Hopital Cochin
Hopital Georges Pompidou
CHU NICE
Chu Amiens
Chu Toulouse
Hopital Bicetre
Hospital Clinic
Gent University Hospital
Hopital Louis Mourrier
Hopital Henri Mondor
Chu Besancon
Chru Lille
Chu Rouen
Chu Strasbourg
Hopital Erasme
Hopital Saint Louis
Chu Marseille - Hopital Nord
Chu Reims
Chu Tours
Hospital Ramon Y Cajal
Leuven University Hospital
Hopital Haut Leveque
Helsinki University Hospital
Hopital St Antoine
Ulb - Clinique Saint Luc


title: Randomized, Double-blind, Placebo-controlled Multicenter Study Evaluating the Interest of a Long-term (3 Years) Treatment With Peginterferon Alfa-2b and Ribavirin on Liver Fibrosis in Non-responder Chronic Hepatitis C Patients.

summary: Patients with chronic hepatitis C who did not respond to previous antiviral treatment develop liver fibrosis leading to cirrhosis. Maintenance low dose pegylated interferon therapy of fibrosis is currently under investigation in large multicenter trials. The aim of our study is to assess if peginterferon alpha2b plus ribavirin is more efficient than peginterferon alpha2b alone. 454 patients will be randomized between the 2 arms and the efficacy will be assessed, after 3 years of treatment, on Metavir liver fibrosis score improvement.

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Merck Sharp & Dohme LLC
Rennes University Hospital

location_facility: Service d'Hépatogastroentérologie - Hôpital Beaujon

location_facility: Service d'Hépatogastroentérologie - Hôpital de la Source

location_facility: Service d'Hépatogastroentérologie - CH Montélimar

location_facility: Service d'Hépatogastroentérologie - Hôpital Pontchaillou

location_facility: Service d'Hépatogastroentérologie - Hôpital Purpan

location_facility: Service d'Hépatogastroentérologie, Clinique médicale B - Hôpital Civil

location_facility: Service d'Hépatologie - Gastroentérologie - Cancérologie digestive - CHU Angers

location_facility: Service d'Hépatogastroentérologie - Hôpital de la Cavale Blanche

location_facility: Service d'Hépatogastroentérologie - CH Sud Francilien

location_facility: Service d'Hépatogastroentérologie - Hôpital Tenon

location_facility: Service d'Hépatogastroentérologie - Hôpital Brabois

location_facility: Service d'Hépatogastroentérologie - CH La Roche sur Yon

location_facility: Service d'Hépatologie - Gastroentérologie - Nutrition -Hôpital de la Côte de Nacre

location_facility: Service d'Hépatogastroentérologie - Hôpital Saint Joseph

location_facility: Service d'Hépatogastroentérologie - Hôpital La Pitié Salpétrière

location_facility: Service d'Hépatogastroentérologie - Hôpital Trousseau

location_facility: Service d'Hépatogastroentérologie - Hôpital Avicenne

location_facility: Service d'Hépatogastroentérologie - CHU Rouen

location_facility: Service d'Hépatogastroentérologie - Hôpital du Bocage

location_facility: Service d'Hépatogastroentérologie - CHU d'ESTAING

location_facility: Service d'Hépatogastroentérologie et d'Assistance nutritive - Hôpital Haut-Lévêque

location_facility: Service des Maladies du Foie et de l'appareil Digestif - Hôpital de Bicêtre

location_facility: Service d'Hépatogastroentérologie et d'endoscopie digestive - CH du Pays d'Aix

location_facility: Service d'Hépatogastroentérologie - CH Montauban

location_facility: Service d' Hépatogastroentérologie - Hôpital Jean Verdier

location_facility: Service d'Hépatogastroentérologie - Hotel de la Croix Rousse

location_facility: Service d'Hépatogastroentérologie - Hôtel Dieu

location_facility: Département d'Hépatogastroentérologie - CH Le Mans

location_facility: Service d'Hépatogastroentérologie - Hôpital Nord

location_facility: Service d'Hépatogastroentérologie - Hôpital Saint Eloi

location_facility: Service d'Hépatogastroentérologie - CHRU - Hôpital Claude Huriez


title: Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery. It is not yet known if surgery is more effective with or without radiation therapy and chemotherapy in treating esophageal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without radiation therapy and chemotherapy in treating patients who have esophageal cancer.

ReferenceCitation: Mariette C, Robb WB, Piessen G. Reply to Letter: "The Role of Surgery for Patients With a Complete Clinical Response After Chemoradiation for Esophageal Cancer". Ann Surg. 2015 Dec;262(6):e101-2. doi: 10.1097/SLA.0000000000000668. No abstract available.

ReferenceCitation: Mariette C, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Robb WB, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF. Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901. J Clin Oncol. 2014 Aug 10;32(23):2416-22. doi: 10.1200/JCO.2013.53.6532. Epub 2014 Jun 30.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Robb WB, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF, Mariette C; Federation Francaise de Cancerologie Digestive, Societe Francaise de Radiotherapie Oncologique, Union des Centres de Lutte Contre le Cancer, Groupe Cooperateur Multidisciplinaire en Oncologie, French EsoGAstric Tumour working group, Federation de Recherche En Chirurgie. Impact of neoadjuvant chemoradiation on lymph node status in esophageal cancer: post hoc analysis of a randomized controlled trial. Ann Surg. 2015 May;261(5):902-8. doi: 10.1097/SLA.0000000000000991.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Robb WB, Messager M, Dahan L, Mornex F, Maillard E, D'Journo XB, Triboulet JP, Bedenne L, Seitz JF, Mariette C; Federation Francophone de Cancerologie Digestive; Societe Francaise de Radiotherapie Oncologique; Union des Centres de Lutte Contre le Cancer; Groupe Cooperateur Multidisciplinaire en Oncologie; French EsoGAstric Tumour working group - Federation de Recherche En Chirurgie. Patterns of recurrence in early-stage oesophageal cancer after chemoradiotherapy and surgery compared with surgery alone. Br J Surg. 2016 Jan;103(1):117-25. doi: 10.1002/bjs.9959. Epub 2015 Oct 29.

publisher_dissemination: Oxford University Press

collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group

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

location_country: Germany Netherlands Belgium France

location_facility: Centre Hospitalier de Bourgoin - Jallieu

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

location_facility: Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault

location_facility: CHR - Clinique Saint Joseph - Hopital de Warqueguies

location_facility: Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Centre Hospitalier Intercommunal de Poissy

location_facility: Assistance Publique Hopitaux de Marseille Hopitaux Sud

location_facility: Centre Hospitalier General De Saint-Malo

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Klinikum der Albert - Ludwigs - Universitaet Freiburg

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: CHU Brest - Hopital De La Cavale Blanche


title: FOUR ARMS PHASE III CLINICAL TRIAL FOR T3-T4 RESECTABLE RECTAL CANCER COMPARING PRE-OPERATIVE PELVIC IRRADIATION TO PRE-OPERATIVE IRRADIATION COMBINED WITH FLUOROURACIL AND LEUCOVORIN WITH OR WITHOUT POST-OPERATIVE ADJUVANT CHEMOTHERAPY

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, giving the drugs in different ways, and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare radiation therapy alone before surgery with radiation therapy plus fluorouracil and leucovorin before surgery, with and without fluorouracil and leucovorin after surgery in patients with rectal cancer that can be surgically removed.

ReferenceCitation: Bonnetain F, Bosset J, Gerard J, et al.: An analysis of preoperative chemoradiotherapy with 5FU/leucovorin for T3-4 rectal cancer on survival in a pooled analysis of EORTC 22921 and FFCD 9203 trials: surrogacy in question? [Abstract] J Clin Oncol 29 (Suppl 15): A-3506, 2011.

ReferenceCitation: den Dulk M, Putter H, Collette L, Marijnen CAM, Folkesson J, Bosset JF, Rodel C, Bujko K, Pahlman L, van de Velde CJH. The abdominoperineal resection itself is associated with an adverse outcome: the European experience based on a pooled analysis of five European randomised clinical trials on rectal cancer. Eur J Cancer. 2009 May;45(7):1175-1183. doi: 10.1016/j.ejca.2008.11.039. Epub 2009 Jan 6.

ReferenceCitation: Monnien F, Zaki H, Borg C, Mougin C, Bosset JF, Mercier M, Arbez-Gindre F, Kantelip B. Prognostic value of phosphorylated STAT3 in advanced rectal cancer: a study from 104 French patients included in the EORTC 22921 trial. J Clin Pathol. 2010 Oct;63(10):873-8. doi: 10.1136/jcp.2010.076414.

ReferenceCitation: Tiv M, Puyraveau M, Mineur L, Calais G, Maingon P, Bardet E, Mercier M, Bosset JF. Long-term quality of life in patients with rectal cancer treated with preoperative (chemo)-radiotherapy within a randomized trial. Cancer Radiother. 2010 Oct;14(6-7):530-4. doi: 10.1016/j.canrad.2010.06.017. Epub 2010 Aug 24.

ReferenceCitation: Collette L, Bosset JF, den Dulk M, Nguyen F, Mineur L, Maingon P, Radosevic-Jelic L, Pierart M, Calais G; European Organisation for Research and Treatment of Cancer Radiation Oncology Group. Patients with curative resection of cT3-4 rectal cancer after preoperative radiotherapy or radiochemotherapy: does anybody benefit from adjuvant fluorouracil-based chemotherapy? A trial of the European Organisation for Research and Treatment of Cancer Radiation Oncology Group. J Clin Oncol. 2007 Oct 1;25(28):4379-86. doi: 10.1200/JCO.2007.11.9685.

ReferenceCitation: Bosset JF, Collette L, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, Daban A, Bardet E, Beny A, Ollier JC; EORTC Radiotherapy Group Trial 22921. Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med. 2006 Sep 14;355(11):1114-23. doi: 10.1056/NEJMoa060829. Erratum In: N Engl J Med. 2007 Aug 16;357(7):728.

ReferenceCitation: Bosset J, Calais G, Mineur L, et al.: Preoperative radiotherapy in rectal cancer: role and place of fluorouracil-based chemotherapy. Final results of the EORTC 22921 phase III trial. [Abstract] American Society of Clinical Oncology 2005 Gastrointestinal Cancers Symposium, 27-29 January 2005, Miami, Florida. A-255, 2005.

ReferenceCitation: Bosset JF, Calais G, Mineur L, et al.: Preoperative radiation (Preop RT) in rectal cancer: effect and timing of additional chemotherapy (CT) 5-year results of the EORTC 22921 trial. [Abstract] J Clin Oncol 23 (Suppl 16): A-3505, 247s, 2005.

ReferenceCitation: Bosset JF, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, Daban A, Bardet E, Beny A, Briffaux A, Collette L. Enhanced tumorocidal effect of chemotherapy with preoperative radiotherapy for rectal cancer: preliminary results--EORTC 22921. J Clin Oncol. 2005 Aug 20;23(24):5620-7. doi: 10.1200/JCO.2005.02.113. Epub 2005 Jul 11.

ReferenceCitation: Bosset JF, Calais G, Mineur L, et al.: Does the addition of chemotherapy (CT) to preoperative radiotherapy (preopRT) increase the pathological response in patients with resected rectal cancer: report of the 22921 EORTC phase III trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-3504, 246, 2004.

ReferenceCitation: Bosset JF, Calais G, Daban A, et al.: Does the addition of chemotherapy to preoperative radiation increase acute toxicity in patients with rectal cancer: report of 22921 EORTC phase III trial . [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1179, 2003.

ReferenceCitation: Kouloulias VE, Bosset JF, van Tienhoven G, Davis BJ, Pierart M, Poortmans P; EORTC Radiotherapy Group. European Organization for Research and Treatment of Cancer. Quality assurance in the EORTC 22921 trial on preoperative radiotherapy with or without chemotherapy for resectable rectal cancer: evaluation of the individual case review procedure. Eur J Cancer. 2002 Sep;38(14):1849-56. doi: 10.1016/s0959-8049(02)00174-0.

ReferenceCitation: Bosset JF, Calais G, Mineur L, Maingon P, Stojanovic-Rundic S, Bensadoun RJ, Bardet E, Beny A, Ollier JC, Bolla M, Marchal D, Van Laethem JL, Klein V, Giralt J, Clavere P, Glanzmann C, Cellier P, Collette L; EORTC Radiation Oncology Group. Fluorouracil-based adjuvant chemotherapy after preoperative chemoradiotherapy in rectal cancer: long-term results of the EORTC 22921 randomised study. Lancet Oncol. 2014 Feb;15(2):184-90. doi: 10.1016/S1470-2045(13)70599-0. Epub 2014 Jan 17.

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

location_country: Germany France Poland Netherlands Switzerland Belgium Spain Turkey Serbia Israel

location_facility: Service Cancerologie Polyclinique Clairval

location_facility: Centre Hospitalier Universitaire de Tivoli

location_facility: Hospital General Universitari Vall d'Hebron

location_facility: Centre Hospitalier Universitaire Henri Mondor

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

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Institut Catala d'Oncologia - Hospital Duran i Reynals

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Dokuz Eylul University School of Medicine


acronym: PROMOTE-ALI

summary: The primary objective of this study is to evaluate the effect of different treatment modalities on clinical outcome of patients suffering from acute lower limb ischemia (ALI). Depending on clinical presentation, anatomical as well as technical considerations, different treatment options are available for revascularisation of affected limbs. Using an observational, international, multicentric study design (min. patient number of 500), the defined primary endpoint of the study, amputation-free survival 90 days after the diagnosis of ALI, will be evaluated.

ReferenceCitation: Behrendt CA, Bjorck M, Schwaneberg T, Debus ES, Cronenwett J, Sigvant B; Acute Limb Ischaemia Collaborators. Editor's Choice - Recommendations for Registry Data Collection for Revascularisations of Acute Limb Ischaemia: A Delphi Consensus from the International Consortium of Vascular Registries. Eur J Vasc Endovasc Surg. 2019 Jun;57(6):816-821. doi: 10.1016/j.ejvs.2019.02.023. Epub 2019 May 22.

ReferenceCitation: Bjorck M, Earnshaw JJ, Acosta S, Bastos Goncalves F, Cochennec F, Debus ES, Hinchliffe R, Jongkind V, Koelemay MJW, Menyhei G, Svetlikov AV, Tshomba Y, Van Den Berg JC, Esvs Guidelines Committee, de Borst GJ, Chakfe N, Kakkos SK, Koncar I, Lindholt JS, Tulamo R, Vega de Ceniga M, Vermassen F, Document Reviewers, Boyle JR, Mani K, Azuma N, Choke ETC, Cohnert TU, Fitridge RA, Forbes TL, Hamady MS, Munoz A, Muller-Hulsbeck S, Rai K. Editor's Choice - European Society for Vascular Surgery (ESVS) 2020 Clinical Practice Guidelines on the Management of Acute Limb Ischaemia. Eur J Vasc Endovasc Surg. 2020 Feb;59(2):173-218. doi: 10.1016/j.ejvs.2019.09.006. Epub 2019 Dec 31. No abstract available.

ReferenceCitation: Gratl A; European Vascular Research Collaborative (EVRC). Study Protocol of a Prospective Multicenter Observational Study Evaluating Acute Lower Limb Ischemia. J Surg Res. 2023 Feb;282:280-284. doi: 10.1016/j.jss.2022.09.023. Epub 2022 Nov 5.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repository_institution: University of Bristol - Bristol Research

unpaywall_oa_status: hybrid

lead_sponsor: Medical University Innsbruck

location_country:
Germany
Hungary
United Kingdom
Netherlands
Austria
Switzerland
Croatia
Moldova, Republic of
Serbia
France

location_facility: Department of Vascular Surgery, Bordeaux University Hospital

location_facility: Department of Vascular Surgery, Ambroise Paré University Hospital, Boulogne-Billancourt and Simone Veil Health Sciences Medical School, Versailles-Saint-Quentin-en-Yvelines University and Paris-Saclay University

location_facility: European Vascular Center Aachen-Maastricht, University Hospital Aachen, RWTH Aachen University

location_facility: Department of Vascular and Endovascular Surgery, University Hospital Münster

location_facility: Department of Vascular Surgery, University Hospital of Nancy

location_facility: Institute for Cardiovascular Disease, Belgrade

location_facility: Department of Cardiovascular Surgery, Inselspital, University of Bern

location_facility: Department of Vascular Surgery and Kidney Transplantation, University Hospitals of Strasbourg

location_facility: Department of Vascular- and Endovascular Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf

location_facility: Division of Vascular and Endovascular Surgery Department for Visceral-, Thoracic and Vascular Surgery Medical Faculty Carl Gustav Carus and University Hospital Carl Gustav Carus Dresden Technische Universität Dresden

location_facility: Department of Vascular Surgery, University Hospital Wales

location_facility: Clinic for Vascular Surgery, Clinical Center Niš

location_facility: CHU Nantes, l'institut du thorax, service de chirurgie cardio-vasculaire

location_facility: Department of Vascular and Endovascular Surgery, Brest University Hospital

location_facility: Department of Vascular and Thoracic Surgery, Bichat Hospital, Paris, Université de Paris

location_facility: Department of Cardio-Vascular Surgery, Clinic Floridsdorf and Karl Landsteiner Institute for Cardio-Vascular Research

location_facility: Department of Vascular Surgery, Ambroise Paré University Hospital, Assistance Publique-Hôpitaux de Paris

location_facility: Amsterdam University Medical Center, Department of Surgery

location_facility: Department of Vascular and Endovascular Surgery, Heart and Vascular Center, Semmelweis University

location_facility: Clinic for Vascular and Endovascular Surgery, Clinical Center of Serbia

location_facility: Department of Vascular Surgery, CHU de Reims

location_facility: Department of Vascular Surgery, Henri Mondor University Hospital

location_facility: Department of Vascular Surgery, Hospital of Antibes Juan-les-Pins

location_facility: Department of General Surgery, Division of Vascular Surgery, Medical University of Vienna

location_facility: Department of Vascular and Endovascular Surgery, Hospital Ottakring

location_facility: Bristol Centre for Surgical Research, Bristol NIHR Biomedical Research Centre, University of Bristol

location_facility: Medical University of Innsbruck, Department of Vascular Surgery

location_facility: University Hospital of Nice, Université Côte d'Azur

location_facility: Department of Vascular Surgery, Kantonsspital Winterthur

location_facility: Vascular Surgery Department, Hospices Civils de Lyon

location_facility: Department of Vascular Surgery, University Hospital of Dijon

location_facility: Vascular Surgery Department, Georges Pompidou European Hospital, APHP, Paris University

location_facility: University Medical Center Utrecht, Department of Vascular Surgery

intervention_type: Procedure


title: Prospective, Randomized, Multi-center Trial to Assess the Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients

acronym: EarlyMob

summary:
The purpose of the present study is to compare usual care in terms of mobilization performed to intubated ICU patients to a standardized program designed to deliver early mobilization at least 5 days a week.

This study has a before / after design with a control group during the experimental phase. The first phase of the study corresponds to an observational phase during which every act of mobilization performed to the included patients is going to be documented. During this first study period, total duration of mechanical ventilation is going to be recorded for all the patients included.

At the end of this first study period, the participating ICU are going to be randomized (Cluster randomization) in two groups either observational or experimental. The corresponding strategy is going to be applied to all the patients included during the second study period. During this second period, total duration of mechanical ventilation is also going to be recorded for all the patients included.

The study hypothesis is that applying a protocolized early mobilization strategy increases the number of ventilator free-days during the 28 days after intubation in ICU patients.

status: Unknown status

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Angers

location_country: Switzerland Belgium France

location_facility: CHRU de Lille - Pôle de réanimation -Hôpital Roger Salengro

location_facility: Cliniques Universitaires Saint-Luc - Service des soins intensifs

location_facility: CHU de Brest - Service de réanimation médicale

location_facility: Centre Hospitalier Le Mans - Service de Réanimation médico-chirurgicale

location_facility: CH de Pontoise - Serive de réanimation médicale - CH René Dubos

location_facility: AP-HP Hôpital Tenon - Service de Réanimation

location_facility: Groupe Hospitalier du Havre - Service de Réanimation médico-chirurgicale - Hôpital Jacques Monod

location_facility: AP-HP Hôpital Henri Mondor - Service de Réanimation Médicale

location_facility: Cliniques Universitaires UCL de Mont-Godinne - Service intensifs généraux

location_facility: Centre Hospitalier La Rochelle - Ré- Aunis - Réanimation polyvalente

location_facility: CHU de Nantes - Service de Réanimation Médicale Polyvalente

location_facility: AP-HP Hôpitaux Universitaires Paris Ouest- Service de réanimation médicale - Hôpital Européen Georges Pompidou

location_facility: CHR Citadelle - Services Soins intensifs, gériatriques et pédiatriques

location_facility: CHU Angers - Service de Réanimation Médicale et de Médecine Hyperbare

location_facility: CHU Grenoble - Service de Réanimation Médicale - Hôpital A, Michallon

location_facility: CH St Joseph St Luc - Service de Réanimation Polyvalente

location_facility: CHU Toulouse - service de néphrologie Hémodialyse HTA Transplantation d'Organes - Hôpital Rangueil

location_facility: CHU de Nice - Service de réanimation médicale - Hôpital de l'Archet

location_facility: Service de Réanimation Polyvalente -CHU de Toulouse - Hôpital Rangueil

location_facility: CHD Vendée - Service de Réanimation Polyvalente

location_facility: CHU de Liege - Service de soins intensifs généraux

appel_a_projets: PHRIP

region: Pays de la Loire

nom_etablissement: CHR ANGERS

acronyme: EarlyMob

titre: Impact de la mobilisation précoce sur la durée de ventilation mécanique des patients de réanimation -- Etude multicentrique randomisée

discipline_principale: anesthésiologie / réanimation

nom_porteur: POIROUX

prenom_porteur: Laurent


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977+Ribavirin for 12 Weeks in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection.

summary: This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.

ReferenceCitation: Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, Illeperuma A, Svarovskaia E, Brainard DM, Symonds WT, Subramanian GM, McHutchison JG, Weiland O, Reesink HW, Ferenci P, Hezode C, Esteban R; VALENCE Investigators. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014 May 22;370(21):1993-2001. doi: 10.1056/NEJMoa1316145. Epub 2014 May 4.

evidence: open (via free article)

license: public-domain

license_normalized: public-domain

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

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

evidence: oa repository (semantic scholar lookup)

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12.

evidence: oa repository (via OAI-PMH title and last author match)

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

repositories:
CiteSeerX
PubMed Central

repositories_concat: CiteSeerX;PubMed Central

lead_sponsor: Gilead Sciences

location_country:
Germany
Italy
Poland
United Kingdom
Sweden
Netherlands
Austria
Spain
Estonia
France

location_facility: Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

location_facility: Wojewodzki Szpital Specjalistyczny im Dluskeigo

location_facility: Complejo Hospitalario de Especialidades Virgen de la Victoria

location_facility: Hospital General Universitario de Valencia

location_facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda

location_facility: Azienda Ospedaliera Universitaria San Giovanni Battista di Torino

location_facility: Fondazione PTV - Policlinico Tor Vergata

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: SP ZOZ Wojewodzki Szpital Zakazny w Warszawie

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN

location_facility: Southampton University Hospital NHS Trust

location_facility: Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Royal Free Hospital and University College London Hospital

location_facility: Centrum fuer interdisziplinaere Medizin Muenster GmbH

location_facility: Département Hépatogastroentérologie - CHU de Grenoble

location_facility: Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico


title: Effect of Roflumilast in COPD Patients Treated With Tiotropium. A 24-week, Double-blind Study With 500 µg Roflumilast Once Daily Versus Placebo. The HELIOS Study

acronym: HELIOS

summary: The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of tiotropium. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.

ReferenceCitation: Fabbri LM, Calverley PM, Izquierdo-Alonso JL, Bundschuh DS, Brose M, Martinez FJ, Rabe KF; M2-127 and M2-128 study groups. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):695-703. doi: 10.1016/S0140-6736(09)61252-6.

ReferenceCitation: Cazzola M, Picciolo S, Matera MG. Roflumilast in chronic obstructive pulmonary disease: evidence from large trials. Expert Opin Pharmacother. 2010 Feb;11(3):441-9. doi: 10.1517/14656560903555201.

location_country:
Germany
Italy
Hungary
United Kingdom
Austria
Spain
France

location_facility: Altana Pharma/Nycomed Investigational Site


title: Multi-Centre Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone, As Adjuvant Treatment After Resection Of Liver Metastases For Colorectal Cancer.

summary: To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone.

lead_sponsor: Pfizer

location_country:
Germany
Italy
Portugal
Israel
Hong Kong
Denmark
United Kingdom
Sweden
Switzerland
Belgium
Korea, Republic of
Spain
South Africa
Taiwan
Ukraine
France


title: Prevalence of Barrett's Esophagus in Adolescents and Young Adults With Esophageal Atresia

acronym: Oesophagix

summary: The frequency of Barrett's esophagus (BE) has increased in adults in the last decades, but BE is rare in children. Esophageal atresia (EA), the most common congenital anomaly affecting the esophagus, predisposes the patient to severe and prolonged gastroesophageal reflux disease. Because gastroesophageal reflux disease plays a major role in the development of BE by causing repeated mucosal damage, development of BE is a concern even in children and young adults in this specific population. The aim of this study is to assess the prevalence of BE (gastric and/or intestinal metaplasia) in a population of adolescents/young adults who had been treated for EA in early infancy. All eligible patients received upper gastrointestinal endoscopy under general anesthesia with standardized esophageal staged biopsies. Histological suspicion of metaplasia was confirmed centrally.

ReferenceCitation: Schneider A, Gottrand F, Bellaiche M, Becmeur F, Lachaux A, Bridoux-Henno L, Michel JL, Faure C, Philippe P, Vandenplas Y, Dupont C, Breton A, Gaudin J, Lamireau T, Muyshont L, Podevin G, Viola S, Bertrand V, Caldari D, Colinet S, Wanty C, Sauleau E, Leteurtre E, Michaud L. Prevalence of Barrett Esophagus in Adolescents and Young Adults With Esophageal Atresia. Ann Surg. 2016 Dec;264(6):1004-1008. doi: 10.1097/SLA.0000000000001540.

lead_sponsor: University Hospital, Lille

location_country: Canada Luxembourg Belgium France

location_facility: Hôpital Mère-Enfants Ste Justine, Montréal, Canada

location_facility: Department of Pediatric Gastroenterology, AZ VUB,

location_facility: Department of Gastroenterology CHC, Liège

location_facility: Department of Pediatric Gastroenterology, HUDERF,

location_facility: University Hospital, Hôpital Jeanne de Flandres


title: A Multi-center, Single Arm Study of Enzalutamide in Patients With Progressive Metastatic Castration-Resistant Prostate Cancer Previously Treated With Abiraterone Acetate

summary: The objective of this study was to evaluate the efficacy and safety of enzalutamide treatment in patients with progressive metastatic castration-resistant prostate cancer previously treated with abiraterone acetate.

ReferenceCitation: de Bono JS, Chowdhury S, Feyerabend S, Elliott T, Grande E, Melhem-Bertrandt A, Baron B, Hirmand M, Werbrouck P, Fizazi K. Antitumour Activity and Safety of Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer Previously Treated with Abiraterone Acetate Plus Prednisone for >/=24 weeks in Europe. Eur Urol. 2018 Jul;74(1):37-45. doi: 10.1016/j.eururo.2017.07.035. Epub 2017 Aug 23.

oa_host_type: publisher

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Europe B.V.

sponsor_collaborators:
Astellas Pharma Europe B.V.
Medivation, Inc.

location_country:
Germany
United Kingdom
Belgium
Spain
France

location_facility:
Site FR33001
Site DE49014
Site FR33013
Site DE49012
Site BE32001
Site FR33012
Site DE49003
Site GB44007
Site ES34003
Site FR33010
Site BE32007
Site BE32003
Site FR33015
Site ES34006
Site FR33005
Site ES34002
Site FR33007
Site DE49017
Site DE49009
Site DE49001
Site DE49002
Site FR33009
Site DE49008
Site GB44001
Site GB44006
Site ES34010
Site DE49007
Site ES34004
Site GB44010
Site DE49004
Site ES34008
Site GB44009
Site ES34011
Site FR33011
Site DE49006
Site DE49010
Site GB44003
Site ES34001
Site BE32004
Site DE49016
Site DE49005
Site FR33002
Site ES34009
Site GB44004
Site FR33014
Site FR33003
Site FR33008
Site DE49015
Site GB44002
Site BE32002


title: Second Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors After PCV-Chemotherapy

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors following combination chemotherapy.

ReferenceCitation: Kouwenhoven MC, Kros JM, French PJ, Biemond-ter Stege EM, Graveland WJ, Taphoorn MJ, Brandes AA, van den Bent MJ. 1p/19q loss within oligodendroglioma is predictive for response to first line temozolomide but not to salvage treatment. Eur J Cancer. 2006 Oct;42(15):2499-503. doi: 10.1016/j.ejca.2006.05.021. Epub 2006 Aug 17.

ReferenceCitation: van den Bent MJ, Chinot O, Boogerd W, Bravo Marques J, Taphoorn MJ, Kros JM, van der Rijt CC, Vecht CJ, De Beule N, Baron B. Second-line chemotherapy with temozolomide in recurrent oligodendroglioma after PCV (procarbazine, lomustine and vincristine) chemotherapy: EORTC Brain Tumor Group phase II study 26972. Ann Oncol. 2003 Apr;14(4):599-602. doi: 10.1093/annonc/mdg157.

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

location_country:
Finland
Germany
Italy
Portugal
Hungary
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
France

location_facility: Neurologische Klinik der Henriettenstiftung

location_facility: Academisch Ziekenhuis der Vrije Universiteit

location_facility: Centre Hospitalier Universitaire de Bicetre

location_facility: Instituto Portugues de Oncologia de Francisco Gentil


acronym: HCT versus CT elderly AML

lead_sponsor: European Society for Blood and Marrow Transplantation

summary: A study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.

sponsor_collaborators: Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

sponsor_collaborators: HOVON - Dutch Haemato-Oncology Association

sponsor_collaborators: East German Study Group of Hematology and Oncology (OSHO)

sponsor_collaborators: Swiss Group for Clinical Cancer Research

location_facility: Centre hospitalier et universitaire (CHU) de Nice

location_facility: Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität

location_facility: Centre hospitalier et universitaire (CHU) d´ Estaing

location_facility: ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen

location_facility: II. Medizinische Klinik, Hämatologie/Internistische Onkologie

location_facility: Hanusch Krankenhaus der Wiener Gebietskrankenkasse

location_facility: Centre hospitalier et universitaire (CHU) de Limoges

location_facility: Academisch Ziekenhuis bij de Universiteit Amsterdam

location_facility: Erasmus MC-Daniel den Hoed Cancer Centre

status: Terminated

title: Randomized Phase III Study Comparing Conventional Chemotherapy to Low Dose Total Body Irradiation-Based Conditioning and HCT From Related and Unrelated Donors as Consolidation Therapy for Older Patients With AML in 1st Complete Remission

location_country: Germany Australia Netherlands Austria Belgium Switzerland France


acronym: Not applicable

lead_sponsor: Ipsen

summary: To identify the proportion of patients remaining medically castrated (testosterone level < 50 ng/dL) on Day 240 following two administrations of a 4-month sustained-release (SR) formulation of triptorelin.

location_facility: UAB 'Vilniaus onkourologijos-ginekologijos klinika

location_facility: Scientific Research Institute of Urology

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

location_facility: Ivano Frankovsk State Medical University

location_facility: Paula Stradina Kliniska Universitates slimnica

location_facility: Academisch Ziekenhuis Vrije Universiteit Brussel

title: A Phase III, Single Arm, Multicentre Study to Evaluate the Efficacy and Safety of a Subcutaneous Four Months Sustained-release Formulation of Triptorelin, a Gonadotrophin Releasing Hormone Analogue in Patients With Prostate Cancer

location_country:
Lithuania
Poland
United Kingdom
Belgium
Latvia
Spain
Ukraine
France


title: A Non-Interventional Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis

summary: This is a Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis in order to evaluate the effectiveness of treatment with tofacitinib on disease activity, remission, and Quality of Life, in a real-world setting over a 12-month observation period

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country: Finland France Israel Denmark Sweden

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Norrlands University Hospital Umeå, Reumatologiska kliniken Västerbotten

location_facility: The Baruch Padeh Medical Center - Poriya

location_facility: CHU Clermont Ferrand - Hopital Gabriel Montpied


lead_sponsor: Hoffmann-La Roche

summary: This study will evaluate the safety, efficacy, pharmacokinetics and immunogenicity of induction treatment consisting of atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma (FL), followed by maintenance treatment with atezolizumab plus obinutzumab plus lenalidomide in patients who achieve a complete response (CR), a partial response (PR), or stable disease at end of induction.

location_facility: Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny

location_facility: Memorial Sloan-Kettering Cancer Center; Hematology/Oncology

title: A Phase Ib/II Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma

location_country:
United States
France


title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, Efficacy and Pharmacodynamics of KBSA301 in Severe Pneumonia (S. Aureus)

summary: The objectives of this study are to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical outcome of patients who have severe pneumonia caused by Staphylococcus aureus (S. aureus) after a single intravenous administration of KBSA301 in addition of standard of care antibiotic treatment.

ReferenceCitation: Francois B, Mercier E, Gonzalez C, Asehnoune K, Nseir S, Fiancette M, Desachy A, Plantefeve G, Meziani F, de Lame PA, Laterre PF; MASTER 1 study group. Safety and tolerability of a single administration of AR-301, a human monoclonal antibody, in ICU patients with severe pneumonia caused by Staphylococcus aureus: first-in-human trial. Intensive Care Med. 2018 Nov;44(11):1787-1796. doi: 10.1007/s00134-018-5229-2. Epub 2018 Oct 21.

publisher_dissemination: Springer-Nature

lead_sponsor: Aridis Pharmaceuticals, Inc.

location_country:
United States
Spain
Belgium
France

location_facility:
Site 37
Site 11
Site 31
Site 34
Site 39
Site 36
Site 81
Site 33
Site 80
Site 51
Site 40
Site 35
Site 38
Site 83
Site 52
Site 16
Site 41
Site 32


acronym: Ph2 Platform Trial of Novel Regimens vs. SoC in NSCLC

lead_sponsor: GlaxoSmithKline

summary: This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study has assessed the clinical activity of novel regimen (Feladilimab plus Docetaxel) with SOC (Docetaxel) in participants with NSCLC.

sponsor_collaborators:
GlaxoSmithKline
iTeos Belgium SA

title: A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants

ipd_sharing_description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

location_country:
Germany
Italy
Poland
Romania
Sweden
Netherlands
United States
Korea, Republic of
Spain
Canada
Russian Federation
France


title: Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA

summary:
This is an open label single group, Phase 2, 1-arm study for treatment to evaluate efficacy, safety, and Pharmacokinetic (PK) of tusamitamab ravtansine in nonsquamous non-small-cell-lung-cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA).

Participants who will be enrolled, will receive tusamitamab ravtansine as monotherapy every two weeks (Q2W) until disease progression, unacceptable adverse event (AE), initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment, whichever comes first. A total of approximately 38 participants are planned to be treated.

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, blank 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 trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi

location_country:
Italy
Japan
Belgium
United States
Spain
Turkey
France

location_facility:
Investigational Site Number :7920001
Investigational Site Number :7920003
Investigational Site Number :7920004
Investigational Site Number :7240001
Investigational Site Number :7920002
Investigational Site Number :0560001
Renovatio Clinical-Site Number:8400003
Investigational Site Number :3800003
Investigational Site Number :2500002
Investigational Site Number :3920001
Investigational Site Number :2500001
Investigational Site Number :2500008
Investigational Site Number :3800002
Investigational Site Number :7240006
Investigational Site Number :7920005
Investigational Site Number :3920002
Investigational Site Number :7240005
Investigational Site Number :2500006
Investigational Site Number :2500007
Investigational Site Number :7240002
Investigational Site Number :3800001
Investigational Site Number :0560002
Investigational Site Number :7240003
Investigational Site Number :7240008
Investigational Site Number :3920003
Investigational Site Number :2500003
Investigational Site Number :0560003
Investigational Site Number :7240007
Investigational Site Number :7240004


title: Prospective, Multicenter, Non-randomized, Single-arm Observational Study to Evaluate Safety and Effectiveness of iCover Covered Stent for the Treatment of the Aorto-iliac Occlusive Disease

acronym: ILICO

summary: The objective of this prospective, multicenter, non-randomized, single-arm observational study is to evaluate the efficacy and the safety of the iCover covered stent for the treatment of de novo aorto-iliac atherosclerotic lesions in patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5).

lead_sponsor: iVascular S.L.U.

location_country: Germany Spain Belgium France

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Hospital Universitari Germans Trias i Pujol

intervention_type: Device


title: A Phase 2 Study Evaluating Futibatinib (TAS 120) Plus Pembrolizumab in the Treatment of Advanced or Metastatic Urothelial Carcinoma

summary: The purpose of the trial is to evaluate the antitumor activity and confirm the safety for the combination of Fibroblast Growth Factor Receptor (FGFR) inhibitor futibatinib and anti-programmed cell death-1 (PD-1) antibody pembrolizumab in patients with advanced or metastatic urothelial cancer who are not candidates to receive a platinum-based treatment regimens.

lead_sponsor: Taiho Oncology, Inc.

sponsor_collaborators:
Taiho Oncology, Inc.
Merck Sharp & Dohme LLC

location_country:
United States
Spain
France

location_facility: Institut Paoli Calmettes - HÃ´pital de jour

location_facility: ALTHAIA, Xarxa Assistencial Universitària de Manresa

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Centre Leon Berard - departement d'oncologie medicale

location_facility: ICANS - Institut de cancérologie de Strasbourg Europe

location_facility: Centre Regional de Lutte Contre le Cancer de Lorraine

location_facility: Hospital Universitario Marqués de Valdecilla


acronym: COBRA

intervention_type: Other

lead_sponsor: LEO Pharma

summary: The trial investigates the efficacy and safety of brodalumab against guselkumab in treatment for patients with moderate-to-severe plaque psoriasis who still have some remaining symptoms after ustekinumab treatment.

location_facility:
LEO Pharma investigational site
LEO Pharma Investigational Site
LEO Pharma Investigational Site 2
Pharma Investigational Site
LEO Pharma Investigational Site 1

title: Efficacy and Safety Comparison of Brodalumab Versus Guselkumab in Adult Subjects With Moderate-to-severe Plaque Psoriasis and Inadequate Response to Ustekinumab

ipd_sharing_description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

location_country:
Germany
Italy
United Kingdom
Sweden
Switzerland
Austria
Belgium
Spain
Greece
France


acronym: CAB And RPV Implementation Study in European Locations

lead_sponsor: ViiV Healthcare

summary: The overall objective of the CAB LA + RPV LA clinical development program is to develop a highly effective, well-tolerated, two-drug, LA injectable regimen which has the potential to offer improved treatment convenience, compliance and improved quality of life for people living with HIV compared to current standard of care. This interventional study will examine different implementation strategies in different clinic settings across European countries to identify strategies which best meet the needs in each local context and involve both participants receiving study treatment CAB LA + RPV LA (patient study participants [PSP]) as well as the healthcare providers at the investigator site level (staff study participants [SSP]). SSPs consists of 2 groups: standard and enhanced arm.

sponsor_collaborators:
ViiV Healthcare
Janssen Pharmaceuticals

title: A Phase IIIb, Open-label, Hybrid Type III Trial Evaluating Implementation Strategies for Long-acting Cabotegravir Plus Long-acting Rilpivirine Every Two Months in HIV-1 Infected, Virologically Suppressed Adults in Select European Healthcare Settings

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country: Germany Netherlands Belgium Spain France


title: A Multicenter Open-label Phase 1/1b Study to Evaluate the Safety and Preliminary Efficacy of SO-C101 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced/Metastatic Solid Tumors

summary: A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors

lead_sponsor: SOTIO Biotech AG

sponsor_collaborators:
SOTIO Biotech AG
SOTIO Biotech a.s.

location_country:
United States
Czechia
Spain
France

location_facility: Hôpitaux Universitaires de Marseille Timone

location_facility: Masarykův Onkologický Ústav Brno Klinika komplexní onkologické péče


lead_sponsor: Novartis Pharmaceuticals

summary: The study is an open-label, single-arm, Phase I/II multi-center study to investigate the PK, activity and safety of ruxolitinib added to the patient's immunosuppressive regimen in infants, children, and adolescents ages ≥28 days to <18 years old with either grade II-IV aGvHD or grade II-IV SR-aGvHD. The trial design includes four age groups: Group 1 includes patients ≥12y to <18y, Group 2 includes patients ≥6y to <12y, Group 3 includes patients ≥2y to <6y, and Group 4 includes patients ≥28days to <2y.

title: A Phase I/II Open-label, Single-arm, Multi-center Study of Ruxolitinib Added to Corticosteroids in Pediatric Patients With Grade II-IV Acute Graft vs. Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Italy
Denmark
Japan
Belgium
Korea, Republic of
Spain
Canada
France


title: Safety and Performance Evaluation of the AccuCinch® Ventricular Restoration System for the Treatment of Heart Failure With or Without Functional Mitral Regurgitation Due to Dilated Ischemic or Non-Ischemic Cardiomyopathy - The CorCinch-EU Study

summary: This is prospective, non-randomized, single-arm, international, multicenter, clinical safety and performance clinical investigation to evaluate the AccuCinch® Ventricular Repair System for the treatment of heart failure, with or without functional mitral regurgitation due to dilated ischemic or non-ischemic cardiomyopathy

lead_sponsor: Ancora Heart, Inc.

location_country:
Belarus
Italy
Lithuania
Poland
United Kingdom
Netherlands
Switzerland
Belgium
Czechia
France

location_facility: Republican Scientific and Practical Centre of Cardiology

location_facility: Vilnius University Hospital Santaros Klinikos


title: Feature Assessment Study for Indications Based Programming

acronym: FASt-IBP

summary: The purpose of this evaluation is to assess the acceptance level of specific programming recommendations based on the patient's clinical needs and primary indications when using the feature 'Indications Based Programming' (IBP) available in the ZOOMVIEW Software Application for the TELIGEN DR / VR and COGNIS family of devices compared to daily life programming chosen by physicians.

lead_sponsor: Boston Scientific Corporation

sponsor_collaborators:
Boston Scientific Corporation
Guidant Corporation

location_country: Germany Slovakia Netherlands Austria Belgium Switzerland China Latvia Spain Greece France

location_facility: Narodny ustav srdcvych a cievnych chorob

location_facility: Praxis Schnabel der Praxisgemeinschaft Kardiologie Meissen

location_facility: Paul Stradina Clinical University Hospital

location_facility: Hartcentrum Hasselt - Dienst Cardiologie

location_facility: EHRU de Brest - Hospital de la Cavale Blanche

location_facility: Hospital Universitario Central de Asturias

location_facility: KH der Barmherzigen Schwestern Ried/Innkreis

location_facility: Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH


title: First International Randomized Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment

summary: The purpose of this study is to determine whether treatment with etoposide, doxorubicin, cisplatin and mitotane (EDP/M) prolongs survival as compared to streptozotocin and mitotane (Sz/M) in patients with advanced adrenocortical carcinoma (ACC) whose disease is not amenable to complete surgical resection.

ReferenceCitation: Fassnacht M, Terzolo M, Allolio B, Baudin E, Haak H, Berruti A, Welin S, Schade-Brittinger C, Lacroix A, Jarzab B, Sorbye H, Torpy DJ, Stepan V, Schteingart DE, Arlt W, Kroiss M, Leboulleux S, Sperone P, Sundin A, Hermsen I, Hahner S, Willenberg HS, Tabarin A, Quinkler M, de la Fouchardiere C, Schlumberger M, Mantero F, Weismann D, Beuschlein F, Gelderblom H, Wilmink H, Sender M, Edgerly M, Kenn W, Fojo T, Muller HH, Skogseid B; FIRM-ACT Study Group. Combination chemotherapy in advanced adrenocortical carcinoma. N Engl J Med. 2012 Jun 7;366(23):2189-97. doi: 10.1056/NEJMoa1200966. Epub 2012 May 2.

lead_sponsor: Collaborative Group for Adrenocortical Carcinoma Treatment

collaborators: German Federal Ministry of Education and Research

location_country:
Germany
Italy
Australia
Sweden
Netherlands
Austria
United States
France

location_facility: Clinica Endocrinologica, Università di Padova, Azienda Ospedaliera di Padova

location_facility: Uppsala University Hospital - Dept of Medical Sciences

location_facility: Zentrum für Innere Medizin - Endokrinologie des Universitätsklinikum Essen

location_facility: Department of Medicine, The Jubileum Institute, Lund University

location_facility: University of Michigan, Department of Internal Medicine

location_facility: Department of Oncology, Sahlgrenska University Hospital

location_facility: University of Munich, Dept. of Internal Medicine (Innenstadt)

location_facility: Otto-von-Guericke University; Dept. of Endocrinology

location_facility: National Cancer Institute - Center for Cancer Research

location_facility: University of Turin, Dept of Internal Medicine

location_facility: Maxima Medisch Centrum; Dept. of Internal Medicine

location_facility: Academisch Medisch Centrum; Dept. of Endocrinology

location_facility: University Hospital Groningen; Dept. of Internal Medine

location_facility: Endokrinologie Medizinische Hochschule Hannover

location_facility: Charité-University, Dept. of Endocrinology; Campus Benjamin Franklin

location_facility: University of Wuerzburg - Dept. of Medicine

location_facility: University of Duesseldorf, Dept. of Endocrrinology

location_facility: Dept of Surgery, Karolinska Hospital, Stockholm

location_facility: Charité-Universitätsmedizin Berlin - Campus Mitte

location_facility: Department of Oncology, Linköping University Hospital


title: Diffuse Large B Cell And Peripheral T-Cell Non-Hodgkin's Lymphoma In The Frail Elderly. Progressive And Cautious Treatment Strategy In Poor Status Patients. A Phase II Trial With Emphasis On Geriatric Assessment And Quality Of Life

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer 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 combination chemotherapy in treating older patients who have non-Hodgkin's lymphoma.

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

location_country:
Portugal
United Kingdom
Netherlands
Switzerland
Belgium
Egypt
France

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Hospitais da Universidade de Coimbra (HUC)


type: Other Grant/Funding Number

title: Spironolactone In The Treatment of Heart Failure- A Double-blind, Randomized, Placebo-controlled, Parallel Group Interventional Phase III Study to Determine Efficacy and Safety of Spironolactone on the Composite Endpoint of Recurrent Heart Failure Hospitalizations and Cardiovascular Death in Patients With Heart Failure With Mid-range or Preserved Ejection Fraction

acronym: SPIRIT-HF

summary: The purpose of this study is to determine whether the treatment of patients with HFmrEF and HFpEF at high risk of cardiovascular events with the mineralocorticoid receptor antagonist (MRA) spironolactone reduces a composite of recurrent heart failure hospitalizations and cardiovascular mortality.

lead_sponsor: Charite University, Berlin, Germany

collaborators: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

collaborators: Ludwig-Maximilians - University of Munich

collaborators: Institute for Cardiovascular Computer-assisted Medicine, Charité

collaborators: Coordinating Centre for Clinical Trials, Charité

location_country: Germany Netherlands Austria Serbia France

location_facility: Praxis Dr. Markus Knapp/Daniela Breuninger

location_facility: Kardiologische Praxis Dr. Wolfgang Jungmair

location_facility: Insitute of Cardiovascular Diseases of Vojvodina

location_facility: Zentrum für klinische Studien Südbrandenburg

location_facility: Kardiologische Praxis Am Park Sanssoucci

location_facility: University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University

location_facility: German Heart Center Berlin, Clinic for Internal Medicine - Cardiology

location_facility: Charité University of Medicine Berlin, CCM

location_facility: Herz- und Diabeteszentrum NRW, Bad Oeynhausen

location_facility: University Hospital Klinikum rechts der Isar (TUM)

location_facility: University Medical Center of Schleswig-Holstein, Campus Kiel

location_facility: University Hospital Munich, Ludwig-Maximilians University

location_facility: Clinical Hospital Center Dr. Dragisa Misovic

location_facility: Heart Center Dresden, Technical University of Dresden

location_facility: Heart Center Leipzig-University Hospital

location_facility: University Hospital Schleswig-Holstein, University Heart Centre Lübeck

location_facility: Groupe Hospitalier de la Rochelle-Ré-Aunis


title: "Prognostic Role of Portal Hypertension Assessed by Non-invasive Methods to Stratify Surgical Risk in Compensated Advanced Chronic Liver Disease Patients Undergoing Elective Extrahepatic Surgery: ELASTOSURGERY STUDY."

summary: The ELASTO-SURGERY study aims to evaluate the prognostic role of portal hypertension evaluated by non-invasive methods in predicting post-operative morbidity (at 90 days) and mortality (at 365 days) in patients with advanced chronic liver disease undergoing elective extrahepatic surgery.

ReferenceCitation: Uyei J, Taddei TH, Kaplan DE, Chapko M, Stevens ER, Braithwaite RS. Setting ambitious targets for surveillance and treatment rates among patients with hepatitis C related cirrhosis impacts the cost-effectiveness of hepatocellular cancer surveillance and substantially increases life expectancy: A modeling study. PLoS One. 2019 Aug 26;14(8):e0221614. doi: 10.1371/journal.pone.0221614. eCollection 2019.

ReferenceCitation: Newman KL, Johnson KM, Cornia PB, Wu P, Itani K, Ioannou GN. Perioperative Evaluation and Management of Patients With Cirrhosis: Risk Assessment, Surgical Outcomes, and Future Directions. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2398-2414.e3. doi: 10.1016/j.cgh.2019.07.051. Epub 2019 Jul 31.

ReferenceCitation: Reverter E, Cirera I, Albillos A, Debernardi-Venon W, Abraldes JG, Llop E, Flores A, Martinez-Palli G, Blasi A, Martinez J, Turon F, Garcia-Valdecasas JC, Berzigotti A, de Lacy AM, Fuster J, Hernandez-Gea V, Bosch J, Garcia-Pagan JC. The prognostic role of hepatic venous pressure gradient in cirrhotic patients undergoing elective extrahepatic surgery. J Hepatol. 2019 Nov;71(5):942-950. doi: 10.1016/j.jhep.2019.07.007. Epub 2019 Jul 19.

ReferenceCitation: Colecchia A, Ravaioli F, Marasco G, Colli A, Dajti E, Di Biase AR, Bacchi Reggiani ML, Berzigotti A, Pinzani M, Festi D. A combined model based on spleen stiffness measurement and Baveno VI criteria to rule out high-risk varices in advanced chronic liver disease. J Hepatol. 2018 Aug;69(2):308-317. doi: 10.1016/j.jhep.2018.04.023. Epub 2018 May 3.

ReferenceCitation: Colecchia A, Montrone L, Scaioli E, Bacchi-Reggiani ML, Colli A, Casazza G, Schiumerini R, Turco L, Di Biase AR, Mazzella G, Marzi L, Arena U, Pinzani M, Festi D. Measurement of spleen stiffness to evaluate portal hypertension and the presence of esophageal varices in patients with HCV-related cirrhosis. Gastroenterology. 2012 Sep;143(3):646-654. doi: 10.1053/j.gastro.2012.05.035. Epub 2012 May 27.

ReferenceCitation: Ma X, Wang L, Wu H, Feng Y, Han X, Bu H, Zhu Q. Spleen Stiffness Is Superior to Liver Stiffness for Predicting Esophageal Varices in Chronic Liver Disease: A Meta-Analysis. PLoS One. 2016 Nov 9;11(11):e0165786. doi: 10.1371/journal.pone.0165786. eCollection 2016.

ReferenceCitation: Cescon M, Colecchia A, Cucchetti A, Peri E, Montrone L, Ercolani G, Festi D, Pinna AD. Value of transient elastography measured with FibroScan in predicting the outcome of hepatic resection for hepatocellular carcinoma. Ann Surg. 2012 Nov;256(5):706-12; discussion 712-3. doi: 10.1097/SLA.0b013e3182724ce8.

ReferenceCitation: Marasco G, Colecchia A, Dajti E, Ravaioli F, Cucchetti A, Cescon M, Festi D. Prediction of posthepatectomy liver failure: Role of SSM and LSPS. J Surg Oncol. 2019 Mar;119(3):400-401. doi: 10.1002/jso.25345. Epub 2018 Dec 18. No abstract available.

lead_sponsor: Azienda Ospedaliera Universitaria Integrata Verona

location_country:
Germany
Italy
United Kingdom
Hong Kong
Denmark
Switzerland
Austria
United States
Korea, Republic of
Spain
Canada
France

location_facility: Hospices Civils de Lyon Hopital Hotel Dieu

location_facility: A.O.U. Città della Salute e della Scienza di Torino

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Clinica di Gastroenterologia ed Epatologia Ancona

location_facility: Gastroenterology Unit - Azienda Ospedaliera Universitaria Sant'Orsola - Malpighi

location_facility: Room Nottingham Digestive Diseases Centre BRU

location_facility: Barcelona Hepatic Hemodynamic Lab. Liver Unit. Hospital Clinic. Barcelona

location_facility: ASUGI Clinica Patologie del Fegato, Clinica Chirurgica

location_facility: hôpital Antoine-Béclère, Hôpitaux Universitaires Paris-Sud, Assistance Publique-Hôpitaux de Paris

location_facility: Gastroenterology Unit, University of Palermo