summary: This is an open-label, multicenter, Phase I/II study to assess the safety, tolerability, and pharmacokinetics of GDC-0032. The Phase I portion will be divided into two stages. During Stage 1, GDC-0032 will be administered every day orally and at escalating doses in participants with locally advanced or metastatic solid tumors. During Stage 2, GDC-0032 will be administered alone or as combination therapy within indication-specific cohorts. In Phase II of the study, the efficacy and safety of the combination GDC-0032 and fulvestrant will be evaluated in post-menopausal female participants with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, hormone receptor-positive breast cancer.

location_facility: University of California Irvine Medical Center

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: Washington University; Division of Oncology

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Vanderbilt Breast Center; Vanderbilt Health Pharmacy

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Florida Cancer Specialists - Fort Myers (New Hampshire Ct)

title: An Open-Label, Phase I/II, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

location_country:
United States
Spain
Canada
France


type: EudraCT Number

title: A Phase Ib, Multicenter, Open-label Study of HCD122 Administered Intravenously in Combination With Bendamustine in Patients With CD40+ Follicular Lymphoma Who Are Refractory to Rituximab

acronym: LIFT

summary: This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with bendamustine in patients with follicular lymphoma.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Australia
Belgium
United States
Spain
Canada
France

location_facility: Duke University Medical Center Duke Hem & Onc

location_facility: Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: International Observational Retrospective Case Review of Efficacy and Safety of Switch Between Agalsidase Beta to Agalsidase Alfa for Enzyme Replacement in Males and Females With Anderson-Fabry Disease

acronym: SWITCH

summary: The current approved treatment for Fabry disease is enzyme replacement therapy (ERT). There are actually 2 products in this therapeutic class available: Replagal® (agalsidase alfa) and Fabrazyme® (agalsidase beta). Both are indicated for long-term treatment in patients with a confirmed diagnosis of Fabry disease (alfa-galactosidase A deficiency). Both have been commercially available in Europe for almost 10 years, yet little information is available about the clinical and safety profile of patients who switch from one therapy to the other. An extended shortage of Fabrazyme® that began in June 2009 has necessitated that a large number of patients switch from Fabrazyme® to Replagal®. This offers the possibility to study the clinical status and adverse events in patients who switch from Fabrazyme® to Replagal® on a large-scale basis. In addition, as a result of the increasing Fabrazyme® shortage, many of these patients received a reduced dosage of Fabrazyme® for an extended period before transitioning to treatment with Replagal®.

study_start_date_type: Actual

study_type: Observational

time_perspective: Other

ReferenceType: background

ReferenceCitation: Rolfs A, Bottcher T, Zschiesche M, Morris P, Winchester B, Bauer P, Walter U, Mix E, Lohr M, Harzer K, Strauss U, Pahnke J, Grossmann A, Benecke R. Prevalence of Fabry disease in patients with cryptogenic stroke: a prospective study. Lancet. 2005 Nov 19;366(9499):1794-6. doi: 10.1016/S0140-6736(05)67635-0. Erratum In: Lancet. 2006 Dec 23;368(9554):2210.

ReferenceCitation: Rolfs A, Martus P, Heuschmann PU, Grittner U, Holzhausen M, Tatlisumak T, Bottcher T, Fazekas F, Enzinger C, Ropele S, Schmidt R, Riess O, Norrving B; sifap1 Investigators. Protocol and methodology of the Stroke in Young Fabry Patients (sifap1) study: a prospective multicenter European study of 5,024 young stroke patients aged 18-55 years. Cerebrovasc Dis. 2011;31(3):253-62. doi: 10.1159/000322153. Epub 2010 Dec 21.

ReferenceCitation: Kint JA. Fabry's disease: alpha-galactosidase deficiency. Science. 1970 Feb 27;167(3922):1268-9. doi: 10.1126/science.167.3922.1268.

ReferenceCitation: Mehta A, Ricci R, Widmer U, Dehout F, Garcia de Lorenzo A, Kampmann C, Linhart A, Sunder-Plassmann G, Ries M, Beck M. Fabry disease defined: baseline clinical manifestations of 366 patients in the Fabry Outcome Survey. Eur J Clin Invest. 2004 Mar;34(3):236-42. doi: 10.1111/j.1365-2362.2004.01309.x.

ReferenceCitation: MacDermot KD, Holmes A, Miners AH. Anderson-Fabry disease: clinical manifestations and impact of disease in a cohort of 98 hemizygous males. J Med Genet. 2001 Nov;38(11):750-60. doi: 10.1136/jmg.38.11.750.

ReferenceCitation: Eng CM, Banikazemi M, Gordon RE, Goldman M, Phelps R, Kim L, Gass A, Winston J, Dikman S, Fallon JT, Brodie S, Stacy CB, Mehta D, Parsons R, Norton K, O'Callaghan M, Desnick RJ. A phase 1/2 clinical trial of enzyme replacement in fabry disease: pharmacokinetic, substrate clearance, and safety studies. Am J Hum Genet. 2001 Mar;68(3):711-22. doi: 10.1086/318809. Epub 2001 Feb 1.

ReferenceCitation: Schiffmann R, Kopp JB, Austin HA 3rd, Sabnis S, Moore DF, Weibel T, Balow JE, Brady RO. Enzyme replacement therapy in Fabry disease: a randomized controlled trial. JAMA. 2001 Jun 6;285(21):2743-9. doi: 10.1001/jama.285.21.2743.

ReferenceCitation: Moore DF, Altarescu G, Herscovitch P, Schiffmann R. Enzyme replacement reverses abnormal cerebrovascular responses in Fabry disease. BMC Neurol. 2002 Jun 18;2:4. doi: 10.1186/1471-2377-2-4.

ReferenceCitation: Schiffmann R, Floeter MK, Dambrosia JM, Gupta S, Moore DF, Sharabi Y, Khurana RK, Brady RO. Enzyme replacement therapy improves peripheral nerve and sweat function in Fabry disease. Muscle Nerve. 2003 Dec;28(6):703-10. doi: 10.1002/mus.10497.

ReferenceCitation: Hoffmann B, Reinhardt D, Koletzko B. Effect of enzyme-replacement therapy on gastrointestinal symptoms in Fabry disease. Eur J Gastroenterol Hepatol. 2004 Oct;16(10):1067-9. doi: 10.1097/00042737-200410000-00020.

ReferenceCitation: Hajioff D, Goodwin S, Quiney R, Zuckerman J, MacDermot KD, Mehta A. Hearing improvement in patients with Fabry disease treated with agalsidase alfa. Acta Paediatr Suppl. 2003 Dec;92(443):28-30; discussion 27. doi: 10.1111/j.1651-2227.2003.tb00217.x.

ReferenceCitation: Hoffmann B, Garcia de Lorenzo A, Mehta A, Beck M, Widmer U, Ricci R; FOS European Investigators. Effects of enzyme replacement therapy on pain and health related quality of life in patients with Fabry disease: data from FOS (Fabry Outcome Survey). J Med Genet. 2005 Mar;42(3):247-52. doi: 10.1136/jmg.2004.025791.

ReferenceCitation: Beck M, Ricci R, Widmer U, Dehout F, de Lorenzo AG, Kampmann C, Linhart A, Sunder-Plassmann G, Houge G, Ramaswami U, Gal A, Mehta A. Fabry disease: overall effects of agalsidase alfa treatment. Eur J Clin Invest. 2004 Dec;34(12):838-44. doi: 10.1111/j.1365-2362.2004.01424.x.

ReferenceCitation: Banikazemi M, Ullman T, Desnick RJ. Gastrointestinal manifestations of Fabry disease: clinical response to enzyme replacement therapy. Mol Genet Metab. 2005 Aug;85(4):255-9. doi: 10.1016/j.ymgme.2005.04.009.

ReferenceCitation: Banikazemi M, Bultas J, Waldek S, Wilcox WR, Whitley CB, McDonald M, Finkel R, Packman S, Bichet DG, Warnock DG, Desnick RJ; Fabry Disease Clinical Trial Study Group. Agalsidase-beta therapy for advanced Fabry disease: a randomized trial. Ann Intern Med. 2007 Jan 16;146(2):77-86. doi: 10.7326/0003-4819-146-2-200701160-00148. Epub 2006 Dec 18.

ReferenceCitation: Ramaswami U, Wendt S, Pintos-Morell G, Parini R, Whybra C, Leon Leal JA, Santus F, Beck M. Enzyme replacement therapy with agalsidase alfa in children with Fabry disease. Acta Paediatr. 2007 Jan;96(1):122-7. doi: 10.1111/j.1651-2227.2007.00029.x.

ReferenceCitation: Ries M, Clarke JT, Whybra C, Timmons M, Robinson C, Schlaggar BL, Pastores G, Lien YH, Kampmann C, Brady RO, Beck M, Schiffmann R. Enzyme-replacement therapy with agalsidase alfa in children with Fabry disease. Pediatrics. 2006 Sep;118(3):924-32. doi: 10.1542/peds.2005-2895.

ipd_sharing: Undecided

lead_sponsor: CENTOGENE GmbH Rostock

location_country:
Germany
United Kingdom
Argentina
Denmark
Belgium
Croatia
Czechia
France

location_facility: National University Hosoital Rigshospitalet, Endokrinologisk ward

location_facility: Royal Free Hospital, Dep. of Academic Haematology, Lysosomal Storage Disorders Unit

location_facility: Université de Versailles - Saint Quentin en YvelinesService de Génétique Médicale

location_facility: University Hospital "Sestre Milosrdnice" Department of neuroimmunology and neurogenetic

location_facility: Unidad Renal Corrientes SRL, Medicina Interna Nefrólogo

location_facility: Kinderklinik München-Schwabing Städt. Klinikum GmbH

location_facility: Miroslava Hajkova, 2nd Dept of Cardiology&Angiology, Fakultni poliklinika

location_facility: Juan Fernandez Hospital, Department of Neurology


title: A Phase 1b/2 Randomized Study of MEDI-575 in Combination With Carboplatin Plus Paclitaxel Versus Carboplatin Plus Paclitaxel Alone in Adult Subjects With Previously Untreated, Advanced Non-Small Cell Lung Cancer

summary: The purpose of this study is to evaluate the dose, antitumor activity, safety and pharmacology of MEDI-575 in combination with carboplatin/paclitaxel in subjects with previously untreated, advanced non-small cell lung cancer (NSCLC).

status: Terminated

design_allocation: Randomized

lead_sponsor: MedImmune LLC

location_country:
Germany
Poland
Hungary
Japan
United States
Canada
France

status_simplified: Unknown


title: Phase III Study of LI [Multikine®] Plus SOC (Surgery + Radiotherapy or Surgery + Concurrent Radiochemotherapy) in Subjects With Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate vs. SOC Only

acronym: IT-MATTERS

summary: The purpose of this study was to determine whether LI administered in combination with cyclophosphamide, indomethacin and zinc in a multivitamin (CIZ) combination prior to standard of care therapy (surgery followed by radiotherapy or concurrent radiochemotherapy) is safe and will increase the overall survival of subjects with previously untreated locally advanced primary squamous cell carcinoma of the oral cavity or soft palate at a median of 3 to 5 years

ipd_sharing: No

ipd_sharing_description: There is no plan

lead_sponsor: CEL-SCI Corporation

collaborators: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Poland
Bosnia and Herzegovina
Thailand
Turkey
Croatia
Canada
Serbia
France
Belarus
Hungary
United States
Sri Lanka
Ukraine
India
Romania
Malaysia
Italy
United Kingdom
Austria
Spain
Taiwan
Russian Federation
Israel

location_facility: Acibadem University Maslak Hospital ENT Department

location_facility: Khon Kaen University Dept of Otolaryngology

location_facility: Zaporiz'ka Regional Clinical Oncology Dispensary

location_facility: Dept of Head and Neck Surgery School of Medical Sciences Univ. Sains

location_facility: Clinic for Stomatology department for maxillofacial Surgery

location_facility: Grigoriev Institute for Medical Radiology of National Academy of Medical Science of Ukraine Dept. of Remote, Combined Radiation and Complex Therapy

location_facility: Samodzielny Publiczny Szpital Kliniczny Klinika Otolarryngologii I Onkologii Laryngologicznej

location_facility: Wojewodzki Szpital Specjalistyczny im Kopernika

location_facility: Weilkopolskie Centrum Onkologii Klinika Chirurgii Glowy Szye Onkologii Laryngologiczne

location_facility: Simmons Cancer Institute at Southern Illinois University

location_facility: Kiev City Clinical Oncology Center of the Main Health Care Dept. of the Kiev Day Hospital

location_facility: Clincal Center Serbia Clinic for Oral and Maxillofacial Surgery

location_facility: N.N. Alexandrov Research Istitute of Oncology and Medical Radiology

location_facility: Sujan Regional Cancer Hospital & Amravati Cancer Foundation

location_facility: Kaohsiung Branch Chang Gung Memorial Hospital

location_facility: University of Pecs Institute of Oncotherapy

location_facility: Kiev City Clinical Oncology Center of the Main Health Care Dept of Kiev Day Hospital Radiotherapy Dept.

location_facility: N.N. Blokhin Russian Cancer Research Center

location_facility: Buddhist Tzu Chi General Hospital, Hualien Branch

location_facility: Medical College Of South Carolina MSC550

location_facility: University of Debrecen Medical and Health Scioence Centre

location_facility: National Cancer Institute Dept of Clinical Oncology & Radiotherapy

location_facility: Kharkiv Regional Clinical Oncology Center Dept. Of Head and Neck Tumour

location_facility: Ospedale S.G. Moscati Santissima Annunziata

location_facility: University of Szeged Dept of Oral and Maxillofacial Surgery

location_facility: Szpital Specialistyczny im. Ludwika Rydgiera

location_facility: Clinical Hospital Center Zagreb Kispaticeva 12

location_facility: Budget Institution of Healthcare of Omsk Region Clincal Oncology Dispensary

location_facility: Serbia Clinic for ENT and Maxillofacial Surgery

location_facility: Clinical Diagnostic Laboratory of Dnepropetrovsk Municipal Institution City Multidisciplinary Clinical Hospital No. 4

location_facility: V.N. Cancer Center G. Kuppuswamy Naidu Memorial Hospital

location_facility: Clinical center Vojvodina Clinic for ORL

location_facility: Meenakshi Mission Hospital and Research Centre

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: Linkou Branch Chang Gung Memorial Hospital

location_facility: VA Puget Sound Healthcare System & University of WA

location_facility: Lviv State OncologyRegional treatment and Diagnostic Center

location_facility: Hospital Madrid North Universitaro de Sanchinnaro

location_facility: HNO-Klinik der medizinischen Universitat Graz

location_facility: Henry Ford Health System Henry Ford Hospital

location_facility: Haceteppe University Dept of Otolaryngology - Head and Neck Surgery

location_facility: St. Josephs Healthcare Department of Surgery

location_facility: Uniwersitecki Szpital Kliniczny Klinika Otolaryngologii Chirugii Glowy i Szxyi

location_facility: Sumy Regional Clinical Oncology Dyspensary

location_facility: Military Medical Academy Clinic for Maxillofacial Surgery

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Consorsio Hospital General Universitario de valencia

location_facility: Centrum Onkologi-Instytut im. Marie Sklodowskiej-Curie

location_facility: Clinical Centre Vojvodina Clinic for Maxillofacial Surgery

location_facility: Clinical Centre University of Sarejevo Clinic for ENT

location_facility: Faculty of Dental Medicine Clinic for Maxillofacial Surgery

location_facility: Cherkasky Regional Oncological Dyspensary Dept. Head and Neck tumour

location_facility: Oncology Unit Teaching Hospital Karapitya


title: A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer

acronym: BAGPAC

summary:
Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.

Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.

Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints: response duration, disease control rate, time to progression, progression-free survival, overall survival, safety and tolerability.

Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and weekly throughout the study; Safety follow-up visit 30 days after the last dose of study treatment; Survival follow up monthly for up to 8 month after LPFV.

lead_sponsor: Bayer

location_country:
Germany
Italy
Poland
Norway
United Kingdom
Belgium
United States
Czechia
France


intervention_type: Biological

lead_sponsor: Ipsen

summary: The purpose of this research study was to determine the long term safety and efficacy of repeated treatments with Dysport® used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy.

location_facility: Non-public Healthcare Unit Mazovian Neurorehabilitatio

location_facility: Centro de Rehabilitacion Integral de Queretaro (CRIQ)

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Gillette Children's Speciality Healthcare

location_facility: Non-public Healthcare Unit at the Association for Disabled People KROK PO KROKU

location_facility: Yildirim Beyazit Training and Research Hospital

location_facility: Club De Leones Cruz Del Sur Rehabilitation Corporation Punta Arenas

location_facility: Neurorehabilitation Laboratory, Pontifical Catholic University

location_facility: Ghulane Military Medical Academy and School of Medicine

location_facility: Texas Scottish Rite - Hospital for Children

location_facility: Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastirma Hastanesi

location_facility: Non-public Healthcare Unit - Grunwaldzka Clinic

title: A Phase III, Prospective, Multicentre, Open Label, Extension Study Assessing the Long Term Safety and Efficacy of Repeated Treatment With DYSPORT® Used in the Treatment of Lower Limb Spasticity in Children With Dynamic Equinus Foot Deformity Due to Cerebral Palsy

source: euctr

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.

location_country:
Poland
Mexico
United States
Turkey
Chile
France

ipd_sharing: Yes


summary: The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy. In addition this study will also check whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.

location_facility: Club De Leones Cruz Del Sur Rehabilitation Corporation, Punta Arenas

location_facility: Hospital Central Dr Ignacio Morones Prieto

title: A Phase III, Multicentre, Double Blind, Prospective, Randomised, Placebo Controlled Study Assessing the Efficacy and Safety of DYSPORT® Used in the Treatment of Lower Limb Spasticity in Children With Dynamic Equinus Foot Deformity Due to Cerebral Palsy


title: Optimization of Treatment and Management of Schizophrenia in Europe

acronym: OPTIMISE

summary: The purpose of the study is optimising current treatments in schizophrenia and explore novel therapeutic options for schizophrenia. The study intends to both address basic, but so far unanswered, questions in the treatment of schizophrenia and develop new interventions. It is expected that the project will lead to evidence that is directly applicable to treatment guidelines, and will identify potential mechanisms for new drug development.

ReferenceType: derived

ReferenceCitation: Fraguas D, Diaz-Caneja CM, Pina-Camacho L, Winter van Rossum I, Baandrup L, Sommer IE, Glenthoj B, Kahn RS, Leucht S, Arango C. The role of depression in the prediction of a "late" remission in first-episode psychosis: An analysis of the OPTiMiSE study. Schizophr Res. 2021 May;231:100-107. doi: 10.1016/j.schres.2021.03.010. Epub 2021 Apr 7.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

version: publishedVersion

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

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: Pollak TA, Vincent A, Iyegbe C, Coutinho E, Jacobson L, Rujescu D, Stone J, Jezequel J, Rogemond V, Jamain S, Groc L, David A, Egerton A, Kahn RS, Honnorat J, Dazzan P, Leboyer M, McGuire P. Relationship Between Serum NMDA Receptor Antibodies and Response to Antipsychotic Treatment in First-Episode Psychosis. Biol Psychiatry. 2021 Jul 1;90(1):9-15. doi: 10.1016/j.biopsych.2020.11.014. Epub 2020 Nov 24. Erratum In: Biol Psychiatry. 2021 Jul 1;90(1):69.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

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

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repository_institution: University of Sussex - Sussex Research Online

version: acceptedVersion

repositories:
HAL
PubMed Central
UCL Discovery
sro.sussex.ac.uk

unpaywall_oa_status: hybrid

ReferenceCitation: Kahn RS, Winter van Rossum I, Leucht S, McGuire P, Lewis SW, Leboyer M, Arango C, Dazzan P, Drake R, Heres S, Diaz-Caneja CM, Rujescu D, Weiser M, Galderisi S, Glenthoj B, Eijkemans MJC, Fleischhacker WW, Kapur S, Sommer IE; OPTiMiSE study group. Amisulpride and olanzapine followed by open-label treatment with clozapine in first-episode schizophrenia and schizophreniform disorder (OPTiMiSE): a three-phase switching study. Lancet Psychiatry. 2018 Oct;5(10):797-807. doi: 10.1016/S2215-0366(18)30252-9. Epub 2018 Aug 13.

repository_institution: King's College London - Research Portal

version: submittedVersion

lead_sponsor: Rene Kahn

collaborators: Ludwig-Maximilians - University of Munich

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Denmark
Australia
Romania
Netherlands
Austria
Belgium
Switzerland
Spain
Czechia
Bulgaria
France

location_facility: Martin-Luther-University (MLU) of Halle-Wittenberg

location_facility: Katholieke Universiteit Leuven (KU Leuven)

location_facility: Department of Adult Psychiatry, University of Medical Sciences

location_facility: Sheba Medical Centre Department of Psychiatry

location_facility: Department of Psychiatry University of Naples

location_facility: Department of Biological Psychiatry, Innsbruck University Clinics

location_facility: University Specialised Hospital for Active Treatment in Neurology and Psychiatry "St. Naum"

location_facility: King's College London, Departments of Psychological Medicine, Psychiatry & Cognitive Neuroscience

location_facility: Psychiatrická klinika LF UK, Fakultní nemocnice

location_facility: Clienia Schlössli AG, Privatklinik für Psychiatrie und Psychotherapie

location_facility: Instituto de Investigación Hospital 12 de Octubre

location_facility: Institut National de la Santé et de la Reserche Médicale (INSERM)

location_facility: Deprtment of Psychiatry, University of Heidelberg


title: (OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis

acronym: OSKIRA-X

summary: The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).

study_completion_date_type: Anticipated

lead_sponsor: AstraZeneca

location_country:
Germany
Poland
Argentina
Australia
Brazil
Chile
Canada
Serbia
France
Czech Republic
Lithuania
Colombia
Portugal
Slovakia
Hungary
United States
Latvia
Ukraine
India
Romania
Belgium
Peru
Estonia
Italy
United Kingdom
Mexico
Spain
South Africa
Bulgaria
Russian Federation
Israel


title: Multicenter Study on Use and Interpretation of Adrenal Vein Sampling

acronym: AVIS

summary:
The AVIS Study is a retrospective multicenter international study that aims to answer a series of questions on the use and performance of adrenal venous catheterization (AVS) for the diagnosis of primary hyperaldosteronism subtype. A questionnaire will be circulated among the centres that are internationally recognized and have published in the field of AVS and have agreed to participate in the study.

The first aim of the AVIS study is to collect summary data on how AVS is being performed throughout the world to answer the following questions:

How many AVS studies haw been performed yearly from 2005 to 2010 at each center?
How many adrenal vein ruptures occurred during the AVS at each center?Has the rate of adrenal vein rupture been steady or has it changed over the 5 years?
How many centers use bilaterally simultaneous and how many use sequential AVS catheterization?
How many radiologists perform AVS at each center?
How many centers use a cosyntropin stimulation during AVS?
What is the percentage of PA patients in whom AVS is performed?
How many centres calculate the selectivity index? What is the minimum cutoff used?
How many centers calculate the lateralization index? What is the minimum cutoff used?
Are the AVS studies that are not bilaterally selective used for diagnosis?
How many centers calculate the controlateral suppression index and what is the minimum cutoff used?
What is the cost of AVS for the National Health System or Insurance and for patients? The second aim of the study is to calculate the rate of AVS studies that are selective and show lateralization of aldosterone excess at each center by applying predefined set of criteria for defining selectivity and lateralization. Data on the final diagnosis of the PA subtype will be gathered and used as reference to assess the performance of AVS using receiver operating characteristic curves analysis and the Youden index to determine the optimal cutoffs. A worksheet will need to be completed providing information on the following: Demography; Date of AVS;Baseline blood pressure (BP) values and serum K+;Dynamic test during the AVS if any; plasma aldosterone and cortisol concentration in the infra-adrenal inferior vena cava and in the right and left adrenal vein; diagnosis of PA subtype; treatment (adrenalectomy or pharmacological therapy); post-treatment BP and serum K+ values; concordance/discordance between imaging (CT or RM) and AVS.

time_perspective: Retrospective

ReferenceCitation: Funder J, Carey R, Fardella C, Gomez-Sanchez C, Mantero F, Stowasser M, Young W, Montori VM. Withdrawn: Case detection, diagnosis, and treatment of patients with primary aldosteronism: an Endocrine Society clinical practice guideline. Eur J Endocrinol. 2009 Sep 30. doi: 10.1530/EJE-09-0870. Online ahead of print.

ReferenceCitation: Stewart PM, Allolio B. Adrenal vein sampling for Primary Aldosteronism: time for a reality check. Clin Endocrinol (Oxf). 2010 Feb;72(2):146-8. doi: 10.1111/j.1365-2265.2009.03714.x. Epub 2009 Sep 21. No abstract available.

ReferenceCitation: Seccia TM, Miotto D, De Toni R, Pitter G, Mantero F, Pessina AC, Rossi GP. Adrenocorticotropic hormone stimulation during adrenal vein sampling for identifying surgically curable subtypes of primary aldosteronism: comparison of 3 different protocols. Hypertension. 2009 May;53(5):761-6. doi: 10.1161/HYPERTENSIONAHA.108.128553. Epub 2009 Apr 6.

ReferenceCitation: Rossi GP, Pitter G, Bernante P, Motta R, Feltrin G, Miotto D. Adrenal vein sampling for primary aldosteronism: the assessment of selectivity and lateralization of aldosterone excess baseline and after adrenocorticotropic hormone (ACTH) stimulation. J Hypertens. 2008 May;26(5):989-97. doi: 10.1097/HJH.0b013e3282f9e66a.

ReferenceCitation: Mulatero P, Bertello C, Sukor N, Gordon R, Rossato D, Daunt N, Leggett D, Mengozzi G, Veglio F, Stowasser M. Impact of different diagnostic criteria during adrenal vein sampling on reproducibility of subtype diagnosis in patients with primary aldosteronism. Hypertension. 2010 Mar;55(3):667-73. doi: 10.1161/HYPERTENSIONAHA.109.146613. Epub 2010 Feb 1.

ReferenceCitation: Auchus RJ, Wians FH Jr, Anderson ME, Dolmatch BL, Trimmer CK, Josephs SC, Chan D, Toomay S, Nwariaku FE. What we still do not know about adrenal vein sampling for primary aldosteronism. Horm Metab Res. 2010 Jun;42(6):411-5. doi: 10.1055/s-0030-1252060. Epub 2010 Apr 21.

ReferenceCitation: Nishikawa T, Saito J, Omura M. Adrenal venous sampling is absolutely requisite for definitively diagnosing primary aldosteronism as well as for detecting laterality of the adrenal lesion. Hypertens Res. 2007 Nov;30(11):1009-10. doi: 10.1291/hypres.30.1009. No abstract available.

ReferenceCitation: Rossi GP, Crimi F, Rossitto G, Amar L, Azizi M, Riester A, Reincke M, Degenhart C, Widimsky J, Naruse M, Deinum J, Kool LS, Kocjan T, Negro A, Rossi E, Kline G, Tanabe A, Satoh F, Rump LC, Vonend O, Willenberg HS, Fuller PJ, Yang J, Chee NYN, Magill SB, Shafigullina Z, Quinkler M, Oliveras A, Wu VC, Kratka Z, Barbiero G, Battistel M, Seccia TM. Feasibility of Imaging-Guided Adrenalectomy in Young Patients With Primary Aldosteronism. Hypertension. 2022 Jan;79(1):187-195. doi: 10.1161/HYPERTENSIONAHA.121.18284. Epub 2021 Nov 17.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Rossi GP, Crimi F, Rossitto G, Amar L, Azizi M, Riester A, Reincke M, Degenhart C, Widimsky J, Naruse M, Deinum J, Schultze Kool L, Kocjan T, Negro A, Rossi E, Kline G, Tanabe A, Satoh F, Christian Rump L, Vonend O, Willenberg HS, Fuller PJ, Yang J, Chee NYN, Magill SB, Shafigullina Z, Quinkler M, Oliveras A, Cent Wu V, Kratka Z, Barbiero G, Seccia TM, Battistel M. Identification of Surgically Curable Primary Aldosteronism by Imaging in a Large, Multiethnic International Study. J Clin Endocrinol Metab. 2021 Oct 21;106(11):e4340-e4349. doi: 10.1210/clinem/dgab482.

evidence: open (via free article)

publisher_dissemination: The Endocrine Society

ReferenceCitation: Rossitto G, Amar L, Azizi M, Riester A, Reincke M, Degenhart C, Widimsky J, Naruse M, Deinum J, Schultzekool L, Kocjan T, Negro A, Rossi E, Kline G, Tanabe A, Satoh F, Rump LC, Vonend O, Willenberg HS, Fuller P, Yang J, Nian Chee NY, Magill SB, Shafigullina Z, Quinkler M, Oliveras A, Chang CC, Wu VC, Somloova Z, Maiolino G, Barbiero G, Battistel M, Lenzini L, Quaia E, Pessina AC, Rossi GP. Subtyping of Primary Aldosteronism in the AVIS-2 Study: Assessment of Selectivity and Lateralization. J Clin Endocrinol Metab. 2020 Jun 1;105(6):dgz017. doi: 10.1210/clinem/dgz017.

oa_colors: green other

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

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

repository_institution: The University of Glasgow - Enlighten: Publications

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

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

ReferenceCitation: Rossi GP, Rossitto G, Amar L, Azizi M, Riester A, Reincke M, Degenhart C, Widimsky J Jr, Naruse M, Deinum J, Schultze Kool L, Kocjan T, Negro A, Rossi E, Kline G, Tanabe A, Satoh F, Christian Rump L, Vonend O, Willenberg HS, Fuller PJ, Yang J, Chee NYN, Magill SB, Shafigullina Z, Quinkler M, Oliveras A, Dun Wu K, Wu VC, Kratka Z, Barbiero G, Battistel M, Chang CC, Vanderriele PE, Pessina AC. Clinical Outcomes of 1625 Patients With Primary Aldosteronism Subtyped With Adrenal Vein Sampling. Hypertension. 2019 Oct;74(4):800-808. doi: 10.1161/HYPERTENSIONAHA.119.13463. Epub 2019 Sep 3.

ReferenceCitation: Rossi GP, Barisa M, Allolio B, Auchus RJ, Amar L, Cohen D, Degenhart C, Deinum J, Fischer E, Gordon R, Kickuth R, Kline G, Lacroix A, Magill S, Miotto D, Naruse M, Nishikawa T, Omura M, Pimenta E, Plouin PF, Quinkler M, Reincke M, Rossi E, Rump LC, Satoh F, Schultze Kool L, Seccia TM, Stowasser M, Tanabe A, Trerotola S, Vonend O, Widimsky J Jr, Wu KD, Wu VC, Pessina AC. The Adrenal Vein Sampling International Study (AVIS) for identifying the major subtypes of primary aldosteronism. J Clin Endocrinol Metab. 2012 May;97(5):1606-14. doi: 10.1210/jc.2011-2830. Epub 2012 Mar 7.

lead_sponsor: University Hospital Padova

location_country:
Germany
Italy
Australia
Japan
Netherlands
United States
Taiwan
Canada
Czech Republic
France

location_facility: Institute of Clinical Endocrinology, Tokyo Women's Medical University

location_facility: Radboud University Nijmegen Medical Center

location_facility: Centre Hospitalier de l'Université de Montreal (CHUM)

location_facility: Hospital of The University of Pennsylvania, Philadelphia

location_facility: Foothills Medical Centre, University of Calgary

location_facility: University of Paris, Hopital Européen Georges Pompidou

location_facility: National Hospital Organizatio, Kyoto Medical Center

location_facility: Medicina 2, Dipartimento di Medicina Interna e Specialità Mediche, Azienda Ospedaliera Santa Maria Nuova

location_facility: Endocrine Hypertension Research Centre, University of Queensland School of Medicine, Greenslopes Hospital

location_facility: Dept Clinical and Experimental Medicine (DMCS), University Hospital of Padova, Italy

lead_sponsor_type: academique


title: A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors

summary: This rollover study is designed to provide continued access to GSK2118436 for eligible subjects with BRAF mutation-positive tumors who have previously participated in a GlaxoSmithKline (GSK)-sponsored GSK2118436 study (parent study), who have no evidence of progressive disease and who have tolerated GSK2118436 in the parent study without significant toxicities. Subjects will be enrolled into the appropriate cohort based upon the treatment received in their parent study. Safety assessments (physical examinations, vital signs, 12-lead electrocardiograms, echocardiograms, clinical laboratory assessments, and monitoring of adverse events) will be made throughout the study. Clinical activity will be assessed using local standard of care imaging practices and the appropriate response criteria as determined by the investigator.

location_country:
Germany
Italy
Poland
United Kingdom
Australia
United States
Spain
Canada
France


title: A Phase 3 Multi-Center Parallel Design Clinical Trial to Compare the Efficacy and Safety of 5% Minoxidil Foam vs. Vehicle in Females for the Treatment of Female Pattern Hair Loss (Androgenetic Alopecia)

summary: This is a six month clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation applied once a day versus a topical foam vehicle (placebo) formulation applied once a day.

lead_sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

collaborators: Johnson & Johnson Consumer and Personal Products Worldwide

location_country:
United States
United Kingdom
Germany
France

location_facility: Clinical Research Center for Hair and Skin Science Universitätsmedizin Berlin

location_facility: Hôpital Saint Jacques Service de Dermatologie


type: Other Identifier

title: A Cluster Randomized Trial Comparing a Conservative Management and Primary Laser Surgery

summary: The objective of this trial is to compare both strategies (Expectative Vs Fetoscopic laser surgery) for patients with stage 1 TTTS and favorable obstetrical parameters in an international randomized controlled trial. This trial will answer an important question and will help in the management and tailoring of surgical indications in stage 1 TTTS.

ReferenceCitation: Stirnemann J, Slaghekke F, Khalek N, Winer N, Johnson A, Lewi L, Massoud M, Bussieres L, Aegerter P, Hecher K, Senat MV, Ville Y. Intrauterine fetoscopic laser surgery versus expectant management in stage 1 twin-to-twin transfusion syndrome: an international randomized trial. Am J Obstet Gynecol. 2021 May;224(5):528.e1-528.e12. doi: 10.1016/j.ajog.2020.11.031. Epub 2020 Nov 26.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: Leiden University - Leiden Repository

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_country:
United States
Canada
France

location_facility: Mount Sinai Hospital, University of Toronto

location_facility: The Texas Fetal Center, Children's Memorial Hermann Hospital, University of Texas Medical School

location_facility: Fetal Care Center of Cincinnati, Cincinnati Children's Hospital Medical Center

location_facility: Children's Hospital Colorado and Colorado Fetal Care Center

location_facility: Fetal Diagnosis and Treatment, The Children's Hospital of Philadelphia

location_facility: The Ohio State University / OSU Fetal Therapy Program

location_facility: University of MD /Department of Obstetrics, Gynecology & Reproductive Sciences

location_facility: Fetal Treatment Program of New England, Hasbro Children's Hospital, The Warren Alpert Medical School of Brown University.

location_facility: Fetal Therapy Program, Evergrenn Hospital Medical Center

intervention_type: Procedure


title: Retrospective Cohort Study of Rebif® Use in Pediatric MS Patients

acronym: REPLAY

summary: The aim of this retrospective study is to review and describe safety, tolerability and efficacy of Rebif® (subcutaneous interferon [IFN]-beta-1a) in children and adolescents, using information already recorded in medical records. The study duration is 13 July 2010 (first data collected) to 13 July 2011 (last data collected). In this study, Data of the subjects evaluated between 1997 and 2009 was observed.

lead_sponsor: EMD Serono

location_country:
Italy
Venezuela
Argentina
Tunisia
United States
Canada
Russian Federation
France


title: A Phase Ib, Double Blind RCT to Evaluate and Compare the PK, PD and Safety of MabThera® With TL011, in Combination With CHOP, in Subjects With CD20+ DLBCL

summary: This is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of MabThera® and TL011, in combination with CHOP in previously untreated patients with diffuse large B cell lymphoma.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Italy
Poland
Hungary
Latvia
Spain
Ukraine
Bulgaria
Estonia
Russian Federation
France

location_facility:
Teva Investigational Site 58013
Teva Investigational Site 58011
Teva Investigational Site 50017
Teva Investigational Site 30001
Teva Investigational Site 56003
Teva Investigational Site 51026
Teva Investigational Site 50012
Teva Investigational Site 31005
Teva Investigational Site 59005
Teva Investigational Site 55002
Teva Investigational Site 30002
Teva Investigational Site 50010
Teva Investigational Site 31001
Teva Investigational Site 31003
Teva Investigational Site 35066
Teva Investigational Site 56001
Teva Investigational Site 50004
Teva Investigational Site 55001
Teva Investigational Site 50001
Teva Investigational Site 50006
Teva Investigational Site 53010
Teva Investigational Site 58017
Teva Investigational Site 50003
Teva Investigational Site 50011
Teva Investigational Site 50009
Teva Investigational Site 31004
Teva Investigational Site 31002
Teva Investigational Site 59001
Teva Investigational Site 50005
Teva Investigational Site 59002
Teva Investigational Site 59003
Teva Investigational Site 31006
Teva Investigational Site 58010
Teva Investigational Site 58016
Teva Investigational Site 58012
Teva Investigational Site 56002
Teva Investigational Site 58015
Teva Investigational Site 58014
Teva Investigational Site 59004
Teva Investigational Site 50015
Teva Investigational Site 50014


title: A Randomised, Double-blind, Parallel-group, Placebo Controlled Induction Trial to Assess the Clinical Efficacy and Safety of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease

summary: This trial is conducted in Europe and North America. The aim of the trial is to assess disease activity and safety in subjects with moderately to severely active Crohn's disease (CD) when treated with NNC 0142-0000-0002.

ReferenceCitation: Allez M, Skolnick BE, Wisniewska-Jarosinska M, Petryka R, Overgaard RV. Anti-NKG2D monoclonal antibody (NNC0142-0002) in active Crohn's disease: a randomised controlled trial. Gut. 2017 Nov;66(11):1918-1925. doi: 10.1136/gutjnl-2016-311824. Epub 2016 Aug 3.

oa_host_type: closed

publisher_dissemination: British Medical Journal

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Hungary
Israel
Belgium
United States
Canada
Russian Federation
France


acronym: OSKIRA - 3

summary: The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate and have had an inadequate response to a single TNF-alpha antagonist. The study will last for approximately six months.

title: (OSKIRA-3): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With Inadequate Response to a TNF-alpha Antagonist

location_country:
France
Germany
Italy
Portugal
Hungary
Argentina
Israel
United Kingdom
Brazil
Mexico
Belgium
United States
Spain
South Africa
Canada
Czech Republic


acronym: A-LONG

lead_sponsor: Bioverativ Therapeutics Inc.

summary: The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm 1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical treatment regimen. The secondary objectives of this study are: to characterize the PK profile of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to characterize the range of dose and schedules required to adequately prevent bleeding in a prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes in an on-demand, weekly treatment, or prophylaxis setting.

ReferenceType: result

ReferenceCitation: Mahlangu J, Powell JS, Ragni MV, Chowdary P, Josephson NC, Pabinger I, Hanabusa H, Gupta N, Kulkarni R, Fogarty P, Perry D, Shapiro A, Pasi KJ, Apte S, Nestorov I, Jiang H, Li S, Neelakantan S, Cristiano LM, Goyal J, Sommer JM, Dumont JA, Dodd N, Nugent K, Vigliani G, Luk A, Brennan A, Pierce GF; A-LONG Investigators. Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. Blood. 2014 Jan 16;123(3):317-25. doi: 10.1182/blood-2013-10-529974. Epub 2013 Nov 13.

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

publisher_dissemination: American Society of Hematology

ReferenceCitation: Shapiro AD, Ragni MV, Kulkarni R, Oldenberg J, Srivastava A, Quon DV, Pasi KJ, Hanabusa H, Pabinger I, Mahlangu J, Fogarty P, Lillicrap D, Kulke S, Potts J, Neelakantan S, Nestorov I, Li S, Dumont JA, Jiang H, Brennan A, Pierce GF. Recombinant factor VIII Fc fusion protein: extended-interval dosing maintains low bleeding rates and correlates with von Willebrand factor levels. J Thromb Haemost. 2014 Nov;12(11):1788-800. doi: 10.1111/jth.12723. Epub 2014 Oct 10.

ReferenceCitation: Katragadda S, Neelakantan S, Diao L, Wong N. Population Pharmacokinetic Analysis of Recombinant Factor VIII Fc Fusion Protein in Subjects With Severe Hemophilia A: Expanded to Include Pediatric Subjects. J Clin Pharmacol. 2021 Jul;61(7):889-900. doi: 10.1002/jcph.1854. Epub 2021 Apr 14.

publisher_dissemination: Wiley

sponsor_collaborators:
Bioverativ Therapeutics Inc.
Swedish Orphan Biovitrum

title: A-LONG: An Open-Label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia A

location_country:
Germany
New Zealand
Australia
Brazil
Japan
Canada
France
Hong Kong
Switzerland
United States
India
Belgium
Italy
United Kingdom
Sweden
Austria
Spain
South Africa
Israel


lead_sponsor: Pfizer

summary: This study will compare the effectiveness and safety of two different doses of temsirolimus (Torisel).

location_facility: Spitalul Universitar de Urgenta Bucuresti, Clinica de Hematologie

location_facility: Veterans Affairs New Jersey Healthcare System-Hematology/Oncology Section (111)

location_facility: Presidio Ferrarotto - A.O.U. - PoliclinicoVittorio Emanuele

location_facility: Institutul Clinic Fundeni Bucuresti, Sectia II Hematologie

location_facility: Dipartimento di Medicina Diagnostica, Clinica e di Sanità Pubblica

location_facility: Mercy Hospital Oklahoma City-Oncology Infusion

location_facility: Klinik fuer Onkologie und Haematologie, Medizinische Klinik IV

location_facility: Klinikum Johannes-Gutenberg -Universitaet, III. Medizinische Klinik und Poliklinik

location_facility: Struttura Complessa di Ematologia, Dipartimento di Oncologia ed Ematologia-

location_facility: Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva

location_facility: Republican Clinical Oncology Dispensary of the Ministry of Healthcare of Tatarstan Republic

location_facility: Spitalul Clinic Coltea, Clinica de Hematologie

location_facility: GBOU VPO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov"

location_facility: Clinical Centre of Serbia,Clinic for Hematology

location_facility: Mercy Clinic Oklahoma Communities dba Mercy Clinic Oncology/Hematology-McAuley

title: A RANDOMIZED PHASE 4 STUDY COMPARING 2 INTRAVENOUS TEMSIROLIMUS (TEMSR) REGIMENS IN SUBJECTS WITH RELAPSED, REFRACTORY MANTLE CELL LYMPHOMA

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:
Germany
Italy
Poland
Romania
Australia
United States
Korea, Republic of
Czechia
Serbia
Russian Federation
France


summary: The purpose of this study was to determine whether, in patients with mild to moderate knee osteoarthritis, canakinumab is safe and tolerable when injected intra-articularly.

location_facility: Rush-Presbyterian St. Lukes Medical Center

location_facility: Cotton O'Neil Clinical Research Institute

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: San Diego Arthritis & Osteoporosis Medical Clinic

title: A Randomized, Double Blind, Placebo and Naproxen Controlled, Multi-center, Study to Determine the Safety, Tolerability, Pharmacokinetics and Effect on Pain of a Single Intra-articular Administration of Canakinumab in Patients With Osteoarthritis in the Knee

location_country:
United States
Germany
Finland
France


title: A Phase II, Single-blind, Randomized, Placebo-controlled Trial to Study the Efficacy and Safety of Anti-von Willebrand Factor Nanobody Administered as Adjunctive Treatment to Patients With Acquired Thrombotic Thrombocytopenic Purpura

acronym: TITAN

summary:
This study was a Phase II, single-blind, randomized, placebo-controlled trial to determine whether anti-vWF Nanobody is safe and effective as adjunctive treatment in patients with aTTP.

Patients received either placebo or anti-vWF Nanobody as adjunctive therapy to plasma exchange (PE).

ReferenceCitation: Peyvandi F, Cataland S, Scully M, Coppo P, Knoebl P, Kremer Hovinga JA, Metjian A, de la Rubia J, Pavenski K, Minkue Mi Edou J, De Winter H, Callewaert F. Caplacizumab prevents refractoriness and mortality in acquired thrombotic thrombocytopenic purpura: integrated analysis. Blood Adv. 2021 Apr 27;5(8):2137-2141. doi: 10.1182/bloodadvances.2020001834.

ReferenceCitation: Peyvandi F, Scully M, Kremer Hovinga JA, Cataland S, Knobl P, Wu H, Artoni A, Westwood JP, Mansouri Taleghani M, Jilma B, Callewaert F, Ulrichts H, Duby C, Tersago D; TITAN Investigators. Caplacizumab for Acquired Thrombotic Thrombocytopenic Purpura. N Engl J Med. 2016 Feb 11;374(6):511-22. doi: 10.1056/NEJMoa1505533.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: University of Bern - Bern Open Repository and Information System

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Holz JB. The TITAN trial--assessing the efficacy and safety of an anti-von Willebrand factor Nanobody in patients with acquired thrombotic thrombocytopenic purpura. Transfus Apher Sci. 2012 Jun;46(3):343-6. doi: 10.1016/j.transci.2012.03.027. Epub 2012 Apr 3.

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: Ablynx, a Sanofi company

location_country:
Germany
Italy
Israel
United Kingdom
Romania
Australia
Switzerland
Austria
Belgium
United States
Spain
Bulgaria
France


acronym: PALLAS

lead_sponsor: Sanofi

summary:
Primary Objective:

Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation [AF] and additional risk factors

Secondary Objective:

Demonstrate the efficacy of Dronedarone in preventing cardiovascular death

This was an event-driven study where a common study end date [CSED] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).

ReferenceCitation: Connolly SJ, Camm AJ, Halperin JL, Joyner C, Alings M, Amerena J, Atar D, Avezum A, Blomstrom P, Borggrefe M, Budaj A, Chen SA, Ching CK, Commerford P, Dans A, Davy JM, Delacretaz E, Di Pasquale G, Diaz R, Dorian P, Flaker G, Golitsyn S, Gonzalez-Hermosillo A, Granger CB, Heidbuchel H, Kautzner J, Kim JS, Lanas F, Lewis BS, Merino JL, Morillo C, Murin J, Narasimhan C, Paolasso E, Parkhomenko A, Peters NS, Sim KH, Stiles MK, Tanomsup S, Toivonen L, Tomcsanyi J, Torp-Pedersen C, Tse HF, Vardas P, Vinereanu D, Xavier D, Zhu J, Zhu JR, Baret-Cormel L, Weinling E, Staiger C, Yusuf S, Chrolavicius S, Afzal R, Hohnloser SH; PALLAS Investigators. Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med. 2011 Dec 15;365(24):2268-76. doi: 10.1056/NEJMoa1109867. Epub 2011 Nov 14. Erratum In: N Engl J Med. 2012 Feb 16;366(7):672.

ReferenceCitation: Hohnloser SH, Halperin JL, Camm AJ, Gao P, Radzik D, Connolly SJ; PALLAS investigators. Interaction between digoxin and dronedarone in the PALLAS trial. Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1019-25. doi: 10.1161/CIRCEP.114.002046. Epub 2014 Nov 6.

title: A Randomized, Double Blind, Placebo Controlled, Parallel Group Trial for Assessing the Clinical Benefit of Dronedarone 400mg BID on Top of Standard Therapy in Patients With Permanent Atrial Fibrillation and Additional Risk Factors

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Chile
Canada
France
Czech Republic
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
Romania
Belgium
Malaysia
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: DECAAF: DE-MRI Determinant of Successful Radiofrequency Catheter Ablation of Atrial Fibrillation

acronym: DECAAF

summary:
This is a multi-center, observational, 1-year prospective cohort study (1 year follow-up, at 3, 6 and 12 month) with approximately 675 participants. We will conduct a thorough outcomes assessment utilizing data from Magnetic Resonance Imaging (MRI) scans, as well as pre-procedure and follow-up data. Scans will be blinded to location of participating site. MRI scans will be sequenced and analyzed as they arrive from the database.

Imaging Protocol: All patients will undergo a Delayed-Enhancement MRI (DE-MRI) within 30 days prior to the atrial fibrillation (AF) ablation procedure. The purpose of the initial MRI is to quantify the degree of atrial structural remodeling or fibrosis pre-ablation. Following ablation, DE-MRI will be obtained at 3, 6, and 12 months follow-up to detect and quantify ablation-related scar formation.

Clinical Follow-up: The institution where the ablation was performed will continue post-procedural care following standard of care procedures.

Atrial arrhythmia recurrences will be catalogued up to one year post-ablation and predictors of recurrences of AF will be determined by statistical analysis. The specific mechanism and electrophysiological characteristics of atrial arrhythmia recurrence will also be analyzed.

Our hypotheses are (1) DE-MRI will reproducibly stage the progression left atrium fibrosis in AF; (2) DE-MRI will reproducibly aid in quantifying and identifying the distribution of catheter ablation-related scarring in the left atrium; and (3) the stage of left atrium fibrosis pre-ablation and the amount and location of scarring will predict success of catheter ablation therapy for AF.

time_perspective: Prospective

ReferenceCitation: Oakes RS, Badger TJ, Kholmovski EG, Akoum N, Burgon NS, Fish EN, Blauer JJ, Rao SN, DiBella EV, Segerson NM, Daccarett M, Windfelder J, McGann CJ, Parker D, MacLeod RS, Marrouche NF. Detection and quantification of left atrial structural remodeling with delayed-enhancement magnetic resonance imaging in patients with atrial fibrillation. Circulation. 2009 Apr 7;119(13):1758-67. doi: 10.1161/CIRCULATIONAHA.108.811877. Epub 2009 Mar 23.

ReferenceCitation: McGann CJ, Kholmovski EG, Oakes RS, Blauer JJ, Daccarett M, Segerson N, Airey KJ, Akoum N, Fish E, Badger TJ, DiBella EV, Parker D, MacLeod RS, Marrouche NF. New magnetic resonance imaging-based method for defining the extent of left atrial wall injury after the ablation of atrial fibrillation. J Am Coll Cardiol. 2008 Oct 7;52(15):1263-71. doi: 10.1016/j.jacc.2008.05.062.

ReferenceCitation: Segerson NM, Daccarett M, Badger TJ, Shabaan A, Akoum N, Fish EN, Rao S, Burgon NS, Adjei-Poku Y, Kholmovski E, Vijayakumar S, DiBella EV, MacLeod RS, Marrouche NF. Magnetic resonance imaging-confirmed ablative debulking of the left atrial posterior wall and septum for treatment of persistent atrial fibrillation: rationale and initial experience. J Cardiovasc Electrophysiol. 2010 Feb;21(2):126-32. doi: 10.1111/j.1540-8167.2009.01611.x. Epub 2009 Oct 5.

ReferenceCitation: Calkins H, Brugada J, Packer DL, Cappato R, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, Haines DE, Haissaguerre M, Iesaka Y, Jackman W, Jais P, Kottkamp H, Kuck KH, Lindsay BD, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Natale A, Pappone C, Prystowsky E, Raviele A, Ruskin JN, Shemin RJ; Heart Rhythm Society; European Heart Rhythm Association; European Cardiac Arrhythmia Society; American College of Cardiology; American Heart Association; Society of Thoracic Surgeons. HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation developed in partnership with the European Heart Rhythm Association (EHRA) and the European Cardiac Arrhythmia Society (ECAS); in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), and the Society of Thoracic Surgeons (STS). Endorsed and approved by the governing bodies of the American College of Cardiology, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, and the Heart Rhythm Society. Europace. 2007 Jun;9(6):335-79. doi: 10.1093/europace/eum120. No abstract available. Erratum In: Europace. 2009 Jan;11(1):132.

lead_sponsor: University of Utah

location_country:
Germany
Australia
Netherlands
Belgium
United States
Spain
France

location_facility: Sarah Cannon Research Institute (Centennial)

location_facility: Institut für Diagnostische und Interventionelle Radiologie - koln

location_facility: Hôpital Cardiologique du Haut-Lévêque/Bordeaux


title: Prospective Collection of Data in Pts With Peripheral T-Cell Lymphoma: PTCL,NOS;AITL; Extranodal NK/T-cell;Enteropathy-type; Hepatosplenic γ-δ; Subcutaneous Panniculitis-like; ALCL,Primary Systemic Type. By the Intl. T-Cell Lymphoma Project

summary:
The designed study follows up the retrospective previous one by the International T-cell Non-Hodgkin's Lymphoma Study Group (International Peripheral T-Cell Lymphoma Project).

It is designed as a prospective collection of information potentially useful to predict the prognosis of newly diagnosed patients with the more frequent subtypes of Peripheral T-cell lymphoma (Peripheral T-cell lymphoma unspecified and Angioimmunoblastic T-cell lymphoma) and to better define clinical characteristics and outcome of the more uncommon subtypes

enrollment_type: Anticipated

ReferenceCitation: Harris NL, Jaffe ES, Diebold J, Flandrin G, Muller-Hermelink HK, Vardiman J, Lister TA, Bloomfield CD. World Health Organization classification of neoplastic diseases of the hematopoietic and lymphoid tissues: report of the Clinical Advisory Committee meeting-Airlie House, Virginia, November 1997. J Clin Oncol. 1999 Dec;17(12):3835-49. doi: 10.1200/JCO.1999.17.12.3835.

ReferenceCitation: Jones D, O'Hara C, Kraus MD, Perez-Atayde AR, Shahsafaei A, Wu L, Dorfman DM. Expression pattern of T-cell-associated chemokine receptors and their chemokines correlates with specific subtypes of T-cell non-Hodgkin lymphoma. Blood. 2000 Jul 15;96(2):685-90.

ReferenceCitation: Picker LJ, Weiss LM, Medeiros LJ, Wood GS, Warnke RA. Immunophenotypic criteria for the diagnosis of non-Hodgkin's lymphoma. Am J Pathol. 1987 Jul;128(1):181-201.

ReferenceCitation: Cooke CB, Krenacs L, Stetler-Stevenson M, Greiner TC, Raffeld M, Kingma DW, Abruzzo L, Frantz C, Kaviani M, Jaffe ES. Hepatosplenic T-cell lymphoma: a distinct clinicopathologic entity of cytotoxic gamma delta T-cell origin. Blood. 1996 Dec 1;88(11):4265-74.

ReferenceCitation: Melnyk A, Rodriguez A, Pugh WC, Cabannillas F. Evaluation of the Revised European-American Lymphoma classification confirms the clinical relevance of immunophenotype in 560 cases of aggressive non-Hodgkin's lymphoma. Blood. 1997 Jun 15;89(12):4514-20.

ReferenceCitation: Armitage JO, Weisenburger DD. New approach to classifying non-Hodgkin's lymphomas: clinical features of the major histologic subtypes. Non-Hodgkin's Lymphoma Classification Project. J Clin Oncol. 1998 Aug;16(8):2780-95. doi: 10.1200/JCO.1998.16.8.2780.

ReferenceCitation: Ascani S, Zinzani PL, Gherlinzoni F, Sabattini E, Briskomatis A, de Vivo A, Piccioli M, Fraternali Orcioni G, Pieri F, Goldoni A, Piccaluga PP, Zallocco D, Burnelli R, Leoncini L, Falini B, Tura S, Pileri SA. Peripheral T-cell lymphomas. Clinico-pathologic study of 168 cases diagnosed according to the R.E.A.L. Classification. Ann Oncol. 1997 Jun;8(6):583-92. doi: 10.1023/a:1008200307625.

ReferenceCitation: Lopez-Guillermo A, Cid J, Salar A, Lopez A, Montalban C, Castrillo JM, Gonzalez M, Ribera JM, Brunet S, Garcia-Conde J, Fernandez de Sevilla A, Bosch F, Montserrat E. Peripheral T-cell lymphomas: initial features, natural history, and prognostic factors in a series of 174 patients diagnosed according to the R.E.A.L. Classification. Ann Oncol. 1998 Aug;9(8):849-55. doi: 10.1023/a:1008418727472.

ReferenceCitation: Savage KJ, Chhanabhai M, Gascoyne RD, Connors JM. Characterization of peripheral T-cell lymphomas in a single North American institution by the WHO classification. Ann Oncol. 2004 Oct;15(10):1467-75. doi: 10.1093/annonc/mdh392.

ReferenceCitation: Gallamini A, Stelitano C, Calvi R, Bellei M, Mattei D, Vitolo U, Morabito F, Martelli M, Brusamolino E, Iannitto E, Zaja F, Cortelazzo S, Rigacci L, Devizzi L, Todeschini G, Santini G, Brugiatelli M, Federico M; Intergruppo Italiano Linfomi. Peripheral T-cell lymphoma unspecified (PTCL-U): a new prognostic model from a retrospective multicentric clinical study. Blood. 2004 Apr 1;103(7):2474-9. doi: 10.1182/blood-2003-09-3080. Epub 2003 Nov 26.

ReferenceCitation: Zaja F, Russo D, Silvestri F, Fanin R, Damiani D, Infanti L, Salmaso F, Mariuzzi L, Di Loreto C, Baccarani M. Retrospective analysis of 23 cases with peripheral T-cell lymphoma, unspecified: clinical characteristics and outcome. Haematologica. 1997 Mar-Apr;82(2):171-7.

ReferenceCitation: Tsuchiya T, Ohshima K, Karube K, Yamaguchi T, Suefuji H, Hamasaki M, Kawasaki C, Suzumiya J, Tomonaga M, Kikuchi M. Th1, Th2, and activated T-cell marker and clinical prognosis in peripheral T-cell lymphoma, unspecified: comparison with AILD, ALCL, lymphoblastic lymphoma, and ATLL. Blood. 2004 Jan 1;103(1):236-41. doi: 10.1182/blood-2002-05-1352. Epub 2003 Sep 4.

ReferenceCitation: Federico M, Bellei M, Pesce, E, Zucca E, Pileri S, Montoto S, Weisenburger DD, Ruediger T, KO YH, Liang R, Zinzani PL, Connors JM, Foss FM, Horwitz SM, Polliack A, Vose JM. T-Cell Project: an international, longitudinal, observational study of patients with aggressive peripheral T-cell lymphoma. Revista Brasileira de Hematologia e Hemoterapia 31(suppl 2):21-25,2009.

ReferenceCitation: Federico M, Bellei M, Pesce EA, Zucca E, Pielri S, Montoto S, Weisenburger D, Rugiger T, Ko Y, Liang R, Zinzani PL, Connors J, Foss F, Horwitz S, Polliack A, Vose J. T-Cell Project: an international, prospective, observational study of patients with aggressive Peripheral T-cell Lymphoma. Analysis of the first 524 patients. 11 ICML, Lugano (Switzerland), 15-18 June 2011. Abs 241. Ann Oncol 22 (suppl 4), 2011

ReferenceCitation: Bellei M, Chiattone CS, Luminari S, Pesce EA, Cabrera ME, de Souza CA, Gabus R, Zoppegno L, Zoppegno L, Milone J, Pavlovsky A, Connors JM, Foss FM, Horwitz SM, Liang R, Montoto S, Pileri SA, Polliack A, Vose JM, Zinzani PL, Zucca E, Federico M. T-cell lymphomas in South america and europe. Rev Bras Hematol Hemoter. 2012;34(1):42-7. doi: 10.5581/1516-8484.20120013.

ReferenceCitation: Federico M, Bellei M, Luminari S, Horwitz SM, Montoto S, Zucca E, Pileri SA, Ko YH, Zinzani PL, Connors JM, Foss FM, Polliack A, Cabrera ME, Kim WS, Spina M, De Souza CA, Bobillo Varela S, Dlouhy I, Advani RH, Vose J and T-Cell Project. CD30+ expression in Peripheral T-cell lymphomas (PTCLs): A subset analysis from the international, prospective T-Cell Project. Journal of Clinical Oncology, 2015 ASCO Annual Meeting (May 29 - June 2, 2015).Vol 33, No 15_suppl (May 20 Supplement), 2015: 8552

ReferenceCitation: Federico M, Bellei M, Pesce EA, et al. T-Cell Project: an international, prospective, observational study of patients with aggressive Peripheral NK/T-Cell Lymphoma: Lesson from the first 1308 patients. 13 ICML, Lugano (Switzerland) 17-20 June, 2015. Abstract 070. Hematol Oncol 2015; 33(Suppl1):100-180

ReferenceCitation: Bellei M, Marcheselli L, Pesce EA, et al. Clinical Characteristics and Patterns of Care of Patients (pts) with Peripheral T-cell Lymphoma (PTCLs) according to age at time of diagnosis: A T-Cell Project snapshot. 13 ICML, Lugano (Switzerland) 17-20 June, 2015. Abstract 231. Hematol Oncol 2015; 33(Suppl1):181-243

ReferenceCitation: Horwitz SM, Bellei M, Marcheselli L, et al. The role of transplant in the treatment of Peripheral T-cell Lymphomas (PTCLs): an analysis from the T-cell Project database. 13 ICML, Lugano (Switzerland) 17-20 June, 2015. Abstract 247. Hematol Oncol 2015; 33(Suppl1):181-243

ReferenceCitation: Bellei M, Sabattini E, Pesce EA, Ko YH, Kim WS, Cabrera ME, Martinez V, Dlouhy I, Paes RP, Barrese T, Vassallo J, Tarantino V, Vose J, Weisenburger D, Rudiger T, Federico M, Pileri S. Pitfalls and major issues in the histologic diagnosis of peripheral T-cell lymphomas: results of the central review of 573 cases from the T-Cell Project, an international, cooperative study. Hematol Oncol. 2017 Dec;35(4):630-636. doi: 10.1002/hon.2316. Epub 2016 Jun 3.

ReferenceCitation: Chiattone C, Civallero M, Fischer T, Miranda E, Manni M, Zing NPC, Pileri SA, Montoto S, Horwitz SM, Cabrera ME, De Souza CA, Nagler A, Luminari S, Ferreri AJM, Carson KR, Re A, Rigacci L, Nassi L, Stepanishyna Y, Federico M, Inghirami G. Characteristics and clinical outcomes of patients with ALK-positive anaplastic large cell lymphoma: Report from the prospective international T-cell lymphoma project. Hematol Oncol. 2022 Dec;40(5):953-961. doi: 10.1002/hon.3074. Epub 2022 Sep 15.

ReferenceCitation: Advani RH, Skrypets T, Civallero M, Spinner MA, Manni M, Kim WS, Shustov AR, Horwitz SM, Hitz F, Cabrera ME, Dlouhy I, Vassallo J, Pileri SA, Inghirami G, Montoto S, Vitolo U, Radford J, Vose JM, Federico M. Outcomes and prognostic factors in angioimmunoblastic T-cell lymphoma: final report from the international T-cell Project. Blood. 2021 Jul 22;138(3):213-220. doi: 10.1182/blood.2020010387.

endpoint_id: nbfzapbzoypsdcgeiryx

repository_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

repositories_concat: PubMed Central;iris.unimore.it

ReferenceCitation: Shustov A, Cabrera ME, Civallero M, Bellei M, Ko YH, Manni M, Skrypets T, Horwitz SM, De Souza CA, Radford JA, Bobillo S, Prates MV, Ferreri AJM, Chiattone C, Spina M, Vose JM, Chiappella A, Laszlo D, Marino D, Stelitano C, Federico M. ALK-negative anaplastic large cell lymphoma: features and outcomes of 235 patients from the International T-Cell Project. Blood Adv. 2021 Feb 9;5(3):640-648. doi: 10.1182/bloodadvances.2020001581.

oa_colors: green gold

unpaywall_oa_status: gold

ReferenceCitation: Fox CP, Civallero M, Ko YH, Manni M, Skrypets T, Pileri S, Kim SJ, Cabrera ME, Shustov AR, Chiattone CS, Horwitz SM, Dlouhy I, Spina M, Hitz F, Montoto S, Nagler A, Martinez V, De Souza CA, Fernandez-Alvarez R, Ballova V, Gabus R, Inghirami G, Federico M, Kim WS. Survival outcomes of patients with extranodal natural-killer T-cell lymphoma: a prospective cohort study from the international T-cell Project. Lancet Haematol. 2020 Apr;7(4):e284-e294. doi: 10.1016/S2352-3026(19)30283-2. Epub 2020 Feb 24.

ReferenceCitation: Bellei M, Foss FM, Shustov AR, Horwitz SM, Marcheselli L, Kim WS, Cabrera ME, Dlouhy I, Nagler A, Advani RH, Pesce EA, Ko YH, Martinez V, Montoto S, Chiattone C, Moskowitz A, Spina M, Biasoli I, Manni M, Federico M; International T-cell Project Network. The outcome of peripheral T-cell lymphoma patients failing first-line therapy: a report from the prospective, International T-Cell Project. Haematologica. 2018 Jul;103(7):1191-1197. doi: 10.3324/haematol.2017.186577. Epub 2018 Mar 29.

evidence: oa journal (via doaj)

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ipd_sharing_description: Preliminary analysis results will be made available during the study on the single population and separately for each subtype. Final results will be made available 6-12 months after the end of the study

lead_sponsor: Associazione Angela Serra per la ricerca sul cancro

collaborators: INTERNATIONAL T-CELL NON-HODGKIN'S LYMPHOMA STUDY GROUP

location_country:
Italy
Slovakia
Israel
Argentina
United Kingdom
Brazil
Switzerland
United States
China
Korea, Republic of
Spain
Uruguay
Chile
France

location_facility: University Hospital Birmingham NHS Foundation Trust

location_facility: Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino

location_facility: Istituto Scientifico Universitario San Raffaele

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Franda

location_facility: Azienda Ospedaliera S. Giovanni Battista

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

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: University of Southampton School of Medicine

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Ospedale Casa Sollievo della Sofferenza IRCCS

location_facility: Azienda Ospedaliera Maggiore della Carità


title: The Parkinson's Progression Markers Initiative (PPMI)

acronym: PPMI

summary:
This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD patient subtypes.

The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies.

primary_purpose: Other

ReferenceCitation: Kim R, Park S, Yoo D, Jun JS, Jeon B. Association of Physical Activity and APOE Genotype With Longitudinal Cognitive Change in Early Parkinson Disease. Neurology. 2021 May 11;96(19):e2429-e2437. doi: 10.1212/WNL.0000000000011852. Epub 2021 Mar 31.

ReferenceCitation: Simuni T, Brumm MC, Uribe L, Caspell-Garcia C, Coffey CS, Siderowf A, Alcalay RN, Trojanowski JQ, Shaw LM, Seibyl J, Singleton A, Toga AW, Galasko D, Foroud T, Nudelman K, Tosun-Turgut D, Poston K, Weintraub D, Mollenhauer B, Tanner CM, Kieburtz K, Chahine LM, Reimer A, Hutten S, Bressman S, Marek K; Parkinson's Progression Markers Initiative Investigators. Clinical and Dopamine Transporter Imaging Characteristics of Leucine Rich Repeat Kinase 2 (LRRK2) and Glucosylceramidase Beta (GBA) Parkinson's Disease Participants in the Parkinson's Progression Markers Initiative: A Cross-Sectional Study. Mov Disord. 2020 May;35(5):833-844. doi: 10.1002/mds.27989. Epub 2020 Feb 19.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: Simuni T, Uribe L, Cho HR, Caspell-Garcia C, Coffey CS, Siderowf A, Trojanowski JQ, Shaw LM, Seibyl J, Singleton A, Toga AW, Galasko D, Foroud T, Tosun D, Poston K, Weintraub D, Mollenhauer B, Tanner CM, Kieburtz K, Chahine LM, Reimer A, Hutten SJ, Bressman S, Marek K; PPMI Investigators. Clinical and dopamine transporter imaging characteristics of non-manifest LRRK2 and GBA mutation carriers in the Parkinson's Progression Markers Initiative (PPMI): a cross-sectional study. Lancet Neurol. 2020 Jan;19(1):71-80. doi: 10.1016/S1474-4422(19)30319-9. Epub 2019 Oct 31.

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Simuni T, Caspell-Garcia C, Coffey CS, Weintraub D, Mollenhauer B, Lasch S, Tanner CM, Jennings D, Kieburtz K, Chahine LM, Marek K. Baseline prevalence and longitudinal evolution of non-motor symptoms in early Parkinson's disease: the PPMI cohort. J Neurol Neurosurg Psychiatry. 2018 Jan;89(1):78-88. doi: 10.1136/jnnp-2017-316213. Epub 2017 Oct 6.

evidence: open (via page says license)

ReferenceCitation: Latourelle JC, Beste MT, Hadzi TC, Miller RE, Oppenheim JN, Valko MP, Wuest DM, Church BW, Khalil IG, Hayete B, Venuto CS. Large-scale identification of clinical and genetic predictors of motor progression in patients with newly diagnosed Parkinson's disease: a longitudinal cohort study and validation. Lancet Neurol. 2017 Nov;16(11):908-916. doi: 10.1016/S1474-4422(17)30328-9. Epub 2017 Sep 25.

ReferenceCitation: Smith KM, Xie SX, Weintraub D. Incident impulse control disorder symptoms and dopamine transporter imaging in Parkinson disease. J Neurol Neurosurg Psychiatry. 2016 Aug;87(8):864-70. doi: 10.1136/jnnp-2015-311827. Epub 2015 Nov 3.

ReferenceCitation: Oliveira FP, Castelo-Branco M. Computer-aided diagnosis of Parkinson's disease based on [(123)I]FP-CIT SPECT binding potential images, using the voxels-as-features approach and support vector machines. J Neural Eng. 2015 Apr;12(2):026008. doi: 10.1088/1741-2560/12/2/026008. Epub 2015 Feb 24.

collaborators: Institute for Neurodegenerative Disorders

location_country:
Germany
Italy
Israel
Norway
United Kingdom
Australia
Austria
United States
Spain
Greece
France

location_facility: Univ of Washington and VA Puget Sound Health Care System

location_facility: University of Cincinnati/Cincinnati Children's Hospital

location_facility: Foundation for Biomedical Research of the Academy of Athens

location_facility: Institute For Neurodegenerative Disorders

location_facility: Parkinson's Disease& Movement Disorder Center of Boca Raton


title: Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease

summary: The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease.

primary_purpose: Diagnostic

ReferenceCitation: Nishi T, Piroth Z, De Bruyne B, Jagic N, Mobius-Winkler S, Kobayashi Y, Derimay F, Fournier S, Barbato E, Tonino P, Juni P, Pijls NHJ, Fearon WF. Fractional Flow Reserve and Quality-of-Life Improvement After Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease. Circulation. 2018 Oct 23;138(17):1797-1804. doi: 10.1161/CIRCULATIONAHA.118.035263.

ReferenceCitation: Xaplanteris P, Fournier S, Pijls NHJ, Fearon WF, Barbato E, Tonino PAL, Engstrom T, Kaab S, Dambrink JH, Rioufol G, Toth GG, Piroth Z, Witt N, Frobert O, Kala P, Linke A, Jagic N, Mates M, Mavromatis K, Samady H, Irimpen A, Oldroyd K, Campo G, Rothenbuhler M, Juni P, De Bruyne B; FAME 2 Investigators. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. N Engl J Med. 2018 Jul 19;379(3):250-259. doi: 10.1056/NEJMoa1803538. Epub 2018 May 22.

repository_institution: University of Ferrara - Institutional Research Information System University of Ferrara

repository_institution: Eindhoven University of Technology - Eindhoven University of Technology Research Portal

repository_institution: University of Southampton - ePrints Soton

ReferenceCitation: Ciccarelli G, Barbato E, Toth GG, Gahl B, Xaplanteris P, Fournier S, Milkas A, Bartunek J, Vanderheyden M, Pijls N, Tonino P, Fearon WF, Juni P, De Bruyne B. Angiography Versus Hemodynamics to Predict the Natural History of Coronary Stenoses: Fractional Flow Reserve Versus Angiography in Multivessel Evaluation 2 Substudy. Circulation. 2018 Apr 3;137(14):1475-1485. doi: 10.1161/CIRCULATIONAHA.117.028782. Epub 2017 Nov 21. Erratum In: Circulation. 2018 May 29;137(22):e820.

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

ReferenceCitation: Fearon WF, Nishi T, De Bruyne B, Boothroyd DB, Barbato E, Tonino P, Juni P, Pijls NHJ, Hlatky MA; FAME 2 Trial Investigators. Clinical Outcomes and Cost-Effectiveness of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease: Three-Year Follow-Up of the FAME 2 Trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation). Circulation. 2018 Jan 30;137(5):480-487. doi: 10.1161/CIRCULATIONAHA.117.031907. Epub 2017 Nov 2.

ReferenceCitation: Barbato E, Toth GG, Johnson NP, Pijls NH, Fearon WF, Tonino PA, Curzen N, Piroth Z, Rioufol G, Juni P, De Bruyne B. A Prospective Natural History Study of Coronary Atherosclerosis Using Fractional Flow Reserve. J Am Coll Cardiol. 2016 Nov 29;68(21):2247-2255. doi: 10.1016/j.jacc.2016.08.055.

ReferenceCitation: De Bruyne B, Fearon WF, Pijls NH, Barbato E, Tonino P, Piroth Z, Jagic N, Mobius-Winckler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd K, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Limacher A, Nuesch E, Juni P; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med. 2014 Sep 25;371(13):1208-17. doi: 10.1056/NEJMoa1408758. Epub 2014 Sep 1. Erratum In: N Engl J Med. 2014 Oct 9;371(15):1465.

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

repositories_institution: University of Bern - Bern Open Repository and Information System

ReferenceCitation: Fearon WF, Shilane D, Pijls NH, Boothroyd DB, Tonino PA, Barbato E, Juni P, De Bruyne B, Hlatky MA; Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 2 (FAME 2) Investigators. Cost-effectiveness of percutaneous coronary intervention in patients with stable coronary artery disease and abnormal fractional flow reserve. Circulation. 2013 Sep 17;128(12):1335-40. doi: 10.1161/CIRCULATIONAHA.113.003059. Epub 2013 Aug 14.

ReferenceCitation: De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27. Erratum In: N Engl J Med. 2012 Nov;367(18):1768. Mobius-Winckler, Sven [corrected to Mobius-Winkler, Sven].

location_country:
Germany
Italy
Hungary
United Kingdom
Denmark
Sweden
Netherlands
Belgium
United States
Czechia
Canada
Serbia
France

location_facility: Azienda Ospedaliero Universitaria de Ferrara

location_facility: Masaryk University and University Hospital Brno

location_facility: Gottsegen Hungarian Institute of Cardiology

location_facility: Centre Hospitalier de l'Universite de Montreal


title: The Kiva® System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial

acronym: KAST

summary: The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures of the thoracic or lumbar spine.

ReferenceCitation: Beall DP, Coe JD, McIlduff M, Bloch D, Hornberger J, Warner C, Tutton S. Serious Adverse Events Associated with Readmission Through One Year After Vertebral Augmentation with Either a Polyetheretherketone Implant or Balloon Kyphoplasty. Pain Physician. 2017 Sep;20(6):521-528.

lead_sponsor: Benvenue Medical, Inc.

location_country:
Germany
Belgium
United States
Canada
France

location_facility:
CORE Orthopaedic Medical Center
Universitatsklinikum Bonn
Radiology Imaging Associates
Penn State Hershey Medical Center
Mayo Clinic Jacksonville
Clinical Radiology of Oklahoma
Toronto Western Hospital
CHC Saint Joseph
Montreal General Hospital
Adventist Hospital
CHU Amiens Sud
Klinikum Ernst von Bergmann gGmbH
Mayo Clinic-Rochester
St. Mary's Spine Center
Medical University of South Carolina
Sierra Regional Spine Institute
Spine Institute of Louisiana
Evanston Hospital
Radiological Associates of Sacramento
El Camino Hospital
Medical College of Wisconsin

intervention_type: Device


title: NeuroThera® Efficacy and Safety Trial - 3 (NEST-3) A Double-blind, Randomized, Sham-controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Efficacy of Transcranial Laser Therapy With the NeuroThera® Laser System for the Treatment of Acute Ischemic Stroke Within 24 Hours of Stroke Onset

summary: The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject between 4.5 and 24 hours of stroke onset.

ReferenceCitation: Hacke W, Schellinger PD, Albers GW, Bornstein NM, Dahlof BL, Fulton R, Kasner SE, Shuaib A, Richieri SP, Dilly SG, Zivin J, Lees KR; NEST 3 Committees and Investigators. Transcranial laser therapy in acute stroke treatment: results of neurothera effectiveness and safety trial 3, a phase III clinical end point device trial. Stroke. 2014 Nov;45(11):3187-93. doi: 10.1161/STROKEAHA.114.005795. Epub 2014 Oct 7.

lead_sponsor: PhotoThera, Inc

location_country:
Finland
Germany
Sweden
Switzerland
Austria
United States
Spain
Peru
Canada
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Klinikum der Stadt Ludwigshafen am Rhein

location_facility: Klinik und Poliklinik für Neurologie Leipzig

location_facility: Guilford Neuro/The Moses H. Cone Memorial Hospital

location_facility: Mission Hospital/Mission Neurology Services

location_facility: University of Alberta Hospital - Walter C Mackenzie Health Science Center

location_facility: Complejo Hospitalario Universitario Albacete


lead_sponsor: LEO Pharma

summary: The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO 80185 gel in adolescent subjects (aged 12 to 17) with scalp psoriasis. LEO 80185 gel has marketing approval in many countries under the brand names Xamiol® gel and Taclonex Scalp® Topical Suspension for the treatment of scalp psoriasis in adults. No studies have been performed in subjects younger than 18 years

location_facility: The Centre for Dermatology and Cosmetic Surgery

location_facility: The Guenther Dermatology Research Centre

location_facility: Royal University Hospital, Division of Dermatology

location_facility: CHU Saint-Etienne - Hôpital Nord, Service de Dermatologie

title: Safety and Efficacy of Calcipotriol Plus Betamethasone Dipropionate Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis

location_country:
United Kingdom
Canada
France


acronym: SUSTAIN

summary:
Primary Objective:

To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with ankylosing spondylitis (AS)

Secondary Objective:

To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

title: A Multicenter Uncontrolled Extension Study Evaluating the Long Term Safety and Efficacy of SAR153191 in Patients With Ankylosing Spondylitis (AS)

location_country:
Lithuania
Poland
Hungary
Australia
Netherlands
Austria
Belgium
United States
Spain
Czechia
Canada
France


acronym: IMPRES Extn

lead_sponsor: Novartis Pharmaceuticals

summary: This is a multinational, multi center extension study. This study will provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension.

title: An Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension: IMPRES Extension

location_country:
Germany
Italy
United Kingdom
Japan
Netherlands
Austria
Belgium
Switzerland
United States
Korea, Republic of
Spain
Canada
France


lead_sponsor: AMAG Pharmaceuticals, Inc.

summary: The purpose of the study is to evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA).

ReferenceCitation: Strauss WE, Dahl NV, Li Z, Lau G, Allen LF. Ferumoxytol versus iron sucrose treatment: a post-hoc analysis of randomized controlled trials in patients with varying renal function and iron deficiency anemia. BMC Hematol. 2016 Jul 26;16:20. doi: 10.1186/s12878-016-0060-x. eCollection 2016.

ReferenceCitation: Hetzel D, Strauss W, Bernard K, Li Z, Urboniene A, Allen LF. A Phase III, randomized, open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy. Am J Hematol. 2014 Jun;89(6):646-50. doi: 10.1002/ajh.23712.

location_facility: For additional this triinformation regarding investigative sites for al, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

title: A Phase III, Randomized, Open-label, Active-Controlled, Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia

location_country:
Germany
Italy
Lithuania
Poland
Hungary
United Kingdom
Romania
Australia
Korea, Republic of
Latvia
Spain
South Africa
Ukraine
France


title: A Phase I/IIa Study of Safety and Efficacy of Alpharadin® With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer

summary: The main purpose of this study is to establish a recommended dose of Alpharadin to be used in combination with docetaxel in patients with bone metastases from castration-resistant prostate cancer and to investigate safety and explore efficacy of the recommended dose.

ReferenceCitation: Morris MJ, Loriot Y, Sweeney CJ, Fizazi K, Ryan CJ, Shevrin DH, Antonarakis ES, Pandit-Taskar N, Deandreis D, Jacene HA, Vesselle H, Petrenciuc O, Lu C, Carrasquillo JA, Higano CS. Radium-223 in combination with docetaxel in patients with castration-resistant prostate cancer and bone metastases: a phase 1 dose escalation/randomised phase 2a trial. Eur J Cancer. 2019 Jun;114:107-116. doi: 10.1016/j.ejca.2019.04.007. Epub 2019 May 11.

repository_institution: University of Turin - Institutional Research Information System University of Turin

repositories_concat: PubMed Central;iris.unito.it

ReferenceCitation: Gkialas IK, Fragkoulis C. Emerging therapies targeting castration-resistant prostate cancer. J BUON. 2015 Nov-Dec;20(6):1389-96.

lead_sponsor: Bayer

location_country:
United States
France


title: NGR015: Randomized Double-blind Phase III Study of NGR-hTNF Plus Best Investigator's Choice (BIC) Versus Placebo Plus BIC in Previously Treated Patients With Advanced Malignant Pleural Mesothelioma (MPM)

summary: The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen.

ReferenceCitation: Gregorc V, Gaafar RM, Favaretto A, Grossi F, Jassem J, Polychronis A, Bidoli P, Tiseo M, Shah R, Taylor P, Novello S, Muzio A, Bearz A, Greillier L, Fontana F, Salini G, Lambiase A, O'Brien M. NGR-hTNF in combination with best investigator choice in previously treated malignant pleural mesothelioma (NGR015): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2018 Jun;19(6):799-811. doi: 10.1016/S1470-2045(18)30193-1. Epub 2018 May 9.

lead_sponsor: AGC Biologics S.p.A.

location_country:
Ireland
Italy
Poland
United Kingdom
Sweden
Netherlands
Belgium
United States
Spain
Canada
Egypt
France

location_facility: Maria Sklodowska Memorial Cancer Center and Institute of Oncology

location_facility: Azienda Ospedaliero-Universitaria Careggi di Firenze

location_facility: Azienda Unità Sanitaria locale di Ravenna

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: A.O. Salvini Garbagnate, Ospedale di Rho

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

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: H. Lee Moffitt ancer Center and Research Institute

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: University Health Network, Princess Margaret Hospital

location_facility: UAB - Alberta Cancer Board - Cross Cancer Institute

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Edinburgh Cancer Centre, Western General Hospital


title: A 28-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study to Assess AIN457 Versus Placebo in Inducing and Maintaining Uveitis Suppression in Adults With Active, Non-infectious, Intermediate, Posterior or Panuveitis Requiring Immunosuppression (INSURE Study)

acronym: INSURE

summary: This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression.

ReferenceCitation: Dick AD, Tugal-Tutkun I, Foster S, Zierhut M, Melissa Liew SH, Bezlyak V, Androudi S. Secukinumab in the treatment of noninfectious uveitis: results of three randomized, controlled clinical trials. Ophthalmology. 2013 Apr;120(4):777-87. doi: 10.1016/j.ophtha.2012.09.040. Epub 2013 Jan 3.

location_country:
Germany
India
Hungary
Israel
Singapore
Japan
United Kingdom
Switzerland
United States
Spain
Canada
Egypt
France


title: Multicenter, Randomized, Double-blind, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple Sclerosis

summary: This study is an extension to the study AC-058B201 and will investigate the long-term safety, tolerability and efficacy of ponesimod in patients with relapsing-remitting multiple sclerosis.

lead_sponsor: Actelion

location_country:
Finland
Germany
Poland
Czechia
Canada
Serbia
France
Hungary
Switzerland
United States
Ukraine
Romania
United Kingdom
Sweden
Netherlands
Austria
Spain
Bulgaria
Russian Federation
Israel


title: Study on the Signature Personalised Patient Care System With the Vanguard Knee System

summary: The purpose of this study is to determine whether the percentage cases which have ideal mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting blocks is higher than those without the use of Signature when measured immediately post-operatively.

lead_sponsor: Zimmer Biomet

location_country:
Portugal
United Kingdom
Denmark
Australia
Sweden
Netherlands
Austria
Belgium
United States
France

location_facility:
The Queen Elizabeth Hospital
Danderyd Hospital
Addenbrooke's Hospital
The Orthopaedic Hospital Speising
Logan Hospital
General Hospital Kreuzschwestern
Medipole de Savoie
Torres Verdras Hospital
Aalborg University Hospital
St Luc General Hospital
Amphia Ziekenhuis Breda
Insall Scott Kelly Institute