title: A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Children With Sickle Cell Disease Previously Immunized With 23vPS Vaccine

lead_sponsor: Pfizer

location_country:
Saudi Arabia
Italy
United Kingdom
Lebanon
United States
France
Egypt

summary: This study is to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of antibodies (the proteins that fight off germs) produced by children with Sickle Cell Disease after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18 years of age. They will be given the vaccination twice, each vaccination separated by approximately 6 months.


status: Completed

primary_purpose: Treatment

acronym: ENVISION

intervention_type: Drug

title: A Phase 3, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX-770 in Subjects Aged 6 to 11 Years With Cystic Fibrosis and the G551D Mutation

study_completion_date_type: Actual

lead_sponsor: Vertex Pharmaceuticals Incorporated

source: euctr

design_allocation: Randomized

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Davies JC, Wainwright CE, Canny GJ, Chilvers MA, Howenstine MS, Munck A, Mainz JG, Rodriguez S, Li H, Yen K, Ordoñez CL, Ahrens R; VX08-770-103 (ENVISION) Study Group. Efficacy and safety of ivacaftor in patients aged 6 to 11 years with cystic fibrosis with a G551D mutation. Am J Respir Crit Care Med. 2013 Jun 1;187(11):1219-25. doi: 10.1164/rccm.201301-0153OC.

enrollment_type: Actual

location_country:
United Kingdom
Ireland
Australia
Canada
United States
France
Germany

location_facility: East Tennessee Children's Hospital Pediatric Pulmonary and Respiratory Care

location_facility: University of Virginia Pediatric Respiratory Medicine

location_facility: Hôpital Robert Debré - Service de gastro-entérologiemucoviscidose et nutrition

location_facility: University of Nebraska Medical Center Pediatric Pulmonary/ CF

location_facility: Dept of Gene Therapy, Imperial College London

location_facility: Helen DeVos Children's Hospital Spectrum Health Hospitals

location_facility: Mukoviszidose-Zentrum am Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Kinder- und Jugendmedizin

location_facility: University of Utah Pediatric Pulmonology

location_facility: Kinder- und Jugendklinik Universitätsklinikum Erlangen

location_facility: University of Iowa Department of Pediatrics

summary: The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic adenosine monophosphate (AMP)-dependent protein kinase A (PKA) activation.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint

acronym: PARSC

summary:
The aim of this study is to enroll 785 eligible stage II colon cancer patients in order to validate the performance of ColoPrint in estimating 3-year relapse rate.

Secondary objectives include comparing the objective risk assessment results from the prognostic profile (ColoPrint) to both the risk assessment based on the ASCO criteria, as well as the Investigator's independent assessment. As this is the first prospective study of ColoPrint, this study will also address the logistics and quality assurance of using ColoPrint in clinical practice.

Patient treatment is at the discretion of the physician, adhering to National Comprehensive Cancer Network (NCCN)-approved regimens or a recognized alternative.

The enrollment period will be 6 years. It is expected that 1800 to 2400 patients will be enrolled in order to obtain 785 analysable stage II samples from eligible patients. Approximately 25-35 clinical sites will be involved worldwide.

The statistical analysis will be performed by Agendia and an independent research institute or hospital.

Study Design Extension Study:

This will be a prospective study to measure the impact of ColoPrint on adjuvant treatment in stage 2 colorectal cancer patients. After surgery the tumor sample will be shipped in RNA Retain to Agendia. The online Clinical Report Form (CRF) 0 will be completed to document if the patient fulfils the inclusion criteria. Baseline clinical data and the patient and physician chemotherapy intention, patient's perceived recurrence risk and decisional conflict without knowing the ColoPrint result will be entered in CRF 1. After completion of CRF1 the ColoPrint result is released. CRF2 will be completed after the final treatment decision has been made.

This CRF will capture the patient and physician chemotherapy intention, patient's perceived recurrence risk and decisional conflict, impact of ColoPrint and the actual treatment the patient will receive. CRF3 will be completed 12 months after enrolment and will capture the patient status, patient's perceived recurrence risk and decisional conflict. CRF4 and 5 will be completed 3 and 5 years after surgery and will capture the patient status. A sample size of 210 stage 2 colon cancer patients is required to detect a 10% overall treatment change (5% significance and 90% power).

Reporting of the Results:

Blinded Study; The ColoPrint results will not be reported to the physician and/or patient at the time of enrolment. All samples will be stored in a freezer until 550-575 eligible stage II patients have been enrolled. Samples will then be analyzed in one batch in a blinded fashion from the clinical results.

Extension Study; The ColoPrint results will be reported to the physician and patient after CRF1 has been completed.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Agendia

location_country:
Denmark
Spain
United Kingdom
Austria
Netherlands
Switzerland
Sweden
United States
France
China
Japan
Germany

location_facility: IDIBELL Institut Catala d'Oncologia (ICO)

location_facility: Immunology Akademiska sjukhuset/ University Hospital

location_facility: South Orange County Surgical Medical Group

location_facility: University of Hong Kong/ Queen Mary Hospital

location_facility: Sutter Roseville Medical Center /Research

location_facility: Albert Einstein College of Medicine, Montefiore Medical Center

status_simplified: Unknown


title: A 24-week Randomized Placebo-controlled, Double-blind Multi-center Clinical Trial Evaluating the Efficacy and Safety of Oral QTI571 as an add-on Therapy in the Treatment of Severe Pulmonary Arterial Hypertension: Imatinib in Pulmonary Arterial Hypertension, a Randomized, Efficacy Study (IMPRES)

acronym: IMPRES

summary: A multinational, multicenter, double blind, placebo-controlled study evaluating the efficacy and safety of imatinib as an add-on therapy in the treatment of patients with severe pulmonary arterial hypertension (PAH).

ReferenceCitation: Querejeta Roca G, Campbell P, Claggett B, Solomon SD, Shah AM. Right Atrial Function in Pulmonary Arterial Hypertension. Circ Cardiovasc Imaging. 2015 Nov;8(11):e003521; discussion e003521. doi: 10.1161/CIRCIMAGING.115.003521.

ReferenceCitation: Querejeta Roca G, Campbell P, Claggett B, Vazir A, Quinn D, Solomon SD, Shah AM. Impact of lowering pulmonary vascular resistance on right and left ventricular deformation in pulmonary arterial hypertension. Eur J Heart Fail. 2015 Jan;17(1):63-73. doi: 10.1002/ejhf.177. Epub 2014 Nov 4.

ReferenceCitation: Shah AM, Campbell P, Rocha GQ, Peacock A, Barst RJ, Quinn D, Solomon SD; IMPRES Investigators. Effect of imatinib as add-on therapy on echocardiographic measures of right ventricular function in patients with significant pulmonary arterial hypertension. Eur Heart J. 2015 Mar 7;36(10):623-32. doi: 10.1093/eurheartj/ehu035. Epub 2014 Feb 23.

ReferenceCitation: Hoeper MM, Barst RJ, Bourge RC, Feldman J, Frost AE, Galié N, Gómez-Sánchez MA, Grimminger F, Grünig E, Hassoun PM, Morrell NW, Peacock AJ, Satoh T, Simonneau G, Tapson VF, Torres F, Lawrence D, Quinn DA, Ghofrani HA. Imatinib mesylate as add-on therapy for pulmonary arterial hypertension: results of the randomized IMPRES study. Circulation. 2013 Mar 12;127(10):1128-38. doi: 10.1161/CIRCULATIONAHA.112.000765. Epub 2013 Feb 12.

lead_sponsor: Novartis Pharmaceuticals

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

location_facility:
Novartis Investigative Site
Novartis investigative site
University Hospital Basel


title: A Phase I/II Multi-centre Study of AZD8931 in Combination With Weekly Paclitaxel to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and in a Selected Population With Low HER2-expressing Locally Recurrent and/or Metastatic Breast Cancer

acronym: THYME

summary: The main purpose of this study is to determine if AZD8931 can improve the efficacy of standard chemotherapy for the treatment of advanced breast cancer. This study will be conducted in 2 parts: the first part (phase I) will determine a dose of AZD8931 that can be safely administered with paclitaxel chemotherapy. The second part (phase II) will determine the efficacy and safety of AZD8931 in combination with paclitaxel chemotherapy in breast cancer.

lead_sponsor: AstraZeneca

location_country:
Brazil
Spain
Italy
United Kingdom
Canada
Czech Republic
Switzerland
Hungary
France
Panama
Peru
Belgium
Sweden
Bulgaria


title: Asymptomatic Carotid Surgery Trial-2 (ACST-2): an International Randomised Trial to Compare Carotid Endarterectomy With Carotid Artery Stenting to Prevent Stroke

summary:
The trial randomise patients with asymptomatic carotid artery narrowing in whom prompt physical intervention is thought to be needed, but there there is still substantial uncertainty shared by patient and doctor about whether surgery or stenting is the more appropriate choice.

The study is looking at immediate risks (within one month)and at long term benefits

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Halliday A, Mansfield A, Marro J, Peto C, Peto R, Potter J, Thomas D; MRC Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group. Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: randomised controlled trial. Lancet. 2004 May 8;363(9420):1491-502. Erratum in: Lancet. 2004 Jul 31;364(9432):416.

lead_sponsor: University of Oxford

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Kazakhstan
United States
Belgium
Japan
Czechia
Poland
Portugal
Slovenia
Austria
Russian Federation
Israel
Norway
Singapore
Sweden
Slovakia
Egypt
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Greece
Ireland
Estonia
France
Netherlands

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: HCFM Ribeirao Preto da Universidade de Sao Paulo

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Klinikum rechts der Isar derTechnischen Universität Muenchen

location_facility: Policlinico Universitario Campus Bio-medico di Roma

location_facility: Hospital Clinic 1 Provinical de Barcelona

location_facility: Fondazione Policlinico U. Agostino Gemeli IRCCS

location_facility: Nuovo Ospedale Civile Sant' Agostino Estense

location_facility: University of Dresden 'Carl-Gustav-Carus'

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico di Milano

location_facility: V.A. Almazov National Medical Research Centre

location_facility: University of Warsaw/ Institute of Psychiatry

location_facility: Dept. of Vascular Surgery, Attikon University Hospital

location_facility: Saint Petersburg Scientific Research Institute for Emergency Care

location_facility: Novosibirsk Research Institute of Circulation Pathology

intervention_type: Procedure

lead_sponsor_type: academique


type: Other Identifier

title: Betaferon Treatment and Exercise Data Gathering IN Early MS

acronym: BEGIN

summary: The purpose of this observational study is to obtain a survey on physical activity in patients who for the first time have experienced symptoms which indicate a high risk for developing multiple sclerosis (MS) and in patients with recently diagnosed MS, and to obtain information on factors potentially influencing the patients' level of activity.

lead_sponsor: Bayer

location_country:
Spain
Italy
United Kingdom
Kazakhstan
Belgium
Portugal
Slovenia
Austria
Australia
Indonesia
Israel
Mexico
Norway
Sweden
Egypt
Kuwait
Bahrain
Lebanon
Canada
Switzerland
Germany
Denmark
Taiwan
Jordan
Greece
Oman
Czech Republic
Thailand
Korea, Republic of
France
Colombia
Netherlands
United Arab Emirates


intervention_type: Biological

title: A Multicenter, Long-term Follow-up Study of the Safety and Efficacy of Two Dose Levels of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity

lead_sponsor: Allergan

study_start_date_type: Actual

ReferenceCitation: Kennelly M, Dmochowski R, Schulte-Baukloh H, Ethans K, Del Popolo G, Moore C, Jenkins B, Guard S, Zheng Y, Karsenty G; 191622-094 Investigators. Efficacy and safety of onabotulinumtoxinA therapy are sustained over 4 years of treatment in patients with neurogenic detrusor overactivity: Final results of a long-term extension study. Neurourol Urodyn. 2017 Feb;36(2):368-375. doi: 10.1002/nau.22934. Epub 2015 Nov 24.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
South Africa
Belgium
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Singapore
Slovakia
Brazil
Canada
Germany
Taiwan
New Zealand
France
Netherlands

summary: The purpose of this study is to assess the long-term safety and effectiveness of botulinum toxin type A on patients with overactive bladder as a result of spinal cord injury or multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376 and NCT00461292).


title: A Single and Repeat Dose Escalation Study of the Safety, Pharmacokinetics and Pharmacodynamics of GSK1223249 in ALS Patients

summary:
The drug being tested in this study is GSK1223249. It is being developed by GlaxoSmithKline to treat symptoms in patients with Amyotrophic Lateral Sclerosis (ALS).

The drug works by inhibiting the protein that prevents nerve growth.

This will be the first time the drug will be given to man. The trial is expected to involve approximately 76 patients. The study objective is to investigate the tolerability, safety and the way the body handles GSK1223249 after a range of single doses or repeat dose escalation in patients with ALS.

ReferenceCitation: Meininger V, Pradat PF, Corse A, Al-Sarraj S, Rix Brooks B, Caress JB, Cudkowicz M, Kolb SJ, Lange D, Leigh PN, Meyer T, Milleri S, Morrison KE, Orrell RW, Peters G, Rothstein JD, Shefner J, Lavrov A, Williams N, Overend P, Price J, Bates S, Bullman J, Krull D, Berges A, Abila B, Meno-Tetang G, Wurthner J. Safety, pharmacokinetic, and functional effects of the nogo-a monoclonal antibody in amyotrophic lateral sclerosis: a randomized, first-in-human clinical trial. PLoS One. 2014 May 19;9(5):e97803. doi: 10.1371/journal.pone.0097803. eCollection 2014.

lead_sponsor: GlaxoSmithKline

location_country:
United States
Italy
United Kingdom
France


title: PENTASA in Active Crohn's Disease: A 10-week, Double-blind, Multi-centre Trial Comparing PENTASA Sachet 6 g/Day (Mesalazine, Mesalamine) With Placebo.

acronym: PEACE

summary: The purpose of this trial is to demonstrate that Pentasa administered as a 2 g morning dose and a 4 g evening dose is efficacious in active mild to moderate CD.

status: Terminated

lead_sponsor: Ferring Pharmaceuticals

location_country:
Denmark
United Kingdom
Sweden
United States
France
Belgium
Germany

location_facility: Center for Digestive and Liver Disease, Inc

location_facility: Internist Gastroenterologie, Evangelisches Krankenhaus Kalk Akad. Lehrkrankenhaus für die Universität Köln


title: Prospective, Multicenter, Randomized, Clinical Investigation of TransMedics Organ Care System (OCS) for Cardiac Use

acronym: PROCEEDII

summary: The purpose of the study is to compare survival of both patients and newly transplanted hearts following heart transplantation among patients who were transplanted with donated hearts preserved on ice and those who were transplanted with donated hearts using the Organ Care System (OCS). The Organ care system preserves the hearts in a warm blood perfused beating state. The study also compares the number of rejection episodes, heart related adverse events, ICU time, and ventilation time between the two groups. The study is considered a success if survival in the OCS group was not inferior to the ice group.

ReferenceCitation: Ardehali A, Esmailian F, Deng M, Soltesz E, Hsich E, Naka Y, Mancini D, Camacho M, Zucker M, Leprince P, Padera R, Kobashigawa J; PROCEED II trial investigators. Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II): a prospective, open-label, multicentre, randomised non-inferiority trial. Lancet. 2015 Jun 27;385(9987):2577-84. doi: 10.1016/S0140-6736(15)60261-6. Epub 2015 Apr 14.

lead_sponsor: TransMedics

location_facility: Azienda Ospedaliera S. Maria della Misericordia

intervention_type: Device


title: A Prospective Study to Establish Normative Values, Demographic Variations, Referent Diagnostic Values and Disease Severity Correlations for Dry Eye Disease and TearLab Osmometry.

acronym: CVS

summary: This is a prospective, observational case series to determine the clinical utility of tear osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to establish referent values for objective tests of the disease.

ReferenceType: result

ReferenceCitation: Lemp MA, Bron AJ, Baudouin C, Benítez Del Castillo JM, Geffen D, Tauber J, Foulks GN, Pepose JS, Sullivan BD. Tear osmolarity in the diagnosis and management of dry eye disease. Am J Ophthalmol. 2011 May;151(5):792-798.e1. doi: 10.1016/j.ajo.2010.10.032. Epub 2011 Feb 18.

ReferenceCitation: Sullivan BD, Whitmer D, Nichols KK, Tomlinson A, Foulks GN, Geerling G, Pepose JS, Kosheleff V, Porreco A, Lemp MA. An objective approach to dry eye disease severity. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6125-30. doi: 10.1167/iovs.10-5390. Epub 2010 Jul 14.

ReferenceCitation: Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012 May;31(5):472-8. doi: 10.1097/ICO.0b013e318225415a.

ipd_sharing: Yes

ipd_sharing_description: Data was published in AJO May 2011 and IOVS Dec.2010.

lead_sponsor: TearLab Corporation

location_country:
United Kingdom
Spain
United States
France
Germany

location_facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts


title: A Multi-center, Randomized, Controlled Study of Mechanical Left Ventricular Unloading With Counterpulsation to Reduce Infarct Size Pre-PCI for Acute Myocardial Infarction - CRISP AMI

acronym: CRISP-AMI

summary: Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased MI size.

ReferenceCitation: Patel MR, Smalling RW, Thiele H, Barnhart HX, Zhou Y, Chandra P, Chew D, Cohen M, French J, Perera D, Ohman EM. Intra-aortic balloon counterpulsation and infarct size in patients with acute anterior myocardial infarction without shock: the CRISP AMI randomized trial. JAMA. 2011 Sep 28;306(12):1329-37. doi: 10.1001/jama.2011.1280. Epub 2011 Aug 29.

ReferenceCitation: Patel MR, Thiele H, Smalling RW, Chandra P, Zhou Y, Cohen M, Perera D, Ohman EM. A multicenter, randomized, controlled study of mechanical left ventricular unloading with counterpulsation to reduce infarct size prepercutaneous coronary intervention for acute myocardial infarction: rationale and design of the Counterpulsation Reduces Infarct Size Acute Myocardial Infarction trial. Am Heart J. 2011 Jul;162(1):47-55.e1. doi: 10.1016/j.ahj.2011.03.037.

lead_sponsor: Datascope Corp.

location_country:
United Kingdom
Ireland
Italy
Australia
Netherlands
United States
France
India
Belgium
Germany

location_facility: University of Medicine and Dentistry of New Jersey

location_facility: University of Rochester Medical Center-Strong Memorial Hospital

location_facility: University of Texas Health Science Center at Houston

location_facility: Klinik fur Innere Medizin und Kardiologie

location_facility: Saint John's Medical College and Hospital

location_facility: Essentia Institute of Rural Health (St Mary's)

location_facility: Baroda Heart Institute and Research Centre

location_facility: Azienda Ospedaliero Universitaria Cargeei


title: Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery of Hip or Knee

acronym: XAMOS

summary: The main goal is to provide additional information to the risk-benefit assessment of the drug.

ReferenceCitation: Turpie AG, Haas S, Kreutz R, Mantovani LG, Pattanayak CW, Holberg G, Jamal W, Schmidt A, van Eickels M, Lassen MR. A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17,701 patients with propensity score adjustment. Thromb Haemost. 2014 Jan;111(1):94-102. doi: 10.1160/TH13-08-0666. Epub 2013 Oct 24.

ReferenceCitation: Turpie AG, Schmidt AC, Kreutz R, Lassen MR, Jamal W, Mantovani L, Haas S. Rationale and design of XAMOS: noninterventional study of rivaroxaban for prophylaxis of venous thromboembolism after major hip and knee surgery. Vasc Health Risk Manag. 2012;8:363-70. doi: 10.2147/VHRM.S30064. Epub 2012 Jun 1.

location_country: Macedonia, The Former Yugoslav Republic of


type: EudraCT Number

title: CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2, AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN CLINICAL TRIALS

summary: To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial

status: Active, not recruiting

ipd_sharing: No

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:
Taiwan
United Kingdom
Italy
Russian Federation
Hungary
Korea, Republic of
United States
France
Japan
Germany
Czechia

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center

location_facility: The University of Texas M.D. Anderson Cancer Center

location_facility: Nottingham City Hospital / Oncology Department

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: University of Wisconsin - Hospital and Clinics

location_facility: Providence Regional Medical Center Everett - Providence Regional Cancer Partnership

location_facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar

location_facility: Charité - Universitaetsmedizin Berlin, Charité Campus Mitte

location_facility: Fondazione IRCCS, Istituto Nazionale Tumori, S.S.D Oncologia Medica dei Tumori testa-collo

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: FSBSI "N.N. Blokhin Russian Cancer Research Center"

location_facility: Fondazione IRCCS, Istituto Nazionale Tumori, Laboratorio

status_simplified: Ongoing


type: Registry Identifier

title: A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patients With High-Risk Stage II or Stage III Colon Cancer: A Randomized Controlled Trial

acronym: CHALLENGE

summary:
RATIONALE: Participating in a physical activity program designed to increase free time physical activity and receiving written health education materials may influence the chance of cancer recurring as well as impact on physical fitness, psychological well-being and the quality of life of patients who have undergone surgery and chemotherapy for colon cancer. It is not yet known whether giving a physical activity program together with health education materials is more effective than giving health education materials alone for patients who have undergone colon cancer treatment.

PURPOSE: This randomized phase III trial is studying a physical activity program given together with health education materials to see how well it works compared with giving health education materials alone for patients who have undergone treatment for high-risk stage II or stage III colon cancer.

status: Recruiting

primary_purpose: Other

ReferenceCitation: Courneya KS, Booth CM, Gill S, O'Brien P, Vardy J, Friedenreich CM, Au HJ, Brundage MD, Tu D, Dhillon H, Meyer RM. The Colon Health and Life-Long Exercise Change trial: a randomized trial of the National Cancer Institute of Canada Clinical Trials Group. Curr Oncol. 2008 Dec;15(6):279-85.

ReferenceCitation: Vallance J, Lesniak SL, Belanger LJ, Courneya KS. Development and assessment of a physical activity guidebook for the Colon Health and Life-Long Exercise Change (CHALLENGE) trial (NCIC CO.21). J Phys Act Health. 2010 Nov;7(6):794-801.

ReferenceCitation: Courneya KS, Vardy JL, O'Callaghan CJ, Friedenreich CM, Campbell KL, Prapavessis H, Crawford JJ, O'Brien P, Dhillon HM, Jonker DJ, Chua NS, Lupichuk S, Sanatani MS, Gill S, Meyer RM, Begbie S, Bonaventura T, Burge ME, Turner J, Tu D, Booth CM. Effects of a Structured Exercise Program on Physical Activity and Fitness in Colon Cancer Survivors: One Year Feasibility Results from the CHALLENGE Trial. Cancer Epidemiol Biomarkers Prev. 2016 Jun;25(6):969-77. doi: 10.1158/1055-9965.EPI-15-1267. Epub 2016 Apr 8.

lead_sponsor: Canadian Cancer Trials Group

location_country:
United Kingdom
Australia
Canada
Korea, Republic of
United States
France

location_facility: Trillium Health Partners - Credit Valley Hospital

location_facility: Macarthur Cancer Therapy Centre - Campbelltown Hospital

location_facility: University of North Carolina at Chapel Hill

location_facility: Exercise Medicine Center for Diabetes and Cancer

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences

location_facility: North Coast Cancer Institute Coffs Harbour

location_facility: North Coast Cancer Institute - Port Macquarie

location_facility: Stronach Regional Health Centre at Southlake

intervention_type: Other


title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis

summary: This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, multiple dose escalation study, enrolling approximately 48 subjects. Part A of the study will enroll subjects with Systemic Lupus Erythematosus (SLE) without Glomerulonephritis (GN) into 3 cohorts. Part B of the study will enroll SLE subjects with GN into 3 cohorts. The purpose of the study is to evaluate the multiple dose of AMG 811 on safety. Tolerability and pharmacokinetics.

lead_sponsor: Amgen

location_country:
Hong Kong
United States
France
Mexico
Malaysia


title: Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib

acronym: GIDEON

summary: In this international non-interventional study safety and clinical data concerning the treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.

ReferenceCitation: Ye SL, Chen X, Yang J, Bie P, Zhang S, Liu F, Liu L, Zhou J, Dou K, Hao C, Shao G, Xia Q, Chen Y, Yang J, Deng X, Liu Y, Yuan Y, Fu Z, Nakajima K, Yip CS, Lu Z. Safety and efficacy of sorafenib therapy in patients with hepatocellular carcinoma: final outcome from the Chinese patient subset of the GIDEON study. Oncotarget. 2016 Feb 9;7(6):6639-48. doi: 10.18632/oncotarget.6781.

ReferenceCitation: Ye SL, Yang J, Bie P, Zhang S, Chen X, Liu F, Liu L, Zhou J, Dou K, Hao C, Shao G, Xia Q, Chen Y, Yang J, Deng X, Liu Y, Yuan Y, Fu Z, Nakajima K, Lv Z. Safety assessment of sorafenib in Chinese patients with unresectable hepatocellular carcinoma: subgroup analysis of the GIDEON study. BMC Cancer. 2018 Mar 2;18(1):247. doi: 10.1186/s12885-018-4144-9.

ReferenceCitation: Kudo M, Lencioni R, Marrero JA, Venook AP, Bronowicki JP, Chen XP, Dagher L, Furuse J, Geschwind JF, Ladrón de Guevara L, Papandreou C, Sanyal AJ, Takayama T, Yoon SK, Nakajima K, Lehr R, Heldner S, Ye SL. Regional differences in sorafenib-treated patients with hepatocellular carcinoma: GIDEON observational study. Liver Int. 2016 Aug;36(8):1196-205. doi: 10.1111/liv.13096. Epub 2016 Apr 1.

ReferenceCitation: Lencioni R, Marrero J, Venook A, Ye SL, Kudo M. Design and rationale for the non-interventional Global Investigation of Therapeutic DEcisions in Hepatocellular Carcinoma and Of its Treatment with Sorafenib (GIDEON) study. Int J Clin Pract. 2010 Jul;64(8):1034-41. doi: 10.1111/j.1742-1241.2010.02414.x.

location_country:
Croatia
Spain
Italy
Ukraine
Venezuela
Kazakhstan
United States
Romania
Japan
Philippines
Hong Kong
Portugal
Russian Federation
Syrian Arab Republic
Indonesia
Uruguay
India
Israel
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Canada
Hungary
China
Greece
Qatar
Finland
Czech Republic
Thailand
Vietnam
Korea, Republic of
France
Libyan Arab Jamahiriya
Colombia
Pakistan
United Arab Emirates


title: An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients With Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

design_allocation: Non-Randomized

location_country:
Poland
Belgium
Romania
Italy
Mexico
United States
France
Peru
Colombia
Germany
Bulgaria

summary: The purpose of this new research study is to gain additional information about how safe and effective R935788 is over a longer period of time.


title: An Open-label, Multicenter Protocol Providing Pegylated-interferon Alfa-2a (PEGASYS®) as Monotherapy or in Combination With Ribavirin (COPEGUS®) for Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols

summary: This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised or deemed appropriate following completion of the original protocol ('donor' protocol). Patients who qualify for treatment or re-treatment will begin PEGASYS monotherapy, at a maximum dose of 180 µg weekly, or combination therapy with Copegus, 800-1200 mg daily, as continuation of treatment after the wash-out period defined in their donor protocol. PEGASYS treatment is not to exceed the approved treatment duration of 48 weeks in genotype G1 with a treatment-free follow up period of 24 weeks.

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Austria
Canada
United States
France
Germany


title: A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol

summary: The objective of this protocol is to provide SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol

location_country:
United Kingdom
Greece
Italy
Australia
Canada
Switzerland
Sweden
United States
France
Singapore
Netherlands


title: An Adaptive Dose-ranging, Multi-center, Single-blind, Double-dummy, Active-controlled Trial to Determine the Target Dose of Canakinumab (ACZ885) in the Treatment of Acute Flares in Gout Patients Who Are Refractory or Contraindicated to NSAIDs and/or Colchicine

summary: This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the management of acute flare in gout patients who are contraindicated to Non-Steroidal anti-inflammatory drugs and/or colchicine. The efficacy of ACZ885 will be compared to the corticosteroid triamcinolone acetonide.

ReferenceCitation: Chakraborty A, Van LM, Skerjanec A, Floch D, Klein UR, Krammer G, Sunkara G, Howard D. Pharmacokinetic and pharmacodynamic properties of canakinumab in patients with gouty arthritis. J Clin Pharmacol. 2013 Dec;53(12):1240-51. doi: 10.1002/jcph.162. Epub 2013 Sep 30.

ReferenceCitation: Schlesinger N, De Meulemeester M, Pikhlak A, Yücel AE, Richard D, Murphy V, Arulmani U, Sallstig P, So A. Canakinumab relieves symptoms of acute flares and improves health-related quality of life in patients with difficult-to-treat Gouty Arthritis by suppressing inflammation: results of a randomized, dose-ranging study. Arthritis Res Ther. 2011 Mar 25;13(2):R53. doi: 10.1186/ar3297.

ReferenceCitation: So A, De Meulemeester M, Pikhlak A, Yücel AE, Richard D, Murphy V, Arulmani U, Sallstig P, Schlesinger N. Canakinumab for the treatment of acute flares in difficult-to-treat gouty arthritis: Results of a multicenter, phase II, dose-ranging study. Arthritis Rheum. 2010 Oct;62(10):3064-76. doi: 10.1002/art.27600.

lead_sponsor: Novartis

location_country:
Poland
United Kingdom
Russian Federation
Argentina
Canada
Switzerland
United States
France
Turkey
Belgium
Germany

location_facility: New Mexico Clinical Research & Osteoporosis Center, Inc.

location_facility: San Diego Arthritis & Osteoporosis Medical Clinic

location_facility: Regional Clinical Research Rheumatology Assoc.

location_facility: Center for Clinical Trials of San Gabriel

location_facility: Northern California Institute for Bone Health


title: A Randomized, Double-blind, Placebo-controlled Study of RAD0001 in the Treatment of Angiomyolipoma in Patients With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)

ReferenceCitation: Bissler JJ, Kingswood JC, Radzikowska E, Zonnenberg BA, Frost M, Belousova E, Sauter M, Nonomura N, Brakemeier S, de Vries PJ, Whittemore VH, Chen D, Sahmoud T, Shah G, Lincy J, Lebwohl D, Budde K. Everolimus for angiomyolipoma associated with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis (EXIST-2): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2013 Mar 9;381(9869):817-24.

ReferenceCitation: Bissler JJ, Nonomura N, Budde K, Zonnenberg BA, Fischereder M, Voi M, Louveau AL, Herbst F, Bebin EM, Curatolo P, Zonta A, Belousova E. Angiomyolipoma rebound tumor growth after discontinuation of everolimus in patients with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis. PLoS One. 2018 Sep 7;13(9):e0201005. doi: 10.1371/journal.pone.0201005. eCollection 2018.

ReferenceCitation: Bissler JJ, Budde K, Sauter M, Franz DN, Zonnenberg BA, Frost MD, Belousova E, Berkowitz N, Ridolfi A, Christopher Kingswood J. Effect of everolimus on renal function in patients with tuberous sclerosis complex: evidence from EXIST-1 and EXIST-2. Nephrol Dial Transplant. 2019 Jun 1;34(6):1000-1008. doi: 10.1093/ndt/gfy132.

ReferenceCitation: Sparagana S, Franz DN, Krueger DA, Bissler JJ, Berkowitz N, Burock K, Kingswood JC. Pooled analysis of menstrual irregularities from three major clinical studies evaluating everolimus for the treatment of tuberous sclerosis complex. PLoS One. 2017 Oct 12;12(10):e0186235. doi: 10.1371/journal.pone.0186235. eCollection 2017.

ReferenceCitation: Bissler JJ, Kingswood JC, Radzikowska E, Zonnenberg BA, Frost M, Belousova E, Sauter M, Nonomura N, Brakemeier S, de Vries PJ, Berkowitz N, Miao S, Segal S, Peyrard S, Budde K. Everolimus for renal angiomyolipoma in patients with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis: extension of a randomized controlled trial. Nephrol Dial Transplant. 2016 Jan;31(1):111-9. doi: 10.1093/ndt/gfv249. Epub 2015 Jul 8.

location_country:
Poland
Spain
Italy
Russian Federation
Netherlands
United Kingdom
Canada
United States
France
Japan
Germany

location_facility: Massachusetts General Hospital Massachussetts General Hospita

location_facility: Cincinnati Children's Hospital Medical Center

summary: This study will evaluate the safety and efficacy of RAD001 in treating patients with Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic Lymphangioleiomyomatosis.


title: Betaferon Prospective Study on Adherence, Coping and Nursing Support

acronym: BEACON

summary:
The Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS). The Investigator will document the relevant medical data regarding multiple sclerosis at every hospital visit, the patient will fill in two questionnaires at every visit: one about coping with the disease and the other about anxiety and depression.
The Study particularly looks at the role of the support of the patient given by the multiple sclerosis nurses.The nurse will provide additional standardised information at start of treatment and will regularly phone the patient to ask standardised questions about the general condition with regard to the treatment, the disease and social support. At the end of the Study it will be assessed if the supportive measures and the standards in terms of adherence management in the hospital have some influence to increase long-term treatment adherence.

ReferenceCitation: Patti F, Penaherrera JN, Zieger L, Wicklein EM. Clinical characteristics of middle-aged and older patients with MS treated with interferon beta-1b: post-hoc analysis of a 2-year, prospective, international, observational study. BMC Neurol. 2021 Aug 23;21(1):324. doi: 10.1186/s12883-021-02347-w.

location_country:
Saudi Arabia
Italy
United Kingdom
Venezuela
Belgium
Portugal
Slovenia
Argentina
Syrian Arab Republic
Israel
Mexico
Norway
Singapore
Sweden
Slovakia
Egypt
Kuwait
Bosnia and Herzegovina
Bahrain
Lebanon
Canada
China
Germany
Taiwan
Jordan
Estonia
Iran, Islamic Republic of
New Zealand
Czech Republic
Korea, Republic of
France
Libyan Arab Jamahiriya
Colombia
Netherlands
Pakistan
United Arab Emirates


title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AVE5530 When Added to Ongoing Stable Statin Therapy at High Doses in Patients With Severe Primary Hypercholesterolemia

summary:
The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing treatment with high doses of statin in a double-blind manner in comparison with placebo, in the management of patients with severe primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment.

The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.

lead_sponsor: Sanofi

location_country:
Russian Federation
Australia
Canada
Czech Republic
Ukraine
United States
France
Israel
South Africa
Belgium
Netherlands
Bulgaria
Slovakia

location_facility: sanofi-aventis Australia & New Zealand administrative office


title: Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY

acronym: CARGOII

summary: The Cardiac Allograft Rejection Gene Expression Observational (CARGO) II Study is designed to provide independent evidence of the clinical performance of the non-invasive AlloMap test. Sensitive detection of cardiac allograft rejection and dysfunction is the basis for successful recipient management. The CARGO II Study will assess the correlation between the presence or absence of acute cellular rejection as determined by examination of endomyocardial biopsy specimens with results from the AlloMap Test. Of 17 participating transplant centers, 4 are in North America and 13 are in Europe.

ReferenceCitation: Crespo-Leiro MG, Stypmann J, Schulz U, Zuckermann A, Mohacsi P, Bara C, Ross H, Parameshwar J, Zakliczyński M, Fiocchi R, Hoefer D, Colvin M, Deng MC, Leprince P, Elashoff B, Yee JP, Vanhaecke J. Clinical usefulness of gene-expression profile to rule out acute rejection after heart transplantation: CARGO II. Eur Heart J. 2016 Sep 1;37(33):2591-601. doi: 10.1093/eurheartj/ehv682. Epub 2016 Jan 7.

ReferenceCitation: Crespo-Leiro MG, Stypmann J, Schulz U, Zuckermann A, Mohacsi P, Bara C, Ross H, Parameshwar J, Zakliczyński M, Fiocchi R, Hoefer D, Deng M, Leprince P, Hiller D, Eubank L, Deljkich E, Yee JP, Vanhaecke J. Performance of gene-expression profiling test score variability to predict future clinical events in heart transplant recipients. BMC Cardiovasc Disord. 2015 Oct 9;15:120. doi: 10.1186/s12872-015-0106-1.

ReferenceCitation: Crespo-Leiro MG, Zuckermann A, Bara C, Mohacsi P, Schulz U, Boyle A, Ross HJ, Parameshwar J, Zakliczyński M, Fiocchi R, Stypmann J, Hoefer D, Lehmkuhl H, Deng MC, Leprince P, Berry G, Marboe CC, Stewart S, Tazelaar HD, Baron HM, Coleman IC, Vanhaecke J. Concordance among pathologists in the second Cardiac Allograft Rejection Gene Expression Observational Study (CARGO II). Transplantation. 2012 Dec 15;94(11):1172-7. doi: 10.1097/TP.0b013e31826e19e2.

lead_sponsor: XDx

location_country:
Poland
Spain
Italy
Austria
United Kingdom
Canada
Switzerland
United States
France
Belgium
Germany

location_facility: UKM - Medizinische Klinik und Poliklinik C (Kardiologie und Angiologie)

location_facility: Medical University of Vienna (Medizinische Universität Wien)

location_facility: Inselspital - Universitätsspital Bern Postfach 33

location_facility: Medizinische Universität Innsbruck, Klinische Abteilung für Herzchirurgie


title: Efficacy and Safety of AP 12009 in Adult Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma as Compared to Standard Chemotherapy Treatment: A Randomized, Actively Controlled, Open Label Clinical Phase III Study.

acronym: SAPPHIRE

summary: In this multinational Phase III study the efficacy and safety of 10 µM AP 12009 is compared to standard chemotherapy (temozolomide or BCNU or CCNU) in adult patients with confirmed recurrent or refractory anaplastic astrocytoma (WHO grade III) or secondary glioblastoma (WHO grade IV).

lead_sponsor: Isarna Therapeutics GmbH

location_country:
Poland
Taiwan
Brazil
Spain
United Kingdom
Austria
Russian Federation
Argentina
Canada
Hungary
Korea, Republic of
United States
France
India
Mexico
Germany

location_facility: Chelyabinsk City Hospital #3; Department of Neurosurgery

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Edinburgh Centre for Neuro-Oncology, Western General Hospital

location_facility: Medizinische Hochschule Hannover Neurochirurgische Klinik

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Neurochirurgii i Neurochirurgii Dziecięcej

location_facility: Advanced Centre for Treatment Research and Education in Cancer (ACTREC)

location_facility: Universitätsklinikum Leipzig, Neurochirurgische Klinik

location_facility: Universitätsklinik Innsbruck, Abteilung für Neurologie

location_facility: Severance Hospital, Yonsei University College of Medicine

location_facility: Universitätsklinik Heidelberg Neurologische Klinik

location_facility: Montreal Neurological Institute and Hospital

location_facility: Otto-von-Guericke-Universität, Klinik für Neurochirurgie

location_facility: Klinik und Poliklinik für Neurochirurgie

location_facility: State Institution Russian Oncology Research Center N.N. Blokhin

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: Samara Region Clinical Hospital M.I. Kalinin

location_facility: Kliniczny Oddzial Neurochirurgii SUM w Sosnowcu Wojewódzki Szpital Specjalistyczny nr 5

location_facility: Centrum Onkologii - Instytut Im. Marii Sklodowskiej-Curie

location_facility: Russian Scientific Research Neurosurgical Institute A.L. Polenov

location_facility: Amrita Institute of Medical Sciences Research Center

location_facility: All India Institute of Medical Sciences (AIIMS)

location_facility: Wojskowy Szpital Kliniczny, Klinika Neurochirurgii

location_facility: Manipal Hospital & Manipal Institute for Neurological Disorders

location_facility: Military Medical Academy, Neurosurgery Dept

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Postgraduate Institute of Medical Education & Research (PGIMER)

location_facility: Universitätklinikum Hamburg-Eppendorf, Klinik für Neurochirurgie

location_facility: NJ Neuroscience Institute; JFK Medical Center

location_facility: Neurochirurgische Klinik an der Universität Ulm am Bezirkskrankenhaus Günzburg

location_facility: SP ZOZ Uniwersytecki Szpital Kliniczny nr 1, Klinika Neurochirurgii


title: A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System

summary: A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.

lead_sponsor: Boston Scientific Corporation

location_country:
Denmark
Italy
United States
France
Belgium
Germany

location_facility:
Mayo Clinic
Hopital Edouard Herriot
Erasme Hospital - Belgium
California Pacific Medical Center
Beth Israel Deaconess Medical Center
Medical University of South Carolina
Bispebjerg Hospital, Denmark
Cleveland Clinic Foundation
Columbia University Medical Center
Policlinico Agostino Gemelli
Evangelisches Krankenhaus Dusseldorf
University of Colorado Hospital
University of Pittsburgh
Indiana University Medical Center
Fox Chase Cancer Center


acronym: REPLACE

title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]) for the Treatment of Adults With Hypoparathyroidism

lead_sponsor: Shire

ReferenceCitation: Ayodele O, Mu F, Berman R, Swallow E, Rejnmark L, Gosmanova EO, Kaul S. Lower Risk of Cardiovascular Events in Adult Patients with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study. Adv Ther. 2022 Aug;39(8):3845-3856. doi: 10.1007/s12325-022-02198-y. Epub 2022 Jun 11.

ReferenceCitation: Chen KS, Gosmanova EO, Curhan GC, Ketteler M, Rubin M, Swallow E, Zhao J, Wang J, Sherry N, Krasner A, Bilezikian JP. Five-year Estimated Glomerular Filtration Rate in Patients With Hypoparathyroidism Treated With and Without rhPTH(1-84). J Clin Endocrinol Metab. 2020 Oct 1;105(10). pii: dgaa490. doi: 10.1210/clinem/dgaa490.

ReferenceCitation: Vokes TJ, Mannstadt M, Levine MA, Clarke BL, Lakatos P, Chen K, Piccolo R, Krasner A, Shoback DM, Bilezikian JP. Recombinant Human Parathyroid Hormone Effect on Health-Related Quality of Life in Adults With Chronic Hypoparathyroidism. J Clin Endocrinol Metab. 2018 Feb 1;103(2):722-731. doi: 10.1210/jc.2017-01471.

ReferenceCitation: Mannstadt M, Clarke BL, Vokes T, Brandi ML, Ranganath L, Fraser WD, Lakatos P, Bajnok L, Garceau R, Mosekilde L, Lagast H, Shoback D, Bilezikian JP. Efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study. Lancet Diabetes Endocrinol. 2013 Dec;1(4):275-83. doi: 10.1016/S2213-8587(13)70106-2. Epub 2013 Oct 7. Erratum in: Lancet Diabetes Endocrinol. 2014 Jan;2(1):e3. Dosage error in article text.

location_country:
Denmark
United Kingdom
Italy
Canada
Hungary
United States
France
Belgium

location_facility: Chetre Hospitalier Universitaire de Liege

location_facility: University of Cincinnati Bone Health and Osteoporosis Center

location_facility: Capital District Health Authority, QEII Health Sciences Centre

location_facility: University of California-San Francisco VA Medical Center

summary: Use of PTH (1-84) a recombinant hormone in escalating doses for the treatment of adults with hypoparathyroidism. The use of PTH should result in a decrease of calcium and vitamin D supplements.


title: A Multicenter, Double-blind, Randomized, 12-month, Placebo-controlled Study to Evaluate the Lipid-lowering Effect, Safety and Tolerability of AVE5530 25 mg/Day and 50mg/Day When Added to Ongoing Stable Statin Therapy (HMG-CoA Reductase Inhibitors) in Patients With Primary Hypercholesterolemia

summary:
The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing statin treatment in a double-blind manner in comparison with placebo, in the management of patients with primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment.

The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.

location_country:
Denmark
Poland
Spain
Russian Federation
Australia
Netherlands
Canada
Czech Republic
Sweden
Hungary
United States
France
Israel
Belgium
Norway
Germany

location_facility: sanofi-aventis Australia & New Zealand administrative office


title: Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic as Post-consolidation Therapy in Adult Patients With Acute Myeloid Leukemia

summary: This study is being done to evaluate the safety of a WT1 Antigen-Specific Cancer Immunotherapeutic (WT1 ASCI) as post-consolidation therapy in adult patients with WT1-positive Acute Myeloid Leukemia in first complete remission. It will also be analyzed to what extent this treatment induces an immune response, specific to the malignancy.

location_country:
United States
France


title: A 3-year, Multicenter, Double-blind, Randomized, Placebo-controlled Extension to CZOL446H2301E1 to Evaluate the Efficacy and Long Term Safety of 6 and 9 Years Zoledronic Acid Treatment of Postmenopausal Women With Osteoporosis

lead_sponsor: Novartis Pharmaceuticals

location_country:
Poland
Hong Kong
Colombia
Italy
Australia
New Zealand
Argentina
Canada
Finland
Switzerland
Sweden
Hungary
Thailand
United States
France
Belgium
Norway
Germany

summary: This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis


title: A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057

lead_sponsor: Human Genome Sciences Inc., a GSK Company

ReferenceCitation: Bruce IN, Urowitz M, van Vollenhoven R, Aranow C, Fettiplace J, Oldham M, Wilson B, Molta C, Roth D, Gordon D. Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care. Lupus. 2016 Jun;25(7):699-709. doi: 10.1177/0961203315625119. Epub 2016 Mar 1.

ReferenceCitation: van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.

ReferenceCitation: Urowitz MB, Ohsfeldt RL, Wielage RC, Dever JJ, Zakerifar M, Asukai Y, Ramachandran S, Joshi AV. Comparative analysis of long-term organ damage in patients with systemic lupus erythematosus using belimumab versus standard therapy: a post hoc longitudinal study. Lupus Sci Med. 2020 Oct;7(1). pii: e000412. doi: 10.1136/lupus-2020-000412.

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

location_country:
Spain
Italy
United Kingdom
Peru
Belgium
Philippines
Romania
Czechia
Poland
Hong Kong
Austria
Russian Federation
Argentina
Puerto Rico
India
Israel
Mexico
Sweden
Slovakia
Brazil
Canada
Germany
Taiwan
Korea, Republic of
France
Chile
Colombia
Netherlands

summary: This is a long-term continuation study to provide continuing treatment to subjects with SLE.


title: A Phase 2, Multicenter, Randomized, Double-Blind, Comparative Study Of The Safety And Efficacy of 2 Doses Of Tigecycline Versus Imipenem/Cilastatin For The Treatment Of Subjects With Hospital-Acquired Pneumonia

summary:
This study will compare the safety and efficacy of a tigecycline regimen versus an imipenem/cilastatin regimen for the treatment of subjects who are hospitalized with hospital-acquired pneumonia (HAP). At least 70% of enrolled subjects will have ventilator-associated pneumonia (VAP). Two dose levels of tigecycline will be assessed and compared to imipenem/cilastatin in parallel. Subjects will receive intravenous therapy from a minimum of 7 & up to 14 consecutive days, the exact duration will be at the decision of the investigator based on the subject's condition. Additional protocol specified antibiotics may be given to ensure appropriate coverage. A final assessment at test-of-cure (TOC) visit will be done 10 to 21 days after the last day of therapy. The total duration of subject participation will be between 17 and 44 days, including a follow up period of 30 days after the last day of therapy for SAEs.

Subjects will be followed for safety and efficacy. The safety assessment will include: physical examinations, vital signs, assessment of the clinical signs and symptoms of pneumonia, collection of adverse events, 12-lead ECG, collection of samples for hematology, serum chemistries, and coagulation parameters, & a serum or urine pregnancy test before study entry for women of childbearing potential. The clinical and microbiological efficacy will both be evaluated.

ReferenceCitation: Ramirez J, Dartois N, Gandjini H, Yan JL, Korth-Bradley J, McGovern PC. Randomized phase 2 trial to evaluate the clinical efficacy of two high-dosage tigecycline regimens versus imipenem-cilastatin for treatment of hospital-acquired pneumonia. Antimicrob Agents Chemother. 2013 Apr;57(4):1756-62. doi: 10.1128/AAC.01232-12. Epub 2013 Jan 28.

lead_sponsor: Pfizer

location_country:
Croatia
Taiwan
Brazil
Latvia
Russian Federation
Australia
Argentina
Canada
Hungary
Korea, Republic of
United States
Chile
France
Colombia


title: Study to Evaluate the Safety of GSK Biologicals' Herpes Simplex Candidate Vaccine (gD2t) With MPL in HSV Seropositive or Seronegative Subjects Without Genital Herpes Disease

summary: This study will evaluate, versus a placebo, the safety of Herpes simplex candidate vaccine with adjuvant in initially HSV seropositive or seronegative subjects who have no genital herpes disease.

lead_sponsor: GlaxoSmithKline

location_country:
Denmark
Spain
Austria
Australia
Canada
Switzerland
Puerto Rico
United States
France
South Africa
Belgium
Germany


title: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date

summary: The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.

ReferenceCitation: Hughes JR, Russ C, Messig MA. Association of deferring a quit attempt with smoking cessation success: a secondary analysis. J Subst Abuse Treat. 2014 Feb;46(2):264-7. doi: 10.1016/j.jsat.2013.08.015. Epub 2013 Sep 24.

ReferenceCitation: Rennard S, Hughes J, Cinciripini PM, Kralikova E, Raupach T, Arteaga C, St Aubin LB, Russ C; Flexible Quit Date Study Group. A randomized placebo-controlled trial of varenicline for smoking cessation allowing flexible quit dates. Nicotine Tob Res. 2012 Mar;14(3):343-50. doi: 10.1093/ntr/ntr220. Epub 2011 Nov 11.

location_country:
Taiwan
Brazil
United Kingdom
Italy
Argentina
Canada
Czech Republic
Hungary
Korea, Republic of
United States
France
China
Mexico
Germany


title: A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide (TAC) Versus 5-fluorouracil in Combination With Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of Operable Breast Cancer Patients With Positive Axillary Lymph Nodes.

summary: The purpose of this study was to compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary lymph nodes.

ReferenceCitation: Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C; Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005 Jun 2;352(22):2302-13.

ReferenceCitation: Mackey JR, Martin M, Pienkowski T, Rolski J, Guastalla JP, Sami A, Glaspy J, Juhos E, Wardley A, Fornander T, Hainsworth J, Coleman R, Modiano MR, Vinholes J, Pinter T, Rodríguez-Lescure A, Colwell B, Whitlock P, Provencher L, Laing K, Walde D, Price C, Hugh JC, Childs BH, Bassi K, Lindsay MA, Wilson V, Rupin M, Houé V, Vogel C; TRIO/BCIRG 001 investigators. Adjuvant docetaxel, doxorubicin, and cyclophosphamide in node-positive breast cancer: 10-year follow-up of the phase 3 randomised BCIRG 001 trial. Lancet Oncol. 2013 Jan;14(1):72-80. doi: 10.1016/S1470-2045(12)70525-9. Epub 2012 Dec 12.

location_country:
Poland
Brazil
Portugal
Spain
Greece
Austria
United Kingdom
Argentina
Canada
Czech Republic
Sweden
Hungary
Uruguay
United States
France
Israel
South Africa
Germany
Slovakia
Egypt

location_facility:
sanofi-aventis Administrative office
Sanofi-Aventis Administrative Office
Sanofi-aventis administrative office
Sanofi-aventis adminsitrative office


title: Clinical Phase I/IIA Study of Subcutaneously Administration of Ofatumumab in Rheumatoid Arthritis Patients on Stable Dose Methotrexate

summary: This study will examine the safety and tolerability, PK and PD of subcutaneously administered GSK1841157 in patients with RA on stable dose Methotrexate. The study comprises a single dose escalation/de-escalation phase to investigate the minimal efficacious dose based on PD markers with an acceptable safety profile.

ReferenceCitation: Kurrasch R, Brown JC, Chu M, Craigen J, Overend P, Patel B, Wolfe S, Chang DJ. Subcutaneously administered ofatumumab in rheumatoid arthritis: a phase I/II study of safety, tolerability, pharmacokinetics, and pharmacodynamics. J Rheumatol. 2013 Jul;40(7):1089-96. doi: 10.3899/jrheum.121118. Epub 2013 Jun 1.

location_country:
Poland
Spain
Italy
Russian Federation
Australia
New Zealand
United States
France
Belgium


title: An Open Label, Dose Titration of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphatemic Chronic Kidney Disease Patients Not On Dialysis

summary: Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 20 sites within Europe and 5-10 in Australia. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is an effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 14 weeks.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Denmark
United Kingdom
Australia
France
Germany

location_facility: Universitätsklinikum Aachen, Medizinsche Klinik II

location_facility: Renal Unit, The Queen Elizabeth Hospital

location_facility: The Royal Melbourne Hospital, Department of Nephrology

location_facility: Stadt Klinken Solingen, Klinik für Nephrologie und Allgemeine Innere Medizin

location_facility: Nephrology Department, Princess Alexandra Hospital

location_facility: Medicinsk Afdeling, nefrologisk, Roskilde Sygehus

location_facility: Melbourne Renal Research Group, Epworth Medical Centre

location_facility: Renal Dialysis Unit, Manchester Royal Infirmary

location_facility: Renal Research Unit, Launceston General Hospital

location_facility: Department of Renal Medicine, Hope Hospital

location_facility: Renal Department, The Royal London Hospital

location_facility: Birmingham Hospital, Queen Elizabeth Medical Centre


title: A Randomized, Double-Blind, Placebo-controlled Trial of Long-term (2-year) Treatment of Galantamine in Mild to Moderately-Severe Alzheimer's Disease

summary: The purpose of this study is to compare the effectiveness and safety of 2 years of treatment with galantamine as compared with placebo of patients who have mild to moderately severe Alzheimer's disease (AD).

ReferenceCitation: Hager K, Baseman AS, Nye JS, Brashear HR, Han J, Sano M, Davis B, Richards HM. Effect of concomitant use of memantine on mortality and efficacy outcomes of galantamine-treated patients with Alzheimer's disease: post-hoc analysis of a randomized placebo-controlled study. Alzheimers Res Ther. 2016 Nov 15;8(1):47.

ReferenceCitation: Hager K, Baseman AS, Nye JS, Brashear HR, Han J, Sano M, Davis B, Richards HM. Effects of galantamine in a 2-year, randomized, placebo-controlled study in Alzheimer's disease. Neuropsychiatr Dis Treat. 2014 Feb 21;10:391-401. doi: 10.2147/NDT.S57909. eCollection 2014. Erratum in: Neuropsychiatr Dis Treat. 2014;10:1997.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Slovenia
Greece
Latvia
Estonia
Russian Federation
Lithuania
Czech Republic
Ukraine
France
Romania
Germany
Slovakia


title: Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation

summary: This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.

lead_sponsor: Bausch Health Americas, Inc.

location_country:
Portugal
United Kingdom
Italy
Australia
Mexico
Canada
United States
France
Belgium
Germany

location_facility:
Salix Investigational Site
Pfizer Investigational Site


acronym: eXplore

title: A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Trial to Explore the Effects of 78 Weeks Omalizumab Treatment Given as Add on Therapy on Markers of Airway Inflammation and Remodeling in Patients With Moderate to Severe Persistent Allergic Asthma Receiving Inhaled Corticosteroids and Long Acting Beta-agonists

location_country:
United Kingdom
Netherlands
Canada
Sweden
United States
France
Germany

summary: This study aims to investigate the effect of omalizumab on the number of tissue eosinophils and other markers of airway inflammation and remodeling, including thickness of the lamina reticularis, in moderate to severe asthmatics with persistent symptoms and evidence of airway inflammation despite treatment with inhaled corticosteroids and long acting beta-agonists. This study will also investigate the correlation between systemic and pulmonary inflammation, and the correlation between clinical outcomes and changes within the tissue, to assist in the future identification of patients with tissue eosinophilia and their response to treatment, without the need for invasive bronchoscopy.


title: Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis

acronym: MORE

summary: To study the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without existing vertebral fractures.

ReferenceCitation: Melamed ML, Blackwell T, Neugarten J, Arnsten JH, Ensrud KE, Ishani A, Cummings SR, Silbiger SR. Raloxifene, a selective estrogen receptor modulator, is renoprotective: a post-hoc analysis. Kidney Int. 2011 Jan;79(2):241-9. doi: 10.1038/ki.2010.378. Epub 2010 Oct 6.

lead_sponsor: Eli Lilly and Company

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Poland
Slovenia
Austria
Australia
Argentina
Israel
Mexico
Norway
Singapore
Sweden
Slovakia
Canada
Hungary
Germany
Denmark
New Zealand
Finland
Czech Republic
France
Netherlands

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


title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients With Rheumatoid Arthritis Who Have Failed at Least One Biologic

summary: The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) Inhibitor, R935788 (R788) at a dose of 100 mg, tablet, orally, twice-a-day is effective in the treatment of Rheumatoid Arthritis in patients who have 'failed' a biologic therapy.

lead_sponsor: Rigel Pharmaceuticals

location_country:
Belgium
Italy
United States
France
Peru
Colombia
Germany

location_facility: Azienda Ospedaliera Santa Maria della Miseri

location_facility: Clinical Research Center of Reading, LLP

location_facility: Arthritis & Rheumatic Disease Specialties

location_facility: Memorial Medical Group Clinical Research Inst

location_facility: North Shore Long Island Jewich Health System

location_facility: Rheumazentrum am Universitatsklinikum Leipzig

location_facility: Reumatologia Azienda Ospedaliera Universitaria

location_facility: The Osteoporosis & Clinical Trials Center


title: Randomized, Double-Blind, Multicenter, Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA

summary: To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such as pain and swelling.

location_country:
Denmark
Brazil
Portugal
Slovenia
Spain
Russian Federation
Mexico
Canada
Sweden
United States
France
Peru
Belgium
Germany
Slovakia


title: A Multinational, Multi-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over

summary: To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day [TID]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.

ReferenceCitation: Wirostko BM, Tressler C, Hwang LJ, Burgess G, Laties AM. Ocular safety of sildenafil citrate when administered chronically for pulmonary arterial hypertension: results from phase III, randomised, double masked, placebo controlled trial and open label extension. BMJ. 2012 Feb 21;344:e554. doi: 10.1136/bmj.e554.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Czechia
Poland
Hong Kong
Australia
Israel
Mexico
Norway
Malaysia
Singapore
Sweden
Brazil
Hungary
Germany
Denmark
Korea, Republic of
France
Netherlands


title: A Phase II Study Assessing the Activity of Valproate Acid Plus Doxorubicin in Refractory or Recurrent Malignant Mesothelioma

summary: The purpose of this study is to determine the response rate to the combination of doxorubicin and valproate acid in patients with MM failing after at least one previous chemotherapy regimen including platinum derivatives .

ReferenceCitation: Scherpereel A, Berghmans T, Lafitte JJ, Colinet B, Richez M, Bonduelle Y, Meert AP, Dhalluin X, Leclercq N, Paesmans M, Willems L, Sculier JP; European Lung Cancer Working Party (ELCWP). Valproate-doxorubicin: promising therapy for progressing mesothelioma. A phase II study. Eur Respir J. 2011 Jan;37(1):129-35. doi: 10.1183/09031936.00037310. Epub 2010 Jun 7.

lead_sponsor: European Lung Cancer Working Party

location_country: France Belgium

location_facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

location_facility: Department of Pneumology Hôpital Ixelles-Molière

location_facility: Department of Pneumology CHR St joseph - Warquignies

location_facility: Department of Pneumology Hôpital Saint-Joseph


title: Post-authorization Safety Study to Prospectively Monitor the Incidence of Relevant Drug-related Adverse Events and EPO-related Lack of Efficacy Among CKD Subjects Receiving HX575 Recombinant Human Erythropoietin Alfa i.v.

acronym: EPO-PASS

summary: Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney Disease (CKD) subjects receiving HX575 epoetin alfa i.v.

ReferenceCitation: Hörl WH, Locatelli F, Haag-Weber M, Ode M, Roth K; Epo-PASS study group. Prospective multicenter study of HX575 (biosimilar epoetin-α) in patients with chronic kidney disease applying a target hemoglobin of 10--12 g/dl. Clin Nephrol. 2012 Jul;78(1):24-32.

ipd_sharing: Undecided

lead_sponsor: Sandoz

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Multiprofile Hospital for Active Treatment Dr. Kiro Popov

location_facility: Praxis für Innere Medizin und Nephrologie

location_facility: U.O. Nefrologia e Dialisi, P.O. Ospedale Casati, Centro Dialisi

location_facility: Radomski Szpital Specjalistyszny im. Dr Tytusa Chalubinskiego

location_facility: Ternopilska Oblasna Klinichna Likarnia, Viddilennia Nefrologii ta Gemodializu

location_facility: Facharzt für Innere Medizin und Nephrologie, Dialyse Centrum

location_facility: Tsentralnyi miskyi klinichnyi hospital, Viddilennia gemodializu

location_facility: Miska klinichna likarnia#3, Miskyi nefrologichnyi tsentr

location_facility: U.O.C. Nefrologia e Dialisi, C.G. Mazzoni

location_facility: Azienda Ospedaliera ospedale S. Salvatore

location_facility: Oblasna klinichna likarnia imeni I.I.Mechnikova

location_facility: FGUZ Clinical hospital No. 83 of FMBA of Russia

location_facility: Nieren- und Diabeteszentrum Viersen-Nettetal

location_facility: Multiprofile Hospital for Active Treatment Dr. Tota Venkova

location_facility: Ministry of Interior-Central Clinical Base

location_facility: Azienda Ospedaliera CTO - Maria Adelaide

location_facility: Wojewodzki Szpital Specjalistyczny im. Najswietszej maryi Panny

location_facility: Instytut nefrologii AMN Ukrainy viddil nefrologii ta dializu

location_facility: Mykolaivska Oblasna Klinichna Likarnia, Viddilennia Gemodializu

location_facility: Ospedaliero Universitaria Policlinico S. Orsola Malpighi

location_facility: Multiprofile Hospital for Active Treatment Sv. Ivan Rilski

location_facility: Universitaria Degli Studi di Genova Clinica Nefrologica, Dialisi e Trapianto

location_facility: Fachpraxis für Nieren und Hochdruckerkrankungen

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej AVITUM

location_facility: Azienda Ospdealiero "Istituti Ospitalieri"

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4

location_facility: KfH Kuratorium für Nierentranplantation und Dialyse e.V.

location_facility: Oblasna klinikchna likarnia, tsentr transplantologii ta gemodializu

location_facility: Azienda Ospedaliera Ospedale San Carlo Borromeo

location_facility: Szpital Powiatowy im. Lekarza Z. Koprowskiego

location_facility: Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel

location_facility: Multiprofile Hospital for Active Treatment Rousse

location_facility: Szpital Specjalistyczny Sw. W. Adalberta

location_facility: Samodzielnym Publicznym Zakladzie Opieki Zdrowotnej Dzialdowo

location_facility: Universitätsklinik für Innere Medizin III

location_facility: Specjalistyczny Szpital Wojewodzki w Ciechanowie

location_facility: PHO Clinical Hospital Dr. Trifun Panovski

location_facility: Azienda Ospedaliera Carlo Poma di Mantova

location_facility: Alwall Praxis für Nieren- und Hochdruckkrankheiten

location_facility: Dialysezentrum und Schwerpunktpraxis für Nieren- und Hochdruckerkrankungen

location_facility: Diabetes- und Dialysezentrum Merker, Vogt

location_facility: Kuratorium ür Dialyse und Nierentransplantation e.V.

location_facility: GUZ "Yaroslavl regional clinical hospital"

location_facility: Multiprofile Hospital for Active Treatment Pazardzhik

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca Granda

location_facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.


title: A Single-Masked, Randomized, Multi-Center, 2-Arm Parallel Study Comparing the Safety and Effectiveness of Bulkamid® and Contigen® as Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

summary: The primary purpose of this study is to demonstrate the safety and effectiveness of Bulkamid® in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence

lead_sponsor: Contura

location_country:
United States
Canada
France

location_facility: University of Miami and Jackson Memorial Hospital

location_facility: UT Southwestern Medical Center at Dallas - Department of Urology

location_facility: University of Vermont - The Continence Center

location_facility: Medical University of South Carolina - Department of Urology

location_facility: Virgina Mason Medical Center - Section of Urology and Renal Transplantation

location_facility: Hospital for the University of Pennsylvannia - Penn Center for Continence and Public Health: Division of Urology

location_facility: Stanford UniveritySchool of Medicine - Departmert of OB/GYN

location_facility: Midwest Institute for Research & Education

location_facility: South California Permanente Medical Group

location_facility: Tower Urology - Institute for Continence - Cedars-Sinai Medical Office


acronym: STEP

title: Sorafenib Long Term Extension Program

lead_sponsor: Bayer

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Poland
Taiwan
Brazil
Hong Kong
Spain
Colombia
Italy
Australia
New Zealand
Canada
United Kingdom
Ukraine
Korea, Republic of
United States
France
China
Belgium
Germany
Bulgaria

summary:
The primary purpose of program was to enable patients, currently receiving sorafenib (Nexavar) in a Bayer/Onyx sponsored clinical trial, to continue sorafenib treatment after their respective study had met its primary endpoint and/or had reached the end as defined in the original protocol. Patients were able to continue treatment until (i) the treating physician felt the patient was no longer benefiting from the treatment or (ii) the treatment becomes commercially available and reimbursed for the respective indication as applicable in the country in which the patient lived and the patient could obtain suitable amounts of drug for treatment through standard mechanisms of commercial availability (ie, there should be no interruption in the patient's treatment schedule when switching to commercially available product) or (iii) the patient could join a Post-Trial-Access Program, another study or can receive sorafenib through any other mechanism (e.g. local access program) in accordance with local legal and compliance rules, with no cost to the patient with respect to sorafenib.

An additional objective was the assessment of the safety of Nexavar or Nexavar combination treatment.


title: A Two-arm, Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Evaluate Safety and Tolerability and to Explore the Neuroprotective Effect of Atacicept as Assessed by Optical Coherence Tomography (OCT) in Subjects With Optic Neuritis (ON) as Clinically Isolated Syndrome (CIS) Over a 36-week Treatment Course

summary: This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS. The study was randomized. Study medication was administered via subcutaneous (under the skin) injections.

lead_sponsor: EMD Serono

location_country:
Spain
United Kingdom
Australia
Lebanon
Canada
Czech Republic
Switzerland
United States
France
Belgium
Germany


title: A Multicenter, Open-Label, Randomized Study Comparing Efficacy and Safety of S-1 as Single Agent Versus 5-FU Bolus for the Treatment of Patients With Metastatic Pancreatic Cancer Previously Treated With a Gemcitabine-Based Regimen

acronym: S-1 Pancreas

summary:
The primary objective of this study is to determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy.

The secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of S-1.

lead_sponsor: Sanofi

location_country:
Denmark
Brazil
Romania
Greece
Austria
Canada
Tunisia
Guatemala
Hungary
Sweden
United States
Costa Rica
France
Israel
Panama
Peru
South Africa


acronym: AVERT

summary: The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).

ReferenceCitation: Schaff H, Carrel T, Steckelberg JM, Grunkemeier GL, Holubkov R. Artificial Valve Endocarditis Reduction Trial (AVERT): protocol of a multicenter randomized trial. J Heart Valve Dis. 1999 Mar;8(2):131-9.

ReferenceCitation: Dávila-Román VG, Waggoner AD, Kennard ED, Holubkov R, Jamieson WR, Englberger L, Carrel TP, Schaff HV; Artificial Valve Endocarditis Reduction Trial echocardiography study. Prevalence and severity of paravalvular regurgitation in the Artificial Valve Endocarditis Reduction Trial (AVERT) echocardiography study. J Am Coll Cardiol. 2004 Oct 6;44(7):1467-72.

ReferenceCitation: Schaff HV, Carrel TP, Jamieson WR, Jones KW, Rufilanchas JJ, Cooley DA, Hetzer R, Stumpe F, Duveau D, Moseley P, van Boven WJ, Grunkemeier GL, Kennard ED, Holubkov R; Artificial Valve Endocarditis Reduction Trial. Paravalvular leak and other events in silzone-coated mechanical heart valves: a report from AVERT. Ann Thorac Surg. 2002 Mar;73(3):785-92.

ReferenceCitation: Englberger L, Carrel T, Schaff HV, Kennard ED, Holubkov R; AVERT Investigators. Differences in heart valve procedures between North American and European centers: a report from the Artificial Valve Endocarditis Reduction Trial (AVERT). J Heart Valve Dis. 2001 Sep;10(5):562-71.

ReferenceCitation: Englberger L, Schaff HV, Jamieson WR, Kennard ED, Im KA, Holubkov R, Carrel TP; AVERT Investigators. Importance of implant technique on risk of major paravalvular leak (PVL) after St. Jude mechanical heart valve replacement: a report from the Artificial Valve Endocarditis Reduction Trial (AVERT). Eur J Cardiothorac Surg. 2005 Dec;28(6):838-43. Epub 2005 Nov 7.

lead_sponsor: Abbott Medical Devices

location_country:
Spain
Italy
Netherlands
Canada
Switzerland
United States
France
Germany

location_facility:
Mayo Clinic
Fond Ne Centro S. Raffaele
University of British Columbia
Texas Heart Institute
Hospital 12 de Octubre
LDS Hospital
Deutches Herzzentrum Berlin
Florida Heart Group
Hôpital G. Et R. Laënnec
St. Antonius Ziekenhuis
Hopital Regional-Service de Cardiologie
University of Alberta Hospital
Sisters of Providence Health System
Brigham and Womens Hospital
Inselspital
Massachusetts General Hospital


title: A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Rimonabant 20 mg Daily for the Treatment of Type 2 Diabetic Patients With Nonalcoholic Steatohepatitis (NASH).

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Romania
Philippines
Belgium
Poland
Portugal
Australia
Argentina
Puerto Rico
Mexico
Malaysia
Brazil
Switzerland
Hungary
China
Germany
Taiwan
France
Chile
Colombia

summary: The purpose of this study is to assess the effect of rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH) in patients with Type 2 diabetes.


title: A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Rimonabant 20 mg Daily for the Treatment of Non-diabetic Patients With Nonalcoholic Steatohepatitis (NASH)

summary: The purpose of this study is to assess the effect of Rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH).


title: A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer

acronym: VANILLA

summary:
The main objective of the study was to evaluate the effectiveness of aflibercept treatment by comparison to placebo in increasing the overall survival (OS) in participants with metastatic pancreatic cancer, treated with gemcitabine.

The secondary objectives were to evaluate progression free survival, clinical benefit, overall response, safety and immunogenicity of aflibercept, in the two treatment arms (Arm 1: Aflibercept and Gemcitabine; Arm 2: Placebo and Gemcitabine).

The study included an interim analysis of OS. In accordance with the study protocol, an interim analysis was performed for the purpose of futility and overwhelming efficacy. On the basis of the interim analysis, the Data Monitoring Committee (DMC) recommended that this study be terminated for futility based on predefined boundary rules.

ReferenceCitation: Rougier P, Riess H, Manges R, Karasek P, Humblet Y, Barone C, Santoro A, Assadourian S, Hatteville L, Philip PA. Randomised, placebo-controlled, double-blind, parallel-group phase III study evaluating aflibercept in patients receiving first-line treatment with gemcitabine for metastatic pancreatic cancer. Eur J Cancer. 2013 Aug;49(12):2633-42. doi: 10.1016/j.ejca.2013.04.002. Epub 2013 Apr 30.

location_country:
Spain
Italy
United States
Romania
Belgium
Poland
Austria
Russian Federation
Argentina
Puerto Rico
India
Mexico
Slovakia
Cyprus
Canada
Switzerland
Hungary
Germany
Bulgaria
Greece
Czech Republic
France
Chile
Colombia


acronym: TAMARIS

title: A Randomized Double-Blind Placebo-Controlled Parallel Group Study of the Efficacy and Safety of XRP0038/NV1FGF on Amputation or Any Death in Critical Limb Ischemia Patients With Skin Lesions

ReferenceCitation: Van Belle E, Nikol S, Norgren L, Baumgartner I, Driver V, Hiatt WR, Belch J. Insights on the role of diabetes and geographic variation in patients with critical limb ischaemia. Eur J Vasc Endovasc Surg. 2011 Sep;42(3):365-73. doi: 10.1016/j.ejvs.2011.04.030. Epub 2011 Jun 21.

ReferenceCitation: Belch J, Hiatt WR, Baumgartner I, Driver IV, Nikol S, Norgren L, Van Belle E; TAMARIS Committees and Investigators. Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemia. Lancet. 2011 Jun 4;377(9781):1929-37. doi: 10.1016/S0140-6736(11)60394-2. Epub 2011 May 28.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
South Africa
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Turkey
Mexico
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Belarus
Greece
Estonia
Finland
Czech Republic
Korea, Republic of
France
Chile

summary:
Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin lesions.

Secondary objectives are to evaluate:

The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major amputation;
The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death;
The safety of riferminogene pecaplasmid in the study population.


title: SOLE, Study of Letrozole Extension, A Phase III Trial Evaluating the Role of Continuous Letrozole Versus Intermittent Letrozole Following 4 to 6 Years of Prior Adjuvant Endocrine Therapy for Postmenopausal Women With Hormone-Receptor Positive, Node Positive Early Stage Breast Cancer

acronym: SOLE

summary:
RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen of letrozole is more effective in postmenopausal women who have received hormone therapy for early-stage breast cancer.

PURPOSE: This randomized phase III trial is comparing two different regimens of letrozole in preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for hormone receptor-positive, lymph node-positive, early-stage breast cancer.

ReferenceCitation: Guerini-Rocco E, Gray KP, Fumagalli C, Reforgiato MR, Leone I, Rafaniello Raviele P, Munzone E, Kammler R, Neven P, Hitre E, Jerusalem G, Simoncini E, Gombos A, Deleu I, Karlsson P, Aebi S, Chirgwin J, Di Lauro V, Thompson A, Graas MP, Barber M, Fontaine C, Loibl S, Gavilá J, Kuroi K, Müller B, O'Reilly S, Di Leo A, Goldhirsch A, Viale G, Barberis M, Regan MM, Colleoni M. Genomic Aberrations and Late Recurrence in Postmenopausal Women with Hormone Receptor-positive Early Breast Cancer: Results from the SOLE Trial. Clin Cancer Res. 2021 Jan 15;27(2):504-512. doi: 10.1158/1078-0432.CCR-20-0126. Epub 2020 Oct 20.

ReferenceCitation: Colleoni M, Luo W, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Hitre E, Graas MP, Simoncini E, Kamby C, Thompson A, Loibl S, Gavilá J, Kuroi K, Marth C, Müller B, O'Reilly S, Di Lauro V, Gombos A, Ruhstaller T, Burstein H, Ribi K, Bernhard J, Viale G, Maibach R, Rabaglio-Poretti M, Gelber RD, Coates AS, Di Leo A, Regan MM, Goldhirsch A; SOLE Investigators. Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):127-138. doi: 10.1016/S1470-2045(17)30715-5. Epub 2017 Nov 17.

lead_sponsor: ETOP IBCSG Partners Foundation

location_country:
Denmark
Spain
Italy
Austria
Australia
New Zealand
Russian Federation
United Kingdom
Switzerland
Sweden
Hungary
United States
Chile
France
India
Belgium
Japan
Germany
Peru
South Africa

location_facility: Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Allgemeinen Krankenhaus Celle Kinderklinik

location_facility: Hospital Clinico Regional de Valdivia at University Austral de Chile

location_facility: Kumamoto University Faculty of Medical and Pharmaceutical Sciences

location_facility: Praxis Dr. Wilke - Onkologie am Klinikum Fuerth

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Brustzentrum Thurgau at Kantonsspital Frauenfeld

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: National Institute of Oncology - Budapest

location_facility: Karolinska University Hospital - Huddinge

location_facility: Algemeen Ziekenhuis Sint-Maarten - Campus Rooiberg

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Centre Hospitalier Universitaire Vaudois

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

location_facility: Hospital Santiago Oriente Dr. Luis Tisne Brousse

location_facility: Aarhus Universitetshospital - Aarhus Sygehus

location_facility: Gemeinschaftspraxis Gynaekologie & Geburtshilfe

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Russian Academy of Medical Sciences Cancer Research Center

location_facility: Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Copenhagen County Herlev University Hospital


title: A Study of INT 747 (6α-ethyl Chenodeoxycholic Acid (6-ECDCA)) in Combination With Ursodeoxycholic Acid (URSO®, UDCA) in Patients With Primary Biliary Cirrhosis

summary: The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.

ReferenceCitation: Hirschfield GM, Mason A, Luketic V, Lindor K, Gordon SC, Mayo M, Kowdley KV, Vincent C, Bodhenheimer HC Jr, Parés A, Trauner M, Marschall HU, Adorini L, Sciacca C, Beecher-Jones T, Castelloe E, Böhm O, Shapiro D. Efficacy of obeticholic acid in patients with primary biliary cirrhosis and inadequate response to ursodeoxycholic acid. Gastroenterology. 2015 Apr;148(4):751-61.e8. doi: 10.1053/j.gastro.2014.12.005. Epub 2014 Dec 11.

lead_sponsor: Intercept Pharmaceuticals

location_country:
Spain
United Kingdom
Austria
Netherlands
Canada
United States
France
Germany

location_facility: Centre de Recherche du CHUM / University of Montreal

location_facility: University of Miami - Center for Liver Diseases

location_facility: University Medical Centre Hamburg-Eppendorf


title: A Phase 3 Randomized, Placebo-Controlled, CLinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia

lead_sponsor: Sunovion

ReferenceCitation: Nasrallah HA, Silva R, Phillips D, Cucchiaro J, Hsu J, Xu J, Loebel A. Lurasidone for the treatment of acutely psychotic patients with schizophrenia: a 6-week, randomized, placebo-controlled study. J Psychiatr Res. 2013 May;47(5):670-7. doi: 10.1016/j.jpsychires.2013.01.020. Epub 2013 Feb 17.

ReferenceCitation: Hopkins SC, Ogirala A, Worden M, Koblan KS. Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS. Clin Drug Investig. 2021 Dec;41(12):1067-1073. doi: 10.1007/s40261-021-01094-7. Epub 2021 Nov 9.

ReferenceCitation: Correll CU, Cucchiaro J, Silva R, Hsu J, Pikalov A, Loebel A. Long-term safety and effectiveness of lurasidone in schizophrenia: a 22-month, open-label extension study. CNS Spectr. 2016 Oct;21(5):393-402. Epub 2016 Apr 6.

ReferenceCitation: Nasrallah HA, Cucchiaro JB, Mao Y, Pikalov AA, Loebel AD. Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies. CNS Spectr. 2015 Apr;20(2):140-7. doi: 10.1017/S1092852914000285. Epub 2014 Jun 23.

location_country:
Russian Federation
Ukraine
India
United States
France
Romania
Malaysia

location_facility: Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"

location_facility: Dnipropetrovsk Regional Clinical Hospital named Mechnikov

location_facility: City Psychiatric Hospital #3 of Skvortsov-Stepanov

location_facility: Spitalul Clinic Judetean de Urgenta Arad

location_facility: Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy

location_facility: California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road

location_facility: Bekhterev Psychoneurological Research Institute

location_facility: City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets

location_facility: Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3

location_facility: City Psychoneurological Dispensary #7 (with Hospital)

location_facility: Segal Institute for Clinical Research, Fidelity Clinical Research, Inc.

location_facility: Centrul de Recuperare si Reabilitare Gura Ocnitei

location_facility: Madras Medical College & Government General Hospital

location_facility: Lv. St. Med. Univ. n. af. D. Halytskiy Oblast Clin. Psychon. Hosp

location_facility: Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1

location_facility: K&S Professional Research Services, LLC.

location_facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia

summary: Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.


title: PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER EFFICACY AND SAFETY STUDY OF TANEZUMAB AS ADD-ON THERAPY TO OPIOID MEDICATION IN PATIENTS WITH PAIN DUE TO BONE METASTASES

lead_sponsor: Pfizer

ReferenceCitation: Sopata M, Katz N, Carey W, Smith MD, Keller D, Verburg KM, West CR, Wolfram G, Brown MT. Efficacy and safety of tanezumab in the treatment of pain from bone metastases. Pain. 2015 Sep;156(9):1703-1713. doi: 10.1097/j.pain.0000000000000211.

ReferenceCitation: Bapat AA, Hostetter G, Von Hoff DD, Han H. Perineural invasion and associated pain in pancreatic cancer. Nat Rev Cancer. 2011 Sep 23;11(10):695-707. doi: 10.1038/nrc3131. Review.

location_country:
Croatia
Bosnia and Herzegovina
Poland
Latvia
Austria
Hungary
Korea, Republic of
United States
France
India
Peru
Mexico
Slovakia

location_facility: Fovarosi Onkormanyzat Jahn Ferenc Del-pesti Korhaz - Fajdalom Ambulancia

location_facility: Fovarosi Onkormanyzat Peterfy Sandor Utcai Korhaz - Fajdalom Ambulancia

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: WK River Cities Clinical Research Center

location_facility: Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center

location_facility: Medical University of South Carolina, Department of Urology

location_facility: Hospicjum im. Ks. Eugeniusza Dutkiewicza SAC w Gdansku

location_facility: Fejer Megyei Szt. Gyorgy Korhaz - Rendelointezet/Aneszteziologiai es Intenziv Betegellato Osztaly

location_facility: Rajiv Gandhi Cancer Institute and Research Centre,

location_facility: Chhatrapati Shahuji Maharaj Medical University

location_facility: Willis Knighton Pierremont Health Center

location_facility: Huntsman Cancer Institute at the University of Utah

location_facility: Fakultna Nemocnica s Poliklinikou F.D.Roosevelta

location_facility: Poradnia Medycyny Paliatywnej, Hospicjum Palium

location_facility: 10th Department, Latvian Oncological Centre / Riga Eastern Clinical University Hospital

location_facility: Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine

location_facility: Landeskrankenhaus Graz - Universitaetsklinik fuer Orthopaedie und Orthopaedische Chirurgie

location_facility: Shri Siddhivinayak Ganpati Cancer Hospital

location_facility: Institute of Oncology, University Clinical Center Sarajevo

location_facility: Krankenhaus der Elisabethinen Linz, Institut fuer Anaesthesiologie und Intensivmedizin

summary: The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.


title: Extension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis

summary: To assess the long-term effects of early therapeutic intervention, i.e. within two years following a first clinical demyelinating event suggestive of MS.

ReferenceCitation: Nagtegaal GJ, Pohl C, Wattjes MP, Hulst HE, Freedman MS, Hartung HP, Miller D, Montalban X, Kappos L, Edan G, Pleimes D, Beckman K, Stemper B, Polman CH, Sandbrink R, Barkhof F. Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome. Mult Scler. 2014 Feb;20(2):234-42. doi: 10.1177/1352458513494491. Epub 2013 Jul 10.

location_country:
Denmark
Poland
Slovenia
Italy
Austria
Netherlands
Spain
Canada
Czech Republic
Finland
Switzerland
Sweden
Hungary
France
Israel
Belgium
Norway
Germany