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• Authorised

• ‘Stem cell Trial of recovery EnhanceMent after Stroke 2’ (STEMS2) pilot randomised placebo-controlled trial of granulocyte-colony stimulating factor in mobilising bone marrow stem cells in sub-acute stroke. - STEMS2
• Ischaemic and Haemorrhagic Stroke MedDRA version: 8.1 Level: LLT Classification code 10042244 Term: Stroke
• United Kingdom
• 2007-01-26

• Authorised

• An Open Multi-centre Study to Investigate the Safety and Efficacy of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and von Willebrand Factor Concentrate, in Patients with von Willebrand Disease who are Undergoing Surgery - A Study with OPTIVATE® in von Willebrand Disease Patients Who are Having Surgery
• von Willebrand disease
• United Kingdom
• 2006-12-07

• Authorised

• A randomised placebo controlled study of transdermal testosterone therapy (testosterone 1% hydroalcohol gel) to investigate the efficacy and safety in men with abdominal obesity, low testosterone levels and early stages of the metabolic cluster syndrome. - ARTinMMS
• The metabolic syndrome constitutes a cluster of risk factors for cardiovascular disease with increased morbidity and mortality. The metabolic syndrome is referred to as a concomitant occurrence of hypertension, hyperlipidemia, impaired glucose tolerance with insulin resistance and abdominal obesity. . MedDRA version: 8.1 Level: LLT Classification code 10052066 Term: Metabolic syndrome
• Austria, Germany, Sweden
• 2006-11-09

• Authorised

• A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with Methotrexate Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005.
• Rheumatoid Arthritis, Nos
• Austria, Belgium, Czech Republic, Germany, Ireland, Italy, Spain, United Kingdom
• 2005-07-15

• Authorised

• Effect of Aggrenox® / Asasantin® Retard compared with Clopidogrel on Endothelial function as measured by Microalbuminuria, Inflammatory markers CRP, MCP-1, and MMP-9 in Patients with Type 2 Diabetes Mellitus and a history of TIA or stroke. - Aggrenox in Diabetic patients study
• Patients with Type 2 Diabetes Mellitus and a history of TIA or stroke. MedDRA version: 9.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent MedDRA version: 9.1 Level: LLT Classification code 10023027 Term: Ischaemic stroke NOS MedDRA version: 9.1 Level: LLT Classification code 10044391 Term: Transient ischemic attacks
• Norway
• 2008-11-26

• Authorised

• A RANDOMIZED PHASE II STUDY COMPARING IMATINIB AND THE COMBINATION OF IMATINIB AND PEGYLATED INTERFERON ALPHA-2B IN NEWLY DIAGNOSED NON-HIGH RISK CHRONIC MYELOID LEUKEMIA PATIENTS IN COMPLETE HEMATOLOGICAL REMISSION AFTER IMATINIB INDUCTION THERAPY - Nordic IR-LR Study
• Newly diagnosed chronic myeloid leukemia (CML) belonging to intermedia (IR) or low risk (LR) by the Sokal prognostic score
• Finland
• 2004-08-24

• Authorised

• ?TWIST?. RANDOMIZED PROSPECTIVE PHASE II STUDY OF TEMSIROLIMUS WITH OR WITHOUT LOW-DOSE INTERFERON ALPHA IN METASTATIC NON-CLEAR RENAL CELL CARCINOMA: GOIRC STUDY 02/2008 - TWIST
• Patients with advanced non-clear Cell Renal Carcinoma. MedDRA version: 9.1 Level: LLT Classification code 10050513 Term: Metastatic renal cell carcinoma MedDRA version: 9.1 Level: PT Classification code 10038458 Term: Renal granular cell carcinoma MedDRA version: 9.1 Level: PT Classification code 10038414 Term: Renal cell carcinoma stage IV
• Italy
• 2008-07-10

• Authorised

• A 26-week randomised, controlled, open label, multicentre, multinational, treat to target trial investigating the impact of dietary intervention on weight change and the relationship between weight change and baseline body mass index (BMI) in subjects with type 2 diabetes inadequately controlled on oral antidiabetic drugs (OADs) initiating insulin therapy with insulin detemir in combination with metformin Ensayo aleatorizado, controlado, abierto, multicéntrico, multinacional, de 26 semanas de duración, con ajuste de dosis para investigar los efectos de la intervención dietética sobre el cambio en el peso corporal y la relación entre el cambio en el peso corporal y el índice de masa corporal (IMC) basal en pacientes con diabetes tipo 2 mal controlada en tratamiento con antidiabéticos orales (ADO) que están empezando el tratamiento con insulina detemir en combinación con metformina Levemir DIET - Levemir® DIET?
• Type 2 Diabetes Diabetes mellitus tipo 2 MedDRA version: 12.1 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus MedDRA version: 13 Level: HLT Classification code 10012602 Term: Diabetes mellitus (incl subtipos)
• Germany, Slovenia, Spain
• 2010-06-23

• Authorised

• A phase II study to assess the efficacy and safety of frontline combination of dasatinib (SPRYCEL®) and pegylated-interferon alpha 2b (Peg-IFNa2b) therapy in patients newly diagnosed with chronic phase chronic myeloid leukaemia (CP-CML) - DASA-PEGIFN
• Patients with newly diagnosed chronic phase Chronic Myeloid Leukemia (CP-CML), not previously treated with Tyrosine Kinase Inhibitors (TKIs). First line therapy. MedDRA version: 14.1 Level: LLT Classification code 10054352 Term: Chronic phase chronic myeloid leukemia System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
• France
• 2013-05-21

• Authorised

• An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects =1 and =30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
• Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma MedDRA version: 20.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10066109 Term: Precursor B-lymphoblastic leukemia acute System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10066110 Term: T-cell lymphoblastic leukemia acute System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
• Belgium, France, Germany, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
• 2018-03-08

• Authorised

• TIvantinib as Maintenance treatment in Extended Small-cell lung cancer
• Small Cell Lung Cancer (SCLC) after first-line platinum plus etoposide therapy MedDRA version: 17.0 Level: PT Classification code 10041068 Term: Small cell lung cancer extensive stage System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• Italy
• 2014-10-13

• Authorised

• Efficacy of ketamine in refractory convulsive status epilepticus in children: a multicenter, randomized, controlled, open-label, no-profit, with sequential design study.
• Refractory convulsive status epilepticus, defined as the recurrence of crisis for more than 60 minutes and / or drug-resistant I l and II line. br>MedDRA version: 17.1 Level: LLT Classification code 10057955 Term: Convulsive status epilepticus System Organ Class: 100000004852 ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
• Italy
• 2014-01-31

• Authorised

• THE EFFECT OF DIFLUNISAL ON FAMILIAL TRANSTHYRETIN AMYLOIDOSIS (Buildup of abnormal deposits of a protein called amyloid (amyloidosis) in the body's organs and tissues). An open follow-up study of the diflunisal trials (IND 68092 and DFNS01), and an open label observational study on previously untreated patients with familial transthyretin amyloidosis complicated by cardiomyopathy (diseases of the heart muscle).?
• Familial transthyretin amyloidosis complicated by cardiomyopathy MedDRA version: 18.0 Level: LLT Classification code 10019893 Term: Hereditary neuropathic amyloidosis, Swedish type System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
• Sweden
• 2015-07-06

• Authorised

• Imaging study evaluating the utility of pre-treatment zirconium-89 labelled trastuzumab PET/CT (Imaging of the membranair receptor HER2 with the tracer zirconium 89 trastuzumab) and an early FDG-PET/CT response (early metabolic assessment) to identify patients with HER-2 positive invasive carcinoma of the breast with locally recurrent (not amenable to resection with curative intent) or metastatic disease unlikely to benefit from a novel anti-HER2 therapy: T-DM1
• Locally recurrent (not amenable to resection with curative intent) or metastatic disease scheduled for a first or any subsequent metastatic treatment line br>MedDRA version: 18.0 Level: PT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• Belgium, Netherlands
• 2012-01-27

• Authorised

• A study of Durvalumab Versus Standard of Care in Advanced Non Small-Cell Lung Cancer
• First line patients with Advanced Non Small-Cell Lung Cancer (NSCLC) with PD-L1 positive membrane expression in tumoral tissue and lacking activating epdermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) infusions. MedDRA version: 20.0 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
• Australia, China, Hungary, Korea, Republic of, Netherlands, Poland, Russian Federation, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam
• 2018-05-16

• Authorised

• The role of gut hormones replacement in improving blood flow to the brain after stroke that affects swallowing.
• We plan to give a synthetic form of GLP-1 (Liraglutide) that is already available and licensed for use in patients with diabetes in the UK, to patients who have had an acute stroke, in order to determine whether increased levels protect the brain during its recovery, resulting in better recovery. MedDRA version: 14.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
• United Kingdom
• 2011-12-06

• Authorised

• A study to compare masitinib in combination with irinotecan to placebo in combination with irinotecan in the treatment of patients with esophagogastric adenocarcinoma
• ?atients with advanced-stage esophagogastric adenocarcinoma who have relapsed after first-line chemotherapy MedDRA version: 18.1 Level: LLT Classification code 10017776 Term: Gastric carcinoma stage III System Organ Class: 100000004864 MedDRA version: 18.1 Level: LLT Classification code 10017777 Term: Gastric carcinoma stage IV NOS System Organ Class: 100000004864 MedDRA version: 18.1 Level: LLT Classification code 10017778 Term: Gastric carcinoma stage IV without metastases System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
• Brazil, European Union, Greece, Peru
• 2016-02-23

• Authorised

• Dendritic cells as autologous vaccine in patients with chronic myeloid leukemia
• Chronic myeloid leukemia is a malignant disease of the blood. Without therapy it has an unfavourable prognosis. Under first-line therapy with newer inhibitors of the thymidinkinase some few patients only respond poorly. This condition is called "minimal residual disease". The aim of this study is to investigate if a vaccination with autologous dendritic cells can evoke a T-cell response or even improve prognosis in the above mentioned patients.;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
• Germany
• 2007-08-13

• Authorised

• An open label, Phase II study of vaccination with Survivin peptides emulsified in Montanide ISA 51VG after IMP 321 injection in prostate carcinoma patients with biochemical failure (PROVAX study) - ND
• Prostate cancer, biochemical failure after all potentially curative standard local therapies (radiotherapy, brachytherapy and surgery) or biochemical progression while patients have castrated levels of testosterone or after first-line anti hormonal therapy br>MedDRA version: 12.1 Level: LLT Classification code 10001200 Term: Adenocarcinoma of the prostate stage I
• Italy
• 2010-06-15

• Authorised

• Randomized cross-over study of patient preference for oral or intravenous vinorelbine in the treatment of advanced NSCLC. A phase IV study
• Patients affected by stage IIIB or stage IV NSCLC candidates to receive a first line chemotherapy with vinorelbine due to age = 70 and Eastern Cooperative Oncology Group (ECOG) Performance status =2 or age = 70 but ECOG PS = 2 MedDRA version: 15.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 15.0 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• Italy
• 2012-10-11