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• Authorised

• Eficacia de la profilaxis antibiótica en dosis única nocturna frente al control clínico y tratamiento precoz de las infecciones urinarias para prevenir secuelas parenquimatosas y pielonefritis de repetición en niños afectos de reflujo vesicoureteral primario de grado III a V. - Eficacia de la profilaxis antibiótica en dosis única nocturna frente al control clínico
• Demostrar que en los reflujos de alto grado (de III a V de la Clasificación Internacional del Reflujo) no hay menos incidencia de cicatrices renales ni de pielonefritis con el uso de la dosis única nocturna de antibiótico profiláctico si lo comparamos con un seguimiento clínico con diagnóstico y tratamiento precoz de cada episodio de infección urinaria. MedDRA version: 9.1 Level: LLT Classification code 10047371 Term: Vesicoureteral reflux br>MedDRA version: 9.1 Level: LLT Classification code 10066700 Term: Prophylaxis urinary tract infection MedDRA version: 9.1 Level: LLT Classification code 10065144 Term: Renal scarring MedDRA version: 9.1 Level: LLT Classification code 10037596 Term: Pyelonephritis
• Spain
• 2010-03-01

• Authorised

• A randomized multi-center treatment study (COALL 08-09) to improve the survival of children with acute lymphoblastic leukemia on behalf of the German Society of Pediatric Hematology and Oncology - COALL 08-09
• acute lymphoblastic leukemia in children and adolescents 1 to = 18 years of age MedDRA version: 12.1 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia
• Germany
• 2010-01-04

• Authorised

• A single arm, open-label trial assessing the effect of Capecitabine (Xeloda®) on progression-free survival rate at four months in breast cancer patients with CNS progression after whole brain radiotherapy - RADEX
• Female breast cancer patients with progression of brain metastasis following WBRT and at least one measurable lesion in the brain (defined as any lesion >1 cm in longest dimension at MRI). MedDRA version: 9.1 Level: LLT Classification code 10006128 Term: Brain metastases
• France
• 2009-07-07

• Authorised

• FEIBA NF: A prospective, open-label, randomized, parallel study to evaluate efficacy and safety of prophylactic versus on-demand treatment in subjects with hemophilia A or B and a high titer inhibitor - FEIBA NF Prophylaxis Study
• Hemophilia A or B and a high titer inhibitor MedDRA version: 9.1 Level: LLT Classification code 10056492 Term: Haemophilia A with anti factor VIII br>MedDRA version: 9.1 Level: LLT Classification code 10056494 Term: Haemophilia B with anti factor IX
• Bulgaria, France, Italy
• 2009-06-26

• Authorised

• The effect of selective PDE-5 inhibition on capillary recruitment, glucose uptake and endothelial function following a mixed meal in patients with type 2 diabetes
• Our primary objective is to elucidate whether increase in cGMP mediated by acute administration of tadalafil, a selective well tolerated PDE-5 inhibitor, may affect capillary recruitment and muscle glucose uptake in type 2 diabetes subjects following a mixed meal. Our secondary objective is to elucidate whether tadalafil may modulate arterial stiffness as indicated by changes in pulse wave velocity. MedDRA version: 9.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent
• Sweden
• 2009-05-11

• Authorised

• The effect of a new anti-diabetic drug (Liraglutide) on body weight in patients with type 2 diabetes mellitus
• patients with type 2 diabetes mellitus MedDRA version: 14.0 Level: PT Classification code 10053247 Term: Insulin-requiring type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
• Netherlands
• 2011-11-02

• Authorised

• Is there a correlation between the pain relief and the A-delta- and C-fiber function after topical application of lidocaine (5%) in patients with peripheral neuropathic pain?
• Patients with proven diagnosis of painful peripheral neuropathic pain syndromes as diagnosed as: 1. Peripheral nerve lesion or 2. Postherpetic neuralgia. MedDRA version: 14.0 Level: PT Classification code 10036376 Term: Post herpetic neuralgia System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.0 Level: PT Classification code 10034586 Term: Peripheral nerve injury System Organ Class: 10022117 - Injury, poisoning and procedural complications ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
• Germany
• 2011-07-25

• Authorised

• Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder - Bergen_Lith_Bipol
• The goal of this work is to identify genes associated with good response of bipolar patients to two commonly used mood stabilizing agents, lithium and valproate. 1. All patients will be started on lithium, then enter the maintenance phase where they will be followed for 2 years or until relapse. Those that fail lithium will be crossed over to valproic acid (VPA). Those that fail on VPA will be again crossed-over to a standardized treatment as usual (TAU) arm. MedDRA version: 14.0 Level: LLT Classification code 10004908 Term: Bipolar affective disorder System Organ Class: 10037175 - Psychiatric disorders
• Norway
• 2011-03-01

• Authorised

• International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia
• acute lymphoblastic leukemia in children and adolescents 1 to MedDRA version: 20.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864
• Austria, Czech Republic, Germany, Italy
• 2009-10-23

• Authorised

• A clinical trial to determine the most suitable dose of a combination of eribulin and capecitabine for use in late stage breast cancer patients
• Phase 1 - Advanced and/or metastatic cancer Phase 2 - Advanced and/or metastatic breast cancer MedDRA version: 17.0 Level: LLT Classification code 10027477 Term: Metastatic carcinoma System Organ Class: 100000004864 MedDRA version: 17.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
• Bulgaria, Russian Federation, United Kingdom
• 2009-08-21

• Authorised

• IDES IN ASYMPTOMATIC TTP PATIENTS
• Asymptomatic antibody-mediated thrombotic thrombocytopenic purpura (TTP) with low ADAMTS13 activity MedDRA version: 19.0 Level: PT Classification code 10043648 Term: Thrombotic thrombocytopenic purpura System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
• United Kingdom
• 2016-05-19

• Authorised

• TRIAL TO ASSESS THE EFFICACY OF LENVATINIB IN METASTATIC NEUROENDOCRINE TUMORS (TALENT STUDY).?
• Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO classification neuroendocrine tumors of the pancreas after progression to a previous targeted agent (cohort A) or gastrointestinal tract after progression to somatostatin analogues (cohort B). MedDRA version: 18.0 Level: LLT Classification code 10062476 Term: Neuroendocrine tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: PT Classification code 10068909 Term: Pancreatic neuroendocrine tumour metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• Spain
• 2015-07-10

• Authorised

• Safety and efficacy study in patients with untreated follicular non-Hodgkin´s lymphoma.
• Untreated stage III or IV non-Hodgkin’s lymphoma (CD20+ Follicular Lymphoma of Grade 1, 2 or 3a, requiring chemotherapy) MedDRA version: 14.1 Level: HLT Classification code 10016903 Term: Follicle centre lymphomas, follicular grade I, II, III System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
• Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Guatemala, Hong Kong, Hungary, India, Indonesia, Italy, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Panama, Peru, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam
• 2011-12-06

• Authorised

• A prospective, randomized, masked and controlled trial of intravitreal bevacizumab (Avastin) versus verteporfin photodynamic therapy (PDT) in patients with neovascular age-related macular degeneration.
• Age-related macular degeneration (AMD) is the leading cause of visual impairment and social blindness in people 60 years or older. Approximately 75% of patients with severe visual loss exhibit neovascular AMD with choroidal neovascularization (CNV). Newly formed vessels invade the retinal pigment epithelium (RPE) and neural retina, causing edema and hemorrhage, ultimately inducing damage or apoptotic cell death of photoreceptors.
• Sweden
• 2006-06-22

• Authorised

• Does caffeine reduce dipyridamole-induced protection against ischemia-reperfusion injury?
• Reperfusion after an ischemic accident will limit tissue damage (infacrt size), though on the other hand reperfusion injury will also cause tissue damage by the release of ROS and facilitating cellular apoptosis. Means to inhibit and-or decrease the reperfusion injury, can prevent further damage thereby prevent further mortality or morbidity. MedDRA version: 8.1 Level: LLT Classification code 10062828 Term: Ischemic heart disease prophylaxis
• Netherlands
• 2007-06-14

• Authorised

• A prospective, randomized, masked and controlled trial of intravitreal ranibizumab (Lucentis®) combined with transpupillary thermotherapy (TTT) in patients with neovascular age-related macular degeneration (AMD)
• Age-related macular degeneration (AMD) is the leading cause of visual impairment and social blindness in people 60 years or older. Approximately 80% of patients with severe visual loss exhibit neovascular AMD with choroidal neovascularization (CNV). Newly formed vessels invade the retinal pigment epithelium (RPE) and neural retina, causing edema and hemorrhage, ultimately inducing damage or apoptotic cell death of photoreceptors.
• Sweden
• 2007-10-15

• Authorised

• Nutrition, growth and development among very preterm infants - PRENU
• The main purpose of this study is to evaluate the effect of increased supply of energy, protein, vitamin A and the long chain polyunsaturated fatty acids DHA and AA to Very Low Birth Weight Infants (VLBW,birth weight below 1500 grams) on 1) growth 2)brain maturation 3)cognitive function 4)morbidity such as retinopathy of prematurity, bronchopulmonary dysplasia, periventricular leucomalacia, necrotizing enterocolitis, sepsis. 5)mortality (defined as percent dead before hospital discharge).
• Norway
• 2010-05-11

• Authorised

• Platinum and PARP inhibitor for Neoadjuvant treatment of Triple NEgative and/or BRCA positive breast cancer
• ER negative and HER2 negative Early Breast Cancer or BRCA 1 or 2 germline mutated Early Breast Cancer MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
• France, Netherlands, Spain, United Kingdom
• 2015-12-01

• Authorised

• A TRIAL OF QPI-1007 DELIVERED BY SINGLE OR MULTI-DOSE INTRAVITREAL INJECTION(S) TO SUBJECTS WITH ACUTE OPTIC NEUROPATHY (NAION)
• NAION typically presents as an abrupt, painless monocular vision loss. Visual loss varies widely, ranging from visual field loss only to complete blindness. The neuronal degeneration process in NAION is thought to occur as primary retinal ganglion cell (RGC) axonal and glial damage from ischemia; Damage to RGC axons causes retrograde death of the associated RGC soma by apoptosis, Neuroprotection of partially damaged RGCs would further limit the loss of visual function MedDRA version: 20.0 Level: LLT Classification code 10068242 Term: Nonarteritic anterior ischaemic optic neuropathy System Organ Class: 100000014125 ;Therapeutic area: Diseases [C] - Eye Diseases [C11]
• Australia, China, Germany, India, Israel, Italy, United States
• 2016-07-21

• Authorised

• Efficacy of alitretinoin versus cyclosporine in patients with severe vesicular hand eczema.
• Hand eczema is a common condition with a 1-year period prevalence up to 10%. Systemic treatment with alitretinoin is registered for all clinical types of hand eczema. However, it is especially effective in the hyperkeratotic subtype. Cyclosporine is often prescribed for hand eczema in daily practice and has shown to be especially effective in patients with vesicular hand eczema. The efficacy of cyclosporine in severe recurrent vesicular hand eczema could prove superior to that of alitretinoin.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
• Netherlands
• 2016-06-01