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• Authorised

• The precision of three pain scales as a function of sedation
• This is a patient study in patients with a planned operation under general anaesthesie including healthy or merately ill patients (anaesthesia risk classification ASA 1-3). Pain self assessment as a function of sedation by IMP is studied.
• Austria
• 2008-08-26

• Authorised

• This open label trial will recruit patients with HIV who are already receiving anti-HIV treatment which includes a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) and emtricitabine/tenofovir disoproxil fumurate (Truvada). Patients will be randomised to either remain on the same anti-HIV drugs as prior to the study (namely consisting of NNRtI and Truvada) or switch to receive an investigational single tablet regimen (EVG/COBI/FTC/TDF) which contains 2 experimental drugs (EVG and COBI).
• Human Immunodeficiency Virus (HIV-1) Infections MedDRA version: 14.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
• Australia, Austria, Canada, Germany, Italy, Puerto Rico, Spain, United Kingdom, United States
• 2011-11-21

• Authorised

• A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease
• Moderately to severely active Crohn's disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
• Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, European Union, Germany, Hungary, Iceland, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Russian Federation, Serbia, South Africa, Spain, United Kingdom, United States
• 2011-05-26

• Authorised

• The degradation and elimination of Infliximab
• Inflammatory bowel disease (Ulcerative Colitis, Crohn's disease) MedDRA version: 17.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 17.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
• Austria
• 2013-11-07

• Authorised

• A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn?s Disease Estudio multicéntrico, ciego, controlado con placebo, aleatorizado, de fase 3, sobre la inducción y el mantenimiento de la respuesta clínica y la remisión con MLN0002 en pacientes con enfermedad de Crohn moderada o grave.
• Moderate to Severe Crohn's Disease Enfermedad de Crohn moderada o grave MedDRA version: 9.1 Level: LLT Classification code 10013099 Term: Disease Crohns ;Moderate to Severe Crohn's Disease Enfermedad de Crohn moderada o grave MedDRA version: 9.1 Level: LLT Classification code 10013099 Term: Disease Crohns
• Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Malta, Netherlands, Portugal, Slovakia, Spain, Sweden, United Kingdom
• 2008-10-24

• Authorised

• Metformin-Wirkung am Ovar bei PCOS (MAO-Studie) - eine Pilotstudie
• Polycystic ovary syndrome is one of the most common endocrine disorders, affecting approximately 10% of women of reproductive age, associated with hyperandrogenaemia and menstrual dysfunction. The aim of the study is to examine the effects of the insulin sensitizing drug metformin on ovarian function and ovulation rate in women with PCOS. MedDRA version: 9.1 Level: LLT Classification code 10014695 Term: Endocrine disorder
• Austria
• 2007-02-07

• Authorised

• A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination with Cabozantinib vs. Placebo with Cabozantinib in Patients with Advanced or Metastatic Renal Cell Carcinoma. Randomized means allocation to CB-839 or a placebo isde termined by chance. 1 out of every 2 patients will get CB-839. Double-blinded means that neither the participant nor investigator knows what group the patient is assigned to. Every patient on study will get cabozantinib.
• Advanced or metastatic clear-cell renal cell carcinoma;Therapeutic area: Diseases [C] - Cancer [C04]
• Australia, France, Germany, Italy, New Zealand, Spain, United Kingdom, United States
• 2018-05-21

• 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

• Changes in genes associated with metformin intolerance
• We want to investigate the pharmacokintetics of metformin in patients with type 2 diabetes or polycystic ovary syndrome in association with the patients genotype;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
• Austria
• 2014-01-13