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A Multi-national Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC 0129-0000-1003 (N8-GP) when Administered for Treatment and Prophylaxis of Bleeding in Patients with Haemophilia A

Co-Primary Objectives* To evaluate the immunogenicity of N8-GP in previously treated patients with haemophilia A* To evaluate the clinical efficacy of N8-GP in bleeding prohylaxis (number of bleeds during prophylaxis)Secondary Objectives* To…

MEtoclopramide, DExamethasone or Aloxi (palonosetron) for the prevention of delayed chemotherapy-induced nausea and vomiting in moderately emetogenic non-AC-based chemotherapy: the MEDEA trial

In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antiemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed CINV induced by non-AC based…

Colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler. A Multi-Center Randomized Controlled Trial (C-seal study)

Primary objective: efficacy of the C-seal in reducing anastomotic leakage (AL).Secondary objectives: The number of dismantled anastomoses; AL within 30 days according to the ISGRC classification; interval between the operation and AL; The pain score…

Effect of C1-esterase inhibitor on systemic inflammation in trauma patients with a femur or pelvic fracture.

A previous study of from our laboratory showed that administration of the drug C1-INH (100E/kg) significantly reduced the concentration of circulating pro-inflammatory cytokines, such as IL-6, in healthy male volunteers during human experimental…

A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC-0156-0000-0009 when used for Treatment and Prophylaxis of Bleeding Episodes in Patients with Haemophilia B

Primary Objective: To evaluate the immunogenicity of N9-GP.Key Secondary Objectives: * To evaluate clinical efficacy of haemostasis (treatment of bleeding episodes) of N9-GP.* To evaluate clinical efficacy of N9-GP in long term bleeding prophylaxis…

Vitamin D supplementation in elderly nursing home residents: daily supplementation compared to a loading dose and monthly supplementation, a randomised trial

Primairy aim:-to investigate whether with a loading dose based on body weight and baseline serum 25(OH)D level more patients achieve adequate serum 25(OH)D levels compared to 800 IU a day on T 1( 5 weeks) and T2 (12 weeks).-to determine the best…

Prevention of Acute Radiation cystitis by using Intra-vesical chondroitin Sulphate.

The primary objective of this study is to evaluate whether preventive intravesical instillations with 0.2% chondroitin sulphate solution reduce bother related to acute radiation cystitis symptoms patients undergoing pelvic radiotherapy.

Efficacy and Safety of Epanova® in Severe Hypertriglyceridemia

The purpose of this study is to see the effects of three different doses of Epanova on Triglyceride levels of 332 patients with severe hypertriglyceridemia, compared to placebo. The study will also try to determine how much Epanova is needed to have…

A randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP (CANTOS study, CACZ885M2301)

Primary: to demonstrate the superiority of at least one dose of canakinumab compared to placebo in reducing the risk of recurrent major cardiovascular disease events (cardiovascular death, non-fatal MI and stroke) in a population of clinically…

A Phase 3b Clinical Study To Assess Whether Regular Administration Of Advate In The Absence Of Immunological Danger Signals Reduces The Incidence Rate Of Inhibitors In Previously Untreated Patients With Hemophilia A

Primary objective:Determine the incidence rate of inhibitor formation in PUPs with severe and moderately severe hemophilia A during the first 50 exposure days (EDs) to starting with a once weekly prophylactic regimen together with the minimization…

LUX-Head & Neck 2;A randomised, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemoradiotherapy in primary unresected patients with stage III, IVa, or IVb loco-regionally advanced head and neck squamous cell carcinoma

The objective is to investigate the efficacy and safety of afatinib over placebo when given as adjuvant therapy for patients with no evidence of disease after CRT in primary unresected patients with LA SCC stage III or IVa/b of the oral cavity,…

Safety and Efficacy of NNC-0156-0000-0009 after Long-Term Exposure in Patients with Haemophilia B

Primary Objective: To evaluate the immunogenicity of N9-GPKey Secondary Objectives:* To evaluate clinical efficacy of haemostasis (treatment of bleeding episodes) of N9-GP* To evaluate clinical efficacy of N9-GP in long term bleeding prophylaxis (…

A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients with Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD).

The objectives of this study are:- to evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in adult patients with stable coronary heart disease (CHD), CHD risk equivalents or at elevated risk for cardiovascular…

Effects of low-dose aspirin taken at bedtime on blood pressure of subjects with who use aspirin for prevention of recurrent cardiovascular events: the Aspirin In Reduction of Tension II (ASPIRETENSION II) Study

The aim of our project is to study whether treatment with aspirin at bedtime compared with intake at morning has additional benefits in patients using aspirin to prevent recurrent cardiovascular events. 1. Our primary objective is to study the…