Nycomed

This monocenter trial is conducted to obtain first data on safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after multiple ascending doses of BYK324677 in humans. In addition, the trial should provide preliminary information on a possible influence of sex, food intake, and posology (once or twice daily administration of BYK324677) to support the further planning of the drug development programme.

Ischemic stroke (IS) causes high mortality and severe disability. To improve outcome it's very important to choose the right way of the management of the patient and an appropriate drugs.
There is a large number of the so-called neuroprotective drugs, which were effective in laboratory, but didn't show positive results in clinical studies with using traditional clinical scales scores as a primary outcome measures.
Specialists suggest, that the investigators could receive better results if the investigators change design of the studies, particularly if the investigators select more precise and sensitive method of assessment.
Aim of this study: to determine the role of navigated brain stimulation (NBS) for evaluation of the changes in the motor centers and motor tracts after administration of different cerebroprotective drugs. (The substances won't be compared to each other).

There is increasing evidence in the literature that COPD should not be considered as a localised pulmonary disorder but as a systemic disease involving pathology in several extra pulmonary tissues. Well characterized systemic features are a chronic low grade systemic inflammation, altered body composition and a skeletal muscle fibre type shift. There are indications that an absolute or relative increase of fat mass puts COPD patients at increased risk for cardiovascular pathology while muscle atrophy is associated with a high prevalence of osteoporosis and with impaired physical function. The origin of systemic inflammation is poorly understood. Both endogenous and exogenous risk factors contribute to systemic inflammation and extra-pulmonary manifestations of COPD.
Overall objective of study 3:
To compare the pattern and severity of the systemic inflammatory profile in relation to skeletal muscle weakness and cardiovascular risk profile in COPD patients with mild to moderate disease compared to non-susceptible smokers.
Specific objectives:
To study the relative contribution of pulmonary and extra pulmonary factors on exercise capacity, skeletal muscle function and health status
To relate diet, physical activity and cardiovascular risk factors to body composition, skeletal muscle function and exercise capacity status
To study the influence of the emphysema phenotype on extra pulmonary pathology in COPD
To study muscle fibre type size and composition and to relate muscle oxidative phenotype with insulin sensitivity, inflammation (local and systemic) and molecular signatures of oxidative energy and protein metabolism.
Study design:
Cross-sectional study. Healthy smoking subjects and COPD patients will undergo extensive clinical, metabolic and inflammatory assessment at the university clinics in Groningen, Maastricht and CIRO Horn.
Study population:
Totally 60 subjects will be included
30 healthy subjects who after 20 pack years smoking have no signs of COPD (age 40-75 years)
30 COPD patients with GOLD stage II (age 40-75 years)