Nordic iii trial

From to , academic research rose by 86 percent compared to a decrease of 26 percent in industry sponsored clinical trials. Additionally, in the intervening years, a trend emerged where more trial participants signed up for academic trials than studies by industry sponsors.

Some of that could be owed to the fact that roughly 60 percent of the clinical trials at the time were multinational studies with many taking place outside of Denmark.

As a country, Sweden has had a strong background in clinical research, with experts attributing that success to partnerships formed between industry, universities and healthcare organizations.

In order to begin a trial, however, the proposed study must gain further approval by the relevant Board of Ethics Review. Over the years, Finland has established itself as a prime location for vaccine clinical trials. Fimea, the Finnish Medicine Agency, is the main regulatory body that oversees clinical trial applications of medical products. Similarly, the National Supervisory Authority of Health and Welfare, Valvira, is the competent authority on all regulatory matters concerning medical device clinical trials.

Overall, clinical trial activity in Norway appears to be in steady decline. In , 69 percent of clinical trials were industry sponsored compared to 55 percent in Applications for clinical trial approval are encouraged to be submitted electronically to the Norwegian Medicines Agency. Among the Nordic countries, Iceland started the fewest number of trials in the region with six active studies in Both temozolomide and hypofractionated radiotherapy should be considered as standard treatment options in elderly patients with glioblastoma.

MGMT promoter methylation status might be a useful predictive marker for benefit from temozolomide. Abstract Background: Most patients with glioblastoma are older than 60 years, but treatment guidelines are based on trials in patients aged only up to 70 years. Substances Dacarbazine Temozolomide. Safety: For safety reasons, stent thrombosis after one month will be monitored continuously.

Analysis population: The results will be analyzed according to the intention-to-treat principle, i. Protocol violations will be noted and the responsible centres notified. Sample size calculation: A total of patients will be included in each group, in total patients.

By including patients in each group, a possible dropout before follow-up is counted for. Randomization procedure: The patient will be randomized after successful stenting of the main vessel. The patients will be computer randomized by a 24 hour telephone service. Monitoring of the study: The study will be monitored according to the GCP rules by independent professionals.

Publication: Results, positive as well as negative, will be published in an international cardiovascular journal. Publication and author issues will be decided by the steering committee on basis of general involvement in the study core lab.

FDA Resources. Arms and Interventions. Implantation of coronary stent in bifurcation lesion. Percutaneous coronary intervention with implantation of stent and not using kissing balloon postdilatation. Outcome Measures. Primary Outcome Measures : Combined end point of: cardiac death, index lesion myocardial infarction, stent thrombosis or target lesion revascularisation [ Time Frame: After 6 months ]. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.

Inclusion Criteria: Stable or unstable angina pectoris. ST-elevation infarction within 24 hours. Allergy to Aspirin, Clopidogrel or Ticlopidine. Allergy to Sirolimus. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.

More Information. Additional Information: Publication, primary outcome. Randomized comparison of final kissing balloon dilatation versus no final kissing balloon dilatation in patients with coronary bifurcation lesions treated with main vessel stenting: the Nordic-Baltic Bifurcation Study III. Epub Dec PCI Bifurcation lesion. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Coronary Artery Disease. Procedure: Percutaneous coronary intervention PCI.