There are about 5161 clinical studies being (or have been) conducted in Norway. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The objective of this study was to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy
The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated with exemestane and everolimus After implementation of CSP Amendment 10, only a limited number of subjects will remain in this study, in order to reduce the burden to study subjects, collection of data will be reduced and will focus mainly on acute safety, SSE, and OS. Once subjects are rolled over, the long-term safety will be collected and assessed entirely in the separate extended safety follow-up study.
The purpose of the trial was to evaluate and describe the long term safety of tolvaptan in participants with autosomal dominant polycystic kidney disease (ADPKD).
The purpose of this study is to compare the outcome of patients with vestibular schwannomas in two groups of randomised to either radiosurgery or expectation. The optimal treatment for a small vestibular schwannoma is a matter of controversy and there are no class 1 studies investigating this. Even the natural tumor growth rate remains controversial and is reported to be from near 100% of cases showing growth to 40-60% in various reports. The clinical results of various treatment strategies are documented, but comparative studies are very few. Immediate radiosurgery or wait-and scan with subsequent treatment upon growth are two strategies that have both been used in many different centers. There are only two studies comparing these treatment modalities .These studies indicate significant effect of GKRS in reducing tumor growth, with less differences in hearing and complaint outcomes. None of the studies are blinded or randomised, allowing for bias. The present study aims at comparing the two modalities above. To achieve this, we intend to randomise patients with newly diagnosed VS to either of Wait-and Scan or immediate radiosurgery. The primary study endpoint is the relative tumor size measured as the ratio between tumor volume at four years compared with volume at inclusion. Secondary endpoints include symptom and sign development measured by clinical examination and by patient's responses to standardised validated questionnaires. In addition, the health economics involved with both strategies will be evaluated and compared, as well as the patient's working status. Patients will be asked to participate if their VS is diagnosed within the last six months, their age is between 18 and 70, and pending there are no exclusion criteria (see below). A power analysis indicates that about 50 patients per group is sufficient. In case of failure to recruit patients, we will change the design to a study based on patient's own choice of treatment. The study will be announced according to international guidelines. A steering committee will monitor the study and an intermediate analysis will be performed when the study group has been followed for two years. If the effect aim is already observed, the study should nonetheless continue, as it is too early to evaluate the results after such a short time course. It will also be discussed to do a follow-up of all patients ten years after inclusion.
Outcomes evaluation is a critical component in outpatient cardiac rehabilitation. The aim of this study is to examine factors who predict long-term effects of improved peak oxygen uptake one year after participating in cardiac rehabilitation. Secondary to evaluate the short and long-term outcome of a 12-week outpatient cardiac rehabilitation program.
To study the efficacy of everolimus combined with temozolomide as first-line treatment in advanced gastroenteropancreatic neuroendocrine carcinoma with a Ki67 of 20-55%, measured as disease control rate (non-progressive disease) at 6 months.
The study aims at: Using Intervention mapping as a planning approach for behavior change intervention programs, based on an ecological approach to health and local community and user participation. - Explore the behavioral change processes utilizing qualitative methods. - Develop theory-based behavior change programs across different domain at healthy living centres. - Evaluate the effect of behavior change intervention programs across different domains. - Increase health providers` competence in effective behavioral change intervention techniques by networks and education seminars between municipalities and research groups. - The programs will specifically target the underlying causes of chronic disease. The investigators will map the distribution of lifestyle habits among individuals and families. The investigators will also explore how lifestyle habits relate to known determinants of social health inequality, such as adverse previous experiences, participation in working life and low income. - The investigators also intend to study if socioeconomic differences are of importance for entering or dropping out of HLC interventions, and the ability to sustain lifestyle changes. The investigators will do so by stratified analyses, or by using socioeconomic variables as determinants in effect analyses.
Evaluation of pupillary reflex in patients on high-dose opioids. Clinical assessment of pain intensity, sedation score, and other side effects of opioids. Measurements of the concentration of opioids and their active metabolites in blood.
Native tissue repair for pelvic organ prolapse (POP) is the predominant surgical technique in the investigators department and the Manchester operation the preferred procedure. The investigators long-term reoperation rates for pevic organ prolapse are very low, as documented in the investigators previous long-term follow-up study (Oversand et al, International Urogynecology Journal 2013), however the data were retrospective and patients with avulsions of the levator ani muscle were not identified. The investigators hypothesize that correct fixation and elevation of the vaginal apex, as part of a three-compartment repair procedure, is essential in the POP surgical repair, also when treating women with levator ani avulsions. The purpose of this study is to: - prospectively evaluate if cardinal/sacrouterine ligament plication (as part of the 3-compartment Manchester procedure) gives an adequate elevation and fixation of the vaginal apex. - assess changes in subjective symptoms between the preoperative evaluation and the 1 and 5-year postoperative evaluations. - evaluate whether the patients identified with levator avulsions in the investigators population have an increased risk of failure (objectively and subjectively).
The purpose is to characterise the tolerability of Modufolin (arfolitixorin) in combination with 5-FU alone, in combination with 5-FU and Oxaliplatin, in combination with 5-FU and Irinotecan and in combination with 5-FU, Oxaliplatin and Bevacizumab. Another purpose is to investigate 4 doses of Modufolin to identify the best dose for further assessment.