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.
This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel. Participants in both cohorts will subsequently undergo surgical treatment and then resume pertuzumab and trastuzumab treatment.
This study is to evaluate the performance attributes and user progression of participants with motor complete and incomplete spinal cord injury (SCI) while utilizing the Ekso robotic exoskeleton in an eight week over ground, locomotor program. We hypothesize an improvement in progression and overall health while using Ekso.
The relationship between physical activity and academic performance has received widespread attention owing to the pressure on schools to graduate pupils who meet accepted academic standards. As important, there are global concerns regarding the increased prevalence of lifestyle-related non-communicable diseases (NCDs). First, Norway has a history of mediocre scores on international comparative academic performance tests such as Trends in International Mathematics and Science Study (TIMSS) and the Programme for International Student Assessment (PISA) [1]. It is therefore important to develop and evaluate strategic programs that may enhance pupil's academic performance. It is increasingly evident that a physical activity strategy that brings about enhanced cognitive function, better blood flow, and more, plays a key role in this effort [2]. Second, the prevalence of NCDs, such as diabetes mellitus type 2, is increasing worldwide, and such NCDs affect people of all ages [3]. Hence, healthcare costs are escalating to unaffordable levels. The best means to deal with this immense problem is through primary prevention, and physical activity is a powerful common denominator known to play a key role in preventing a host of NCDs [4]. Consequently, both World Health Organization (WHO) and the Norwegian health authorities call for effective primary prevention strategies to promote physical activity in children and adolescents [5, 6]. Prop. 90 L (2010-2011) Act on public health work [6] emphasizes that physical activity in school can benefit both the learning process and public health prevention. Therefore, the objective of the ASK-study is to investigate the effects on academic performance of 60 minutes of daily physical activity during one school year. Furthermore, due to the complexity in the relationship between physical activity and academic performance, it is necessary to identify possible mediating and moderating variables as cognitive performance, quality of life (QoL), classroom behavior, motor skills and motivation. Also, we aim to investigate changes in risk factors related to NCDs and factors that influence NSDs, such as physical activity, sedentary behavior and health-related fitness. In addition a qualitative part of the ASK-Study will be conducted to get an in-depth understanding of the children's embodied experiences and the meaning of the social learning culture in school physical activity (PA). This will give us an in-depth description of the intervention context, offer insight in how the intervention possibly influences children's overall development and enables us to estimate potential long term effects of the intervention. If successful, the ASK cluster-randomized controlled trial (RCT) could provide much needed solutions to enhancing schoolchildren's academic performance and position the school as an effective setting for a massive public health intervention concerning the prevention of NCDs.
The study is performed to assess the efficacy and safety of different doses of BAY1002670 in subjects with uterine fibroids. The dose-response relationship will be evaluated. Further, the study aims to establish a population pharmacokinetic/pharmacodynamic relationship for BAY1002670 in subjects with uterine fibroids. To assess the efficacy of BAY1002670 the interchangeability of menstrual pictogram and alkaline hematin method for the judgement of menstrual blood loss will be assessed.
This study is a pilot study to investigate whether intake of lean or fatty fish, or lean meat would affect parameters related to health in healthy non-obese adults, and will serve as basis for future calculation of group sizes in coming studies. Participants consumed 750g/week of fillets of fish or meat for 4 weeks. Hypothesis: High intake of either lean or fatty fish will not affect serum concentrations of lipids and inflammatory markers as well as improve glucose tolerance during the 4 week intervention period when compared to lean meat intake.
Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.
The objective of this project is to assess the impact of a Game-Based Appointment System on both, the clinical settings, and on the use of the educational web app www.sjekkdeg.no. An A/B testing methodology will be used. This methodology consist on the redirection of the users to two different versions of the website, and therefore allows to assess the interactivity of the users according to the design of the webpage and determine which one has a higher impact on the clinical settings, and consequently on prevention of STDs. For the A/B test we will test the interactivity of two versions of a web page www.sjekkdeg.no: the A version (control), consisting en the educative web app; and the B version, consisting in the web app www.sjekkdeg.no including the Game-Based Appointment System. The Game-Based Appointment System will offer the users the option of booking appointments at the venereology department at the University Hospital of North Norway. The system will include an automatic priority appointments function, with three levels of prioritization (triage): 1) Emergency-appointment: The user should go to the doctor on the same day or the following day. 2) Haste-appointment: Within 3-4 days; or 3) Routine-appointment: within 2-3 weeks. The hypotheses of this research project are: 1. The number of visits with the health professionals will be larger in the game-based appointment group than in the control group. 2. The number of visits to the educative components of www.sjekkdeg.no will increase after the launch of the Game-Based Appointment System functionality. 3. The number of visits to the educative components of www.sjekkdeg.no will be larger in the appointment group than in the control group. 4. The time spent per visit to the website will be larger in the appointment group than in the control group, meaning a higher exposure to health information. 5. The visitors returning rate is larger in the appointment group than in the control group.
Cerebral palsy (CP) is the most common motor disability in childhood (2-3 per 1000 live born), and is frequently accompanied by cognitive impairments and behavioural problems. The present study is a controlled clinical trial, a multicenter-study involving three health regions, as well as the Norwegian University of Science and Technology (NTNU). Its primary research goal will be to evaluate the effects of computer-based cognitive training in children with CP. In addition, this study will be the first to conduct a comprehensive neuropsychological examination to improve our understanding of cognitive impairments as well as cognitive resources in CP children in Norway to aid in intervention planning.
This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 [NCT01461317]) or the Phase III studies (GA28948 [NCT02163759], GA28949 [NCT02171429], GA28950 [NCT02100696], GA29102 [NCT02165215], and GA29103 [NCT02136069]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 9 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.
This is a randomized controlled clinical trial to investigate the effectiveness, safety and tolerability of platelet-rich plasma (PRP) injections for treatment of patellar tendinopathy in adults 18-50 years of age. Subjects will be randomly assigned to three parallel treatment groups: 1. Leukocyte-rich PRP injection + exercise 2. Leukocyte-poor PRP injection + exercise 3. Saline injection + exercise (control) Primary endpoints are (1) the number (rate) and severity of adverse events as reported by both patients and study physicians during the first 12 weeks after initiation of treatment, (2) patient-rated tolerability of treatment; (3) the change in function (VISA score) and treatment success (global improvement scale) over six months of a post-injection exercise protocol.