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.
TENSION (Efficacy and safety of ThrombEctomy iN Stroke with extended leSION and extended time window) is a prospective, open label, blinded endpoint (PROBE), European two-arm, randomized, controlled, post-market study to compare the safety and effectiveness of endovascular thrombectomy as compared to best medical care alone in the treatment of acute ischemic stroke patients with extended stroke lesions defined by an Alberta Stroke Program Early CT Score (ASPECTS) score of 3-5 and in an extended time window (up to 12 hours or unknown time of symptom onset). Up to 665 subjects will be randomized. Primary endpoint will be functional outcome assessed by the modified Rankin scale at 90 days post-stroke ("mRS shift analysis"). By this, TENSION will provide evidence of efficacy and safety of thrombectomy in an acute stroke population with uncertain benefit of endovascular stroke treatment.
This study was designed to characterize dose response, and evaluate safety and efficacy of three different doses of EMA401 compared to placebo in patients with post-herpetic neuralgia (PHN).
A considerable number of patients with mild and moderate traumatic brain injury (TBI) experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their capacity to return to work (RTW). Although several studies have described medical, psychological and work-related factors that predict RTW after TBI, well-controlled intervention studies regarding RTW in this group are scarce. Furthermore, there have traditionally been weak collaborations among rehabilitation services in the health sector, the Labor and Welfare Administration (NAV), and the work-places. The current project proposal describes an innovative randomized controlled trial (RCT) which will explore the effect of combined manualized cognitive rehabilitation efforts and supported employment in real-life competitive work settings for patients who have not returned to work 8 weeks post-injury. The project combines the rehabilitation and vocational science perspectives; it involves multidisciplinary collaboration, and explores the efficacy of increased cross-sectorial collaboration between specialized health care services and the welfare system. If the intervention proves efficient, the project will further describe the cost-effectiveness and utility of the program, and thereby provide important information of use for policy makers. In addition, the study aims at generating knowledge on the RTW-process both for the persons with TBI, and their workplaces, and to disseminate this knowledge in order to create new multidisciplinary and collaborative practices. The project has potential to generate knowledge of relevance for other patients with neurological deficit.
Patients with severe Chronic Obstructive Pulmonary Disease (COPD) and low oxygen levels in the blood are at risk of developing pulmonary hypertension and strain on the right side of the heart, both of which are known to increase symptoms and worsen prognosis It is not fully established whether interval exercise training in patients with severe COPD and concomitant low oxygen levels is beneficial. This study aims to evaluate the effects of aerobic interval exercise training in patients with severe COPD and low oxygen levels in the blood, with a particular emphasis on such effects on the cardiovascular system and pulmonary circulation.
With the recent addition of carfilzomib as a treatment option for multiple myeloma, no data is available yet on how the drug is being used outside of the clinical trial setting. This study will therefore provide essential data to demonstrate the real world utilization of carfilzomib in routine clinical practice, including dosage, administration schedule, regimen, duration of treatment and reason for discontinuation in Europe.
Athletes, especially in endurance sports, are at increased risk of oxidative stress and inflammation-related diseases and injuries. The production of reactive oxygen and nitrogen species (RONS) and inflammatory markers increase during exercise and especially during altitude training. Antioxidant supplementation is commonly used among athletes in the belief that it prevents oxidative stress and oxidative damage. A transient increase of RONS is however necessary to activate signaling cascades initiating training adaptation. Antioxidant supplementation has been shown to inhibit the exercise effects in several independent studies, possibly by interfering/reducing the signal cascades initiated by RONS. However, it is unknown whether a high intake of antioxidant rich foods can affect the amount of RONS, inflammation markers and/or training adaptation. The investigators want to examine whether an increased intake of natural antioxidants in the form of antioxidant-rich foods fruits, vegetables and berries, in line with the official Norwegian dietary advice can affect antioxidant status, immune function and training adaptation associated with altitude training in Norwegian elite athletes.
A major concern in today's oncology is the complexity of treatment that increases costs. A main contributor is the increasing use of chemo- and radiotherapy during end of life (EoL: the last 12 months of life). Importantly, intensive chemotherapy in EoL has uncertain efficacy, may result in frequent hospitalizations and less time spent at home. Also, patients with incurable disease who receive intensive treatment at EoL have worse quality of life (QoL). A systematic palliative care (PC) approach that focuses on optimal symptom management and maintenance of QoL of patients and family is often introduced too late in the disease trajectory. Studies indicate that early introduction of PC in patients with unfavorable prognosis may improve QoL and other symptoms and prolong survival. These and related findings have made international stakeholders advocate a stronger integration of oncology and PC for patients with incurable cancer. The present project is a national multicenter cluster-randomized trial (RCT) in 12 oncology departments in all 4 Norwegian health regions. The project tests the efficacy of a complex tripod intervention that integrates oncology and PC for cancer patients with a life-expectancy <12 months who receive chemotherapy and includes: A) systematic electronic assessment of symptoms, B) implementation of standardized care pathways and C) an education program for oncologists/PC physicians. The PC pathway focuses on the patient's journey through the PC trajectory including EoL care in order to improve quality of care and reduce the variability in clinical practice and costs. The intervention aims at empowering physicians, patients and relatives and promoting shared-decision-making.
Leg ulcers are a significant cause of impaired functional ability and quality of life for approximately 1-2 percent of the population in western countries. Although pain seems to be one of the most devastating aspects of living with a chronic ulcer, research is limited and there is a lack of knowledge about wound-related pain characteristics. Little is known about prevalence, pain intensity, qualities, location, temporal fluctuations, to witch degree pain impact on physical- and psychosocial functioning, as well as relieving and exacerbating factors. The overall purpose of this study is to investigate the prevalence and characteristics of wound related pain in patients with chronic leg ulcers. More specific research questions are: 1) What is the prevalence and characteristics of wound related pain in patients suffering from various types of persistent ulcers, 2) How do patients with different ulcer diagnoses report the quality of the wound related pain, 3) Is there any differences in wound pain characteristics among patients with different etiology leg ulcers, 4) How is the pain temporal pattern in patients with chronic leg- and foot ulcers, 5) What is the reported quality of life in patients with different ulcer diagnosis, and 6) Is there any association among pain characteristics, sleep and quality of life in patients with chronic leg/foot ulcers? The study has a non-experimental, explorative and descriptive approach. A cross-sectional questionnaire design will be used to explore patient's experience of wound-related pain. The patients will be recruited at the outpatient clinic appointment and home-care nursing in Norway. Participants will fill out self-report questionnaires. The battery of questionnaires will obtain information about demographic data, pain characteristics, quality of life and sleep. Pain characteristics, quality of life and sleep will be assessed by using different questionnaires that has demonstrated high validity and reliability. In addition, the temporal pattern of pain will be assessed by asking the participants to fill out a form stating subjective level of pain (NRS) every hour during a typical day, and to mark times that they rest and sleep. Relevant information about the diagnosis/classification of ulcer, comorbidities, the ulcer management and pain management will be collected in a clinical examination.
This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication.
This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks. The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.