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 study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia (HeFH).
Multiple long term conditions entails various needs for complex medication treatment, which is a huge clinical challenge considering medication interactions and disease-medication interactions. It might affect quality of life, increase medical costs and needs, and cause patients to live several years with disabilities and reduced functional level. Multiple long term conditions is an important public health problem, since it is increasingly more common as the population is getting older. It is well documented that communication problems exist between sectors in the healthcare system and that it creates an area of risk. There are many transfers that could be associated with risk for errors, as when patients are discharged from the hospital and is being transferred to the next level of care. When patients are discharged from the hospital, there is a need for transfer of correct information regarding medications. Transition of care leads to risk for medication discrepancies for the patients. Medication discrepancies are common within primary care and studies show that up to 90% of patients have at least one medication discrepancy in their lists. Different interventions have been tested to reduce medication discrepancies, but the interventions do not eliminate the need for medication reconciliations. Higher patient satisfaction have been associated with improved patient safety, clinical effectiveness, health outcomes, adherence and lower resource utilization. According to Norwegian legislation, patients or users have a right to participate in the implementation of healthcare services, e.g. the choice between available and justifiable forms of service, examination methods and treatment methods. Person-centered care (PCC) is a concept that shifts the focus away from the traditional biomedical model to personal choice by applying shared decision-making. PCC reduce symptom burden, enhance patient activation, reduce readmission rates and improve quality of life. Obtaining knowledge about medication discrepancies and perceptions from patients, next of kin and healthcare personnel (HCP) after the patient's hospital discharge could contribute to a better success rate for future interventions and services. It is therefore of interest to investigate which factors that are of importance for a successful seamless person-centered intervention to optimize medication use across healthcare levels. To obtain knowledge about medication discrepancies and perceptions, the study will include both quantitative and qualitative methods, and be using a design thinking framework. The persons included will represent a wide selection with respect to, among other things, age, gender, socio-economic background, profession and diagnoses. The patients, next of kin and HCP will be included after written, informed consent. The aim of the project is to obtain knowledge about how the investigators can strengthen patient's self-efficacy and improve the information flow when it comes to medications, in the transition between the healthcare levels. To do so, the investigators need to identify facilitators and barriers to achieve a seamless medication treatment based on the user's needs. The results will form a basis for a new, improved intervention, which follow patients during the hospital stay and further out in the primary healthcare. The aim of this project is divided into the following parts: - Investigate the frequency and type of medication discrepancies between the medication list in the discharge summary and medication use after hospital stay, to identify risk factors for which and why medication discrepancies occur in patients with multiple long term conditions. - Map the perceptions of patients with multiple long term conditions and next of kin regarding medication use, shared decision-making and their opinions about previously published interventions to improve medication use. - Evaluate HCP's perceptions regarding elements in patients with multiple long term conditions care that works well, what HCP believe do not work, with particular emphasis on the treatment with medications and transfer of care. In addition, how this care could be improved especially with the new intervention in mind. - Using design thinking framework to create prototypes for a new intervention Overall hypothesis for the project: Knowledge about medication discrepancies and perceptions from patients, next of kin and HCP regarding barriers and facilitators for a seamless medication treatment can contribute to an improved efficacy and implementation of the new, improved intervention.
The study objective is to determine the biomarker status of a participant's tumor tissue and use that status to determine eligibility for a linked Roche clinical trial.
The natural course for meningioma suggests that a majority will grow over time. Treatment is usually indicated in growing or symptomatic meningiomas. Surgery is usually primary treatment, but there is a significant risk of adverse effects. Stereotactic radiotherapy is most often reserved to treat relapses after surgery, and except for surgery and radiotherapy there are no other established treatment methods. Endovascular embolization may be used in selected cases as a preoperative adjunct to reduce intraoperative bleeding. There is a need for more treatment options in patients with meningioma, both in uncomplicated, asymptomatic cases and in more complex cases. The aim of this study is to assess radiological and clinical results of therapeutic endovascular embolization for meningioma
Many patients suffering from posttraumatic stress disorder (PTSD) are resistant to established treatment consisting of psychotherapy. Patients often go years with this debilitating disorder without experiencing sufficient improvement. Approximately 1/3 of patients will drop out of treatment because of psychological burden and overactivation. A novel ketogenic diet treatment could amend established treatment, and potentially upregulate the threshold for exciting neurons in dysfunctional brain regions, mediated through various mechanisms. This may reduce PTSD symptoms, and thus enabling patients to respond to psychological treatment without getting overactivated and unable to process trauma. The purpose of this study is to investigate whether it is possible to carry out a ketogenic diet therapy for patients with PTSD for four weeks.
Inflammatory bowel disease (IBD), primarily ulcerative colitis (UC) and Crohn's disease (CD), is a chronic disease entity affecting individuals of all ages, and which may severely impact the lives of the patients and their families as well as society. Individuals with IBD may have to live with relapsing symptoms, such as diarrhea, abdominal pain, and fatigue. Further, a substantial proportion of patients develop serious complications such as bowel obstruction and fistula, and some develop complicating liver disease and eventually colorectal cancer. The consequences are that many patients suffer hospitalizations, recurring sick-leave, life-long medication, and surgical interventions. As IBD has become increasingly common in Western populations there is a clear need to improve the outcome from IBD. IBD is a heterogeneous disease entity with substantial differences between patients and personalized medicine may help provide strategies for better treatment . Currently, one of the main unmet needs is the glaring lack of robust biomarkers for individual disease characterization. This lack leads to delayed diagnosis, worse outcomes, increased mortality and an amplified disease burden. Furthermore, diagnosis of IBD is difficult and early diagnosis is crucial as it helps avoid the development of irreversible organ damage. Therefore, there is an emerging focus on the development of simple, non-invasive, and cheap biomarkers to support clinical decision-making in IBD. This Nordic, prospective, clinical study has the aim of identifying markers that are associated with the diagnosis of IBD and prediction of clinical outcomes with various disease manifestations. Importantly, this study will evaluate the markers in a relevant clinical setting, i.e. among patients referred to the hospital for suspicion on IBD using the ECCO Criteria. Specifically the aims of the study are to: - Improve the accuracy to diagnose IBD - Improve the accuracy to define the prognosis of IBD The study is approved by the local Ethics Committee (S-20200051) and the local Data Agency (20/54594).
Ankle fractures constitute 9% of all fractures and have an incidence of approximately 187 per 100,000 persons per year in Norway. A posterior malleolar fragment (PMF), located on the lower backside of the tibia, is present in up to 46% of Weber B. Weber B fractures are the most common type of fractures of the fibula, located at the height of the syndesmosis. Patients with a PMF were recently shown to have significantly lower patient-reported outcome measures (PROM) than the general population. For this reason, the indication and choice of intervention for these fractures have been the object of increased interest over the recent years. It is one of the most debated areas within ankle fracture surgery. Traditionally, these PMFs have been treated with closed reduction, without direct manipulation of the PMF, anteroposterior screw fixation, or even no-fixation of the smaller fragments. A more novel posterior approach to the ankle for open reduction and internal fixation is increasingly popular and has led to fixation of smaller and medium-sized PMFs. Studies suggest fracture reduction is better with a posterior approach. However, there is no consensus as to what the best treatment is. There are no available randomized controlled studies examining PROM in patients after surgery with fixation versus no fixation for the PMF. Through a multicenter prospective randomized controlled trial initiated from Haukeland University Hospital, patients will be recruited and randomized to receive treatment with or without fixation of the PMF. Patients will be recruited at six study hospitals from all Regional Health Trusts in Norway. Treatment today is often based on local tradition and retrospective, ambiguous literature. As there is no clear evidence supporting the choice to fixate, or not fixate, the posterior malleolus fracture. The current study can contribute new knowledge and thereby contribute to an evidence-based approach to treating these patients. Mason and Molly type 2A and 2B fractures will be included in the study.
Stability dictates treatment choice for trans-syndesmotic fibula fractures. Optimal treatment for partially unstable fractures remains a topic of debate. The purpose of this study is to evaluate possible outcome non-inferior of functional orthosis treatment versus cast immobilization for these fractures.
Investigators would like to test the effects of spinal anesthesia as an adjunct to general anesthesia in patients undergoing laparoscopic abdominoperineal rectal amputation. Investigators hypothesize that spinal anesthesia as an adjunct to general anesthesia will reduce postoperative pain and opioid requirements.
This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.