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.
Gentamicin, in combination with a beta-lactam antibiotic, is commonly used for treatment of neonatal sepsis. Neonates have a high volume of distribution. It is a paradox that most neonatal dosing schedules still recommend lower gentamicin doses (4-5 mg/kg) than in older children (≥ 7 mg/kg). In the neonatal unit in Tromsø a simplified gentamicin high-dose (6 mg/kg) regimen has been in use since 2004. The investigators have previously shown that this regimen was associated with low number of elevated trough levels, low numbers of prescription errors and no evidence for ototoxicity in the immediate neonatal period. However, the long-term safety of gentamicin therapy in neonates is not well studied when it comes to ototoxicity and possible nephrotoxicity. The objective of the current study is therefore to perform a detailed hearing evaluation, including an extended high-frequency (EHF; 9-16 kHz) audiometry, in a follow-up study of children (participants) aged 6-15 years who were exposed to a high-dose gentamicin regimen in the neonatal period. Moreover, we will investigate blood pressure and urine biomarkers to assess renal tubular function. The aim is to include 250 children exposed to gentamicin in the neonatal period and a control group of 25 healthy children. EHF audiometry is a more sensitive method for detecting ototoxic damage and provides evidence of ototoxicity before any hearing loss is detected by conventional systems. This is the background for choice of method. The primary outcome is the difference in average hearing threshold in the EHF range between the control group and the exposed group. Secondary outcomes are i) difference in average hearing threshold in the EHF range between the children with gentamicin trough levels > 1.0 mg/L versus those who had lower trough levels, ii) markers of renal tubular function (kidney injury molecule 1) and iii) blood pressure.
Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.
This study includes designing, implementing and evaluating the effectiveness of process-based measures for improving interprofessional collaboration in Norwegian primary schools (5-7th grades). Focusing on leadership and organizational development, the overarching aim is to improve the use of existing interprofessional competence within schools. The interventions include meetings at municipal-level (strategic), school-level (operative) and class-level (operative), with feedback procedures to ensure communication between and within all levels. Also school internal and school external collaborators are involved at all levels of intervention. In order to avoid contradictory roles, an implementation team is responsible for developing and implementing the intervention, while the research team conduct an independent evaluation. The model will be evaluated by a cluster-randomized design to evaluate the effectiveness of the intervention. The hypothesis is that schools that utilize the process-based intervention (intervention group) will improve their interprofessional team work in a way that enhances the pupil's learning- environment and teachers professional competence, self-efficacy and efficient use of working hours compared to their counterparts in the control group. We anticipate main effects to be found at pupil level, mainly through improved early assessment, intervention and efficient follow-up. The project is a collaboration between four Norwegian municipalities and includes a total of 37 Schools, half of which will be randomized to experimental condition and half to control condition. The project is financed by The Norwegian Directorate for Education and Training with a duration of three years and three months. The project is led by Professor Ira Malmberg-Heimonen. The project is a collaboration between Faculty of Social Sciences and the Work Research Institute (AFI), at Oslo and Akerhus University College of Applied Sciences. Participants in the project are Ira Malmberg-Heimonen (project leader), Anne Grete Tøge, Therese Saltkjel, Knut Fossestøl, Elin Borg and Selma Therese Lyng. Participants in the implementation team are Øyvind Pålshaugen, Hanne Christoffersen and Christian Wittrock, also from Oslo and Akerhus University College of Applied Sciences, in addition to Torbjørn Lund from the Arctic University of Norway
The study investigates if a computer-based clinical decision support tool for skin cancer may improve the diagnostic accuracy of general practitioners (GPs). The aim of the program is to help GPs increase their diagnostic accuracy, in particular regarding the selection of suspicious skin lesions that need biopsy or referral to specialist health care for further assessment. Half of the physicians in the trial will have the clinical decision support tool available during consultations, while the other half has no such tool available. We hypothesize that general practitioners using the clinical decision support tool will have a higher number of correct classifications of skin lesions compared to doctors without the tool.
The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal. The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids.
The aim of this study is to analyze whether and how a systemic school-level approach to dropout prevention (the IKO-model), increase the completion rate from upper secondary school. The hypothesis is that schools that implement the model (i.e. randomized to the experimental group), will reduce the amount of students in risk of dropout, compared to their counterparts in schools randomized to the control group. The main expected outcomes in the study are; 1) increased amounts of students in upper secondary education completing their education within the three-year standard length of education, 2) decreased amounts of school-drop out, and 3) reduced values in mediating variables, such as low achievement, course failures, lack of attendance and lack of school-motivation and -effort. Accordingly, implementation quality and fidelity to the model will be assessed, both with quantitative (survey) and qualitative (interviews and observation) data. A total of five counties and 42 upper secondary schools participate in the evaluation project. One of the counties (Akershus County) have developed and piloted the model and function as a mentor in the other four counties (Oppland, Hedmark, Nord-Trøndelag and Hamar). While 20 schools have been randomized to the experimental group, 22 schools have been randomized to the control group. Schools randomized to the control group will work as earlier with school dropout.
The main objective is to evaluate ocular and systemic safety and tolerability of BI 1467335 as well as whether BI 1467335 monotherapy has a potential to improve retinal lesions in patients with moderately severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 47) or severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 53), without Center-involved diabetic macular edema (CI-DME)
Anxiety and depression are among the most common mental disorders in the population. Anxiety and depression have significant consequences at the individual, family and community level, and mental illness is estimated to cost the Norwegian society 180 billion Norwegian kroner annually. The majority of this amount is accounted for by anxiety and depression disorders. Meanwhile, access to mental health services to treat these disorders is limited. The proportion of people who do not receive treatment of those who are in need of treatment is estimated to be over 50%. Prompt Mental Health Care (PMHC) is a pilot project initiated in 2012 by the Directorate of Health commissioned by the Ministry of Health, with the goal of increasing access to evidence-based treatment for adults with anxiety disorders and mild-to-moderate levels of depression. The treatment offered is cognitive behavioural therapy and should lead to reduced levels of symptoms of anxiety and depression, improved quality of life and better employability. PMHC is based on the English program "Improving Access to Psychological Therapy (IAPT)", which is established in virtually all health communities in England. The evaluations of IAPT and PMHC have until now been based on relatively weak research designs which make it difficult to know to what extent the initiative really has the desired effect. In this study, PMHC is compared with a control group that receives treatment as usual (often provided by the general practioner) in two PMHC pilot sites (Kristiansand and Sandnes). Participants are randomly assigned to either the PMHC or the control group. The investigators aim to include 1100 clients in the study. The key objectives of this study are to investigate whether PMHC treatment is more effective as compared to treatment in the control group with regard to symptoms of anxiety and depression, work participation, functional status, and mental well-being. Cost-effectiveness of PMHC is also examined.
The primary objective is to compare the failure rate due to splenic bleeding between the patients undergoing pre-emptive splenic arterial embolization (SAE) as part of non-operative management (NOM) and the patients not undergoing SAE. We hypothesize that the use of pre-emptive SAE will decrease the delayed bleeding rate and increase the success rate of NOM.
This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single intravenous (IV) dose of MK-7655A (a fixed ratio combination of imipenem/cilastatin/relebactam), hereafter referred to as IMI/REL.