Clinical trials

The project will establish a research cohort (called STELIR; STEatotisk Liver-risk In Rogaland) based on a biobank with an associated health register. The purpose is to collect, store and analyze biological material and clinical data from people at risk of steatotic liver disease (fatty liver disease). The research cohort will consist of individuals who agree to participate and will be followed over many years with planned examinations/tests at baseline, after 2 years, after 5 years and every 5 years thereafter. The STELIR cohort consists of individuals between 40 and 70 years of age who have one or more of the following risk factors: Obesity, type 2 diabetes or hazardous or harmful alcohol consumption. The biological material and clinical data collected will be stored and used for research on liver-related disease risk, diagnostics and treatment.

The goal of this placebo-controlled double-blind Phase 2 clinical trial is to test in people with early Alzheimer's Disease. The main questions it aims to answer are: * Does treatment with fasudil, a ROCK-inhibitor, lead to significant improvement in working memory (based on computer-based working memory composite scores) compared to placebo in individuals with early Alzheimer's disease (AD) over 12 months? * What is the effect of fasudil treatment for 12 months on other cognitive functions, brain metabolism measured by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET), and other relevant clinical functions and biomarkers in individuals with early Alzheimer's disease (AD)? * Treatment will be escalated to a maintenance dose of 120 mg total daily dose for up to 50 weeks, with regular clinic visits for efficacy and safety evaluations. * Assessments will include cognitive tests, FDG-PET scans, and biomarker analyses, with follow-up by the Data and Safety Monitoring Board for ongoing safety review. The study will compare participants receiving fasudil with those receiving placebo to see if fasudil treatment leads to improvements in cognitive functions, brain metabolism measured by FDG-PET.

A hip fracture is a large burden to the patient with increased mortality, pain and increased need for daily assistance. Trochanteric fractures of the femur (FTF) represents about 35% of the hip fractures. Today FTFs are mainly treated with internal fixation using sliding hips screws (SHS) or intramedullary nail (IMN), whilst hip arthroplasty (THA/HA) is rarely used. Despite advances in the design of the internal fixation implants there is a high failure rate, in particular in cases of FTFs classified as unstable fractures. Since the introduction of hip arthroplasty in femoral neck fractures there has been a reduction in complication rates, early mobilization and shorter hospital stays. The primary objective of this project is to investigate if treatment with hip arthroplasty in unstable FTFs will increase the postoperative mobility, give a better general health outcome for the patient, better quality of life and reduce re-operation rate for the patients compared to those operated with the traditional IMN.

* A prospective, observational study on clinical outcomes of surgical management of primary and metastatic colorectal cancer * Prospective collection of tissues to explore potential biomarkers in blood and/or primary or secondary cancers and/or normal colon

The goal of this feasibility study is to test whether a new blended digital intervention for adolescents with anxiety disorders is feasible and acceptable for use, and to help plan future larger scale studies. The main questions it aims to answer are: * A: Can the investigators recruit appropriate participants? * B: How appropriate are the data collection procedures and outcome measures? * C: Are the study procedures and interventions suitable for and acceptable to the participants? * D: Does the research team have the resources and ability to manage the study and intervention? * E: Does the intervention show promise of being successful for adolescents with anxiety disorders? Participants will: * Receive outpatient anxiety treatment, typically every other week or weekly. * Use the Sidekick app as a homework supplement to plan, carry out, and evaluate exposure exercises between treatment sessions. * Complete questionnaires before, during, after, and three months after using the app. * Some participants and therapists will be invited to take part in qualitative interviews following the intervention.

Study background: Specialized Group Outpatient Clinic within specialist mental health services, tailoring two year group treatment programmes for severe Avoidant PD (AvPD) and Borderline PD (BPD) with Affect Consciousness (AC) targeting specific areas of emotional dysfunction. Aims: Our main hypothesis, adding AC to Mentalization- based treatment (MBT) to expand the breadth and depth of therapeutically productive work on affect, will aim to examine health indicators, processes and mechanisms of change in depth. The study will extracts preliminary data after 5 years and 10 years to investigate clinical change, variation and outcome during MBT for PD employing AC as add on to MBT. The study has a randomized controlled trail design, with MBT with or without AC as add-on. The RCT is grounded on original literature on Affect Theory, as a framework for understanding patient functioning, and MBT, framing the therapy.Implications: AC methodology as add on can lead to more tailored treatment programmes, service planning, allocation of resources, guidelines, ACI certification and method development for PDs.

The study aims at studying the outcomes of a protocol-based handling of newly diagnosed Inflammatory bowel disease ( IBD ) patients within a defined uptake area in Norway. It is a descriptive study and no hypothesis is predefined. Cytokine studies, QoL and fatigue assessment will be included for hypothesis-generating purposes.

The AMIC study is a double-blind, placebo-controlled, multicenter, nationwide, randomized controlled academic pharmaceutical trial. OVERALL PRIMARY OBJECTIVES: * To study the clinical efficacy of antibiotics in children with chronic wet cough (CWC). * To study if duration of treatment with antibiotics in children with CWC has impact on efficacy or time to relapse of symptoms. OVERALL SECONDARY OBJECTIVE: -To study respiratory pathogens and the diversity/composition of airway and gut microbiome in children with CWC compared to healthy controls, and changes in pathogens/microbiome after treatment with antibiotics. OVERALL TERTIARY OBJECTIVE: -To study the role of inflammation, immunology, and genetics in children with chronic wet cough and suspicion of PBB to increase the knowledge of pathophysiological mechanisms associated with PBB. The study will include two different RCTs AMIC 1 and AMIC 2: AMIC 1: Participants will be randomly assigned to 14 days amoxicillin-clavulanate syrup or placebo. AMIC 2: Participants will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup.

Non-inferiority trial comparing intraocular air and gas tamponade for closure of macular holes.

Patients with central serous chorioretinopathy (CSC) will be monitored with laser speckle flow graphy (LSFG), swept source optical coherence tomography (SS-OCT) and SS-OCT angiography (SS-OCTA). The aim is to unveil the flow and pulse wave characteristics of the choroidal circulation in acute CSC and chronic CSC.

Alcohol is contributing to many health problems and disorders, as well as accidents and social problems. Alcohol consumption has been on the rise the past 25 years, especially in Norway. The highest increase is found in older adults, in line with the development in most other countries in the western world. Older adults have a higher risk for alcohol related health problems, due to age related physiological changes, medical conditions and medications. Still, alcohol use is seldom addressed for older people. This means that older people rarely receive help to change alcohol habits. Norwegian health authorities have issued mandates ordering the regional health trusts to implement strategies in somatic hospital wards, mental health services and drug treatment services to identify and treat alcohol and drug problems affecting the patients' health. In this observational study we will explore patient trajectories three years prior to and three years after an admittance to hospital where risky or harmful alcohol consumption is identified and brief interventions are delivered. Hospitals that have implemented such strategies are invited to the study. Patient trajectories are studied in national health registries. This will provide important knowledge on what characterizes the patients identified, and what happens after they have received a brief intervention related to a hospital admittance.

"The Norwegian Adult Mental Health Registry" (NAMHR) is a medical quality register collecting and systematizing data on patients and their treatment in specialist mental health care for adults in Norway. The main purpose is to create a documentation basis for quality assurance, evaluation, and improvement of assessment and treatment for patients who are offered treatment for mental disorders in the specialist health service. The register uses automatic data capture from various existing data sources. New patients are automatically included, but given the opportunity for reservations from the register without affecting their services and treatment.

Alzheimer's disease (AD) may currently be diagnosed using molecular biomarkers in cerebrospinal fluid (CSF) and/or positron emission tomography (PET). These diagnostic procedures are highly accurate, but the high cost and low availability hamper their feasibility. Recently, ultrasensitive blood tests predicting Alzheimer pathologies in the brain have been developed. These tests have a reliable ability to differentiate AD from other neurodegenerative disorders and identify AD across the clinical continuum with high sensitivity and specificity in research cohorts with a high prevalence of AD. This project will assess the predictive value of these tests in a general practice population. The hypothesis is that the actual blood panel will have high positive predictive value for a diagnosis of Alzheimer's disease in the primary health care setting.

REBECCA-1 is an observational study. Clinical research is undergoing a revolutionary change. The use of electronic patient records (EHR), digital registers, smartphones etc will create "real-world data" (RWD) that provides great opportunities for advancing clinical research, but so far this opportunity has been little exploited. The REBECCA -1 study will observe and monitor fatigue in breast cancer survivors. Investigators will use self reported questionnaires (PROM-data), blood tests and objective regulations like the REBECCCA -1 smart watch that will register amount of steps every day, leaving the house, visiting friends, cafes etc. There will be three observational arms; 1.high fatigue, 2. low fatigue and 3. a healthy control arm. After the patients have finished their treatment, they will receive the REBECCA smart watch, a REBECCA app on the smart phone and a REBECCA plus device on their computer, The next offend are also invited to report their evaluation through the same apps. The observational time will be 1 year and comparison between the subjective PROM data , the objective REBECCA watch and the biological samples will be obtained.