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.
IMPORTANT study is a multicenter, open-label, prospective, randomized-controlled, non-inferiority trial with a pragmatic approach involving older patients (≥ 70 years old) with advanced hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer, not amenable for curative treatment and without prior therapy for advanced disease, who are suitable to receive CDK 4/6-inhibitors plus endocrine therapy as first line therapy. The study implements two approaches with high level of evidence, namely the use of comprehensive geriatric assessment (CGA) approach in treatment decision making and the use of CDK 4/6-inhibitors as the initial treatment of choice, to investigate whether a common clinical practice (starting dose reduction of CDK 4/6-inhibitors in older patients) with evidence of low certainty can be standardized using a more individualized-based approach. On the basis of baseline CGA assessment, patients will either receive full dose of CDK 4/6-inhibitors plus endocrine therapy (if patients are fit according to CGA) or be randomized to full dose vs. reduced initial dose of CDK 4/6-inhibitors (if vulnerable or frail according to CGA). The study hypothesis is that adjusting the dose according to vulnerability will allow patients to tolerate treatment better without jeopardizing the treatment efficacy. This project has received funding from the European Union's HORIZON 2022 research and innovation actions supporting the implementation of the Mission on Cancer under grant agreement No 101104589.
With an overall aim to ensure a safe and sound kindergarten environment for all Norwegian children in accordance with the Kindergarten Act §§41-43, the objectives of the current project are: To evaluate the effectiveness of Be-Prox Norway to prevent and handle negative behavior and bullying among peers in Norwegian kindergartens. To examine implementation factors that promote and inhibit the effectiveness of Be-Prox Norway in Norwegian kindergartens. To describe the cost-effectiveness of the Be-Prox Norway intervention in Norwegian kindergartens. To generate knowledge on how the Be-Prox Norway intervention can be aligned and implemented in Norwegian kindergartens.
This study aimed to assess if a multidimensional individually tailored intervention, including Norwegian Psychomotor Physiotherapy (NPMP), elements of cognitive behavioural therapy and a rehabilitation plan, helped reduce inspiratory distress and dysfunctional breathing in adolescent athletes with EILO. A mixed methods design, which combined qualitative and quantitative research, was used. Data, including subjective experiences of respiratory distress, findings from NPMP body examinations and objective measurements of lung function and aerobic capacity were gathered before and after a five month intervention involving 18 participants.
Randomized controlled trial to evaluate effectiveness of behavioral Brief Intervention administered by General practitioners (GPs) versus business as usual on use of Z-hypnotics by elderly patients in primary care.
Background: Almost 90% of people with dementia develop serious symptoms such as apathy, agitation, pain, and sleep disturbances. Movement and participation in daily activities also decrease dramatically over time. Traditional measures for these symptoms are usually in the form of a questionnaire and are not very accurate. Technology, such as a smartwatch, can be an effective tool for complementing traditional measures. Currently, there are few studies which look at activity and symptom measurements at the end-of-life. This makes results from this study extremely valuable for future care decisions, especially for people which may not be able to communicate their needs during the end-of-life period. Method/Design: DIgital PHenotyping in DEMentia (DIPH.DEM), a 3-year cross-sectional observational study (N=50), will look at activities, apathy, agitation, and sleep disturbances using sensing technologies to monitor participants at the end of life. The objective of the study is to use a smartwatch and wireless radar (bedside) device (Somnofy), in addition to validated assessment tools to describe the activity patterns for patients with dementia at the end of life (baseline and every 6.months). We hypothesize that this will enable better estimation of time of death, facilitating discussion surrounding improvement of end-of-life interventions and directives. Discussion: The use of sensors (smartwatch and wireless beside device) can provide valuable knowledge on living and dying with dementia, improve end-of-life directives, and provide guidance for timely, appropriate interventions, including referral to palliative services. Impact on society: DIPH.DEM has the potential to enable more timely, precise, and quality care for people with dementia living at home, in nursing homes, and hospitals.
This clinical trial will investigate whether metallic lateralization in reverse shoulder arthroplasty is as stable as bony lateralization during the first two postsurgical years, measured with CT-based motion analysis (CTMA).
The goal of this clinical trial is to compare two different types of reverse shoulder replacements. Researchers will compare a conventional reverse shoulder replacement with a lateralized reverse shoulder replacement to see if there is a difference in how well the patients function after two years.
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 inflammatory markers in children with CWC and the impact of treatment with antibiotics. Furthermore, identify children with CWC who have primary immunodeficiency (PID) based on functional laboratory markers and genetic markers of PID. The study will include two different interventions: INTERVENTION 1: Participants will be randomly assigned to 14 days antibiotics or placebo INTERVENTION 2: Participants will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup
The elderly population today relies heavily on medication consumption. While there are cases where using multiple medications is necessary and reasonable, it also increases the risk of inappropriate treatment and adverse drug effects. This randomized, controlled trial aims to examine the effectiveness of incorporating drug reviews as an integral part of clinical practice for older patients admitted to a Municipal in-patient acute care (MipAC) unit in Oslo, Norway. The intervention involves a clinical drug review conducted by a MipAC physician under the guidance of a geriatrician, followed by a telephone consultation between the MipAC physician and the patient's family physician (FP). The primary outcome measure is health-related quality of life, while secondary outcome measures include physical and cognitive function, dry mouth, hospital admissions, and survival. The environmental impact of the study intervention will also be assessed and compared to usual care.
This is a multi-center study in patients with un-resectable Recurrent or Metastatic HPV16-positive Head and Neck Squamous Cell Carcinoma (HNSCC). The trial is designed to investigate VB10.16, an investigational therapeutic DNA vaccine in combination with another medicine, pembrolizumab, which is the standard of care for patients with previously untreated metastatic or resectable recurrent PD-L1 positive HNSCC. The study is divided in 2 parts: a phase 1, dose escalation part, testing 3 different doses of VB10.16 in combination with a standard fixed dose of pembrolizumab. The goal of this part is to evaluate the safety and tolerability of the combined treatment and to decide on the dose of VB10.16 to be used in the second part of the trial. In the second part of the trial, a phase 2a, dose expansion part, participants will receive either the highest safe dose of VB10.16 from part 1 or the 3 mg dose both in combination with pembrolizumab. The dose given to each participant will be decided in random. The trial is designed to define the optimal dose of VB10.16 in combination with pembrolizumab for future clinical studies based on the safety, tolerability and anti-tumor effect data generated.