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.
Introduction In shift work, quick returns refer to transitions between two shifts with less than 11 hours available rest time. Twenty-three per cent of employees in European countries reported having quick returns. Quick returns are related to short sleep duration, fatigue, sleepiness, work-related accidents, and sickness absence. The present study is the first randomized controlled trial (RCT) to investigate the effect of a work schedule without quick returns for six months, compared to a work schedule that maintains quick returns during the same time frame. Methods and analysis A parallel-group cluster RCT in a target sample of more than 4000 healthcare workers at Haukeland University Hospital in Norway will be conducted. More than 70 hospital units will be assessed for eligibility and randomized to a work schedule without quick returns for six months or continue with a schedule that maintains quick returns. The primary outcome is objective records of sickness absence; secondary outcomes are questionnaire data (n ≈ 4000 invited) on sleep and functioning, physical and psychological health, work-related accidents, and turnover intention. For a subsample, sleep diaries and objective sleep registrations with radar technology (n ≈ 50) will be collected. Ethics and dissemination The study protocol was approved by the Regional Committee for Medical and Health Research Ethics in Western Norway (2020/200386). Findings from the trial will be disseminated in peer-reviewed journals and presented at national and international conferences. Exploratory analyses of potential mediators and moderators will be reported. User-friendly outputs will be disseminated to relevant stakeholders, unions and other relevant societal groups.
Post hepatectomy liver failure (PHLF) is one of the most severe complications after liver re-section. Preoperative evaluation of liver function is complicated and imprecise. The volume and function needed for each individual patient is unknown and the methods used for evaluation are uncertain. Preoperative MRI with Gadolinium may give dynamic information regarding liver function correlating with postoperative liver failure. A retrospective analysis will be performed regarding this topic.
Many patients with irritable bowel syndrome (IBS) do not experience adequate symptom relief with current treatments. The pathophysiology of IBS is diverse, controversial and not completely understood. The next disruptive frontier would be to find a cure where the effect is predictable and lasting. The study groups phase 2 pilot trial was the first indication of a possible benefit from treating IBS with fecal microbiota transplantation (FMT) (Number needed to treat only five) (Fecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomized, placebo-controlled, parallel-group, single-centre trial he Lancet Gastroenterology and Hepatology 2018). Additional results from the same trial show that the treatment response may be predicted (unpublished data), and that the pathophysiologic mechanisms behind the treatment response also can be identified (Effects of fecal microbiota transplantation in subjects with irritable bowel syndrome are mirrored by changes in gut microbiome, Gut Microbes 2020). This study is the first phase 3 trial of FMT for IBS worldwide. The hypothesis of the trial is that donor FMT is more effective than placebo FMT in treating IBS, with little adverse events or complications. Patients ≥18 years with IBS are enrolled at five Norwegian Hospitals in this double blind randomized, placebo controlled, parallell-group multi center trial. Participants are randomized to FMT from a healthy donor (intervention group), or their own feces (placebo group). The primary outcome is the proportion of patients with ≥75 points decrease in the Irritable bowel Symptom Severity score 90 days after treatment.
Depression is a common mental illness which is costly for both society and for those affected. There is a need for effective treatments of depression and there is a need to make sure that the treatments that are given are based on scientific findings. In this study the investigators want to examine and compare two common treatment models for depression - Cognitive Behavioral Therapy and Emotion-Focused Therapy. The investigators want to investigate what characterizes these treatments when they are successful, and seek to better understand what it is like for patients to receive these treatments. Also, the investigators will investigate the experience of patients who abruptly discontinue treatment. To investigate these questions, self-report measures, interviews and analysis of session recordings will be used.
The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)
This multinational, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent transcatheter mitral valve implantation (TMVI), in comparison to those screened for TMVI but deemed ineligible, who subsequently underwent interventional mitral valve edge-to-edge repair, mitral valve surgery or medical/conservative therapy.
This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.
The overarching objective for this prospective cohort study of COVID-19 in adolescents is to study the long-term effects, with particular emphasis on post-infectious chronic fatigue. A total of 500 individuals with a SARS-CoV-2 positive test will be enrolled in the acute phase of COVID-19 and followed for 6 months. A total of 100 individuals with SARS-CoV-2 negative test will be included during the same time period as a control group. Investigations include autonomic, pulmonary and cognitive assessement; a questionnaire charting symptoms, emotionality, personality, loneliness, life events and demographics; and extensive biobanking including genetic markers, viable PBMC, urine, feces and hair. A subgroup of 40 SARS-CoV-2 positive and 20 SARS-CoV-2 negative individuals will also undergo detailed cardiological examination by echocardiography. Primary endpoints are fatigue at 6 months as assessed by the Chalder Fatigue Scale and post-COVID-19 syndrome cases at 6 months according to the WHO definition
This prospective randomized non-inferiority study is designed to compare the rate and severity of complications after axillary and inguinal lymph node dissection in stage III melanoma patients in a study group where the drain is left in place for three weeks and a control group consisting of patients managed according to the standard institutional protocol. Furthermore, variables associated with complications will be examined.
This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.