There are about 196 clinical studies being (or have been) conducted in Iceland. 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.
Sleep problems are common among adolescents which can have a variety of serious biological, emotional, cognitive and psychological consequences. Numerous studies have shown that adolescents who suffer from insufficient sleep and poor sleep quality experience decreased mental well-being which is a growing concern in modern societies. Effective interventions that enhance sleep quality among adolescents are lacking. One possible reason for sleep problems among adolescents is disturbance in the body's circadian rhythms. As light is known to be the main coordinating factor in circadian rhythms, light therapy is an auspicious method which aims to entrain the circadian rhythms, thereby enhancing sleep quality and well-being. Indeed, bright light therapy (BLT) has been shown to be a promising treatment to improve sleep and decrease depressive symptoms among different patient groups. However, BLT interventions among healthy adolescents are needed. Therefore, the current study will investigate whether BLT in classrooms of 16 year old students can improve their sleep quality and well-being. The results from the study can be important as it is the first one to examine whether light intensity in the classroom affects sleep and well-being among adolescents. Furthermore, if the hypothesis will be supported, a simple and relatively inexpensive method can be implemented to promote better sleep quality and thus have an extensive effect on adolescent's well-being. Aim 1 - Assess whether BLT will improve sleep quality of adolescents. Aim 2 - Assess whether BLT will decrease depressive symptoms in adolescents. Aim 3 - Assess whether BLT will improve mood in adolescents.
The purpose of this study is to estimated prevalence of obstructive sleep apnea (OSA) in 4-8 year old children. To date, most studies estimating prevalence of sleep apnea in young children are based on utilizing subjective questionnaires. The few studies that have utilized objective sleep measures have tested only those children suspected of sleep apnea based on subjective questionnaires, finding prevalence in the range of 1-13%. Untreated OSA is associated with significant morbidities in children, affecting their behavior, cognitive development, cardiovascular-and cardio metabolic health, endocrine and immune function. Better understanding of prevalence of sleep apnea in young children should be beneficial. This study will help to understand the prevalence of sleep apnea in each age-group of children 4-8 years of age and whether certain groups, such as children with obesity or asthma have higher prevalence and/or more severe disease. The primary objective of this study is to get better understanding of prevalence and severity of sleep apnea in young children using objective sleep measures for all participants.
Sidekick Health has developed an interactive digital therapeutic program (SK-421) specifically designed for reducing side effects in breast cancer patients. The study will be a single center pilot study with an intervention group and a comparison group recruiting 66 breast cancer patients prescribed to surgery, chemotherapy, radiation and/or hormonal therapy according to standard breast cancer treatment. The 14-week pilot study will determine whether the interactive digital therapeutic program, supporting lifestyle changes, can positively impact management of side effects, quality of life, physical activity and fitness and medication adherence in this patient population. Patients will be randomized to receive either the standard of care (SoC) treatment alone or SoC with the addition of the digital therapeutic program.
Sidekick Health has developed a digital behavioral change program (SK-241) specifically designed for people with metabolic derangements and non-alcoholic fatty liver disease (NAFLD). The SK-241 is delivered through a mobile application and aims at improving lifestyle and health outcomes by focusing on improving diet, increasing activity levels and reducing stress. In this study, the feasibility of the newly developed digital behavioral change program (SK-241) will be evaluated in a minimum of 30 individuals with a NAFLD diagnosis. The primary aim is to explore the acceptability of the SK-241 program by its users, in addition to exploring changes in clinical outcomes and medication adherence after a 12-week intervention with 6 months follow up.
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).
Hip and knee total joint arthroplasty are one of the most frequently performed surgery worldwide. However, prosthetic joint infection remains a devastating complication of them, associated with severe morbidity, increased mortality and huge costs. Several underlying medical conditions that have been identified as independent risk factors for development of prosthetic joint infection. The hypothesis of the study is that by utilizing the waiting time for operation (6 -12 months) to improve the state of known modifiable risk factors the frequency of prosthetic joint infection may be decreased. This optimization was established with co-operation between hospital and primary care. Therefore a prospective non-randomized quality control study before and after an intervention regarding preoperative preparation for total joint arthroplasty of either hip or knee was planned. The control arm was included one week prior to surgery at the anesthesia preoperative assessment outpatient clinic and were operated on between 27/8 2018 and 7/9 2020 and consists of 738 patients. Inclusion of the interventional arm happened at the orthopedic outpatient clinic from 2/1 2019 - 30/1 2021, 6 -12 months prior to surgery and an appointment with their general physician ensured within 3 weeks for further evaluation. Enlisted have been 1010 patients, operation of them started 25/3 2019 and to date 710 patients have been operated on, but due to delays caused by Covid-19 (SARS-CoV-2) surgery of them is still ongoing. The effect of the intervention will be evaluated with by comparison of patient characteristics and frequency of surgical site and prosthetic joint infections before and after.
The purpose of this study is to characterize the distribution of lipoprotein(a) (Lp(a)) levels among participants with a history of ASCVD as defined by their medical history and is 2-fold: - Evaluate the distribution of Lp(a) value in the overall participants with documented history of ASCVD - Evaluate the distribution of Lp(a) value in participants with documented history of ASCVD by demographics and regions
Individuals (n=180) with subacute (<1 month, >3 months) WAD grade I and II with medium to high-risk symptoms of working age will be randomized into three groups with block randomization in a prospective, assessor-blinded randomized controlled trial. Two primary intervention groups (A and B) will receive manual therapy (MT) in the same out-patient clinic. In addition, group A will receive a remote, novel, computer-based cervical kinaesthetic exercise program starting at visit two, whereby quality and quantity of exercise performance, as well as compliance (frequency and duration), will be registered into the physical therapy clinic's system for evaluation. Group B will receive neck exercises (not computer-based) provided by the corresponding physical therapist. Group A will continue remote exercise therapy until 6 months post baseline measurements regardless of whether they are still being treated in-clinic or discharged. Hypothesis 1.a.: Internet-based neck-specific CKE combined with in-clinic manual therapy and exercises will be superior to manual therapy and exercises alone at a physiotherapy clinic (i.e., treatment A is superior to treatment B) for self-reported and measured (movement performance) outcome measures. Hypothesis 1.b.: Improvements in self-reported outcomes will positively correlate with outcomes of movement performance testing, as will the pre- to post-intervention changes from baseline to follow-up assessments. The groups will be compared to a "treatment as usual" group (C). Objective measures include measurements for motor control, proprioception, and cervical range of motion. Neck disability and pain intensity, general health, self-perceived handicap, and physical, emotional and functional difficulties due to dizziness will be measured using questionnaires. Short-term effects will be measured at 10-12 weeks and long-term effects at 6- and 12-months post baseline measurements. Hypothesis 2.a.: Participants of groups A and B will improve significantly more than those in group C for subjective and objective outcome measures.
The study aim is to determine whether a 12-month digitally delivered behaviour change solution for patients with heart failure improves symptom frequency, mental health, quality of life, medication adherence, and self-care behaviour. The primary and secondary endpoints will be captured at 6- and 12-months follow-up visits to assess longer term effect on outcomes.
Purpose: To demonstrate that personalised therapy can be delivered to patients with IBD, by treating patients with an increased risk of poor disease course, defined by a serum protein signature at diagnosis, with a top-down treatment, and that this treatment strategy improves clinical outcomes. Objectives: Primary objective: To assess if a top-down treatment can improve treatment outcomes in IBD patients with a high risk of poor disease course, defined by a serum protein signature at diagnosis. Secondary objective: To assess if a top-down treatment can improve quality of life and health resource allocation in IBD patients with a high risk of poor disease course, defined by a serum protein signature at diagnosis. Study design: A multi-centre, biomarker-stratified open-label controlled trial, where newly diagnosed IBD patients are randomised (1:1) to a group with access to the protein signature or a group without access to the protein signature. Study subjects within the protein signature arm who display a high-risk protein profile, will be treated according to a top-down treatment algorithm (anti-TNF agent with/without an immunomodulatory) and subjects without access to the protein signature will be treated according to current clinical practice. Study population: Newly diagnosed IBD patients. Number of subjects:250 Primary variables: Composite of both corticosteroid-free clinical remission and endoscopic remission at Week 52, defined as below. Surgery because of IBD during follow-up will be defined as treatment failure. Ulcerative colitis; - Clinical remission per patient reported Mayo: A stool frequency subscore (SFS) ≤ 1, and not greater than baseline, and a rectal bleeding subscore (RBS) of 0. - Endoscopic remission: An endoscopic Mayo subscore of 0 (OR in patients without endoscopy at week 52, normalization of f-Calprotectin, defined as < 250μg/g Crohn's disease; - Clinical remission: An average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline. - Endoscopic remission: SES-CD≤2 (OR in patients without endoscopy at week 52, normalization of f-Calprotectin, defined as < 250μg/g.