There are about 8563 clinical studies being (or have been) conducted in Sweden. 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.
Irritable Bowel Syndrome (IBS) is a common functional gastrointestinal (GI) condition which is strongly associated with dietary and psychosocial factors. Management of IBS remains challenging for primary health care. The aim is to perform a comprehensive phenotyping of patients with IBS within the primary health care in Region Örebro County, Sweden. Following this phenotyping, the investigators will perform a prospective randomized controlled trial of two different treatments versus control as described below. Subsequently, the investigators want to evaluate the result of the treatments in order to see whether the presence of a certain phenotype can predict the efficacy of different treatments. Our hypothesis is that the presence of certain baseline symptom characteristics in patients with IBS can predict how effective internet based cognitive behavioral therapy (iCBT) and low FODMAP (low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols) treatment will be for each patient. 200 patients with IBS aged 18-65 years will be recruited from the primary health care in Region Örebro County. The study plan is structured as follows: 1. Phenotyping of IBS patients. Investigation of the correlation between different psychological parameters, IBS symptom severity and Quality of Life. 2. The effect and outcome of 10-weeks internet-based cognitive behavioral therapy (iCBT) versus control in IBS patients. 3. The effect and outcome of 10-weeks low FODMAP diet versus control in IBS patients. 4. Comparison of iCBT and low FODMAP treatment in IBS patients and identification of baseline phenotypic characteristics predicting treatment outcome for both treatments. Stool and blood samples will be taken before and after treatment for analysis of gut microbiota, proteomics and epigenetics and to correlate these with the clinical phenotype. All participants will undergo phenotyping regarding GI symptoms and psychological variables using questionnaires. Participants will afterwards be randomised to either 10 weeks treatment with iCBT (80 participants), low FODMAP (80 participants) or control group (40 participants) (2:2:1 randomization). The control group will wait 10 weeks before being randomised to either iCBT (20 participants) or low FODMAP (20 participants). Significance This study will provide effective and individualized treatment for IBS patients. This may lead to the development of a guideline to improve the effectiveness of treatment and care for patients with IBS.
Investigator initiated, randomised, placebo-controlled, double-blind, multi-centre primary intervention study to assess whether daily administration of B. infantis EVC001 from age 7 days to 6 weeks (+14 days) until age 12 months (+ 14 days) to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies in childhood.
The primary purpose of this study is to evaluate the efficacy of ION363 on clinical function and survival in carriers of fused in sarcoma mutations with amyotrophic lateral sclerosis (FUS-ALS).
Glucocorticoid (GC) therapy is used to treat a variety of inflammatory conditions such as rheumatoid arthritis, inflammatory bowel disease, bronchial asthma, allergies, ankylosing spondylitis and some forms of cancers. Despite the well-known side-effects, GC treatment is widely used. Oral GC therapy leads to a rapid and profound effects on bone metabolism, with increased osteoblast apoptosis and prolonged osteoclast survival, which increases bone resorption, resulting in bone loss, and a subsequent increased fracture risk. Within days of high dose oral GC, glucose tolerance decreases and bone turnover is shifted in favour of less bone formation and increased bone resorption. Bone formation and bone resorption can be estimated by measuring serum bone turnover markers. The gut microbiota is involved in regulating bone metabolism and recently it was demonstrated that Lactobacillus reuteri 6475 (LR) could reduce bone loss over 12 months by half in older women. In a recent experimental study, it was discovered that mice treated either with broad spectrum antibiotics, eradicating gut microbiota, or with LR did not experience GC induced bone loss in the spine and femur. L. reuteri has been widely studied in clinical trials and has been shown to have probiotic, health-promoting effects in both adults and children. The aim of this planned randomized, double-blind, placebo-controlled trial is to investigate if daily supplementation with LR, compared to placebo, can prevent the negative effects of oral glucocorticoid (GC) on bone turnover and on blood glucose regulation in healthy young adult men and women. If LR is able to prevent deleterious side effects, such as bone loss and impaired glucose tolerance, of oral GC treatment, the probiotic could potentially be recommended and used to improve health in a substantial yearly number of patients treated with GC.
A Phase I/IIa, double-blind, placebo-controlled, randomised study designed to evaluate the safety, tolerability, exploratory efficacy and exposure of LTX-109 administered topically to the anterior nares in subjects with persistent carriage of S. aureus (methicillin-susceptible S. aureus [MSSA] and/or methicillin-resistant S. aureus [MRSA]).
The objective of prospective RELOC-AGE is to study housing choices and relocation and to examine the effects on active ageing among people aged 55+ considering relocation. All data collection will be conducted at baseline and after 1, 3, 5 and 7 years of follow-up.
This is a multiple dose, randomized, placebo-controlled, double-blind study of belcesiran to evaluate the safety, tolerability, PK, and PD in adult patients with PiZZ AATD-associated liver disease (AATLD). The study will be conducted in 3 separate cohorts. A total of up to 16 participants may be enrolled in Cohort 1 and 2. A total number of 30 subjects will be enrolled in cohort 3. The 3 cohorts are differentiated by the duration of the treatment period, the number of doses administered, and the timing of the second liver biopsy.
The primary purpose of this study is to further characterise the hepatotoxicity in participants with advanced or unresectable hepatocellular carcinoma (HCC) treated with lenvatinib, and to further characterise the overall safety profile (serious adverse events [SAEs], grade 3 to 5 adverse events [AEs], dose modifications and discontinuations due to AEs) in participants with advanced or unresectable HCC treated with lenvatinib.
RT001-014 is a Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects with Amyotrophic Lateral Sclerosis
Young cancer survivors are at higher risk of cancer reoccurrence, frailty, suicidal ideation, sedentary behaviour, reduced quality of life, and reduced overall life expectancy, compared to their siblings or healthy young persons. Development of new interventions after cancer treatment is urgently needed in order to reduce and diminish these unwanted risks in young cancer survivors. Previous studies have reported that wilderness therapy may reduce anxiety/depression, improve body image and self-efficacy, and increase physical activity in young adult cancer survivors. High quality randomized controlled studies are lacking and thereby urgently needed to investigate the impact of wilderness programs on mental and physical health of adolescent and young adult cancer survivors. The primary aim of this study is to conduct a pilot randomized controlled trial (RCT) on a wilderness program versus an attention-control activity in adolescent and young adult cancer survivors. We will examine the feasibility of performing a RCT and examine health outcomes, in preparation for a larger RCT with adolescent and young adult cancer survivors. A total of 40 adolescent and young adult cancer survivors (aged 16-39) will be randomized to a wilderness intervention or an attention-control group. The wilderness intervention is a one-week outdoor program where participants have individualized and group activities such as climbing, hiking, kayaking, bush crafting and mindfulness. After this week, participants continue a 3-month program to incorporate elements of the intervention into their daily life. The control group will join a relaxing one-week holiday at a Wellness Center and will be followed for 3 months to control for attention. Study outcomes will be recruitment speed, willingness to be randomized, study adherence, self-reported mental health using validated scales, and tests of physical activity and health (six-minute walk test, submaximal oxygen uptake, blood pressure, sedentary behaviour and physical activity). Outcomes are measured at the start of the study, 1 week and 3 months after intervention. One year follow up of self-reported outcomes will be online. Findings of the study will provide important insights into the feasibility of a large study as well as on ways by which wilderness therapy can promote health in young cancer survivors.