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.
Primary Objective: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years, with LDL-C >=130 milligrams per deciliter (mg/dL) (3.37 millimoles per litre [mmol/L]) on optimal stable daily dose of statin therapy +/- other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins for at least 4 weeks prior to the screening period. Secondary Objective: - To evaluate the safety and tolerability of alirocumab. - To evaluate the pharmacokinetics profile of alirocumab. - To evaluate the effects of alirocumab on other lipid parameters.
We designed an explorative clinical study to assess the effectiveness of an enriched intense and task-oriented therapy program in enhancing motor recovery in patients with moderate to moderately severe hemiplegia after stroke. This enriched comprehensive task-specific therapy (ETT) program combines intensive and task-specific therapy with the sensory-motor, social, and cognitive stimulation inherent to environmental enrichment. We also investigated whether ETT improves gait, balance, upper and lower limb function, and confidence in task performance, health-related quality of life (HRQoL) and reduces fatigue and depression.
The newly developed CBT for ADHD inattentive-type (ADHD-I) protocol is tested for feasibility and acceptability in a pilot study with a single group design. The study also evaluates measurements and recruiting possibilities, and effects of the intervention. Research hypotheses include: 1. There is a basis for recruiting ADHD-I patients for participation in an RCT at psychiatric outpatient units, 2. The measurements in the study are feasible and reasonable in regards to patient characteristics; that is, the patients are responding to the questionnaires as intended, 3. The CBT for ADHD-I intervention is feasible in terms of treatment completion, compliance to home assignments, and credibility and relevance, and is lacking of or involves a tolerable degree of adverse effects, and 4. The CBT for ADHD-I protocol reduces core symptoms of ADHD-I as well as symptoms of stress, depression, and anxiety, and improves quality of life.
Background: Fecal incontinence (FI) affects 2-13% of an adult general population. The prevalence increases with age, and after 50 years of age prevalence rates up to 26% in women have been reported. Quality of life in patients with FI is decreased considerably, in a similar extent as in patients with ulcerative colitis in relapse. Management of FI usually involves a stepwise approach; beginning with more conservative strategies and moving on to more appropriately tailored medications, bowel-retraining, biofeedback and psychosocial support. Although a combination of these treatment alternatives often improves symptoms they are not always successfully. Neuromodulation is a relatively new treatment modality for FI that is based on recruitment of residual anorectal neuromuscular function pertinent to continence by electrical stimulation of the peripheral nerve supply. Sacral Nerve Stimulation (SNS) is one type of neuromodulation and it employs direct electrical stimulation of the sacral nerves. Recently an alternative neuromodulation technique to SNS has been developed in treating FI i.e. tibial nerve stimulation. The tibial nerve contains afferent and efferent fibers originating from the forth and the fifth lumbar nerves and the first, second and third sacral nerves. Thus, stimulation of the tibial nerve may lead to changes in anorectal neuromuscular function similar to those observed with SNS but without the need of a permanent surgically implanted device. Tibial nerve stimulation is therefore an attractive treatment alternative for FI patients since the treatment is well-tolerated and treatment results have been very promising. Aim: The overall aim is to measure the effect of percutaneous tibial nerve stimulation (PTNS) in combination with biofeedback on symptoms in consecutive FI patients compared with biofeedback alone. The investigators also aim to study which FI patients have most profit of the addition of PTNS. Methods: The study will take place at the Pelvic Floor Unit, department of Gastroenterology, University Hospital Linköping. Prior to the first visit to the hospital a symptom diary will be mailed to the FI patients and they are instructed to record their FI symptoms, bowel habits and gastrointestinal symptoms prospectively on a 24-hour diary during 2 weeks. Before consideration of enrolment into the study, gastroenterologists assess all the patients' medical history and perform a physical examination. Subjects will also have an endoanal ultrasonography and the investigators will measure rectal volumes, sensational thresholds and anal sphincter function. FI patients who fulfil inclusion criteria will then be randomly assigned to either PTNS in combination with biofeedback or biofeedback alone. The treatment will be performed by physiotherapists.
A brief treatment program (MI/CBT) via face-to-face or via internet is tested in association with an outpatient addictions clinic.
Rotator cuff tear is a very common and disabling condition that can be related to acute trauma such as falling on the shoulder. A tear is associated with symptoms such as pain in abduction, abduction weakness and night pain. Rotator cuff tear surgery is a well-established form of treatment in acute rotator cuff tears, although beneficial results have been reported for both conservative and surgical treatment of rotator cuff tears. Rotator cuff tear repair surgery involves a considerable amount of re-ruptures, and it is possible that the repaired tendon do not heal despite surgical repair. On the other hand rotator cuff tears are also found in completely asymptomatic persons and the clinical significance of a rupture may be generally lower than estimated. The above-mentioned factors, as well as recent research and meta-analysis on the treatment of mainly degenerative rotator cuff tears indicate that there is a limited evidence that surgery is not more effective in treating symptomatic rotator cuff tear than conservative treatment alone. However, these previous research findings cannot be applied directly to traumatic tears, although degeneration can be considered always to contribute to the creation of a rotator cuff tear. During few last decades, despite the lack of evidence on the superiority of one treatment over another, the use of surgery to treat this disorder has been substantially increased. Treatment expectations are found to be important in predicting patient related outcome measures. In addition, surgery itself may produce a profound placebo effect. There are no previous placebo-controlled trials on the topic of interest. In order to find out the true efficacy of surgical treatment of acute, trauma related rotator cuff tears involving mainly the supraspinatus tendon, the investigators have designed this multi-centre, randomized, placebo-controlled efficacy trial.
It is well known that participation in sports activities as a youth has several health benefits, but at the same time, studies report that the risk is high to obtain injuries related to participation. There is, however, increasing evidence that many of these injuries can be prevented if necessary measures are taken. Prospective studies are therefore needed to be able to plan and carry out measures to prevent the occurrence of injuries. The overall aim of the project KLUB is to study the prevalence and incidence of injuries among athletics youths aged 12-15 years. A particular focus will be placed on identifying factors associated with injury occurrence.
This study seeks to evaluate the efficacy and safety of ABBV-8E12 in participants with early Alzheimer's disease (AD).
Barrett`s esophagus (BE) is the major esophageal pre-neoplastic lesion in which dysplastic transformations eventually can lead to cancer development. Today, the only way for early detection of pre-neoplastic lesions is an endoscopic surveillance programme with tissue sampling for histopathology, the latter being the only validated biomarker for esophageal adenocarcinoma (EAC)-risk available. New biomarkers are warranted for better patient selection before inclusion into BE surveillance programmes. Epidemiologic studies have demonstrated suppressed numbers of cancer prevalence in cohorts being under different medical treatment. In a British epidemiological study 2007 Sjöberg et al noted a lower prevalence of EAC among patients treated with antihypertensive drugs interfering with the renin-angiotensin system (RAS) such as AT1R-blockers and ACE-inhibitors. The last decade this endocrine signalling system has been proven to be involved in pathological conditions such as inflammation, wound-healing and even cancer, in several organ systems. Earlier reports from the investigators laboratory indicate the existence of a local RAS in the esophageal wall musculature and in the squamous mucosa. In the investigators latest explorative study, the investigators discovered the altered expression of "classical" RAS components in BE with and without dysplasia (unpublished results). By a possible alteration in RAS-related protein-expression in BE with increasing grade of dysplasia towards EAC, the investigator may have a possible "pathway" leading to biomarkers for cancer-development. Furthermore, the already well-known anti-hypertensive drugs ACE-inhibitors and AT1R-blockers may interfere with the risk of malignancy in BE. The investigators therefore wish to test, in an exploratory prospective randomized placebo-controlled setting, whether RAS-related protein-expressions in BE are altered by the addition of RAS-suppressant pharmaceuticals. In the same manner the investigators wish to see if the expressions of well-known biomarkers for cancer and inflammation are altered.
The present collaboration study on the treatment of distal radius fractures is aimed to: (i) to compare non-operative treatment to volar plating in the treatment of initially malaligned distal radius fractures in patients aged 65 and older in terms of functional outcome measured with PRWE (ii) to compare non-operative treatment to volar plating in the treatment of distal radius fractures with early instability during follow-up, i.e., loss of reduction at 1 week (range 5 to 10 days) in patients aged 65 and older in terms of functional outcome measured with PRWE (iii)to compare pain, disability, quality of life, grip strength, and the number of complications after non-operative treatment and the initial and delayed operative treatment of distal radius fracture (iv) to assess the effect of pain catastrophizing score (PCS) on the functional outcome of non-operatively and operatively treated distal radius fracture (v) to assess the association between physical activity and the number of wrist movements measured with Axivity accelerometer and functional outcome measured with PROMs of non-operatively and operatively treated distal radius fractures (vi) to assess the effect of initial as well as the final radiological parameters on the functional outcome (vii) to assess the correlation of probability of radiological malalignment estimated by clinical prediction rule (EWC) with functional outcome measured with PRWE and PASS