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.
Opioid dependence, for example involving addiction to injected or inhaled heroin or similar compounds, is associated with high mortality, typically from opioid overdose, and causes major physical and mental health complications, social problems and crime. Opioid maintenance treatment (OMT) has proven effective in opioid dependence. In 2014, a patient's choice reform in Skåne county, Sweden, was introduced and led to a vast extension of OMT in the region, including a large number of treatment providers and high access to treatment. Still, opioid-related mortality in the region remains high. While patients' access to treatment has been increased, the content and nature of treatment in the present system has been questioned. The present system, which dramatically altered treatment conditions and access for OMT in this region, has never been formally evaluated in any large-scale study. This study aims to assess clinical course of patients receiving OMT before and during the patient choice reform system, and effects on the extent and nature of opioid-related mortality in the region.
Background: An individualized internet-based treatment program from a biopsychosocial perspective has been developed within the Västra Götaland region (VGR) with funds from the Innovation Fund. The treatment program is called Learn to live with migraine and goes by the abbreviation I AM (Internet Approach to Migraine). I AM is a complement to the medical treatment and focuses on pain management and learning to live as good a life as possible with the disease migraine. During the spring of 2022, I AM has been tested regarding the feasibility of primary care on 29 research subjects in a pilot RCT (DNR 2020-02359). A weighted preliminary assessment shows moderate effect size on mental health, that the participants accept the intervention, and that I AM with recruitment and care process can be carried out in a primary care context. Purpose: An overall purpose of the study is to evaluate the effect of the addition of the internet-based biopsychosocial treatment I AM compared to usual treatment (TREATMENT as usual - TAU) in primary care regarding frequency and severity of migraine attacks, functional level, mental health, quality of life and employment rate with a randomized controlled trial design (RCT). An additional aim is to evaluate whether it is possible to prevent episodic migraine from developing into chronic migraine among those who have episodic migraine at the start of the study via the supplement treatment program I AM. Expected results: The greatest expected benefit of I AM is to reduce the burden and suffering of migraines for all the people affected. AM is also expected to increase the availability of treatment with a biopsychosocial perspective, have a quality-enhancing effect in terms of method and increase the patient's participation in their treatment. An environmental aspect is that neither patient nor therapist need to travel, accessibility also increases for individuals living in smaller communities who receive equal treatment.
Two devices will be tested in this research: 1. Mantis Photonics' hyperspectral camera for non-invasive retinal examination (i.e., a hardware medical device under investigation). 2. Blekinge CoGNIT cognitive ability test (i.e., an assessment).
This study investigates if circulating tumor DNA can improve the detection of early treatment failure or recurrence in localized squamous cell carcinoma of the anus (SCCA) after curative chemoradiotherapy thereby increasing the potential for cure. This will be done by comparing the standard follow-up program with ctDNA guided imaging follow-up. Secondly, the aim is to establish early interventions against late morbidities.
The Mobile-based intervention intended to stop obesity in preschoolers (MINISTOP) program has been developed to be a comprehensive digital support program for all children irrespective of weight status. However, a one size fits all approach may not be sufficient as some families may require extra support through in-person activities to achieve the required lifestyle behaviour change in order to attain and maintain a healthy weight. Therefore, the aims of this pilot randomized controlled trial are to evaluate the efficacy and feasibility of the MINISTOP Plus Program in pre-school children with overweight and obesity on: (i) children's BMI z-scores; (ii) intake of fruit and vegetables, sweet and savoury snacks, and sweet drinks; (iii) time spent in different physical activity intensities; (iv) screen time; and (v) parental self-efficacy.
This is a multi-center study of MFA-370 in patients with metastatic urothelial cancer. The objective of the study is to assess the safety and efficacy of MFA-370, i.e.a combination of two approved pharmaceuticals today used within other indications. The combination was developed after the finding that a multidiseased man with e.g. muscle-invasive bladder cancer also was treated for his recent parasitic infection resulted in that the parasitic infection together with the cancer got a complete remission. After extensive experimental complementing studies a combination treatment called MFA-370 was developed supporting the rationale for this treatment. This is the first clinical trial where the combination product MFA-370 is evaluated as anti-cancer treatment. Up to 50 patients will participate. MFA-370 is taken orally once daily for up to 24 weeks. If the treatment is of clinical benefit for the patient, as assessed by the investigator, the treatment period can be prolonged to up to 2 years. The patients will be monitored for safety, tolerability, pharmacokinetics, tumor response by RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 and survival.
Cirrhosis or cancer of the liver caused by hepatitis B virus (HBV) are major global health problems. Chronic HBV infection has become more common in Sweden with immigration. The risk of cancer and the availability of effective antivirals has led to more and more people receiving long-term treatment with antiviral drugs. The disadvantages of this treatment are that it does not have a defined duration and that it very rarely leads to the cure. Several published studies suggest that a large proportion of patients who discontinue antiviral therapy after at least three years may achieve lasting cure of the infection or at least do not need to resume treatment. The mechanism of this effect is not known, but it is thought to be due to the fact that the immune response, which is activated when the amount of virus increases after the end of treatment, becomes more effective in eradicating infected liver cells than it was before starting treatment. As a consequence of these findings updated guidelines for treatment of hepatitis B state that for patients that have received nucleoside analogue treatment for > 3 years, discontinuation is an accepted therapeutic alternative. The purpose of the planned study is to investigate the results of discontinued treatment, in terms of clinical outcome as well as immunological and virological mechanisms. The aim is to include 120 patients at four regional infectious diseases clinics (in Gothenburg, Borås, Skövde and Trollhättan), of which 90 will be randomized to discontinue and 30 to continue antiviral treatment. Blood samples will be taken regularly to monitor the outcome and for detailed studies of viral antigens and nucleic acid in the blood and for specific analyzes of the cells of the immune system. The goal is to understand why the discontinued treatment in some patients activates an effective immune response and how such an effect can be predicted even before or early after the treatment is stopped.
The interest in Para sport is steadily increasing. A concern is, though, that elite Para athletes report a high incidence of injuries and illnesses. Altogether, there is an urgent need to prevent such incidents among athletes already suffering from an impairment. However, most of the existing training-based prevention programmes are not adapted or accessible to Para athletes. Also, recent research suggests that sports safety work advantageously should facilitate disease prevention and health promotion. Such intervention would hypothetically also have the potential to reduce injuries, illnesses and improve health among Para athletes. To allow full implementation, the intervention would need to be adapted to the Para athletes´ various impairments, abilities and sports. MAIN QUESTIONS TO BE ADRESSED - Can an evidence-based eHealth health promotion platform prevent sports injuries and illnesses in elite para athletes over 6 months, 12 months and 5 years? - Can such platform improve overall health parameters such as sleep, nutrition and mental health in elite para athletes and influence the performance parameters training quantity and training quality over 6 months, 12 months and 5 years? - Can such platform improve health literacy among Para athletes?
This is a multicentre open labelled phase III adjuvant trial of disease-free survival in patients with resected pancreatic ductal adenocarcinoma randomized to allocation of oxaliplatin- or gemcitabine-based chemotherapy by standard clinical criteria (control arm) or by a transcriptomic treatment specific stratification signature or TSS (test arm).
Dissemination from pancreatic ductal adenocarcinoma (PDAC) occurs in clinical practice either in the form of recurrence after initial treatment with curative intent resection (metachronous) or more frequently prevails already at the time of diagnosis (synchronous). Traditionally, metastatic pancreatic cancer (mPDAC) is considered not to be eligible for meaningful aggressive therapies to be implemented. However, with the development of local as well as more effective systemic therapeutic regimens a variety of clinical situations have to be reevaluated. For instance, recent reports have indicated an option for maintained or even prolonged survival after resections and/or ablations of oligometastatic pancreatic cancer (OMDPDAC), as represented by a single or few liver metastasis (es). These reports are burdened by methodological weaknesses such as being retrospective, single institution and reporting only from highly selected case series. A common denominator of acceptable outcome is, however, that all metastatic lesions have been preoperatively treated and responded to chemotherapy, indicating an advantageous tumor biology. Hence an unbiased approach, including neo-adjuvant chemotherapy before any aggressive local treatment must be explored to the updated management opportunities in terms of assessing the prevalence, safety, feasibility, tolerability and possible disease control options. Primary objective (clinical): To prospectively investigate (on an intention to treat basis) the safety, feasibility, tolerability and clinical outcomes of all patients with PDAC presenting with limited metastatic disease, where a treatment option can be launched with the ambition of local disease control and eventually better survival. The cohorts to be included are: Primary cohort: Patients with liver limited (metachronous and synchronous) metastasis(es) due to PDAC. This cohort is further subdivided to: Limited liver disease. Extended liver disease. Secondary cohort: Patients with OMDPDAC and at least one extrahepatic manifestation of PDAC. Secondary objective (translational) is to improve the understanding of PDAC liver metastases biology by studying the mechanistic aspects of metastases invasion as well as intra- and peri-tumoral liver metastatic niche, and by charting the cellular composition of liver metastases on single cell level with a focus on the impact of cellular interactions on tumor cell growth and differentiation. Furthermore, the study aims to identify blood-based biomarkers of response to oncologic/surgical treatment.