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.
The ICONIC-M study is a multicenter randomized controlled study to assess patient response to CRT comparing ECGI map guided left ventricular lead placement with empirical lead placement. The hypothesis of the investigation is to demonstrate that CRT LV lead implantation guided by a map obtained with the Amycard 01C System and showing LV Latest Electrical Activated Site (LEAS) in combination with a CT cardiac venogram improves CRT outcome. An improved CRT outcome is defined as a ≥30% increase in LVESVi reduction compared to empiric CRT LV lead implantation. The sample size will be 136 in the Control arm and 194 in the Active arm. A total of 330 subjects. The study follows an adaptive design, in where one interim analysis at 70% enrollment will be performed. The sponsor may stop enrollment when either one of the following conditions apply: - Statistical significant difference between groups in the primary endpoint has been reached confirming a difference in reduction of the LVESVi of ≥30% in the Active arm compared to the Control arm - There is no trend or reason to believe statistical significance will be reached with a higher sample size. Statistical significance (primary endpoint) is reached at interim (70%) or at total (100%) of enrollment with a significance value P lower than 0.025.
The STEPCARE-trial is a 2x2x2 randomised trial studying patients who have been resuscitated from cardiac arrest and who are comatose. It will include three different interventions focusing on sedation targets, temperature targets and mean arterial pressure targets.
Research problem and specific questions: Approximately 2.8 million surgeries are conducted yearly in Sweden and of these almost 50% are persons ≥ 60 years. Postoperative cognitive recovery is a concern for older persons. To date, there is no evidence for treating postoperative neurocognitive decline (POCD) and no assessment of cognitive function is routinely performed. The purpose is to is to test digital monitoring in clinical practice: I) test recruitment process and measure attrition rate; II) estimate the difference in main clinical outcomes (POCD) that will inform sample size calculations for the longitudinal observational mixed methods study, III) determine the usability and feasibility of digital monitoring. Participants: 50 patients ≥60 years undergoing inpatient surgery. Outcomes: depression, frailty, cognitive function, postoperative recovery and functional status .
The purpose of this study is to provide continued access to treatment for participants who continue to benefit from treatment.
The study is a 4-week double-blind, randomized, controlled, parallel design investigation to investigate the impact of intermittent negative pressure on spasticity and pain in people with multiple sclerosis (pwMS). The investigational device (FlowOx2.0™) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the same pressure chamber but be randomized to either a Control Unit that generates intermittent negative pressure (INP) of - (minus) 40 mmHg or a Control Unit that generates INP of - 10 mmHg. FlowOx2.0™ generating -40 mmHg is the investigational device, and FlowOx2.0™ generating -10 mmHg, is the comparator device. After the initial 4-week double-blind period, all participants will be offered the -40mmHg control unit to be used during a 6-months optional extension part.
Sweden has an aging population and people with dementia often have their needs met in their own homes. The Social Services Act states that eldercare should aim at strengthening older people's ability to live an independent life, in dignity and with well-being. Although few would question the importance of influence and individualized support, research has shown that older people with extensive and complex needs, such as dementia, may be at risk of being excluded from the same opportunities as more privileged groups of eldercare recipients. Care managers and home care staff have to handle both the choice of services and providers as well as the more detailed design of the home care services without developed working methods that support the possibility of informed choices for people with dementia or other cognitive difficulties. The need for some form of decision aid in these situations has therefore been raised. So-called TalkingMats have in previous studies in the United Kingdom (UK) been shown to promote influence in decision-making for people with dementia. Within the framework of this study, our aim is therefore to evaluate the effect of TalkingMats as decision aid in needs assessment and planning home care services for people with mild to moderate dementia. The study is designed as a two-armed RCT study, where the effectiveness and implementation of TalkingMats are evaluated both quantitatively and qualitatively, in collaboration between eldercare in four municipalities in the Sjuhärad region, the Department of Social Work at Göteborg University, the University college of Borås and R & D Sjuhärad Welfare.
The primary objective with this study is to investigate the feasibility and acceptability of ten weeks of internet delivered prolonged exposure delivered through a digital platform with therapist support. The secondary objective is to investigate preliminary effects of internet delivered prolonged exposure in terms of reducing symptoms of post-traumatic stress, depression and increase quality of life.
The Epidemiology of Perioperative Care in Sweden (EPeCS) study is a registry-based, retrospective extensive analysis of the whole adult (≥18 years) surgical population in Sweden during six full years, 1 January 2015 - 31 December 2020. Patients are retrieved from the Swedish Perioperative Registry (SPOR) which has full national coverage of public healthcare. The study aspire to integrate pre-, peri- and postoperative components of the whole perioperative process as well as process, patient, anaesthesia and surgical factors. This allows for careful risk-adjustment and is a major strength of the project. This will require cross-matching data from several national quality registries. EPeCS will serve as a database to be used as the foundation for several substudies that are to be conducted (10 at the present moment). Specific study focuses and aims are described in the "Detailed Description" section below. The present study aims to provide a comprehensive audit of the surgical population in Sweden, and to identify factors that are of importance for outcome. The investigators aim to identify factors that will allow a better prediction of outcome, if they are modifiable, and if they are different for different lengths of follow-up. The ultimate goal is to provide hypotheses for directed therapies (eg. different types of anaesthesia), processes (eg. designated around-the-clock hip-fracture surgical teams), postoperative care (eg. extended PACU care instead of intensive care) in order to decrease suffering and increase cost-efficacy in Swedish healthcare.
This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are anti Scl-70 antibody positive. Systemic sclerosis is also called scleroderma. The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems. Participants are put into 2 groups by chance. One group takes Avenciguat (BI 685509) tablets 3 times a day and the other group takes placebo tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can continue to take the tablets until the last participant has completed the 11-months treatment period. This means that the time in the study and duration of treatment is different for each participant, depending on when they start the study. At the beginning of the study, participants visit the study site every 2 weeks. The time between the visits to the study site gets longer over the course of the study. After the 11-months treatment period, participants visit the study site every 3 months. During the study, participants regularly do lung function tests. The results are compared between the 2 groups to see whether the treatment works. The participants also regularly fill in questionnaires about their scleroderma symptoms. The doctors regularly check participants' skin condition and general health and take note of any unwanted effects.
RCT to determine if a less restrictive postoperative rehabilitation protocol following meniscal repair results in a faster return to normal knee function without compromising rates of healing.