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.
A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumors (phase 1). Neuroblastoma tumor specific cohort to further evaluate antitumor activity of palbociclib in combination with topotecan and cyclophosphamide in children, adolescents, and young adults with recurrent or refractory neuroblastoma. Phase 2 to learn about the efficacy of palbociclib in combination with irinotecan and temozolomide when compared with irinotecan and temozolomide alone in the treatment of children, adolescents, and young adults with recurrent or refractory Ewing sarcoma (EWS).
An exploratory, open label, multiple dose, multicentre phase I/II trial evaluating safety and efficacy of postnatal or prenatal and postnatal administration of allogeneic expanded fetal mesenchymal stem cells for the treatment of severe Osteogenesis Imperfecta compared with a combination of historical and untreated prospective controls.
Exercising postpartum is important for the health of mother and child. However, there are physical changes postpartum which can prevent women from exercising postpartum. About 30% of women postpartum have problems with stress urinary incontinence. Almost as many have a remaining separation of the two parts of the muscle rectus abdominis. Over the last decenium there has been an increased interest but also disparate information about these conditions. This has led to an increased uncertainty among women who wants to resume exercising postpartum. More and more women seek help of physiotherapists to verify an appropriate function in their muscles after pregnancy. However, reliable and valid examination methods are scarce and it is unclear how to interpret the examination results to give individualized exercise advice. The aim of this study is to test the reliability of examination methods for the pelvic floor function and separation of the rectus abdominis and the criterion validity of these examination methods regarding exercising without leaking urine and lumbopelvic pain. Another aim is to identify if exercising postpartum has effects on the function of the muscles and (less) leaking of urine and lumbopelvic pain/disability. Recruitment of 300 women approximately 8 weeks postpartum in the Region Västra Götaland. For testing interrater reliability on manual examination of the pelvic floor and the separation of the rectus abdominis by caliper two physiotherapists will examine the participants´ pelvic floor and abdominal muscles. The examinations will be tested for criterion validity using a questionnaire for pelvic floor function, lumbopelvic pain/disability and physical activity level. In an observational component of this study the questionnaire will also be used to evaluate the effects of exercising postpartum on the recovery of pelvic floor and abdominal muscles at 6, 9 and 12 months postpartum. This study will provide knowledge about the reliability of examination methods for pelvic floor function and separation of the rectus abdominis, their correlation to urinary leakage and pain/disability (criterion validity) and the effects of exercising on muscle function postpartum.
Phase II study to evaluate safety and efficacy of DCP-001 in patients with AML in CR, and with presence of MRD
Background: Deep caries is the most frequent reason for performing root canal treatments. Minimally invasive methods for the treatment of deep carious lesions might therefore be relevant to avoid pulp exposures and consequently to prevent root canal treatments. A 2 step carious removal approach has shown to avoid exposures. But we do not know whether a selective removal of carious tissue in well-defined deep caries lesions involving the pulpal quarter of the dentin can be successfully completed in 1 step. Objectives: To investigate partial (selective) excavation by 1 vs 2 step in the treatment of deep caries in permanent teeth. Design: RCT multinational superiority study with 2 parallel groups and blinded outcome assessment. The allocation sequence for partial (selective) carious removal vs 2 step stepwise carious removal (1:1) will be centralized and computer-generated, stratified for age and centre and concealed for the investigators. Inclusion criteria: children (≥9 years) and adults with primary well-defined deep caries in a permanent tooth. The lesion should reach the pulpal ¼ of the dentin with presence of a radiodense zone on a bitewing. Exclusion criteria: spontaneous and prolonged pain within the last 6 months; pain causing disturbed night sleep; negative pulp test; apical radiolucency; restoration in close contact with pulp; the patient has communication problems; no written informed consent. Experimental intervention: 1-step selective carious removal to soft or firm dentine at central site , and peripheral non selective carious removal to hard dentin followed by a permanent resin restoration. Control intervention: Stepwise excavation (2- step, involving first step which is identical to the experimental intervention but a base material and a temporary glass-ionomer restoration is placed. The amount removed is as much as a proper restoration can be placed. After 4-6 months the patients are recalled and the temporary restoration is removed and final selective carious removal is completed until firm dentin remains followed by permanent resin restoration. The primary outcome is to avoid pulp complication at the 1-year follow-up evaluating. The secondary outcomes are to arrest caries progression and sufficient restoration at the 1-year follow-up. All outcomes will further be assessed 3 years after inclusion.
The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).
Sweden, like most countries, is undergoing population ageing. This is accompanied by an epidemiologic transition of equal importance, leading to a greater number of people than ever before affected by dementia. Dementia affects thinking, memory, behavior and ability to perform everyday activities, including daily time management. Time orientation and daily management has been shown to influence well-being in older people. There is evidence suggesting that time assistive products can have positive effects on the well-being of both primary users and informal care givers, but this is not sufficient to provide evidence-based guidance for effective interventions, nor to develop innovative and effective solutions. In order to contribute to the development and use of affordable and appropriate innovative assistive products and services for older people with mild or moderate dementia, the purposes of this project are to investigate and model the relationship between the use of time assistive products by older people with dementia, their daily time management and their well-being, and to devise strategies for the acceptance and use of such products by older people with dementia and informal caregivers. A mixed longitudinal approach will be used to attain the first purpose, while the second purpose will be accomplished by applying a qualitative method. Women and men aged 65 or older diagnosed with early or moderate dementia (n=74), and their significant others will be eligible for inclusion. Cooperation with researchers in India and Japan will generate a set of core data, which allows for cross-cultural comparisons of factors related to daily time management and well-being. The three-year project started September 2017, the main study in September 2018. This project can be expected to contribute important knowledge that can advance the effectiveness of cornerstone social policies such as support for ageing in place and healthy and active ageing, and the reduction of social exclusion of older people.
The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in participants with moderately to severely active psoriatic arthritis (PsA).
This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of ripretinib to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to ripretinib 150 mg once daily (continuous dosing for 6 week cycles) or sunitinib 50 mg once daily (6 week cycles, 4 weeks on, 2 weeks off).
The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).