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.
Negative psychological effects of cancer are common, but cancer survivors are rarely offered structured psychological treatment. Internet-delivered treatments have shown some promise, but specific treatment components have not been empirically evaluated which means that it is not clear which therapies that should be prioritized. In this factorial pilot study, 48 cancer survivors with psychiatric symptoms are enrolled in variations on a 10-week therapist-guided online psychological treatment intended to address common negative psychological long-term effects of cancer. The aim of this study is to assess the feasibility of the study design and online treatment format. Key feasibility outcomes include interest in the study, patient-reported credibility of the intervention, adherence to the treatment protocol, satisfaction with the treatment, acceptability of the measurement strategy, missing data rates, adverse events, and preliminary efficacy on anxiety, depression, the fear of recurrence, and health-related quality of life.
The goal of this interventional study is to learn about the effects of different proteins (from animals or plants) on the metabolism in healthy, normal weight women between 18-45 year who are not on hormonal birth-control. The main questions the study aims to answer are: 1. How do different proteins affect biological markers of the metabolism and which protein has the strongest effect? 2. How are the different proteins digested and taken up from our body? Participants will drink four different shakes on four different study days in a random order. Three of them contain each a different protein and one does not contain protein. Right before drinking the shake and on 11 timepoints after drinking the shake blood samples will be drawn.
The purpose of this Randomized Controlled Trial is to develop and evaluate a digi-physical intervention within primary health care lactation counselling and breastfeeding support to promote exclusive breastfeeding rates during the first 6 months after birth and to prevent depressive symptoms. The project addresses parents during pregnancy week 20 and 32 and will continue during the infant's first year of life. All participants will get access to an evidence-based information package (theory and practical advises) during pregnancy. Study aim is to develop and evaluate digital evidence-based information materials and continuous support for both parents in order to increase prevalence of exclusive breastfeeding and duration as well as decreasing the risks of symptoms of post-partum depression.
IMPORTANT study is a multicenter, open-label, prospective, randomized-controlled, non-inferiority trial with a pragmatic approach involving older patients (≥ 70 years old) with advanced hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer, not amenable for curative treatment and without prior therapy for advanced disease, who are suitable to receive CDK 4/6-inhibitors plus endocrine therapy as first line therapy. The study implements two approaches with high level of evidence, namely the use of comprehensive geriatric assessment (CGA) approach in treatment decision making and the use of CDK 4/6-inhibitors as the initial treatment of choice, to investigate whether a common clinical practice (starting dose reduction of CDK 4/6-inhibitors in older patients) with evidence of low certainty can be standardized using a more individualized-based approach. On the basis of baseline CGA assessment, patients will either receive full dose of CDK 4/6-inhibitors plus endocrine therapy (if patients are fit according to CGA) or be randomized to full dose vs. reduced initial dose of CDK 4/6-inhibitors (if vulnerable or frail according to CGA). The study hypothesis is that adjusting the dose according to vulnerability will allow patients to tolerate treatment better without jeopardizing the treatment efficacy. This project has received funding from the European Union's HORIZON 2022 research and innovation actions supporting the implementation of the Mission on Cancer under grant agreement No 101104589.
The primary objective of the study is to evaluate the long-term safety and tolerability BIIB059 (litifilimab) in participants who completed the parent study 230LE301 (NCT05531565) with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy. The secondary objectives of the study are to evaluate the long-term effect of litifilimab on disease activity and the effect of litifilimab in preventing disease damage in participants with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarials; to evaluate the long-term effect of litifilimab on preventing lupus flare in participants with CLE with systemic lupus erythematosus (SLE); to assess long-term use of oral corticosteroid (OCS) in participants receiving litifilimab treatment; to assess the impact of litifilimab on participant-reported health-related quality of life (HRQoL); to evaluate long-term effect of litifilimab on laboratory parameters; to evaluate the immunogenicity and pharmacokinetics (PK) of litifilimab.
The PROP(ofol)-study (EU CT number: 2022-502292-39-00, protocol number: ) is a clinical trial phase IV single centre prospective randomized controlled trial with parallel groups. A total of 80 women who undergoes examination and repair of obstetric perineal lacerations (grade I and II) are randomized into two arms (1:1); analgesia with pudendal nerve block (PNB) with ropivacaine (clinical routine, control group), or analgesia with PNB in combination with patient-controlled sedation with propofol (PCS, PCS group). The hypothesis is that PNB in combination with PCS improves patient experienced pain/discomfort during the examination and repair of the perineal laceration. The primary endpoint is patient experienced pain/discomfort. Secondary endpoints are time of repairing the perineal laceration, ability to have skin-to-skin contact with the baby during perineal repair, time until micturition after the perineal repair, procedure feasibility, amount of drugs used during perineal repair, and use of pain relief 24h postpartum. The study is planned to start during the second half of 2023 and end during the first half of 2024.
Rationale: Preterm neonates with low platelet counts receive prophylactic platelet transfusions with the aim to prevent bleeding. However, it is not clear in which cases platelet transfusions reduce the risk of bleeding or whether they do more harm than good. A large, randomized trial showed that the higher platelet count threshold for transfusion was associated with a higher rate of death and major bleeding, which suggests that platelet transfusions caused harm in neonates. To gain insight into the risk/benefits of platelet transfusions, the investigators will validate a recently developed dynamic prediction model for major bleeding in multiple NICUs in Europe and investigate the effects of prophylactic platelet transfusions on the risks of bleeding and potential transfusion-associated adverse events. This model could then be used in future studies to define enhanced indications for transfusion, with the ultimate goal to prevent transfusion-associated harm in this vulnerable population. Objectives: 1. Validation of the existing dynamic prediction model in an international cohort of preterm neonates with severe thrombocytopenia (platelet count <50x10^9/L) admitted to a NICU. 2. Model amendment to enable prediction of bleeding risks under various hypothetical platelet transfusion strategies in preterm neonates with severe thrombocytopenia. 3. To examine whether prophylactic platelet transfusions are causally associated with the occurrence of bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), proven sepsis, retinopathy of prematurity (ROP), major bleeding, and mortality. Study design: Multicenter international retrospective cohort study. Study population: Neonates with a gestational age <34 weeks and a platelet count <50x10^9/L, admitted to a NICU between January 1st 2017 and January 1st 2022. Main study endpoints: Major bleeding, BPD, NEC, proven sepsis, ROP and mortality. Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Not applicable, as this is a retrospective study.
Covid-19 is a disease where both clinical experience and thus knowledge about the long-term effects of the disease are currently sparse. However, current follow-up results indicate a more pronounced cognitive and respiratory impairment than previously seen in a normal ICU population. As we know that the prevalence of impairments in neurocognitive and Health Related Quality of Life (HRQoL) is increased in a majority of ICU patients, it would be of benefit to gain knowledge about the impact on the recovery trajectory for patients treated for Covid-19, and to increase the understanding of which factors that affect the HRQoL and recovery and in what way these differs between patients treated in ICU for Covid-19 and other causes respectively. This can contribute to better structures for follow-up and possibility to individualisation that better address which patients are in risk for decreased HRQoL and where benefit for the patient, health care and social economic can be achieved.
The primary aim of the project is to map fatigue, cognitive and visual dysfunctions and possible underlying pathophysiological mechanisms in persons with long-term symptoms after a mild to moderate COVID-19 infection. Secondary goals are to study whether covarying factors such as depression and sleep disorders contribute to the results.
IPSA (Improving Parenting Skills adult ADHD) is a new parent training (PT) program developed and adapted for parents who themselves have Attention-Deficit/Hyperactivity Disorder (ADHD). This study evaluates the efficacy of the IPSA program, that is, whether participation in IPSA is associated with desired treatment outcomes (e.g., improved parental self-efficacy). In addition, it examines the program's feasibility (e.g., what parents think about the program, the extent to which parents complete the program, and program safety). The study is a so called randomized controlled trial (RCT), where participants are randomly assigned to one of two groups: Treatment (IPSA) or Control (continued routine services; offered IPSA approximately six months later). Participants are adults with ADHD (any form) that have at least one child in the ages between 3 and 11 years. Data are primarily collected using questionnaires, completed by parents before and after IPSA, as well as in connection with an IPSA booster session (follow-up).