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 non-inferiority, prospective parallel group, multi-center, randomized controlled trial to investigate whether selection of a single blastocyst for transfer using the deep learning tool, iDA, results in non-inferior clinical pregnancy rate compared to trained embryologists using standard morphology criteria.
This study will investigate the effect of a peripheral acting opioid antagonist (PAMORA) on the disease course of patients with recurrent acute inflammation of the pancreas (acute pancreatitis). The study will be conducted by treating outpatients suffering from recurrent acute pancreatitis with a PAMORA (naldemedine) for 12 months.
The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.
Background: Chronic obstructive pulmonary disease (COPD) is a common chronic disease characterized by persistent respiratory symptoms and airflow restriction, due to airway and/ or alveolar abnormalities usually caused by significant exposure to harmful particles or gases, in particular cigarette smoking. Sleep disorders are common in society and it is not surprising that they also affect individuals with COPD. Patients with COPD, especially those in severe stages of the disease suffer from many sleep disorders and its prevalence varies depending on the disease. Epidemiological studies report that approximately 75% of COPD patients experience nocturnal symptoms of the disease. The most common are sleep-breathing disorders (nocturnal hypoxemia, central sleep apnea, difficulty breathing, sleep-related hypoventilation), insomnia and sensory motor disorders during sleep, including restless legs syndrome. Patients with COPD not only experience poorer sleep quality and concomitant sleep disorders but also have a higher chance of sudden nocturnal death, especially during a period of COPD exacerbation. Scientific studies show that elevated posture during sleep (>30 degrees raised head and back from the supine position) has a positive effect on sleep quality. To date, this has not been proven in patients with COPD who are a special group with sleep disorders. Research questions and objectives: The primary study objective is to evaluate if adjusted sleeping position with electrical bed backrest improves the quality of sleep in patients with COPD. The exploratory objectives are: 1. To evaluate if adjusted sleeping position improves total sleep time, respiratory patterns, oxygen saturation and heart rate (measured by CASIS, WatchPat and Sleepiz). 2. To investigate if adjusted sleeping position decreases COPD-related symptoms during sleep and daytime (measured with CAT score). 3. To evaluate if adjusted sleeping position reduces patient's fatigue during the day (measured with FSS questionnaire). 4. To evaluate if better sleep at night is associated with more energy, more activity and less breaks for rest during the day (measured with OQ-S, 6MWT and smartwatch). 5. To compare the results from the two sleep recording technologies (single night minimal contact sleep recorder-WatchPat versus several nights without contact sleep recorder-Sleepiz). Study design: Prospective, open label, cross-over clinical trial with randomized treatment order. Every subject will use the assigned intervention for 4 weeks. The intervention is an electrical bed backrest used during sleep time. The randomization will be non-adjusted, in ratio 1:1. A total of 40 patients will be included in the study.
The aim of this study is to evaluate if internet- delivered cognitive behavior therapy (CBT), based on exposure principles and behavioral activation, improves QoL and symptom burden in patients with symptomatic atrial fibrillation (AF), controlling for expectancy of improvement and attention from a caregiver, using an active control group (stress management). The study will include 260 patients with symptomatic AF despite optimal medical treatment in accordance with current guidelines.
Aortic dissection is a life-threatening condition and a consequence of a tear of the innermost of the three aortic layers- the intima. When a tear occurs, blood surges through the tear and causes the flow of blood between the aortic layers, causing a "false lumen". This causes a weakening of the aortic wall and hinders the blood from reaching its target organs and life saving emergent surgery is performed as routine. Approximately 20% of patients undergoing acute type a aortic dissection (ATAAD) surgery suffer from postoperative neurological injuries and It has been demonstrated that neurological injuries account for 10-15% of in-hospital deaths. In association with other cardiac procedures where the left side of the heart is opened and air may be trapped within the arterial circulation, carbon dioxide flooding is used to displace open air from the surgical wound. In comparison to air, carbon dioxide is significantly more soluble in blood and may therefore decrease the risk of air embolism. In cardiac surgery, carbon dioxide flooding has been demonstrated to reduce levels of biomarkers of cerebral injury, but carbon dioxide is not routinely employed in ATAAD surgery and has not been studied in association with these procedures. The hypothesis is that carbon dioxide flooding reduces cerebral air embolism and the aim of this project is to evaluate whether carbon dioxide flooding may reduce neurological injuries following ATAAD surgery. This is a prospective, randomized, controlled, patient- and reviewer blinded interventional study. Patients will be randomized to undergo surgery with carbon-dioxide flooding at 5L/min to the open chest cavity or conventional surgery without carbon dioxide flooding. Remaining aspects of the procedure will be identical. The patient, external statistician and the reviewer analyzing the primary endpoints will be blinded for the randomization arms. The study will assess the following endpoints: Primary outcomes: Presence, number and volume of ischaemic lesions observed using magnetic resonance imaging (MRI) after ATAAD surgery. Secondary outcomes: Clinical signs of neurological injury. Levels of biomarkers of neurological injury (S100B, neuron specific enolase (NSE) , neurofilament protein (NFL), Glial fibrillary acid protein (GFAP) , Ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) and Tau-protein (TAU)) before and after surgery. Quality of life, postoperative recovery and neurological function after ATAAD surgery. Primary outcomes in relation to retrograde cerebral perfusion. Start of inclusion is anticipated to start Jan 1st, 2022. The writing of a manuscript describing the study methods and study objectives is expected to be started in 2021 and the final manuscript is expected to be written during 2025. An interim analysis of the primary endpoints and the safety arm will be performed after 40 patients have been randomized. An external statistician together with the principle investigator will hereafter decide for the study to be continued or terminated due to harms, futility or superiority. The safety arm will include intraoperative mortality, in-hospital mortality, re-operation for bleeding, stroke, myocardial infarction or other thromboembolic events. Update August 2023: Interim analyses were performed after 40 study participants had been included. Results from the interim analyses raised important questions which need to be assessed by a Data Safety and Monitoring Board (DSMB). Since there are no documented harmful effects of the intervention, a DSMB was not appointed before initiation of the trial. The study was suspended on Aug 18th 2023. A DSMB will be appointed, analyze the interim analyses, collect necessary additional information and make a recommendation to the PI whether the study is may proceed or is to be terminated prematurely. Update September 2023. The DSMB has reviewed the interim analyses and additional study data. The DSMB concluded that there was no reason to terminate the study and have recommended for the study to proceed. Recruitment was re-initiated on September 5th 2023.
There is still no consensus on how to manage suicidal behavior in youth with recurrent self-harm at times when the risk for suicide is imminent (1). Brief Admission (BA) has evolved as a promising crisis intervention for adults with self-harm (2). The characteristics of BA is different from other types of admission, being focused on prevention through increased autonomy and self-care, based on structured and voluntary brief self-referrals to hospital (3). As a result of a randomized controlled trial, BA is since January 2019, continuously offered to adults with self-harm at risk for suicide in Skåne (4). Parallel to this clinical trial, the method has been adapted to work in a psychiatric setting for adolescents. At present 24 adolescents have access to the method in Skåne. Clinical experiences from staff are promising, however, the lived experiences have not been collected in a standardized way. The aim of the present study is to gather information on how BA in its present, standardized form works for adolescents, their loved ones and staff working at the ward providing BA. This will be done through semi-structured interviews with: 1. Adolescents using BA and their loved ones 2. Staff working at the ward providing BA. Data will be analyzed with qualitative analysis (5, 6). The ultimate aim is to use these results to optimize the current standardized version of BA for adolescents in order to test in a randomized clinical trial.
As a result of a randomized controlled trial (NCT02985047) BA is continuously offered to persons with self-harm at risk for suicide in Skåne, Sweden. This qualitative inductive study aims to provide experiences among family members, carers and significant others of Brief Admission by self-referral for self-harming and suicidal persons based on individual semi-structured interviews. Participants will be identified through suggestion from persons with an active BA contract. Interviews, estimated to last 30-60 minutes, will be analyzed by a phenomenological hermeneutic method or by content analysis depending on richness and depth in the interviews. Findings from this study will be published.
This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population.
Internet-based multidisciplinary interventions will be offered to participants suffering from longterm COVID-19 syndrome. Data will be collected by internet platform at Karolinska Institutet (BASS) before, after rehabilitation and at follow-up after 6 months. Both self-scored questionnaires and physical tests performed at home will be collected to understand the symptomatology, functioning and activity level. Rehabilitation during 8 weeks period will be given in groups as face-to-group, pre-recorded film sessions and by individual approach, the participants will use ExorLive app for physical activity.