Clinical trials

Brief Summary The goal of this clinical trial is to learn whether a no-test telemedicine medical abortion model can provide abortion care that is as effective and safe as standard clinic-based medical abortion care among women aged 18 years and older with an early pregnancy who wish to have a medical abortion at home. The main questions it aims to answer are: * Is no-test telemedicine medical abortion (without routine ultrasound) as effective as standard clinic-based medical abortion (with routine ultrasound) in achieving complete abortion? * Is no-test telemedicine medical abortion as safe, acceptable, and cost-effective as standard clinic-based medical abortion? Researchers will compare no-test telemedicine medical abortion to standard clinic-based medical abortion to determine whether the telemedicine model results in similar effectiveness and safety outcomes while improving access to care. Participants will: * Be randomly assigned to receive either no-test telemedicine medical abortion or standard clinic-based medical abortion. * Receive counseling and clinical assessment according to their assigned care model. * Use medical abortion treatment at home. * Complete follow-up assessments approximately 6 weeks after the abortion. * Provide information about treatment outcomes, complications, healthcare contacts, satisfaction with care, and contraceptive use. This study will enroll 978 women across five healthcare regions in Sweden. The results will inform future evidence-based guidelines for medical abortion care and may improve access to abortion services, particularly for individuals living in rural and underserved areas.

The aim of this randomized controlled trial is to evaluate the effectiveness and cost-effectiveness of Tiny Heroes, a parent-directed internet-delivered cognitive behavioral therapy (iCBT) program for anxiety problems in children aged 3 to 6 years within first-line mental health care in Region Stockholm, Sweden. The study will compare Tiny Heroes with treatment as usual at MALINA clinics and investigate whether the intervention leads to greater reductions in child anxiety symptoms. Secondary objectives include assessing effects on parental self-efficacy, family accommodation, life interference, treatment satisfaction, adverse events, and healthcare-related costs.

Blood pressure is routinely monitored during anesthesia in children, but blood pressure alone may not accurately reflect blood flow to vital organs. This is particularly important in infants and young children, in whom normal cardiovascular values vary with age. The CARFLOW study is a prospective observational study of 100 children aged 0-5 years undergoing anesthesia and surgery. The purpose is to investigate how blood flow in the common carotid artery, measured non-invasively using Doppler ultrasound, relates to blood pressure and cardiac output during anesthesia. Carotid artery blood flow will be measured before and during anesthesia and compared with blood pressure recorded as part of routine monitoring. In children who are intubated, cardiac output will also be measured non-invasively using a capnodynamic method. The main questions are whether changes in blood pressure are associated with changes in carotid artery blood flow, how carotid artery blood flow relates to cardiac output, and whether reference values for carotid artery blood flow during anesthesia can be established for young children. All clinical decisions and treatment will follow routine clinical practice. Measurements performed as part of the study will not be used to guide treatment.

Wrist osteoarthritis is often caused by past trauma to the wrist. The primary symptom is joint pain. Salvage surgery is the final solution if exercise therapy, analgesics, orthoses, or cortisone injections fail to relieve pain. This trial aims to evaluate if a web-based rehabilitation protocol is non-inferior to standard, face-to-face, rehabilitation in terms of patient-reported outcome after surgical salvage procedures.

The goal of this observational study is to learn how the timing of mobilisation after endovascular thrombectomy (EVT) affects complications in patients with acute ischaemic stroke. The main questions it aims to answer are: Does mobilisation approximately 12 hours after EVT, compared to approximately 24 hours after EVT, affect the risk of complications such as access site haematoma (ASH), venous thromboembolism (VTE), infections, and delirium? How common are these complications after EVT, and which factors are associated with increased risk? Participants undergoing EVT as part of their regular stroke care at two hospitals with different mobilisation routines will be followed during their hospital stay. Researchers will collect information about mobilisation timing, complications, clinical assessments, and medical history using case report forms, electronic health records, and national stroke registries.

The goal of this observational study is to learn whether tumors of bone and soft tissue can be sorted into groups by their genes. Today these tumors are named mainly by how they look under a microscope. There are more than 150 names in use. The same tumor can be given different names by different doctors. The study includes people of any age with a bone or soft tissue tumor. All of them had tissue sampled at Karolinska University Hospital in Stockholm, Sweden. The main questions it aims to answer are: Can tests of a tumor's genes sort these tumors into clearer groups than the names used today? How often does a tumor's gene group differ from the name it was given at diagnosis? Can a computer program tell these groups apart from scanned pictures of the tissue? Researchers will compare the groups found by the gene tests with the diagnoses given at the time. They will also look at how each group did over the years that followed. This shows which way of sorting tumors better matches what happened to participants. Participants will not have extra visits, tests, or treatment for this study. The study does not change anyone's care. Researchers will: Use tumor tissue that was already taken as part of regular care Read the deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) in the tumor, which carry its genetic instructions Read the chemical marks on the tumor's DNA that switch genes on and off Scan the glass slides of the tissue into digital pictures Collect facts about treatment and health from medical records Participants who are newly diagnosed will also be asked for a blood sample. Blood shows which gene changes a person was born with and which ones started in the tumor. If the study finds a gene change that matters for a participant's care, the study team tells the treating doctors through normal hospital routines.

For many years, people with moderate to advanced chronic kidney disease (CKD) have been advised to limit their intake of potassium, a mineral found in many foods such as fruit, vegetables, legumes, whole grains, and nuts. The reason for this has been the risk of hyperkalemia, a condition in which the potassium level in the blood becomes too high and can be dangerous. In recent years, however, this view has been questioned. New research suggests that the link between potassium in food and high potassium levels in the blood may not be as clear as previously thought. People who follow a strict potassium-restricted diet experience a lower quality of life and less satisfaction with their dietary treatment. At the same time, they miss out on the health benefits of eating a varied and nutritious diet. Today, many experts advocate a more individualized approach to potassium intake: instead of generally restricting potassium, the goal should be to maintain normal potassium levels in the blood, while encouraging a healthy diet. However, this message is not always clear in healthcare, and many people therefore continue to avoid potassium-rich foods altogether. The result is that they eat fewer natural ingredients and instead consume more processed and ultra-processed foods. Such foods can be more harmful, partly because they often contain potassium additives that are absorbed effectively by the body and their quantities are not reported in the nutritional label. This "hidden" potassium can contribute more to high potassium levels in the blood than the potassium that occurs naturally in plant-based foods. In addition, potassium from whole plant-based foods is absorbed more slowly, partly due to its fiber content. Plant-based diets may also have other positive effects for people with kidney disease: they can contribute to reduced blood acidity, known as metabolic acidosis, healthier gut flora, lower levels of inflammation, and reduced phosphorus intake. Together, these factors can counteract several of the metabolic complications associated with kidney disease. In a previous study, our research group showed that even patients with advanced kidney disease (CKD stage 4-5) and already elevated potassium levels could follow a healthy plant-based diet if they also used a potassium-binding drug (sodium zirconium cyclosilicate, SZC). This enabled them to eat more fruit, vegetables, and legumes, while also experiencing improved quality of life. The current study builds on these results and is planned as a pilot study in which patients with moderate to advanced kidney disease, but who are not yet being treated with dialysis, are assigned to two different dietary strategies for six months: * Healthy plant-based diet (healthy-PBD): a more liberal and balanced plant-based diet without specific potassium restrictions. * Potassium-restricted plant-based diet (restricted-PBD): a traditional plant-based diet with restrictions on potassium-rich foods, according to current standard recommendations. The main purpose is to investigate whether the healthy plant-based diet leads to more or more severe cases of hyperkalemia than the restricted diet. Our hypothesis is that potassium levels may increase slightly in the group with a liberal diet, but not to dangerous levels. The study will also examine secondary outcomes, such as quality of life, satisfaction with treatment, and how well patients accept the diet. In addition, taste experiences will be tested with taste strips (sweet, sour, salt, bitter and umami) before and after the intervention in both groups. If this pilot study shows that a healthier and less restrictive diet is safe, it could pave the way for a larger study investigating the long-term metabolic effects of a plant-based diet in kidney care.

Vulvar squamous cell carcinoma is a rare cancer that is usually treated with surgery. Some patients need removal of lymph nodes from one or both groins, called inguinofemoral lymphadenectomy. The standard open operation can cause wound infections, wound separation, fluid collections, prolonged drainage, and swelling of the leg. These complications are especially important because many people with vulvar cancer are older and may have other health conditions. SP-RAIL is an international, multicenter, randomized phase 2 study comparing two surgical approaches to inguinofemoral lymphadenectomy. The study plans to enroll 64 adults with a new diagnosis of vulvar squamous cell carcinoma who require this lymph-node surgery. Participants will be assigned by chance in a 1:1 ratio to either single-port robot-assisted inguinofemoral lymphadenectomy or traditional open inguinofemoral lymphadenectomy. Both groups will receive lymph-node removal according to the same anatomical boundaries. Sentinel lymph-node mapping or biopsy may also be performed as described in the protocol. The main question is whether the single-port robotic approach reduces clinically important complications during the first 30 days after surgery. Complications will be graded using the Clavien-Dindo classification, and grades 2 to 5 will be included in the primary outcome. Reoperations for separation of the vulvar wound will not be counted as complications caused by the groin lymph-node procedure. The study will also compare operating time, blood loss, complications during surgery, conversion to another surgical approach, length of hospital stay, duration of drainage, number of lymph nodes removed, later treatment-related problems, symptoms of leg or groin lymphedema, quality of life, groin recurrence, recurrence-free survival, overall survival, and health-care costs. Participants will complete quality-of-life and lymphedema questionnaires before treatment and at specified times after treatment. Clinical follow-up will continue regularly through 24 months, and survival follow-up is planned through 60 months. An early safety and feasibility review will take place after the first 10 participants have entered the robotic surgery group. The study will stop if the median number of lymph nodes removed per groin in that group is fewer than six. Groin recurrences will be monitored throughout the study, and enrollment may be stopped if an unexpectedly high recurrence rate is observed.

The goal of this register-based retrospective observational study is to understand the risk of cervical cancer following incident, persistent and history-unknown HPV detection by HPV genotype in healthy women participating in HPV-based cervical screening. The main questions it aims to answer are: 1. Whether an incident HPV detection with certain HPV genotypes has low risk of cervical cancer in 3 to 5 years thus does not need further clinical assessment before the next screening test? 2. How risky a persistent HPV detection is, and whether persistent detection of any high-risk HPV genotype warrant immediate clinical assessment? 3. How risky a HPV detection is, if no previous HPV test result is available? As being a register-based retrospective observational study, study subjects will not be asked to do any specific task for this study.

This nationwide observational cohort study will investigate the association between frailty, chronological age, and clinical outcomes in critically ill patients receiving continuous renal replacement therapy (CRRT) in Sweden. Using data from the Swedish Intensive Care Registry, the study will assess whether the Clinical Frailty Scale (CFS) and other measures of comorbidity and illness severity provide prognostic information beyond chronological age. Outcomes will include 30-day mortality, intensive care unit length of stay, and mortality at 60, 90, and 365 days following intensive care unit (ICU) admission. The study aims to contribute to more individualized assessment of critically ill patients who may require CRRT.

Background and purpose At present, occasional referral to psychiatric or addiction services is the only aftercare option offered following an intoxication/overdose requiring intensive care. The investigators intend to test whether a new self-help tool can serve as a complement to this, and are now conducting a pilot study to determine whether the application could help prevent further severe intoxications/overdoses. The research principals for the project - ie the responsible organizations, are Region Stockholm and Karolinska Institutet. The research has been approved by the Swedish Ethical Review Authority; the reference number for the review is 2025-03529-01. How is the study conducted? You will receive a brochure/card with information and access to the self-help tool called Preventox. Preventox is a website where you can create a personal login and set goals, keep an alcohol/substance diary, identify high-risk situations, create a crisis plan, learn about cravings, and obtain information on where to turn if you need support. No one other than you and the participating researchers can see what you record under your login. A reminder will be sent via 1177. After 12 months, the investigators will use registry data to determine whether you have received care for a further intoxication/overdose. Only participating researchers will have access to this information, which will subsequently be de-identified. Data handling and confidentiality Use of the service is entirely personal, i.e. only you have access to your login and the information you record there. Registry data will be processed confidentially and thereafter de-identified, so that no unauthorised person can access your information. Medical record review may be carried out to validate procedures. The results of the study will be presented at group level. Responsible for your personal data are the Emergency Hospitals Board, Region Stockholm, and Karolinska Institutet. Data will be stored in accordance with the recommendations of Karolinska Institutet and Section 3 of the Swedish Archives Act (1990:782). Under the EU General Data Protection Regulation, you have the right to obtain, free of charge, access to the information about you that is processed within the project, and to have any errors corrected. You may also request that information about you will be erased and that the processing of your personal data will be restricted. If you wish to access the information, please contact the responsible researcher listed below. The Data Protection Officers can be reached by email at: [email protected] and [email protected]. Information about the study results and questions If you wish, the results can be shared with you on request. If you have any other questions, you are welcome to contact the persons listed below. Voluntary participation Participation is entirely voluntary. You may discontinue your participation in the study at any time, without explanation and without giving any reason, and without this affecting your other care and treatment. If you wish to do so, please contact one of the contact persons listed below.

The overarching aim of this study is to develop and evaluate a new blended treatment format, which combines face-to-face and digital treatment components, for Emotion Regulation Individual Therapy for Adolescents (ERITA). This brief, transdiagnostic, and blended treatment targeting nonsuicidal self-injury (NSSI) - referred to as blended ERITA - will be specifically designed for adolescents with NSSI and low levels of functioning within intensive outpatient psychiatric services. The specific purpose of this pilot trial is to investigate feasibility in preparation for a larger trial.

Brief Summary: Migraine and/or Cluster Headache: Study Overview \*\*Background:\*\* Migraine and cluster headache are two primary headache disorders that significantly impact quality of life and functionality in those affected. According to the WHO's recurring burden of disease reports, migraine is among the neurological conditions responsible for the highest number of years lost due to illness. The headaches associated with migraine and cluster headache range from moderate to severe and cause great suffering. Available treatments do not work for everyone and are often associated with adverse side effects. Physical activity has been shown in several studies to have a positive effect on headache. Given the high prevalence of mental health issues, stress, and sleep problems within this patient group, relaxation and low-intensity exercise such as yoga-based movements (YB) could potentially help individuals improve sleep and well-being, while also providing some preventive effect on headaches. \*\*Hypothesis:\*\* Individuals with severe migraine or cluster headache have a strong need for new treatment options. Alternative therapies such as yoga-based exercises, when combined with standard medical treatment as per clinical guidelines, may positively impact: Headache symptoms, Sleep quality and Overall life quality * Purpose and Goals:\*\* This randomized controlled study aims to evaluate the effect of a web-based yoga (YB) or live face to face (FTF) intervention in individuals suffering of primary headaches-mainly chronic migraine and/or cluster headache. The study will assess the effect of YB on health-related changes in headache frequency, intensity, and duration associated with primary headache conditions, with a focus headache frequency. A secondary objective is to analyze quality of life, sleep quality, mental health as depression and anxiety. The RCT will also measure objective sleep and biomarkers. We are now summarizing the effects after a pilot study. * Relevance for the Patient Group:\*\* The core objective of the project is to determine whether yoga-based exercises can serve as a complementary treatment to enhance quality of life and health in patients with severe primary headache. To ensure equal healthcare access, this intervention will be delivered in digital format and/or FTF to optimize availability and expand care for individuals with primary headache disorders. These efforts aim to improve life quality and well-being in a vulnerable patient population. Headache conditions often affect individuals in their most productive years, and many live with symptoms for decades. Both work and private life are frequently disrupted, resulting in sick leave and social isolation. Close relatives are also affected, as those suffering from headaches require more recovery time to cope with daily life. With this proposed project, we aim to use physical yoga, rooted in holistic traditional medicine, to help individuals with severe primary headache achieve better physical and mental health-particularly improved sleep quality, which in turn enhances overall life quality.

This large national cohort study, including over 500,000 patients, where around 5% are treated with continuous renal replacement therapy (CRRT) , aims to evaluate the association between time to initiation of CRRT and intensive care unit (ICU) length of stay (LOS).

The overall aim is to investigate the health outcomes and consequences, from an individual and a societal perspective, of adding licensed Manual Therapists as first-contact healthcare providers in Primary Health Care centers to triage (not treat) patients seeking care for Neck and Back Pain. A hybrid, quasi-experimental Target Trial Emulation design employing mixed methods contextualized to participating Primary Health Care centers will be used. Neck and Back Pain patients with a physician's appointment at a participating Primary Health Care center will be included and followed one year; * 300 patients with care as usual who see their physician (control group), * 300 patients who see a licensed naprapath/chiropractor for an initial evidence-based assessment/screening before the physicians' visit. Patient outcomes include recovery, function and work ability, as well as health economy are compared between the groups.

This study will evaluate whether people with non-small cell lung cancer (NSCLC) can collect small blood samples themselves using a finger-prick sampling kit. Participants will be receiving standard treatment with docetaxel, paclitaxel, alectinib, or lorlatinib. The blood samples will be used to measure the amount of cancer medicine in the blood. Most samples will be collected by participants at home and returned to a laboratory for analysis. The study will assess how easy the sampling method is to use, whether the collected samples are suitable for laboratory analysis, and how patients and healthcare professionals experience this way of collecting blood samples. The study will also explore whether measured drug levels are related to side effects, dose changes, treatment delays, or other clinical outcomes. The drug-level results collected in this study will be used for research purposes and will not be used to change participants' cancer treatment. About 80 participants will take part in the study and will be followed for approximately 3 months. The microsampling device is CE-marked and used within its approved use exclusively for research and feasibility evaluation. Study results do not influence ongoing clinical treatment decisions. This study is being conducted as part of Project-COMFORT, a European multi-country initiative aiming to evaluate the feasibility and implementation of PCmS across various populations and healthcare systems.

The aim of this clinical trial is to study the impact of ultra-early transnasal evaporative cooling after cardiac arrest and subsequent hypothermia at hospital, on survival with complete neurologic recovery, compared to currently recommended normothermia. The study population will consist of patients 18-79 years old, with out-of-hospital cardiac arrest with initial shockable rhythm. The main research question it aims to answer is whether there is a difference in survival with complete neurologic recovery at 90 days after cardiac arrest between the group of patients that received ultra-early cooling, compared to the group that was treated with normothermia. Participants will be randomized to two groups. One group (the intervention group) will receive ultra-early trans-nasal evaporative cooling initiated by EMS personnel at the scene of the cardiac arrest, and subsequent systemic hypothermia for 24 hours at hospital arrival. The other group (the control group), will receive standard of care (advanced cardiac life support and normal body temperature (normothermia)).

The purpose of this trial is to evaluate the clinical efficacy, the cost-effectiveness and the effect durability of a therapist-guided, internet-delivered cognitive-behavior therapy intervention for obsessive-compulsive disorder (OCD) in children and adolescents with autism. A process evaluation of the treatment will also be conducted.

The goal of this clinical trial is to evaluate the effect of adding a digi-physical treatment tool as a complement to the local treatment with obesity medication in adolescents with obesity. The main question it aims to answer is: \- Can a combination of a digi-physical treatment tool and obesity medication improve treatment outcomes for patients with obesity compared to patients treated with obesity medications alone? This is a randomized controlled two-arm multicenter study where participants will be randomized to the intervention group (digi-physical treatment+medication) or control group (medication only). Participants will be followed for six months.

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 randomized factorial trial at Karolinska Institutet, Stockholm, Sweden, 400 cancer survivors with psychiatric symptoms are enrolled in variations on a 10-week therapist-guided online psychological treatment intended to address the negative psychological long-term effects of cancer. The aim is to determine the contribution of treatment components to the overall effect.

This pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary effects of two digital parenting interventions for parents experiencing difficulties with anger in parenting. The interventions are internet-delivered adaptations of evidence-based parenting programs, collectively called the Supporting Healthier Interactions in Families by Online Tools (SHIFT) parenting programs. The main questions the study aims to answer are: 1. Are the study procedures and design feasible for a full-scale RCT? 2. Are the SHIFT parenting programs feasible and acceptable? 3. How do therapists and parents experience the SHIFT parenting programs? 4. Is participation in one of the SHIFT parenting programs, relative to the other and relative to waitlist control, associated with improvements in parent-reported intervention outcomes? 5. Is participation in the SHIFT parenting programs, relative to each other and waitlist control, associated with improvement in weekly measures of target mechanisms? Researchers will compare the two programs against each other and against a waitlist control. The first intervention (SHIFT) is a behavioral parent training (BPT) program with parenting strategies to manage child behavior problems. The second intervention (SHIFT+) includes the same BPT strategies with emotion regulation (ER) techniques from anger-management treatments. Participants will: * Be randomized to SHIFT, SHIFT+ or waitlist control. * Take part in one of the digital interventions and receive support in text messages and phone calls from a therapist at family support services in Swedish municipalities. Some participants will take part in the intervention after the waitlist period. * Respond to questionnaires and take part in interviews.

Idiopathic scoliosis is the most common spinal deformity in children and adolescents with an estimated prevalence of 3%. About one tenth of the children with scoliosis develop a deformity that requires treatment with brace or surgery with the current treatment protocol. In Sweden, mild scoliosis curves not requiring treatment, but at risk for progression during childhood, are only observed until skeletal maturity without active treatment. If progression occurs and treatment is required, standard treatment consists of bracing 20 hours or more per day. Scoliosis-specific exercises have been reported to be a possible treatment modality in terms of halting progression in mild scoliosis, but the findings are not generally accepted.

Idiopathic scoliosis is the most common spinal deformity in children and adolescents with an estimated prevalence of 3%. About one tenth of the children with scoliosis develop a deformity that requires treatment with brace or surgery with the current treatment protocol. When brace treatment for scoliosis is indicated, standard treatment consists of bracing 20 hours or more per day. Outcomes of brace treatment depend to a large extent on wearing time and since many adolescents feel uncomfortable in the brace, it is of importance to combine efficacy and comfortability of the brace.

Long-term pain, which is pain that lasts for more than three months, is a major health problem. It can severely impact a person's physical and mental well-being, quality of life, and ability to work. It also carries high costs for society, mainly due to high rates of sick leave. For many people with long-term pain, there is no clear injury or disease that fully explains why it hurts. In these cases, the pain is believed to be caused by how the brain and nervous system process pain signals. This is sometimes called "nociplastic pain." Even though there are many treatments for pain-like medications and therapies-they don't work for everyone, and many people are left without meaningful relief. Because of this, it is important to find and test new ways to treat pain. In this study, the investigators evaluate a relatively new psychological treatment called Pain Reprocessing Therapy (PRT), which has been tested in the US with promising results. PRT helps individuals with chronic pain to understand and change how they think about their pain by explaining how the brain works. The treatment focuses on teaching the difference between acute (new) pain and long-term pain. It also involves exercises to help people alter emotions related to their pain. A key part of the treatment is a technique where patients practice paying attention to what is happening in their bodies in a safe, relaxed way. The goal is to teach the brain that the pain signals are not a threat. This can help break the vicious cycle of fear, avoiding activities, and worsening pain. While many people are interested in treatments like PRT, it hasn't yet been tested in specialized care for patients with complex pain. This trial is a pilot study-a smaller, initial investigation to evaluate how well the treatment works in a clinical setting, and to determine if both patients and therapists find it acceptable and practical to use. This will give us important information to help prepare for larger studies in the future. The main goal of this pilot study is to see if PRT is a practical and accepted treatment in a Swedish pain rehabilitation setting. The investigators also want to look at whether the treatment helps reduce pain, psychological distress, negative thoughts about pain, and the fear of moving. Finally, the investigators will explore how a patient's expectations and thinking skills (such as memory and focus) might affect how well the treatment works, and take physical measurements before and after the treatment to see if the nervous system becomes better at regulating pain.

The dominating proportion of patients in the ICU are men. Studies indicate that men receive more mechanical ventilation, vasoactive drugs, renal replacement therapy, invasive monitoring and have longer length of stay in the ICU. These differences do not unambiguously translate into a survival benefit for men; if survival would be altered if women were admitted to ICU in the same extent is unknown. Factors affecting ICU admission include age, co-morbidities, physiological parameters (indicating severity of the acute illness) and, additionally, the number of available ICU beds. Factors that should not affect ICU admission include patient gender or ethnicity. This study aims at studying if bias against women and people of certain ethnicities exist. Do clinicians have differing thresholds for ICU admission due to non-medical reasons? The investigators propose testing this hypothesis using a blinded randomized factorial survey study.