Varberg

This trial focuses on elderly patients aged 80 years or older, or those 75 years and older who are considered frail, with untreated diffuse large B-cell lymphoma DLBCL and related lymphoma subtypes. The study is a phase III, randomized, open-label, multicenter trial conducted in several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. It aims to compare the standard chemotherapy regimen R-miniCHOP with an experimental treatment R-pola-miniCHP, where vincristine is replaced by polatuzumab vedotin, to assess differences in outcomes for this patient population. Participants will be randomly assigned to one of two treatment groups. One group will receive R-mini-CHOP consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone over six 21-day cycles. The other group will receive R-pola-mini-CHP, which includes rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin instead of vincristine, also given over six 21-day cycles. Both treatments last approximately 18 weeks. The study includes a screening period lasting up to 4 weeks before treatment begins. During the study, participants will be followed for up to 36 months after completing treatment to monitor progression-free survival over two years. Researchers will evaluate disease progression and safety outcomes through regular assessments during and after the treatment period. Participants will provide informed consent and undergo evaluations including health status and disease measurements to ensure eligibility and monitor treatment effects throughout the trial.

Researchers are investigating the effects of aerobic group exercise compared to leisure group activities in adolescents aged 13 to 17 with mild to moderate depression. The study aims to measure improvements in depression symptoms using the Childrens Depression Rating Scale - Revised CDRS-R at 13 weeks after starting the interventions. Additional goals include assessing changes in clinical severity, self-reported depressive symptoms, physical fitness, biological markers related to neuroprotection and inflammation, cost-effectiveness, and understanding participants experiences through interviews. Participants will be randomly assigned to one of two groups an aerobic exercise group or a leisure activities group. The aerobic exercise group will engage in 60-minute supervised sessions three times a week for 12 weeks, including aerobic, strength, and mixed training with gradually increased intensity. The leisure group will participate in non-heart rate increasing group activities, such as games and supportive discussions, at the same frequency and schedule. After 26 weeks, those in the leisure group will have the opportunity to join aerobic exercise sessions. During the study, participants will complete assessments at baseline, 13 weeks, 26 weeks, and one year, including video evaluations of depression and functioning, physical fitness tests, body composition analysis, blood sampling for biological markers, and questionnaires on depressive symptoms, quality of life, and costs. Self-reported measures will be collected regularly during the intervention and follow-up periods. Safety monitoring will track adverse events related to depression and exercise. The entire trial spans one year of follow-up after the interventions, with ongoing data collection and evaluation.

Researchers are evaluating whether adding a diagnostic assessment and the option of guided self-help Cognitive Behavioral Therapy CBT to Primary Care Behavioral Health PCBH can improve patient functioning and symptoms compared to standard PCBH that uses contextual assessments and brief interventions. The study also investigates the overall impact of PCBH on outcomes for both patients and healthcare organizations. This multicenter trial focuses on patients with various mental and behavioral health problems, aiming to address challenges in primary care related to mental health treatment access and quality. Participants will be randomly assigned to either standard PCBH, which involves contextual assessments and brief interventions based on psychological treatment components like CBT and Acceptance and Commitment Therapy, or to an extended PCBH version with diagnostic assessments and the possibility of self-help CBT. The diagnostic assessment includes structured interviews and screening instruments, and if suitable, patients receive guided self-help CBT using scientifically evaluated self-help books supported by therapist contacts. Brief interventions involve 1-4 appointments focusing on behavioral changes and are delivered by trained clinicians. Treatment duration for self-help CBT ranges from 6 to 12 weeks with 3-6 therapist contacts, including in-person and remote support. Participants will complete various assessments throughout the study, including the WHO Disability Assessment Schedule 2.0 and several mental health questionnaires at multiple intervals up to one year. Researchers will monitor patient symptoms, functioning, quality of life, and treatment experiences, along with implementation outcomes like feasibility and satisfaction. Data on adverse events and behavioral changes will also be collected. The study aims to determine the effectiveness and practicality of integrating self-help CBT into PCBH for better mental health care in primary settings.

Spontaneous intracerebral hemorrhage ICH is a serious type of stroke with high death and disability rates. Researchers are investigating whether a structured treatment package called a Care Bundle can improve the 3-month outcomes for patients with acute ICH compared to standard care. The study is an international, multicenter, parallel, cluster-randomized clinical trial focusing on implementing this Care Bundle in high-income countries, building on results from previous trials mostly done in low- and middle-income countries. The Care Bundle includes early intensive blood pressure lowering, treatment of fever and high blood sugar, rapid reversal of oral anticoagulation, and timely referrals to intensive care or neurosurgery when needed. Hospitals are randomized in batches through three phases usual care, randomized evaluation of the Care Bundle versus usual care, and a post-implementation follow-up where all hospitals apply the Care Bundle. Each batch lasts 18 months, with 6 months per phase, and the overall study rollout spans 2.5 years. Participants are adults aged 18 or older diagnosed with spontaneous ICH confirmed by imaging within 24 hours of symptom onset. During the study, patient management details and outcomes will be closely monitored, including brain imaging, blood pressure, glucose levels, and functional status. The primary outcome is functional recovery measured by a utility-weighted modified Rankin Scale score at 180 days. Secondary outcomes include disability, death, and health-related quality of life. The study also collects data on treatments and care decisions to evaluate the Care Bundles effectiveness and sustainability.

Researchers are comparing one-visit versus two-visit root canal treatments for infected necrotic teeth in general dental practice. The study aims to evaluate the outcomes one and four years after treatment, focusing on periapical health, root filling quality, and complication rates. A pilot study will first identify and address any protocol issues before the main multicenter trial across several clinics in Sweden begins. Patients will be randomly assigned to receive either a root canal treatment completed in one visit or in two visits spaced at least one week apart. Both treatment methods follow standard clinical practices without rigid protocols. After treatment, patients will have a phone call 5-7 days later, a control visit at one month, and clinical evaluations at one and four years including intra-oral radiographs reviewed by independent observers. During the study, participants will undergo regular assessments of post-operative pain, medication use, tooth survival, and any complications. Follow-up includes clinical exams and radiographic checks to determine treatment success based on clinical and radiographic normalcy. The study plans to recruit about 1000 patients to ensure statistically meaningful results, with monitoring continuing up to four years after treatment completion.

Researchers are evaluating treatments for patients with metastatic prostate cancer, including both hormone-sensitive and castration-resistant forms. This international trial uses biomarker signatures identified from tumor or liquid biopsies to guide treatment assignments. The study compares standard care based on national guidelines with experimental treatments tailored to genetic changes related to prostate cancer. It uses an adaptive design to assign treatments based on ongoing results to improve patient outcomes. Participants are randomized to either a control group receiving standard care or an experimental group receiving treatments matched to their biomarker profile. Experimental treatments include androgen receptor signaling inhibitors, taxane-based chemotherapy combined with AR inhibitors, PARP inhibitors, AKT inhibitors, and carboplatin, depending on the biomarker signature and disease stage. Patients progressing during the trial may be re-assigned up to three times to different treatments based on updated biomarker profiles. Throughout the study, patients undergo regular assessments including progression-free survival monitoring up to 60 months. Researchers also track treatment response rates, overall survival, patient-reported outcomes, cost-effectiveness, and safety through adverse event reports. An independent board regularly reviews data to evaluate treatment effectiveness and may modify treatment assignments accordingly. The trial aims to personalize therapy for metastatic prostate cancer based on genetic markers.

Researchers are evaluating the effects of a restrictive approach to giving non-resuscitation fluids compared to usual care in adult patients with septic shock. The goal is to understand both the beneficial and harmful impacts of limiting these fluids in this critical condition. This trial is led by Region Skane and involves adult patients diagnosed with septic shock under specific clinical criteria. Participants are assigned randomly to one of two groups. One group receives non-resuscitation fluids following a strict protocol that starts within two hours of randomization and continues during their ICU stay, up to 90 days. This protocol includes stopping maintenance fluids if fluid balance is positive and the patient is not dehydrated, adjusting intravenous and enteral fluids to correct electrolyte disturbances, and using concentrated intravenous medications. The other group receives fluids according to usual local care routines, which involve maintenance fluids at about 1 mlkgh unless otherwise specified and glucose at a maximum concentration of 10%, with medications concentrated per local protocol. Participants are monitored during their ICU stay and followed for up to 90 days to assess mortality, complications, and days free from mechanical ventilation. Cognitive function and health-related quality of life are evaluated six months after inclusion. The study uses a triple-blind randomized design to compare outcomes between the protocolized fluid reduction and usual care. Regular assessments and follow-up visits will track participant status and safety throughout the study period.

Researchers are evaluating the effect of spironolactone combined with standard care compared to standard care alone in patients with Heart Failure with Preserved Ejection Fraction HFPEF. This condition is common and serious, but currently lacks effective treatment. The trial is a phase 3 Registry-Randomized Clinical Trial RRCT involving patients from the Swedish Heart Failure Registry and the US. HFPEF is defined by heart failure symptoms, elevated NT-proBNP levels, and an ejection fraction of 40% or higher. Participants will be randomly assigned to receive either spironolactone added to their usual care or usual care alone. Spironolactone will be given as 25 mg tablets, starting at 25 mg per day with a possible increase to 50 mg daily if tolerated. If spironolactone is not tolerated, eplerenone may be prescribed instead. The control group will continue with their standard care without spironolactone. The study duration is planned for 9 years, with enrollment lasting 7 years. During the study, researchers will collect data on cardiovascular death and hospitalizations due to heart failure as the primary outcomes. Secondary outcomes include hospitalizations for various causes, adverse events, and treatment adherence. In Sweden, outcomes will be obtained by linking national registries, while in the US, sites and call centers will report outcomes. The trial aims to enroll approximately 2000 patients, with follow-up continuing for at least 5 years after study start to monitor these outcomes.

Researchers are evaluating the effectiveness and safety of apixaban as a stroke prevention treatment in adults with stage 5 chronic kidney disease CKD who also have atrial fibrillation AF or atrial flutter AFL. This study compares apixaban to no anticoagulation to see if it reduces the risk of ischemic stroke without increasing fatal or brain bleeding events. The trial also examines all-cause mortality, cardiovascular events, and major bleeding risks in this patient group. Participants are randomly assigned to one of two groups one receiving apixaban 2.5 mg twice daily plus standard care, and the other receiving standard care without anticoagulation. The study is open-label and conducted over 12 to 72 months across around 50 sites in several European countries. Patients already on warfarin, apixaban, or low molecular weight heparin may join after stopping their current anticoagulation. Routine blood tests are done at inclusion. During the trial, participants will be monitored for ischemic stroke, intracranial or fatal bleeding, death, cardiovascular events, and major bleeding according to established criteria. Additional outcomes include thromboembolic events and kidney transplant-related complications. The study lasts up to 72 months per participant or until a set number of events occur. Safety and efficacy data are reviewed by independent boards throughout the study.

Researchers are evaluating the TeamBirth-SWE care process to improve safety and person-centered care during childbirth. This project aims to enhance teamwork and communication between care providers, women, and their partners to improve maternal and infant health outcomes. The study focuses on reducing adverse events during labor and delivery by addressing communication failures and promoting shared decision-making. The intervention has been adapted and piloted in Sweden and is now being studied in a large-scale project to assess its effectiveness and impact on patient experiences and safety climate. The intervention involves the entire care team conducting regular huddles with the birthing woman and her partner, using a shared planning board visible in the birthing room. This board displays team members names, the womans preferences, the care plan, and the timing of the next huddle to support transparent communication and collaboration. The study uses an interrupted time series design to evaluate outcomes before and after the implementation of TeamBirth-SWE across multiple labor wards in Sweden, with data collected from 2020 to 2028. The project includes three work packages focusing on patient safety, patient-reported experiences, and interprofessional collaboration. Participants will be women aged 15 years or older with spontaneous or induced labor after 22 weeks of pregnancy, proficient in Swedish or English. Data sources include national pregnancy registers and patient surveys conducted eight weeks after birth. Staff surveys measuring patient safety climate and teamwork will be collected before and up to 24 months after implementation. Researchers will assess outcomes such as rates of births without major interventions or complications, shared decision-making, and patient satisfaction, as well as safety climate and teamwork among healthcare professionals. The study will take place over several years, with ongoing monitoring and analysis of maternal and infant health and care quality.