Varberg

Researchers are conducting a phase III randomized, open-label, multicenter trial across several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. The study focuses on elderly patients with untreated diffuse large B-cell lymphoma (DLBCL), defined as patients aged 80 years or older, or those aged 75 years or older who are considered frail based on a simplified Comprehensive Geriatric Assessment. The trial aims to compare the effectiveness of two treatment regimens in this population. Participants are randomly assigned to receive either the standard R-miniCHOP treatment or an experimental R-pola-miniCHP regimen where vincristine is replaced with an immunoconjugate, polatuzumab vedotin. Both treatments involve cycles of drugs including rituximab, cyclophosphamide, doxorubicin, and prednisone, administered over 18 weeks. The trial includes a screening period lasting up to 4 weeks, followed by the active treatment phase, and then a follow-up period lasting up to 36 months after treatment completion. Throughout the study, participants will be monitored to measure progression-free survival over 2 years as the primary outcome. The study involves regular assessments including clinical evaluations and safety monitoring. Enrollment began in the first quarter of 2020, with the last patient visit expected by the first quarter of 2027, allowing for long-term observation of treatment effects and patient outcomes.

Researchers are evaluating treatments for adults with relapsed or refractory multiple myeloma who have previously received an anti-CD38 antibody and lenalidomide. The study compares the effectiveness of talquetamab combined with pomalidomide (Tal-P), talquetamab combined with teclistamab (Tal-Tec), and investigator's choice between two standard regimens: elotuzumab with pomalidomide and dexamethasone (EPd), or pomalidomide with bortezomib and dexamethasone (PVd). This Phase 3 trial aims to understand which combination best controls the disease progression. Participants will receive talquetamab as a subcutaneous injection, pomalidomide orally, teclistamab as a subcutaneous injection, elotuzumab intravenously, dexamethasone either orally or intravenously, and bortezomib as a subcutaneous injection. The study involves comparing these combinations with varying administration routes. The trial includes multiple treatment arms to assess different drug combinations in patients who have undergone 1 to 4 prior therapies. During the study, participants will be monitored for progression-free survival up to 3 years and 5 months. Researchers will regularly assess disease status, treatment response, and safety. Participants' performance status will be evaluated, and adherence to treatment and potential side effects will be carefully tracked. This long-term observation will help determine how well each treatment combination controls the disease over time.

Researchers are evaluating the effects of aerobic group exercise compared to leisure group activities in adolescents aged 13 to 17 years with mild to moderate depression. This study aims to measure changes in depression symptoms using the Children's Depression Rating Scale-Revised (CDRS-R) after 13 weeks of intervention, with additional assessments at 26 weeks and one year. The study also examines secondary outcomes like global impressions of severity and improvement, self-reported depressive symptoms, functional assessments, physical fitness measures, body composition, biological markers related to neuroprotection and inflammation, and cost-effectiveness. Participants will be randomly assigned to either a 12-week aerobic group exercise program or a leisure activity group, both held three times a week for one hour. The aerobic exercise includes strength, conditioning, and mixed sessions with increasing intensity over time, while the leisure group engages in non-heart rate increasing activities like games and supportive social interaction. After 26 weeks, those in the leisure group are offered the opportunity to participate in the aerobic exercise program. The study is conducted at specialized child and adolescent psychiatric clinics in Sweden. During the study, participants will complete regular assessments through video calls and web-based questionnaires, including depression scales, quality of life measures, and cost evaluations. Physical fitness tests and blood samples will be collected at multiple time points. Safety and adherence are monitored throughout, with participants able to withdraw at any time. The total study duration includes baseline, 13-week, 26-week, and one-year follow-up assessments to evaluate both short- and long-term effects of the interventions.

Researchers are evaluating whether adding a diagnostic assessment and the option of guided self-help Cognitive Behavioral Therapy (CBT) can improve the effects of Primary Care Behavioral Health (PCBH) on patient functioning and symptoms compared to the standard PCBH approach. This study will also assess how PCBH impacts patient and organizational outcomes overall. PCBH is a model where mental health professionals provide short, focused visits integrated into primary care, using brief interventions based on therapies like CBT and Acceptance and Commitment Therapy (ACT). The study addresses challenges in primary care related to mental health support, including limited access to specialized providers and lack of clear care pathways. Participants will be randomized to receive either the usual PCBH care with brief, contextual assessments and brief interventions or an extended version that includes a diagnostic assessment. If appropriate, patients in the extended group may receive guided self-help CBT using scientifically validated self-help books tailored to conditions such as depression, anxiety disorders, insomnia, and stress. The self-help CBT involves 3 to 6 therapist contacts over 6 to 12 weeks, combining in-person and remote sessions. Brief interventions typically involve 1 to 4 appointments focused on behavioral change without a formal diagnosis. Both treatment approaches involve trained clinicians and regular supervision. During the study, patients will be monitored for changes in their everyday functioning and symptoms using the WHO Disability Assessment Schedule 2.0 12-item scale at multiple time points including before treatment and up to one year after. Data on work environment, satisfaction with PCBH implementation, and treatment fidelity will also be collected. The study aims to understand if guided self-help CBT adds benefits without reducing access or increasing costs, and whether standard PCBH alone is sufficient. Participation reflects real-world primary care settings where clinical judgment guides inclusion.

Spontaneous intracerebral hemorrhage (ICH) is a severe type of stroke accounting for 10-15% of all strokes but causing about half of stroke-related deaths and disabilities. Many patients with ICH have decreased consciousness when admitted, yet intensive care and neurosurgical treatments are not common. Prior studies in low- and middle-income countries showed that a treatment package including early intensive blood pressure lowering and managing fever and high blood sugar improved outcomes. The I-CATCHER study aims to test a similar structured Care Bundle approach in Sweden, Australia, and other high-income countries to improve treatment and prognosis for patients with spontaneous ICH. This study compares a Care Bundle involving early intensive blood pressure control, reversal of oral anticoagulation within 30 minutes, fever management, blood sugar control, and timely referrals to intensive care or neurosurgery against standard care. The Care Bundle targets specific blood pressure levels depending on initial readings and aims to avoid do-not-resuscitate orders or withdrawal of care for 48 hours. Repeat brain imaging is done as needed. Hospitals are randomized in batches over three phases lasting 18 months each: usual care, randomized evaluation, and post-implementation follow-up, with the entire study rolling out over 2.5 years. Participants are adults aged 18 or older with spontaneous ICH confirmed by imaging and admitted within 24 hours of symptom onset. Patient information, treatments, and outcomes are recorded, including functional status measured by the Utility Weighted modified Rankin Scale at 180 days. The study collects data on various treatments, monitoring, and complications to assess if the Care Bundle improves recovery. Safety and sustainability of the Care Bundle are evaluated through continued hospital participation and follow-up.

Researchers are comparing the results of one-visit versus two-visit root canal treatments performed in general dental practices for infected (necrotic) teeth. The study focuses on how well the treatments work one and four years after completion, as well as differences in root filling quality and complication rates. This multi-center study involves several clinics across five counties in Sweden and plans to recruit 1,000 patients to ensure statistically meaningful results. Participants will be randomly assigned to receive either a single-visit or a two-visit root canal treatment. In the single-visit group, treatment including access, cleaning, shaping, and root filling may be completed in one appointment. In the two-visit group, the treatment is split into two appointments at least one week apart, with cleaning and medication placement done in the first visit and root filling in the second. Treatments follow usual clinical practices without a strict protocol. During the study, patients will be contacted by phone 5-7 days after treatment to check for complications and will have a follow-up visit one month post-treatment. Clinical examinations and X-rays will be done one and four years after treatment to assess healing. Two independent observers will review the radiographs to determine success based on clinical and radiographic normalcy. The study aims to detect differences in outcomes using statistical tests with significance set at p<0.05.

Researchers are conducting an international, adaptive, multi-arm clinical trial to study treatments for men with metastatic prostate cancer, including hormone-sensitive and castration-resistant types. The trial uses a biomarker-driven approach, assigning patients to treatments based on tumor gene signatures identified through specialized genetic testing. This Phase 3 study aims to compare standard care with experimental treatments tailored to these biomarker profiles to improve progression-free survival. Participants will be randomized into either a control group receiving standard care or an experimental group receiving treatments matched to their biomarker signatures. Treatments include androgen receptor signaling inhibitors, taxane chemotherapy combinations, PARP inhibitors, and targeted therapies such as AKT inhibitors. Adaptive randomization will adjust treatment assignment probabilities based on ongoing results. Patients who experience disease progression can re-enter the trial and be reassigned up to three times. Throughout the study, patients will be monitored for progression-free survival for up to 60 months. Regular assessments will include clinical evaluations and biomarker profiling via tissue or liquid biopsies. An independent safety board will review results to determine if treatments show superiority or should be discontinued for futility. The study allows for adding new treatments and biomarker signatures over time. Participation includes signing informed consent and ongoing follow-up visits to evaluate treatment outcomes and safety.

This trial evaluates the effects of a restrictive approach to giving non-resuscitation fluids in adults with septic shock, a serious condition caused by infection leading to dangerously low blood pressure. The study aims to assess both the potential benefits and harms of limiting these fluids compared to usual care. The trial focuses on adult patients diagnosed within 12 hours of intensive care unit (ICU) admission who require medication to support blood pressure. Participants are randomly assigned to one of two groups. The first group follows a protocol to reduce non-resuscitation fluids, where maintenance fluids are stopped if the patient has a positive fluid balance and is not dehydrated. Fluids and nutrition are carefully managed according to specific guidelines, including concentrated intravenous medications and nutrition support if needed. The second group receives usual care with fluids and medications given according to local routines, including maintenance fluids at a set dose unless otherwise specified. During the study, researchers monitor participants closely, focusing on mortality within 90 days after enrollment as the primary outcome. Fluid balance, medication use, nutrition, and patient condition are assessed to compare the two approaches. The study includes adult patients admitted to the ICU with septic shock and requires monitoring during their stay and follow-up to understand the effects of fluid management strategies on survival and safety.

Heart failure with preserved ejection fraction (HFPEF) is a common and serious condition without effective treatment options. Researchers are evaluating whether adding spironolactone, a medication, to standard care can reduce the combined risk of cardiovascular death and hospitalizations for heart failure in patients with HFPEF. This study is a Phase 3 trial including patients from the Swedish Heart Failure Registry and the US, all having symptoms of heart failure, elevated heart-related blood markers, and an ejection fraction of 40% or higher. Participants are randomly assigned to one of two groups: one receiving spironolactone along with usual care, and the other receiving usual care alone without spironolactone. The study is designed as a registry-randomized clinical trial and will continue until 721 cardiovascular death or heart failure hospitalization events occur, with an enrollment period of 7 years and a total study duration of 9 years. Data collection in Sweden uses registry linkages, while data in the US comes from site reports and supplemented call center follow-up. During the study, researchers will monitor participants for hospitalizations due to heart failure or cardiovascular death as the primary outcome. Secondary outcomes include other hospitalizations, side effects, and how well patients follow their treatment plans. Outcomes are tracked through national registries and direct reporting, with the main data locked and analyzed five years after the study begins. Approximately 2000 patients aged 50 to 99 years will be included to achieve the event target needed for study conclusions.

Researchers are evaluating the safety and effectiveness of apixaban to prevent strokes in adults with stage 5 chronic kidney disease (CKD) who also have atrial fibrillation (AF), a heart rhythm disorder. This phase 3b clinical trial compares apixaban treatment to no anticoagulation to see if apixaban lowers the risk of ischemic stroke without causing unacceptable increases in fatal or brain bleeding. The study also looks at the risk of death from any cause, cardiovascular events, and major bleeding in this patient group. Participants are randomly assigned to receive either apixaban 2.5 mg tablets twice daily along with standard care or standard care without anticoagulation. The study is open-label, meaning both patients and doctors know the treatment given. Apixaban will be prescribed and renewed by the local investigator. The study lasts between 12 and 72 months and includes about 1000 to 1400 patients from multiple sites in Sweden, Finland, Norway, Iceland, Poland, and possibly other European countries. During the study, participants will have routine blood tests including kidney function and coagulation checks. Researchers will monitor the time to first ischemic stroke, fatal or intracranial bleeding, overall mortality, cardiovascular events, and major bleeding events. A safety board will oversee the trial, and outcomes will be reviewed independently. The study may also explore outcomes related to kidney transplant complications and thrombosis. Participation ends after 72 months or when enough primary events have occurred.