Boras

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are investigating whether regular radiological assessments during follow-up after surgery for high-risk malignant melanoma improve patient survival. The study addresses concerns about the resource demands, potential radiation exposure, and anxiety caused by such imaging, especially given the recent introduction of effective medical treatments for melanoma. There is currently no clear evidence supporting routine imaging in this context. Participants are randomly assigned to one of two groups. One group follows national guidelines with regular doctor appointments for 3 years, while the other group receives the same follow-up plus additional whole-body CT or PET scans and blood tests at baseline, 6, 12, 24, and 36 months. An interim analysis will be done after 1,000 patients enroll. During the study, researchers will monitor overall survival at 5 years as the primary outcome. They will also assess quality of life through questionnaires over the 3-year follow-up. Participants will attend scheduled visits for clinical evaluations, imaging, and blood tests, with the study aiming to provide clear evidence about the role of imaging in post-surgical melanoma care.

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 evaluating sacituzumab tirumotecan alone and in combination with pembrolizumab compared to treatment chosen by the physician in participants with hormone receptor positivehuman epidermal growth factor receptor-2 negative HRHER2- breast cancer that is locally advanced, unresectable, or metastatic. The study aims to see if these treatments improve progression-free survival compared to standard physician-chosen therapies. This is a Phase 3 clinical trial assessing advanced breast cancer treatments. Participants are randomly assigned to one of three groups sacituzumab tirumotecan alone given by intravenous infusion every two weeks until disease progression or discontinuation sacituzumab tirumotecan plus pembrolizumab with sacituzumab tirumotecan given every two weeks and pembrolizumab given every six weeks for up to about two years or treatment chosen by the physician, which may include various chemotherapy options such as paclitaxel, nab-paclitaxel, capecitabine, or liposomal doxorubicin, administered with schedules depending on the drug. Treatments continue until disease progression or discontinuation. During the study, participants will have regular assessments including imaging to evaluate progression-free survival, overall survival, response rates, and quality of life measures using questionnaires. Safety is monitored by tracking adverse events and treatment discontinuations. The primary outcome is measured up to approximately 38 months, with additional secondary outcomes followed up to about 77 months. Participants are followed closely through study visits and evaluations throughout the trial period.

Researchers are evaluating surzetoclax, an investigational drug, alone or combined with other anti-myeloma agents, in adults with relapsed or refractory multiple myeloma MM. The study aims to assess safety and changes in disease activity, including adverse events and response to treatment. This phase 12 trial includes participants who have previously received multiple therapies and have limited treatment options. The study has two substudies. Substudy 1 has a dose escalation phase testing surzetoclax combined with daratumumab and dexamethasone, followed by a dose expansion phase where participants receive surzetoclax with daratumumab and dexamethasone or with daratumumab, pomalidomide, and dexamethasone. Substudy 2 involves Japanese participants receiving various doses of surzetoclax alone. The total duration of participation may last about 4.5 years. Participants will attend regular visits for medical assessments, blood tests, and monitoring of side effects throughout the study. Researchers will measure dose-limiting toxicities and adverse events up to approximately 4.5 years, along with response rates, progression-free survival, duration of response, and overall survival. The study includes frequent safety and disease activity checks to evaluate the treatments impact over time.

Researchers are evaluating a modified version of the Attempted Suicide Short Intervention Program ASSIP tailored specifically for adults aged 65 and older who are at risk of suicide. This study addresses a significant gap in suicide prevention research for older adults, as this age group experiences higher suicide rates in Sweden and many other countries. The trial aims to determine if the adapted ASSIP-Older Adult program ASSIP-OA can reduce new suicide attempts and deaths compared to usual treatment, and also to assess its feasibility, acceptability, and impact on psychiatric symptoms and coping skills. The study compares two groups one receiving ASSIP-OA along with treatment as usual TAU, and the other receiving only TAU. The ASSIP-OA intervention includes up to five sessions involving narrative interviews, video playback for self-reflection, personalized case conceptualization, safety strategy training, and an optional session involving close relatives or support persons. Therapists will also send standardized letters periodically during the two-year follow-up. TAU typically involves antidepressant medication, possibly combined with other psychoactive drugs, electroconvulsive therapy for severe cases, and supportive contacts with mental health professionals. Participants will be monitored over 24 months with follow-up assessments at 6, 12, and 24 months to track new suicidal episodes, suicidal thoughts, depressive and anxiety symptoms, coping abilities, quality of life, and healthcare usage. The study also gathers information on participants experiences and therapists perspectives regarding the intervention. This comprehensive evaluation includes questionnaires and clinical monitoring to measure the programs preventive effects and its suitability for older adults at risk of suicide.

Researchers are studying patients who experience out-of-hospital cardiac arrest OHCA with ventricular fibrillation VF or ventricular tachycardia VT that do not respond to initial defibrillation. The study aims to evaluate whether using double sequential defibrillation DSD earlier, after the first failed standard defibrillation, can improve 30-day survival compared to continuing with standard defibrillation. This trial addresses important gaps in knowledge about optimal defibrillation strategies to increase survival in this critical condition. The trial compares two treatment groups one using early double sequential defibrillation, where a second defibrillator with pads placed in the anterior-posterior position is applied as soon as possible, delivering rapid sequential shocks from two devices and the other continuing with standard single defibrillation using one defibrillator with anterior-lateral pad placement. Both groups receive resuscitation until return of spontaneous circulation, resuscitation is stopped, or the patient is transported to the hospital. The study is randomized and open-label, involving ambulance units equipped with two study-specific defibrillators. Participants are adult OHCA patients with an initial shockable rhythm and at least one failed standard defibrillation. During the study, ambulance teams perform screening, randomization, treatment according to assigned group, and initial follow-up. The main outcome measured is survival at 30 days. Secondary outcomes include return of spontaneous circulation, survival to hospital admission and discharge, and neurological function at discharge. The study will continue monitoring these outcomes to assess the effectiveness of early DSD compared to standard defibrillation strategies.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating elacestrant compared to standard endocrine therapy in patients with estrogen receptor-positive ER and human epidermal growth factor receptor 2-negative HER2- breast cancer who have a relapse detected by circulating tumor DNA ctDNA. This international, multi-center, randomized, open-label phase III trial focuses on patients without distant metastasis who show ctDNA positivity during screening. The study aims to assess whether elacestrant can improve outcomes over the current standard endocrine treatments. The study consists of two phases. First, during the ctDNA screening phase, patients on standard adjuvant endocrine therapy will have plasma samples collected every six months for about 5.7 years to detect ctDNA. Patients who test positive will undergo imaging to confirm no distant metastasis and then be randomized 11 to either continue their current endocrine therapy or receive elacestrant 400 mg orally once daily. Treatment duration depends on prior endocrine therapy length, lasting between 2 to 6 years. Intensive follow-up with ctDNA testing and imaging occurs for up to 3 years after randomization. Participants will be monitored closely with blood tests for ctDNA at weeks 4, 16, and every 16 weeks thereafter, along with yearly mammograms, bone scans, and CT scans every 16 weeks to detect metastases or recurrences. Safety, quality of life, and overall survival are assessed throughout, with follow-up continuing until three years after the last patient enrolls. The primary outcome measured is distant metastasis-free survival at 6.25 years after the first randomization.

This research aims to determine if hip replacement surgery arthroplasty can reduce the need for additional operations compared to internal fixation in elderly patients with an undisplaced femoral neck fracture. Patients aged 75 years and older with this type of fracture will be included and randomly assigned to one of two treatments through the Swedish Fracture Register platform. The study focuses on combining reoperation rates and mortality into a single main outcome measure to evaluate which treatment offers better results. Participants will receive either arthroplasty, which may be hemi or total hip replacement depending on the patients condition and surgeons decision, or internal fixation using screws, pins, or a sliding hip screw device based on hospital routine. The study is a randomized controlled trial without blinding, comparing these two device-based treatments for hip fractures in elderly patients. During the study, researchers will monitor the combined rate of reoperations and mortality for 1 to 2 years after surgery. Additional outcomes include reoperation rates, short- and long-term mortality, and patient-reported physical function one year after surgery. Participants will be followed up to assess these outcomes, with care taken to track their progress and safety over the study period.