Helsingborg

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.

Dyspnea, or shortness of breath, is a common and urgent problem in the Emergency Department that requires quick and accurate diagnosis to ensure timely treatment. Researchers are evaluating whether point-of-care ultrasound POCUS, performed by emergency medicine specialists and residents with limited ultrasound training, can improve diagnostic accuracy for patients with dyspnea compared to routine assessments. This study focuses on several important diagnoses such as heart failure, pneumonia, pulmonary embolism, and exacerbations of chronic lung diseases. In this prospective observational study, specially trained emergency physicians will use a structured ultrasound protocol to examine the lungs, heart, and inferior vena cava of adult patients presenting with severe dyspnea or low oxygen levels. After an initial routine clinical assessment, the physician will estimate the likelihood of key diagnoses. Following this, a certified colleague will perform POCUS and share the results, allowing the initial physician to update their diagnostic estimates. Additional tests like chest imaging and blood markers will also be collected as part of routine care. Participants will be adults arriving with serious respiratory distress or hypoxia in the Emergency Department. Researchers will compare the diagnostic accuracy before and after POCUS by reviewing the final discharge diagnosis. Outcome measures include sensitivity and specificity of diagnoses such as heart failure and pneumonia. Safety is monitored by ensuring no delay in urgent care, and all patients will undergo routine clinical testing. The study aims to improve diagnostic tools for emergency doctors and enhance patient care during acute breathlessness episodes.

Researchers are evaluating the agreement, smallest detectable change, and reliability of repeated liver stiffness measurements using transient elastography in patients with chronic viral hepatitis. The study aims to determine how consistent the test results are when repeated and to identify factors that may cause differences in measurements between operators. This investigation addresses gaps in previous studies that focused on reliability but did not evaluate measurement agreement for this condition. Participants will undergo repeated transient elastography tests, which measure liver stiffness in kilopascals kPa. The study is observational and includes patients with chronic viral hepatitis from infectious disease departments. Measurements will be taken during a single 30-minute visit to the outpatient clinic. The study focuses on test-retest agreement and smallest detectable changes between operators. During the visit, liver stiffness will be measured multiple times to assess agreement and reliability. Researchers will also collect information about patient and exam characteristics that might influence measurement differences. The primary outcome is the level of disagreement between operators defined by a difference of 33% or more in liver stiffness results. Secondary outcomes include the intra-class correlation as a reliability estimate and factors associated with differences. The study is sponsored by Lund University and participation involves one brief clinic visit.

Researchers are evaluating biomarkers in adult patients who have been treated in intensive care units after experiencing out-of-hospital cardiac arrest. This study is part of the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation STEPCARE trial, which is a randomized trial exploring different sedation, temperature, and blood pressure targets in comatose patients after cardiac arrest. The substudy focuses on collecting and analyzing blood samples to understand outcomes better. Blood samples are collected at 12, 24, 48, and 72 hours after randomization at selected sites that participate in the biomarker substudy. These samples, including serum, plasma, and PAX-RNA vials, are processed and frozen on-site before being sent to a central biobank for batch analysis after the trial ends. Patients in this substudy have already been randomized in the main STEPCARE trial to different sedation, temperature, and blood pressure intervention groups. Participants will have their functional outcome assessed at 30 days and 6 months after cardiac arrest, with the primary outcome being poor functional outcome measured by the modified Rankin Scale at six months. Survival at 6 months and functional outcomes at 30 days are also measured. The study involves intensive care treatment and monitoring, with data collected during the hospital stay and follow-up assessments to evaluate recovery and survival over time.

Researchers are exploring the differences in clinical, molecular, and genetic features among cutaneous melanoma, melanoma in situ, dysplastic nevi, and benign nevi. The study also seeks to understand biological aggressiveness and find objective diagnostic markers for both primary and secondary melanoma. It includes patients suspected of having primary melanoma or metastatic melanoma and collects detailed information to support this research. Participants are adults receiving routine dermatological, surgical, or oncological care who are scheduled for surgical excision or cytological diagnostics of pigmented skin lesions or metastatic melanoma. Before surgery, imaging and blood samples are collected. During surgery, skin punch biopsies of the lesion and nearby normal skin are taken and stored frozen. Tissue samples from metastatic melanoma are also collected through biopsies during treatment and follow-up. Participants complete questionnaires about risk factors, medical history, lifestyle, and quality of life. Researchers document lesions with imaging and collect histology and molecular data stored securely. The study measures genomic and transcriptomic differences across melanoma types and tracks these findings over time. The total participation period spans from initial inclusion through follow-up, with samples and data collected before, during, and after treatments.

Researchers are evaluating optimized pharmacologic treatments for patients with Takotsubo Syndrome, a condition often referred to as broken heart syndrome. This large randomized registry clinical trial aims to include 1000 participants registered in SWEDEHEART to better document effective treatments, as current data from large patient groups are lacking. The trial is a Phase 4 study sponsored by Vastra Gotaland Region and is designed as an open-label, multinational, multicenter trial. Participants are randomly assigned to different treatment groups. One group receives an adenosine infusion for 3 hours followed by oral dipyridamole twice daily until left ventricular function normalizes or up to about one month. Another group receives usual care per European Society of Cardiology recommendations. A separate randomization compares oral apixaban twice daily until normalization of heart function or about one month versus no anticoagulant therapy. The study monitors heart function with echocardiographic assessments at 48-96 hours and possibly later. During the study, participants undergo regular heart ultrasounds to assess wall motion and ejection fraction, along with monitoring for events such as death, cardiac arrest, heart failure, thromboembolic events, and bleeding. The trial collects data up to 30 days after treatment begins. Researchers also track heart rhythm problems and use standardized scoring to evaluate heart muscle movement. Safety and treatment outcomes are closely observed throughout the study period, which lasts until December 2028.

Researchers are evaluating the impact of two different guidelines for monitoring labor progress on neonatal and maternal outcomes. The study compares the World Health Organizations Labour Care Guide LCG with standard delivery care in Sweden. The goal is to see if using the LCG can reduce adverse neonatal outcomes and lower the rate of intrapartum Cesarean sections. This study uses a multicenter, stepped-wedge cluster randomized design to explore these effects along with economic considerations and experiences related to childbirth. Participants will receive labor monitoring either according to the WHOs LCG guidelines or standard care. The study will involve multiple delivery units in Sweden, and women in active labor will be randomly assigned to either group as the new guidelines are gradually introduced. Alongside the main study periods, researchers will examine perinatal interventions, labor complications, and collect qualitative data through questionnaires, focus groups, and interviews with women, their partners, and healthcare providers. During participation, women and their partners will be asked about their childbirth experiences, while providers compliance and views on using the LCG will also be assessed. The study will track outcomes such as perinatal mortality, neonatal morbidity, cesarean section rates, and obstetric events like postpartum hemorrhage and labor duration. Data collection and follow-up will occur from 12 weeks up to 18 months after delivery, including economic evaluations and provider experiences to fully understand the effects of the labor monitoring methods.

Researchers are evaluating early treatment with peripheral intravenous noradrenaline compared to standard fluid therapy in adults with low blood pressure or shock in Danish and Swedish Emergency Departments. The study aims to see if early noradrenaline can help control shock faster, reduce ICU admissions, and lower mortality rates. This is a pragmatic, multi-center, randomized trial focused on improving emergency care for hypotensive patients. Participants will be randomly assigned to receive noradrenaline infused at 0.05-0.15 mcgkgmin for up to 24 hours in the Emergency Department until shock control is achieved. If shock control is not reached within 24 hours, or treatment cannot be stopped, patients will be transferred to the ICU for further care without continuing the trial intervention. The comparison group will receive standard care, which includes fluid therapy and ICU transfer if needed but no noradrenaline during the ED stay. During the study, patient data will be collected from bedside monitoring, electronic health records, and national registries. One year after enrollment, participants will be contacted to assess their physical function and daily self-care ability. The primary outcome measures the proportion of patients achieving target blood pressure 90 minutes after inclusion. Secondary outcomes include ICU-free days alive within 30 days, time without shock within 24 hours, and mortality rates at 30 days and hospital discharge.

Researchers are investigating whether the neurological outcome after an out-of-hospital cardiac arrest can be predicted earlier than the currently recommended 72-hour time point. This study focuses on adult patients who suffered a cardiac arrest of presumed cardiac or unknown cause and are unconscious after resuscitation. It explores combining clinical exams, brain injury markers like neurofilament light NFL, EEG, and head CT scans to predict poor functional outcomes at 24 hours post-arrest without false positives. The study is a prospective observational substudy within the larger STEPCARE trial, conducted by Lund University and involving multiple international centers. The study involves collecting blood samples to measure brain injury markers at 12, 24, 48, and 72 hours after randomization. EEG and CT scans are performed as early as possible after 24 hours in patients still unconscious. Additional neuroimaging and electrophysiological data, including SSEP and MRI, are collected for central blind review. Patients receive intensive care according to STEPCARE trial protocols, which include varying sedation, fever treatment, and blood pressure targets, but decisions about life-sustaining therapy withdrawal follow current guidelines and are not made solely on early exam results. Participants will be assessed with clinical exams, blood tests, EEG, and imaging during their hospital stay, with data stored securely using study IDs. Functional outcomes are evaluated six months after randomization using the modified Rankin Scale, with poor outcomes defined as moderate to severe disability or death. The study aims to determine whether early prognostic tools can predict neurological outcomes accurately and safely, with final biomarker analyses performed after trial completion.

Researchers are evaluating tozorakimab as an additional treatment to standard care in adults hospitalized with viral lung infection who need supplemental oxygen. The study aims to determine if tozorakimab can help prevent death or the need for invasive mechanical ventilation or extracorporeal membrane oxygenation. This Phase III trial involves a large group of participants to assess the safety and effectiveness of this approach. Participants are randomly assigned to one of two groups one group receives a single intravenous dose of tozorakimab on the first day, while the other group receives a matching placebo. The study uses a double-blind design, meaning neither participants nor researchers know which treatment is given. This helps ensure unbiased results. The treatments are given once, and participants continue to receive standard care during the trial. During the study, participants are closely monitored and evaluated up to 60 days after treatment. Researchers track important outcomes such as death rates, progression to invasive ventilation, days alive outside intensive care, and oxygen use. They also assess clinical progression using a World Health Organization scale and monitor for any anti-drug antibodies. The trial lasts until November 2027, with multiple assessments throughout to understand the treatments impact and safety.