Helsingborg

Researchers are investigating whether adding regular radiological scans during follow-up after surgery for high-risk malignant melanoma improves patient survival. This study focuses on patients who have undergone radical surgery for stage IIb-c and III cutaneous malignant melanoma. Since radiological exams can be costly, cause anxiety, and expose patients to radiation, the study aims to determine their value especially given the availability of effective medical treatments for melanoma. Participants are randomly assigned to one of two groups for a 3-year follow-up period. One group receives routine follow-up with regular doctor visits according to national guidelines. The other group receives the same follow-up plus whole body CT or PET scans and blood tests at baseline, 6, 12, 24, and 36 months. An interim analysis will be done after 1000 patients have enrolled. Throughout the study, researchers will monitor overall survival over a 5-year period. Participants will have scheduled assessments including scans and blood tests if assigned to the imaging group. The study also tracks adherence to follow-up visits and any health changes. This approach aims to provide clear evidence on the benefit and impact of imaging during follow-up after melanoma surgery.

Researchers are investigating the use of point-of-care ultrasound (POCUS) to improve diagnosis accuracy in adult patients presenting with acute dyspnea and hypoxia in the Emergency Department (ED). Dyspnea is a common and urgent symptom requiring quick and accurate diagnosis to guide treatment. This study aims to compare diagnostic accuracy before and after the use of POCUS performed by ED physicians with limited ultrasound training, addressing the need to evaluate POCUS in real-world settings beyond highly experienced users. The study involves emergency medicine specialists and residents who receive short training and certification to perform a structured ultrasound protocol focusing on the heart, lungs, and inferior vena cava. Patients who meet criteria for acute dyspnea and hypoxia are first assessed using routine diagnostic methods. After consent, the certified physician performs POCUS and shares findings with the initial physician, who then updates their diagnostic likelihood for several conditions including heart failure, pneumonia, and pulmonary embolism. This observational study compares diagnostic accuracy before and after POCUS by analyzing discharge diagnoses. Participants undergo standard bedside tests and additional laboratory assessments such as chest imaging, blood markers like pro-BNP, C-reactive protein, and white blood count. The study measures final discharge diagnoses and evaluates sensitivity, specificity, and predictive values of diagnoses before and after POCUS. Inclusion depends on the patient’s triage category and respiratory symptoms, and exclusion applies if study participation delays urgent care or if the patient is discharged without hospital admission. This study helps determine if POCUS can enhance diagnosis and treatment decisions in the ED setting.

This research aims to evaluate the agreement, smallest detectable change, and reliability of repeated liver stiffness measurements using transient elastography (TE) in adults with chronic viral hepatitis. The study addresses gaps in previous research by focusing specifically on agreement metrics and factors linked to measurement disagreements in this patient group. Participants will undergo transient elastography, a diagnostic test that measures liver stiffness in kilopascals (kPa). The study involves repeated TE measurements to analyze consistency and identify the smallest change that can be reliably detected. This cross-sectional test-retest design allows comparison of results between operators and examination of factors influencing measurement differences. During the study, participants will attend a 30-minute outpatient clinic visit where liver stiffness measurements will be repeated by different operators. Researchers will assess disagreement between operators defined as a difference in TE results of 33% or more, along with the smallest detectable change (SDC95). Participants will provide informed consent and be monitored for study adherence and safety throughout the visit.

Researchers are evaluating biomarkers in adult patients treated in intensive care units after out-of-hospital cardiac arrest. This prospective multicenter study recruits patients from sites involved in the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation (STEPCARE) trial, which studies sedation, temperature, and blood pressure targets in comatose patients after cardiac arrest. The goal is to understand functional outcomes related to these interventions. Blood samples are collected at 12, 24, 48, and 72 hours after randomization from selected sites where samples are processed and frozen on-site before being stored in a central biobank. Sample analysis occurs after the trial ends. The STEPCARE trial randomizes patients to different sedation levels, temperature management strategies, and blood pressure targets to evaluate their effects. Participants undergo assessments of functional outcomes at 30 days and 6 months after cardiac arrest, with the primary outcome being poor functional outcome measured by the modified Rankin Scale at 6 months. Survival at 6 months and functional outcomes at 30 days are secondary outcomes. The study involves close monitoring and data collection during the intensive care period and follow-up evaluations to determine recovery and survival.

Researchers are investigating the differences in clinical, molecular, and genetic characteristics among cutaneous melanoma, melanoma in situ, dysplastic nevi, and benign nevi. This study also examines metastatic melanoma, aiming to identify objective diagnostic markers and understand biological aggressiveness in both primary and secondary melanoma. The study collects detailed patient information through validated questionnaires covering medical history, UV exposure, family cancer history, skin type, smoking, alcohol use, and quality of life. Participants undergo diagnostic and prognostic imaging, and molecular analyses using omics and machine learning methods. Blood samples are collected before surgical removal of primary lesions and during follow-up treatments for secondary disease. Dermatologists take full-thickness skin punch biopsies from the lesion and nearby normal skin, which are snap-frozen and stored. Tissue from suspected or confirmed secondary melanomas is obtained mainly through surgical and core needle biopsies before, during, and after treatment or disease progression. Throughout the study, participants provide comprehensive questionnaire responses and undergo imaging and histologic examinations documented in a secure database. Researchers analyze molecular and clinical data from tissue and blood samples to explore differences across melanoma types and nevi. The study spans from November 2013 to December 2026 and monitors genomic and transcriptomic variations to improve understanding and diagnosis of melanoma and related skin lesions.

Researchers are evaluating optimized drug treatments for patients with Takotsubo Syndrome, also known as Broken Heart Syndrome. This large Phase 4 trial aims to include 1000 patients registered in SWEDEHEART to provide documented evidence for effective pharmacologic care, as current data is limited. The study is a multinational, multicenter, registry-based, open-label, randomized controlled trial focused on improving treatment outcomes for this heart condition. Participants may receive one of several treatments: an infusion of Adenosine at 70 g/kg/min for 3 hours, oral Dipyridamole 200 mg twice daily, oral Apixaban 5 mg twice daily, or care guided by recommendations from the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology, which may vary by local practice. The trial includes two randomizations with specific treatment options and criteria. During the study, researchers will assess heart function using wall motion scores and monitor for serious events such as death, cardiac arrest, heart failure hospitalization, or reduced heart ejection fraction up to 30 days after treatment. They will also track thromboembolic events and cardiac thrombus via echocardiography within the first few days and through day 30. Safety and treatment adherence will be monitored throughout, with detailed follow-up to understand treatment effects and patient outcomes.

Researchers are evaluating whether using the World Health Organization's Labour Care Guide (LCG) instead of standard care for monitoring labor progress can improve outcomes for newborns and mothers. This study compares these two guidelines to see if the LCG can reduce adverse neonatal outcomes, such as perinatal mortality, neonatal complications, and the need for cesarean sections during labor. The research also looks at other perinatal interventions, complications, and economic factors, using a multicenter, stepped-wedge cluster randomized trial design conducted from 2023 to 2025 in Sweden. Participants will receive care based on either the WHO's LCG or standard labor monitoring guidelines. The LCG is a next-generation partograph designed to follow the latest intrapartum care recommendations. The study involves multiple delivery units where women in active labor receive monitoring according to the assigned guideline. Researchers will compare outcomes such as neonatal morbidity, cesarean section rates, use of oxytocin, postpartum hemorrhage, labor duration, and experiences of women, their partners, and healthcare providers. Throughout the study, participants will be monitored for neonatal complications including low Apgar scores, hypoxic ischemic encephalopathy, intracranial hemorrhage, seizures, meconium aspiration syndrome, and neonatal unit admissions. The study will also assess maternal outcomes and collect feedback via questionnaires and interviews about childbirth experiences and guideline compliance. The primary outcomes are adverse neonatal events and intrapartum cesarean rates, with follow-up from 12 weeks up to 18 months after birth to gather comprehensive data on health and safety.

Researchers are conducting a pragmatic, multi-center, superiority, randomized clinical trial to compare early treatment using intravenously infused noradrenaline with fluid-only therapy in patients experiencing hypotension or shock in Danish and Swedish Emergency Departments. The study aims to determine if early noradrenaline can speed up shock control, reduce ICU admissions, and decrease mortality in non-bleeding hypotensive patients. Participants will be urgently treated during their Emergency Department stay with either noradrenaline or the usual fluid therapy. The treatment is administered through a vein and given early after presentation. After treatment completion in the Emergency Department, patient data will be collected from bedside measurements, electronic health records, and national registers. One year after inclusion, participants will be contacted to answer questions about their daily physical function and ability to care for themselves. Throughout the study, researchers will monitor blood pressure to assess the proportion of patients achieving target levels within 90 minutes of inclusion. Data will also include time to shock control, ICU admission rates, and mortality. The study includes ongoing safety monitoring and long-term follow-up to evaluate patient outcomes over the course of a year.

Researchers are studying early neurological prognostication after out-of-hospital cardiac arrest in adult patients. This prospective observational substudy of the STEPCARE trial aims to determine if neurological outcomes can be predicted earlier than the current guideline recommendation of 72 hours post-arrest. The study evaluates the combination of clinical examination, brain injury marker neurofilament light (NFL), electroencephalography (EEG), and head computed tomography (CT) to predict poor outcomes at 24 hours without false positives. It also investigates whether sedation affects the accuracy of these methods. The substudy will recruit patients from hospitals participating in the STEPCARE trial, which tests different intensive care interventions after cardiac arrest. Biomarker samples will be collected at 12, 24, 48, and 72 hours after randomization. EEG and CT scans will be performed as early as possible after 24 hours in patients who remain unconscious. The study will centrally evaluate EEG, somatosensory evoked potentials (SSEP), and neuroimaging data. Patient treatment follows the STEPCARE trial protocol including randomization to sedation, fever treatment, and blood pressure targets. Participants will be assessed for neurological function six months after cardiac arrest using the modified Rankin Scale. Poor outcome is defined as moderate to severe disability or death. Early neurological prognostication will not solely determine withdrawal of life-sustaining therapy, which follows current European guidelines. The study collects detailed clinical data, blood samples, imaging, and electrophysiology to better understand brain injury and recovery after cardiac arrest.

Researchers are evaluating the effects of three different treatments on major adverse kidney events (MAKE) in adults who are unconscious after being resuscitated from out-of-hospital cardiac arrest. This sub-study is part of the larger STEPCARE trial and involves 3,500 participants. The study focuses on kidney-related outcomes, including death within 30 days, need for kidney replacement therapy, and kidney function changes measured by creatinine levels at hospital discharge. The main trial randomly assigns patients to one of three treatments: continuous deep sedation for 36 hours versus minimal sedation; fever control using a feedback-controlled device if body temperature rises above 37.7°C versus fever control without a device; and two blood pressure targets with mean arterial pressure (MAP) set to either ≥65 mmHg or ≥85 mmHg maintained by vasopressors for 36 hours. The feedback-controlled temperature device is set to maintain temperature at 37.5°C when used. Participants will be closely monitored during their hospital stay with data collected prospectively according to the main trial protocol. Researchers will assess major adverse kidney events within 30 days and examine creatinine changes during the hospital stay and within 72 hours after resuscitation. The study aims to understand how these treatments affect kidney outcomes after cardiac arrest, with analyses following a predefined statistical plan.