Arendal

Researchers are evaluating a complex intervention aimed at implementing advance care planning (ACP) for severely ill elderly patients who live at home and are acutely admitted to hospital. The study uses a cluster randomized design involving twelve Norwegian hospital units specializing in geriatric care. It seeks to understand current ACP implementation, identify barriers and facilitators at multiple levels, explore ethical dilemmas, and assess the benefits and challenges experienced by patients, relatives, and healthcare staff. The project also aims to measure the impact of an implementation support program on communication quality, decision-making, and healthcare outcomes, as well as its cost-effectiveness. The intervention includes a comprehensive implementation support program featuring leadership commitment, responsive evaluation, a whole ward approach, and a train-the-trainer model to ensure sustainability. This program provides an implementation team and ACP coordinators, along with training, supervision, network conferences, and shared resources such as guidelines and teaching materials. The clinical intervention involves routine information and invitation to ACP for eligible patients, written materials for patients and relatives, and documentation with collaboration across healthcare levels. Half of the hospital units receive this support immediately, while the others receive it after the intervention period. Participants are involved through questionnaires to staff, clinicians, patients, and relatives, as well as patient record reviews and qualitative interviews. The study measures fidelity to the ACP model at multiple time points and evaluates patient-reported, relative-reported, and clinician outcomes during the intervention period, which spans 10 to 18 months after starting the support. Researchers also assess barriers and facilitators in wider healthcare contexts and perform economic analyses. The total involvement includes baseline and follow-up assessments up to 18 months.

Massive rotator cuff tears (MRCT) affect a significant portion of adults aged 60 and older, causing pain and limited treatment options. This trial studies the surgical treatment of MRCT by comparing a new approach using a biodegradable balloon as a subacromial spacer alongside standard treatment. The goal is to evaluate this new method's effects in a randomized controlled setting, as previous studies on this treatment have been small and non-randomized. Participants undergo arthroscopic surgery with debridement and biceps tenotomy. Before randomization, surgeons assess if partial suture is possible to balance groups. Those randomized to the balloon group receive the biodegradable spacer implanted at surgery's end. Both groups follow the same postoperative mobilization: two weeks of sling immobilization with gentle exercises, then free movement with lifting restrictions until six weeks, followed by gradual range of motion and weight lifting improvements through 12 weeks. During the study, patients are monitored through clinical tests performed by blinded physiotherapists. Outcomes focus on the change in shoulder function measured by the Constant score at multiple time points up to 10 years. Surgeons classify osteoarthritis and tendon condition during surgery. The follow-up includes long-term assessments to track recovery and treatment effects over time.

Researchers are evaluating whether D-serine, a modulator of the N-methyl-D-aspartate receptor (NMDAR), has therapeutic effects on Parkinson's disease (PD). This randomized, double-blind, placebo-controlled Phase 2 trial includes 100 participants diagnosed with PD within the past 5 years. The study aims to assess D-serine's impact on symptom severity using the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and also investigates effects on brain dopamine transporter levels and cognitive function. Participants will receive both placebo and D-serine during different periods of the 58-week treatment phase. D-serine dosing begins with 2 capsules of 500 mg twice daily in the first week and increases to 4 capsules twice daily for the remaining intervention period. Participants' existing dopaminergic medications will be optimized before study start and maintained stable for the first 32 weeks; adjustments may be made after this time. Following the treatment phase, participants will stop study drugs and enter a 12-week washout period with a final study visit. Throughout the study, participants will undergo clinical evaluations including rating scales and questionnaires, cognitive testing, blood sample collection, and dopamine transporter imaging using single-photon emission tomography (DaTscan). Researchers will monitor changes in clinical symptoms, brain dopamine transporter levels, and cognition, as well as safety aspects. The total study duration for each participant includes screening, 58 weeks of treatment, and 12 weeks of follow-up after stopping study drugs.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

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.

Infectious keratitis can cause partial vision loss and blindness and is challenging to diagnose accurately. This study aims to improve the diagnosis of microbial keratitis by identifying whether the infection is bacterial, viral, fungal, or parasitic. Researchers are investigating new diagnostic methods to help provide faster and more precise detection of the keratitis subtype, which may lead to better-targeted treatments and reduce repeated clinic visits and worsening vision. Patients will undergo non-invasive examinations including in vivo confocal microscopy (IVCM) to observe the cornea's cellular condition and detect microbes in real-time. Tear film samples will also be collected and stored for analysis of molecular cytokine signatures associated with different microbial infections. These advanced diagnostics aim to develop specific cytokine profiles and combine imaging with molecular data to improve keratitis diagnosis. Participants will be monitored over 18 months to assess the IVCM findings and cytokine profiles in relation to different microbial subtypes. The study involves collecting tear samples and performing corneal imaging without invasive procedures. Researchers will evaluate the accuracy of these methods compared to traditional microbiological culture to understand how well they predict clinical progression and outcomes of keratitis.

Researchers are investigating the effects of a standardized intervention program for parents and professionals working with children and adolescents aged 2.5 to 18 years who have Fetal Alcohol Spectrum Disorders (FASD). The study focuses on improving caregivers' understanding and handling of behavioral problems and self-regulation difficulties caused by early brain damage from prenatal alcohol exposure. The goal is to enhance family empowerment, parenting skills, and reduce stress, while also improving children's behavior and functional outcomes. The intervention consists of an eight-session program lasting about two months, including six interactive digital psychoeducational sessions. Topics covered include general information about FASD, intervention strategies in schools, managing daily living activities, coping with self-regulatory deficits, executive functions, social development, guidance in social settings, and addressing challenging behaviors. This treatment is designed as a manual-based tool for professionals responsible for children diagnosed with FASD. Participants will be assessed before and after the intervention using tools like the Children's Global Assessment Scale and the Family Empowerment Scale over a period of up to ten months. The study monitors changes in family empowerment, parenting stress, children's behavior, and professional knowledge about FASD. Data collection includes behavioral evaluations and questionnaires to measure the effects of the program on both children and their caregivers throughout the study.

Colorectal cancer is a common cancer that often develops from benign polyps in the colon. Removing these polyps through colonoscopy reduces the risk of cancer, but patients with removed polyps need regular surveillance because they remain at risk for new polyps and cancer. This trial investigates whether using a fecal test for blood (FIT) is as effective as colonoscopy for monitoring patients after polyp removal, aiming to reduce the burden of frequent colonoscopies which can be uncomfortable, resource-intensive, and sometimes cause complications. Participants eligible for three-year post-polypectomy surveillance are randomly assigned to either standard colonoscopy or regular fecal blood testing using FIT. If the FIT test is positive, a colonoscopy will be performed. This approach could reduce the number of colonoscopies needed by over half, lowering costs and patient discomfort while maintaining effective cancer surveillance. The trial compares these two surveillance methods over time. During the study, participants will undergo either colonoscopy or FIT-based monitoring, with colonoscopy follow-up if blood is detected by FIT. Researchers will track colorectal cancer incidence over 12 years from the start of the trial. The study includes assessments such as colonoscopies and fecal tests, with careful monitoring for cancer development, complications, and overall effectiveness of the surveillance methods. Participants will be followed long-term to evaluate outcomes and safety.

This research evaluates three different treatment targets for patients who are comatose after being successfully resuscitated from cardiac arrest. The trial involves 3500 participants and focuses on sedation levels, temperature management, and blood pressure goals to understand their effects on survival. The study aims to improve care strategies in the critical period following cardiac arrest by comparing different approaches in a randomized design. Participants are assigned to one of two groups for each treatment target: sedation (deep sedation for 36 hours versus minimal sedation), temperature control (using a feedback-controlled device at 37.5°C versus fever management without a device), and mean arterial pressure (MAP) targets (>85mmHg versus >65mmHg). Vasopressors will be adjusted to maintain the assigned MAP for 36 hours. The interventions are applied during intensive care after the cardiac arrest event. During the study, patients will be monitored closely with follow-ups at 30 days and 6 months after treatment. The primary outcome is survival at 6 months. Researchers will assess mortality and other health indicators during this period to determine the impact of the different treatment approaches. The total participation duration includes the initial treatment phase and these follow-up periods for outcome measurement.

This research aims to provide detailed information on the long-term outcomes related to neuroprotection and recovery improvements for survivors of out-of-hospital cardiac arrest. It evaluates different targets for sedation, temperature, and blood pressure management in these patients, as well as the impact on caregivers who support them. The study is part of a larger international, multi-center randomized trial called STEPCARE. Participants who survived out-of-hospital cardiac arrest and were part of the STEPCARE trial will be followed at selected sites. They will have experienced various interventions such as deep or minimal sedation, different blood pressure targets using vasopressors, and fever management either with or without a feedback-controlled temperature device. These treatments are applied during the first 36 hours after cardiac arrest. The study involves follow-up assessments at 6 and 12 months after the cardiac arrest event. Survivors will be evaluated for cognitive function using the Montreal Cognitive Assessment, while caregivers will be assessed for burden using the Zarit Burden Interview. The study plans to enroll about 600 survivors along with one nominated caregiver per survivor to understand both patient outcomes and caregiver impact over time.