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Found 4 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Age: 40Years - 80YearsAll GendersPhase 3
920 locations
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Actively Recruiting

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.

Age: 70Years +All GendersPhase Not Applicable
12 locations
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Actively Recruiting

Researchers are comparing two types of intramedullary nails used to treat fractures in the upper part of the femur, focusing on a newer extended-short nail versus a traditional long nail. This study aims to provide clearer guidelines for treatment by evaluating whether the extended-short nail can improve surgical and functional outcomes. The trial is a randomized controlled study involving patients with specific types of proximal femur fractures, addressing a gap in evidence where nail choice often depends on surgeon preference rather than data. Participants will be randomly assigned to receive either a long TFNA nail (260-480 mm) or an extended-short TFNA nail (235 mm). The extended-short nail is designed to combine the strength of a long nail with the surgical ease of a short nail, potentially reducing operating time, bleeding, fluoroscopy time, and postoperative pain. Both devices are implanted during surgery as part of the treatment for the fracture. During the study, researchers will collect information from the operation and follow-up visits to assess differences in surgical and functional outcomes. The primary outcome measure is the Short Physical Performance Battery (SPPB) score at 3 months and 1 year post-surgery. The study also monitors complications, reoperation rates, mortality, and other recovery aspects to evaluate the benefits and risks of each nail type.

All GendersPhase Not Applicable
2 locations
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Actively Recruiting

This research aims to understand if vision training can improve functional vision in adults who have lost part of their visual field due to a stroke. It also explores how vision training might affect participants' awareness of their vision abilities and their strategies to cope with visual field loss, especially in daily activities like driving. The study focuses on people who lost their Class 1 Norwegian driving license within the last five years because of visual impairments after stroke. Participants will engage in individual home-based vision training exercises lasting 20 minutes daily for 8 weeks. These exercises include online and manual eye movement tasks, scanning, and visual search activities. The study has two groups: one starts training immediately (fast track), and the other begins after an 8-week delay (delayed start). Both groups receive weekly phone calls to support motivation and track progress. During the study, participants will be evaluated at multiple points: baseline, after 8 weeks of training, and at long-term follow-ups up to 28 weeks. Visual field measurements using saccadic reaction time will be taken twice an hour apart at several visits. Participants will keep a training diary and be contacted weekly by phone. Researchers will assess changes in functional vision and compensatory strategies related to traffic situations, aiming to identify markers that predict rehabilitation benefits.

Age: 20Years - 85YearsAll GendersPhase Not Applicable
2 locations