Sarpsborg

Amyotrophic lateral sclerosis (ALS) is a serious, fast-progressing nervous system disease with an average survival of 2.5 years after diagnosis. Currently, effective treatments are limited to Riluzole. Research suggests that increasing cell access to Nicotinamide Adenine Dinucleotide (NAD) and stimulating enzymes called sirtuins may slow disease progression. This study aims to evaluate whether a combination of Nicotinamide Riboside (NR) and Pterostilbene, called EH301, can slow neurodegeneration, delay disease progression, improve survival, and enhance quality of life in ALS patients. The NO-ALS extension study follows patients who completed the original NO-ALS trial. All participants receive the active treatment EH301, which combines Nicotinamide Riboside and Pterostilbene, as an open-label extension. This study provides patients the option for compassionate use of the supplement while assessing its effects on motor symptoms, lung function, and survival. Participants will be monitored for adverse events throughout the study, which lasts up to 1 year. Researchers will track safety, progression of motor symptoms, changes in vital capacity, and overall survival. This extension allows long-term observation of EH301's impact on ALS progression and patient well-being.

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.

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.

Amyotrophic lateral sclerosis (ALS) is a serious and rapidly progressing nervous system disease with an average survival of two to three years after diagnosis. Patients experience significant physical and psychological suffering, and apart from the drug Riluzole, no effective treatment exists. The care for advanced ALS is costly, and one major challenge is deciding whether to extend ventilation support as the disease progresses, which can maintain quality of life but also imposes a heavy caregiving burden on family and healthcare workers. This study evaluates the impact of long-term mechanical ventilation support on the quality of life of ALS patients and their families. Patients either choose life-prolonging treatment with long-term mechanical ventilation support or decline it. The study involves using questionnaires to measure overall quality of life, health-related quality of life, and disease-specific quality of life before and after starting ventilation support. Participants include ALS patients, their partners, and children aged 8 and older. The study collects data at inclusion and at 3, 9, 15, and 21 months after inclusion using the Quality of Life Scale. Researchers aim to provide valuable information to help patients and clinicians make shared decisions about ventilation support by understanding its effects on patients and their families over time.

Researchers are investigating hallux valgus, a common deformity of the adult forefoot, to identify clinical and radiological factors that can predict the outcomes of corrective surgery. The study focuses on the challenges in treating hallux valgus, which is often viewed as a complex deformity involving multiple planes, and the lack of clear guidelines for surgical treatment. Despite many surgical techniques available, outcomes remain inconsistent, with high recurrence rates and frequent treatment failures. Participants will undergo hallux valgus corrective surgery, including procedures like chevron osteotomy and the Lapidus procedure. The study compares preoperative clinical features such as medical history, age, body mass index, and occupational status, along with patient-reported outcome measures and radiological parameters, to postoperative results. Both two-dimensional and three-dimensional radiological assessments will be used to evaluate the deformity and surgical correction. During the study, participants will be assessed before surgery and followed up at 6 weeks, 12 weeks, and 52 weeks after surgery. Researchers will collect data using clinical evaluations, patient questionnaires including the Manchester-Oxford Foot Questionnaire, and imaging studies to compare pre- and postoperative outcomes. The goal is to better understand which factors influence surgical success and patient satisfaction over the course of one year following the procedure.

Researchers are evaluating whether surgery is more effective than conservative treatment for people with mild to moderate hallux valgus deformity. This randomized controlled trial aims to compare these two approaches by measuring patient-reported outcomes, focusing on pain and foot function. The study includes adults aged 18 to 80 years who have painful hallux valgus with specific deformity angles. Participants will be randomly assigned to one of two groups: the operative group, receiving traditional surgery for the deformity, or the conservative group, receiving orthopedic aids such as wide shoes. Each group will include 60 participants who will be followed for a period of two years. Evaluations will occur at 6 months, 1 year, and 2 years after treatment begins. During the study, participants will complete patient-reported outcome measures, including the Manchester-Oxford Foot Questionnaire (MOxFQ) and visual scales to assess pain and function. Researchers will also examine radiological changes to evaluate correction or progression of the deformity. The main outcome is the clinical result measured by MOxFQ after two years, with additional monitoring for safety and treatment effects over the full study period.

Researchers are studying a treatment called Izalontamab Brengitecan compared to standard platinum-based chemotherapy for people with advanced urothelial cancer that has worsened after immunotherapy. This trial includes both Phase 2 and Phase 3 stages and focuses on patients whose disease progressed despite prior immune-based treatments. The goal is to evaluate how well these treatments control the cancer and how safe they are over time. Participants in this study will receive either Izalontamab Brengitecan or platinum-based chemotherapy drugs such as cisplatin, gemcitabine, or carboplatin. Each drug is given at specified doses on certain days, following the study plan. The Phase 2 portion aims to determine the best dose for further testing over about three months, while the Phase 3 portion will compare how long patients live without their cancer worsening and overall survival up to five years. Throughout the study, participants will have regular assessments to measure tumor size and monitor health status using standardized criteria and performance scales. Researchers will track progression-free and overall survival as main outcomes. The total follow-up may extend up to five years to observe long-term effects and safety of the treatments.

Researchers are evaluating whether adding the cholesterol-lowering medication rosuvastatin to standard blood thinner treatment can reduce the risk of new blood clots in patients who have had deep vein thrombosis (DVT) or pulmonary embolism (PE). This phase 3 study also aims to see if rosuvastatin can lessen damage to veins and lower the chance of post thrombotic syndrome (PTS). While rosuvastatin is approved in Canada to lower cholesterol, its use for preventing blood clots is investigational and being studied here. Participants will receive usual blood thinner treatment plus either rosuvastatin or a placebo pill that looks like rosuvastatin but has no active ingredients. The study compares rates of recurrent major venous thromboembolism (VTE), including proximal DVT or segmental or larger PE, between the two groups. The study also monitors major bleeding events and uses the Villalta scale at the end to assess PTS incidence. During the study, patients are closely monitored for new blood clots and bleeding complications for up to 60 months. Researchers will assess vein health and collect data on recurrence of VTE and side effects. Participation involves regular follow-up visits and evaluations to track safety and effectiveness of adding rosuvastatin to standard care over the long term.

Researchers are investigating the effects of opevesostat compared to alternative treatments abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC). This phase 3, randomized, open-label study focuses on participants who have already been treated with next-generation hormonal agents and taxane-based chemotherapy. The study aims to assess overall survival (OS) in participants with and without androgen receptor ligand binding domain (AR LBD) mutations, hypothesizing that opevesostat may improve survival. Participants will receive either oral opevesostat or an alternative hormonal agent such as abiraterone acetate or enzalutamide. Additional supportive medications like hydrocortisone, fludrocortisone acetate, prednisone, or dexamethasone may be given orally or as needed. The study compares these treatments directly during the trial period. Throughout the study, participants will provide tumor tissue samples and undergo regular assessments including imaging scans, laboratory tests, and performance status evaluations. Researchers will monitor overall survival for up to approximately 54 months, differentiating outcomes based on AR LBD mutation status. Safety and treatment effects will be carefully tracked during this time to evaluate the benefits and risks of the treatments.

Researchers are evaluating a new diagnostic approach for patients suspected of having deep vein thrombosis (DVT) in the lower limbs. This study compares a machine learning-based prediction model combined with point-of-care (POC) D-dimer testing and POC compression ultrasound performed by emergency physicians against the standard clinical assessment that uses laboratory D-dimer tests and ultrasound by radiologists. The main goal is to determine if the new algorithm and POC D-dimer can exclude DVT in more patients than the current methods alone. All participants will undergo the usual diagnostic procedures for suspected DVT, including physician examination, laboratory D-dimer testing, and ultrasound by a radiologist if D-dimer is positive. Additionally, each participant will receive POC D-dimer testing and POC ultrasound performed by emergency physicians, along with blood samples taken for biobanking and photographs of the lower limbs. The machine learning model's predictions will be tested for accuracy and assessed to see if it could potentially reduce the need for ultrasound in some patients. These extra procedures will not affect the patients' diagnosis or treatment. Participants will be monitored from enrollment through a 90-day primary assessment period to evaluate the safety of the new diagnostic strategy. Researchers will track how well the combined approach performs in excluding DVT compared to the usual care. Patient involvement includes undergoing diagnostic tests, blood sampling, and photographic documentation. The study focuses on measuring the safety and effectiveness of the machine learning algorithm alongside POC tests in managing suspected DVT cases.