Sarpsborg

Amyotrophic lateral sclerosis ALS is a severe and fast-progressing nervous system disease with a typical survival time of about 2.5 years after diagnosis. Currently, Riluzole is the only treatment available, and the care for advanced ALS is very costly. Research suggests that increasing access to Nicotinamide Adenine Dinucleotide NAD and activating enzymes called sirtuins might slow disease progression. Nicotinamide riboside NR increases NAD, and Pterostilbene stimulates sirtuins. The study aims to evaluate whether a combination of NR and Pterostilbene can slow neurodegeneration, delay disease progression, improve survival, and enhance quality of life in ALS patients. This extension study follows patients who completed the initial NO-ALS trial, where all participants receive the combination supplement EH301 Nicotinamide Riboside and Pterostilbene. It is an open-label study offering compassionate use and monitoring adverse events. The study will assess if this combination can reduce motor symptom progression, preserve lung function, and increase survival over a one-year follow-up. Participants who completed the original NO-ALS trial will be followed for one year with regular assessments. Researchers will monitor adverse events throughout this period and measure disease progression using the ALS Functional Rating Scale Revised and changes in vital lung capacity. The study aims to provide long-term safety and efficacy data while allowing continued access to the supplement. Total participation duration is one year from enrollment in the extension study.

Researchers are evaluating a complex intervention to improve advance care planning ACP for severely ill elderly people living at home who are acutely admitted to hospital. This cluster randomized study involves twelve Norwegian geriatric hospital units and aims to enhance patient and family involvement in treatment decisions, improve quality of life, and support ethical and legal care planning. The project also explores barriers and facilitators to implementing ACP at clinical, health service, and governmental levels, including economic analyses. The intervention group receives a comprehensive support program that includes leadership commitment, training for staff, implementation teams, ACP coordinators, and practical tools such as guidelines and documentation templates. The control group receives no implementation support during the trial but will be offered the program afterward. The study period includes baseline, 9-month, and 18-month assessments for the intervention group and baseline and 18-month assessments for the control group. Participants will undergo questionnaires and interviews with patients, relatives, clinicians, and staff at multiple time points before, during, and after the implementation. Data from patient records and national health registers will be collected to assess the fidelity of ACP implementation, clinical outcomes, communication quality, and cost-effectiveness. The trial runs until December 2026 and includes various measures to evaluate the impact of the support program on ACP delivery and related outcomes.

Researchers are evaluating whether D-serine, a co-agonist of the N-methyl-D-aspartate receptor NMDAR, can improve symptoms and slow progression in Parkinsons disease PD. This randomized, double-blind, placebo-controlled trial involves 100 participants diagnosed with PD within the past 5 years. The study aims to measure changes in clinical severity using the Movement Disorder Society Unified Parkinsons Disease Rating Scale MDS-UPDRS, along with dopaminergic brain activity and cognitive function. Participants will be randomly assigned to two groups that receive both D-serine and placebo during different study periods over 58 weeks. D-serine dosing starts with 2 capsules of 500 mg twice daily in the first week and increases to 4 capsules twice daily thereafter, while placebo capsules are given similarly. After the intervention phase, a 12-week washout period will follow where the study drug is stopped, with a final visit 12 weeks after discontinuation. During the study, participants will undergo clinical evaluations including rating scales and questionnaires, cognitive testing, blood sampling, and dopamine transporter imaging via SPECT scans. Researchers will closely monitor motor and non-motor symptoms, brain dopamine function, and cognitive changes. The trial includes a screening and treatment optimization phase before randomization to ensure stable Parkinsons treatment. This study may provide important insights into D-serines potential effects on Parkinsons disease progression.

Amyotrophic lateral sclerosis ALS is a severe and rapidly progressing nervous system disease with an average survival of two to three years after diagnosis. Patients experience significant physical and psychological challenges, and apart from the drug Riluzole, effective treatments are lacking. This study aims to understand how life-sustaining ventilation support, either non-invasive or with tracheostomy, impacts the quality of life of ALS patients, their partners, and children, addressing a difficult ethical issue in ALS care. Participants are divided into two groups those who choose life-prolonging treatment with long-term mechanical ventilation support and those who decline such treatment. The study involves a longitudinal questionnaire approach conducted in Norway, measuring overall, health-related, and disease-specific quality of life over time. Assessments occur at inclusion and then every three months up to 21 months. Throughout the study, ALS patients, their partners, and children complete various quality of life questionnaires, including the Quality of Life Scale, EQ-5D-5L, ALS-specific scales, and caregiver burden surveys. Researchers monitor changes in these assessments to understand the effects of ventilation support. The study is sponsored by Haukeland University Hospital and includes participants aged 8 years and older, with data collection planned until 2032.

Researchers are evaluating clinical and radiological factors that may predict outcomes after surgery for hallux valgus HV, a common adult forefoot deformity. The study focuses on understanding the deformity in three dimensions using new radiological parameters, aiming to improve insight into why current surgical techniques often have variable results and high recurrence rates. This prospective observational study seeks to address the lack of clear treatment guidelines and consensus for surgical intervention in HV. Participants accepted for corrective surgery for hallux valgus at Ostfold Hospital Trust will be invited to join the study. The study compares preoperative clinical data, patient-reported outcome measures PROMs, and radiological parameters with postoperative assessments. Participants will be evaluated using the Manchester-Oxford Foot Questionnaire and radiological imaging before surgery and at 6 weeks, 12 weeks, and 52 weeks after surgery. During the study, participants will complete questionnaires and undergo radiological exams at specified intervals to track changes in foot function and deformity correction. The main outcome is comparing pre- and postoperative MOXFQ scores to assess patient-reported outcomes. Secondary measures include comparing traditional and newer rotational radiological parameters with PROMs. The study aims to include 200-250 participants and will monitor them for up to one year post-surgery.

Researchers are evaluating the outcomes of operative versus conservative treatment in adults with mild to moderate hallux valgus deformity. This randomized controlled trial aims to determine whether surgery is superior to conservative care for this condition. The study focuses on patient-reported outcomes to assess the effectiveness of each treatment approach over a two-year period. Participants will be randomly assigned to one of two groups the operative group receiving traditional surgery for hallux valgus, and the conservative group using orthopedic aids and wide shoes as non-surgical treatment. Both groups will be monitored and evaluated at 6 months, 1 year, and 2 years after starting treatment. The study also looks at radiological changes including correction and progression of the deformity. During the trial, participants will complete patient-reported outcome measures such as the Manchester-Oxford Foot Questionnaire MOxFQ, the Visual Analog Scale VAS, and the Likert scale to assess clinical results. The researchers will use these tools to compare the effectiveness of the treatments over the two-year follow-up. Safety and progress will be regularly assessed, and a total of 120 participants will take part in this study sponsored by Ostfold Hospital Trust.

Researchers are evaluating Izalontamab Brengitecan compared to platinum-based chemotherapy for patients with metastatic urothelial cancer that has progressed after immunotherapy. This Phase 23 randomized trial aims to find the best dose and assess progression-free survival and overall survival over up to five years. Participants must have confirmed advanced urothelial carcinoma and have experience with Anti-PD-L1 therapy. Participants will be assigned to receive either Izalontamab Brengitecan or platinum-based chemotherapy such as Cisplatin, Gemcitabine, or Carboplatin at specified doses on defined days. The study includes several arms and evaluates treatment effects in parallel groups. The Phase 2 portion focuses on determining the recommended Phase 3 dose, while Phase 3 assesses efficacy outcomes over several years. Throughout the trial, participants will undergo regular assessments including tumor measurement by RECIST v1.1, performance status evaluations, antibody-drug conjugate concentrations, and quality of life measurements. Outcome measures include progression-free survival, overall survival, objective response, duration of response, and time to response. The study involves long-term follow-up lasting up to five years to monitor treatment effects and safety.

Researchers are evaluating whether adding a statin medication called rosuvastatin to the usual blood thinner treatment can reduce the risk of new blood clots in patients diagnosed with deep vein thrombosis or pulmonary embolism. This study focuses on patients with symptomatic major venous thromboembolism and aims to see if rosuvastatin decreases recurrent clotting and vein damage compared to a placebo. The study is a Phase 3 randomized controlled trial designed to explore potential benefits beyond standard anticoagulant therapy. Participants will be randomly assigned to one of two groups one group will take a daily 20 mg tablet of rosuvastatin, while the other will receive a daily placebo tablet that looks like rosuvastatin but contains no active medication. All participants will continue to receive their usual blood thinner treatment alongside the study medication or placebo. The study treatments will be taken by mouth for the entire duration of participation, which can last up to 60 months. During the study, participants will undergo regular assessments to monitor for new or recurrent venous thromboembolism events, bleeding events, and vein health using the Villalta scale. Researchers will also track arterial vascular events and overall survival during follow-up. The study involves long-term monitoring up to five years to evaluate safety and effectiveness. Participants will be monitored closely to ensure adherence and safety throughout the study period.

Researchers are evaluating the drug opevesostat in a phase 3, randomized, open-label study for men with metastatic castration-resistant prostate cancer mCRPC who have previously been treated with next-generation hormonal agents and taxane-based chemotherapy. The study aims to compare overall survival between participants receiving opevesostat and those receiving alternative treatments, including abiraterone acetate or enzalutamide. The research focuses on participants with specific androgen receptor mutations to determine if opevesostat provides better outcomes. Participants are assigned to one of two groups one group receives opevesostat 5 mg orally twice daily along with dexamethasone and fludrocortisone acetate daily, with hydrocortisone available as rescue medication. The other group receives either abiraterone acetate 1000 mg daily plus prednisone 5 mg twice daily or enzalutamide 160 mg daily. Treatments continue until disease progression, with prior prednisone use replaced by hydrocortisone in later protocol versions. During the study, participants undergo regular assessments including scans and laboratory tests to monitor prostate cancer progression and treatment effects. Researchers measure overall survival and several secondary outcomes such as progression-free survival, response duration, pain progression, and adverse events for up to approximately 54 months. The study also tracks safety and treatment discontinuation, with ongoing evaluations throughout the treatment period and follow-up.

Researchers are evaluating a new diagnostic approach for patients suspected of having deep vein thrombosis DVT in the lower limbs. The study aims to compare a machine learning-based algorithm combined with point-of-care POC D-dimer testing to the standard use of laboratory D-dimer tests and compression ultrasound. The main goal is to determine if this new strategy can exclude DVT in more patients than the current clinical assessment methods alone. All participants will receive the usual diagnostic care including physician examination, laboratory D-dimer testing, and ultrasound by a radiologist if the D-dimer test is positive. In addition, POC D-dimer testing and POC ultrasound performed by emergency department physicians will be conducted, along with blood sampling for biobanking and photographs of the lower limbs. The machine learning model will be tested against these results to assess its accuracy and whether it could potentially reduce the need for ultrasound. Participants will be monitored from enrollment through a 90-day primary assessment period. Researchers will evaluate the safety of the new diagnostic approach, the agreement between POC and laboratory tests, and compare the timing and efficiency of the new strategy versus standard care. Ultrasound results performed by emergency physicians will also be compared to those by radiologists. The study involves no changes to patient treatment based on the additional tests, and participants will be followed to assess safety and outcomes over the study period.