Forde

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 studying the use of molecular biomarkers to personalize treatment for patients with endometrial cancer. This includes evaluating biomarkers identified in prior studies to improve surgical treatment decisions and chemotherapy response predictions. The trial is divided into two parts: first, testing biomarker-guided lymphadenectomy during surgery; second, assessing the biomarker stathmin to predict response to taxane chemotherapy in endometrial and ovarian cancer patients. In the first part, patients with low-risk tumors defined by hormone receptor status will avoid pelvic and para-aortic lymphadenectomy, while high-risk patients will undergo this surgical procedure. In the second part, patients receiving weekly taxane treatment will have tissue biopsies and urine samples collected to measure stathmin levels, with imaging performed every eight treatment cycles until disease progression. Stathmin levels are analyzed centrally to guide treatment decisions. Participants will be followed clinically for five years, with ongoing collection of survival and recurrence data. They will complete quality of life questionnaires during follow-up. For the chemotherapy group, urine and blood samples are collected weekly during treatment cycles and imaging is done periodically. The main outcomes include the number of cancer recurrences five years after diagnosis and the duration of treatment response in metastatic disease as related to stathmin levels.

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 evaluating whether proactive therapeutic drug monitoring (TDM) is better than standard care for maintaining steady disease control in adults with rheumatoid arthritis (RA) who are treated with a subcutaneous tumor necrosis factor inhibitor (adalimumab). This Phase 4 study aims to determine if adjusting drug doses based on regular blood tests for drug levels and anti-drug antibodies can prevent disease flare-ups more effectively than standard dosing without such monitoring. Participants will be randomly assigned to one of two groups. The TDM group will have their adalimumab doses adjusted following specific rules based on blood test results to keep drug levels within a therapeutic range. Dose intervals may be shortened, lengthened, or therapy switched depending on antibody levels and drug concentration. The standard care group will continue treatment without these blood test-based adjustments. The study lasts 18 months with visits at baseline, 4, 8, 12, and 18 months, along with digital visits at 2, 6, 10, 14, and 16 months, including blood sampling at each visit. Participants will have regular blood tests to measure drug levels and antibodies every two months. They will attend on-site and digital visits for assessments of disease control and safety. The primary outcome is sustained disease control without flare over the 18-month follow-up. Researchers will monitor adherence, safety, and treatment effectiveness throughout the study period to compare the two treatment approaches.

Researchers are investigating the genetic factors that may contribute to the development of Amyotrophic Lateral Sclerosis (ALS) in Norway. The study aims to better understand genetic causes relevant to ALS by analyzing gene frequencies, new ALS genes, and genetic risk factors from 2020 through 2030. Participants will provide written informed consent and complete a brief questionnaire about their family history. A blood sample will be collected for genetic analysis, which is carried out at the Department of Medical Genetics, Telemark Hospital Trust throughout the recruitment period. Participants may opt to receive their genetic results in a diagnostic setting. During the study, participants will be involved in providing clinical information, completing questionnaires, and submitting blood samples. Researchers will monitor genetic characteristics and analyze data related to gene frequency and new ALS genes over time. The study includes adults aged 16 to 100 years and involves continuous genetic analysis from 2020 to 2030.

Researchers are evaluating if a treat-to-target approach that includes structured imaging assessments leads to better long-term outcomes in patients with psoriatic arthritis compared to a conventional treat-to-target strategy. Psoriatic arthritis is a complex disease that can be hard to assess clinically, and imaging techniques like ultrasound and magnetic resonance imaging (MRI) can reveal inflammation not detected through clinical exams. This study specifically aims to see if adding these imaging assessments improves the chances of sustained remission, defined as very low disease activity at 16, 20, and 24 months. The study randomly assigns patients into two groups for a 24-month follow-up. One group receives conventional treat-to-target care based on clinical disease activity assessments alone. The other group follows an imaging informed treat-to-target strategy that includes ultrasound assessments of joints, tendons, and entheses at every visit and MRI scans of the spine and sacroiliac joints at the start and one year. If imaging shows signs of enthesitis or axial inflammation, patients in the imaging group move directly to biological disease modifying antirheumatic drug treatment. Ongoing inflammation detected by ultrasound indicates the treatment target has not been reached. Participants will be monitored regularly with clinical and imaging assessments to track disease activity, inflammation, quality of life, and any adverse events. Outcomes include sustained remission at 16, 20, and 24 months, as well as other disease activity measures and safety. The study follows current European treatment recommendations, and all patients are treated according to a defined algorithm. The total study duration for each participant is 24 months.

Researchers are investigating the effectiveness of approved anti-cancer drugs used outside their usual indications for patients with advanced cancer who have specific molecular changes identified through genetic testing. This nationwide, phase 2 study in Norway uses a combined umbrella and basket design to explore drug and biomarker combinations across different cancer types. Biological samples will be collected at diagnosis, during treatment, and if the disease progresses to better understand factors affecting drug response and resistance. Patients eligible for this study have advanced cancer that has been previously treated with standard therapies and have acceptable organ function and performance status. Treatment is guided by molecular testing results and recommendations from a national tumor board. Patients receive drugs matched to their tumor's molecular profile, with treatment eligibility confirmed before starting. New patient groups may be opened if no suitable cohort exists. The drug Atezolizumab is among those evaluated, administered according to protocol-specific criteria. Participants will be closely monitored for tumor response, survival, treatment duration, and side effects including serious toxicities. They will undergo molecular testing including whole genome sequencing from tumor biopsies and liquid biopsies. Data on treatment outcomes and molecular markers will be collected and reported to national cancer registries. Patients not enrolled in treatment cohorts will be followed for 16 weeks to track disease progression and survival, with long-term follow-up planned through national health databases.

This research investigates whether adding gastropexy, a surgical technique of suturing the gastric remnant to the gastrocolic ligament, can reduce gastroesophageal reflux disease (GERD) symptoms and objective signs in patients undergoing laparoscopic sleeve gastrectomy (LSG) for morbid obesity. LSG is a common weight-loss surgery that removes part of the stomach but can increase reflux, possibly due to the stomach moving into the chest area after surgery. The study aims to find out if preventing this movement with gastropexy can lower reflux rates. Participants in this trial will be randomly assigned to one of two groups: sleeve gastrectomy with gastropexy or sleeve gastrectomy without gastropexy. A total of 550 patients planned for primary LSG will be included. The study will monitor and compare reflux outcomes between the groups over several years, with follow-up visits scheduled at six weeks, one year, two years, and five years after surgery. During the study, researchers will assess reflux symptoms, use of acid-reducing medications, and any reoperations due to reflux over a two-year period. Patient-reported outcome questionnaires will be used to capture symptoms, and follow-up evaluations will help determine the effectiveness of gastropexy in preventing reflux after sleeve gastrectomy. Long-term monitoring will continue up to five years to observe lasting effects.

Researchers are evaluating screen delivery as an alternative to office delivery for cognitive therapy in youth aged 14 to 18 years with social anxiety disorder (SAD). The study aims to compare the effectiveness, acceptability, and sustainability of screen delivery against traditional office-based therapy. It also seeks to identify factors that influence therapy outcomes, including the credibility of the treatment and the therapeutic alliance between youth and therapists. The study involves a randomized controlled trial where 200 youth with SAD are assigned to either screen delivery or office delivery of cognitive therapy based on the CT-SAD-A manual. Participants attend 14 weekly therapy sessions, each lasting 90 minutes, with an additional booster session offered six months after treatment. Therapists deliver therapy either via video communication or in-person at clinics across four regional sites in Norway. Participants complete an initial screening questionnaire and a diagnostic interview online before starting therapy. During treatment, they fill out weekly questionnaires, and researchers conduct interviews and assessments at the end of therapy, as well as at 6 months, 2 years, and 4 years post-treatment. Parents are also interviewed and informed. Outcomes are measured using scales for social anxiety symptoms, and therapy sessions are monitored for adherence and competence. Safety monitoring includes reports of anxiety, depression, and suicidality, with procedures in place for any signs of deterioration.

Researchers are studying the long-term safety and effectiveness of biological disease modifying anti-rheumatic drugs (DMARDs) and kinase inhibitors in treating inflammatory joint diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and other related conditions. This observational study aims to understand how these treatments work in real clinical practice by measuring disease activity, quality of life, joint function, and joint damage. Additional goals include assessing cost-effectiveness, predicting treatment outcomes and side effects, evaluating work participation impacts, and improving follow-up care for patients. The study builds on previous research conducted in Norwegian rheumatology departments from 2000 to 2012 and involves structured follow-up visits starting at treatment initiation and continuing at 3, 6, and 12 months, then yearly thereafter. During each visit, clinical assessments, patient questionnaires, and blood tests are performed to monitor disease and treatment effects. Serious adverse events will be systematically recorded, and other side effects may be tracked through linkage to other health registries. Participants are closely monitored through repeated clinical evaluations, patient-reported outcomes, and laboratory measurements, including blood samples stored in a biobank. The study focuses on long-term data collection to better understand treatment safety and effectiveness in everyday settings. Patients are expected to attend regular visits over the course of their biological DMARD or kinase inhibitor therapy, allowing researchers to gather comprehensive information on health status, treatment response, and adverse events.