Forde

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 the use of specific molecular biomarkers to personalize treatment for patients with endometrial cancer. This study focuses mainly on biomarkers found promising in previous research and aims to improve surgical and medical treatment decisions. The trial has two parts one tests the use of biomarkers to guide lymphadenectomy during surgery, and the other assesses the biomarker stathmins potential to predict response to taxane chemotherapy in endometrial and ovarian cancer. The study includes an implementation phase where lymphadenectomy is performed based on hormone receptor status ER and PR to define patient risk and guide surgery. Patients considered low risk based on tumor grade and receptor status may avoid lymphadenectomy, while higher-risk patients undergo pelvic and para-aortic lymphadenectomy. In the second phase, patients receiving weekly taxane treatment have tissue biopsies and urine samples analyzed for stathmin levels before and during treatment. Imaging scans and blood tests are conducted regularly to monitor disease progression. Participants will receive routine clinical follow-up for five years, including quality of life questionnaires. Researchers will collect data on survival, disease recurrence, and quality of life over this period. For patients in the taxane treatment phase, urine and blood samples will be collected weekly, with imaging every eight treatment cycles. The studys main outcomes include the number of cancer recurrences after five years and the duration of treatment response in metastatic disease, along with correlations of stathmin levels in various samples.

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.

This research aims to explore the genetic causes related to the development of Amyotrophic Lateral Sclerosis ALS in Norway. The study focuses on individuals diagnosed with probable or definite ALS according to the El-Escorial criteria. Understanding genetic factors may help in better characterizing the disease and its risk factors over time. Participants diagnosed with ALS will be followed through the Norwegian health-care system. After giving informed consent, they will complete a brief questionnaire about their family history and provide a blood sample. These samples, along with clinical information and consent forms, are sent to the Department of Medical Genetics at Telemark Hospital Trust for ongoing genetic analysis throughout the recruitment period. Participants may choose to receive their genetic results as part of a diagnostic process. During the study, participants will be involved in providing blood samples and completing questionnaires. Researchers will analyze genetic data to identify gene frequency, new ALS genes, and genetic risk factors between 2020 and 2030. The study involves observation only, with no additional treatments. Participation includes genetic testing and data collection to better understand ALS genetics, with the study continuing until 2035.

Researchers are investigating whether a treat-to-target strategy that includes structured imaging assessments improves patient outcomes in psoriatic arthritis compared to a conventional treat-to-target approach. The study focuses on sustained remission, defined as very low disease activity at 16, 20, and 24 months. This two-arm, parallel-group study randomizes patients to either conventional clinical assessments or additional imaging assessments using ultrasound and MRI to guide treatment decisions. Participants receive treatment following European recommendations, with the conventional arm targeting disease activity based on clinical measures such as DAPSA remission, enthesitis, and psoriasis body surface area. The imaging-informed arm adds ultrasound assessments of joints, tendons, and entheses at every visit, plus MRI of the spine and sacroiliac joints at baseline and one year. Imaging results influence treatment progression, including advancing to biologic disease-modifying drugs if inflammation is detected. During the 24-month follow-up, patients undergo clinical and imaging assessments, including joint counts, enthesitis indices, and skin evaluations. Researchers measure disease activity, inflammation, health-related quality of life, and adverse events throughout the study. The primary outcome is sustained remission, while secondary outcomes include various disease activity scores and safety monitoring. The study aims to provide insights into the benefits of incorporating imaging in psoriatic arthritis management.

Researchers are evaluating the effectiveness of approved anti-cancer drugs used outside their usual indication for patients with advanced cancer who have specific molecular changes identified through diagnostic testing. This nationwide, phase 2 clinical trial in Norway uses a combined umbrella and basket design with a Simon two-stage model to study various drug and biomarker combinations across different cancer types. Biological samples will be collected at presentation, during treatment, and upon disease progression to better understand drug response and resistance through advanced genetic analyses, including whole genome sequencing. The study involves patients who have advanced cancers no longer benefiting from standard treatments and who have molecular profiles indicating potential benefit from one of the approved drugs in the trial. Participants will receive treatment with drugs such as atezolizumab, alectinib, and others, used beyond their usual indications based on biomarker profiles. Treatment plans are guided by a national molecular tumor board, and fresh tumor biopsies will be collected before treatment to support biomarker studies. New patient cohorts may be opened as needed based on molecular subgroups and drug availability. Participants will be monitored for tumor response, progression-free survival, overall survival, and treatment duration. Data on treatment toxicity will be collected, and all treatment and outcome information, along with molecular screening results, will be reported to the Cancer Registry of Norway. Long-term follow-up will also use national registries to track patient outcomes. Patients who are screened but not enrolled will be followed for 16 weeks to monitor survival and disease progression.

This trial investigates gastropexy as a method to reduce gastroesophageal reflux disease GERD symptoms in adults who are morbidly obese and scheduled for laparoscopic sleeve gastrectomy LSG. The study compares two groups to determine whether gastropexy decreases reflux symptoms and objective signs of reflux. LSG is widely used as a bariatric surgery, but it may increase GERD by allowing the stomach remnant to migrate upward into the chest, which this study aims to prevent by using gastropexy. Participants are randomly assigned to receive either sleeve gastrectomy with gastropexy, where the stomach remnant is sutured to the gastrocolic ligament, or sleeve gastrectomy without gastropexy. The study plans to enroll 550 patients. Follow-up visits to assess outcomes are scheduled at six weeks, one year, two years, and five years after surgery. During the study, researchers will monitor the number of participants using acid-reducing medication or those who require reoperations due to GERD over two years. Additional assessments include endoscopic examinations, patient-reported outcomes via questionnaires, and pH-metry tests to measure acid exposure. The study uses double-blind methods and randomization to fairly compare the two groups, with the goal of better understanding the impact of gastropexy on reflux after LSG.

Researchers are evaluating screen delivery as an alternative to traditional office delivery for cognitive therapy in youth aged 14 to 18 years with social anxiety disorder SAD. This study aims to compare the effectiveness, acceptability, and sustainability of these two delivery methods and identify factors that influence therapy outcomes. The study is a randomized controlled trial involving 200 youth and addresses important questions about therapy access, economic and climate benefits, and therapeutic alliance. Participants will receive cognitive therapy based on the CT-SAD-A manual, delivered either by video screen or in an office setting. Therapy consists of 14 weekly 90-minute sessions plus a booster session six months after treatment. Therapists involved have specialized training and participate in supervision, with sessions recorded and stored securely. The study also includes a feasibility phase with feedback from therapists, youth, and parents. During the trial, participants complete questionnaires weekly and attend interviews at multiple time points before treatment, after therapy, and at 6 months, 2 years, and 4 years post-treatment. Parents also provide information through interviews. Researchers monitor therapy adherence, therapeutic competence, and safety, including suicidality and mood symptoms. Overall participation spans several years, with data collected to assess therapy effectiveness and long-term outcomes.

Researchers are evaluating the long-term safety and effectiveness of biological disease modifying anti-rheumatic drugs DMARDs in people with inflammatory joint diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and other related conditions. This observational study aims to measure disease activity, quality of life, joint function, joint damage, and work productivity, as well as the cost-effectiveness and predictors of treatment outcomes. The study also focuses on ensuring systematic follow-up of patients treated with these therapies. The study involves regular visits starting at the beginning of a new biological DMARD or kinase inhibitor treatment, with follow-up visits at 3, 6, and 12 months, then every 12 months thereafter. Each visit includes clinical assessments, patient questionnaires, and laboratory tests including blood samples collected for biobank storage at baseline and 3 months. Serious adverse events are systematically recorded, with additional information collected through linkage to other registries. Participants will be involved in ongoing monitoring through clinical evaluations, patient-reported outcomes, and laboratory tests such as blood inflammatory markers. Various disease activity scores and questionnaires are used at multiple time points up to five years to track treatment effects and safety. The study is designed to provide long-term data on the use of biological DMARDs in real-world clinical practice with continued follow-up and safety monitoring.

Researchers are conducting an observational study to understand how new immunotherapies are used in treating multiple myeloma and related conditions in Norway. The study aims to fill knowledge gaps, provide evidence for future trials, and help develop guidelines for monitoring and managing side effects to improve patient survival and quality of life. This research focuses on patients with multiple myeloma, primary plasma cell leukemia, and AL amyloidosis. Participants are observed while receiving immunotherapies including Teclistamab, Elranatamab, Talquetamab, Idecabtagene vicleucel, and Ciltacabtagene Autoleucel as part of their routine care outside of clinical trials. The study monitors how these treatments are used in real-world settings, including dosing and administration. There is no assigned treatment group or placebo instead, the study collects data on treatments given during regular healthcare. Throughout the study, participants response to treatment, progression-free survival, time to next treatment, overall survival, and adverse events are tracked for up to ten years. Researchers collect data on infections, antibiotic resistance, airway viruses, and use of antimicrobial prophylaxis during therapy. This long-term monitoring aims to provide comprehensive safety and effectiveness information to guide future care and research.