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Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are evaluating the efficacy and safety of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced Stage III, unresectable non-small cell lung cancer NSCLC whose disease has not progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

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.

This research investigates the use of a carbohydrate-rich diet as a treatment for acute intermittent porphyria AIP, a genetic condition causing buildup of porphobilinogen leading to severe symptoms like abdominal pain, paralysis, fatigue, inflammation, and increased risk of kidney and liver problems. The study aims to understand how different carbohydrate levels impact tissue and serum glucose, insulin, inflammatory markers, amino acids, gut bacteria, mitochondrial activity, and genetic markers in AIP patients. Researchers will explore how these factors relate to AIP symptoms and overall health. Participants will follow two diet plans in a randomized crossover design one with 60-65% of energy from carbohydrates and another with 40-45% carbohydrates, each lasting four weeks with a four-week washout period between. Half of the participants start with the higher carbohydrate diet and then switch to the lower, while the other half do the reverse. Nutritional plans meet recommended guidelines to maintain stable weight. The study is conducted by multiple institutions, including Nordland Hospital and the University of Oslo, with expert teams developing diets and analyzing results. During the study, participants will have various assessments including urine tests for porphobilinogen, blood and tissue glucose levels, insulin, cytokines, amino acids, gut microbiota, physical activity, body composition, blood pressure, and mitochondrial function. These measures are taken before and after each diet period, with continuous glucose monitoring and physical activity tracking using devices. Researchers will also analyze genetic markers linked to energy metabolism. The total participation includes two four-week diet periods separated by a washout, with detailed monitoring throughout.

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.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

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.

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 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.