Inflammatory Reaction

Researchers are studying the use of the imaging agent 68Ga Ga-FAPI in PET/CT scans to explore its potential in diagnosing and monitoring various chronic inflammatory and fibrotic diseases. This pilot study involves 13 different clinical conditions such as rheumatoid arthritis, liver fibrosis, systemic lupus, and others. The goal is to determine if this new imaging method can improve disease evaluation and support further clinical development in these areas. The study adds a 68Ga Ga-FAPI PET/CT scan to usual routine care. Depending on the condition and treatment plan, patients may have this scan once at the start or multiple times over 3 to 6 months if their therapy is intensified. This imaging agent targets the fibroblast activation protein (FAP), which is involved in tissue remodeling and fibrosis, helping to highlight disease activity in affected tissues. Participants will undergo the PET/CT scans along with routine clinical evaluations and may be followed up at baseline, 3 months, and 6 months. Researchers will measure PET uptake intensity and correlate imaging results with pathology findings, biomarkers, functional parameters, and imaging characteristics over time. The study aims to assess the usefulness of 68Ga Ga-FAPI PET/CT in improving diagnosis and monitoring of these chronic diseases while participants continue their usual care.

Researchers are investigating how the medicine Filgotinib works to relieve pain in patients with moderate to severe active rheumatoid arthritis (RA). This study focuses on understanding two main factors influencing pain relief: brain pathways linked to central nervous system sensitization seen in fibromyalgia, and the inflammation surrounding joints and related immune signals. The study aims to clarify why Filgotinib may provide faster pain relief compared to other treatments by examining these mechanisms. Participants prescribed Filgotinib will be observed using advanced 7 Tesla MRI brain imaging to measure changes in brain connectivity and glutamate levels associated with pain processing. The study will assess Filgotinib's impact on both central nervous system pain pathways and peripheral inflammation over periods of up to 12 weeks. This observational test-retest design does not involve altering prescribed treatments but focuses on detailed imaging and biological assessments. During the study, participants will undergo brain MRIs and evaluations of joint inflammation through ultrasound and blood tests measuring cytokines and chemokines. They will also complete questionnaires on pain, fatigue, anxiety, sleep, and cognitive function. Researchers will monitor changes in these measures at intervals up to 12 weeks to understand how Filgotinib affects pain and related symptoms. Total participation time aligns with the 12-week observation period.

Researchers are evaluating Siltuximab in a Phase II clinical trial for patients with multiple myeloma who develop cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) after CAR-T cell therapy. This study aims to assess the resolution of these side effects that can occur following CAR-T treatment in this patient group. Participants who have persistent grade 1 or higher CRS or ICANS after CAR-T therapy will receive an immediate dose of Siltuximab at 11 mg/kg. If symptoms continue after 12 hours, a repeat dose of Siltuximab and corticosteroids may be given. If symptoms remain unresolved or worsen, rescue treatment with tocilizumab, corticosteroids, or other medications will be provided as needed. During the study, participants will be monitored to measure the rate of complete CRS resolution within 14 days and ICANS resolution within 28 days. Researchers will also assess safety and response to treatment. The total duration and detailed follow-up plans are not specified, but assessments will include symptom monitoring after treatment interventions.

Researchers are studying the human microbiome, which consists of bacteria and other microorganisms living on and inside the body, to understand how it affects health and disease. This observational study aims to build a repository of microbiome samples that can be used for future research. The study focuses on collecting biological specimens to improve testing methods and identify targets for new clinical trials related to microbiome-associated diseases. Participants of all ages, including healthy volunteers and those with various health conditions, are invited to provide samples such as stool, urine, saliva, vaginal fluid, breast milk, and cells from areas like the cheek, nose, mouth, skin, rectum, and vagina. Some samples can be collected at home using swabs, while blood samples may be drawn at a clinic or collected by finger or heel prick for young children. Intestinal and skin tissue samples may also be collected if participants undergo related medical procedures. During the study, participants will complete questionnaires about their medical history and diet. Researchers will collect and store various biological specimens to analyze the host microbiome response. These samples will help validate assays, optimize collection and processing techniques, and serve as controls for other studies. The study will continue until 2032, with ongoing monitoring of sample collection and analysis to support future microbiome research.

Researchers are studying whether ziltivekimab can help people living with heart failure and inflammation. The trial focuses on participants with heart failure who have mild to preserved heart function and systemic inflammation. This phase 3 study compares ziltivekimab, a new medicine not yet approved, to an inactive placebo to understand its effects on heart failure symptoms and physical function. Participants will receive either ziltivekimab or a matching placebo administered as a subcutaneous injection once a month for 12 months. Both groups will continue their standard heart failure care alongside the study treatment. The treatment assignment is randomized, meaning participants have an equal chance of receiving the active medicine or placebo, and the study uses a quadruple masking method to keep participants and researchers unaware of the treatment given. During the study, participants will be monitored for changes in heart failure symptoms using tools like the Kansas City Cardiomyopathy Questionnaire and a 6-minute walk test. Researchers will also assess inflammation markers, heart function measures, and quality of life at regular intervals over the 12 months. The study aims to observe the effects of ziltivekimab compared to placebo over this period, with safety and symptom improvement carefully tracked.

Researchers are exploring the immune cell makeup of bronchoalveolar lavage (BAL) fluid from cancer patients who develop pneumonitis caused by cancer treatments such as immune checkpoint blockade (ICI), radiotherapy (RT), or tyrosine kinase inhibitors (TKI). This observational study aims to identify detailed immune cell profiles at the single-cell level, which may lead to new diagnostic biomarkers and treatment targets. Additionally, the study investigates whether single-cell analysis of blood samples can reveal non-invasive biomarkers for immune checkpoint blockade toxicity. The study uses advanced single-cell RNA and TCR sequencing techniques on up to 5,000 cells per sample from BAL fluid and peripheral blood mononuclear cells (PBMC). Researchers analyze gene expression and cell surface proteins to classify immune cells and their states, including T cells, NK cells, B cells, and myeloid cells. The study groups include cancer patients experiencing pneumonitis induced by immune checkpoint blockade, radiotherapy, or targeted therapy (TKI), all receiving standard-of-care treatments. Participants provide BAL fluid samples during bronchoscopy and blood samples for analysis. The study monitors immune cell proportions and gene expression changes in these samples over approximately two years from inclusion. Researchers use bioinformatics tools to characterize immune profiles linked to different types of treatment-induced pneumonitis. The study does not involve any investigational treatments but focuses on detailed immune profiling to improve understanding and diagnosis of therapy-related lung toxicity.

Researchers are evaluating the safety and feasibility of infusing donor-derived virus-specific T-cells selected by the cytokine capture system (CCS) in patients who have undergone hematopoietic stem cell transplantation (HSCT) and have treatment-resistant viral infections. This study focuses on infections caused by cytomegalovirus (CMV), Epstein-Barr virus (EBV), and adenovirus. The CCS technology has been used successfully in previous clinical studies in Germany and the UK. The study is conducted as a single-center, open-label, single-arm trial where donor-derived interferon-gamma (IFN-B3) positive T-cells are generated and infused into HSCT recipients with viral infections. Six patients from the University Hospital of Basel will be included. If safety is confirmed, future studies will explore the treatment's efficacy and expand its use to other pathogens and patient groups, including solid organ transplant recipients. Participants will receive the selected IFN-B3 positive T-cell infusions and be closely monitored. Researchers will assess the level of enriched IFN-B3 positive T-cells within 7 days and evaluate treatment efficacy at the same timepoint. Safety and viral response will be regularly checked during the study. The trial started in December 2014 and is expected to continue until December 2026.

Researchers are monitoring the safety of the medicine Rinvoq14 (upadacitinib), which is used to treat several inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease. This observational Phase 4 study is led by the University of Porto and conducted in hospital settings to gather real-world data on adverse effects after the medicine was approved and placed under additional monitoring by the European Medicines Agency. The study observes patients who have been prescribed Rinvoq14, tracking their experiences without altering their treatment. It includes both prospective and retrospective monitoring, with contacts scheduled at the start of treatment and at multiple points over three months. Researchers focus on identifying serious adverse events such as cancers, cardiovascular problems, infections, liver injuries, and bone fractures. They also assess how well patients follow safety recommendations issued for the medicine's use. Participants will be contacted at baseline, 2 weeks, 1 month, 2 months, and 3 months after starting Rinvoq14 to report any adverse events and to check compliance with safety measures. The study collects detailed patient information through questionnaires administered by telephone. This ongoing monitoring aims to better understand the risks and safety profile of Rinvoq14 in real-world use, with all data collected in the Porto district hospitals from 2024 onwards.

This research investigates whether consuming apple cider vinegar affects post-meal oxidative stress in adults with obesity. The study focuses on changes in plasma malondialdehyde (MDA), a marker of lipid peroxidation linked to oxidative damage and cardiometabolic risk. Researchers aim to provide evidence on the acute effects of apple cider vinegar on postprandial lipid peroxidation, which has not been extensively studied before. Participants will be randomly assigned to one of two groups: an intervention group that receives a single dose of 15 mL apple cider vinegar diluted in 250 mL water before a standardized meal, and a control group that receives only 250 mL water. After beverage consumption, participants eat a standardized meal. The study includes a one-week run-in period with diet education and lifestyle restrictions to reduce factors affecting oxidative stress. During the study visit, participants fast overnight and provide blood samples before and three hours after the meal to measure plasma MDA levels. The primary outcome is the change in postprandial plasma MDA concentration. Compliance with meal and beverage intake is monitored, and non-compliant participants will be excluded from per-protocol analysis. The total study duration includes pre-intervention education and a single intervention visit.

Researchers are evaluating an intervention aimed at reducing weight bias internalization (WBI) and weight stigma among adolescents aged 13 to 17 years who have a body mass index (BMI) at or above the 95th percentile for their age and sex. The study will examine whether addressing WBI alongside a behavioral weight management program can improve physical and mental health outcomes, including biological stress markers and eating behaviors. This randomized pilot trial compares this combined intervention to a control group receiving general health information plus weight management. Participants will be randomly assigned to one of two groups. The first group will receive a 4-week program focused on weight stigma and WBI, followed by a 16-week behavioral weight management intervention that integrates WBI content. The second group will receive 4 weeks of health education on topics unrelated to weight, such as smoking cessation and skin cancer prevention, followed by the same 16-week behavioral weight management program without WBI content. Weekly 75-minute sessions are led by behavioral experts, and caregivers participate in four sessions with their teens. During the 20-week study, participants will attend weekly group sessions and undergo assessments at the start, after 4 weeks, and at the end of the program (20 weeks). These assessments include questionnaires measuring WBI, weight-related teasing, and eating behaviors, as well as biological tests for stress and inflammation markers like cortisol, CRP, and IL-6. Researchers will also track attendance, retention, and intervention acceptability. The study aims to gather data for larger future trials focused on adolescent weight management.