Inflammatory Reaction

Researchers are exploring the potential use of the imaging agent 68Ga Ga-FAPI in PETCT scans for diagnosing and monitoring various chronic inflammatory and fibrotic diseases. This pilot study focuses on 13 different clinical conditions such as rheumatoid arthritis, liver fibrosis, and systemic lupus to assess whether this new radiotracer can improve disease evaluation compared to current methods. The study aims to gather initial data to guide further development and possible routine use of this imaging technique in these diseases. Participants receive a 68Ga Ga-FAPI PETCT scan in addition to their usual medical care. The imaging is performed either once at baseline or longitudinally at baseline and again at 3 and 6 months if their treatment is intensified at inclusion. This approach allows researchers to observe how the radiotracer behaves in different diseases and over time, helping to refine its clinical application. During the study, participants undergo PETCT scans to measure the intensity of the PET uptake and correlate these findings with pathology evaluations, biomarkers, functional parameters, and imaging characteristics at baseline, 3 months, and 6 months. This detailed assessment helps to understand the diagnostic value of 68Ga Ga-FAPI in chronic inflammatory and fibrotic conditions. The study runs until October 2028 and is conducted at a single center, with participants followed through these imaging and clinical evaluations.

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 Filgotinibs 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 mgkg. 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 includes bacteria and other microorganisms living on and inside the body, to understand its role in health and disease. This observational study aims to collect various microbiome samples to create a repository that will support future research. The samples will help validate tests, improve sample handling techniques, and identify targets for future clinical trials related to microbiome-associated diseases. Participants in this study may be asked to provide different types of biological samples including stool, urine, saliva, vaginal fluid, breast milk, and cells from areas like the cheek, nose, mouth, skin, rectum, or vagina. Some samples can be collected at home and mailed to researchers. Blood samples may be collected by needle or heelfinger prick for young children. Tissue samples from the intestine or skin may be collected if participants are undergoing endoscopy, colonoscopy, or biopsy for other reasons. During the study, participants will complete a questionnaire about their medical history and diet. Researchers will collect and store biological specimens for assay validation and research use. The study will assess the hosts microbiome response over time. Participants may be seen at the NIH clinic if over 3 years old. The study will continue until 2032, with ongoing sample collection and data gathering throughout the period.

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 treatments 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 evaluating whether breathing oxygen in a pressurized chamber after intense cycling exercise can help competitive male cyclists recover better and improve their performance the next day. The study focuses on healthy male road cyclists aged 18 to 40 who compete at the national level in Belgium. Despite widespread use of hyperbaric oxygen therapy in sports recovery, clear scientific evidence of its benefits after a single session of strenuous endurance exercise is lacking. Participants complete a fatiguing cycling session then are randomly assigned to one of four groups receiving different oxygen levels during recovery. Two groups breathe pure oxygen at increased pressures of 2.5 or 1.4 atmospheres absolute inside a hyperbaric chamber. Another group breathes pure oxygen at normal atmospheric pressure, and the fourth receives a sham treatment that mimics the chamber environment without extra oxygen. The study is double-blind, so neither participants nor assessors know who receives which treatment. During the study, researchers measure next-day endurance performance by assessing the decline in time to exhaustion relative to baseline. Blood samples and physiological data are also collected to understand recovery mechanisms. Participation involves one hour of oxygen exposure after exercise, and the study spans about 18 months to capture these effects. Safety and recovery responses are closely monitored throughout.

Researchers are exploring the use of adebrelimab combined with platinum-based chemotherapy as neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma ESCC. This phase II, single-arm study aims to evaluate the pathological complete response pCR rate after surgery and assess the safety of this treatment approach. The study is motivated by the need for more effective and well-tolerated therapies, as current standard treatments have limitations including higher recurrence and surgical complexity. Participants will receive at least two cycles of neoadjuvant therapy every three weeks, consisting of intravenous adebrelimab at 20 mgkg on day 1, combined with chemotherapy drugs given on day 2. Chemotherapy includes either cisplatin or carboplatin along with liposomal paclitaxel or nab-paclitaxel. All patients undergo surgery following neoadjuvant treatment. The trial also plans to develop organoids from tumor and normal tissue for future research. During the study, patients will be monitored for pathological response, safety including treatment-related and immune-related adverse events, and quality of life. Secondary outcomes include major pathological response, objective response rate, tumor downstaging, surgery success, and perioperative complications. Exploratory endpoints include overall and relapse-free survival. The study involves detailed pathological evaluations at the end of 2 to 4 treatment cycles and aims for comprehensive assessment of treatment impact over the course of neoadjuvant therapy and surgery.

Researchers are studying the use of methylene blue MB as an additional treatment for patients who develop cytokine release syndrome CRS or immune effector cell-associated neurotoxicity syndrome ICANS after receiving CAR-T cell therapy or bispecific antibody treatments. This Phase I, single-arm clinical trial aims to assess the safety and potential benefits of MB in reducing these immune-related side effects while maintaining the cancer-fighting effects of the immune cells. Participants will receive intravenous infusions of methylene blue once daily for 3 to 5 consecutive days. The study uses a dose-escalation design with three groups receiving different doses 1 mgkg, 2 mgkg, or 3 mgkg, each infused over 20 minutes. Alongside MB treatment, patients may also receive standard supportive care such as tocilizumab, dexamethasone, ruxolitinib, or cetuximab if needed. During the trial, participants will be closely monitored for vital signs like temperature, blood pressure, and oxygen levels, as well as laboratory tests including inflammatory markers and neurotoxicity assessments. The main measurements focus on any serious side effects related to MB, its impact on immune cell expansion and therapy effectiveness, and the frequency and duration of CRS and ICANS symptoms. The study lasts up to 35 days after starting MB treatment to observe safety and outcomes.

This research aims to evaluate a new advanced wireless skin sensor system designed to monitor vital signs in healthy newborn infants of at least 35 weeks gestational age. The study focuses on assessing the feasibility, safety, and accuracy of this wireless system compared to the standard wired monitoring during the first two hours after birth, especially during unsupervised parental care in the obstetrical center. The goal is to improve early detection and prevention of Sudden Unexpected Postnatal Collapse SUPC, a rare but serious condition affecting newborns shortly after delivery. Participants will have both the wireless monitoring system and the standard wired system placed on their chest and limb. For vaginal births, the wireless system is placed first, followed by the wired system after 15-20 minutes for C-section births, the order of placement is randomized. Both monitoring systems remain in place for two hours to continuously record vital signs such as heart rate, respiratory rate, oxygen saturation, and skin temperature. During the study, newborns vital signs will be recorded and compared between the two systems for up to two hours immediately after delivery. Researchers will evaluate the feasibility by checking for gaps in data and user satisfaction, assess safety through skin and pain scores, and measure accuracy using statistical comparisons. The study also includes monitoring the time between sensor placement and data display. Participation lasts only the initial two-hour period after birth, with monitoring done under real-world conditions in the obstetrical center.

This research investigates the effects of an Aescin-based herbal extract called Reparil compared with Ibuprofen in managing symptoms after surgical removal of impacted lower wisdom teeth. The study focuses on people aged 18 to 40 who undergo this common oral surgery, aiming to find out if the herbal treatment offers pain relief and reduces swelling and limited mouth opening with fewer side effects than traditional nonsteroidal anti-inflammatory drugs NSAIDs. Participants will be randomly assigned to receive either Reparil tablets containing 20 mg Aescin or 400 mg Ibuprofen tablets, each taken orally three times a day for five days after surgery. Both groups follow the same schedule, and a rescue pain medication is available if needed. Assessments will occur before surgery and on days 2 and 7 afterward to measure pain, facial swelling using 3D scanning, and mouth opening using a digital caliper. During the study, participants will have their pain levels, facial swelling, and jaw movement tracked at specific intervals. Researchers will record any adverse effects and analyze data to compare the treatments impacts. The total involvement includes the surgery and follow-up visits on days 2 and 7, helping to evaluate the herbal extract as a potential alternative to Ibuprofen for managing post-surgical symptoms.