Potsdam

Researchers are evaluating the use of belimumab, in addition to standard therapy, for adults with interstitial lung disease ILD linked to connective tissue diseases CTDs such as rheumatoid arthritis and systemic lupus erythematosus. ILD causes lung inflammation and stiffness, leading to symptoms like shortness of breath and fatigue, and is a leading cause of death in people with these conditions. The study aims to see if belimumab can stabilize or improve lung function and symptoms while maintaining an acceptable safety profile. Participants will be randomly assigned to receive either belimumab or a placebo, both alongside their usual standard therapy. Belimumab is administered subcutaneously, and the study is designed as a phase 3, double-blind, placebo-controlled trial. The treatment period lasts 52 weeks, during which lung function and symptoms will be closely monitored. Participants will have assessments including lung function tests measuring forced vital capacity, symptom questionnaires, and imaging scans at the start and after 52 weeks. Researchers will also track safety by monitoring adverse events and hospitalizations related to respiratory issues. The overall study duration includes these evaluations up to 52 weeks to understand the treatments impact on lung disease progression and patient well-being.

Researchers are evaluating the efficacy and safety of belimumab compared to a placebo, both given alongside standard therapy, for adults with systemic sclerosis associated interstitial lung disease SSc-ILD. The study aims to assess how belimumab affects lung function, skin thickening, and symptoms like fatigue that influence quality of life in these patients. This is a Phase 23 randomized, double-blind, placebo-controlled trial sponsored by GlaxoSmithKline. Participants will be randomly assigned to receive either belimumab or a placebo, both administered subcutaneously along with standard therapy. The treatment period lasts 52 weeks, during which the effects on lung function and skin symptoms will be closely monitored. The study involves two groups one receiving belimumab plus standard care and the other receiving placebo plus standard care. During the study, participants will undergo assessments including lung function tests such as Forced Vital Capacity FVC, skin thickness scoring, fatigue evaluations, and quality of life questionnaires at baseline and Week 52. Researchers will also track any adverse events and serious side effects. The main outcome measured is the change in lung function after 52 weeks. Participants will be monitored regularly throughout the 52-week treatment period to evaluate treatment effects and safety.

Researchers are studying the Caris Biorepository, a project designed to collect and store high-quality biological specimens and related clinical data to support research aimed at advancing precision medicine and improving patient care. This observational study focuses on gathering samples and information from various sources, including healthy individuals and cancer patients, to help understand disease treatments and clinical outcomes. The biorepository includes samples from different donor groups, such as those with no disease, treatment-nave patients with new solid tumors, individuals at higher risk for cancer, patients with advanced cancer, and those with a history of cancer but no active disease. The project aims to maintain molecular integrity and clinical relevance of these specimens while providing access to researchers and collaborators for drug development, clinical trials, and healthcare policy enhancements. Participants provide informed consent and contribute biological samples and clinical data that are securely stored and shared for research purposes. The study measures include ensuring specimen quality and relevance over 35 years and facilitating specimen release for testing. Laboratory testing will be conducted throughout the study duration. The project supports long-term research collaboration and aims to impact patient outcomes and treatment practices over time.

Rheumatoid arthritis RA is a chronic autoimmune disease where the immune system attacks joint tissue, causing pain, swelling, and stiffness. This condition affects about 1.5 million people in the US and can lead to serious joint damage if untreated. Access to specialized rheumatology care is limited, especially in rural areas like northern New York, making it difficult for many patients to receive proper treatment. This trial evaluates whether trained primary care providers PCPs can manage stable RA patients as effectively as rheumatologists, potentially improving care access in underserved regions. In this randomized controlled trial, patients with stable RA will be assigned to either continue care with their usual rheumatologist or receive care from a PCP who has completed a structured RA training program. Nine PCPs underwent training including lectures, case studies, and exams, with ongoing monthly case reviews with rheumatology specialists. The study will enroll up to 100 participants and follow them for one year, comparing the two care models. The intervention group receives RA management from trained PCPs, while the control group continues usual care in a rheumatology clinic. Participants will attend visits at screeningbaseline, 6 weeks, 12 weeks, 26 weeks, 40 weeks, and 52 weeks. Assessments include standard RA activity measures like MDHAQ, joint counts, disease activity scores DAS28, CDAI, SDAI, glucocorticoid exposure, patient-reported outcomes, and medical records review. The main outcome is change in DAS-28 at 6 and 12 months. This study will monitor patient status and safety throughout the year to evaluate if PCP-led care can maintain disease control and improve access for rural RA patients.

Postural instability caused by vestibular dysfunction can affect daily activities. Researchers are evaluating a new training method called concurrent headshake and weight shift training Concurrent HS-WST using virtual reality to improve balance and vestibular function in healthy young adults. This approach aims to engage sensory reweighting and enhance vestibular reflexes more effectively than traditional methods. The study is conducted by Clarkson University and focuses on healthy adults aged 18 to 35 years. Participants will undergo vestibular activation training involving headshake and weight shift exercises while wearing a virtual reality headset. The study uses a randomized crossover design where one group receives the training for 6 days followed by a 4-day break and then no training for 6 days, while the other group follows the reverse sequence. Safety measures include an overhead harness and a spotter to prevent falls during training. During the two-week study, participants will perform postural assessments, reactive balance tests after mechanical perturbations, and headshake activities. Researchers will measure vestibulo-ocular reflex VOR gain, eye movement variability, electromyography EMG amplitude and timing, balance scores, and sensory ratios. These evaluations will help understand the effects of the training on vestibular and postural control. Participants adherence and safety will be closely monitored throughout the study.

Researchers are evaluating tozorakimab as an additional treatment to standard care in adults hospitalized with viral lung infection who need supplemental oxygen. The study aims to determine if tozorakimab can help prevent death or the need for invasive mechanical ventilation or extracorporeal membrane oxygenation. This Phase III trial involves a large group of participants to assess the safety and effectiveness of this approach. Participants are randomly assigned to one of two groups one group receives a single intravenous dose of tozorakimab on the first day, while the other group receives a matching placebo. The study uses a double-blind design, meaning neither participants nor researchers know which treatment is given. This helps ensure unbiased results. The treatments are given once, and participants continue to receive standard care during the trial. During the study, participants are closely monitored and evaluated up to 60 days after treatment. Researchers track important outcomes such as death rates, progression to invasive ventilation, days alive outside intensive care, and oxygen use. They also assess clinical progression using a World Health Organization scale and monitor for any anti-drug antibodies. The trial lasts until November 2027, with multiple assessments throughout to understand the treatments impact and safety.

This research aims to evaluate an online relationship program designed for couples where one or both partners are in recovery from substance misuse. The study focuses on strengthening romantic relationships and improving individual well-being by addressing common issues like relationship conflict and distress that can interfere with substance use disorder SUD recovery. The program is based on Integrative Behavioral Couple Therapy IBCT, adapted for digital delivery and tailored specifically to the challenges faced by couples in recovery. Couples in this study will participate in approximately 8 to 10 hours of online content delivered over 5 to 8 weeks. The program includes sections called Observe, Understand, and Respond, which guide partners through identifying relationship problems, understanding core issues, and developing strategies to improve communication and reduce stress. The content features videos, audio, graphics, interactive feedback, and examples of diverse couples. Couples also receive up to five 20-minute coaching calls conducted via phone or Zoom to support their progress throughout the program. Participants will complete online surveys before starting and after finishing the program to assess changes in relationship satisfaction, conflict, emotional trust, and recovery-related factors. Researchers will monitor progress during the approximately 8-week intervention period. The study provides 200 per couple for completing surveys. Throughout participation, couples will have access to digital content and scheduled coaching, aiming to support both relationship and individual recovery. The total involvement includes program completion and follow-up assessments.

This trial focuses on participants with autoimmune or inflammatory conditions who have previously taken part in a Novartis secukinumab study. It aims to evaluate the long-term safety of continuing secukinumab treatment in those who the investigator judges will benefit and who cannot obtain the marketed secukinumab formulation. The study is an open-label extension phase 4 trial sponsored by Novartis Pharmaceuticals. Participants will receive secukinumab injections under the skin at doses of 75 mg, 150 mg, or 300 mg every four weeks, depending on their dose in the prior trial. For those who had intravenous secukinumab, the starting dose will be 300 mg subcutaneously. Dosing may be adjusted based on clinical need and investigator judgment. Pediatric dosing will not exceed the maximum dose evaluated for their weight group in the previous trial. During the study, participants will be monitored for up to two years to assess safety, focusing on adverse events and serious adverse events. They will have regular assessments including communication with investigators and follow study requirements. The total study duration extends up to April 2030, with ongoing evaluation to ensure participants continue to benefit from treatment while monitoring for any risks.