Potsdam

This research aims to evaluate the safety and effectiveness of belimumab in adults with interstitial lung disease (ILD) related to connective tissue diseases (CTDs) such as rheumatoid arthritis, lupus, and others. ILD causes lung inflammation and stiffness, reducing lung volume and leading to symptoms like shortness of breath, cough, and fatigue, significantly affecting quality of life and being a leading cause of death in these patients. The study focuses on whether adding belimumab to standard therapy can stabilize or improve lung function and relieve ILD symptoms while maintaining an acceptable safety profile. Participants will be randomly assigned to receive either belimumab or a placebo, both administered as a subcutaneous injection alongside their standard treatment. The study is a phase 3, double-blind, placebo-controlled trial designed to compare these two groups over time. Belimumab treatment is given under careful monitoring to assess its impact on lung disease progression. Throughout the study, participants will undergo assessments including lung function tests, specifically measuring forced vital capacity (FVC) at the start and after 52 weeks. Researchers will monitor changes in lung capacity to determine treatment effects. Participants will be evaluated for safety and symptom changes, with ongoing review of their ability to manage their condition. The total duration includes regular follow-ups and assessments to understand the long-term impact of the treatment.

Researchers are evaluating the efficacy and safety of belimumab compared to a placebo, alongside standard therapy, for adults with systemic sclerosis associated interstitial lung disease (SSc-ILD). This Phase 2/3 randomized, double-blind study aims to assess how belimumab affects lung function and other disease symptoms such as skin thickening and fatigue, which impact quality of life. Participants will receive either belimumab or placebo administered subcutaneously. The study focuses on those diagnosed with diffuse cutaneous systemic sclerosis and active or progressive disease. Treatment is given under blinded conditions, and participants must be capable of self-administering the medication or have a caregiver to assist. During the study, lung function will be monitored by measuring changes in forced vital capacity (FVC) from baseline to Week 52. Researchers will also assess skin involvement and general symptoms. Safety and tolerability will be closely followed throughout the trial, which includes screening and regular assessments to evaluate treatment effects and participant well-being.

Researchers are establishing the Caris Biorepository to collect and store high-quality biological specimens along with clinical and demographic data. This resource aims to support research studies focused on advancing precision medicine and improving patient care, especially in areas related to cancer, early detection of cancer, and minimal residual disease. The biorepository is designed to securely share valuable biospecimen information and clinical outcomes to help develop targeted treatments and improve healthcare. The Caris Biorepository will gather specimens prospectively from multiple sources and maintain molecular integrity and clinical relevance of these samples. It will provide access to this information for researchers both within Caris Life Sciences and external collaborators such as government agencies, academic institutions, and industry partners. The project supports drug development, clinical research trials, publications, and healthcare policy development by bridging the gap between human specimens and associated clinical data. Participants in this research will provide biospecimens and clinical data, with the biorepository managing access and use of these materials over time. The study focuses on developing a high-quality collection of human samples and associated data for up to 35 years, supporting various research purposes. Outcomes include ensuring specimen integrity and releasing specimens for testing while maintaining detailed clinical information to facilitate future medical discoveries and improvements in patient outcomes.

Rheumatoid arthritis (RA) is a chronic autoimmune disease that causes joint inflammation, pain, and stiffness, potentially leading to serious joint damage if untreated. This condition affects about 1.5 million people in the United States, with limited access to specialized care, especially in rural areas like northern New York. This trial investigates whether primary care providers (PCPs) trained in RA management can safely and effectively care for stable RA patients compared to usual specialist care by rheumatologists. The goal is to improve treatment access and affordability for patients in underserved regions. Patients will be randomly assigned to one of two groups: one group will receive RA care from their regular PCP who has completed a structured RA training program, including lectures, case studies, and exams, along with monthly rheumatology team consultations. The other group will continue care with a rheumatologist or rheumatology advanced practice provider. The study will last one year, with data collected at multiple points including baseline, 6 weeks, 12 weeks, 26 weeks, 40 weeks, and 52 weeks, using standard RA assessments and patient feedback. Participants will be involved in regular medical exams, joint assessments, patient questionnaires, and medical record reviews throughout the study. Researchers will monitor changes in disease activity scores and other measures of RA symptoms and function. This study aims to demonstrate if trained PCPs can manage stable RA patients effectively, which could reduce the burden on specialist care and offer a model to improve chronic disease management in rural areas.

Postural instability caused by vestibular dysfunction affects daily activities, and vestibular rehabilitation helps reduce dizziness and improve balance through sensory reweighting. This research aims to study a new training method combining headshake and weight shift exercises using virtual reality to better engage the vestibular and postural control systems. Healthy young adults will participate to explore if this approach improves balance and eye movement control compared to traditional methods. Participants will undergo vestibular training using a virtual reality headset while standing with safety harness support. The study uses a cross-over design where one group receives six days of training followed by a washout and no-training period, while the other group follows the reverse order. Training involves headshake activities and weight shifting while standing, performed for 20 minutes with brief breaks. During the two-week study period, researchers will assess balance, eye movement variability, vestibulo-ocular reflex gains, electromyography responses, and sensory ratios. Participants must stand independently and perform postural assessments including reactive balance. The study aims to guide future rehabilitation methods for people with vestibular or sensorimotor impairments by measuring these outcomes and monitoring safety throughout.

Researchers are evaluating the effect of tozorakimab, added to standard care, in adults hospitalized with viral lung infection who need supplemental oxygen. The study focuses on preventing death or progression to invasive mechanical ventilation or extracorporeal membrane oxygenation by day 28. This is a Phase III, multicenter, randomized, double-blind trial comparing tozorakimab to placebo in patients with viral lung infection causing acute respiratory failure. Participants will receive a single intravenous dose of either tozorakimab or a matching placebo on the first day of the study. Both groups continue to receive standard care for their viral lung infection. The study is designed to assess the safety and efficacy of tozorakimab as an add-on therapy in this patient population. Throughout the study, researchers will monitor participants for survival and the need for invasive mechanical ventilation or ECMO up to 28 days after treatment. The main outcome measured is the proportion of patients who die or require mechanical ventilation or ECMO by day 28. Participants will be closely observed during hospitalization, with data collected on their respiratory status and treatment outcomes to evaluate the study drug's impact and safety.

Researchers are evaluating the effectiveness of an online program designed to strengthen romantic relationships and improve individual well-being for couples where one or both partners are in recovery from substance misuse. The program is based on Integrative Behavioral Couple Therapy and has been adapted to address issues related to addiction and recovery. Previous studies showed that the program improved relationship satisfaction, confidence, and reduced conflict, with additional benefits in individual mental health and functioning. The program includes approximately 8 to 10 hours of digital content delivered over 5 to 8 weeks. Couples complete most of the material independently and come together for 2 to 3 key conversations focused on identifying and addressing core relationship problems. The content features videos, interactive feedback, and tailored information addressing recovery-related challenges. Participants also receive up to 100 minutes of coaching calls via Zoom or phone, spread before, during, and after the program. Participants complete online surveys before and after the program, which lasts about 8 weeks, and are compensated for their time. Researchers assess relationship satisfaction and conflict from enrollment until the end of the program or dropout. The study recruits couples from recovery organizations and monitors their progress through questionnaires and coaching sessions, aiming to support relationship and recovery outcomes.

Researchers are evaluating ways to improve advance care planning (ACP) among underserved communities, who often receive lower quality end-of-life care and unwanted, costly treatments. This study compares two conversation-based tools designed to encourage discussions about end-of-life wishes and motivate ACP behaviors. The goal is to increase high-quality end-of-life care, reduce health disparities, and lessen unnecessary suffering for patients and families. The study is a cluster randomized controlled trial involving 75 underserved communities across the US. It compares a serious conversation game called Hello, the widely used Conversation Project (CP) Starter Kit, and usual care where only an advance directive is distributed. The Hello game has 32 questions prompting sharing of values and beliefs about end-of-life issues, while the CP Starter Kit is a workbook with prompts and resources to facilitate conversations. The third group receives a general conversation game called Table Topics. Participants include adults from underserved populations who have not completed an advance directive in the past 5 years. Researchers will assess completion of a visually verified advance directive six months after the intervention. Other ACP behaviors will also be measured. The study involves community events, follow-up, and data collection to understand which tools best engage underserved groups in ACP and improve end-of-life care outcomes.

This research aims to assess the long-term safety of secukinumab in participants who have finished a previous Novartis secukinumab trial and are judged by their investigator to benefit from continued treatment but cannot access the marketed secukinumab form. The study focuses on individuals with autoimmune or inflammatory conditions and is conducted as a Phase 4 trial to monitor treatment safety over an extended period. Participants will receive secukinumab through subcutaneous injections using pre-filled syringes. The study is open-label and multi-center, designed for patients continuing secukinumab therapy after completing a parent study or in cases where the parent study ended prematurely for non-safety reasons. Treatment continuation depends on investigator judgment regarding benefit and risk balance. During the study, participants will be observed for up to two years to evaluate safety by tracking any adverse or serious adverse events. The study includes regular assessments to monitor participant health and treatment effects. Consent and communication with investigators are essential, and participants may sign informed consent or assent forms according to age and local laws. Overall participation duration and detailed safety monitoring are key components of the study.