East Hanover

Researchers are evaluating a new combined approach to improve new learning and memory NLM in people with multiple sclerosis pwMS who have mobility difficulties. This study looks at how combining cognitive rehabilitation using the Kessler Foundation modified Story Memory Technique KF-mSMT, a memory retraining program, with exercise may enhance recovery more than cognitive rehabilitation alone. The study aims to maximize functional recovery by addressing the limitations of cognitive rehabilitation when used by itself. Participants will be randomly assigned to one of two groups. One group will complete a supervised aerobic exercise training program with virtual reality IDEAL three days a week for 12 weeks for the first seven weeks, they do only the exercise, and for weeks 8 to 12, they also do the KF-mSMT memory program two days a week. The other group will do supervised stretching and toning exercises three days a week for 12 weeks, with the same schedule of adding KF-mSMT during weeks 8 to 12. Both interventions are supervised and aim to improve memory and physical activity. Participants will be assessed before the intervention weeks 1 and 2 and after the intervention weeks 15 and 16 to measure changes in objective learning and memory, everyday memory, and brain changes such as hippocampal volume and function. The study includes questionnaires and memory tests, with safety and progress monitored throughout. Participation lasts about 16 weeks in total, including the treatment and follow-up assessments.

Researchers are evaluating the real-world effectiveness and patient-centered outcomes of remibrutinib in adults with chronic spontaneous urticaria CSU, a condition characterized by spontaneous hives and itching. This prospective, non-interventional study compares patients starting remibrutinib treatment to those starting dupilumab, using validated patient reported outcome tools to measure results. The study is based in the United States and sponsored by Novartis Pharmaceuticals. Participants include adult patients diagnosed with CSU who have been prescribed remibrutinib or dupilumab and are expected to start treatment. The study observes two groups one receiving remibrutinib and the other dupilumab. The treatments are not administered by the study but are prescribed by healthcare providers as part of routine care. The study does not involve drug administration or placebo controls, focusing instead on real-world outcomes and patient satisfaction. During the study, participants use electronic devices to complete assessments including the Urticaria Control Test UCT-7 at baseline, week 1, and week 4 to measure symptom control. Treatment satisfaction is measured with the Treatment Satisfaction Questionnaire for Medication TSQM-9 at baseline and week 4. Researchers will monitor changes in these scores to understand treatment impact and patient satisfaction. The study requires participants to be able to read English and provide consent, with ongoing data collection continuing until the study ends in September 2026.

Researchers are studying a strength-based employment program designed to help young adults on the autism spectrum improve their job maintenance skills. This program focuses on using individual strengths rather than correcting deficits, responding to the autism communitys call for more positive and holistic approaches. The study aims to evaluate how effective this approach is in improving work satisfaction and the ability to keep jobs among young adults with autism. Participants in the study are randomly assigned to one of two groups one group receives the strength-based training called KF-STRIDE Into Work, which consists of 10 web-based sessions lasting about 60 minutes each, delivered once or twice a week. The other group continues with their usual services and regular activities without the additional intervention. This randomized, single-masked study compares the outcomes between these two groups. Throughout the study, participants complete various assessments before and immediately after the intervention period of seven to eight weeks. These include questionnaires about employment, self-efficacy, strengths use, flourishing, resilience, work satisfaction, and self-esteem. Researchers also gather participant impressions of change and evaluate job search skills. The study monitors these measures to understand the programs impact on job maintenance skills in autistic young adults.

Researchers are studying men diagnosed with metastatic castration-resistant prostate cancer mCRPC in the United States to understand their treatment patterns, clinical outcomes, and patient characteristics in everyday medical practice. This observational study uses data from the PRECISION data platform to gather real-world information on this condition. Participants are adult males recently diagnosed with mCRPC. The study observes their treatments over time, including prior therapies and multiple lines of therapy, without administering experimental interventions. It tracks therapy types, switches between therapies, and timing of treatment initiation and changes over a period of up to approximately five years. During the study, researchers will collect and analyze data on patient characteristics, treatments received, progression-free survival, and overall survival. The primary outcomes focus on therapy use and timing, while secondary outcomes include survival measures. Participation involves data observation only, with no direct treatment assigned, and will continue for up to five years from diagnosis.

This research evaluates treatment patterns, patient characteristics, and clinical outcomes in adult men with metastatic castration-resistant prostate cancer mCRPC who have previously received at least one androgen receptor pathway inhibitor ARPI, one taxane chemotherapy, and Lutetium-177 Vipivotide Tetraxetan 177Lu-PSMA-617. The study uses real-world data collected from the PRECISION data platform in the United States to better understand how these treatments are applied and their impact. Participants are grouped into an overall mCRPC cohort who have received prior treatments including ARPI, taxane, and 177Lu-PSMA-617. Subgroups include patients who show disease progression after 177Lu-PSMA-617 treatment and those who start at least one new systemic therapy after the index treatment. The index date is defined as the last administration date among their latest ARPI, taxane, or 177Lu-PSMA-617 treatment. During the study, researchers collect data on the number and types of prior therapies, timing and number of PSMA scans, lines of therapy before and after the index date, and time to next therapy initiation, monitoring these outcomes for up to approximately five years. Additional measures include patient characteristics, progression-free survival, overall survival, and biomarkers like PSA levels. The study spans from June 2026 to November 2026, focusing on real-world outcomes without administering treatments directly.

Researchers are studying treatment approaches and clinical results among adults newly diagnosed with gastroenteropancreatic neuroendocrine tumors GEP-NET in the United States. This observational study uses open-source Longitudinal Prescription Claims and Patient Centric Medical Claims databases, combined with mortality data, to understand current treatment patterns and patient outcomes up to approximately 8 years after diagnosis. The study monitors various treatment regimens received by patients, including first-line and later-line therapies such as lutetium Lu 177 dotatate, capecitabine plus temozolomide CAPTEM, and cabozantinib. Participants are grouped based on the treatments they receive during different lines of therapy, and data on treatment duration, discontinuation, and switching between therapies is collected and analyzed. Participants medical and pharmacy claims data are reviewed to capture treatment patterns, therapy cycles, and timing of treatment changes. Key outcomes measured include the number of therapy lines, treatment regimens used, therapy discontinuation rates, and overall survival, with follow-up lasting up to around 8 years. Demographic and clinical characteristics are also recorded to provide a comprehensive view of treatment outcomes in this population.

This research aims to evaluate two intervention programs designed to improve well-being and other lasting outcomes in adults with moderate to severe traumatic brain injury TBI. It addresses the significant changes in personal identity and perceived loss of the pre-injury self that many individuals with TBI experience. The study focuses on how these interventions may help individuals cope better and improve their self-concept over time. Participants will be randomly assigned to one of two groups. One group will complete six weekly web-based sessions of the Signature Strengths program, which teaches participants to recognize and apply their personal strengths in daily life to enhance well-being. The other group will complete six weekly web-based sessions of a TBI Education Course based on fact sheets from the TBI Model Systems Knowledge Translation Center. Each session lasts about 60 minutes. Throughout the study, participants will complete assessments at the start, 3 months, and 6 months after the interventions. These include self-esteem scales, knowledge and use of strengths scales, and measures of character, self-concept, flourishing, quality of life, life satisfaction, mood, stress, resilience, and self-efficacy. The study will monitor how these outcomes change over time to understand the impact of the interventions on well-being after TBI.

Researchers are studying C3 glomerulopathy C3G, a rare kidney disease, to understand the range of symptoms, treatment use, and quality of life experienced by patients and their caregivers. This observational study aims to gather real-world data primarily through home-reported outcomes, supplemented by patient-reported outcome measures collected at the start and monthly during the study. The goal is to capture symptom variability and overall health impact, including information from patients taking the drug iptacopan. Participants will enroll using the Folia mobile app, where they will track their routine treatments, symptoms, treatment changes, and health-related quality of life over an initial six-month period. Monthly surveys will collect additional patient-reported data. The study may also link other data sources like electronic health records or wearable device information to enrich the dataset. Participants have the option to extend their involvement beyond six months by reconsenting. Throughout the study, participants will regularly report their symptoms, treatment patterns, and quality of life using the mobile app. Researchers will measure the frequency and severity of the top 10 symptoms, treatment use, reasons for missed treatments, and changes in quality of life over time. Data linkage and tokenization processes will help validate diagnoses and integrate additional health information. Total involvement starts at six months with potential extended participation.

Researchers are studying Paroxysmal Nocturnal Hemoglobinuria PNH to understand the range of symptoms, treatment use, and overall health-related quality of life experienced by patients with this condition. The study focuses on collecting real-world data, especially from home-reported outcomes, to capture symptom changes and treatment patterns, including for those using orally administered iptacopan. Participants will use the Folia mobile app to enroll, consent, and report their symptoms, treatments, and quality of life over six months. The study is observational, meaning treatments such as eculizumab, ravulizumab, pegcetacoplan, or iptacopan will be used based on clinical decisions and not assigned by the study. Monthly surveys and possible integration of health records will supplement data collection. During the study, participants will regularly track their symptoms and treatment changes through the app. Researchers will measure PNH symptom burden at the start and after six months, as well as monitor treatment use, management of flare events, treatment switching, and quality of life. The study aims to provide a comprehensive view of living with PNH over this half-year period.

Researchers are evaluating a home-based walking exercise program designed to improve thinking skills in adults who have experienced traumatic brain injury TBI. The study focuses on understanding the effects of a 3-month walking program on cognitive performance, including processing speed, memory, and executive function. This research uses a randomized design to compare outcomes between participants who start the exercise immediately and those who wait three months before beginning. Participants are randomly assigned to one of two groups. One group will follow a 3-month walking exercise program at home, walking three times per week with gradually increasing duration starting at 10 minutes per session. A trained exercise leader provides support and meets regularly with participants via video calls. Participants will receive a FitBit device to track their steps, which they can keep after the study. The other group will maintain their usual routine for three months before receiving the exercise program. Participants will complete initial cognitive tests and questionnaires via videoconference. After the 3-month period, cognitive tests and questionnaires are repeated to assess changes. The study monitors adherence, compliance, and any adverse events throughout. The entire participation lasts up to 6 months for the wait-list group, including the exercise period after the wait. This fully remote study requires internet access and is designed to allow participants to engage from home.