Evanston

Researchers are developing and validating a wearable sensor designed to help patients with Parkinsons Disease PD who have swallowing difficulties and drooling problems. This study focuses on improving the devices battery life and size, assessing usability with patient feedback, and testing its ability to detect and encourage swallowing in PD patients. The aim is to provide a digital therapeutic platform that can support swallowing function in this population. The wearable device, called the Aria sensor, is a patch that monitors physiological signals continuously and provides vibratory haptic cues to increase how often participants swallow. Participants will use the sensor for three weeks, with the device actively providing haptic cues only during the second week. This single-arm study tracks how the sensor performs in real-life conditions without randomization or blinding. Participants will be involved for three weeks, during which researchers will measure swallow frequency changes, participant adherence to using the haptic cues, and changes in clinical scales related to drooling and swallowing. Assessments include comparing sensor data to a gold standard and evaluating symptom severity before and after the intervention. The study also includes focus groups to gather patient feedback on usability, and safety monitoring is conducted throughout the study period.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

This trial investigates MZE829 capsules in adults with proteinuric chronic kidney disease who also carry the APOL1 high risk genotype, specifically G1G1, G2G2, or G1G2 variants. The study aims to evaluate the safety, tolerability, and impact on albuminuria, a marker of kidney damage, in this population. It is an open-label Phase 2 trial, meaning all participants receive the study drug and results will help determine its effects and safety profile. Participants receive MZE829 capsules orally in a single-group design. The study includes two cohorts one with chronic kidney disease alongside diabetes, and another with chronic kidney disease without diabetes. The treatment and monitoring occur over a 12-week period, during which the study team assesses drug safety and effects on albuminuria levels. During the trial, participants will be monitored for adverse events and tolerability from baseline through week 12. Researchers will also measure changes in urine albumin-to-creatinine ratio UACR to evaluate kidney function. Blood samples will be taken to assess plasma drug concentrations. The total participation time is approximately 12 weeks, focusing on safety and biological effects of MZE829.

Researchers are evaluating a new form of hormone therapy called ASP5541 for men with advanced prostate cancer that has spread to other parts of the body. This phase 2 study compares ASP5541 given by injection with the standard abiraterone acetate tablets, both combined with a steroid called prednisone or prednisolone. The study aims to assess how well ASP5541 works and its safety in men who have not previously been treated with androgen receptor pathway inhibitors, including specific evaluation in Japanese men. Participants are divided into three groups based on their cancer type and treatment history. ASP5541 is given as a muscle injection every 12 weeks, while abiraterone acetate is taken as a daily tablet. Men with metastatic castration-resistant prostate cancer take prednisone or prednisolone twice daily, and men with metastatic hormone-sensitive prostate cancer take it once daily. All groups also receive standard care such as androgen deprivation therapy. Some participants will monitor blood pressure at home weekly. During the study, men visit the clinic regularly for health checks, safety monitoring, and scans to observe any changes in their cancer. The frequency and type of visits depend on each participants health and treatment stage. Researchers will measure prostate-specific antigen PSA levels, adverse events, physical exams, ECGs, and performance status to evaluate treatment effects and safety. The study may last up to about 3 years for some outcomes, with longer follow-up for certain measures.

Researchers are studying VLS-1488, an oral drug, in a first-in-human phase III trial involving adults with advanced cancers. The study aims to evaluate the safety, tolerability, and early effectiveness of VLS-1488 in different solid tumor types, including ovarian, lung, breast, and endometrial cancers. This includes understanding the drugs effects on tumors with chromosomal instability and exploring its potential in various cancer subtypes. The study has two main parts Dose Escalation and Dose Expansion. During Dose Escalation, participants receive different doses of VLS-1488 to identify the maximum tolerated dose and appropriate dose levels for further testing. Dose Expansion involves treating participants with selected doses to assess safety, drug interactions, food effects, and preliminary efficacy. VLS-1488 is given orally in 28-day cycles and continued until disease progression or unacceptable side effects occur. Participants will undergo regular evaluations including CT or MRI scans to measure tumor response, safety monitoring for side effects, and assessments of drug levels in the body. Researchers will track dose-limiting toxicities, serious adverse events, and treatment-related side effects up to 18 months, with some measures followed for up to 32 months. Results will help determine how well participants tolerate VLS-1488 and its impact on tumor control over time.

Researchers are evaluating the effectiveness, safety, and tolerability of camizestrant combined with ribociclib in patients with advanced ER-positive, HER2-negative breast cancer who have not received any prior systemic treatment for their advanced disease. This Phase IIIb global, multicenter, single-arm study aims to provide insight into this combination therapy as a first-line treatment option. Participants will receive daily oral tablets of camizestrant 75 mg and ribociclib 600 mg at standard doses continuously until they choose to stop treatment or it is discontinued for any reason. Approximately 150 participants will be enrolled and treated within this trial. During the study, participants will be monitored for treatment effectiveness using time to next treatment, time to discontinuation, and progression-free survival over a two-year period. Safety will be assessed by tracking adverse events, including any severe toxicities within the first six months. Participants will undergo regular assessments related to organ function and performance status throughout the treatment period, which may last until discontinuation.

Researchers are assessing the effectiveness and safety of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction GEJ adenocarcinoma whose tumors express PD-L1 CPS 1. The study also evaluates rilvegostomig combined with trastuzumab and chemotherapy to understand the contribution of each treatment component. This is a Phase 2, randomized, open-label, global, multicenter trial sponsored by AstraZeneca. Participants are divided into three groups Arm A receives T-DXd, rilvegostomig, and fluoropyrimidine capecitabine or 5-FU Arm B receives pembrolizumab, trastuzumab, and chemotherapy either 5-FU plus cisplatin or capecitabine plus oxaliplatin Arm C receives rilvegostomig, trastuzumab, and chemotherapy 5-FU plus cisplatin or capecitabine plus oxaliplatin. Treatments are given by intravenous infusion every three weeks or oral administration twice daily for capecitabine. This setup allows comparison of different combinations to evaluate each drugs role. During the study, participants will be monitored for progression-free survival and overall survival up to about six years. Researchers will also assess response rates, duration of response, adverse events, pharmacokinetics, immunogenicity, and quality-of-life factors like eating difficulties and side-effect burden. The study involves regular assessments including tumor measurements and laboratory tests. Participation may last several years, with safety and efficacy closely followed throughout this time.

Researchers are evaluating whether an online mindfulness program can reduce and prevent mood and anxiety symptoms in adolescents who are at risk due to high levels of trait negative affect, a tendency to experience frequent and intense negative emotions. This randomized clinical trial compares the mindfulness program to a supportive comparison group and a no-intervention control group. The study focuses on reducing momentary negative emotions and internalizing problems in youth aged 12 to 17 years old. Participants are randomly assigned to one of three groups the Mindfulness Program, the Supportive Active Comparison, or a Control group. The Mindfulness Program involves nine weekly 30-minute online sessions with a coach teaching mindfulness skills like calm breathing and gratitude. The Supportive Active group also meets weekly online with a coach to discuss personal thoughts and feelings, using active listening and expressive writing. The Control group completes assessments only at the same time points as the other groups. Participants will be assessed before the intervention, after the 9-week program, and again at a six-month follow-up. Assessments include measures of momentary negative affect and internalizing symptoms using ecological momentary assessment and diagnostic evaluations. The study aims to understand how mindfulness training affects emotional regulation and the development of anxiety and depression symptoms in vulnerable youth over time.

Researchers are studying patients with Stage I lung cancer who are undergoing planned pulmonary segmentectomy surgery. The study aims to understand the disease-free survival rates at 3 and 5 years after this surgery in people suitable for this procedure based on clinical staging. Patients with suspected non-small cell lung cancer are included, even if tissue diagnosis is not confirmed before surgery. Participants in this observational study complete questionnaires using the Patient-Reported Outcomes Measurement Information System PROMIS, which evaluates physical function, pain interference, and breathing difficulty. These questionnaires are completed before surgery, between 2 to 4 weeks after surgery, and again 6 months after surgery. The study collects data through this web-based platform developed by the National Institutes of Health. During the study, participants are asked to fill out surveys at specified times to assess their health and symptoms. Researchers will track disease-free survival over 3 and 5 years after surgery to evaluate outcomes. Participation involves completing questionnaires and follow-up over several years, with no investigational treatment being administered. The total study completion is expected by May 2029.

Researchers are evaluating the real-world use and safety of BRIUMVI4 ublituximab-xiiy in adults with relapsing multiple sclerosis RMS. The study aims to understand the safety, effectiveness, and treatment experience of participants prescribed this medication outside of controlled clinical trials. This observational study is sponsored by TG Therapeutics, Inc. and focuses on patients receiving routine care with BRIUMVI4. Participants in this study will receive BRIUMVI4 through intravenous infusion as prescribed for RMS treatment. The study includes participants who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. No placebo or other interventions are involved, and the study observes the treatment as it is given in real-world medical settings. During the study, participants will be monitored for up to 96 weeks to assess their annualized relapse rate ARR. Researchers will also track adverse events, serious adverse events, and infusion-related reactions at each infusion. Participant safety and treatment experience will be observed through regular clinical assessments and data collection, with the study lasting until April 2032.