Evanston

Researchers are developing and validating a wearable sensor to help detect and manage swallowing difficulties (dysphagia) in patients with Parkinson's disease (PD). This study focuses on improving the sensor's battery life to last 48 hours and making it smaller in size. It also involves gathering feedback from PD patients on the sensor's usability and burden, and testing its ability to detect and cue swallowing. Participants will use the Aria sensor, a wearable patch that continuously monitors physiological signals and provides gentle vibratory cues to encourage swallowing. The sensor is worn over three weeks, with active haptic cueing provided only during the second week. The study includes phases for engineering improvements, patient focus groups, and a small trial to assess the sensor's effectiveness. During the study, participants will be assessed for their swallowing frequency and agreement with a gold standard test over one year. Evaluations include monitoring swallow frequency changes during the week when the haptic cues are active. Researchers will also check usability, set-up burden, and feedback from participants. The total participation involves wearing the sensor and attending study assessments while on medication at peak effectiveness.

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

Researchers are evaluating the safety, tolerability, and early effectiveness of VLS-1488, an oral KIF18A inhibitor, in people with advanced cancers. This first-in-human phase I/II trial includes participants with various solid tumors such as high-grade serous ovarian cancer, squamous non-small-cell lung cancer, triple-negative breast cancer, and others characterized by chromosomal instability. The study aims to find the maximum tolerated dose (MTD) and assess preliminary responses to the treatment. The study has two parts: Dose Escalation and Dose Expansion. In Dose Escalation, participants receive increasing doses of VLS-1488 tablets orally in 28-day cycles to determine safety, tolerability, and the MTD using a Bayesian design. Dose Expansion involves treating participants at selected dose levels to further evaluate safety, tolerability, drug interactions, food effects, and early signs of effectiveness across different tumor types and dose groups. Treatment continues until disease progression, unacceptable side effects, consent withdrawal, or other stopping reasons. Participants will be monitored with scans such as CT or MRI to measure tumor response and various safety assessments including adverse event tracking, dose interruptions, and discontinuations for up to 12 to 18 months. Researchers will evaluate dose-limiting toxicities, serious adverse events, treatment-related side effects, and objective response rates. The study collects information on how well participants tolerate VLS-1488 and its early impact on their cancer.

This trial investigates the safety and effectiveness of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) 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 with a combined positive score of 1 or higher. Additionally, rilvegostomig combined with trastuzumab and chemotherapy is studied separately to understand each component's contribution. This Phase 2, randomized, open-label, global study is conducted at 200-250 sites in about 25 countries. Participants are randomly assigned to one of three arms: Arm A receives rilvegostomig, fluoropyrimidine, and T-DXd; Arm B receives trastuzumab, chemotherapy, and pembrolizumab; Arm C receives rilvegostomig, trastuzumab, and chemotherapy. Treatments are administered mostly by intravenous infusion every three weeks, with capecitabine given orally twice daily. The study compares these treatment regimens to evaluate their effects on the cancer. Throughout the study, participants undergo assessments including tumor measurements, organ function tests, and heart function evaluation to ensure safety and monitor disease progression. The main outcomes measured are progression-free survival and overall survival for up to approximately six years. Researchers will also monitor adverse events and overall health status during and after treatment.

Researchers are evaluating a personalized management strategy for people with symptoms suggesting coronary artery disease (CAD). The study compares this strategy, which uses AI-based software to analyze coronary plaque from CT scans, against the usual care based on current guidelines. The goal is to see if this new approach improves diagnosis certainty, risk factor control, and referral efficiency for invasive coronary angiography with appropriate percutaneous coronary intervention (PCI). This is a prospective, randomized, open-label trial focusing on symptomatic patients suspected of having CAD. Participants assigned to the personalized management group will undergo a coronary CT angiography (CCTA) at the start. The images from these scans are processed using Cleerly Labs and Cleerly ISCHEMIA software to assess coronary plaque. This information is used to guide medical and interventional treatment decisions. The usual care group will receive standard diagnostic and treatment approaches based on American Heart Association/American College of Cardiology guidelines. During the study, which lasts about one year, researchers will monitor participants to evaluate the effectiveness and efficiency of these management strategies. They will measure outcomes such as improved diagnosis certainty, better control of CAD risk factors, and more appropriate use of invasive procedures like PCI. Safety and adherence will also be followed throughout the study period to understand the overall impact of the personalized approach compared to usual care.

Researchers are evaluating an online mindfulness program designed for youth aged 12 to 17 who have high levels of trait negative affect, a risk factor for anxiety and depression. This study compares the mindfulness program to a supportive coaching intervention and a no-intervention control group to see if the mindfulness training reduces momentary negative emotions and internalizing symptoms like anxiety and depression. The goal is to determine whether lowering momentary negative affect through mindfulness can prevent worsening or onset of internalizing problems in at-risk adolescents. Participants will be randomly assigned to one of three groups: an online, coached mindfulness training program; remote meetings with a supportive coach as an active comparison; or a no-intervention control group. The mindfulness training is delivered through mobile technology and consists of nine sessions. All groups are evaluated before starting, after completing the nine-session intervention, and again at a six-month follow-up. During the study, participants' momentary negative affect and stress levels are assessed using ecological momentary assessment (EMA). Researchers will measure changes in internalizing symptoms and momentary stress-related negative emotions at week 10 and week 12. The study includes assessments of mood and anxiety symptoms over time, with safety monitoring and adherence tracked throughout the trial.

This research aims to collect real-world data on patients with lung cancer, specifically those diagnosed with Stage I non-small cell lung cancer (NSCLC), who are undergoing pulmonary segmentectomy surgery. The study focuses on understanding patient outcomes after this lung cancer surgery and tracking disease-free survival over several years. Participants are assessed using patient-reported outcome measures to capture their physical function, pain, and breathlessness. Participants will complete surveys using the Patient-Reported Outcomes Measurement Information System (PROMIS), a web-based platform from the National Institutes of Health. These surveys assess physical function, pain interference, and dyspnea severity. Questionnaires will be administered before surgery, between 2 to 4 weeks after surgery, and again 6 months after surgery. The study will also determine disease-free survival at 3 and 5 years following surgery. During the study, participants will provide information through PROMIS surveys at the specified time points. Researchers will monitor disease-free survival to evaluate long-term outcomes after lung surgery. The total participation duration includes follow-up assessments up to 5 years to measure disease-free survival. Data collected will help understand recovery and cancer outcomes for patients undergoing pulmonary segmentectomy for lung cancer.

This research aims to understand the safety, effectiveness, and overall treatment experience of participants prescribed BRIUMVI4 (ublituximab-xiiy) in a real-world setting. The study focuses on people living with relapsing multiple sclerosis (RMS), a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms. It is designed to gather detailed insights from actual use outside of controlled clinical trials. Participants in this study are those who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. There is no intervention assigned by the study itself; instead, it observes the outcomes and experiences of patients treated with BRIUMVI4 as part of their routine care over time. Throughout the study, researchers will track the annualized relapse rate (ARR) up to week 96 to measure disease activity. Participants' safety, treatment adherence, and experiences will be evaluated through regular monitoring, including any adverse events. The total duration of participation covers up to 96 weeks, allowing for a comprehensive understanding of long-term treatment effects and patient-reported outcomes.

Researchers are evaluating the safety and effectiveness of two doses of inhaled pirfenidone (called AP01) compared to a placebo in people with progressive pulmonary fibrosis (PPF). This Phase 2b study is randomized, double-blind, and placebo-controlled, involving up to 300 participants who will continue their standard care during the 52-week trial. The goal is to see how well AP01 works and how safe it is when added to usual treatments for PPF. Participants will be randomly assigned to one of three groups: high-dose AP01, low-dose AP01, or placebo. All treatments are given as an oral inhalation solution twice daily. The study will last for 52 weeks, during which researchers will monitor and compare the effects of these treatments on lung function and disease progression. During the study, participants will undergo various assessments including lung function tests and clinical evaluations to track their respiratory health. Researchers will check for changes in lung capacity and symptoms and monitor safety throughout the treatment period. The main outcome measured is the impact of AP01 doses compared to placebo after 52 weeks of treatment.

This research aims to evaluate the safety and effectiveness of the combination of avutometinib and defactinib compared to standard treatments chosen by investigators in women with recurrent low-grade serous ovarian cancer (LGSOC) who have experienced disease progression after prior platinum-based therapy. Both avutometinib and defactinib are investigational kinase inhibitors designed to block cancer cell growth. The study will also assess overall survival, other measures of treatment effectiveness, safety, and quality of life impacts. Participants will be randomly assigned to receive either the combination of oral avutometinib and defactinib or one of four standard treatments recommended for recurrent LGSOC: pegylated liposomal doxorubicin and paclitaxel (both given intravenously), or the oral drugs letrozole or anastrozole. Patients treated with standard therapies who experience disease progression may be eligible to switch to the investigational combination. The study is open-label and conducted internationally by specialists in gynecological cancer. Throughout the study, participants will have regular follow-up visits including scans and tests to measure disease progression, with a primary focus on progression-free survival up to 24 months. Researchers will monitor safety, side effects, and overall survival while collecting information on quality of life and symptoms. The study involves ongoing assessments of treatment effects and participant health until the study concludes or disease progression occurs.