Chicago, IL Paid Clinical Trials

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Merkel Cell Carcinoma (MCC) who have failed treatment with at least one anti-PD-1 or anti-PD-L1 immunotherapy or in combination with avelumab in MCC patients who are anti-PD-1 or anti-PD-L1 treatment naïve. Inhibition of MDM2 is a novel mechanism of action in MCC. Read Less

Frailty is a significant problem in patients undergoing liver transplant and is associated with poor outcomes and survival. Hence, optimizing physical fitness and counteracting frailty is important. However, many interventions are very resource intensive and therefore not feasible. In this study, the investigators aim to test the effectiveness of a newly designed intervention to improve frailty in liver transplant candidates. The "LIver FrailTy" intervention (LIFT) will consist of an evaluation by a physical therapist, an individualized home exercise prescription (HEP), exercise tracking using a smart phone application, daily text reminders to exercise and recurrent telephone check-ins. The investigators also aim to perform "Realistic Effort Action Planning" (REAP), which is a form of personality-informed motivational interviewing, in a subset of patients to determine if this enhances the LIFT intervention. Read Less

This pragmatic cluster randomized clinical trial (cRCT) aims to evaluate the comparative effectiveness (CER) of two approaches to preventing destabilization ("tipping points") that lead to unplanned hospitalization and increased disability. The cRCT compares the outcomes of patients randomized in clusters by site within four Federally Qualified Health Center (FQHC) networks in New York City (NYC) and Chicago to either: 1) the Patient Centered Medical Home (PCMH); or 2) the Patient Centered Home plus a health coaching intervention that employs a positive affect/self-affirmation intervention to help motivate patients to succeed at implementing self-management by setting life goals (experimental). This RCT embeds novel effective interventions within large FQHC networks, namely, Community Healthcare Network and the Family Health Centers of New York University (NYU) Langone in NYC and Erie Family Health Centers and Friend Family Health Center in Chicago, serving patients with multiple chronic diseases or high comorbidity. This CER study compares two PCMH-based strategies and will provide a manualized training system that can be disseminated and implemented across the national FQHC networks, with over 9,000 delivery sites that serve nearly 25 million low-income and minority patients, and can be implemented in a wider range of practice settings, organization types and population characteristics. Among 1920 adult patients with a Charlson Comorbidity Index ≥4 who are established primary care patients of 16 Federally Qualified Health Centers (FQHCs) in NYC (8 FQHCs) and Chicago (8 FQHCs) this pragmatic cRCT aims to evaluate the effectiveness of two approaches to preventing destabilization that leads to unplanned hospitalization and increased disability. This Patient-Centered Outcomes Research Institute (PCORI) study builds on the National Patient-Centered Clinical Research Network (PCORnet) Clinical Data Research Networks (CDRNs) in NYC and Chicago. Patients will be identified via electronic health records (EHRs) and their outcomes assessed through comprehensive, longitudinal, electronic health records that are aggregated by these PCORnet CDRNs. Read Less

The Rett Syndrome Registry is a longitudinal observational study of individuals with MECP2 mutations and a diagnosis of Rett syndrome. Designed together with the IRSF Rett Syndrome Center of Excellence Network medical directors, this study collects data on the signs and symptoms of Rett syndrome as reported by the Rett syndrome experts and by the caregivers of individuals with Rett syndrome. This study will be used to develop consensus based guidelines for the care of your loved ones with Rett syndrome and to facilitate the development of better clinical trials and other aspects of the drug development path for Rett syndrome. Read Less

I3LUNG is an international project aiming to develop a medical device to predict immunotherapy efficacy for NSCLC patients using the integration of multisource data (real word and multi-omics data). This objective will be reached through a retrospective - setting up a transnational platform of available data from 2000 patients - and a prospective - multi-omics prospective data collection in 200 NSCLS patients - study phase. The retrospective cohort will be used to perform a preliminary knowledge extraction phase and to build a retrospective predictive model for IO (R-Model), that will be used in the prospective study phase to create a first version of the PDSS tool, an AI-based tool to provide an easy and ready-to-use access to predictive models, increasing care appropriateness, reducing the negative impacts of prolonged and toxic treatments on wellbeing and healthcare costs. The prospective part of the project includes the collection and the analysis of multi-OMICs data from a multicentric prospective cohort of about 200 patients. This cohort will be used to validate the results obtained from the retrospective model through the creation of a new model (P-Model), which will be used to create the final PDSS tool. Read Less

This is a Phase II, open label, single-arm trial study of adding hydroxychloroquine to encorafenib and cetuximab in patients with metastatic BRAF V600E colon cancer with progression on at least 1 prior line of therapy. We hypothesize that autophagy is a major mechanism of resistance to BRAF inhibition in stage IV BRAF V600E colorectal cancer, and that the addition of hydroxychloroquine to standard encorafenib and cetuximab therapy will help overcome this resistance. Read Less

The VQI TCAR Surveillance Project is designed to monitor the safety and effectiveness of stents placed directly into the carotid artery while reversing blood flow within the carotid artery to reduce stroke risk. It will compare this less-invasive surgical procedure with standard carotid endarterectomy in centers that participate in the Society for Vascular Surgery Vascular Quality Initiative. Read Less

RADIANT is a network of 14 clinical sites and several laboratories dedicated to the study of atypical diabetes. The objective of this study is to define new forms of diabetes and the unique mechanisms underlying these forms of atypical diabetes. The specific aims are to: 1. Identify and enroll individuals and families with undiagnosed rare and atypical forms of diabetes. 2. Determine the etiologic basis of the metabolic disorder among individuals and families with novel forms of rare and atypical diabetes. 3. Understand the pathophysiology of individuals and families with novel forms of rare and atypical forms of diabetes. Read Less

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy. Condition or disease: Breast Cancer Intervention/treatment: Drug: Gedatolisib Drug: Palbociclib Drug: Fulvestrant Drug: Alpelisib Phase 3 Read Less

Our goal is to enhance repeated exposure to acute intermittent hypoxia (rAIH)/training-induced aftereffects on upper and lower limb function recovery in humans with chronic spinal cord injury (SCI). Read Less

Partial nephrectomy (PN) is the standard treatment for localized renal masses and should be preferred in clinical T1 (\<7 cm tumor diameter) renal tumors over radical nephrectomy (RN) whenever technically feasible. Nonetheless, indications, approaches, techniques for PN, and correct reporting of outcomes, are still a matter of great debate within the urology community. Concurrently, case-report series suggested that alternative strategies for the treatment of localized renal tumors (ablation techniques (AT), watchful waiting (WW), active surveillance (AS)) could be feasible with acceptable oncologic outcomes in particular settings of patients with localized renal tumors. In this complex clinical scenario, the role surgeon-related and environmental factors (such as surgical experience, hospital resources, countries' social background and performance of health system) are important to address the best personalized approach in patients with renal tumors. In the light of current evidence, many unsolved questions still remain and many unmet needs must be addressed. In particular, 1) the risk-benefit trade-offs between PN and RN for anatomically complex renal localized tumors; 2) the definition of evidence-based strategies to tailor the management strategy (AT vs WW vs AS vs surgery) in different subset of patients with particular clinical conditions (i.e. old, frail, comorbid patients); and 3) the definition of evidence-based recommendations to adapt surgical approach (open vs laparoscopic vs robotic) and resection techniques to different patient-, tumor-, and surgeon-specific characteristics. To meet the challenges, to overcome the limitations of current kidney cancer literature (such as the retrospective study design, potential risk of biases, and heterogeneous follow-up of most series), and to provide high-quality evidence for future development of effective clinical practice Guidelines, we designed the international REgistry of COnservative or Radical treatment of localized kiDney tumors (i-RECORD) Project. The expected impact of the i-RECORD project is to provide robust evidence on the leading clinical and environmental factors driving selection of the management strategy in patients with kidney cancer, and the differential impact of different management strategies (including AS, WW, AT, PN and RN) on functional, perioperative and oncological outcomes, as well as quality of life assessment, at a mid-long term follow-up (5-10 years). Read Less

Retinopathy of Prematurity (ROP) is a vascular disease affecting the retinas (back of the eye) of low birth weight infants. Although it can be treated effectively if diagnosed early, it continues to be a leading cause of childhood blindness in the United States and throughout the world. The investigators feel that this study will result in specific knowledge discovery about ROP, as well as general knowledge about how image-based data and genetic data can be combined to better understand clinical disease. Participants will be recruited from the neonatal intensive care unit (NICU) at OHSU, along with 4 collaborating institutions (William Beaumont Hospital, Stanford University, University of Illinois Chicago and University of Utah). Hospitalized infants who receive ROP screening examinations for routine care will be eligible for this study, and will be offered the opportunity to participate. Subjects who provide informed consent will have clinical data from routine care collected along with demographic characteristics, results from routine ROP screening examinations, presence of systemic disease or risk factors. Retinal photographs will be taken during these routine eye exams, using a commercially-available camera that has been FDA-cleared for taking pictures from retinas of premature infants. These retinal pictures do not contain any identifiable patient information, and are taken as routine standard of care. The long-term goal of this research is to establish a quantitative framework for retinopathy of prematurity (ROP) care based on clinical, imaging, genetic, and informatics principles. The investigators have previously recruited and rigorously phenotyped and genotyped a large study cohort, including implementation of a novel reference standard diagnosis; and built a world-class research consortium for image, genetic, and bioinformatics analysis. Read Less