Chicago, IL Paid Clinical Trials

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

Adults with psychiatric disabilities get sick and die 20 to 30 years younger than same-age peers, with even greater disparities occurring when the person is from a low SES or of color. Factors explaining this difference are complex and include genetic comorbidity, iatrogenic effects of medication, life choices, and life consequences. These factors are worsened by service disparities which are often fragmented in the public health system. Peer navigators are part of a program in which providers escort people with psychiatric disabilities around the fragmented system to meet their health and wellness goals, often a demanding task for the person who has needs addressed at clinics, labs, and pharmacies spread across an urban area. Navigators are peers because they have lived experience of recovery and are often from similar ethnic groups. A community-based participatory research program supported by NIMHD and PCORI developed a peer navigator program specific to the needs of people with psychiatric disabilities. Results of two small pilots funded by NIMHD and PCORI showed the Peer Navigator Program (PNP) led to significant improved service engagement which corresponded with better health, recovery, and quality of life. The studies included fidelity measurement which showed peer navigators conducting the intervention at high levels of fidelity. The current research is an efficacy study with a more fully powered test of PNP versus treatment as usual, which is integrated care (TAU-IC). The investigators aim to recruit 300 adults with psychiatric disability who wish to improve physical health/wellness through peer health navigation randomized to TAU-IC or TAU-IC plus PNP. Individuals will participate in assigned interventions as part of 8-month cohorts with data being obtained at baseline, 4, 8, and 12 months. Data will include personal descriptors (demographics, diagnosis, life consequences report), outcomes (service engagement, physical symptoms, blood pressure, recovery, and quality of life), mediators (personal empowerment, self-determination, and perceived relationship for recovery), and process measures (fidelity, feasibility, and acceptability). Investigators hypothesize that those in PNP intervention will have improved outcomes over the integrated care as usual. A cost-benefit analysis will seek to model impact based on quality-adjusted life years. Larger effect sizes will permit post hoc identification of how PNP effects vary by participant characteristics such as ethnicity and gender. Read Less

The SIESTA-Rehabilitation protocol combines two sleep-promoting interventions, (1) empowering nurses to reduce unnecessary disruptions and (2) a systematic protocol to screen, diagnose, and treat sleep-disordered breathing, to determine its impact on relevant sleep and rehabilitation outcomes in the acute inpatient stroke rehabilitation setting compared to the standard of care. Our primary outcome is change in Quality Indicator (QI) score, a measure that has replaced the Functional Independence Measure (FIM) in the inpatient setting at the Shirley Ryan AbilityLab, between admission and discharge. Read Less

The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL. Read Less

The purpose of the study is to evaluate the impact on progression-free survival (PFS) with the combination carboplatin - pembrolizumab in patients with CTC (circulating tumor cells) positive, HER2 negative metastatic breast cancer previously treated with anthracyclines and taxanes. Previous studies have indicated that recurrent breast cancers are more resistant to chemotherapy and maybe associated with a weak immune system. This study is investigating the use of an immune therapy drug, pembrolizumab, that has the ability to restore the capacity of controlling and killing cancer cells of an important component of your immune system called T-cells. Pembrolizumab has been found effective in other types of cancer and has already been approved by FDA for those indications, but the efficacy in breast cancer is still unknown. In this study, pembrolizumab will be combined with chemotherapy to increase the cancer cell killing. There is no control or placebo treatment in this study. Read Less

As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose and method of delivery regardless of their pre-operative risk of transfusion. Therefore, the aim of the study is to determine whether or not repeated dosing of oral or a different method of delivery like intravenous (IV) TXA reduces the post-operative reduction in hemoglobin, hematocrit, number of transfusions, and postoperative blood loss following open spine surgery. Read Less

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention. Phase I studies also try to define the appropriate dose of the investigational therapy to use for further studies. "Investigational" means that the intervention is still being studied and that research doctors are trying to find out more about it. Retroperitoneal sarcomas are soft tissue tumors located at the far back of the abdomen. Typically, patients with retroperitoneal sarcomas either have surgery for the removal of their tumors alone, or have their tumors removed, followed by standard radiation therapy, or have pre-operative radiation followed by surgery. When conventional radiation therapy is delivered after surgery, it can damage normal tissue. In this study, you will undergo proton beam radiation therapy or IMRT before undergoing surgery for the removal of your tumor. Proton radiation and IMRT are FDA approved radiation delivery systems. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop inside the body. In theory, this allows better control of where the radiation dose is delivered as compared to photons. Since proton radiation is more targeted, it may help to reduce unwanted side effects from radiation. In this study, a standard dose of radiation will be given to the majority of the tumor, while a simultaneously integrated boost of additional radiation will be given to certain areas of the tumor identified as higher risk. This means that a higher radiation dose will be given to the higher risk areas of the tumor. The purpose of this study is to determine the highest dose of radiation therapy with protons or IMRT that can be delivered safely in patients with retroperitoneal sarcomas and the effectiveness of proton beam radiation therapy as an intervention for patients with retroperitoneal sarcomas. Read Less

This is a randomized control trial that will evaluate the effectiveness of transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals with hemiplegia due to stroke. Read Less

The current study aims to elucidate the effectiveness of a preventative delirium protocol in patients older than 65 years of age undergoing elective surgery. Read Less

Patients who are ill with COVID-19 may benefit from receiving convalescent plasma infusions containing antibodies from donors who have recovered from the disease and are proven to no longer be infected. Given the current public health emergency due to COVID-19, the FDA has recently fast-tracked the use of convalescent plasma. The purpose for this study is to assess if convalescent plasma collected from donors previously infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, can provide clinical benefit to those acutely ill with the virus and to evaluate if such treatment is safe. There will be two arms in the interventional study, where subjects will either be treated with convalescent plasma or fresh frozen plasma in a randomized and blinded manner. As an additional comparison, the clinical course of subjects enrolled during the period of the study who do not receive an alternative treatment for COVID-19 will be assessed. Read Less

The purpose of this study is to evaluate the platelet count change from baseline and safety of OMS721 in adults and adolescents with atypical hemolytic uremic syndrome (aHUS). The study will also evaluate pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody response (ADA). Read Less