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NCT03924674
Intravenous fluids (IVF) are used in hospitalized patients to replenish the fluid and electrolyte losses of patients who cannot take adequate hydration by mouth or through their gut. Inappropriate use of IVF may cause serious problems, including abnormalities in blood electrolytes such as sodium, which can lead to serious but rare neurologic harm; pain and discomfort from multiple IV insertions and subsequent complications (e.g., IV infiltration); and inadequate monitoring for adverse effects. Investigators currently don't know what the most commonly used IVF in hospitalized pediatric patients are, and there are no national benchmark data for IVF use. The American Academy of Pediatrics published a Guideline on maintenance IVF in November 2018, which contains one major recommendation: to use isotonic (having a similar electrolyte concentration to blood plasma) maintenance IVF in medical and surgical patients 28 days to 18 years old without pre-existing serious illnesses. This project aims to better describe and standardize the use of IVF in inpatient pediatric settings across the U.S. and evaluate the impact of an intervention bundle on maintenance IVF use. This project aims to improve health care value by reducing the number of routine laboratory draws. In Quality Improvement research, there are three different types of measures - outcome measures, process measures and balancing measures. In this project, the following will be used as a process measure: The proportion of daily weight measurements for patients on maintenance IVF. The following will be used as balancing measures: 1. There will be no increase in the number of floor-to-PICU transfers during hospitalization from baseline. 2. There will be no increase in the number of serum sodium lab results obtained from baseline. 3. There will be no increase in adverse events prompting a change in clinical management from baseline: hypertension or edema requiring a diuretic, hypertension requiring anti-hypertensive medication, and acute kidney injury (AKI) requiring renal replacement therapy (RRT)/dialysis.
NCT03861936
Based on the results of the Phase 2 Study 191622-130 \[NCT02010775\], the current Phase 2b study is designed to further evaluate the safety and efficacy of BOTOX® for the treatment of Masseter Muscle Prominence (MMP) in adults.
NCT00078754
This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED).
NCT04681599
Several clinical procedures have been described as aerosol generating procedure (AGP), including nebulization, high-flow nasal cannula oxygen therapy, noninvasive ventilation, and bronchial hygiene treatment, etc. However, the understanding on the transmission risk of these treatments is still unclear, particularly the methods to reduce the airborne particulate concentrations during these treatments are still lacking. This study is aimed to compare different modalities in reducing airborne particulate concentrations during these aerosol generating procedures, in order to find the most effective method to reduce particle concentrations, ultimately to decrease the transmission risk and protect health care providers.
NCT01887717
This is a two-arm, open-label, prospective, multi-center, randomized, active-controlled clinical trial to assess efficacy and safety of TheraSphere in comparison to standard of care therapy (sorafenib) in the treatment of participants with inoperable liver cancer and blockage of the portal vein.
NCT03795597
In this protocol, the investigators hypothesize that the combination of intravenous busulfan and melphalan with carfilzomib will be an effective preparative regimen with acceptable toxicity for participants with multiple myeloma who are candidates for autologous stem cell transplantation. To test this hypothesis, the investigators designed a phase I/II trial combining IV busulfan 130 mg/m2 plus melphalan 140 mg combined with escalating doses of carfilzomib ranging from 20 mg/m2 to 45 mg/m2. These results will be compared with the center's historical controls of participants treated with melphalan, busulfan and bortezomib.
NCT04052815
Is well known that obesity is increasing in the United States (US) and particularly among Hispanic/ especially in in socially disadvantaged groups. Studies have shown that the prevalence of metabolic syndrome is about 1.5 times higher among Mexican American females living in the US compared to non-Hispanic females. Culturally among Hispanic/Latino females some activities like grocery shopping and meal cooking in households that most likely impact other family members. Culturally grounded interventions can be made readily tailored and translated into real-world settings by utilizing collaborative, community based participatory approaches. The overall objective of this study is to offer a diabetes prevention program to the community, targeting adult females with Hispanic/Latino background population that could benefit from a sustainable change behavior program to reduce the risk of developing Type 2 Diabetes, metabolic syndrome and cardiovascular disease. Sessions will be conducted in Spanish or English according to participants' preferences. The program format is to meet for one year. Cadence will be once a week for the next 16 weeks (Core curriculum), then once a month (maintenance curriculum). In addition to the DPP curriculum a structured physical activity component will be added, with the objective of facilitating achievement of program goals. Other culturally tailored activities will be included like: grocery shopping, recipes community walking maps and other available community resources. In addition the investigators will utilize a qualitative approach to gather information about project's feasibility and acceptability. To do so, investigators plan to conduct 60 minutes focus groups and semi structured interviews at the end of the 16 week core-program and at the end of the program (program participants and staff members).
NCT02522884
This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in subjects with post-balloon angioplasty (post-PTA) dissection(s) type(s) A through F in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm.
NCT03425188
Prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System.
NCT03203629
To conduct a prospective, observational study to evaluate the non-interventional feasibility of using heart sounds measurements recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD) for monitoring clinical evidence of heart failure decompensation.
NCT00674661
Prospective, randomized multicenter study to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with ectasia after refractive surgery.
NCT01972854
The objectives of this study are to evaluate the safety and efficacy of corneal collagen cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as compared to placebo in impeding the progression of, and/or reducing, maximum corneal curvature.
NCT01167595
Critically ill patients are consistently underfed. Feeding protocols are standardized system tools used to guide nutrition practices, but to date have failed to improve delivery of nutrition. The PEP uP Protocol is a new enhanced feeding protocol. Twenty North American Intensive Care Units (ICUs) will assess baseline nutrition practices. Ten ICUs will be randomized to implement the PEP uP Protocol and educational intervention, and ten will be randomized to continue usual care. Nutrition practices will be reevaluated 6 months after baseline. The investigators hypothesize that the PEP uP Protocol will increase delivery of nutrition, and may ultimately lead to improved survival of critical illness.
NCT01844765
To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to \<18 years).
NCT01090362
The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF Registry) is a non-interventional, observational study that characterized a global population of non-valvular atrial fibrillation patients. The registry was used to document global baseline characteristics, current treatment strategies and outcome measures. Characterisation of a number of AF sub-populations was also completed. GARFIELD-AF is an independent academic research initiative sponsored by the Thrombosis Research Institute (London, UK) and supported by an unrestricted research grant from Bayer AG (Berlin, Germany).
NCT02661217
To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.
NCT00442364
The purpose of this study is to determine the safety of the Varisolve® procedure in patients with right-to-left cardiac shunt (a defect in the heart).
NCT01893359
The objectives of this study are to evaluate the safety and efficacy, with regards to regression of refractive outcome, as measured by manifest refraction spherical equivalent (MRSE), of two treatment regimens for hyperopic and hyperopic astigmatic subjects: LASIK followed by cross-linking performed with the KXL System and Photrexa ZD™ (Riboflavin Ophthalmic Solution), as compared to LASIK alone.
NCT03317444
This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12 weeks once daily. The maximum study duration is anticipated to be up to 16 weeks.
NCT03296163
This is a multicenter, multinational, double-blind, 1:1 randomized, parallel-group, equivalence Phase 3 study to compare the efficacy and safety of MB02 plus chemotherapy (carboplatin and paclitaxel) versus Avastin® plus chemotherapy (carboplatin and paclitaxel) in subjects with Stage IIIB/IV non-squamous NSCLC
