Tennessee Paid Clinical Trials

XLPAD is an observational study designed to evaluate the effectiveness and use of stent and non-stent based therapies among PAD patients. The study will create a registry that will include entry of procedural and clinical follow-up information into an online data collection software, REDCAP.Data available since Jan 1 2005 will be included in the registry, until 14,000 patients have been included. The primary objectives of this observational registry study are to: 1. Compare stent and non-stent based outcomes defined as a composite of symptom driven target vessel revascularization (TVR), unplanned surgical revascularization of the target limb and need for target limb amputation through 12 months post-index procedure (Primary efficacy endpoint) 2. Compare stent and non-stent based outcomes defined as a composite of causes such as: death, myocardial infarction (MI), stroke, peri-procedural complications, target vessel revascularization (TVR) and unplanned surgical revascularization/amputation of the target limb through 12 months (Primary safety endpoint) 3. Compare stent and non-stent based change in walking distance, Rutherford category and/or ankle- brachial index (ABI) at 12 months compared to baseline (Primary clinical improvement endpoint) Approximately 14,000patients will be enrolled at approximately 60 sites worldwide. Enrollment in the observational study will be monitored in an effort to achieve at least 20% (and no more than 80%) of the population receiving stents as the initial treatment strategy. Follow-up visits by sites will be reported at 6 and 12 months after index procedure to collect data on treatment patterns and effectiveness, and outcomes. The follow-up procedures are not mandated by the registry protocol. Each site will be encouraged to enter follow-up information derived from clinically indicated follow-up visits. All events post-index procedure till the 7th month will be reported under the 6 month follow-up form and subsequent follow-up till the 13th month post-procedure will be entered on the 12 month follow-up form. Patient management and treatment decisions are at the discretion of the care team per routine clinical practice. The procedural aspects (including selection of stent type or non-stent based treatments) and follow-up are not mandated by the registry and will be up to the discretion of the operator and/or based upon the practice dictated by the clinical care of the patient. Therefore the study poses minimal risk to the patient. Read Less

This study will validate a previously developed pediatric prognostic biomarker algorithm aimed at improving prediction of risk for the later development of chronic graft-versus-host disease (cGvHD) in children and young adults undergoing allogeneic hematopoietic stem cell transplant. By developing an early risk stratification of patients into low-, intermediate-, and high-risk for future cGvHD development (based upon their biomarker profile, before the onset of cGvHD), pre-emptive therapies aimed at preventing the onset of cGvHD can be developed based upon an individual's biological risk profile. This study will also continue research into diagnostic biomarkers of cGvHD, and begin work into biomarker models that predict clinical response to cGvHD therapies. Read Less

The objective of this study is to improve medication, symptom, and disease management of patients with hematological malignancies and multiple chronic conditions (2 or more conditions in addition to cancer) through care coordination between pharmacists working in oncology practices and those working in primary care or community practices (Pharmacists Coordinated care Oncology Model \[PCOM\]). This is a pilot study in which the investigators will examine the association between outcome measures, but the study design and sample size are insufficient to quantify the impact of OAA initiation or OAA adherence on adherence to chronic medications. This pilot study and data analyses are being done in preparation for a larger, controlled study. Read Less

RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at molecular predictors of cancer in patients at high risk of lung cancer. Read Less

Anterior vertebral body tethering (AVBT) is a novel, minimally invasive, growth modulation technique that was recently approved by the FDA under a Humanitarian Device Exemption (HDE). The goal of AVBT is to control curve progression by applying compression on the convex side of the spine deformity. While there has been great initial enthusiasm about the technique as an alternate treatment option to spinal fusion for skeletally immature children with scoliosis, there is a need to better understand the long-term outcomes. The purpose of this study is to report the long-term clinical outcomes of skeletally immature patients treated with AVBT, specifically: 1. The effect on three-dimensional spine growth as compared to normal controls 2. Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity 3. Complications associated with both the procedure and the device Read Less

This is a prospective implementation study that will include patients that are identified as being average risk for colorectal cancer (CRC) according to USPSTF guidelines and who have opted to be screened for CRC. The purpose of this study is to understand implementation of a noninvasive screening test in primary care and internal medicine clinical settings, and the impact on patient acceptability and adherence of CRC screening. Read Less

This phase II trial tests whether nivolumab and ipilimumab works to shrink tumors in patients with liver cancer that has spread to nearby tissue or lymph nodes (locally advanced), has spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Nivolumab and ipilimumab may be effective in killing tumor cells in patients with liver cancer. Read Less

The study will determine if Therapeutic Plasma Exchange removes RNA biomarkers associated with Alzheimer's Disease and how quickly those biomarkers reappear after treatment. Read Less

A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months. Read Less

The electrolyte test products are composed of powder and provided in individual stick packs with 5 vitamins including Vitamins B3, B5, B6, B12 and Vitamin C. The products are gluten-, soy-, and dairy-free, and provide electrolytes at concentrations well below the daily value (DV). The DV tells us how much a particular nutrient in a serving of a food product contributes to a daily diet, based on a standard 2000 calorie diet. Despite what the name suggests, this product is taken orally, not intravenously. These packets contain a small percentage of the needed total daily electrolytes but adequate amounts to replace lost electrolytes as a result of physical activity. The products will be consumed following a 90-minute bout of cycling exercise at a moderate intensity of 70-80% max heart rate, at 30-32°C (86-89°F) and 50 ± 5% relative humidity. This same exercise duration and room temperature has been used in a recent study, which also utilized the same body temperature monitoring device as proposed in the present study. The purpose of the exercise bout is to simulate what many individuals are exposed to when exercising in the heat and to moderately dehydrate subjects, as would be the case during a moderate run or cycling event in exercise-trained individuals. Subjects will report to the lab on three separate occasions to consume one of the 3 drinks (hydration multiplier, sugar-free hydration matrix, or water), in random order. The drinks will be consumed during the post-exercise period (30 minutes following the completion of exercise). Read Less

This study aims to evaluate the safety, tolerability and efficacy of R2R01 combined with terlipressin as compared to terlipressin alone in the treatment of patients with HRS-AKI Read Less

Objectives / Specific Aims * The purpose of this study is to investigate the acute effects of a single bout of moderate intensity maternal exercise on fetal well-being in a pregnancy affected by fetal growth restriction. Fetal well-being will be measured by biophysical profile (BPP), non-stress test (NST) and umbilical artery dopplers. * The hypothesis is that a single bout of maternal exercise will not significantly alter fetal well-being or fetal status. Read Less