All Clinical Trials

Acupuncture is believed to increase blood pressure in people who struggle with low blood pressure. This is a common problem facing people with heart failure, and sometimes these people need to take medications to artificially increase their blood pressure. This study is designed to determine if using acupuncture in people with heart failure can improve their blood pressure enough to not require medications to artificially increase blood pressure. Read Less

This study will evaluate the retention effects of a four-week whole-body vibration training intervention in children with Cerebral Palsy. The primary outcomes for this study are gait function, including Timed Up and Go and the two-minute walk test. Secondary outcomes of this study include lower extremity gait function, coordination, and gait variability. For this study, a total of 10 children with Cerebral Palsy (CP) will be recruited with 5 being randomly placed into an experimental group and 5 being randomly placed into a control group. Each participant, regardless of group, will complete pre-, post-, and retention testing, with a four-week whole-body vibration training intervention between the pre- and post-testing. The four-week whole-body vibration training will include three visits per week, with the experimental group receiving a vibration stimulus while standing on a vibration platform. Vibration sessions will consist of three-minutes of vibration, followed by three minutes rest, completing this cycle three separate times. The control group will follow a similar pattern, but rather than experiencing vibration, they will hear a sound of the vibration platform through a speaker. Once the four-week training session is finished, participants will return after a three-month retention period to determine whether ambulation function was retained. Read Less

The FIRST project compares the dose of robotic gait training (RGT) with usual care gait training for patients with spinal cord injury (SCI) undergoing rehabilitation at Baylor Scott & White Institute for Rehabilitation (BSWIR). Read Less

This pilot study has been designed to investigate the safety of pembrolizumab treatment for disease relapse following allogeneic stem cell transplant (alloSCT). Pembrolizumab will be administered at a fixed dose of 200 mg IV every 3 weeks. Approximately 12-26 patients with relapsed MDS, AML, or mature B cell (B-NHL, cHL) malignancies that have relapsed following alloSCT will be enrolled on this trial. Pembrolizumab treatment will be administered for up to 24 months, provided that neither disease progression, nor development of a dose-limiting toxicity (DLT), has occurred. Adverse events will be monitored every three weeks throughout the trial and graded in severity according to the guidelines outlined in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. This trial will be conducted in accordance with Good Clinical Practices. Read Less

High sodium intake is a significant risk factor for hypertension. Recently, animal studies connect high sodium intake to the gut-immune axis and highlight the gut microbiome as a potential therapeutic target to counteract salt-sensitive conditions and hypertension. The objective of this project is to determine the effects of high salt intake on gut microbiota composition and gut intestine barrier integrity, leading to increased BP in humans. The investigators also hypothesize that high salt intake affects the gut microbiome in a sex-specific manner. In this pilot study, The investigators also test whether telehealth or in-person nutritional coaching help to decrease dietary sodium intake and improve diet quality Read Less

In 2017, the American College of Cardiology and the American Heart Association changed the diagnostic criteria for hypertension in non-pregnant adults. The parameters for the diagnosis of stage 1 hypertension were revised from a systolic blood pressure (BP) of 140 to 130 mm Hg and a diastolic BP of 90 to 80 mm Hg. Based on new criteria, stage 1 hypertension is associated with a 2-3 fold increased risk of preeclampsia. There are no data regarding prevention of preeclampsia in women with stage 1 hypertension. Low-dose aspirin has been used during pregnancy to prevent preeclampsia for women at high-risk for preeclampsia. Although the precise mechanism remains uncertain, it is possible that low-dose aspirin improves placental perfusion, which results in a decreased rate of preeclampsia. A study that examines the effect of low-dose aspirin on placenta vasculature and tissue elastography by using novel ultrasound tools would be useful. The 2017 Aspirin for Evidence-Based Preeclampsia Prevention trial compared 150 mg aspirin with placebo in women at high-risk of preeclampsia based on a first-trimester screening. They found a significant decrease in the rate of preterm preeclampsia (4.3% vs. 1.6%; P <0.01). Since this study used the screening algorithm including first-trimester serum markers and uterine artery Doppler, the generalizability in the U.S. women with stage 1 hypertension is limited. Our pilot study will examine 1) the effect of low-dose aspirin 81 mg in women with stage 1 hypertension on placental vasculature and shear-wave elastography; 2) the rate of preterm preeclampsia in women with stage 1 hypertension in a control group and in pregnancies treated with low-dose aspirin 81 mg; 3) feasibility of conducting a larger multicenter randomized controlled trial on this subject. Read Less

The Care Continuity Program (CCP), a product of Sure Med Compliance, is a novel, online patient self-assessment used by prescribers of opioids to better identify patient risk factors and therapy benefit. This tool is completed by the patient, outside of the office, using an internet enabled device and follows a compliance driven protocol developed by analyzing case law against physicians in mis-prescribing opioid cases. Results, in the form of a date and time stamped legal report, are instantly transmitted to the prescriber's electronic health records, mitigating the prescriber's civil and criminal risk. A brief of findings is displayed within the software through a dashboard and on the summary page of the report. This software offering includes a mobile and standard web-based application. The objective of the proposed research is to validate the protocols and delivery system of the CCP by measuring patient outcomes, prescriber confidence, and completeness of documentation in the patient chart in primary care and pain management settings, pre and post implementation of the CCP. Read Less

Effective nutrition strategies for combatting and/or preventing obesity still need to be identified. This has been the case despite the numerous and different approaches that have been taken. Potential targets for combatting/preventing obesity have been identified, but long-term solutions have not emerged. This study uses time restricted feeding to study the role of dietary protein in obesity prevention and/or treatment. The objectives are to determine the role of skeletal muscle mass as a driver of energy-sensing mechanisms and peripheral signals that regulate appetite and energy intake in overweight and obese adults and to determine the effects of protein timing on muscle mass to regulate appetite and energy intake in overweight and obese adults. Read Less

This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different targeted outreach interventions aimed at increasing Covid-19 vaccine uptake. Veterans who are eligible for COVID-19 vaccine receipt by priority status (based on institutional guidelines) will be identified. Veterans must be enrolled into Veterans Health Administration (VHA) care and meet age or illness institutional priority guidelines to be eligible. Veterans eligible for enrollment into the trial will be randomized in a 1:1:1 allocation at an individual level, using permuted block randomization (with random block sizes of 3 and 6) to the following interventions: Control arm - receives a text message with standard messaging Arm 2 - receives a text message with a message framed for scarcity Arm 3 - receives a text message with a message framed for improving the social good Read Less

The objective of the Gestational Diabetes Genetic Socioeconomic Risk Study is to generate genome wide association study data (GWAS) to calculate polygenic risk scores (PRS) for the development of gestational diabetes in pregnant women. Oshun Medical's GWAS study will be conducted by collecting DNA samples alongside medical and socioeconomic data and applying data science methodology to generate a polygenic risk score algorithm for gestational diabetes. Our hypothesis is that key genetic variants linked to gestational diabetes will be identified, and sociodemographic characteristics may impact epigenetic factors which further contribute to this risk of gestational diabetes. The PRS generated through our study will be combined with an analysis of epigenetic factors to produce a new method for predicting risk of developing gestational diabetes during pregnancy. Read Less

This study is looking to minimize side effects, while maintaining and potentially improving the therapeutic benefit to patients suffering from Female Sexual Arousal Disorder by providing a topical preparation of Sildenafil locally to the vulvar-vaginal tissue. Read Less

Purpose of this clinical investigation is to establish the performance of the iCareDx PSS-1 RT PCR POC Testing Platform which is used to detect COVID-19 in symptomatic patients using the patients saliva. The study focuses on obtaining a minimum of 30 positive and 30 negative test for this study. Results will serve to establish the assay's performance. Symptomatic patients who are being tested for COVID-19 will be enrolled and consented into this study. If the patient consents, 2 saliva specimens will be collected for PSS-1 testing. One specimen will be used directly on the PSS-1 while the second one will be stored and used later if a repeat test is needed. This will be performed by comparing SARS-CoV-2 results from the clinical specimens on the PSS-1 platform and Roche Cobas 6800 COVID-19 real time-PCR molecular assay. Read Less