Clinical Research Directory

Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City

In this study, individuals living with diabetes in the Birmingham area will participate in a free, 3-month DSMES program hosted by MedsPLUS Consulting, a local independent pharmacy and wellness center, at a local faith-based organization. DSMES sessions meet twice a month and typically address topics including physical activity, nutrition, coping, and reducing risk and complications. Prior to beginning the program, participants will complete a questionnaire that assesses diabetes self-management behaviors (such as diet, physical activity, and medication adherence) and diabetes knowledge. Additionally, they will participate in a biometric screening where clinical data such as blood A1C, blood pressure, blood cholesterol, and BMI are collected. This data will also be collected again after the completion of the program. In this program, participants will be assigned a community health worker who will contact them outside of scheduled DSMES sessions to provide support. Participants will also be randomly assigned to one of two cohorts, the Traditional cohort and the Remote Patient Monitoring (RPM) cohort. The traditional cohort will use paper trackers to track blood pressure and blood sugar outside of DSMES sessions while the RPM cohort will utilize an RPM platform to track this data.

Measurement Agreement Between IBP and NIBP During Induction of Anesthesia in High Risk Patients

The AGREE-BP study aims to evaluate how closely blood pressure measurements taken with an automated upper-arm cuff agree with measurements taken through a small plastic tube placed in an artery, called an arterial catheter, during the start of general anesthesia. Blood pressure can change rapidly when patients receive medication to induce general anesthesia. These changes may be particularly pronounced in patients with heart or blood vessel disease or high blood pressure. An upper-arm cuff measures blood pressure at intervals, whereas an arterial catheter measures it continuously with each heartbeat. Although cuff measurements are widely used, their agreement with arterial catheter measurements during this period of rapid change is not fully evaluated and validated. This observational study will include 120 patients undergoing surgery under general anesthesia at University Hospital Graz, Austria. Participants will have conditions that increase their risk of blood pressure changes and will already require an arterial catheter before anesthesia for medical reasons. During the first five minutes after administration of the medication used to induce anesthesia, researchers will record blood pressure using both methods. The cuff will be placed on the arm opposite the arterial catheter and will take measurements at least once per minute, or more frequently if the monitor allows. Anesthesia and treatment decisions will remain the responsibility of the treating clinician. Participation does not require additional follow-up visits. The main aim is to assess agreement in mean arterial pressure, which is the average pressure in the arteries over a heartbeat. Researchers will also compare systolic pressure, the pressure when the heart contracts, and diastolic pressure, the pressure when the heart relaxes. They will examine whether patient characteristics or treatments are associated with differences between the two measurement methods and will separately assess agreement during particularly large, rapid blood pressure changes. The findings may help clinicians understand when cuff measurements differ meaningfully from arterial catheter measurements and inform future decisions about blood pressure monitoring during the start of anesthesia.

Comparison of HPI-guided Norepinephrine Boluses, ClearSight-guided Norepinephrine Infusion, and Oscillometric-guided Norepinephrine Infusion for Blood Pressure Stability During Cesarean Delivery

Background: Post-spinal hypotension occurs in 50-80% of cesarean deliveries and causes maternal nausea, vomiting, and reduced neonatal vigor; norepinephrine (NE), as boluses or prophylactic infusion, is the mainstay of treatment. Intermittent cuff monitoring cannot anticipate hypotension, whereas the Hypotension Prediction Index (HPI), derived from the noninvasive ClearSight arterial waveform, predicts hypotension (MAP \< 65 mmHg) up to 5 minutes in advance. A previous randomized trial by the investigators showed that HPI-guided management reduced hypotension burden and maternal nausea and vomiting during cesarean delivery. The investigators hypothesize that HPI-guided NE boluses provide better hypotension control than prophylactic NE infusion, with lower total NE dose, less reactive hypertension, and less maternal discomfort. Methods: This single-center, randomized, open-label trial at National Taiwan University Hospital enrolls women aged 20-50 years with singleton pregnancies undergoing non-emergent cesarean delivery under neuraxial anesthesia. Exclusions: preeclampsia, NYHA class ≥ II cardiopulmonary disease, arrhythmia, pre-existing cardiovascular disease, BMI \> 40, and failed spinal or block below T6. A total of 180 parturients will be randomized 1:1:1 into three groups of 60 (51 per group required for 80% power, plus allowance for dropouts). All participants receive standard monitoring (ECG, pulse oximetry, cuff every 2.5 min, ClearSight, bilateral cerebral oximetry), a 1000 mL Ringer's preload, and combined spinal-epidural anesthesia with 12 mg of 0.5% hyperbaric bupivacaine. Hypotension is defined as MAP \< 65 mmHg and bradycardia as HR \< 60/min (treated with atropine 0.01 mg/kg). Group allocation is revealed to the anesthesiologist after block completion. The three groups differ in the monitoring used to guide treatment and in the mode of NE administration: 1. HPI bolus group (reactive boluses guided by continuous monitoring plus prediction): blood pressure is monitored with the ClearSight continuous arterial waveform and HPI, and no values are blinded. No prophylactic infusion is given. The target is HPI ≤ 85; when HPI exceeds 85 for 30 s, NE 5-10 mcg is given as a bolus (plus atropine 0.01 mg/kg if HR \< 60/min). If ClearSight MAP falls below 65 mmHg, NE 5-10 mcg is given immediately regardless of HPI. 2. ClearSight infusion group (prophylactic infusion guided by continuous monitoring): blood pressure is monitored with the ClearSight continuous arterial waveform; cuff readings and HPI are blinded. Prophylactic NE infusion begins immediately after spinal anesthesia at 0.04 mcg/kg/min and is titrated to maintain MAP ≥ 65 mmHg. Rescue boluses of NE 5 mcg (MAP 55-65 mmHg for 30 s) or 10 mcg (MAP \< 55 mmHg for 30 s) are given; the infusion is paused when MAP exceeds 100 mmHg for 30 s and resumed when MAP falls below 75 mmHg. 3. NIBP infusion group (control; prophylactic infusion guided by intermittent cuff monitoring): blood pressure is monitored with the conventional oscillometric cuff only; all ClearSight values are blinded. The same prophylactic NE infusion (0.04 mcg/kg/min, titrated to MAP ≥ 65 mmHg), rescue bolus thresholds (5 mcg for MAP 55-65 mmHg; 10 mcg for MAP \< 55 mmHg), and infusion-pause rule (MAP \> 100 mmHg, resume at \< 75 mmHg) are applied based on cuff readings. The primary outcome is the time-weighted average of MAP \< 65 mmHg (TWA, mmHg) during the first 30 minutes after spinal anesthesia, calculated from ClearSight data in all groups. Secondary outcomes include umbilical arterial and venous blood gases (pH, pCO2, pO2, base excess, lactate); time-adjusted AUC for systolic pressure below 80% of baseline; incidence and total duration of hypotension; area under the 65 mmHg threshold; total NE and atropine doses; maternal symptoms (nausea, vomiting, bradycardia, dizziness, shivering); number of hypotensive events detected by cuff versus ClearSight; MAP and cerebral oximetry at eight time points (baseline through 15 min post-spinal); and breastfeeding effectiveness assessed with the LATCH score on postoperative day 2 and at discharge. Statistical analysis: Continuous data will be compared by one-way ANOVA or Kruskal-Wallis test with Conover-Iman post hoc tests; categorical data by chi-square or Fisher's exact test; repeated measurements by repeated-measures ANOVA or linear mixed-effects models (two-tailed, p \< 0.05). Safety and ethics: The intervention is low risk (finger-cuff discomfort, vasopressor-related hypertension or bradycardia, managed per protocol). Informed consent will be obtained and data coded and securely stored. Enrollment is planned from June 2026 to June 2028, with analysis and manuscript preparation through December 2028.

Monitoring Blood Pressure at Home and Pharmacy Telehealth Among People Living With HIV

The overall goal of this project is to determine if measuring blood pressure at home and staying in contact with a team of pharmacists and physicians to manage participants' blood pressure is useful. The study will enroll 552 participants who are seen at the University of Alabama at Birmingham 1917 Dewberry Clinic and Vanderbilt Comprehensive Care Center. Half of the participants (276 patients) will be asked to measure blood pressure at home, and half of the participants (276 patients) will continue to receive usual care. Participants who measure blood pressure at home will also meet with a pharmacist weekly over the phone to discuss blood pressure readings and have blood pressure medications prescribed if needed. This program will last 6 months.

Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

This study aims to validate the accuracy and reliability of blood pressure (BP) estimates obtained over 24 hours using a PPG-based chest-patch device compared to the gold standard ambulatory blood pressure monitoring (ABPM) method using an upper arm cuff-based oscillometric BP device, in both hypertensive and normotensive individuals referred by their provider to undergo a 24-hours ABPM for clinical indication. The Awake/Asleep test, which is the primary test recommended for automated wearable cuffless BP devices that are cuff-calibrated (based on the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices), will be conducted in this study. The secondary aim of the study is to assess the feasibility and convenience of the PPG-based device.

Wearable Blood-Pressure Monitoring Comparison Study

The goal of this clinical trial is to compare the accuracy, clinical applicability, and usability of different wearable blood pressure monitoring methods integrated in wearable devices, such as smartwatches, in hospitalized patients. The study evaluates novel photoplethysmography (PPG)-based and wrist-oscillometric blood pressure measurement methods against established clinical reference methods (upper-arm cuff measurements on the general ward and invasive arterial blood pressure monitoring (A-line) in the intensive care unit). The main questions the study aims to answer are: * Can novel blood pressure monitoring methods suitable for integration into wearable devices achieve clinically acceptable agreement with established reference measurements? * How does the performance of calibration-dependent wearable devices change over time following calibration? * How does the performance of the investigated methods compare with each other? * How do the investigated methods perform for patients with different pre-existing conditions ? To answer these questions, participants will undergo: * blood pressure measurements using different wearable devices based on PPG and wrist oscillometry * standardized reference blood pressure measurements using an upper-arm cuff (general ward) or an existing invasive arterial line (intensive care unit) * repeated measurements over three consecutive days on the general ward to assess calibration stability and measurement reproducibility,

Noninvasive Blood Pressure Validation Study

The purpose of this study is to test how accurately the Perin Health Patch, a small wearable sensor worn on the chest, measures blood pressure without using an arm cuff. Adults 22 to 90 years of age wore the patch while trained observers took blood pressure readings at the same time using a standard arm cuff and stethoscope. The patch readings were then compared to the standard readings to see how closely they match, following recognized international testing standards for blood pressure devices (ISO 81060-2 and IEEE 1708). Participants visited one of three study sites up to three times over about one week. At the final visit, participants also did light resistance band exercise to briefly raise their blood pressure and relaxation activities to lower it, so the patch could be tested while blood pressure was changing.

Data Collection Study Using CS (CardiacSense) BP (Blood Pressure) Watch and Pillow Systems

Collect raw data from CS Watch System, CS BP Pillow System, Arterial line (A-line) and auscultatory cuff measurements in volunteers. The data collected in the study will be used for development of the CS BP algorithms.

Data Collection Study Using CS BP Pillow System

Collect raw data from CS BP Pillow System ,CS BP Plate System, IR (Infrared) PPG (Photoplethysmography) sensors and Arterial line (A-line) in volunteers. The data collected in the study will be used for development of the CS BP algorithms.

Pressure Sensing Sheath Blood Pressure Monitoring Compared to Traditional Methods in Interventional Procedures

This observational study aims to evaluate the accuracy and safety of pressure sensing sheath blood pressure monitoring compared to traditional invasive and non-invasive blood pressure monitoring methods during neuroendovascular interventional procedures. The study will enroll 50 adult patients undergoing elective neuroendovascular procedures requiring general anesthesia and continuous invasive blood pressure monitoring. Blood pressure will be simultaneously measured using three methods: (1) pressure sensing sheath, (2) radial arterial line, and (3) non-invasive cuff monitoring. The primary outcome is the accuracy of blood pressure measurements from the pressure sensing sheath compared to radial arterial line measurements. Secondary outcomes include the incidence of access site complications, procedure duration, patient comfort scores, and cost-effectiveness analysis. This prospective, single-center study will be conducted at Shanghai Fourth People's Hospital Affiliated to Tongji University from August 2025 to May 2027.

Community Health Worker Coaching to Reduce Cardiovascular Risk Among Women After a Hypertensive Disorder of Pregnancy

The goal of this clinical trial is to find out whether an enhanced program works better than remote blood pressure monitoring (RBPM) alone for women who had high blood pressure during pregnancy. The enhanced program combines RBPM with a lifestyle program led by a community health worker (CHW). The study will examine whether the enhanced program helps women better control their blood pressure, lowers their average resting blood pressure, improves heart health risk factors (such as weight, diet, physical activity), supports mental well-being, and reduces emergency department visits and hospital readmissions by 6 months after delivery.

taVNS During Multi-site HRV Measurement: Reliability & Agreement Study

This study examines the reliability and agreement of autonomic nervous system measurements obtained from different anatomical sites during transcutaneous auricular vagus nerve stimulation (taVNS). taVNS is a non-invasive electrical stimulation delivered to the ear using a small stimulator. Healthy volunteers aged 18-40 years will participate in one laboratory session. Heart rate and heart rate variability will be recorded from the chest (reference), finger, and arm. Blood pressure and pulse will also be measured. Data will be collected in three standardized periods: T0 (5-minute resting baseline), T1 (10 minutes during taVNS), and T2 (5-minute recovery). The main goal is to determine how closely finger- and arm-based measurements match the chest reference and how consistent these measurements are across the study periods. Participation is voluntary, and participants may withdraw at any time. Expected risks are minimal and may include temporary tingling or mild discomfort at the ear and, rarely, lightheadedness. No direct medical benefit is expected, but the findings may help improve how autonomic responses are monitored during taVNS in future research.

Transcutaneous Auricular Vagus Nerve Stimulation and Spirometry: Sham-Controlled Randomized Trial

This study will examine the short-term effects of transcutaneous auricular vagus nerve stimulation (a non-invasive electrical stimulation delivered through the outer ear) on lung function measured by spirometry in healthy adults. The vagus nerve is involved in many automatic body functions, and ear-based stimulation has been used in research to explore its possible effects on different physiological systems. However, it is not clear whether a brief stimulation session can acutely influence breathing test results in people without respiratory disease. Healthy volunteers aged 18-40 will take part in one laboratory visit. Participants will be randomly assigned to one of two groups: (1) active bilateral stimulation applied to specific ear regions that are known to be innervated by the vagus nerve, or (2) sham stimulation using the same device setup but designed to minimize vagal activation. The stimulation session will last approximately 10 minutes. Before and after the stimulation, participants will perform standard spirometry (breathing) tests. Primary spirometric outcomes will include common measures of lung function such as forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and peak expiratory flow (PEF). Heart rate, heart rate variability, and blood pressure may also be recorded to monitor physiological responses and safety during the visit. Participation is voluntary and participants may withdraw at any time. The procedure is considered minimal risk. Possible side effects are usually mild and temporary, such as tingling, warmth, or mild discomfort at the ear. Rarely, participants may feel lightheaded; if this occurs, the procedure will be stopped and the participant will be monitored until symptoms resolve. There is no guaranteed direct benefit to participants. The results may help clarify whether short-term ear-based vagus nerve stimulation can influence spirometric parameters and may inform future studies on autonomic and respiratory interactions.

Impact of Semaglutide Withdrawal on Cardiometabolic Profile and Physiology of Energy Balance: Recovery Effects After Semaglutide Termination

Semaglutide is a medication from the class of drugs called glucagon-like peptide-1 agonists that promote weight loss. There is little clinical data on the best strategy to achieve weight maintenance following weight reduction induced by semaglutide. For people who need to discontinue treatment, it is unknown whether the weight regain, its accompanied health benefits could be ameliorated with a gradual reduction in semaglutide. The investigators will study if a gradual reduction of semaglutide is associated with different heart risk profile and hormones involved in energy regulation as compared to immediate treatment cessation.

Evaluating the Level of Agreement Between AAMI/ESH/ISO Universal Standard Requirements and the HUAWEI D2 Watch-Type Wrist Blood Pressure Monitor

Getting an accurate blood pressure (BP) reading is essential for diagnosing high blood pressure and managing it effectively. High blood pressure is a major health problem, causing about 9.4 million deaths worldwide each year. More people need to monitor their BP at home, so there is greater demand for easy-to-use devices. Traditional BP monitors with arm cuffs can be bulky, uncomfortable, and awkward to use. Modern technology has made it possible to measure BP using wearable devices like smartwatches. HUAWEI has developed a wrist watch that can measure BP and has been tested to meet international standards. The watch passed these tests and was approved for people to use at home to check their own BP. However, the HUAWEI watch was only tested on people in China and the investigators need to know if it works for people from other countries and ethnic backgrounds.

Effect of Music and Warm Foot Bath Therapy on Pregnancy-Related Anxiety, Blood Pressure and Quality of Life

Study Title: The Effects of Music Therapy and Warm Foot Bath on Pregnancy-Related Stress, Blood Pressure, and Quality of Life in Low-Risk Primigravida Women Brief Summary: This randomized controlled trial investigates the impact of music therapy and warm foot bath therapy on pregnancy-related anxiety, blood pressure levels, and quality of life in low-risk primigravida pregnant women. Participants will be randomly assigned into four groups: music therapy, warm foot bath therapy, combined therapy, and control group. The interventions will be carried out for 2 weeks with pre- and post-assessments of anxiety and quality of life.

Non-Invasive Blood Pressure Monitoring in ICU Patients Using the DARE Device

This study tests a new non-invasive device called DARE to monitor blood pressure in patients in intensive care. It compares the device's readings to standard invasive methods and also looks at how well it measures other vital signs like temperature, oxygen levels, and heart rhythm. The goal is to improve patient safety and comfort while helping doctors detect problems earlier.