Clinical Research Directory

Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event

Background: Drugs or cell therapies to treat cancer can sometimes cause cytokine release syndrome (CRS). That is, the body makes too many cytokines after treatment. Cytokines are proteins that play a role in the immune system. CRS can cause fever, chills, fatigue, low blood pressure, or breathing problems. Researchers want to know if continuously monitoring a person s body temperature can help reduce the chance of getting serious CRS. Objective: To learn if an approved patch called TempTraq can detect fever before serious CRS develops. Eligibility: People aged 18 years and older with cancer who are staying at the NIH clinic for treatment with drugs or cell therapies. Design: Participants will receive TempTraq patches and a special NIH tablet. The TempTraq is a small patch applied to clean, dry skin under the arm. It continually monitors body temperature and sends the data to an application on the tablet. Participants will wear the patch most of the time they are admitted to the hospital. They could wear it for up to 15 days. The patch monitoring does not replace regular temperature checks, all participants will still have have their regular temperature checks as part of their treatment plan. Participants may also opt to use VitalTraq, another application on the tablet. They will hold the screen up to their face for about 1 minute. VitalTraq uses the camera in the tablet to measure blood pressure, heart rate, and breathing. They will do this once per day while they are in the clinic; they may do it more often if they have a fever or feel unwell. Blood may be drawn for research. Participants will be asked about their experience within 1 week after TempTraq is removed. Participants who choose to use the patch, complete its use, and return at a later date for another treatment or study, may be able to re-enroll to have the patch used again.

Early Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY

The goal of this clinical trial is to examine how daily behavioral patterns in early pregnancy, including sleep, physical activity, and meal timing, influence continuous glucose dynamics and subsequent risk of gestational diabetes mellitus (GDM) in pregnant women without pre-existing diabetes. The main questions it aims to answer are: 1. Do early-pregnancy chronobehavioral patterns (e.g., irregular sleep, night eating, and unstable rest-activity rhythms) relate to continuous glucose patterns measured using continuous glucose monitoring (CGM)? 2. Can early behavioral and CGM-derived measures predict glucose regulation and metabolic outcomes later in pregnancy (24-28 weeks)? 3. Does real-time self-monitoring using wearable devices and food logging improve glycemic outcomes compared to usual care? This study is a prospective, nested randomized pilot trial embedded within the ongoing Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) cohort (NCT06293235) at KK Women's and Children's Hospital, Singapore. A total of 140 pregnant women without pre-existing diabetes, recruited at ≤13 weeks gestation, will be randomized in a 1:1 ratio to either a pilot arm (wearable-based self-monitoring) or a control arm (usual care). Participants in the pilot arm (n=70) will undergo intensive behavioral and metabolic monitoring over a 14-day period in early pregnancy, including continuous glucose monitoring using a CGM device, wrist actigraphy to assess sleep-wake and rest-activity patterns, and an AI-supported mobile application to record meal timing and dietary intake. Participants will have real-time access to their glucose data and behavioral feedback, enabling self-monitoring and potential behavioral adjustments.

DELphi Procedure for Developing Recommendations for the Implementation of Wearable Devices and Polygenic Risk Scores

DEL-DIP is a prospective observational study employing a Delphi methodology (at least two online rounds) to elicit and consolidate the views of an expert panel within the INNOPREV project. The study aims to develop operational recommendations to support the coordinated implementation of Polygenic Risk Scores (PRS) and wearable devices in cardiovascular prevention. Specifically, it addresses the following research question: which recommendations and requirements-genomic, digital, and clinical/organizational-are necessary to integrate PRS and wearable technologies into routine practice and healthcare services, and for which of these elements do experts achieve consensus (defined as a Content Validity Index, CVI, \> 79%)

Optimizing Radiation Dose and Utilizing Wearable Devices to Reduce Arrhythmia Risk in Patients Undergoing Thoracic Radiotherapy: A Prospective Cohort Study

This prospective observational cohort study aims to assess the risk of radiation-induced cardiotoxicity in patients undergoing thoracic radiotherapy by integrating real-time arrhythmia monitoring using wearable cardiac rehabilitation (wearable CR) devices and AI-based cardiac substructure segmentation. The study will analyze radiation dose exposure to key cardiac structures, including the sinoatrial node (SAN) and pulmonary veins (PV), to identify risk factors for atrial fibrillation (AF) and other arrhythmias. Patients will receive wearable CR monitoring at 3, 12, and 24 months post-radiotherapy, with cardiology follow-up and intervention based on standard clinical guidelines. The study will recruit 111 patients over three years, with a two-year follow-up after radiotherapy. The primary endpoint is the incidence of grade 3+ AF within 2 years, with secondary outcomes including any-grade arrhythmia rates, arrhythmia burden, and survival analysis. By establishing a prospective thoracic radiotherapy patient cohort, this study aims to identify dose-related risk factors, improve early detection and management of radiation-induced arrhythmias, and provide evidence-based strategies to enhance treatment safety and efficacy.

Clinical Application Study of Wearable Multi-channel Electrocardiogram Acquisition Equipment in the Diagnosis of Myocardial Ischemia in Patients with Suspected CHD

Backgroud: With the widespread application of artificial intelligence, sensor technology, and wearable technology in clinical and daily life, wearable devices have shown a promising application prospect and tremendous potential. Currently, both domestic and international clinical applications of wearable ECG devices for the diagnosis and treatment of coronary heart disease are mostly single-lead ECG wearable devices or simulated multi-lead wearable ECG monitoring devices, which are widely used in the diagnosis of arrhythmias such as atrial fibrillation. There is a lack of clinical diagnostic efficacy research on myocardial ischemia in coronary heart disease. Aim: To investigate the diagnostic efficacy of wearable multi-channel ECG acquisition devices for myocardial ischemia in suspected CHD patients Methods：Assessing the sensitivity, specificity, and accuracy of wearable multi-channel ECG devices in diagnosing myocardial ischemia in coronary heart disease by comparing with the "gold standard" SPECT-MPI.The target recruitment is 107 suspected coronary heart disease myocardial ischemia patients.If patients do not meet the exclusion criteria, they will wear the wearable multi-channel ECG device for 7 days after enrollment, followed by a myocardial SPECT examination; there is no specific order for these examinations. After enrollment, baseline information of the patients (such as age, gender, height, weight, etc.), comorbidities (such as hypertension, diabetes, hyperlipidemia, chronic kidney disease, etc.), and auxiliary examination data (such as complete blood count, biochemistry, cardiac injury markers, BNP, echocardiography, wearable multi-channel ECG device data, SPECT-related examination data, such as ST-segment, total load score, total rest score, etc.) will be collected. The endpoint of this study is to evaluate the sensitivity, specificity, and accuracy of the wearable multi-channel ECG device in assessing myocardial ischemia in CHD.