11 Clinical Trials for Various Conditions
This is a randomized controlled open-label trial. During the study, adolescents scheduled to receive at least one intramuscular (IM) vaccine will receive either Buzzy®, Music, or Buzzy® and Music intervention(s) in addition to standard care to evaluate the feasibility and acceptability of these interventions prior to being used in a larger study to assess the effectiveness of the interventions in preventing post-vaccination presyncope and syncope. Feasibility will be assessed according to study staff ability to successfully administer the protocol specified clinic-based interventions and per both study staff and healthcare provider responses to written feasibility assessments. Acceptability will be assessed according to the participant's self-report. In addition, baseline needle phobia and anxiety, post-vaccination pain and presyncope symptoms, and pre- and post- vaccination state anxiety will be assessed per participant written self-report to standardized survey questions.
This study was a prospective, randomized clinical trial that was conducted in adolescents (10 through 14 years of age) receiving at least one recommended intramuscularly administered vaccine to evaluate the efficacy and acceptability of using two different, simultaneously administered interventions that might prevent post-vaccination presyncope, and by extension syncope. The two interventions evaluated together were Buzzy®, which is a medical device designed to reduce vaccination pain, and an electronic game. The investigators evaluated both interventions when administered simultaneously (Buzzy® and electronic game). The investigators enrolled approximately 340 subjects into this study. Eligible adolescents were randomized (1:1) to either the intervention or control group: 1) intervention (Buzzy® and electronic game); or 2) control (usual care) to assess for acceptability and efficacy. Detailed data were collected and described from study participants including demographics, medical history, baseline generalized and state anxiety, and needle phobia. Participants were observed for 20 minutes following receipt of vaccines and reassessed for post-vaccination state anxiety, immediate and subsequent post-vaccination pain (within 1 minute and at 10 minutes), and the occurrence of witnessed syncope or presyncope, and presyncopal symptoms as rated by the modified Blood Donation Reactions Inventory (BDRI). Participants were asked to assess their acceptability of the intervention.
This is a randomized controlled open-label trial. During the study, adolescents and young adults scheduled to receive at least one intra-muscular (IM) vaccine will receive either oral water hydration in addition to standard care or standard of care alone to evaluate the effect of water hydration on the primary outcome of presyncope. This study will also evaluate the acceptability of pre-vaccination hydration among adolescents and young adults.
The purpose of this research is to simplify the standard recording system of the heart rhythm. The investigators desire to improve the ease of monitoring the cardiac rhythm for 24 hours. The investigators intent is to use a very small, innovative monitoring patch system that relieves the patient of wearing a cumbersome and uncomfortable recording system. This research trial will carry the title "The Simple ECG Monitoring" for Comparison of a Sternal ECG Recording System with a Standard ECG Recording System for Holter Monitoring. The data from the investigational device is for comparative purposes only. It will not be used by medical personnel for study subject treatment or diagnostic purposes.
Comparing the arrhythmia diagnostic yield of MCOT as compared to standard loop event monitors in patients presenting with palpitations, syncope or near syncope occurring less frequently than every 24 hours. Patients randomized and are enrolled for 30 days. Prior testing required: 24 hours of non diagnostic monitoring,
Syncope, or transient loss of consciousness, is a common reason for visit to the Emergency Department and often leads to extensive testing and hospitalization. Using objective risk scores to determine which patients with syncope will actually benefit from these interventions, and which can be safely discharged home with minimal testing, is critical to providing sensible medical care. This study will evaluate the validity of two syncope risk-stratification tools and investigate their impact on healthcare utilization and patient safety, thus improving the quality of care for the 1-2 million patients who experience syncope every year in the United States
This Stage II randomized, controlled, longitudinal trial seeks to assess the acceptability, feasibility, and effects of a driving decision aid use among geriatric patients and providers. This multi-site trial will (1) test the driving decision aid (DDA) in improving decision making and quality (knowledge, decision conflict, values concordance and behavior intent); and (2) determine its effects on specific subpopulations of older drivers (stratified for cognitive function, decisional capacity, and attitudinally readiness for a mobility transition). The overarching hypotheses are that the DDA will help older adults make high-quality decisions, which will mitigate the negative psychosocial impacts of driving reduction, and that optimal DDA use will target certain populations and settings.
The purpose of this research is to test the clinical value of a new P-wave sensitive recording vector compared to a standard ECG limb lead II vector from similar easy-to-use long-term cardiac rhythm monitoring patch systems, the Carnation TM Ambulatory Monitoring (CAM) System and the Zio-XT iRhythm. The P-wave is a critical aspect of the electrocardiogram. The purpose of this study is to see if the P-wave centric focus of the CAM system improves arrhythmia diagnosis.
This study is intended to compare the new Carnation patch monitoring system with the Zio patch, which represents the current standard for continuous recording of the ECG over extended periods.
The purpose of this study is to obtain information on real-world device performance clinical assessments and clinical outcomes of patients receiving the Sleuth Implantable ECG Monitoring System.
The investigators want to look at how patients admitted after passing out (syncope) or nearly passing out (pre-syncope) do after going home and how many of them remain free of symptoms of syncope or pre-syncope.