Treatment Trials

8 Clinical Trials for Various Conditions

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WITHDRAWN
Investigation of Cannabinoid Receptor Agonist Dronabinol in Patients With Functional Chest Pain
Description

In a recent study, Dronabinol was shown to reduce symptoms in patients with Functional Chest Pain (non-cardiac chest pain). Additionally, metabolic measures and patients' weights were not adversely affected by this regiment. In fact, some cholesterol measures trended in a favorable direction with Dronabinol. The study lasted 28 days and patients took Dronabinol twice daily. The goal of this current study focuses on reducing the dose of Dronabinol to see if the same goals can be achieved. More so, the study will be extended to 12 weeks to gain a more longitudinal picture of therapy with Dronabinol. It is hypothesized that reducing the dose and extending the duration will continue to show an improvement in symptoms as well as no adverse metabolic outcomes.

TERMINATED
Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study
Description

The primary aim is to develop and test the feasibility of a standardized digital audio home-hypnotherapy (HHT) program for patients with refractory functional chest pain (FCP). The secondary aims of this study are: 1. To obtain pilot data to assess the magnitude of the treatment effect of self-hypnosis in refractory FCP for an anticipated future, larger treatment trial; 2. To determine the stability of the treatment effect of HHT in refractory FCP; 3. To assess the relationship between response to HHT and psychological factors; and 4. To assess the relationship between response to HHT and symptomatic dimensions of chest pain (severity, frequency, and duration). 5. To assess the difference

ACTIVE_NOT_RECRUITING
Association of Endothelial Function and Clinical Outcomes in Subjects Admitted to Chest Pain Unit
Description

It is recognized that endothelial dysfunction is a major factor contributing to the atherogenic process. Abnormal function of the endothelium is detectable prior to obvious intimal lesions in patients with risk factors for atherosclerosis. Endothelial dysfunction is a systemic disorder and a key variable in the pathogenesis of atherosclerosis and its complications. Measurement of peripheral vasodilator response with fingertip peripheral arterial tonometry (PAT) technology (EndoPAT; Itamar Medical, Caesarea, Israel) is emerging as a useful method for assessing vascular function. EndoPAT may be a potential valid test increasing the accuracy, sensitivity and specificity for detection of subjects to chest pain unit (CPU) with chest pain but no obvious coronary artery disease (CAD). This is a relatively fast non-invasive bedside test, relatively low-cost and has no side effects. Therefore, the primary objective of the study is to test the hypothesis that abnormal endothelial function as assessed by EndoPAT testing will increase the prediction of the short (in-hospital) and long-term (1-year) outcome of patients presenting to the chest pain unit.

TERMINATED
Women With Chest Pain and Normal Coronary Arteries Study
Description

The purpose of this study is to compare the effectiveness of standard medical therapy versus usual care in women with chest pain, coronary endothelial dysfunction and unblocked coronary arteries. Coronary endothelial dysfunction (CED) is a condition in which the layers of cells around the heart do not function properly and is believed to be key factor in the development of atherosclerosis (fat deposits in arteries). In addition, CED is associated with an increased risk for future cardiovascular events, such as heart attack and stroke. A coronary angiogram allows physicians to see if any of the arteries in the heart are blocked, usually by fatty plaque. In many instances, angiograms in women experiencing chest pain do not show evidence of coronary disease (free of significant plaque build-up). Currently, there is no standard of care treatment plan for patients with normal coronary arteries, despite symptoms of chest pain, and as a result these patients may not receive medical treatment. However, these women often return to their physicians more than once with chest pain and go through a similar battery of tests.

Conditions
COMPLETED
WISE ARIC: Retinal Photography in Women With Chest Pain
Description

The purposes of this study are: * To correlate the severity of retinal arteriolar narrowing and other microvascular changes, as determined from retinal photographs and video imaging, to measures of coronary microvascular function in women evaluated for chest pain. * To evaluate measures of vascular compliance with applanation tonometry and photoplethysmography using a nasal alar probe.

Conditions
RECRUITING
Technical and Translational Development of Cardiovascular Magnetic Resonance (CMR) Imaging
Description

Background: Magnetic resonance imaging (MRI) is an important non-invasive tool to study and diagnose cardiovascular disease. MRI scanners use strong magnetic fields and radio waves to create pictures of body organs. Researchers want to find better MRI methods and new ways of imaging cardiovascular disease and better understand normal and abnormal cardiovascular and brain function. Researchers are also interested in seeing if gadolinium, the commonly used MRI contrast agent, stays in the body long after the MRI was performed. Objectives: To develop new methods for imaging the heart and other organs of the body. To describe cardiovascular diseases using newer MRI methods To look at the relationship between cardiovascular disease and cardiovascular risk factors and other organ systems To look for gadolinium deposits in the brain from prior exams. Eligibility: Healthy people and people with known or suspected cardiovascular disease ages 7 and older may be eligible for this study. Researchers may be particularly interested in those who: * Have suspected or known cardiovascular disease * Were previously exposed to a gadolinium-based contrast agent, * Need to have a heart MRI scheduled * Need a test of the heart or other body part or will be undergoing a future cardiac catheterization Design: There are multiple arms to the study with optional components; therefore, there are multiple variations as to what an individual participant s experience may involve. Participants will have an MRI scan lasting up to 2 hours. The scanner is a large hollow tube. During the scan, there may be loud knocking and buzzing sounds caused by the scanner. Participants will lie on a table that slides in and out of the tube. Their vital signs may be monitored. Participants may have a test of heart electrical activity using wires connected to pads on the skin. Participants may have blood drawn. Participants may be injected with an MRI contrast agent through a plastic tube inserted in the arm.

RECRUITING
Functional Near-Infrared Spectroscopy and Virtual Reality Relaxation Programs for Pain Management in Patients With Cancer
Description

This study attempts to measure pain severity, location of pain, and feasibility in patients with cancer using functional near-infrared spectroscopy and virtual reality relaxation programs. Functional near-infrared spectroscopy and virtual reality relaxation programs may help relieve pain in patients with cancer who are receiving treatment.

TERMINATED
Orthosis of Acute Traumatic Rib Fractures Via RibFx Belt for Pain Alleviation and Improved Pulmonary Function
Description

Acute traumatic rib fractures are a common issue for patients of trauma surgeons. They inflict substantial morbidity, the most dreaded and consequential of which are pulmonary complications. While these fractures are often treated non-operatively, there is a continued need for effective adjuvant treatments to improve rib fracture pain and outcomes. Prior studies have evaluated outcome measures for traumatic rib fractures that include respiratory failure, tracheostomy requirement, ICU length of stay, hospital length of stay, narcotic requirement, daily maximum incentive spirometry volume, pneumonia, and mortality . Rib belts, which have been present since at least 1945, have long been used to provide pain relief via chest wall stabilization \[3\]. However there is an extreme paucity of literature regarding their clinical efficacy, and their use has largely been abandoned due to concerns that they may have been overly constricting and resulted in poorer respiratory (pulmonary/breathing) outcomes. Newer generation rib belts are more elastic and theoretically less constricting than their earlier generation predecessors, however their clinical efficacy has not been yet demonstrated. The investigators will therefore plan to perform a prospective trial to determine if these rib strapping devices are effective clinical tools in the traumatic rib fracture population. The goal of the study is institutional quality improvement, to determine if the investigators see benefit of these devices for the pain management of our trauma population. The investigators will also conduct this as a pilot trial for hopeful future research applications, however the overall goal is institutional improvement. Patients determined to be eligible for the study by the admitting physician (and per the previously defined criteria) will be recruited to enroll in the project within the first 24 hours of their hospital admission. Recruited patients will be offered the opportunity to consent to enrollment in the study and will be assigned by the study team into either the intervention (RibFx belt +current standard of care) or control (current standard of care) arm in a quasi-experimental prospective design: untreated control group with dependent pretest and posttest samples. In this manner, the intervention arm will be both compared to themselves (pretest vs. posttests) as well as to a control group not exposed to the intervention. The relevant study materials will be included in their paper (physical) and electronic chart. Patients upon enrollment in the study will undergo an initial assessment that will include their baseline pain scores, narcotic consumption, incentive spirometry scores, and the subjective self-reported results of their questionnaire (the pre-test questionnaire- see attached). Patients will continue to be scored on objective (incentive spirometry results, opioid pain medicine consumption) and subjective variables (pain scores) during their hospital course. Between 24-48 hours after enrollment, they will be prompted to again complete a similar 2nd questionnaire post-test (if they are discharged from the hospital at this point in the time course, they will be sent home with the questionnaire and prompted to complete it at home). At their follow up appointment in trauma clinic (which will be coordinated by the research team to be as close as possible to 3 weeks post injury), they will have the opportunity to again voluntarily complete a final short questionnaires (post-test) that assess their pain control and respiratory function over the last 3 weeks. At this point, their involvement in the trial will be complete. Patients themselves will play an active role in data collection during the trial, and will be instructed and prompted in how to do so. Patients will be expected to fill out a worksheet on a daily basis, both while inpatient and after discharge, on their daily incentive spirometry scores as well as their minimum and maximum pain scale scores. This will be used to supplement the survey or questionnaire data, as well as the objective data from the electronic medical record. The investigators will ultimately compare groups using a quasi-experimental design as follows: Untreated control group with dependent pretest and posttest samples. This will allow for a direct comparison of patient to patient within the intervention arm (patient pretest result serving as control compared to posttest result) . To observe for temporal variability, their will be a control group with no intervention as well (no rib belt worn) , however the principle aim of the study is the comparison of patients to themselves in a pre-test, post-test fashion.