cyrilzakka/clinical-trials huggingface dataset:
Magnetic Resonance Spectroscopy (MRS) Validation Study in Individuals With Nonalcoholic Fatty Liver Disease (NAFLD)

The purpose of this study is to see how effective the investigators' optimized magnetic resonance spectroscopy (MRS) sequence in quantifying hepatic triglyceride content (HTGC) to enhance MRS as a diagnostic tool in non-alcohol fatty liver disease (NAFLD).

One way to gauge MRS as an effective diagnostic tool is by looking at the reproducibility of the liver fat measurements on subjects by calculating the coefficient of variation (CV). This study assesses the modified MRS sequence, using both breath holds and free breathing. The HTGC levels are measured twice in the same individuals on two independent events separated by 10 minutes. Subjects are then given a high fat, high carbohydrate meal of Pizza Hut pizza, Pepsi, and Oreo cookies. Two hours after eating the meal, the subjects return to the scanner and repeat all MRS scans.

Eligibility Criteria:
Inclusion Criteria:

* Obese

Exclusion Criteria:

* Diabetes
* Pregnant
Comparison of Intraoperative Best Practice Advisory Reminders to Protocolize Insulin Administration Versus Standard Care in Patients at High Risk of Hyperglycemia

This study will assess the implementation of a glucose management clinical decision support tool. The specific objective is to determine if supplementing the existing glucose check reminder with a best practice advisory (BPA), an actionable insulin dosing calculator, providers will be influenced to improve the control of hyperglycemia.

Poor intraoperative glucose control has been linked to multiple types of infections including surgical site infections and urinary tract infections. Several studies suggest maintaining glucose at less than 180 mg/dL effectively prevents infections, and minimizes risks of hypoglycemia as compared to stricter blood glucose targets.

The insulin dosing protocol that will be used in the study is available for use throughout the Vanderbilt University Medical Center (VUMC) Department of Anesthesiology. The insulin calculator (BPA) automates the protocol guidelines. When a patient meets the study criteria, the BPA will provide an automated notification through the electronic health record system. These automated notifications will pop up intraoperatively after the glucose check reminder in cases where the patient meets the study criteria. The provider is not forced to follow the recommendations of the insulin dosing calculator, rather it just serves as a reminder of best practices as defined by our department.

The specific objective is to determine if supplementing the existing glucose check reminder with a BPA, an actionable insulin dosing calculator, will influence providers to improve the control of hyperglycemia. Study results will guide the future integration of the BPA at VUMC.

Eligibility Criteria:
Patient Participants

Inclusion Criteria:

* All patients having surgery at Vanderbilt University Medical Center Main Operating Rooms (ORs), Vanderbilt Medical Center Children's Hospital, Medical Center East or Gynecological (4S) ORs, who qualify for the glucose check best practice advisory (BPA). To qualify for the glucose BPA, the patient must meet the following criteria: 1) a documented diagnosis of diabetes, without a recorded measurement of glucose within the last 2 hours, or 2) the patient had an insulin administration within the last twelve hours and did not have a recorded measurement of blood glucose within the last hour.

Exclusion Criteria:

* Patients having surgery at other locations
* Patients not qualifying for the VUMC glucose check BPA

Provider participants:

Any provider of eligible patients may receive the BPA while providing care for these patients.
Hawaii Patient Reward And Incentives to Support Empowerment

The purpose of this randomized controlled trial (RCT) study is to examine the extent that financial incentives when combined with diabetes evidence-based practices, improve self-management and biometric measures for adult diabetic Medicaid recipients with an HbA1c of ≥ 6.5 at enrollment. The study will also evaluate the cost-effectiveness of the program.

Specific Aims:

1. Evaluate whether financial incentives for completing American Diabetes Association (ADA) recommended tests, exams, health education, biometric outcome goals, and vaccinations will improve primary biometric outcomes.
2. Evaluate whether financial incentives for completing ADA recommended tests, exams, health education, biometric outcome goals, and vaccinations will improve diabetes patients' self-management as assessed by Summary of Diabetes Self-Care Activities Measure (SDSCA) and 36-Item Short Form Health Survey (SF36v2).
3. Evaluate the extent to which financial incentives for healthy behaviors reduce the cost of health care utilization.

Diabetes is the seventh leading cause of death in the United States (OECD 2013). It is also known that certain populations are at greater risk for diabetes. In Hawaii, diabetes disproportionally affects Native Hawaiians and Pacific Islanders as they are three times more likely to be diagnosed with diabetes. In addition, in 2010 the U.S. Department of Health and Human Services Office of Minority Health reported that Native Hawaiians/Pacific Islanders in Hawaii were 5.7 times as likely as Caucasians living in Hawaii to die from diabetes(Office of Minority Health, 2010).

In order to address the challenges that chronic diseases impose on individuals and the health care system the Centers for Medicare \& Medicaid Services (CMS) is assessing the impact of incentivizing patients to increase self-care and disease management. Previous studies have demonstrated that monetary incentives have been associated with an improvement in behavioral outcomes, most notably when the incentive is received immediately following the targeted behavior (Volpp, K.G., et.al., 2008; Mitchell, M.S., et.al., 2013). Cahill et al. (2008) showed that economic incentives were tied to smoking cessation and led to a decrease in relapse within a year. Our study seeks to build on these findings and determine whether financial incentives may provide a way to improve diabetes self-management.

Data:

Electronic data (Labs, Outcomes) - January 1st, 2013 through December 31, 2015 Electronic data (Claims) - January 1st, 2011 through December 31, 2015

Eligibility Criteria:
Inclusion Criteria:

1. Clinically diagnosed with diabetes mellitus
2. 18 years of age or older
3. Medicaid recipient
4. At recruitment has an HbA1c level of ≥ 6.5
5. At recruitment is receiving care coordination at Kaiser Permanente Hawaii

Exclusion Criteria:

1. Current pregnancy - gestational diabetes
2. End-stage Renal Disease
3. Does not speak English
The Impact of Shallow Reading in Social Media

Social media is pervasively used in our life. There is a research hypothesis that the information in social media is "shallow" and the long-term use of it will cause readers' addiction, insomnia, and inability to pay attention, thus reducing the efficiency of learning and working. However, there is no systematic study on the relationship between "shallow reading" in social media and attention, addiction, sleep quality, and other mental health. Therefore, the investigators intend to explore the effect of "shallow reading" in social media on mental health based on about 300 healthy subjects by conducting questionnaire, cognitive scale assessment, multi-mode MRI scanning and EEG monitoring. A cross-sectional study will be combined with a longitudinal study to explore the clinical characteristics its relationship to brain function.

With the development of social media such as "twitter", "Facebook" and "Microblog", "shallow reading" has gradually become the main way for people to obtain external information and relax. "Shallow reading" is characterized by incomplete and intermittent reading patterns, and readers often "dip into it" without thinking. There is a research hypothesis that the information in social media is "shallow" and the long-term use of it will cause readers' addiction, insomnia, and inability to pay attention, thus reducing the efficiency of learning and working. Some researchers even concern that "shallow reading" is destroying human beings' suspicion spirit, thinking ability and rational thinking which are based on writing and print culture. However, there is no systematic study on the relationship between "shallow reading" and attention or other mental health, not to mention its fMRI and EEG characteristics. Therefore, the investigators intend to explore the effect of "shallow reading" in social media on mental health based on about 300 healthy subjects by conducting questionnaire, cognitive scale assessment, multi-mode MRI scanning and EEG monitoring. A cross-sectional study will be combined with a longitudinal study to better understand both the short-term and long-term effect of "shallow reading" habit to the mental health and imaging characteristics. The collected indexes will be analyzed to explore the clinical characteristics of people with the habit of "shallow reading", and its relationship to mental health, brain imaging characteristics will finally be clarified.

Eligibility Criteria:
Inclusion Criteria:

1. Health volunteers
2. Capable to use smartphone

Exclusion Criteria:

1. Participants with a BMI greater than 30 or less than 18.5
2. Any use of cigarettes or alcohol
3. Color blindness
4. Left-handedness
5. With mental or psychiatric disorders
6. With cognitive impairment
7. Has a history of brain trauma
8. Has a family history of psychiatric disorders
Feasibility Study of Dynasplint to Prevent Trismus in Head and Neck Cancer

The purpose of this study is to see if use of a device called the Jaw Dynasplint® System can be used during and immediately after cancer treatment. The Dynasplint® is a stretching device that is used to treat joint stiffness and limited range of motion in the jaw. The device is currently approved for treatment of trismus once it has developed. This study will investigate the use of the device during and immediately after cancer treatment to prevent trismus.

Data suggest that early intervention with mechanical stretching devices for head and neck cancer patients undergoing curative therapy maximizes their effectiveness in the treatment of trismus. That being said, treatment for trismus typically begins after head and neck cancer patients are found to have moderate to severe reduction in jaw range of motion. Typically, clinicians will begin therapy when the IID is 3.0 cm or less. A subset of head and neck cancer patients will develop severe or rapidly progressive trismus that will fail to respond to treatment. In this cohort, trismus may lead to permanent, severe morbidity. It may be hypothesized that preventative strategies that encourage routine stretching during and immediately after the completion of cancer therapy may prevent or minimize trismus. No studies have examined the prophylactic use of the Jaw Dynasplint® System during cancer treatment.

Furthermore, it is not known whether patients can tolerate wearing a mechanical stretching device during treatment. The investigators would like to test the hypothesis that: 1) preventive use of a mechanical stretching device during cancer treatment and early recovery is feasible, and 2) preventive use of a mechanical stretching device will result in a marked decrease in the incidence and severity of trismus in patients undergoing primary or adjuvant radiation therapy for head and neck cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically proven head and neck cancer
2. Planned primary or adjuvant radiation treatment with 50cGy or greater delivered to a total volume of at least 2cc to the muscles of mastication, unilaterally or bilaterally, over the entire course of radiation treatment
3. Patients receiving induction or concurrent chemotherapy
4. Baseline interincisoral distance \> 35 mm
5. Willing and able to provide informed consent
6. Sufficient manual dexterity to utilize the device
7. All participants must be at least 21 years of age

Exclusion Criteria:

1. Patients with collagen vascular disorders that may predispose to radiation fibrosis
2. Patients with oral health issues that would preclude use of the device as identified during a pre-radiation dental evaluation
Study of BXCL501 In Agitation Associated With Delirium in ICU Patients

This study is designed to determine and evaluate the optimal BXCL501 starting dose (StartD) that will safely and effectively reduce agitation associated with delirium in ICU patients. This is an ascending adaptive dose study evaluating the safety and efficacy of four potential starting doses of BXCL501 (120 μg, 180 μg, 240 μg, and 300 μg) in reducing agitation levels in adult ICU patients with delirium. For subjects 65 years of age and older, the potential doses will be reduced 50% in line with the Precedex (reference drug) label. The purpose of this clinical trial is to identify an optimally safe and effective BXCL501

This is a Phase 2, randomized, double-blind, placebo-controlled, ascending starting dose finding study assessing safety, efficacy, tolerability and PK of BXCL501 in four starting dose cohort groups to reduce agitation levels associated with delirium in patients within the ICU setting. Evaluation of four BXCL501 starting doses compared to placebo will be conducted according to the following ascending doses: Cohort 1 (120 μg or placebo); Cohort 2 (180 μg or placebo); Cohort 3 (240 μg or placebo); Cohort 4 (300 μg or placebo). For subjects 65 years of age and older, the starting doses in each cohort will be reduced 50% in line with the Precedex (reference drug) label. Safety, efficacy, and tolerability will be assessed throughout the treatment period at various timepoints. Subjects will receive the first starting dose (BXCL501 or placebo) when Baseline RASS score is ≥ +1. Repeat doses may be administered in increments of 120 μg every 3 to 6 hours post first dose (StartD) only if the RASS score remains ≥ +1. For subjects 65 years and older, repeat doses may start in increments of 60 μg every 3 to 6 hours post first dose only if RASS is still ≥+1.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for Enrollment (Informed Consent):

1. ICU admitted male and female patients, ≥ 18 years, COVID 19 (+) and (-)
2. Subject or legally appointed representative (LAR) able to read, understand and provide informed consent, or to provide assent

   Inclusion Criteria for Randomization:
3. Positive CAM-ICU
4. RASS score ≥ +1
5. Subject judged to be likely capable of self-administration

Exclusion Criteria:

1. Clinically significant ECG changes, brady- and tachyarrhythmias, QTc prolongation
2. Hepatic dysfunction
3. Pregnancy
4. Known allergy to Dexmedetomidine or Haloperidol.
VIVO™ Accuracy Study

A multi-center study designed to assess the accuracy of VIVO™ in determining the location of a PVC/VT foci in comparison to an electroanatomical mapping system.

The VIVO accuracy study will assess the accuracy of locating a PVC/VT foci by pacing known anatomical locations and comparing the VIVO outcome to that of the Carto system (Biosense-Webster).

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are at least 18 years or older
* Subjects who are scheduled for PVC/VT ablation procedure with structurally normal hearts and less than 10% scar.
* Subjects who have signed an IRB/EC approved Informed Consent Form and applicable subject privacy protection authorization per local law
* Subjects will be selected without regard to gender or age (unless precluded by local regulatory requirements)

Exclusion Criteria:

* Subjects who are contraindicated for CT or MRI (must be able to get one)
* Subject whose MRI or CT scan does not comply with the requirements of this protocol
* Subjects who are contraindicated for an electrophysiology procedure and/or fluoroscopy:
* INR \> 3
* Active infection
* Pregnancy: Females of childbearing potential with a positive pregnancy test.
* Existing mechanical heart valve
Prevalence of Asymptomatic Ventricular Dysfunction

To conduct a population-based study of the prevalence of asymptomatic ventricular dysfunction.

BACKGROUND:

Chronic congestive heart failure (CHF), caused by left ventricular dysfunction (LVD), is a major cause of morbidity and mortality. CHF is the major form of cardiovascular disease that is increasing in prevalence, LVD progresses from an asymptomatic phase to a severe symptomatic phase. Recent clinical trials have proven that angiotensin converting enzyme inhibitor reduced mortality, morbidity, and disease progression in asymptomatic patients with objectively measured LVD. However, available estimates of LVD prevalence are based on symptomatic patients, not on objectively measured ventricular function parameters. The distributions of ventricular function parameters in the United States population are unknown. Since the prevalence of objectively measured asymptomatic LVD is unknown, the total number of patients with LVD who could benefit from medical therapy is also not known. Furthermore, screening techniques to identify persons with treatable asymptomatic LVD have not been evaluated in a population-based setting. The plasma concentration of n-atrial natriuretic peptide (n-ANP) is a marker for the presence of asymptomatic LVD that may be a valuable screening tool for asymptomatic LVD.

DESIGN NARRATIVE:

This is a population-based study of the distribution of ventricular function parameters in 2,050 adult residents of Olmsted County, MN and, in collaboration with the Strong Heart study, in 1,522 adult Northern Plains American Indians. This group of Northern Plains Indians is at increased risk for LVD, having a higher prevalence of cardiovascular disease than the general United States population. Subjects undergo echocardiography to measure ventricular function parameters, as well as a clinical assessment of symptoms, signs and risk factors for LVD. Plasma concentration of n-ANP are measured in these populations to determine the accuracy of n-ANP as a noninvasive marker for asymptomatic LVD. These studies provide: comparative population-based estimates of ventricular function parameters and LVD in Olmsted County and Northern Plains Indians; estimates of the magnitude of the population of patients that could benefit from current therapy; current data on risk factors for prevalent CAD in these populations; a foundation upon which future studies of incidence and clinical course of asymptomatic LVD could be based. They also assess the accuracy of plasma n-ANP in identification of asymptomatic LVD.

The study was renewed in May 2001 and will end in March 2005. Studies continue on testing the hypotheses: that abnormalities of left ventricular systolic/diastolic function and left ventricular structure worsen over time; that increasing plasma brain natriuretic peptide is associated with progressive change of left ventricular structure and function; and that abnormal left ventricular structure/function and brain natriuretic peptide are associated with incident clinical events.

Eligibility Criteria:
No eligibility criteria
Enhancing Physical Activity and Weight Reduction Through Smartcare and Financial Incentives

The investigators are planning to conduct a pilot RCT of young obese population to evaluate the effect of smartcare with or without financial incentives for 12 weeks. Participants will be randomly assigned to a three-arm of control, smartcare, and smartcare plus financial incentives group.

To test the feasibility and potential impact of smartcare with or without financial incentives, the study employed a three-arm, open label randomized controlled trial design: control, smartcare, and smartcare plus financial incentives. The investigators hypothesized that the 'smartcare + financial incentive' arm will show the greatest change in outcomes, followed by the 'smartcare' only arm, and lastly the control arm. Specific aims of the study are as follows:

* To quantify the effectiveness of a 'smartcare' intervention to promote physical activity and reduce weight over a 12 week period.
* To quantify the incremental effectiveness of adding financial incentives to 'smartcare' intervention

Eligibility Criteria:
Inclusion Criteria:

1. male students aged between 19 to 45;
2. body mass index ≥ 27;
3. smartphone user (either Android or iPhone);
4. able and willing to attend a four pre-specified visit during the study period.

Exclusion Criteria:

1. any treatment involving pharmacotherapy, procedure, or surgery;
2. use of any activity tracker device during the last three months.
3. Those who answered positively to any Physical Activity Readiness Questionnaire (PAR-Q) question were also excluded.
Comparative Evaluation of Class V Restorations

To evaluate and compare the 2-year clinical performance of Class V restorations using various restorative systems with ion-releasing and non-ion-releasing composites, utilizing fluoride-free and fluoride-releasing universal adhesives for bonding

The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a parallel design. A total of one hundred adult patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Faculty of Dentistry, University of Mansoura. The study will focus on one hundred Class V restorations.

No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The study is scheduled to be conducted from November 2023 to November 2025. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation.

To determine the appropriate sample size, previous studies examining the clinical success rate of posterior class V restorations restored with ion-releasing materials were considered. These studies reported a 100% success rate at a two-year follow-up. Based on various parameters, including a significance level of 5%, a test power of 80%, and an equivalence limit of 15%, the sample size was calculated. Considering a potential dropout rate of 20%, a sample size of 100 subjects was determined to be suitable.

Eligibility Criteria:
Inclusion Criteria:

* Patients with one primary cervical caries on the buccal surface of any of their upper or lower posterior teeth. The cervical lesions must have an enamel margin occlusally and a cervical dentin margin
* Patients must have a good oral hygiene;
* Patients with tooth gives a positive response to testing with an electric pulp tester
* Patients with normal and full occlusion,
* Patients with opposing teeth should be natural with no restorations.

Exclusion Criteria:

- High caries risk patients with extremely poor oral hygiene,

* Patients involved in orthodontic treatment or periodontal surgery,
* Patients with periodontally involved teeth (chronic periodontitis)
* Patients with heavy bruxism habits and clenching
Effects of E-Cigarette Power and Nicotine Content in Dual Users and Vapers

This study aims to understand the effects of device power and nicotine concentration on the likelihood that someone would use or abuse e-cigarettes.


Eligibility Criteria:
Inclusion Criteria:

* healthy (determined by self-report)
* between the ages of 21-55
* willing to provide informed consent
* able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol

Exclusion Criteria:

* Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.

Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.