Pittsburgh, Pennsylvania

Sweet Scents to Sweet Dreams

The Effect of Energy Drink Ingredients on Cardiovascular Function in Men and Women 18-39 Years Old

Title: The Effect of Energy Drink Ingredients on Cardiovascular Function 1. Statement of the research question Does the caffeine in energy drinks interact with other ingredients to affect cardiovascular function, including QTc interval of the EKG, heart rate and blood pressure in healthy male and female adults after exercise? 2. Purpose and significance of the study Energy drinks are beverages promoted to enhance alertness along with athletic and cognitive performance. The most common ingredients found in energy drinks include water, sugar, caffeine, taurine, and B-vitamins, with variable inclusion of other ingredients, such as carnitine, glucuronolactone, inositol, guarana, ginkgo biloba leaf extract, thistle extract, and ginseng root extract. Since the mid-1990s, the consumption of energy drinks has grown dramatically, with worldwide sales in 2017 exceeding $49 billion. As the sale of energy drinks has grown, so has the number of adverse event case reports for patients who consumed energy drinks. Reported symptoms include cardiac arrhythmias such as ventricular fibrillation, atrial fibrillation, and cardiac arrest. A few small clinical studies have reported that energy drinks can increase systolic and diastolic blood pressure and change electrical activity in the heart as measured by an electrocardiogram (EKG). The intent of the proposed study is to determine whether caffeine or the combination of caffeine with taurine and L-carnitine can alter heart rate, blood pressure and the QTc interval of the EKG. Caffeine stimulates cardiovascular function primarily through antagonism of adenosine receptors. Taurine is a modulator of intracellular calcium ion concentrations which can affect the strength cardiac contraction. Carnitine facilitates fatty acid transport into the mitochondria, thereby increasing the production of adenosine triphosphate, the energy source of cells. Hypothesis: the effects of the ingredients of energy drinks on the heart are mediated in part by interactions between caffeine, taurine and carnitine. The amount of each ingredient in the study was based upon the amount commonly contained in two cans of energy drinks currently on the market.

Maximizing Energy and Reducing Fatigue in Breast Cancer Survivors

Dose-Response to Resistance Exercise on Cardiovascular Health

Participants will be randomly assigned to 1 of four research conditions at varying dosage of resistance exercise (RE) for the duration of 1 year, either 0 min, 30 min, 60 min or 120 min of weekly RE in addition to 60 min of weekly aerobic exercise (AE). Total exercise duration will be split between 2 weekly sessions. Participants in all four groups will receive healthy lifestyle education sessions, and will track daily steps, food intake and activity levels throughout the 1-year intervention. Participants will also complete baseline, 6-month, and 12-month physical examinations, which will include assessments of blood pressure, blood lipids, body composition, and aerobic and muscular fitness. During the first 6 months of intervention will occur in a supervised lab-based setting. Changes in Cardiovascular disease (CVD) risk factors, as well as potential mechanisms (arterial stiffness and inflammatory markers) that might explain a J-shaped dose-response, from baseline to 6 months will be assessed in each of the 4 groups. The second 6 months will follow the same exercise intervention as the first 6 months. However, all participants will be provided with a free health club membership. The second 6 months will be used to investigate the RE dose associated with best adherence in a free-living environment during the second 6 months. In addition, all measures taken at 6 months will also be assessed again at 12 months to examine the long-term effects of different doses of RE as secondary outcomes, given that compliance will not be tightly "enforced" by staff in this unsupervised free-living condition. In this case, the investigators will further carefully consider exercise adherence in data analysis.

An Ophthalmic Safety Study in Patients With Breast Cancer

This is a multicentre study assessing the ophthalmic safety in patients who are participating in a qualifying study. The study will include two cohorts of at least 60 individuals each. To be able to account for events associated with aging, worsening of pre-existing conditions, etc., ophthalmic study assessments will be performed in parallel in two cohorts at the same timepoints. The duration of the study assessment period will be approximately 12 months. Longer duration of the study would result in additional patient burden.

Pioglitazone Versus Empagliflozin for Chronic Pancreatitis/Recurrent Acute Pancreatitis Associated Diabetes Mellitus

This trial will test the efficacy of PIO versus EMPA in improving glycemic control in CP-DM. The anticipated enrollment will consist of 40 subjects, age 18-70 years who have been diagnosed with CP or RAP with DM, at two clinical sites in the United States. The primary objective is to evaluate the efficacy of PIO vs. EMPA to improve glycemic control in people with CP or RAP associated with DM.

Platform Clinical Study for Conquering Scleroderma

Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment

Strategy Training for Individuals With Unilateral Neglect

Unilateral spatial neglect (neglect) post stroke is characterized by a lack of attention to one side of the body or one side of the environment. Individuals with neglect experience significant disability and are often unaware of their neglect symptoms which can make it even more difficult to treat. There are a lack of effective treatments for neglect and new interventions are needed to help reduce disability for these individuals. Metacognitive strategy training (strategy training) is an intervention that has the potential to reduce neglect-related disability and improve individuals' awareness of their neglect. Strategy training teaches individuals to develop personalized goals, self-assess their performance of daily activities, and develop and evaluate strategies designed to overcome barriers and improve their performance of daily activities. While strategy training shows promise for individuals with neglect, no studies have tailored the intervention for this group of individuals or examined the effects of strategy training for individuals with neglect. This study examines whether strategy training facilitates reductions in disability and neglect and improves self-awareness after acute stroke.

Virtual Peer Coaching in Manual Wheelchair Skills

For peer coaches: Coaches will complete the following measures pre and post training: - Demographic questionnaire - Self-Efficacy on Assessing, Training, and Spotting (SEATS) - Feedback survey Prior to coaching trainees, coaches will undergo three training programs as follows: - Virtual training through zoom on peer mentoring - Research ethics training - Wheelchair skills training It will be verified that peer coaches possess the needed skills by administering the SEATS following training. A score of 5 (completely confident) for each training item will be required to advance to the peer coaching sessions. For peer coaching, coaches will lead six 1:1 virtual zoom meetings with each trainee they are matched with. Sessions may include goal setting, review of progress, instruction, and "homework" of prescribed content for trainees to review. For each training session coaches will complete a session log. For trainees: Baseline questionnaires will include: - Demographic questionnaire - Wheelchair setup questionnaire - Wheelchair Skills Test Questionnaire (WST-Q) - Goal Attainment Scale (GAS) (Group 1,3 only) - Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility - Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities - Life Space Assessment (LSA) - Online Learning Readiness Scale (OLRS) - Moorong Self-Efficacy Scale (MSES) - Referral Source - Wheelchair Skills Training Questionnaire - Wheelchair skills training outside of study Group Specific Activities Groups 1 and 2 will complete intervention A following baseline and 6-month assessments, respectively. Group 3 will complete intervention B. Participants in all groups will select what goals are important to them. They are not required to complete training in all skills, only to have at least 5 skills with relevant training goals. Intervention A Trainees will engage in 1:1 virtual zoom meetings facilitated by the study team scheduled weekly for 6 sessions with the opportunity for 2 makeup sessions. Sessions may include goal setting, review of progress, instruction, and "homework" of prescribed content for trainees to review. Participants may upload videos of themselves completing skills through Qualtrics to get feedback. Skills targeted by the intervention - 1. opening/closing doors 2. picking up an object from the ground 3. getting over a gap 4. getting over a threshold 5. up a low curb 6. down a low curb 7. up a high curb 8. down a high curb 9. performing a stationary wheelie 10. up a steep incline 11. down a steep incline 12. getting up stairs 13. getting down stairs 14. uneven transfers 15. floor-to-chair transfer 16. folding and unfolding wheelchair Intervention B Intervention B will be a series of educational videos that participants review and then are encouraged to practice the skills. Participants will have access to the materials for 8 weeks. Group 3 will have access to approximately 3 hours of wheelchair skills video training content. Actual viewing time will depend upon the individual's training goal. While they will receive a weekly reminder about practicing, there is no prescribed frequency for how often they should be practicing the skills in the videos. All participants will complete 2-month follow-up. This will include the following questionnaires: Baseline questionnaires will include: - Wheelchair setup questionnaire - Wheelchair skills training outside of study survey - Wheelchair Skills Test Questionnaire (WST-Q) - Goal Attainment Scale (GAS) - groups 1 and 3 only - Feedback Survey - groups 1 and 3 only - Wheelchair skills training outside of study All participants will complete 6-month follow-up. This will include the following questionnaires: - Wheelchair setup questionnaire - Wheelchair skills training outside of study survey - Wheelchair Skills Test Questionnaire (WST-Q) - Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility - Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities - Life Space Assessment (LSA) - Wheelchair skills training outside of study Groups 2 will then cross-over to complete intervention A. All participants will complete 8-month follow-up. This will include the following questionnaires: - Wheelchair setup questionnaire - Wheelchair skills training outside of study survey - Wheelchair Skills Test Questionnaire (WST-Q) - Goal Attainment Scale (GAS) - group 2 only - Feedback Survey - group 2 only - Wheelchair skills training outside of study All participants will complete 12-month follow-up. This will include the following questionnaires: - Wheelchair setup questionnaire - Wheelchair Skills Test Questionnaire (WST-Q) - Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility - Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities - Life Space Assessment (LSA) - Wheelchair skills training outside of study Follow-up windows will be within approximately 2 weeks before/after the follow-up date. Participants will be asked to select two preferred methods of contact for follow-up reminders that will be sent between timepoints. Spotters are required for trainee participation in the study. Prior to the start of the study, spotters will be required to watch a series of training videos about safe spotting.