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Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
Experimental: Health Status Assessment

Completion of a patient-reported health status assessment preceding each clinic visit. The health status assessment consists of the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) along with additional select questions. The results of the assessment will be available to clinicians in the electronic health record.

Other: Routine Health Status Assessment

Completion of a patient-reported health status assessment preceding each clinic visit. The health status assessment consists of the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) along with additional select questions. The results of the assessment will be available to clinicians in the electronic health record.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

October 4, 2022Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
Cohort X

Phase 0 will include up to 20 subjects in Cohort X (TCD). This phase is for training and feasibility purposes only and data collected will not be used in the final analysis.

Device: NovaGuide 2 Intelligent Ultrasound System

The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient’s temporal acoustic windows.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

October 4, 2022Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA

Cardiac rehabilitation (CR) decreases mortality and both CR and pulmonary rehabilitation (PR) improve function, quality of life, and decrease readmission rates. Despite their proven efficacy, both programs are grossly underutilized, with fewer than 20% of eligible persons participating. Patients with heart and lung disease living in rural communities have even lower rates of participation.

The objective of this proposal is to test the feasibility of performing a full-scale randomized controlled trial (RCT) to compare the effectiveness and value of a stepped care (SC) model versus treatment as usual (TAU) in older frail adults living rural counties. TAU refers to center-based rehabilitation (CBR). The SC model includes initial enrollment into CBR followed by possible step up to three interventions based on prespecified non-response criteria: 1) Transportation-subsidized CBR, 2) Home-based telerehabilitation (TR), and 3) Community health worker-(CHW) supported home-based TR. Unlike traditional SC models, the initial treatment in this model, i.e. CBR, is not the least resource intensive. CBR was chosen as the initial option because it is currently considered the standard of care.

We will conduct a parallel, 2-arm, randomized controlled feasibility trial. Eligible participants will be randomized to TAU (CBR) or SC. Because of the urgent need to address underuse of both CR and PR in rural regions, the proposed feasibility trial will enroll patients referred to either CR or PR. Both arms include an in-person intake evaluation conducted by a certified rehabilitation nurse in the rehabilitation center to determine exercise tolerance and design a tailored 8-week rehabilitation program. Patients randomized to TAU participate in two weekly sessions at the center and are encouraged to exercise at home in between sessions. Patients randomized to the SC arm will also be enrolled in the CBR program. Those who meet prespecified non-response criteria will be stepped up to transportation-subsidized CBR. Providing transportation may not be sufficient for frail older adults who are reluctant to leave their homes in the winter, unfamiliar with exercising, or do not want to exercise in a group setting. Thus, non-responders, will be stepped up to home-based TR. Home-based rehabilitation will be supported by Chanl Health, a virtual platform that supports education and self-management, remote monitoring, and coaching by rehabilitation specialists. Non-responders will be stepped up to CHW-supported home-based TR. The CHW will be help participants use the mobile app, access educational materials, clarify educational content, and exercise during biweekly in-person visits.

Purpose: Heart and lung disease are the first and third leading causes of mortality in the US, respectively. Cardiac rehabilitation (CR) decreases mortality and both CR and pulmonary rehabilitation (PR) improve function, quality of life, and decrease readmission rates. Despite their proven efficacy, both programs are grossly underutilized, with fewer than 20% of eligible persons participating. Patients living in rural communities have even lower rates of participation. Home-based CR and PR has been developed with the goal of improving uptake, and low to moderate strength evidence indicates that these programs are as effective as center-based programs. Further work is needed, however, to examine how best to increase utilization of CR and PR in rural communities. While several studies have examined approaches to improve referral and enrollment, there is little evidence on how to optimize adherence to CR, and no evidence how to optimize adherence to PR.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

October 4, 2022Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
Culinary Medicine vs. Nutrition Education in Diabetes
Experimental: Culinary Medicine

Series of 6 virtual group Culinary Medicine sessions delivered monthly for 6 months

Other: Culinary Medicine Intervention

Participants randomized to the Culinary Medicine intervention will complete a series of 6 virtual culinary medicine cooking classes (1 class per month for 6 months). Virtual sessions will be delivered via Zoom using a combination of large group instruction and small group break-out sessions in which participants prepare a recipe in their home kitchen with the virtual assistance from trained group facilitators. After preparing the dish, participants will enjoy the dish they prepared and report-back to the large group about their dish and experience. Classes will be conducted in English and Spanish with language-concordant instructors and facilitators.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

October 4, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
Evaluating the InPen in Pediatric Type 1 Diabetes

Type 1 Diabetes (T1D) is the most common form of diabetes affecting children, requiring lifelong administration of insulin to prevent complications. The incidence of T1D has increased more among African Americans, Hispanics, and Asian/Pacific Islanders compared to Caucasian youths in the past two decades. Despite advances in insulin delivery systems, fewer black and Hispanic children compared to white children with T1D use insulin pumps. Therefore, most minority children with T1D in urban areas require multiple daily injections (MDI) of insulin which may put them at increased risk of poor glycemic control. Although several factors contribute to worsening glycemic control in adolescents with T1D, studies have shown that missing doses of insulin at mealtimes is a major factor.

Adolescents with T1D who use MDI with a basal-bolus regimen use formulas to calculate insulin doses that involve a four-step process. The complexity of determining insulin doses contributes to inaccuracies in both timing of doses and amount of insulin given, both of which can lead to hyperglycemia and hypoglycemia.

The InPen™ Smart Insulin Pen System (Medtronics) was approved by the FDA for children of all ages with T1D in June 2020. The InPen is a Bluetooth-enabled smart insulin pen that helps with management of insulin dosing and tracking via capture of rapid-acting insulin doses and tracking of insulin in the body through the use of its companion app (free on Apple iOS and Android). The app includes a bolus calculator, which can lead to more accurate insulin dosing, which may improve glycemic control.

The specific benefits of using the InPen include the following: simplifying insulin dose calculations, administering more accurate insulin doses, tracking insulin doses to help prevent hypoglycemia, providing reminders to administer insulin, and storing data in the InPen App that can be easily shared with diabetes healthcare teams to assist with adjusting insulin doses.

The goal of this study is to determine if use of the InPen will improve glycemic control and diabetes numeracy in adolescents with uncontrolled T1D living in urban areas.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

October 4, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
Tumor Treating Fields Therapy in Combination With Chemotherapy for the Treatment of Advanced Solid Tumors Involving the Abdomen or Thorax

PRIMARY OBJECTIVE:

I. To assess the safety and tolerability of TTF, including the maximum tolerated dose (MTD), in combination with cabozantinib (Cohort 1) or with nab-paclitaxel and atezolizumab (Cohort 2) in patients with advanced solid tumors involving the abdomen or thorax to the 4 prespecified tumor types.

SECONDARY OBJECTIVE:

I. To assess the objective response rate, progression-free survival and overall survival of TTF in combination with cabozantinib (Cohort 1) or with nab-paclitaxel and atezolizumab (Cohort 2) in patients with advanced solid tumors involving the abdomen or thorax to the 4 prespecified tumor types.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT 1: Patients receive TTF continuously for at least 18 hours per day on days 1-21 of each cycle. Patients also receive cabozantinib orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

COHORT 2: Patients receive TTF continuously for at least 18 hours per day on days 1-28 of each cycle. Patients also receive nab-paclitaxel intravenously (IV) over 30 minutes on days 1, 8, and 15 of each cycle and atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 6 weeks.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

October 4, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer
Experimental: 68Gallium PSMA-PET/CT

Patients will initially undergo a standard of care FDG PET with diagnostic CT scan followed by an investigational 68Ga PSMA PET/CT scan.

Drug: [68Ga]PSMA

68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.

Diagnostic Test: PET/CT imaging

68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

October 4, 2022Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine
iPSC Repository of Pediatric Cardiovascular Disease

Human induced pluripotent stem cells (iPSCs) are a type of pluripotent stem cell which can be generated from easily accessible patient cells, such as peripheral blood mononuclear cells and skin fibroblasts. As iPSCs are epigenetically reprogrammed from somatic cells, they retain all genetic information of the affected patients, thus providing an ideal model for studying the contribution of genetic variation to pediatric cardiovascular disease. In addition, human iPSCs can be differentiated into cardiomyocytes, endothelial cells, smooth muscle cells and cardiac fibroblasts, which are major affected cell types in the heart responsible for cardiovascular disease. Therefore, patient-specific iPSCs possess great promise in modeling pediatric cardiovascular disease, discovering novel drugs and prospective cell regeneration therapy.

The DNA from these patients will be analyzed for point mutations, rare sequence variations, single nucleotide polymorphisms in known cardiac development genes or for chromosomal copy number changes by using state of the art genetic approaches.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

October 3, 2022Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
Chardonnay Marc and Vascular Response
Experimental: High Flavanol Cocoa Powder

High Flavanol Cocoa Powder (435 mg of flavanols) will be provided as a beverage mixed in water.

Other: Low Flavanol Cocoa Powder

Cocoa Powder providing 30 mg of cocoa flavanols

Other: Vine to Bar Chocolate – 2 servings

Chocolate providing both cocoa flavanols and Chardonnay marc

Other: Vine to Bar Chocolate – 1 serving

Chocolate providing both cocoa flavanols and Chardonnay marc

Other: Vine to Bar Chocolate covered almonds

Almonds covered with Vine to Bar Chocolate that provides both cocoa flavanols and Chardonnay marc

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

October 3, 2022Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
The Inorganic Nitrate and eXercise Performance in Heart Failure (iNIX-HF)

Visit 1 Screening/Phenotyping Day.

  1. Consent: All study procedures will be reviewed with the participants before the investigators obtain written informed consent. Consent includes giving permission for the investigators to review their medical records.
  2. Blood Samples: Participants will report to the Clinical Translational Research Unit (CTRU) at Washington University Medical Center after an overnight (10-12 hour) fast. An intravenous catheter will be placed to facilitate blood sampling 5 times during the visit. The first blood sample (time 0) will be for screening/phenotyping laboratories: NT-proBNP, chemistries (including K+), glucose, and creatinine (for estimation of glomerular filtration rate).
  3. Urine Pregnancy Test: Women of child-bearing age will have a urine pregnancy test.
  4. Physical Exam: Participants will have a brief history and physical examination. Heart rate (HR) and blood pressure (BP) will be taken.
  5. Resting Echocardiogram with contrast: Participants will also undergo a standard 2D Doppler, tissue Doppler and strain imaging echocardiography to quantify left ventricular structure and function.
  6. Questionnaires: Participants will complete a medical history form, the Kansas City Cardiomyopathy Questionnaire (KCCQ), and Minnesota Living with Heart Failure Questionnaire (MLHFQ).
  7. NYHA classification will be determined.
  8. Blood Pressure and Heart Rate: BP and HR will be measured at time 0 and hourly for 4 hours.
  9. Breath Nitric Oxide: Participants will exhale into a tube attached to a portable electrochemical analyzer (NIOX VERO, Aerocrine Inc., Morrisville, NC) following the American Thoracic Society/European Respiratory Society guidelines at time 0 and hourly for 4 hours.
  10. Blood sampling for NO3- and NO2-: Participants will have blood drawn (20mL or about 1.5 tbsp) through their previously placed intravenous catheter at time 0 and hourly for 4 hours.
  11. Exercise Test – Maximal Muscle Power: After 2 hours, knee extensor muscle power will be determined using a Biodex isokinetic dynamometer (Biodex Medical Systems, Shirley, NY).
  12. Exercise Test – Aerobic Capacity: After 10 min of recovery from the muscle power testing, peak oxygen consumption (V̇O2peak) will be determined with an incremental treadmill exercise test to volitional fatigue.
  13. Randomization: Participants will be randomized to the KNO3 or placebo arm in a double-blind fashion, stratified by sex and ischemic/nonischemic status.
  14. Participants will be instructed to take the medication every day at the same time of the AM. Participants will be instructed to take the medication with food.

    Visit 2: Acute Dose Study Day

  15. Baseline blood K+ and eGFR levels. As with Visit 1, participants will report to the CTRU fasted (and not having used mouthwash for 24 hours) and have a physical exam and blood drawn for creatinine and K+.
  16. Ingestion of a gelatin capsule containing either 10 mmol KNO3 or placebo, per the randomization scheme.
  17. HR, BP, plasma NO3- and NO2- , and breath NO: As in Visit 1, HR, BP, plasma NO3- and NO2- , and breath NO will be measured at time 0 (prior to ingestion of a single gelatin capsule) and thereafter hourly for 4 h after the participant ingests a single gelatin capsule containing either 10 mmol KNO3 or placebo, per the randomization scheme.
  18. Exercise Test – Maximal Muscle Power: After 2 hours, knee extensor muscle power will be determined using a Biodex isokinetic dynamometer.
  19. Exercise Test – Aerobic Capacity: After 10 min of recovery from the muscle power testing, peak oxygen consumption (V̇O2peak) will be determined with an incremental treadmill exercise test to volitional fatigue.
  20. Questionnaires: Participants will complete a medical history form, the Kansas City Cardiomyopathy Questionnaire (KCCQ), and Minnesota Living with Heart Failure Questionnaire (MLHFQ).
  21. Intervention: After completion of Visit 2, participants will be given a 6-week course of 10 mmol KNO3 or placebo (such that the participants will be given the same medication (nitrate or placebo) that they were given in the Acute Dose Study), one capsule for each day, to be taken p.o.. Participants will be instructed to not use mouthwash before ingesting the study capsules and to not change their diet or level of physical activity during the study (in particular, to not begin or cease an exercise program while enrolled in the study).

    Visit 3: 6-Week Dose

  22. Procedures: The procedures for this visit will be identical to those described for Visit 2.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

October 3, 2022Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine