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NCT ID: NCT04928456 Completed - Covid19 Clinical Trials

Augmentation of Immune Response to COVID-19 mRNA Vaccination Through OMT With Lymphatic Pumps

Start date: June 11, 2021
Phase: N/A
Study type: Interventional

This study will evaluate the effectiveness of utilizing Osteopathic Manipulative Treatment (OMT) procedures as an addition to current mRNA COVID-19 vaccines in terms of enhancing the immune response of participants as assessed by looking for increased levels and duration of antibody titers.

NCT ID: NCT04928339 Completed - Cardiac Surgery Clinical Trials

Pecto-Intercostal Fascial Plane Block Study

Start date: March 28, 2022
Phase: Phase 4
Study type: Interventional

This study is being done to see if bilateral pecto-intercostal fascial plane blocks (PIFB) with a mixture of liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). 100 participants will be recruited and can expect to be on study for 100 days.

NCT ID: NCT04928326 Completed - Heart Failure Clinical Trials

Comparison of CorWatch With Right Heart Catheter Measurements in Heart Failure

Start date: August 1, 2021
Phase:
Study type: Observational

This is an observational study to evaluate the agreement between the InCardia diagnostic technology CorWatch for the assessment of venous pressure in human subjects. This includes evaluation of InCardia technology in heart failure (HF) patients undergoing invasive right heart catheterization in a cardiac catheterization laboratory (cath lab) and in a cardiac intensive care unit (ICU).

NCT ID: NCT04928287 Completed - Parkinson Disease Clinical Trials

Randomized, Double-Blind Clinical Trial for Parkinson's Disease (Early and Moderate)

PD
Start date: June 28, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, single center, phase 2 study to assess efficacy and safety of multiple HB-adMSCs vs Placebo for the treatment of Parkinson's disease. The trial includes a screening period of up to 4 weeks, a 32-week treatment period, and a safety Follow-up period of 20 weeks after the last investigational product administration. This clinical trial will be open to enroll 24 eligible participants diagnosed with Parkinson's disease. Patients' recruitment will be conducted by the study team, if eligible participants are identified based on eligibility criteria, a screening visit will be scheduled. Informed consent form will be given to the study participants and signed before any study procedures. Informed consent form will include information about the clinical trial and some aspects should be considered during this process.

NCT ID: NCT04928248 Completed - Clinical trials for Diabetes Mellitus, Type 2

Design, Implementation and Evaluation of Scalable Decision Support for Diabetes Care

Start date: September 23, 2021
Phase: N/A
Study type: Interventional

Diabetes is a significant medical problem in the United States and across the world. Despite significant progress in understanding how to better manage diabetes, there is oftentimes still uncertainty in the optimal management strategy for a specific patient. As a result, providers and patients must often use a trial-and-error approach to identify an effective treatment regimen. The project team has previously developed a Diabetes Dashboard that summarizes relevant patient information (e.g., medication history and recent hemoglobin A1c trend). This dashboard allows a clinician to select a target hemoglobin A1c level for the patient in 3 or 6 months, then compare and contrast different options for treatment, including weight loss and the use of different medication regimens. Included in this comparison are known benefits and side effects, as well as the likely chances of achieving the treatment target given the experience of past, similar patients. The Diabetes Dashboard is already available as an optional tab in the EHR system. The project team has also previously developed the Disease Manager App for evidence-based chronic disease management and health maintenance. The Disease Manger Application is fully integrated with the EHR, and it provides care guidance via individual chronic disease modules as well as a unified module that encompasses all relevant modules for chronic diseases and health maintenance. The initial modules that have been developed are for chronic obstructive pulmonary disease, hypertension, diabetes mellitus, and health maintenance. The objective of this research is to evaluate the Diabetes Dashboard integrated with the Disease Manager App. The Intervention consists of the diabetes module of the Disease Manager App, which incorporates content from the Diabetes Dashboard for pharmacotherapy prediction and provides a link to the Diabetes Dashboard.

NCT ID: NCT04928235 Completed - Cellulitis Clinical Trials

Utility of Thermal Imaging in Diagnosis of Cellulitis for Lower Extremity Complaints in the Emergency Department

Start date: July 18, 2021
Phase:
Study type: Observational

The overall purpose of the study is to determine how providing physicians with a quantitative measure of skin surface temperature influences diagnoses and diagnostic confidence in potential cellulitis cases when added to the standard evaluation.

NCT ID: NCT04928001 Completed - Clinical trials for Depression Anxiety and Co-occurring Rural Youth

A Feasibility Study for Implementing and Evaluating an Internet-based Cognitive Behavior Therapy Intervention in School Settings and Its Impact on Adolescent Mental and Behavioral Health

Start date: February 17, 2021
Phase: N/A
Study type: Interventional

This research study examines rural youth's experience of an internet based cognitive behavioral therapy intervention, and their experience of symptoms of depression, anxiety and co-occurring disorders.

NCT ID: NCT04927975 Completed - Clinical trials for Non-Segmental Vitiligo

Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo

Start date: June 16, 2021
Phase: Phase 2
Study type: Interventional

Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo. Adverse effects and change in disease activity will be assessed. Upadacitinib is being evaluated for the treatment of non-segmental vitiligo. The study will enroll approximately 160 participants aged 18-65 with non-segmental vitiligo in 5 treatment arms across 35 sites worldwide. Participants will either receive study drug vs placebo oral tablets once daily (QD) for 24 weeks (Period A). In Period B (up to 52 weeks), participants who received placebo during the first 24 weeks will switch to study drug. Participants who received study drug during the first 24 weeks, will continue to receive study drug. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT04927845 Completed - Anxiety Clinical Trials

StriveWeekly Trial Post-pandemic

Start date: May 19, 2021
Phase: N/A
Study type: Interventional

With the COVID-19 pandemic completely altering the landscape of higher education, students have been experiencing more stress than ever. With Harvard University's plan for students to return to campus for the 2021-2022 academic year, offering an online mental health program such as StriveWeekly could provide students with stress management support as they transition back after 1.5 years of remote learning. This study will use a randomized controlled trial design to test the effectiveness of a waitlist versus StriveWeekly. This study will allow us to test if a program that has previously demonstrated effectiveness with university students in reducing anxiety and depression symptoms will still be effective after the unprecedented amount of stressors during a global pandemic. Primary aim: We aim to evaluate the effectiveness of StriveWeekly in preventing or reducing symptoms of anxiety and depression. The use of a waitlist condition will allow us to experimentally assess if the online intervention is responsible for decreasing / preventing worsened anxiety, depression, and stress symptoms over time. Given the previously established effectiveness of StriveWeekly as an indicated prevention program, we expect students in the intervention condition to experience significantly better symptoms compared to the waitlist from baseline to posttest. Alternatively, if the transition back from remote learning and/or the broad pandemic context interferes with the acceptability or effectiveness of StriveWeekly, then we might expect to see little to no significant differences between the online intervention condition and waitlist condition from baseline to posttest. Secondary aims include: (a) testing moderators of intervention effectiveness and (b) evaluating the intervention in terms of acceptability (e.g., feedback on program name; demographically representativeness of student user sample; satisfactory adherence and satisfaction rates). Exploratory moderation analyses across groups will help determine whether or not the intervention condition produces unique or additive effects for students with certain characteristics over and above changes demonstrated by similar students in the waitlist condition. Acceptability analyses will allow for more nuanced evaluation of StriveWeekly's effectiveness as a program, beyond its ability to facilitate symptom reduction.

NCT ID: NCT04927793 Completed - Clinical trials for Respiratory Syncytial Virus (RSV)

Absorption, Metabolism, and Excretion (AME) Study of [14C]EDP-938 in Healthy Male Subjects

Start date: May 28, 2021
Phase: Phase 1
Study type: Interventional

A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of [14C]EDP-938 in healthy male subjects.