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NCT ID: NCT03411486 Not yet recruiting - Breast Cancer Clinical Trials

Safety and Tolerability of a Modified Vaccinia Ankara (MVA) Priming Followed by Fowlpox Booster Vaccines Modified to Express Brachyury and T-Cell Costimulatory Molecules (MVA-BN-Brachyury/FPV-Brachyury)

Start date: February 6, 2018
Phase: Phase 1
Study type: Interventional

Background: Brachyury controls the expression of other genes in our cells. How this happens is not fully understood. Research shows that in some cancers, brachyury is over-expressed. This may play a role in cancer growth and metastasis. Researchers want to test a vaccine that turns the immune system against brachyury. The vaccine is made up of 2 viruses: Modified Vaccinia Ankara (MVA) and Fowlpox virus (FPV). The goal is to teach the immune system to kill the tumor cells that express the Brachyury protein. Objectives: To test if the booster doses of FPV-Brachyury Fowlpox are safe and can improve the immune response and make it last longer in people with advanced cancer. Eligibility: Adults 18 85 years old with cancer that has not responded to standard therapies. Design: Participants will be screened with medical history, review of their tumor sample, and physical exam. They will have blood and urine tests. They will have scans and X-rays to assess their cancer. They will have a heart test. Participants will get the vaccine in shots under the skin, close to lymph nodes. Shots will be given every 4 12 weeks for 2 years as long as participants can and are willing to continue to participate. At these visits, they will repeat some or all the screening tests, except the tumor sample review. After 2 years, participants will get phone calls every 3 months for 5 years. They will talk about any symptoms they have had.

NCT ID: NCT03401866 Not yet recruiting - Clinical trials for Glioblastoma Multiforme

Multi-site Validation and Application of a Consensus DSC-MRI Protocol

Start date: February 2018
Phase: N/A
Study type: Interventional

This clinical trial is to validate and demonstrate the clinical usefulness of a protocol for Magnetic Resonance Imaging (MRI) in people with high grade glioma brain tumors.

NCT ID: NCT03390920 Not yet recruiting - Osteoarthritis Clinical Trials

Evaluation of Outcomes With Umbilical Cord Allograft for Musculoskeletal Conditions Musculoskeletal Conditions

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to determine the efficacy of an Amniotic Fluid Tissue Product for pain relief and functional improvements for all types of musculoskeletal conditions. The study is prospective, with outcome measures being obtained at numerous time points after the regenerative procedure.

NCT ID: NCT03364725 Not yet recruiting - Hepatitis C Clinical Trials

Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study

ELIMINATEC
Start date: January 15, 2018
Phase: Phase 4
Study type: Interventional

To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants.

NCT ID: NCT03353597 Not yet recruiting - Aging Clinical Trials

Reversing Epigenetic & Other Markers of Senescence by Transfusing Young Plasma To Older Human Subjects

RESET-YOUTH
Start date: May 15, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This trial is designed to study the effects of monthly transfusions of young healthy male donor plasma on biological age as assessed by DNA methylation levels, and changes in cognitive, renal, and pulmonary function, muscle strength, telomere length, testosterone, estrogen, DHEAS, IGF-1, high resolution C-Reactive protein, and expression of P16INK4a in peripheral blood T lymphocytes and skin biopsies.

NCT ID: NCT03345524 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Predictive Analytics and Peer-Driven Intervention for Guideline-based Care for Sleep Apnea

Start date: November 17, 2017
Phase: N/A
Study type: Interventional

Obstructive sleep apnea (OSA) is a prevalent condition that affects 7 to 12% of the US population and is characterized by repetitive collapse of the upper airway during sleep. Continuous positive airway pressure (CPAP) has been shown to be highly effective in the treatment of OSA, however, adherence is poor with up to 54% of patients being non-adherent to CPAP therapy by Medicare criteria, which has been attributed to inadequate patient education and support for CPAP therapy. Poor treatment adherence in patients with OSA can lead to adverse health consequences, poor quality of life, and patient dissatisfaction. Poor treatment adherence may be due to lack of sufficient patient education, time delays in delivery of care, lack of adequate healthcare coordination, or difficulty accessing various healthcare providers across a front desk which serves as a "healthcare bottle-neck". Better efficiency in healthcare delivery, with greater connectivity through knowledgeable and trained peer volunteers and cheap cell-phones integrated by a smart telephone exchange may alleviate some of the care and communication burden faced by the healthcare system. Specifically, such community health education volunteers ("peer-buddies") who are experienced in managing their OSA may be able to impart knowledge and confidence to a recently diagnosed patient in a much more personalized manner than that of a group therapy session.

NCT ID: NCT03345134 Not yet recruiting - Clinical trials for Endoscopic Surgical Procedure

Pembrolizumab in Combination With BCG After Ablation in Patients With UUTTCC Without Nephroureterectomy

Start date: November 30, 2017
Phase: Phase 2
Study type: Interventional

PURPOSE: This study is being conducted to test the safety of the study drug Pembrolizumab, also known as MK-3475, at different dose levels in combination with the current therapy, (BCG), for superficial upper urinary tract transitional cell carcinoma. We want to find out what effects, good and/or bad, it has on upper urinary transitional cell carcinoma OBJECTIVE: To determine the safety of administering MK-3475 at a fixed dose of 200 mg every three weeks in conjunction with intrapelvic BCG treatment in high risk superficial UUTTCC patients who are unfit or unwilling to be treated with radical nephroureterectomy. STUDY DESIGN: Open-label, single center, Phase II, treatment trial TREATMENT: BCG- BCG treatment could be delivered both through a retrograde ureteral catheter placed under fluoroscopic control or through an antegrade nephrostomy tube placed by interventional radiology. Treatment will be once a week for 6 weeks. BCG treatment will begin on Day 1 of Week 7. Depending on patient's response, they may have additional treatments beyond the 6 scheduled, but they will be outside of the patient's participation in this study. Pembrolizumab will be given through an intravenous needle once every 21 days (one cycle) for a total of 6 cycles. It will take 30 minutes for the infusion of the study drug. Pembrolizumab will be given on Day 1 of weeks 1, 4, 7, 10, 13, and 16 while BCG will be given on Day 1 of weeks 7-12. PROCEDURES: Following informed consent, prescreening and screening procedures will be performed, which will include medical history review, baseline chest x ray and EKG, ureteroscopy and pulmonary function tests for final eligibility status. Once subject is eligible, they will undergo physical exams (every 3 weeks), vital signs and weight (each study visit), adverse event monitoring (each study visit), ECGs (screening visit), bloodwork (at screening and then every 3 weeks), urinalysis at selected study visits, and concomitant medication review (each study visit), and questionnaires (selected study visits). After subject has completed week 19, they will have a study discontinuation visit, followed by a 30 day follow up visit. The subject will then be followed at 3, 6, 9, 12, 18 and 24 months post treatment where vital status will be determined as well as disease recurrence status. Ureteroscopy will be performed as standard of care but will be considered measures for efficacy. Biopsy will be performed as clinically indicated.

NCT ID: NCT03335228 Not yet recruiting - Clinical trials for Frontal Fibrosing Alopecia

Platelet Rich Plasma for Frontal Fibrosing Alopecia

Start date: March 1, 2025
Phase: N/A
Study type: Interventional

The primary objective of this study is to assess the efficacy and safety of platelet rich plasma in reducing scalp symptoms and promoting hair growth in patients diagnosed with frontal fibrosing alopecia. Platelet rich plasma is an autologous blood product, and platelet rich plasma will be administered intralesionally for this study. The platelet rich plasma used for this study will be prepared using the Eclipse Easy Spin centrifuge.

NCT ID: NCT03331419 Not yet recruiting - Clinical trials for Chronic Fatigue Syndrome

Exercise-related Post-exertional Malaise

CFS/ME
Start date: November 2017
Phase: N/A
Study type: Observational

This pilot study is intended to identify sex differences in myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS) during recovery from brief but high effort exercise tests. It is expected that women with ME/CFS as compared to males with ME/CFS will show slower recovery from exercise with respect to heart rate and blood pressure, physical functioning, and symptom severity. Also females with ME/CFS as compared to males with ME/CFS will show greater negative impacts on heart rate, blood pressure, physical functioning and symptom severity after the two exercise tests. The findings will have implications for sex differences in the pathophysiology of post-exertional malaise and activity/exercise self-management recommendations, given the expected detrimental effects of the brief intense exercise tests on patients with ME/CFS.

NCT ID: NCT03328455 Not yet recruiting - Healthy Aging Clinical Trials

The Role of GABA-mediated Inhibition in Multisensory Temporal Processing & Postural Control in Older Adults

Start date: December 1, 2024
Phase: N/A
Study type: Interventional

In recent years evidence has accumulated on the association between age-related decline in multisensory temporal processing and postural control. This proposed project aims at examining GABA-mediated inhibition as the potential mechanism behind this link. Our overarching hypothesis is that changes in the excitatory-inhibitory balance with a reduction of GABAergic inhibition is a common mechanism underlying age-related multisensory and postural deficits potentially mediated by age-related reduction in network segregation. To test this hypothesis, we will assess the relationship between age-related multisensory/postural deficits and age-related reduction in GABA concentration in related brain areas and probe the role of GABA-mediated inhibition using cognitive training that specifically targets inhibitory functions. Our multimodal approach is innovative, and findings from this study has the potential to lead to the development of safe and effective rehabilitation protocols for older adults with impaired multisensory temporal integration and postural control.