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NCT ID: NCT03751709 Active, not recruiting - B-ALL Clinical Trials

Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL

Start date: February 14, 2020
Phase: Phase 1
Study type: Interventional

Single center Phase 1 dose escalation trial of the combination of standard-of-care blinatumomab plus Haplo-Mismatched Cellular Therapy (HMCT). HMCT refers to the infusion of donor peripheral blood mononuclear cells collected via pheresis from a haploidentical family member - the procedure is analogous to giving a donor lymphocyte infusion outside of the setting of an allogeneic stem cell transplant; also known as 'microtransplantation'. The HMCT is an unselected mix of lymphocytes and leukocytes, but the product dose escalation will be done based on the T cell content. Ten recipients are planned. Each subject will be administered one infusion of HMCT during the first cycle of blinatumomab and two infusions during cycle two of blinatumomab; the CD3+ cell dose of the HMCT infusion is governed by dose escalation / de-escalation following a Bayesian method.

NCT ID: NCT03751137 Active, not recruiting - Obesity, Childhood Clinical Trials

GI Tract Biomarkers in Infants With Different Diets

Start date: March 10, 2016
Phase:
Study type: Observational

Childhood obesity is increasing with more than one-third of adolescents currently overweight and one in five with obesity. The lifelong incidence of obesity-related morbidities is also increasing with childhood obesity. It is not yet known how obesity develops in an individual, specifically in early childhood. Further, it is unclear what mechanistic role a child's earliest nutrition or changing intestinal flora has in the etiology of obesity. Very young children are developing appetite and satiety patterns early in life. Nutrition and gut microbial flora have impact on how these processes unfold, but specific mechanisms are not yet well understood. The investigators hypothesize that formula-fed infants with changes in their microbial flora are more likely to have altered carbohydrate metabolism, evidenced by greater imbalances of fatty acid production, and are more likely to have accelerated growth trajectory due to satiety disruption. The investigators further hypothesize that altered carbohydrate metabolism, e.g. imbalances of short- and long-chain fatty acid levels in the gut, stimulate cellular stress and affect specific gut hormones. This study will compare the microbiome of the intestinal microbial flora in two groups of infants, one breast fed and the other formula fed, using longitudinally collected fecal samples from both groups. Samples will be subjected to shotgun metagenomic analysis and simultaneous metabolomic analysis. A bioinformatics approach will elucidate key differences among and between sample groups, and will further analyze bacterial gene expression levels related to carbohydrate metabolism. This study will compare the expression of human proteins involved in cellular stress response and gut peptide signaling by applying quantitative Reverse Transcriptase-Polymerase Chain Reaction to human messenger RNA isolated from the longitudinally collected samples from both groups. Finally, this study will monitor the trajectory of growth and feeding over the first 2 years of life. The project's focus on the influence of different early feeding types, microbial flora changes, and altered carbohydrate metabolism leading to disruption of gut-brain signaling will provide critical data for host:microbiome interactions and translational therapeutic targets.

NCT ID: NCT03750903 Active, not recruiting - Aging Clinical Trials

Aging and Cortical Excitability

ACE
Start date: March 4, 2019
Phase: Phase 1
Study type: Interventional

The objective of the current proposal is to identify 1) how aging-related changes in GABAergic cortical inhibition affect motor performance, and 2) how aerobic exercise may improve inhibitory function and facilitate motor learning.

NCT ID: NCT03750825 Active, not recruiting - Cigarette Smoking Clinical Trials

Are Smokers Switching to Vaping at Lower Risk for Cancer? (Electronic Cigarettes and Cancer Risk)

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

This project will address a growing public health concern, namely, the health risks or benefits of e-cig use relative to cigarette smoking. The investigators will use biomarkers of early effects of relevance to cancer to determine the carcinogenic potential of e-cig use relative to cigarette smoking in oral epithelium, which is a target tissue for smoking-associated cancer. The study population will consist of one group of smokers who are interested in switching to e-cig use (Grp 1), one group of smokers who do not intend to change their smoking habits (Grp 2), and one group of non-users who would like to maintain their nonsmoking non-vaping status (Grp 3); The total number of participants in this project is 150 (n = 50, each group). The investigators will use an integrative 'multi-omics' approach complemented with single-locus/gene validation analyses to detect temporal changes in the genome, epigenome, and transcriptome relevant to cancer in the oral cells of the participants as the intervention progresses.

NCT ID: NCT03750422 Active, not recruiting - Striae; Albicantes Clinical Trials

Stretch Marks on Abdomen

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine the effect of Stratacel® wound dressing on cosmetic outcomes following 1064/532nm picosecond laser (Picoway®, Syneron Candela Corp, Wayland, MA, USA) treatment of abdominal striae alba. Secondary objectives include examining the effect of Stratacel® wound dressing on post-laser healing and symptomatology.

NCT ID: NCT03750409 Active, not recruiting - Clinical trials for Mild to Moderate Dementia

Assessing Feasibility of Prolonged Repetitive Near Infrared Light Stimulation in Early to Mid-Stage Dementia

Start date: October 15, 2018
Phase: N/A
Study type: Interventional

This study will gather data to see if infrared and near infrared light frequency can increase the activity of brain cells and provide support for the cell's ability to repair and protect themselves against further damage.

NCT ID: NCT03750006 Active, not recruiting - Frailty Clinical Trials

Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training

HIIT-VA
Start date: December 3, 2018
Phase: N/A
Study type: Interventional

Frailty is a clinical condition of poor physiological reserve that increases risks for adverse health outcomes including falls, hospitalization and mortality. Exercise is beneficial for the prevention and even reversal of frailty, yet participation among older individuals is limited. Short session high intensity interval training (HIIT) is emerging as a promising exercise strategy that achieves performance gains with lower time commitment. The goal of this pilot proposal is to establish the feasibility of HIIT exercise training protocols in 65-85 year old individuals, as well as to demonstrate the ability to detect functional and physiologic benefits. The investigators anticipate the preliminary research findings will lay the foundation for future human clinical studies that will permit us to significantly improve the health of Veterans.

NCT ID: NCT03749434 Active, not recruiting - Clinical trials for Healthcare-Associated Infections

Understanding and Addressing Variations in HAIs After Durable Ventricular Assist Device Therapy

Start date: February 4, 2019
Phase:
Study type: Observational

Substantial center variability exists in healthcare-associated infection (HAI) rates following durable ventricular assist device (VAD) implantation for patients with advanced heart failure. Preliminary evidence suggests that this variability may be related to process (e.g., pre-operative intranasal mupirocin), provider (e.g., surgeon technique, physician teamwork), device, (e.g., centrifugal vs. axial flow), and center specific (e.g., infection prevention strategies and resources) factors. The investigators will undertake a mixed methods study to: (1) identify determinants of center-level variability in HAI rates, (2) develop a comprehensive understanding of barriers and facilitators for achieving low center HAI rates, and (3) develop, iteratively enhance, and disseminate a best practices toolkit for preventing HAIs that accommodates various center contexts.

NCT ID: NCT03749421 Active, not recruiting - Breast Cancer Clinical Trials

Prospective Study of the Prosigna Assay on Neoadjuvant Clinical Decision-making in Women With HR+/Her2- Breast Cancer

Start date: March 21, 2019
Phase:
Study type: Observational

This research study is evaluating a genomic analysis called Predictor Analysis of Microarray 50 (PAM50, by Prosigna®) as a tool to possibly guide the participant and the treating physician to choose the most personalized pre-operative treatment for breast cancer.

NCT ID: NCT03749018 Active, not recruiting - Clinical trials for Diffuse Large B-Cell Lymphoma

Nivolumab With DA-REPOCH Chemotherapy Regimen in Treating Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma

Start date: January 2, 2019
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well nivolumab works with the DA-REPOCH chemotherapy regimen in treating patients with aggressive B-cell non-Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body?s immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as dose-adjusted rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (DA-REPOCH), work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab with DA-REPOCH may work better in treating patients with aggressive B-cell non-Hodgkin lymphoma.