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NCT ID: NCT04245332 Suspended - Muscle Strength Clinical Trials

Effects of Fish Oil and Resistance Training on Muscle Mass and Function

Start date: January 29, 2020
Phase: N/A
Study type: Interventional

This study consists of a free-living, 6-week fish oil (FO) or placebo (PLA) supplementation intervention alongside participants' habitual resistance exercise training (RET) regimens. Twenty young, healthy resistance-trained subjects who do not currently supplement with FO will be recruited to participate. An eligible participant will be between ages 18 and 35 and will have a minimum of two years of RET experience. Participants will be randomized into a FO group and a PLA group. The FO group will supplement with 4g/day of FO (4g fish oil concentrate: 2g EPA+ 1g DHA) and the PLA group will consume 4g/day of coconut oil (saturated fatty acids), as administered via gel capsules, in conjunction with their current RET program. Prior to intervention all participants will complete baseline biometric, strength, and neuromuscular testing. Participants will also have blood drawn to test for omega-3 fatty acid status, and complete and return a 3-day diet record and a physical activity recall. In order to monitor adherence to supplementation, FO and PLA bottles will also be returned weekly and pills will be counted. 3-day diet records will be obtained to ensure calorie and protein intakes remain consistent throughout the intervention period. Weekly physical activity records will also help to ensure consistency of participant training and to make sure all participants are following their training regimes in a progressive fashion. Following 6 weeks of FO or PLA supplementation, subjects will repeat all initial biometric, strength and neuromuscular testing, as well as a second, post-intervention blood draw.

NCT ID: NCT04244058 Suspended - Clinical trials for Traumatic Brain Injury

Changes in Glutamatergic Neurotransmission of Severe TBI Patients

Start date: September 23, 2020
Phase: Early Phase 1
Study type: Interventional

Studies in patients with disorders of consciousness (DOC) after severe brain injury implicate dysfunction of the anterior forebrain mesocircuit dysfunction a key underlying mechanism. The anterior forebrain metabolism in DOC is markedly downregulated across brain regions underpinning highly elaborated cognitive behaviors demonstrating a collapse of the level of synaptic background activity required for consistent goal-directed behavior and arousal regulation. Since dopamine levels are one of the primary controllers of the level of synaptic background activity within these forebrain structures and in regulating excitatory glutamatergic homeostasis, the investigators propose to investigate the specific contribution of presynaptic dopamine function in glutamatergic neurotransmission in posttraumatic DOC. The aim of the present study is to measure metabotropic glutamate receptors 5 occupancy in the main gutamatergic structures of the brain using (3-[18F]fluoro-5-(2-pyridinylethynyl)benzonitrile)-positron emission tomography ( [18F]FPEB-PET) at rest and following a short pharmacological challenge with amantadine, an N-methyl-D-aspartate receptor (NMDA-R) antagonist, following L-DOPA, and amantadine + L-DOPA. Using this novel technique in DOC the investigators will characterize the relevance of a presynaptic deficiency to synthesize and/or release dopamine in the final regulation of excitatory interneurons of the anterior forebrain mesocircuit. It is unknown whether glutamatergic neurotransmission is affected across the population of subjects with DOC and, if this condition is secondary to a presynaptic dopaminergic failure of the anterior forebrain mesocircuit (i.e., down-regulation). Since the investigators previously identified the existence of a presynaptic dopaminergic deficit in these subjects due to a failure in the biosynthesis of dopamine, the investigators will evaluate if by providing the main biological substrate of the biosynthesis process (i.e., L-DOPA) the glutamatergic system regains homeostasis. The investigators therefore propose to investigate patients with posttraumatic DOC using [18F]FPEB-PET at rest and following short pharmacological challenges aimed at increasing glutamate and dopamine release.

NCT ID: NCT04236583 Suspended - Telehealth Clinical Trials

Improving the Hospital-to-Home Transition Through Post-Discharge Virtual Visits in Primary Care

Start date: February 28, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to test a new process for having a virtual visit with a primary care doctor after discharge from the hospital, instead of an in-person visit.

NCT ID: NCT04231877 Suspended - Clinical trials for Aggressive Non-Hodgkin Lymphoma

Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Untreated Aggressive Large B-cell Lymphoma

Start date: October 27, 2020
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects of polatuzumab vedotin when given with combination chemotherapy for the treatment of patients with untreated large B-cell lymphoma that grows and spreads quickly and has severe symptoms (aggressive). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in combination chemotherapy such as etoposide, cyclophosphamide, and doxorubicin 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. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving polatuzumab vedotin in addition to etoposide, prednisone, cyclophosphamide, doxorubicin and rituximab may help treat patients with aggressive large B-cell lymphoma.

NCT ID: NCT04226976 Suspended - Nausea Clinical Trials

Efficacy of a Non-invasive Vestibular System Masking for Improving Outcomes Following Acute Unilateral Vestibulopathy

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

Vestibular disorders are among the most common causes of disability in society and affect over 50% of the population over the age of 65 and a significant percentage of the younger population. Acute unilateral vestibulopathy (AUV) is easy to diagnose and is commonly treated with physical therapy exercises called vestibular rehabilitation. But due to the discomfort experienced during AUV, patients can't usually comply with the treatment plan prescribed by their healthcare provider. In this study, the investigators propose the use of an adjuvant device, the OtoBand, to improve balance, gait, reduce vertigo, and nausea in participants with AUV. Participants enrolled will undergo three vestibular tests batteries: one baseline, one with the OtoBand set at an effective power, and one with the placebo device set at low power. Neither participants nor investigator will know which device is effective and which is placebo. The OtoBand will be set at two different effective power levels. Which power level the participant will receive is randomized and unknown to the participant or investigator.

NCT ID: NCT04225819 Suspended - Ulcerative Colitis Clinical Trials

Adjunctive Treatment With Vitamin D3 in Patients With Active IBD

ACTIVATED
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Inflammatory bowel disease ((IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC)), is a chronic, immune-mediated disease characterized by recurrent episodes of relapse. The incidence of IBD is increasing worldwide and poses as a burden that reduces quality of life and has a significant impact on health care resources. The advent of monoclonal antibodies to tumor necrosis factor-α (anti-TNF) has revolutionized treatment of IBD, improving rates of remission and reducing hospitalizations and surgeries. Nevertheless, many patients do not adequately respond to these therapies or lose response over time. Thus, there is an important need for novel immunomodulating agents to improve our ability to achieve remission. Besides its traditional role in bone homeostasis, several studies have recognized the important role Vitamin D plays in modulating the immune response, cancer, and cardiovascular disease. Specifically, Vitamin D may mediate immunity by modulating autophagy in leukocytes and regulating the gut microbiome. Thus, Vitamin D may play an important role in IBD. Furthermore, evidence suggests that the effect of vitamin D may be mediated through the TNF-α pathway, suggesting a synergy with anti-TNF therapy. This is a randomized, double blind, placebo-controlled trial to study the effect of Vitamin D3 as an adjunct therapy for patients with active CD, UC, or IBD unspecified who are undergoing anti-TNF induction therapy.

NCT ID: NCT04224727 Suspended - Smoking Cessation Clinical Trials

The Impact of Group Commitment Contracts on Smoking Cessation and Weight Loss

Start date: December 18, 2023
Phase: N/A
Study type: Interventional

We will conduct a randomized controlled trial to evaluate the effectiveness of group commitment contracts for smoking cessation and weight loss.

NCT ID: NCT04222309 Suspended - Glioblastoma Clinical Trials

Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)

Start date: January 6, 2020
Phase: Phase 1
Study type: Interventional

This single center, single arm, open-label, phase I study will assess the safety of a laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients. All participants included in the study will undergo standard surgical resection for diagnosed recurrent GBM. Following the resection, the surgical cavity will be lined with a laparoscopically harvested omental free flap. The participant's dura, bone and scalp will be closed as is customary. The participant will be followed for side effects within 72 hours, 7 days, 30 days, 90 days and 180 days. Risk assessment will include seizure, stroke, infection, tumor progression, and death.

NCT ID: NCT04220658 Suspended - Epigenetics Clinical Trials

Biomarker Study to Evaluate Correlations Between Epigenetic Aging and NAD+ Levels in Healthy Volunteers

Start date: December 19, 2019
Phase:
Study type: Observational

This is a single center, prospective study to evaluate correlations between epigenetic aging (as measured via DNA methylation) and NAD+ levels in healthy volunteers.

NCT ID: NCT04209023 Suspended - Surgery Clinical Trials

The Use of Navigated Transcranial Magnetic Stimulation (nTMS) in the Inhibition of Neurofunctional Regions of Interest

Start date: December 16, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the efficacy of task inhibition during TMS to confirm brain region localization. This study could provide an effective pathway for neurofunctional landmark confirmation that may be useful in a number of treatment modalities and medical considerations.