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NCT ID: NCT03473288 Withdrawn - Clinical trials for Autophagy and Apoptosis in Human Satellite Cells

Rejuvenation of Aged Muscle Stem Cells Through Exercise

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

The proposed study will establish a newly-identified signaling pathway regulating both autophagy and apoptosis in human satellite cells. These findings will allow for novel pharmacological targets in satellite cells to return regenerative capacity to elderly individuals. Up to 80 adults, 21 years of age and greater, will undergo a consent visit followed by three blood draws and muscle biopsy visits- baseline (pre), after the first exercise bout (post-acute), and after the 12 week training program (post-chronic). Blood will be obtained and tested for inflammatory (IL-6/TNF/IL-1) and endocrine markers (Testosterone/Estrogen/Thyroid hormone). As part of the intervention, participants will undergo moderate intensity treadmill exercise three times per week for 10-12 weeks or serve as sedentary controls. Muscle stem cell function will be compared across age groups at each time point using a One Way ANOVA or t test for specific comparisons. An alternative analysis will be a longitudinal design following muscle stem cell function from each individual before and after exercise training. This analysis will be performed with repeated measure ANOVAs. Data will be analyzed using GraphPad Prism 6 statistical software. Significance will be accepted as p<.05. Thigh Muscle biopsies may result in momentary pain and discomfort, burning or bleeding, numbness, and rarely fainting or infection. The incision site may leave a scar and muscle soreness may be present up to ten days after the biopsy. While the local numbing medicine xylocaine is almost entirely free from allergic properties (such as causing hives), an allergic reaction is possible, and the participant will not be given xylocaine if they have a history of such a reaction. The xylocaine will be given by a small injection into the skin at the site of the muscle biopsy. Risks associated with a standard blood draw include momentary discomfort and/or bruising. In addition, there is a minimal risk of infection, excess bleeding, clotting, and fainting. An exercise program may result in muscle, bone and/or joint soreness, discomfort and/or injury. All collected data will be stored in a locked file to be accessed only by Dr. White and his study staff. Study records that identify subjects will be kept confidential as required by law.

NCT ID: NCT03472872 Withdrawn - Headache Clinical Trials

A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache

Start date: September 5, 2017
Phase: Phase 4
Study type: Interventional

This randomized, double-blind trial will compare the clinical efficacy of IV acetaminophen to that of IV ketorolac as adjuncts to standard therapy (prochlorperazine and diphenhydramine) in the treatment of patients presenting to the emergency department with chief complaint of "headache" or variants thereof.

NCT ID: NCT03471689 Withdrawn - Pain Clinical Trials

Multisensory Integration and Pain Perception

Start date: November 8, 2017
Phase: N/A
Study type: Interventional

Pain is a predominant disruption of well-being among humans. Feeling pain is a multimodal sensory experience where information is collected and processed from various senses such as sight and touch. Because pain is complex, variable, and experienced differently by each individual, finding more accessible and practical treatments for pain are necessary. Mindfulness meditation (MM) aims to reduce pain by directing focus to perceive thoughts through non-judgmental awareness. Positive reappraisal (PR) is a possible cognitive pain treatment that focuses on changing the meaning of stressful or negative events into positive, benign, valuable, or beneficial. When a stressful event, such as experiencing pain, is positively reappraised, the individual recognizes and engages with the feeling of stress produced by the event and intentionally looks for benefits that change the feeling from negative to positive. The focus of this study is to examine the effect of different cognitive techniques on multimodal innocuous and noxious stimuli. Visual and tactile noxious stimuli will be administered to determine how visual cue integrate to form and modulate the subjective experience of pain. The study team postulates that mindfulness meditation and positive reappraisal will significantly reduce pain in response to multimodal stimulus (visual cue + noxious heat) when compared to a non-manipulation control condition. These findings will be utilized to better understand the multidimensional mechanisms supporting nociception and the cognitive modulation of pain.

NCT ID: NCT03468140 Withdrawn - Clinical trials for End Stage Liver Disease

Pilot Trial of Eculizumab Therapy to Reduce Preservation Injury in Human Macrosteatotic Liver Transplantation

Start date: October 1, 2021
Phase: Early Phase 1
Study type: Interventional

The number of liver transplants that can be performed is limited by the availability of organs. Livers that are steatotic (i.e., infiltrated by triglycerides and other fatty substances) are usually not used for transplants, due to increased risk of adverse events and deaths post-transplant. The investigators propose administering eculizumab to patients receiving macrosteatotic liver transplants and hypothesize that doing so will mitigate post-surgical adverse outcomes.

NCT ID: NCT03466489 Withdrawn - Clinical trials for Surgical Site Infection

Floraseal Versus Iodine Impregnated Adhesive Drapes

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

Infection after total joint arthroplasty can have devastating consequences. Adhesive drapes have been traditionally used at our institution to help reduce the risk of wound contamination and infection by superficial skin flora. Our primary objective is to determine if a cyanoacrylate-based sealant (FloraSeal microbial sealant) is superior to conventional iodine impregnated drapes in prevention of both superficial and deep surgical site infections in total joint arthroplasty (TJA) patients. A prospective, randomized controlled model will be used to answer this question.

NCT ID: NCT03466398 Withdrawn - Diabetes Mellitus Clinical Trials

Effects of a Remote Patient Monitoring Protocol on Glycemic Control in Adolescents With Type 1 Diabetes

Start date: April 11, 2018
Phase: N/A
Study type: Interventional

This study will use a randomized, crossover design. Children aged 13-18 years who have been diagnosed with Type 1 diabetes for at least 1 year and with at least 2 Hemoglobin A1c values ≥10.0% more than 60 days apart within the past year, with the most recent HbA1c value between 10-14%, will be placed into two separate treatment groups. Group A will undergo home monitoring for 12 weeks through the use of the Vivify kit, which contains a wireless tablet with daily medication/diet/symptom questionnaires. Group B will initially continue diabetes management per standard of care, including quarterly office visits. After a period of 12 weeks, Group B will switch to the RPM protocol, while Group A will return to standard of care. Both groups will have HbA1c values checked at the 0, 3, and 6 month time periods to assess the effect of the remote monitoring protocol. Participation in the RPM protocol will involve daily completion of the Care Plan questions, as well as weekly uploads of blood glucose values using the Glooko, Inc (Mountain View, CA) application, and weekly video visits with a member of the endocrinology team that will aim to address barriers to optimal care, whether they be motivation, knowledge or other difficulties. Barriers to care will be assessed in part through the completion of knowledge and self-efficacy assessments.

NCT ID: NCT03465345 Withdrawn - Prostate Cancer Clinical Trials

Study of Metformin Plus Oligomeric Procyanidin Complex for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients

Start date: July 11, 2018
Phase: Phase 1
Study type: Interventional

The overall goal of this study is to identify a safe dose of metformin, in combination with oligomeric procyanidin complex (OPC) for pharmacologic reduction of AGE levels in patients with prostate cancer.

NCT ID: NCT03464162 Withdrawn - Schizophrenia Clinical Trials

OnTrackNY With the Option of Social Network Meetings

Start date: April 11, 2018
Phase: N/A
Study type: Interventional

Early intervention programs for psychosis help improve short-term treatment and recovery outcomes for individuals experiencing psychosis. OnTrackNY is a coordinated specialty care (CSC) program, developed to treat young adults within two years of experiencing a non-affective episode of psychosis. This project aims to expand the role of family engagement and support within the OnTrackNY model. Borrowing from the Needs Adapted and Open Dialogue models, the study team created a family therapy service that includes the client and members of his/her social network to navigate crises and assist in treatment planning. This service, Social Network Meetings, will be offered to individuals enrolled in the OnTrackNY@MHA program as an additional, voluntary, service option. The study proposes that the introduction of Social Network meetings may improve treatment and recovery outcomes.

NCT ID: NCT03463395 Withdrawn - Clinical trials for Laryngopharyngeal Reflux

Efficacy of Reza Band for the Treatment of Laryngopharyngeal Reflux

Start date: July 2020
Phase: N/A
Study type: Interventional

We hypothesize that tissue and salivary pepsin will resolve after 12 weeks use of Reza Band, but not following standard of care alone. Additionally, RFS, RSI and inflammatory cytokines (IL -1β, -6, and -8) will decrease to normative levels following 12 weeks use of Reza Band, but not with standard of care alone. Primary Objective The primary objective is to evaluate the efficacy of the Reza Band for the treatment of LPR. We propose a pilot clinical trial to test the hypothesis that the Reza Band is effective for the treatment of LPR, measured by resolution of pepsin and decrease to normative values for RSI, Reflux Finding Score (RFS) and inflammatory cytokines. The long-term goal is to determine the efficacy of the Reza Band in the sequential progression of reflux-attributed laryngeal inflammatory and neoplastic disease.

NCT ID: NCT03459755 Withdrawn - Prostate Cancer Clinical Trials

Evaluating Race Specific AGE Accumulation as a Behavioral Biomarker Prostate Cancer Survivors

Start date: November 27, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to show that reduction in advanced glycation end-products (AGEs) is associated with the beneficial regulation of receptor for AGE (RAGE) mediated tumor response which may correlate with improved quality of life in PCa survivors. AGEs are produced by the body and are affected by lifestyle, weight and diet.