All Clinical Trials

The specific objective of this study is to perform a small, open-label study to assess the safety and efficacy of intralesional, subcutaneous injection of STS on calcinosis symptoms and lesion size in systemic sclerosis (SSc), mixed connective tissue disease (MCTD) and dermatomyositis (DM) patients. Injection will be guided by ultrasound, lesion size assessed by ultrasound, and symptom burden by patient-reported outcome measures. Read Less

The goal of this open-label single-arm study is to test a meditative neurofeedback intervention for depressed mood. Read Less

The goal of this interventional study is to learn if a digital sleep extension intervention can improve sleep and mood in young urban adults with mood symptoms. The main questions it aims to answer are: Will this intervention improve sleep? Will this intervention improve mood? Does the effect of this intervention change based on environmental factors like noise and light pollution? Researchers will compare participants receiving the sleep intervention to participants receiving a "general healthy living" intervention to see if outcome are different across groups. Participants will: * receive 6 weeks of brief once weekly telephone coaching and read once weekly educational content * have their sleep monitored daily with a FitBit and Somnofy sleep device and during the 6-week intervention period * respond to questionnaires at the start of the intervention, halfway through the intervention, at the end of the intervention, and finally 4 weeks after completing the intervention Read Less

The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be enrolled in the study. The study will be limited to patients in whom it is decided, based on routine clinical practice, that the LVAD will be implanted via a midline sternotomy. In the first 5 study patients, the device will be implanted in the RA; subsequently, the device will be implanted in the LA unless the patient is deemed at high risk of post-LVAD right heart failure, in which case the device will be placed in the RA Read Less

This phase I double-blind study focuses on the safety and feasibility of implanting autologous peripheral nerve tissue (PNT) into the substantia nigra area of the brain in persons who have been diagnosed with either Parkinson's disease (PD) or Multiple System Atrophy (MSA). 7 participants will be enrolled, with 4 participants receiving the graft and 3 receiving a sham surgery. Eligible participants will be early in their diagnosis with a lower burden of symptoms. Participants will be followed initially for one year after surgery. Read Less

This is a phase 2, single-arm, open-label clinical trial determining safety and tolerability of AHCC in subjects with HPV-positive patients with Head and Neck Squamous Cell Carcinoma. These are subjects who have undergone surgery or will be undergoing surgery. Read Less

The phase 1 primary objective is to determine the pediatric recommended phase 2 dose (RP2D) of PEEL-224 as a single agent (phase 1A) and in combination with vincristine and temozolomide (phase 1B). The phase 2 primary objective is to estimate the objective response rate (ORR) in children with refractory, progressive and relapsed NBL and rhabdomyosarcoma (RMS) treated with the RP2D of PEEL-224 in combination with vincristine and temozolomide. Read Less

The growing U.S. cancer survivor population is projected to hit 26M by 2040. Chemotherapy represents an effective cancer treatment but can diminish cancer survivors' quality of life-particularly cognitive function-through select pathophysiological processes. Research on chemotherapy-induced cognitive impairment (hereafter, 'chemo-brain') is therefore critical. Chemotherapy disrupts immune system function and antioxidant regulation, causing inflammatory molecule release and damaging the brain's blood vessels. The brain's vascular function and, possibly, its neurons, are subsequently impaired-likely contributing to chemo-brain. Type 2 diabetes (T2D), a common cancer survivor comorbidity, shares underlying pathophysiology with chemo-brain. T2D-related insulin resistance can precipitate repeated high blood sugar episodes which increase inflammatory molecule release. In individuals with T2D without cancer, negative relationships are observed between inflammatory molecule concentrations and the brain's vascular and/or cognitive function. Cancer survivors with T2D might thus have higher chemo-brain risk than those without T2D. Yet, more research must compare how the brain's vascular function, as well as cognitive, inflammatory, and cardiometabolic indices, differ between these groups. Physical activity (PA) counteracts chemo-brain's and T2D's pathophysiology, with higher PA/fitness resulting in better vascular function of the brain, lower inflammatory molecule concentrations, and improved insulin sensitivity. We are therefore conducting a 30-participant quasi-experimental pilot study in cancer survivors with (cases) and without (controls) T2D. We will first investigate between-group differences in the brain's vascular function as well as cognitive, inflammatory, cardiometabolic, and epigenetic outcomes. We will then examine between-group changes in these outcomes and select psychosocial metrics during a 12-week technology-based PA program-potentially further elucidating involved mechanisms. Read Less

This is an exploratory mixed-methods control-treatment study to evaluate if participation in rhythmic musical activities improves social attention and connectedness in individuals living with mild to moderate bvFTD and AD, and their caregivers. Secondary objectives include evaluating the potential relationships between brain networks associated with rhythm production, social attention, and connectedness in these populations. Read Less

The goal of this research is to evaluate a scientifically rigorous diabetes intervention, Together Overcoming Diabetes (TOD), that has been tailored to address the unique underlying risk and protective factors and social determinants of diabetes among American Indian/Alaska Native (AI/AN) populations. Read Less

The purpose of the proposed study is to test the feasibility and efficacy of a "anxiety-focused" text-delivered counseling program to reduce anxiety symptoms among young adults (18-25) with elevated anxiety symptoms. We are primarily interested in whether the intervention will reduce anxiety. We have adapted an effective in-person, manualized cognitive behavioral therapy treatment for anxiety (Muñoz et al, 2000) into an 8-week, text-delivered anxiety treatment, named CBT-txt-Anxiety. We will test this with 100 young adults who will be randomized to either CBTtxt-Anxiety or waitlist control condition and assessed at baseline, and at 1- month, 2-months, and 3-months post-baseline. Read Less

Since the inception of aerospace travel, NASA has been collecting biospecimens from professional astronauts for research. With the recent growth of civilian aerospace travelers, there is a need for biospecimen banking for civilian astronauts. This protocol addresses this gap by being a biobank for civilian astronauts, their family members (to be controls) and others who are also doing travel to extreme environments (pilots, submariners). Read Less