Virginia Paid Clinical Trials

The purpose of this study is to see the effects of two different standard of care treatments of endometrial cancer on sexual dysfunction. This study will compare two standard of care treatments: HDR (high dose radiation) vaginal brachytherapy 3 fractions of 7 Gy to HDR vaginal brachytherapy 6 fractions of 4Gy for early stage endometrial cancer. Read Less

Spousal caregivers of Alzheimer's Dementia (AD) patients have an elevated risk of developing AD in the future. Past studies have shown the presence of serum indicators correlated with gut biome dysfunction in AD patients. We hypothesize that the same gut biome dysfunction may be present in spousal caregivers of AD patients. Read Less

This proposal uses HER2Bi armed activated T-cells (HER2 BATs) to target breast cancer in combination with pembrolizumab (PBZ) in women with metastatic breast cancer (MBC). Phase I will determine a safe dose of the combination of PBZ and HER2 BATs in 3 to 18 patients. In the phase II portion, an additional 12 patients will be treated at the selected dose to further evaluate the safety and preliminary efficacy. Study treatment includes a combination of 8 infusions of BATs using a previously established schedule and one to three infusions of PBZ (200 mg per dose). PBZ will be added to 8 infusions of BATs in 3 schedules: #1) after the 8th BATs infusion; #2) after the 4th and 8th BATs infusions; and then, #3) before the 1st and after the 4th and 8th BATs infusions. Read Less

This is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor. Read Less

This is an international, multicenter, multi-arm, phase Ib, model-based dose-escalation study. The primary objectives of the study in each arm is to determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), dose limiting toxicities (DLTs) and to evaluate the clinical efficacy at the MTD of various combinations of pembrolizumab, pralatrexate and decitabine. Read Less

Apheleia-001 is a prescreener that aims to identify and characterize participants with reported cognitive impairment using demographic information, clinical history, brief cognitive assessments, and blood-based biomarkers to distinguish appropriate participants for referral to a therapeutic AD clinical trial. Read Less

This is a Phase 1, multicenter, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of CPO-100 administered intravenously in cycles of 3 weekly doses with 1 week rest (1 cycle = 4 weeks) in adult patients with advanced solid tumors. Read Less

Ankle sprains are prevalent and debilitating injuries in daily living and sports activities. The emergency room annually cares for over 206,000 patients with lateral ankle sprain in the United States, resulting in over $12,000 of health care cost per injury. Although many rehabilitation techniques for ankle sprains have been implemented, up to 40% of individuals with ankle sprains experience residual symptoms including recurrent sprain, episodes of ankle joint "giving way," and feelings of instability, which collectively define chronic ankle instability (CAI). Individuals with CAI commonly exhibit neuromuscular dysfunction with reduced motor control due to decreased sensory input to the central nervous system (CNS) after the initial injury. As a result, the CNS sends altered motor signals to lower extremity muscles. These CNS changes contribute to various neuromuscular impairments in CAI patients, the most common of which is reduced balance performance. Neural stimulation techniques, such as the Hoffman reflex (H-reflex) and transcranial magnetic stimulation (TMS) have been used to directly assess changes in the CNS. One of the most consistently identified CNS changes in individuals with CAI is reduced ability to modulate spinal reflex excitability and corticospinal excitability of the calf muscle when transitioning from simpler to more complex balance conditions. Neural excitability refers to the ability of the central nervous system to elicit skeletal muscle contractions. That is, the spinal reflex excitability and corticospinal excitability can be described as the ability to contract muscle conducted by the spine and brain, respectively. Typically, healthy individuals modulate or quiet down their spinal reflexes and rely more on the corticospinal excitability during more demanding balance tasks. However, evidence indicates that the individuals with CAI are unable to modulate spinal reflexes and shift control to brain, leading to reduced balance performance. Given that the calf muscle plays a crucial role in balance, improving proper supraspinal and spinal reflexive control of the calf muscle is imperative to balance maintenance of individuals with CAI. To improve balance function for those with CAI, many balance training programs have been implemented to improve static and dynamic stability and proprioception for those with CAI. The majority of findings indicate that balance training can be effective in preventing initial and recurrent ankle sprains. However, it is unclear if common balance training methods can restore the function of the CNS in those with CAI. Therefore, the purpose of this study is to determine the effects of balance training on the calf muscle spinal-reflexive excitability modulation, corticospinal excitability, and balance performance in individuals with CAI. The rationale for this study is that patients with CAI require effective rehabilitation that can restore their neurosignature and improve balance ability. Read Less

This is a first-in-human study evaluating the anti-T cell immunoglobulin and mucin containing protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts with Part 1 consisting of dose escalation and Part 2 dose expansion. Part 1 will determine the recommended Phase 2 dose (RP2D) of TSR-022 and Part 2 will evaluate the antitumor activity of TSR-022 in combination with TSR-042 or docetaxel and as monotherapy Read Less

Bluestar Genomics has developed a non-invasive test that aids in detection of occult pancreatic cancer in patients with new onset type II diabetes (NOD) who are 50 years old or older. The purpose of this study is to evaluate the performance of Bluestar Genomics early-detection pancreatic cancer test in a clinical setting. The study is prospective, longitudinal and interventional; tests will be ordered and results returned to site-investigators. If the test returns a pancreatic cancer signal "detected" result the study participant will undergo MRI imaging to evaluate for the presence of pancreatic cancer. The study is planned to enroll 6,550 newly diagnosed type 2 diabetic subjects according to inclusion and exclusion criteria. Read Less

A Phase I-II, First-in-Human Study of SKB264 in Patients with Locally Advanced Unresectable/Metastatic Solid Tumors who are refractory to Available Standard Therapies. Patient must have historically documented, incurable, locally advanced or metastatic cancer that are refractory to standard therapies of one of the following types: Triple negative breast cancer Epithelial ovarian cancer Non-small cell lung cancer Gastric adenocarcinoma/Gastroesophageal junction adenocarcinoma Small cell lung cancer HR+/ HER2-breast cancer Head and neck squamous cell carcinoma Endometrial carcinoma Urothelial carcinoma Read Less

Chronic allograft rejection of the transplanted lung (CLAD) is a major health issue in patients after lung transplant. This study is a registry-forming study with concurrent tissue banking from surveillance bronchoscopy in addition to extra tissue sampling of blood and urine. Patients will be characterized by usual clinical phenotyping and the latest imaging methods so that diseased condition underlying CLAD can be better understood. Read Less