All Clinical Trials

Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly, within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined. The purpose of this investigation is to examine the role of endothelin-1, a potent vasoconstrictor, in aberrant microvascular function in otherwise healthy women with a history of GDM and to identify whether this mechanism is influenced by physical activity and sedentary behavior. Read Less

Fibromyalgia (FM) is a chronic pain condition that disproportionately impacts Veterans. Individuals diagnosed with FM patients experience lower self-esteem and positive affect, as well as greater levels of depression, anxiety, negative affect, and pain catastrophizing. Among those experiencing FM, clinical and experimental pain are associated with specific dispositional trait profiles, which are indexed by levels of negative affect and positive affect. Neuroinflammation and inflammation also play a role in FM- related affect and pain. Recent studies that have highlighted neuroinflammation and inflammation as physiological mechanisms associated with changes in dysregulated affect and chronic pain. Veterans with FM can ameliorate their dispositional traits-i.e., increasing positive affect and reducing negative affect-by participating in exercise. However, a gap exists regarding how to optimally engage Veterans with FM in an exercise program. Thus, to fully take advantage of all potential therapeutic benefits of exercise for FM, there is a critical need to identify those factors underlying exercise engagement for FM pain management. The purpose for this study is to 1) determine associations of dispositional trait styles, neuroinflammation, and inflammation with pain outcomes in Veterans with FM; and 2) develop and design a Veteran-informed exercise program. Read Less

This is a Phase 1, randomized, double-blind, placebo-controlled, single-dose, first in human safety, tolerability, and pharmacokinetic study of SPY002-072 in healthy participants. Read Less

Traditional clinical trials in patients with breast cancer leptomeningeal disease (LMD) are challenging as patients often have a rapidly progressive course and prognosis is poor, making meeting standard eligibility difficult. Furthermore, there is limited information about the biology of LMD. The investigators thus propose a study that is as inclusive as possible, which will allow the investigators to collect biospecimens and clinical outcomes to learn more about LMD biology, but still potentially provide benefit for patients, by providing patients rapid diagnostics and multi-disciplinary treatment recommendations. Read Less

The LIMBER UniLeg, a 3D printed single-piece transtibial prosthetic limb, is sufficiently equivalent to traditional passive prosthetic limbs (no motors or sensors), while reducing the cost and time of manufacturing and enabling global reach through the use of digital technologies to solve the worldwide prosthetic accessibility crisis. This is a single-site, Phase I, Clinical Research Study to test the effectiveness and safety of the LIMBER UniLeg. One study group of 30 participants involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month). Read Less

The purpose of this study is to investigate the effectiveness of behavioral cough suppression therapy (BCST) in managing refractory chronic cough (RCC) within a group telehealth setting. RCC is a cough that has lasted at least 8 weeks and has not resolved with standard medical treatment. BCST is a research-based treatment provided by specialty-trained speech-language pathologists (SLPs) for patients with RCC. Although the treatment works very well for a large proportion of patients in a standard one-on-one format, there are a limited number of SLPs available to provide this treatment and patients living in rural areas do not typically have access to an SLP trained in BCST. If BCST can effectively be delivered in a group telehealth model, it would significantly improve accessibility to the treatment. Read Less

The investigators will assess both effectiveness (primary) and implementation (secondary) outcomes for a distress-reducing intervention, Supporting Teen Problem Solving (STePS). STePS has already undergone an efficacy trial. The current study allows for evaluating the outcomes of STePS by delivering it in real-world settings, using real-world providers. The investigators will train these behavioral health providers who are already embedded in diabetes clinics to use the STePS intervention. The investigators will also compare two approaches to intervention delivery: in-person versus telehealth. The investigators have recruited 6 different study sites across the country, representing diversity in rural vs. urban, public vs private insurance, as well as in ethnic and racial background of the participants. 360 teens will be enrolled and randomized to either STePS or an educational control group on a 1:1:1 basis at each of our 6 study sites: STePS in-person (n=120), STePS telehealth (n=120), or educational control via telehealth (n=120). All 3 groups will be delivered as 4.5-month interventions, consisting of 9 sessions offered twice per month. Quantitative data (surveys) will be collected for all participants at baseline, immediately post-intervention, and 6 \& 12 months post-intervention. Qualitative data will also be collected post-intervention through focus groups. Aim 1. To test, in 360 teens across 6 clinical sites, the effectiveness of STePS in improving diabetes- specific emotional distress and preventing worsening glycemic control, both immediately post intervention and over time. Hypothesis 1a: STePS will lead to clinically meaningful and statistically significant improvements in diabetes distress. Hypothesis 1b: STePS will prevent the worsening of glycemic control (A1C and Time in Range). These hypotheses are consistent with the efficacy trial and will prove effectiveness when implemented in real- world settings. Aim 2. To assess the implementation of STePS among key stakeholders (teen participants, interventionists). Recruitment, enrollment, representativeness, feasibility, acceptability, appropriateness, fidelity, and costs will be assessed as well as preferred implementation approaches. Hypothesis 2a. Stakeholders will find few perceived barriers to implementing STePS and many perceived facilitators for adopting it in their clinical settings. Hypothesis 2b. Implementation strategies will be plausible in diabetes clinics across the country. Read Less

A pilot pharmacokinetic trial to determine the safety and efficacy of a flavored, orally administered irinotecan VAL-413 (Orotecan®) given with temozolomide for treatment of recurrent pediatric solid tumors including but not limited to neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, hepatoblastoma and medulloblastoma Read Less

Investigators are conducting a study on alternative treatments for patients who have received an current or previous positive COVID-19 diagnosis with mild-serve symptoms or undiagnosable condition after testing positive for severe acute COVID-19 infection and are experiencing long-haul symptoms. The symptoms of long COVID can include extreme tiredness (fatigue), shortness of breath, memory and concentration issues (brain fog), heart palpitations, dizziness, joint pain, muscle aches, cough, headaches, anxiety, and depression. It's important to note that there are various other symptoms that individuals can experience after a COVID-19 infection, such as loss of smell, chest pain or tightness, difficulty sleeping (insomnia), pins and needles, depression, anxiety, tinnitus, earaches, nausea, diarrhea, stomach aches, loss of appetite, cough, headaches, sore throat, and changes to the sense of smell or taste. To be included in the study, participants must have had symptoms for more than 4 weeks. The goal of the study is to measure biomarkers, identify new ones through clinical trials, and individualize and optimize treatment plans, which may or may not include COVID-19 post-market antivirals, vaccines, and medical care. It's essential to conduct thorough clinical trials to understand the long-term effects of COVID-19 and to develop personalized treatment plans for individuals experiencing long-haul symptoms. Read Less

This study aims to assess changes in empathy levels before and after residential treatment among individuals with substance use disorders. Read Less

Multiple studies have demonstrated oral suppressive antibiotic therapy (SAT), after intravenous antibiotics, maximizes reoperation-free survival of total joint arthroplasty (TJA) debridement, antibiotics, and implant retention (DAIR) for acute periprosthetic joint infection (PJI). However, little is known regarding sequelae of SAT after DAIR for PJI. Prior studies have small or heterogeneous patient cohorts, variable antibiotic regimens, arrive at disparate conclusions, and do not establish antibiotic resistance risk. The investigators propose a prospective randomized controlled multicenter study to expand on findings in a retrospective, multi-center pilot study. Study aims are to evaluate SAT after DAIR of acutely infected primary TJA regarding: 1) adverse drug reactions/intolerance; 2) reoperation for infection; and 3) antibiotic resistance. Read Less

Conventionally, physical therapy (PT) clearance is sought before total joint arthroplasty (TJA) discharge. However, PT staffing limitations may preclude same-day discharge in patients having surgery late in the day. Failed same-day discharge in eligible TJA patients results in unnecessary hospital bed occupancy, which increases costs, limits operating room throughput for patients requiring inpatient admission, and introduces risks associated with longer length-of-stay. In collaboration with an institutional PT department, the investigators developed a protocol for discharging same-day TJA patients without postoperative PT clearance. Immediately preoperatively, PT administers gait training. Patients are then discharged home after ambulating with post-anesthesia care unit (PACU) nurses trained by PT on postoperative mobilization. This allows for the maximum number of patients discharged home, including the last patient of the day, PT staffing limitations notwithstanding. Single-institution pilot data demonstrates no increased risk of falls, emergency room (ER) visits, or readmissions with this process. The investigators propose a prospective, controlled, multicenter study to expand on pilot data. The study aim is to assess safety of day-of-surgery preoperative PT and postoperative ambulation with PACU nursing before TJA discharge. The primary endpoint is postoperative falls, while secondary endpoints include 90-day ER visits, 90-day hospital readmissions, patient-reported outcome measures, and patient satisfaction scores. Read Less