All Clinical Trials

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

The aims of this study are to 1) explore the efficacy of hyperbaric oxygen therapy (HBOT) applied at two different pressures compared to sham treatment in relieving signs and symptoms (both physical and psychological) of opioid withdrawal in human subjects associated with methadone dose reductions; and 2): explore whether HBOT can increase the odds of successful methadone dose reduction in patients who are interested in tapering their opioid dose. The investigators aim to explore, through qualitative methods, individual's experiences with treatment for opioid use disorder (OUD). Read Less

A study aimed to assess the efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine within the study plan of those with chronic conditions who are receiving ketamine. Read Less

This trial is designed to develop and test the efficacy of cognitive training strategies to improve self-regulatory capacities for middle-aged adults to adopt and sustain a physically active lifestyle. The main questions it aims to answer are: * Can cognitive training designed to improve cognitive control improve physical activity adherence? * What are the psychological, physiological, cognitive, and sociodemographic factors that affect the impact of cognitive control on physical activity adherence? Participants will * Complete a 6-week home-based, computerized cognitive training program * Complete a 6-week home-based, aerobic exercise training program with supervision of a health coach and trainer * Complete a 6-week home-based, aerobic exercise training program prescribed by a health coach and trainer * Visit the laboratory before and after cognitive training, and before and after physical training, to complete assessments of cognition and aerobic fitness Read Less

This study aims to examine the effect of force levels in orthodontic treatment during canine retraction. Force levels refer to the pressure applied by the orthodontic devices to move teeth. Data collection will include gingival fluid, dental molds from a digital scanner, and x-rays of the upper canine region on both sides of the mouth during treatment. The null hypothesis to be tested is that there is no significant difference in the rate of canine movement between the light force and the heavy force levels. Read Less