Clinical trials

To determine if the addition of thiamine to standard-of-care treatment will improve neurodevelopmental outcomes for infants with meningitis or bacteremia

Ewing sarcoma (EWS) and osteosarcoma primarily affect adolescents and young adults. Common treatments include chemotherapy, surgery and radiation, however, there have been few recent advancements in the standard of care. By incorporating eflornithine (DFMO) as an additional therapy and/or maintenance therapy we hope to safely observe improved event-free survival and overall survival. There are 5 cohorts covered under this master protocol.

The central hypothesis of the investigators is that the practice of yoga will result in an improvement of endometriosis related pain symptoms for women with endometriosis.

The purpose of this study is to evaluate the investigational drug, silmitasertib (a pill taken by mouth), in combination with FDA approved drugs for solid tumors. An investigational drug is one that has not been approved by the U.S. Food \& Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat. The goals of this part of the study are: * Establish a recommended dose of silmitasertib in combination with chemotherapy * Test the safety and tolerability of silmitasertib in combination with chemotherapy in subjects with cancer * To determine the activity of study treatments chosen based on: * How each subject responds to the study treatment * How long a subject lives without their disease returning/progressing

The goal of this clinical trial is to learn whether a newer sleep-testing device gives results that closely match the standard overnight sleep study, in children and adolescents ages 6-18 who are being evaluated for possible sleep apnea. The main questions it aims to answer are: Does the new device (WatchPAT 400) give breathing and oxygen level results that agree with the standard overnight sleep study (polysomnography)? How reliably can two doctors, each looking at only one test's results, arrive at similar conclusions about a child's sleep apnea? Participants will: Have their regular, already-scheduled overnight sleep study performed exactly as usual Wear the WatchPAT 400 device (a small sensor on one finger, a wrist unit, and one adhesive patch on the chest) at the same time, during that same night Have both sets of results reviewed separately by two different study doctors Researchers will compare the results from the WatchPAT 400 device to the results from the standard sleep study to see how closely they agree, and how well the new device performs at detecting sleep apnea in children and teenagers.

Aim: To examine if parental emotion regulation (ER) moderates the response to parent training interventions. H1: Reduced parental ER capacity will predict diminished efficacy for behavioral parent training to improve negative parenting behavior (NPB) and behavior problems in offspring with ADHD. H2: Increased parental emotional reactivity will predict diminished efficacy for behavioral parent training to improve negative parenting behavior (NPB) and behavior problems in offspring with ADHD.

Endometriosis is a common cause of pelvic pain in women which has been historically under-studied and under-diagnosed. The goal of this research is to pilot-test the feasibility and acceptability of a manualized, single-session brief mindfulness-based intervention (BMBI) among participants with endometriosis-related chronic pelvic pain (ECPP) who undergo surgical treatment, and gather preliminary data necessary for future studies assessing BMBI's impact on outcomes in surgically-treated ECPP. This pilot study will enroll 10-20 adult participants with ECPP to receive either a BMBI adjunctive to treatment as usual (TAU; n=5-10) or education with TAU (n=5-10) prior to their ECPP surgery. The central hypothesis is the BMBI is feasible to deliver pre-operatively, acceptable to patients, and may help improve acute post-surgical outcomes through more adaptive stress coping and pain processing, enabled by mindfulness training.

Obesity is a global health concern that is associated with high blood pressure and an increased risk for developing cardiovascular disease. The purpose of this study is to find out if the investigational drug angiotensin-(1-7) can improve cardiovascular health in people with obesity and high blood pressure.

This study aims to evaluate the role of single-dose 4-aminopyridine on the diagnosis of recurrent laryngeal nerve (RLN) paralysis. In addition, the investigational treatment will be used to test the hypothesis that 4-aminopyridine can speed the determination of nerve continuity after RLN injuries.

This project seeks to determine how e-cigarette (EC) physical design features, including those that allow the user to manipulate the quality and quantity of aerosols, affect exposure and toxicity from oxidants and other aerosol constituents.

This single-arm study will evaluate the feasibility, safety, and preliminary efficacy of tirzepatide in combination with standard levonorgestrel intrauterine device (LNG-IUD) therapy in patients with endometrial intraepithelial neoplasia (EIN) or grade 1 endometrioid endometrial carcinoma with co-existing obesity and metabolic risk factors. Participants will receive tirzepatide once weekly while continuing standard clinical management with an LNG-IUD. Treatment decisions will remain at the discretion of the treating physician. The primary objective is to evaluate pathologic response at approximately 6 months. Secondary objectives include changes in metabolic parameters, assessing the incidence and severity of adverse events of tirzepatide and LNG-IUD therapy, quality of life assessment, change in weight, and change in BMI.

The purpose of this study is to evaluate the investigational oral drug AMXT 1501 in combination with oral eflornithine (DFMO). An investigational drug is one that has not been approved by the U.S. Food \& Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat. The goals of this part of the study are: * Establish a recommended dose of AMXT 1501 in combination with DFMO * Test the safety and tolerability of AMXT 1501 in combination with DFMO * To determine the activity of study treatments chosen based on: * How each subject responds to the study treatment * How long a subject lives without their disease returning/progressing

This Phase I/II open-label trial aims to evaluate the safety and efficacy of the herbal supplement INM176 in patients with a history of prostate cancer or low-risk disease under active surveillance. The study will determine the recommended Phase II dose (RP2D) and assess the efficacy of INM176 in stabilizing or decreasing plasma PSA levels in post-radical prostatectomy (RP) and post-radiation therapy (RT) patients with rising PSA levels.

The goal of this clinical trial is to learn if semaglutide can reduce illicit opioid use in adults in outpatient treatment for opioid use disorder, and who are receiving either buprenorphine or methadone maintenance treatment. The main question it aims to answer is: • Does semaglutide increase the likelihood that participants will refrain from using illicit and nonprescribed opioids? The investigators will compare semaglutide to a placebo (a needle prick that contains no drug) to see if semaglutide works to reduce use of illicit and nonprescribed opioids. The participants will: * Take semaglutide or a placebo every week for 12 weeks * Visit the clinic every week for urine drug screening and pregnancy testing, vital signs, and to complete mental health and drug use questionnaires * Complete smartphone surveys sent at set times during the study

The purpose of this study is to evaluate the aesthetic benefit and safety of serial dermabrasion for free flap skin paddles and donor site scars in head and neck reconstruction.

The purpose of this study is to examine the rotator cuff muscles in your shoulder at one and two year post total shoulder replacement surgery.

The goal of this clinical trial is to learn if messages focused on not losing the functional benefits of exercise can help older adults with walking difficulty continue to exercise regularly. The main questions it aims to answer are: Do these messages make people more likely to anticipate regretting it if they do not exercise? Does more anticipated regret make it more likely they will exercise more regularly? Researchers will compare two versions of messages to see if the content of these one of these message types is more effective than the other. Participants will complete a daily 5-minute at home exercise program for 4 months and complete regular online surveys to track their progress and report their feelings regarding regret.

Care partners of people living with dementia often experience ongoing stress and unmet support needs. This study evaluates the feasibility of a low-intensity, supportive education and resource intervention for care partners who previously participated in an observational study. Participants complete a baseline phone interview and a short stress journaling activity, followed by a six-week series of automated educational and supportive messages delivered by text message or email. Participants may also take part in an optional peer support focus group. The study examines caregiver stress, resilience, engagement with resources, and participant feedback to inform future caregiver support interventions.

The purpose of this voluntary research study is to determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radio frequency ablation (RFA) will have greater efficacy than the traditional approach to lumbar medial branch nerve radio frequency ablation.

In this study, we will randomly assign 360 older adults to 12 months of 5 minutes per day of functional resistance training or to a delayed treatment control condition, and measure the impact of the training on measures of lower extremity performance and walking ability.

Emergence from general anesthesia with a laryngeal mask airway compared with an endotracheal tube has been shown to favorable with respect to limiting emergence phenomena such as coughing, straining, restlessness, and sympathetic stimulation leading to hypertension and tachycardia. Many anesthesiologists would prefer the use of an ETT to an LMA in cases in which higher ventilation pressures may be required, in those patients who are perceived to be high risk for reflux and pulmonary aspiration of gastric contents, as well as during cases that allow the anesthesiologist to have little accessibility the airway. The aim of this study is to investigate an airway management technique that would allow for the benefits of the ETT in terms of a secure airway for the duration of the surgical procedure as well the potential for less emergence phenomena seen when emerging with an LMA.

This is a single-center, double-arm, patient masked, randomized controlled trial. Subjects will be enrolled in the Emergency Department at the Penn State Milton S. Hershey Medical Center. Eligible subjects must present to the ED and be diagnosed with a traumatic corneal abrasion. One eye from each patient will be considered the study eye.

The study objective of this project is to examine the mechanisms of the venous distension reflex (VDR) in humans. We hypothesize that COX blockade with ketorolac tromethamine, an intravenous NSAID, will attenuate the muscle sympathetic nerve activity (MSNA) response to limb venous distension. To gain further insight into whether the COX byproducts directly stimulate chemically-sensitive afferents, or enable venodilation and indirectly evoke afferent stimulation, we will measure vein size using 3T MRI during venous distention with and without ketorolac infusions.

This research is being done to find out whether distension of veins in legs will cause a rise in blood pressure (orthostatic hypertension).

This proposal includes a prospective, parallel group, two-arm RCT with 264 adult-child dyads (adult age 18+, child ages 5-17 years) to examine the effectiveness of the Growing Healthy Hearts (GHH) intervention versus a wait list control on cardiovascular and behavioral health outcomes at 3-, 6- and 12-months follow-up (Aim 1). This proposal will also examine the effect of GHH on home fruit and vegetable (FV) availability, frequency of home-prepared meals that include FV, and child behaviors (FV intake and PA) at 3-, 6- and 12-month follow-up (Aim 2) and intervention implementation (Aim 3)