All Clinical Trials

The goal of this clinical trial is to examine usability of a locally built adaptive rower for people with spinal cord injury using an established and tested design. The main questions it aims to answer are: 1. What exercise intensity of activity do users achieve on the rower for steady state and interval rowing plans? 2. What assistance is required for setup and usage of the adaptive rower? 3. What do users think about the ease of use and what is their satisfaction with the adaptive rower? Participants will complete a one-time exercise session with two adaptive rower bouts (10-15 minutes each) with a rest period in between. Read Less

The language outcome of children receiving cochlear implantation to address bilateral sensorineural hearing loss is more variable than that of typical hearing children. The research is focused upon development of neural predictive models based upon brain imaging to forecast language after cochlear implantation on the individual child level. The long-term goal is improving children's language by using predictive models to enable a custom "predict to prescribe" approach to intervene with more effective behavioral therapy for children at risk to develop poorer language. The investigators previously developed models for short term language outcome of English-learning implanted children. The aims of this study are to 1. Develop models able to predict long term outcome for English- learning and Spanish-learning children; and 2. To evaluate whether English-learning children predicted to achieve lower language based on the investigators' previously constructed models can demonstrate significant gains from Parent Implemented Communication Treatment (PICT). PICT is an intensive parent education program about strategies to improve children's communication. Read Less

Cystic fibrosis (CF) is a multisystem autosomal recessive inherited disease affecting approximately 75,000 individuals in USA. The sweat chloride (Cl) test remains the gold standard for diagnosis of CF but still has a number of limitations. The objectives of this study are: 1)To evaluate a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels as a potential low-cost but potentially accurate test to diagnoses cystic fibrosis (CF) and 2) To evaluate measurements of sweat chloride (Cl) using this same system in comparison to the standard clinical laboratory procedures routinely performed in the Clinical Laboratory at Penn State Health Milton S. Hershey Medical Center (PSH-HMC), Hershey, PA for assessment of the diagnosis of CF. This is a single institution study performed solely at PSH-HMC. Study participants will include 1) adults 18 years of age or older capable of providing signed and dated informed consent, 2) subjects with an established known diagnosis of cystic fibrosis (CF) or healthy volunteers, and 3) able to understand and speak English language. Exclusion criteria include: 1) any medical condition or disorder known to potentially interfere with accurate measurements of sweat chloride and 2) inability to understand and speak the English language. Cystic Fibrosis (CF) subjects will be identified from the population of eligible patients receiving medical care at Penn State Health- Milton S. Hershey Medical Center (PSH-HMC). Healthy donor volunteers will be recruited from various members of the PSH-HMC CF clinical care team, members of the Division of Allergy, Pulmonary and Critical Care (both faculty and trainees) at PSH-HMC, and PSU-University Park research team. The total projected number of combined enrolled subjects is 30. This is a single day single time study that will require approximately 60 minutes of subject participation. Potential risks include a) side effects from pilocarpine iontophoresis sweat test collection (pain, skin discomfort, blisters, rarely burns and b) loss of confidentiality. There will be no cost to subjects for study participation. There will be no reimbursement financially for study participation. There is no benefit to subjects for study participation. There is the potential benefit to medical science via identification of improved method to accurately measure sweat chloride for diagnosis of CF. Read Less

The goal of this observational study is to learn about maternal psychiatric course and infant development in pregnant individuals with severe mental illness, comparing those treated with antipsychotics to those treated with other medications or without medication. The main questions it aims to answer are: 1. Is risk of psychiatric relapse different among individuals who take antipsychotic medication, other medication, or no medication? 2. Are pregnancy and neonatal health outcomes different among individuals who take antipsychotic medication, other medication, or no medication? 3. Do infant behavior and neurodevelopment differ among babies who were exposed to antipsychotic medication, other medication, or no medication in utero? Participants will * complete a psychiatric interview and questionnaires while pregnant; * donate blood from the mother and from the umbilical cord at delivery * have their babies participate in infant behavior evaluations and an EEG procedure. Researchers will compare these outcomes among individuals who were treated either with antipsychotic medication, with psychotropic medications of other classes, and with no medication, to see if psychiatric benefits for the mother and health outcomes for mother and child differ among these three types of treatment. Read Less

This is a prospective, non-randomized, phase I study design evaluating the in vivo activities and expression of OCT1 and BCRP in mammary gland of lactating women at three time points postpartum. Read Less

The purpose of this study is to determine the effects of a readily available dietary supplement on quality of life and digestion in adults with functional dyspepsia. Read Less

MKC-NI-001 is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (MNKD-201) in healthy adult volunteers. The trial consists of a Single Ascending Dose (SAD), followed by a Multiple Ascending Dose (MAD) with a primary objective to evaluate the safety, tolerability, and pharmacokinetics (PK) of MNKD-201 compared to placebo in healthy adult participants. Read Less

Langerhans Cell Histiocytosis (LCH) is a type of cancer that can damage tissue or cause lesions to form in one or more places in the body. Langerhans cell histiocytosis (LCH) is a cancer that begins in LCH cells (a type of dendritic cell which fights infection). Sometimes there are mutations (changes) in LCH cells as they form. These include mutations of the BRAF gene. These changes may make the LCH cells grow and multiply quickly. This causes LCH cells to build up in certain parts of the body, where they can damage tissue or form lesions. For most patients with LCH, standard-of-care vinblastine/prednisone are used as front-line therapy while cytarabine therapy has been used as therapy for patients who develop recurrence. No alternate treatment strategy has been developed for frontline therapy in LCH. The purpose of this research study is to compare previously used vinblastine/prednisone to single therapy with cytarabine for LCH. We will evaluate the utility of an imaging study called a positron emission tomography (PET) scan to more accurately assess areas of LCH involvement not otherwise seen in other imaging studies as well as response to therapy. We also want to identify if genetic and other biomarkers (special proteins in patient's blood and in patient's cancer) relate to the response of patients LCH to study treatment. Read Less

This study is being conducted in order to determine the safety, dose-limiting toxicities, and maximum tolerated dose of cabozantinib in combination with 13-cis-retinoic acid in patients with relapsed or refractory solid tumors including tumors of the central nervous system (CNS) Read Less

Evaluate and study the immunologic changes to the ocular surface in cancer patients. Read Less

Smoke Free SafeCare (SFSC) is a proposed braided intervention consisting of two evidence-based interventions: Some Things are Better Outside (STBO), aimed at promoting smoke free home rules, and SafeCare, aimed at reducing child maltreatment and improving mother and child outcomes. STBO is effective in creating smoke free homes and reducing second-hand smoke in low-SES (socioeconomic status) households. SafeCare is an effective parent training program that is broadly disseminated in child protective services in the United States. SafeCare is a promising mechanism to effectively increase the reach of STBO to reduce SHS (secondhand smoke) exposure in families with documented high rates of tobacco use and children with cumulative risk for negative health outcomes. Read Less

This study will examine the overall capacity of people with Alzheimer's disease learning fall-resistant skills from perturbation training. Read Less