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417 Study Matches

Athletes' Experiences in Sport

In this study, we are interested in learning about how male athletes think about and understand the experience and expression of emotion in competitive sports.
Heather MacArthur at hjm158@psu.edu
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Male
Competitive athlete
Penn State student
18+ years
Exclusion Criteria:
Female
Non-athlete
Non-student
Under 18 years
Education
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Location
State College, PA

The Comparability and Reproducibility of Telomere Length Measurements

This research is being done to improve our understanding of methods to measure in telomere length (TL) and how different tissues contribute to variation in determined telomere length. A telomere is a piece of DNA at the end of each chromosome, which protects the rest of the DNA from being damaged. Knowing the length of the telomeres gives us important information about your cellular age, which can be different from your actual age depending on your exposure to certain risk factors. Studies have associated shorter telomere length with a range of risk factors that predict health problems and shortened life expectancy. However, these studies have been done using different methods and different types of tissues from the body. The differences between these studies make it difficult to compare results or help people understand how to live a healthier life. Participants will be asked to complete questionnaires and provide blood, saliva, and cheek cell samples.
Megan Zinobile at muz144@psu.edu or 814-689-9017
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
Participants must be adult male and female volunteers over the age of 18 at the time of enrollment.
Participants must not have an immune disease or significant medical illness.
Participants must currently be a non-smoker.
Participants cannot be pregnant or breast feeding.
Exclusion Criteria:
Individuals with an immune disease or significant medical illness will be excluded from this study.
Individuals who currently smoke will be excluded from this study.
Individuals who are currently pregnant will be excluded from this study.
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State College, PA

Communication preferences related to over screening for cancer among older adults

The overall objective of this study is to explore the perspectives of older adults on incorporating and communicating risks, benefits and life expectancy into cancer screening decisions. The findings from this study will inform development of an intervention to reduce over-screening for breast, cervical, or colorectal cancers among average risk older adults who are not recommended for screening by current guidelines based on age. Average risk, including age, is defined by screening recommendations. A person is at average risk if they have not had cancer (as defined in the exclusion criteria) or colorectal polyp (within 10 years) or breast biopsy (within 10 years) and they are within the age range. Our hypothesis is that subjects will be more willing to discuss cessation of regular cancer screening risks, benefits, and life expectancy are incorporated into an ongoing dialogue between provider and subject.
Sol Rodriguez-Colon at srodriguezcolon@pennstatehealth.psu.edu or 717-531-5190
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
65 years or older
Willing to participate in focus group discussion
Exclusion Criteria:
Diagnosed with non-skin cancer within the past 5 years
Prevention, Education, Cancer
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Hershey, PA
State College, PA

The role of probiotics in attenuating inflammation and improving gut health in obese adults

We are conducting a clinical study that is investigating the effects of yogurt on markers of inflammation and gut health in older adults (55-75 years old) with an elevated BMI. The participants will be given yogurt for 4 weeks and yogurt with added probiotics for 4 weeks. The order of the yogurt treatments will be random, meaning some participants will get plain yogurt first, and others will get yogurt with probiotics first. The participants will be asked to consume one 8-ounce serving of the given yogurt each day during the four weeks. At the beginning and end of each four-week period, the participants will have clinical evaluations so we can determine the impact of the yogurt on markers of inflammation and gut health. The compensation for this study is $300.
Hannah VanEvery at hqv5028@psu.edu or 814-863-3919
All
18 year(s) or older
This study is also accepting healthy volunteers
NCT03418857
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Inclusion Criteria:
Overweight/obese
age 55-75
Non-smoking
Not currently taking cholesterol- or glucose- lowering medication
Not currently taking anti-hypertensive medication
Exclusion Criteria:
Smoking and/or use of other tobacco products
Fasting glucose > 126 mg/dL
Diastolic blood pressure > 100 mm Hg
Systolic blood pressure: ≥160 mm Hg
Clinical diagnosis of Inflammatory Bowel Disease (IBD) e.g. Crohn’s Disease or ulcerative colitis
Food & Nutrition
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State College, PA

Observational Study for Pediatric Rheumatic Diseases: The CARRA Registry

The original Childhood Arthritis & Rheumatology Research Alliance (CARRA) Registry was first established in 2010 to advance alliance infrastructure,facilitate expanded clinical and translational pediatric research, and transform the culture of pediatric rheumatology toward universal participation in research. Continuation of the CARRA Registry as described in the protocol attached to this IRB submission will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including examining safety questions. The Duke Clinical Research Institute (DCRI) is serving as the CARRA Clinicaland Data Coordinating Center (CDCC) for this protocol.
Jessica Beiler at jbeiler@hmc.psu.edu
All
Younger than 18 years old
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Onset of rheumatic disease prior to age 16 years for Juvenile Idiopathic Arthritis
Onset prior to age 19 years for all other rheumatic diseases
Willing to participate in a registry you will be followed during your treatment and have information about you disease and treatment collected.
Exclusion Criteria:
More than 21 years of age.
Arthritis & Rheumatic Diseases
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Hershey, PA

Effects of Context and Puberty on Rewarded Inhibitory Control

The primary objective of this research is to examine the dynamic relationship between developing brain function, pubertal maturation, and variable social and emotional contexts on reward and inhibitory control processes in children, adolescents, and adults.
Daniel Petrie at djp67@psu.edu or 814-865-1728
All
All
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
Children ages 7-10
Adolescents ages 11-16
Adults ages 25-40
Exclusion Criteria:
Significant current medical or psychiatric illness or prior brain trauma/injury
Women who are pregnant or lactating or who plan to become pregnant or breastfeed during the study.
Current use or dependence on alcohol, tobacco/nicotine and/or other drugs of abuse (except caffeine) as assessed by self-report.
Current major depression as assessed by self-report questionnaire.
Mental & Behavioral Health, Vision & Eyes
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State College, PA

Age-related differences in Sentence Processing: An ERP Investigation

We aim to understand how words are retrieved during language processing, and also how such retrieval might vary between younger and older adults. During sentence comprehension, previously read information needs to be retrieved and integrated with new information for successful comprehension (e.g., in “The taxi driver was not paying attention when he hit the pole.” At ‘he’, you should remember ‘the taxi driver’). Importantly, the retrieval of a word might be slower depending on a number of factors (e.g., interference caused by the presence of other related material (i.e., competitors) or the sentence structure itself or the length of the sentence). Moreover, these differences in sentence processing may also vary across the lifespan. We will use behavioral and EEG methods to better understand these issues.
Hossein Karimi at huk227@psu.edu
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
18 years of age or older
Right-Handed
Normal or corrected-to-normal vision
Native Monolingual English Speaker
Exclusion Criteria:
A history of neurological disorders
A history of language disorders
< 12 years education
illiteracy
Language & Linguistics
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State College, PA

Investigating Face Processing Behavior and Neural Circuitry

The ability to recognize faces differs across people. We are studying this variability in behavior and in brain responses in young adults (ages 18-25 years) in the Lab of Developmental Neuroscience at Penn State. If eligible, you will do face recognition tasks on the computer and answer survey questions. You may also be asked to participate in another session in which we take pictures of your brain using MRI. Volunteers are paid $10/hr for time in the lab. Interested participants can start the screening processing by clicking on this confidential screening link here: https://pennstate.qualtrics.com/jfe/form/SV_9NPJ20bQAPd0VKZ
Dr. Suzy Scherf at suzyscherf@psu.edu
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
18-25 years of age
Native English speaker
Free of neurological and psychiatric disorders
Free of concussions with loss of consciousness
Exclusion Criteria:
Family history of autism spectrum disorders (in parents or full siblings)
Neurology, Mental & Behavioral Health, Vision & Eyes
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State College, PA

A Comparison of Physiological Response to a Social Situation in Young Adults with Autism Spectrum Disorder to Neurotypical Controls

The goal of this experiment is to assess the sympathetic response and recovery time of individuals with ASD when stressed in social situations compared to neurotypical controls.
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
A primary diagnosis of Autism Spectrum Disorder or not for Neurotypical Controls
Between 18 and 35 years of age for both ASD and Neurotypical controls
English as primary language spoken for both ASD and Neurotypical controls
Ability to fluently speak in full sentences for both ASD and Neurotypical controls
Ability to self-report (i.e. understand and answer assessment questions written at a third grade comprehension level) for both ASD and Neurotypical controls
Exclusion Criteria:
Inability to provide consent
A significant language delay
Diagnosed with Social Anxiety Disorder, as indicated by the Social Phobia Inventory
Use of the following medication classes in the two weeks prior to the study: beta blockers, calcium channel blockers, antiarrhythmic, cardiac glycoside, alpha adrenergics.
Mental & Behavioral Health
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Hershey, PA

CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts: A Prospective, Randomized, Double-blind, Multi-center Clinical Trial

This study seeks to verify the findings of the CHARM I pilot study by conducting a multi-center clinical trial. We hypothesize that: • Pancreatic cyst infusion with a specifically designed drug therapy cocktail following normal saline lavage will result in cyst destruction rates that do not significantly differ from those achieved by alcohol-based cyst treatment (ethanol lavage followed by infusion of the same chemotherapeutic cocktail). • The removal of alcohol from the procedure will decrease both serious and minor adverse event rates associated with pancreatic cyst treatment. • There may be molecular markers contained within the fluid of these cystic tumors which identify cysts that are favorable to or resistant to EUS-guided fine needle infusion using this drug combination. As such, we will test all treated cysts for 10 of the best known molecular markers for evaluation in post study analysis. We expect that administering a specifically designed chemotherapeutic cocktail without prior alcohol lavage will result in an equivalent rate of cyst resolution with fewer complications when compared to alcohol. The results of this study will provide important information about the most efficient and safest method for treating premalignant pancreatic cysts, an important step for treating these lesions with a minimally invasive technique and preventing their progression to cancer. Standard alternative treatment options for this patient group (if not taking part in this study) would be ongoing periodic radiographic monitoring with MR or CT imaging waiting for signs of cancer to develop or to consider surgical removal of the affected tissue.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03085004
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Inclusion Criteria:
Adult subjects over the age of 18.
Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which are consistent with a mucinous type cyst as per ASGE guidelines including indeterminate type cysts.
Ability to give written informed consent.
Capable of safely undergoing endoscopy with deep sedation or general anesthesia.
Exclusion Criteria:
Lesions which are consistent with a benign cyst by clinical, cytological, chemical, and radiographic evaluation as per ASGE guidelines37 (i.e., consistent with a pseudocyst or serous cystadenoma).
Known or suspected pancreatic cancer or pathologic lymphadenopathy.
Cysts with the following high risk features: main pancreatic duct dilation of > 5mm,epithelial type mural nodules , pathologically thick wall/septation (> 2mm)..
Septated cysts with > 4 compartments.
Confirmed pancreatitis within the last 3 months.
Digestive Systems & Liver Disease, Cancer
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Hershey, PA

Predicting Ipsilesional Motor Deficits in Stroke with Dynamic Dominance Model

This study will test the hypothesize that the combination of low-moderate to severe paresis and persistent motor deficits in the non-paretic arm limits functional independence in chronic stroke survivors. We, therefore, predict that intense remediation, focused on improving the speed, coordination, and accuracy of the less-impaired arm should improve functional independence.
Candice Maenza at CMaenza@psu.edu or 717-531-0003, ext=283146
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Right handed (pre-stroke)
Motor impairment in the arm
Had a stroke confirmed by neurology
Chronic stage of stroke
Over the age of 18
Exclusion Criteria:
neurological disease other than stroke
a major psychiatric diagnosis (e.g., schizophrenia, major affective disorder)
hospital admission for substance abuse
peripheral disorders affecting sensation or movement of the arms,
currently taking prescription drugs with known sedative properties that interfere with sensory-motor function
Neurology
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Hershey, PA

Daily Experiences and Health Behaviors

This study will investigate the relationship between daily experiences, including different types of stress, and health behavior choices among undergraduate students at the daily level.
Cara Rice at cara.rice@psu.edu or 814-863-9724
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
18 or older
25 or younger
Undergraduate at one of following PSU campuses (Abington, Altoona, Behrend, Berks, Harrisburg, Mont Alto, University Park)
Exclusion Criteria:
Under age 18
Over age 25
Not an undergraduate at one of qualifying PSU campuses
Addiction & Substance Abuse, Mental & Behavioral Health
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Daily Emotions and Experiences

This is a daily questionnaire survey that will examine changes in individuals' emotions and experiences in their daily life.
Kay Shin at kxs558@psu.edu
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
Major depressive disorder
Generalized anxiety disorder
Fluency in English
Exclusion Criteria:
Mania
Substance use disorder
Psychosis
Mental & Behavioral Health
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State College, PA

Human-AI Interaction

We are conducting a series of focus groups to examine why people use technologies driven by artificial intelligence, and what gratifications people gain from those interactions. This is part of a larger project to understand human-AI interaction (HAII), a relatively new concept in the field of human-computer interaction. Our goal is to help pioneer a definition of HAII by first understanding the basics of how and why people use AI-driven technologies. Focus groups will consist of 5-10 people and will take no more than one hour to complete. All consenting adults near the State College area are welcome to participate.
Carlina DiRusso at cdd15@psu.edu
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
Adults ages 18 and older
Able to participate in-person in State College
Willing to discuss technology habits in a group setting
Exclusion Criteria:
Under the age of 18
Unable to attend in-person focus groups
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State College, PA

Site For Habitual Diet and Avocado Trial (HAT)

Site For Habitual Diet and Avocado Trial (HAT)
Kristin Davis at kmd74@psu.edu or 814-863-0856
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
25 years of age or older
Increased waist circumference defined as ≥35 inches for women, ≥40 inches for men
Not currently eating more than 2 avocados per month
Exclusion Criteria:
Does not eat avocados
Not willing or unable to undergo MRI scans
Pregnant, lactating, intention of pregnancy
Food & Nutrition, Heart & Vascular
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State College, PA

Site For PaTH Study for HS Outcome Measures

Site For PaTH Study for HS Outcome Measures
Melissa Butt at mbutt1@pennstatehealth.psu.edu or 717-531-6117
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
patients with Hidradenitis suppurativa
must be 18 years or older
fluent in English
Exclusion Criteria:
cannot read or speak English
under 18 years of age
do not have Hidradenitis suppurativa
Skin Conditions
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Hershey, PA

Study Driver Characteristics in Autonomous Vehicles with a Driving Simulator

This behavioral study aims to quantify the effect of drivers' characteristics on their behavior and performance during their interaction with autonomous vehicles as either drivers or passengers. The driving simulator will be used to simulate different designs of autonomous vehicles and record driver behavior and performance in the simulated autonomous vehicle environments. You will be asked to drive on a driving simulator and complete questionnaires.
Zheng Ma at ZUM152@psu.edu
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
The subjects need to have an valid and unrestricted driver’s license
The subject need to fulfill the questionnaire with the score of the questionnaire fill into certain categories based on the experiment needs.
The subject need to have at least two years of driving experience
Exclusion Criteria:
under the influence of alcohol within 8 hours prior to participating in this study.
Education, Mental & Behavioral Health, Language & Linguistics
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State College, PA

Standard Chemotherapy versus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients with Recurrent Glioblastoma Multiforme (GBM). CSCRGBM

The investigational purpose of this study is to screen chemotherapy drugs currently used for the care of recurrent glioblastoma (a form of brain cancer) and to determine the most effective treatment based on results from a chemosensitivity assay. Chemosensitivity drug assay refers to testing a patient's own cancer cells in the laboratory to drugs that are to be used to treat the patient's cancer. Following surgery, you will be treated either as per chemotherapy agents chosen by the physician or with chemotherapies as suggested by the results of the chemosensitivity testing. The study is looking to determine if patients treated with drugs predicted by the chemosensitivity test have better outcomes than patients treated with drugs chosen by the treating physician.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03632135
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Inclusion Criteria:
Histopathologically confirmed WHO grade IV recurrent astrocytoma (recurrent GBM)
Recurrent surgically resectable tumor
Estimated survival of at least 3 months;
Exclusion Criteria:
Subjects with newly diagnosed GBM
Pregnant women or nursing mothers cannot participate in the study. Women of childbearing age must have a negative pregnancy test within 72 hours prior to study entry.
Neurology, Cancer
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Hershey, PA

Pattern Learning in Human Adults

We are interested in what adults notice about stimuli that are presented to them. These stimuli typically consist of novel objects, abstract images, or made-up words.
Kendra Lange at kxl786@psu.edu
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
Age 18 and older
Fluent in English
Minimum High School Education
Normal or corrected-to-normal vision/ hearing
Exclusion Criteria:
No history of neurological injury or disorder
Those unable to consent, pregnant women, children, and prisoners will be excluded.
Language & Linguistics
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State College, PA

Impact of Perioperative Music on Quality of Life Measures and Biomarker Levels in Breast Cancer Patients

Music therapy could improve post-operative quality of life measures and these improvements may correlate with decreased salivary levels of biomarkers that when elevated, traditionally indicate stress, depression, sleep deprivation, and poorer outcomes. This study aims to determine both if music affects molecular mechanisms through measurement of clinical biomarkers as well as if there is an association with significant quality of life measures
Kristine Widders at kwidders@pennstatehealth.psu.edu or 717-531-8815
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Diagnosis of stage 0 to stage
breast cancer as classified by the American Joint Committee on Cancer
Undergoing a mastectomy or lumpectomy at Penn State Hershey Medical Center
Exclusion Criteria:
Difficulties hearing that prevent one from listening to music
Serious oral health or dental conditions
Patient who have undergone pre-operative chemotherapy or pre-operatively radiation therapy
Should not be taking supplements of melatonin or be taking corticosteroids
History of liver cancer, liver disease, or cirrhosis
Cancer
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Hershey, PA

A prospective, multi-national, non-interventional study in haemophilia A and B patients with or without inhibitors treated according to routine clinical treatment practice (explorer™6)

A non-interventional study designed to prospectively collect comprehensive data on bleeding episodes and health-related quality of life as well as on physical activity in patients with severe congenital haemophilia A (HA) and B (HB), with or without inhibitors under routine local clinical practice, irrespective of the treatment regimen.
Male
All
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
age ≥ 12 years
Severe (< 1%) congenital hemophilia A or B with or without inhibitors
Pts with inhibitors treated on-demand: ≥ 6 treated (with bypassing agent) bleeding episodes within 24 wks of screening
Pts with severe congenital HA/HB treated on-demand: ≥ 5 treated (with factor product) bleeding episodes within 24 wks of screening
Pts with inhibitors treated with FEIBA prophylaxis: ≥ 2 treated bleeding episodes within 24 wks of screening
Exclusion Criteria:
Known or suspected hypersensitivity to monoclonal antibodies
Previous treatment with concizumabdefined as two or more doses administered.
Planned FVIII/FIX Immune Tolerance Induction (ITI) regimens during the study.
Current or planned treatment with emicizumab.
Any known congenital or acquired coagulation disorder other than congenital hemophilia.
Blood Disorders
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Hershey, PA

Habit Learning in Adolescents and Young Adults

This research seeks to exam behavioral and neural differences in the formation and maintenance of habit behavior in adolescents and adults.
Daniel Petrie at djp67@psu.edu or 814-863-5124
All
All
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
Healthy adolescents between the ages of 13 to 17
Health adults between the ages of 25 to 40
Not currently taking medications known to influence body weight, task, food intake, behavior, or blood flow
Exclusion Criteria:
Outside of age ranges specified
Left handed
Diagnosed neurological or psychological condition including anxiety or depression
Currently or planning to follow a diet for weight loss
Non-removable body piercings, pacemaker, or other metal implants that would preclude safe completion of an MRI
Addiction & Substance Abuse, Food & Nutrition, Mental & Behavioral Health
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State College, PA

A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy With or Without Enhanced Anti-Androgen Therapy With Apalutamide in Recurrent Prostate Cancer

To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.
Kathleen Rizzo at kar23@psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03371719
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Inclusion Criteria:
Pathologically (histologically) proven diagnosis of prostate adenocarcinoma.
Post-prostatectomy patients with a detectable serum PSA (≥0.1, but ≤1.0 ng/mL) at study entry (within 90 days of Step 1 registration) a
pN0 or pNx
History/physical examination within 90 days prior to Step 1 registration
Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration
Exclusion Criteria:
Definitive clinical, radiologic, or pathologic evidence of metastatic disease (M1) or lymph node involvement (N1)
Prior invasive malignancy (except non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years
Prior systemic chemotherapy for the study cancer
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
Prior whole gland ablative therapy
Cancer
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Hershey, PA

BHV-0223 Expanded Access Protocol in Patients with Amyotrophic Lateral Sclerosis

This is an Expanded Access Protocol (EAP) to provide a new version of riluzole that is placed under the tongue (sublingual) rather than swallowed.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03520517
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Inclusion Criteria:
Diagnosed with ALS
Swallowing difficulties OR choking at least once per week
Exclusion Criteria:
Pregnancy
Other serious medical condition that would interfere with your participation
Neurology
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Hershey, PA

A Phase Ib/11 Study of Propranolol with fixed-dose Pembrolizumab in Patients with Unresectable Stage III and Stage IV Melanoma

This research is being done to find out the safety of propranolol and, identify the maximum tolerated dose of propranolol that can be administered in combination with pembrolizumab in patients with unresectable stage III and stage IV melanoma. This study will evaluate this novel combination of pembrolizumab and propranolol to see what effect it may have on how your cancer responds to the treatment combination.
Irina Geier at igeier@pennstatehealth.psu.edu or 717-531-4300
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03384836
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Inclusion Criteria:
Age >=18 years.
Participants must be newly diagnosed, treatment-naive with histologically confirmed stage IIIC unresectable melanoma or stage IV melanoma.
Have measurable disease per RECIST v1.1
Have an ECOG performance status 0-1
Exclusion Criteria:
Participants who have received previous immunotherapy for any cancer (excluding melanoma) including PD-1/PD-L1 inhibitors but not interferons and CTLA-4 inhibitors.
Participants with chronic autoimmune diseases
Other invasive cancers diagnosed < 3 years back that required systemic treatment. If diagnosed with other invasive cancer ≥ 3 years, should have complete recovery from all systemic toxicity except neuropathy and alopecia
Cancer
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Hershey, PA

Pivotal study of the LUM Imaging System for assisting intraoperative detection of residual cancer in the tumor bed of female subjects with breast cancer.

The objective of this prospective, multi-center, single-arm study is to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in identifying residual cancer in the lumpectomy bed of female breast cancer patients in order to assist surgeons in reducing the rates of positive margins.
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03686215
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Inclusion Criteria:
Subjects must have histologically or cytologically confirmed primary invasive breast cancer, ductal carcinoma in situ (DCIS) or primary invasive breast cancer with a DCIS component.
Female, age of 18 years or older. Because no dosing or adverse event data are currently available on the use of LUM015 in subjects <18 years of age, children are excluded from this study.
Subjects must be scheduled for a lumpectomy for a breast malignancy.
Subjects must be able and willing to follow study procedures and instructions.
Subjects must have no uncontrolled serious medical problems except for the diagnosis of breast cancer, as per the exclusion criteria listed below.
Exclusion Criteria:
Subjects who are treated for bilateral breast cancer resection procedure.
Subjects who are pregnant at the time of diagnosis of their breast cancer.
Subjects who are sexually active and not willing/able to use 2 medically acceptable forms of contraception (hormonal, barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015.
Subjects who have taken an investigational drug within 30 days of enrollment.
Subjects who will have administration of methylene blue or any dye for sentinel lymph node mapping on the day of the surgery prior to imaging the lumpectomy cavity with the LUM Imaging Device.
Cancer
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Hershey, PA

INDUCTION STUDY #1 - A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ORAL OZANIMOD AS INDUCTION THERAPY FOR MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

This study is for patients who have been diagnosed with or have signs and symptoms of moderately to severely active Crohn's disease (CD) which is a chronic inflammatory disorder of the bowels. People with CD often suffer from diarrhea, abdominal pain, rectal bleeding, weight loss, and fever. This study is being done to see whether an experimental medication that is not approved by the Food and Drug Administration, is safe and effective for the possible treatment of CD. To do this, a comparison will be made between people who receive active drug and people who receive placebo (a ‘dummy treatment’ that looks like the active drug but contains no active ingredient). The purpose of this study is to confirm preliminary results from a phase II study that suggests that the active drug may be safe and effective in treating patients with CD.
Laurie Peiffer at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03440372
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Inclusion Criteria:
Ages 18-75, inclusive
Diagnosis of Crohn's Disease for at least 3 months
Failed prior treatment
Exclusion Criteria:
Will need surgery in 3 months
Stricture or obstruction symptoms
Prior cancers
Drug or alcohol abuse within 1 year
Diagnosis of colitis
Digestive Systems & Liver Disease
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Hershey, PA

Dose-finding study of SPK-8016 gene therapy in patients with hemophilia A to support future evaluations in individuals with FVIII inhibitors.

SPK-8016-101 is a Phase 1/2a, open-label, non-randomized, dose-finding study designed to evaluate the safety, efficacy, and tolerability of SPK-8016 in adult males with clinically severe hemophilia A and no measurable inhibitor against FVIII.
Cynthia Campbell-Baird, RN at cbaird@pennstatehealth.psu.edu or 717-531-5777
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03734588
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Inclusion Criteria:
Clinically severe Hemophilia A
Previous exposure to FVIII therapy
Have >150 exposure days to any recombinant and/or plasma-derived FVIII concentrates
No history of hypersensitivity or anaphylaxis with any FVIII or IV immunoglobulin product
No measurable inhibitor against FVIII
Exclusion Criteria:
Active Hepatitis B or C
Current use of antiviral therapy to treat Hepatitis B or C
Documented significant liver disease
Serological evidence of HIV-1 or HIV-2
Anti-AAV-Spark neutralizing antibody titers >1:5
Blood Disorders
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Hershey, PA

Cognitive and Social Factors Underlying Spoken Language Use

The central purpose of this research is to understand how language users produce and comprehend speech. To do this we ask participants to record speech, make judgments on the speech they hear, and work with a partner on simple language tasks.
Navin Viswanathan at splaco@psu.edu
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
English Speakers
Between 18 and 65 years of age
Exclusion Criteria:
Those with diagnosed speech, hearing or language Issues
Language & Linguistics
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State College, PA

A Multi-Center, Observational Study in Males with Hemophilia A

SPK-8011-301 is a prospective, multi-center, observational study to collect efficacy and selected safety data on frequency and type of bleeding episodes and FVIII prophylaxis replacement therapy in the usual care setting of adult males with clinically severe hemophilia A (i.e., ≤ 2% IU/dL FVIII activity level), who are negative for neutralizing antibody (Nab) to AAV-Spark200.
Cynthia Campbell-Baird, RN at cbaird@pennstatehealth.psu.edu or 717-531-5777
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03876301
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Inclusion Criteria:
Clinically severe Hemophilia A
Patients on prophylactic regimen > 2 months
Previous exposure to FVIII therapy
No history of hypersensitivity or anaphylaxis with any FVIII or IV immunoglobulin product
No measurable inhibitor against FVIII
Exclusion Criteria:
Active Hepatitis B or C within past 12 months
Current use of antiviral therapy to treat Hepatitis B or C
Documented significant liver disease
Serological evidence of HIV-1 or HIV-2
Anti-AAV-Spark neutralizing antibody titers >1:1
Blood Disorders
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Location
Hershey, PA