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Visual perception under dim lighting

The study will test the color discrimination and subjective evaluations of objects in low light levels under different chromaticities.

You will make judge the visual quality of the visual environment and perform a color discrimination test.

10

Yes
 

Dorukalp Durmus
Zora Liu - at ybl5822@psu.edu
Architectural Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00025274
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Inclusion Criteria:
normal or corrected-to-normal vision
over the age of 18

Exclusion Criteria:
color deficiency
poor visual acuity
under the age of 50
Vision & Eyes
Not applicable
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State College, PA ,

Impact of Mental Illness on Blame Attribution and Perception of Dangerousness in Violent Crime Offenders: Implications for Sentencing

This study will be used for an undergraduate honors thesis, focused on mental health’s impact on perceived blameworthiness and dangerousness of violent crime offenders and sentencing suggestions for said offenders. In this study, participants will read a vignette about a crime (homicide or assault) being committed. After reading this scenario, participants will answer 4 questions about the individual who committed the crime. These questions will ask about blame attribution, sentencing suggestions, danger perception and likelihood of reoffending. The data will be analyzed through quantitative techniques.

Participants will read a vignette about a crime (homicide or assault) being committed. After reading this scenario, participants will answer 4 questions about the individual who committed the crime. These questions will ask about blame attribution, sentencing suggestions, danger perception and likelihood of reoffending. Participants will then answer one question about their gender and one question about the school year.

No
 

Ava Paravati
Ava Paravati - at afp5732@psu.edu or 914-327-6514
Division of Undergraduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00025341
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Inclusion Criteria:
Undergraduate students at Pennsylvania State University Park above the age of 18

Exclusion Criteria:
All individuals who are not undergraduate students at Pennsylvania State University Park
Undergraduate students at Pennsylvania State University Park under the age of 18
Education, Mental & Behavioral Health
Not applicable
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Estrogen Deficiency on Cardiovascular Risk: Sympathetic Responses and Pro-inflammatory Cytokines

The purpose of this study is to test if estrogen supplements can help reduce blood pressure and inflammation in postmenopausal women.

•Two lab visits for vascular function measurements•Wear an estradiol or placebo patch for one week.

$25 per hour for the study visits plus $50 if all microdialysis experiments are completed

Yes
 

Lu Qin
Cheryl Blaha - at cblaha@pennstatehealth.psu.edu or 717-531-1605
Heart and Vascular Institute (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT06369363
STUDY00024245
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Inclusion Criteria:
Women 54-75 years old
Healthy
Classified as postmenopausal: stopped having period >1year or had a full hysterectomy surgery
Free of acute medical conditions

Exclusion Criteria:
On hormone replacement therapy
Smoker
Have cardiovascular or metabolic disease
History of gynecological cancers
History of long-term menstrual irregularities
Heart & Vascular, Women's Health
Approved drug(s)
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Hershey, PA ,

A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Progressive Pulmonary Fibrosis (TETON-PPF)

This is a drug study that will examine if inhaled treprostinil is save and effective in people diagnosed with Progressive Pulmonary Fibrosis.

You will be required to attend 8 in-person visits at the Hershey Medical Center over the span of approximately one year. During the study you will have physical examinations, complete questionnaires, review your medical history and current medications, have vital signs and ECGs taken, have blood tests performed, complete pulmonary function testing, and potentially have a high resolution CT scan done. You will take the inhaled treprostinil or placebo daily at home throughout the study.

600

Yes
 

Rebecca Bascom
Tim Sheehan - at tsheehan@pennstatehealth.psu.edu or 717-531-2925
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05943535
STUDY00023883
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Inclusion Criteria:
Diagnosis of Pulmonary Fibrosis
Evidence of progression of pulmonary fibrosis in the last 24 months

Exclusion Criteria:
Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
Evidence of obstructive pulmonary disease
Concomitant use of both nintedanib and pirfenidone is not permitted
Received any PAH-approved therapy in last 60 days
Receiving >10 L/min of oxygen supplementation
Lung Disease & Asthma
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency–Associated Liver Disease With METAVIR Stage F1 Fibrosis

The goal of treatment with fazirsiran is to prevent and improve the build up of these abnormal proteins that cause liver injury and fibrosis by shutting down the production of Z-AAT. Decreasing Z-AAT build up in liver cells is important, as this protein has been clearly identified as the cause of liver injury in AATD.In this study, fazirsiran is being compared with a placebo for patients with AATD LD. A placebo is a liquid like fazirsiran but does not contain any active ingredients.

You will visit the study site approximately 12 times for blood sampling, computed tomography (CT) lung densitometry, lung function tests, FibroScans, ultrasounds, liver biopsy, esophagogastroduodenoscopy (EGD) study drug administration, and questionnaire completion.

Yes
 

Timothy Craig
Kristina Richwine - at krichwine@pennstatehealth.psu.edu or 717-531-4506
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06165341
STUDY00024618
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Inclusion Criteria:
The participant, of any sex, is aged 18 to 75 years, inclusive.
The participant must have a diagnosis of the PiZZ genotype AATD
The participant has evidence of METAVIR stage F1 liver fibrosis
An adult participant must have a body mass index (BMI) between 18.0 and 39.0 kg/m2, inclusive.
The participant is a nonsmoker

Exclusion Criteria:
The participant has evidence of ≥ F2 fibrosis based on liver biopsy during the screening period.
The participant has a history of varices based on a previous esophagogastroduodenoscopy.
The participant has portal vein thrombosis.
The participant has HIV infection as shown by the presence of anti-HIV antibody (seropositive).
The participant is pregnant or breastfeeding or intending to become pregnant before participating in this study, during the study.
Infectious Diseases & Immune System, Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

The Experiences of Asexual Individuals in Health and Sexual Education Classes: Influences on Identity, Body Image, Personal Health, and Patient-Provider Relationships

This project explores the experiences of asexual individuals in health and sexual education classes. Specifically, we are interested in the structure of the courses and the extent to which LGBTQIA+ identities were included in the curriculum. Additionally, we are interested in ways health and sexual education classes have since influenced how asexual individuals view and feel about their bodies, as well as how they approach their personal health. Individuals currently identifying as asexual will be surveyed about their experiences and will have the change to provide recorded interviews if desired.

Participants will be asked to complete an online survey that is expected to take 30-40 minutes. Participants also have the opportunity to elaborate on their survey responses during a recorded Zoom interview.

Participants may enter a raffle to win one of 10 Amazon.com giftcards

No
 

Gail Boldt
Brandon D'Souza - at bdsouza@pennstatehealth.psu.edu or 614-827-5660
Curriculum and Instruction (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00025052
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Inclusion Criteria:
English speaking
Over the age of 18
Took a health/sexual education class in the U.S since the year 2000
Currently identifies as asexual (or an asexual sub-identity)

Exclusion Criteria:
Non-English speaking
Under the age of 18
Did not take a health/sexual education class in the U.S since the year 2000
Does not currently identify as asexual (or an asexual sub-identity)
Education, Mental & Behavioral Health
Survey(s)
I'm interested
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Feasibility of an experimental protocol for studying the effects of changes in bedtime on eating behavior in children

The purpose of this study is to find out if parents and children 6-10 years old are willing and able to follow a protocol to be used to study the effects of short and/or variable sleep in children. During each of three, one-week long periods, we are asking parents to follow one of the following bedtime schedules: 1) habitual bedtime; 2) 1 hour later bedtime; or 3) variable bedtime (+/- 1 hour of habitual bedtime each day). Children will wear a sleep tracker and parents will complete daily diaries. We will also ask participants questions about their experiences completing the protocol.

Participants will attend an enrollment visit at the Noll Laboratory at Penn State's campus where we will go over the study and give participants a sleep monitor. We will then ask parents to put their child to bed at different, specified times over the course of three weeks - normal bedtime in one week; 1 hour later than their usual bedtime in another week; and at a different assigned time each day that will be +/- 1 hour of their normal bedtime during the third week. During all three weeks, children will wear a sleep monitor on their wrist (similar to a Fitbit), and parents will answer a short survey each evening on their smartphone or other device. At the end of the study, participants will attend a final visit (either in-person or by Zoom depending on preference) to answer questions about their experience with the protocol.

$150

Yes
 

Emily Hohman
Emily Hohman - at eeh12@psu.edu or 814-865-5245
Center for Childhood Obesity Research (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
NCT06501690
STUDY00025204
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Inclusion Criteria:
Child 6-10 years
Parent 18+ years
Child has a regular bedtime

Exclusion Criteria:
Child medical conditions affecting sleep or development
Child regular use of supplements or medications for sleep (e.g. melatonin, antihistamines)
Children's Health, Sleep Management
Not applicable
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State College, PA ,

External performance evaluation of INNOVANCE D-Dimer 2.0 on CS-5100

This is a multi-site prospective laboratory analysis of blood specimens utilizing the investigational Innovance 2.0 D-Dimer assay compared to the FDA-approved Innovance 1.0 D-Dimer assay on the FDA-approved CS-5100 instrument. Subjects will be required to provide up to 2 tablespoons of blood (30 ml) collected once (1) in a single visit from up to two (2) attempts to obtain the sample. Samples will be collected by venipuncture, or from an existing intravenous (IV) or arterial line, which are the standard methods of drawing blood in the hospital setting.

If you choose to participate in the study, you will have no more than 2 tablespoons of blood (30 ml) collected once (1) in a single visit from up to two (2) attempts to obtain the sample. Samples will be collected by venipuncture, or from an existing intravenous (IV) or arterial line, which are the standard methods of drawing blood in the hospital setting. The visit should last no more than 60 minutes and will be scheduled in advance with the study team. This visit will include signing a consent form to participate in the study, allowing the study team to draw your blood, and providing a small amount of information about yourself. We are looking for volunteers 10 years and older with confirmed clots in the legs or lungs, or diseases and conditions with increased coagulation activation such as thromboembolic disease, acute aortic dissection, myocardial infarction, malignant diseases, obstetrical complications, third trimester of pregnancy, surgery or polytrauma, sepsis or severe infection. We are looking for healthy volunteers 18 years and older as well.

$75

Yes
 

Olajumoke Oladipo
EMILY MACMILLEN - at emacmillen1@pennstatehealth.psu.edu or 717-531-0003, ext=287538
Pathology: Clinical (HERSHEY)
 

All
All
This study is also accepting healthy volunteers
STUDY00024678
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Inclusion Criteria:
10 years of age or older
Patient with known clot or condition above
Healthy adult (>18) volunteer
Willing to donate a small amount of blood

Exclusion Criteria:
<10 years of age
If healthy volunteer, currently pregnant or hospitalization within the past month
Unable to find transport to Hershey Medical Center for a 1 hour visit on 1 day
Strenuous exercise in the 60 minutes prior to blood draw
Blood Disorders, Heart & Vascular, Pregnancy & Infertility
Experimental device compared to an approved device
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Hershey, PA ,

External design verification study on CN-6000 system.

The purpose of this prospective, multi-site study is to conduct a clinical evaluation of the investigational CN-6000 device using venous plasma specimens from adult participants in different care settings with various disease processes. This is a fully automated blood coagulation analyzer intended for in-vitro diagnostic use to analyze clotting, chromogenic and immuno-chemical methods in 3.2% Na citrated plasma in a clinical laboratory. No more than 2 venous blood draws will be attempted to obtain up to 4 whole blood specimens per subject, totaling no more than 30 mL. Samples may also be tested on the CS-5100 predicate comparator device.

This study will require 1 visit to Hershey Medical Center on a single day for up to two blood draws, no more than 2 tablespoons of blood (30 ml) total. The visit should last no more than 60 minutes and will be scheduled in advance with the study team. This visit will include signing a consent form to participate in the study, allowing the study team to draw your blood, and providing a small amount of information about yourself. We are looking for volunteers with coagulation disorders and healthy volunteers.

$75

Yes
 

Olajumoke Oladipo
Emily MacMillen - at DEMResearch@pennstatehealth.psu.edu or 717-531-0003, ext=287538
Pathology: Clinical (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024281
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Inclusion Criteria:
18 or older
Patient with known or tested for clotting disorders
Patients with severe liver disease
Healthy people without clotting disease or recent hospital stay
Willing to undergo blood draw

Exclusion Criteria:
Known pregnancy or infection
Less than 18 years of age
Unable to find transport to Hershey Medical Center for a 1 hour visit on 1 day
Blood Disorders, Digestive Systems & Liver Disease
Experimental device compared to an approved device
I'm interested
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Hershey, PA ,

Building Future Leaders: Critical Factors for Successful Implementation of Succession Planning in the Eastern Healthcare Cluster Administration in Saudi Arabia

This qualitative study investigates the helping and hindering factors that led to the successful implementation of succession planning in administration of healthcare organizations in Saudi Arabia. This study will investigate what factors, including top management commitment, resource availability, organizational culture, communication, resistance to change, and bureaucratic roadblocks, enable and hinder organizations from implementing succession planning in the Eastern Healthcare Cluster (EHC) in Saudi Arabia. This study will use the enhanced critical incidents techniques (ECIT; Butterfield et al., 2009) to identify the critical factors that help or hinder the successful implementation of succession planning. In addition, it inquires the wish list of the participants about future changes or interventions.

They will complete the selection criteria for the screening process to determine which participants meet the inclusion criteria and which should be excluded from the study.

No
 

Musaad Alqahtani
Musaad Alqahtani - at maa6591@psu.edu or 813-390-6240
Division of Undergraduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00025119
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Inclusion Criteria:
Enroll in the Eastern Healthcare Cluster (EHC)
Organization have a succession plan of any kind
involved in or contributed to the implementation of succession planning
Have three or more years of experience
Have proficiency in conducting interviews in English?

Exclusion Criteria:
not Enroll in the Eastern Healthcare Cluster (EHC)
Organization does not have a succession plan of any kind
Not involved in or contributed to the implementation of succession planning
Have less than three or more years of experience
Does not have proficiency in conducting interviews in English
Education
Not applicable
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Endometriosis and microvascular dysfunction

Endometriosis, is a disorder that occurs in women, is when tissue that should be normally found inside the womb is also found in sites outside of the womb. This disorder impairs the function of the endothelium, the cells that line the body’s blood vessels (endothelium). The endothelium helps to control blood flow in healthy vessels. Women with this disorder not only have an increased risk for high blood pressure and high cholesterol, they also have an increased risk for cardiovascular disease. They have a higher risk for cardiovascular disease, too. With this study, we will learn how endometriosis impairs the lining of blood vessels and increases the risk for disease. We will test two different intervention strategies to reduce long-term cardiovascular disease risk in women with endometriosis.

There will be 3 in person visits, blood draws will occur at all visits. On 2 of the visits blood flow experiments will be conducted. Participants will take oral medications.

390

Yes
 

Lacy Alexander
Susan Slimak - at sks31@psu.edu or 814-863-8556
Kinesiology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05059626
STUDY00018347
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Inclusion Criteria:
Women, 18-45 years of age
Endometriosis

Exclusion Criteria:
Tobacco consumption (e.g. smoking)
Pregnant and/or breastfeeding
Taking blood pressure medication
Heart & Vascular, Pregnancy & Infertility, Women's Health
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Altoona, PA ,
Harrisburg, PA ,
Hershey, PA ,
State College, PA ,
Williamsport, PA ,

Charting Positive Valence Systems Trajectories in Offspring of Depressed Mothers to Predict Internalizing Symptoms in Early Childhood

The purpose of this voluntary research study is to understand the impact of maternal depression on child outcomes, such as how children respond to rewarding or positive information in their environment and their mental health outcomes, such as anxiety and depression.

In this study, you will complete some interviews and surveys about your and your child’s mental health history, parenting practices, and stress exposure. We will also have your child complete a few computer tasks while we measure their brain activity. You and your child will also complete a few discussion tasks. These procedures will be completed three times over the course of two years.

360 dollars

Yes
 

Katie Burkhouse
Katie Burkhouse - at klb5023@psu.edu
Psychology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00025082
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Inclusion Criteria:
Mother-biological child dyads (children ages 4-6 years old, males and females)
High Risk Dyads: Biological mothers must meet criteria for current or past DSM-5 major depressive disorder (MDD) or persistent depressive disorder (PDD) in the child’s lifetime
Low Risk: Biological mothers must have no lifetime diagnosis of a depressive disorder

Exclusion Criteria:
Maternal history of schizophrenia, psychosis disorder, or bipolar disorder
Children with intellectual or developmental disabilities and hearing and vision impairments that would interfere with completing measures.
Children currently taking psychiatric medications (in the past 4 weeks)
Unable to speak or read in English
Unable to access to a computer or a tablet with a video camera and internet that can be used for study appointments by Zoom
Children's Health, Mental & Behavioral Health
Not applicable
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State College, PA ,

Exploring Genetic Correlates of Facial Diversity Among Afghanistan's Major Ethnic Groups

Our first, aim is to quantify the superficial traits among the Hazara, Tajik, and Pashtun populations of Afghanistan by using a computer-based 3D morphometric method. We want to quantify the facial traits, voices and pigmentation, identify genetic regions affecting these traits, and plot phylogenetic trees to explain the probable facial variation and evidence of shared genetic basis they might exhibit across population. The expected number of participants in the study will be ~ 500 individuals which will provide us a better understanding of the evolution of superficial traits among these Afghan ethnic groups. This will be the first study to focus on Afghanistan's population which will provide important insights into a diverse and understudied set of human populations. As a result, a more comprehensive examination of facial genetics could be performed. Our second aim for the study is to uncover which genetic variants affect superficial trait variation by using next-generation sequencing (NGS). To achieve this goal, human saliva samples will be collected which will undergo genetic laboratory procedures for DNA extraction, amplification, quantification, and genotyping. The finding will help us to learn more about the qualitative and quantitative facial genetic variability. We hypothesize that facial variability among Hazara, Tajik, and Pashtun is greater than expected which can lead us to other questions about ancestry, migration, and human evolution. From their geographic proximity genetic and computational analysis will allow us to answer the question of how facial pigmentation and vocal variation among these populations leads to genetic diversity. Climate, migration history, and mate choice are the major contributors to phenotypic variation in the population. Our qualitative and quantitative data will be the best source of understanding facial morphological variation across populations, and how past migration affects gene flow, which has a direct effect on these traits which evolved jointly and differently in each population. Our third aim for this project is to look for forensically important markers that can contribute to the field of forensic genetics and enhance law enforcement and forensic investigations. The discovery of novel forensically important markers that can shape phenotypic variation will make major contributions to the field of forensic anthropology. The fourth and final objective of this research is to determine how human migration affects the variation of the oral microbiome and the subsequent effects of this diversity on human well-being, diet, energetics, and microbial genus.

Our team is visiting the participant location to collect hair, voice, saliva, and 3D images. It will take 30 minutes for each participant to complete the entire activity.

Yes
 

Muhammad Shirzad
Muhammad Rehman Shirzad - at mrs6995@psu.edu or 202-769-9909
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024624
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Inclusion Criteria:
Adults aged between 18 – 65 years.
Participants must have the legal capacity to provide autonomous, voluntary consent.
Participants must identify with either of the Pashtun, Hazara, and Tajik ethnic groups of Afghanistan.
Participants with no facial dysmorphology (any condition, such as major facial surgical intervention, that may result in facial dysmorphology), conspicuous make-ups, conspicuous facial hair, conspicuous tribal marks, or religious facial covering.
The participant must be residing in the United States.

Exclusion Criteria:
Individuals who are less than 18 years of age at the time of enrollment will not be allowed to participate in the study. Individuals who are not Afghan citizens may not participate in the study.
Males with facial hair who are unwilling to shave for the enrollment appointment may not participate in the study.
Individuals with tribal marks or history of facial reconstructive surgery shall be excluded from this study. Females with religious covering who are unwilling to remove the same shall be excluded from the study.
Individuals who have adverse reactions to bright lights or flash photography may not participate in the study.
Pregnant women will be excluded. Individual which are close relative e.g., Siblings.
Skin Conditions, Education, Language & Linguistics
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State College, PA ,

BCC020: A Dose Escalation Study Using Difluoromethylornithine(DFMO) and AMXT-1501 followed by a Randomized Controlled Trial of DFMO with or without AMXT-1501 for Neuroblastoma, CNS Tumors, and Sarcomas

The purpose of this study is to evaluate the investigational drug AMXT-1501 (a pill taken by mouth) in combination with the study drug difluoromethylornithine (DFMO) for infusion administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). An investigational drug is one that has not been approved by the U.S. Food &amp; 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.

You will undergo a number of standard tests and research-related procedures before being able to enroll on this study.

Yes
 

Valerie Brown
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT06465199
STUDY00025296
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Inclusion Criteria:
0-21 years of age at diagnosis

Exclusion Criteria:
Currently receiving another investigational drug
Cancer
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Hershey, PA ,

An Intermediate Expanded Access Protocol with CNM-Au8for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012

The main purpose of this research study is to provide access to the investigational product, CNM-Au8 at a dose of 30mg per day, to up to 180 people living with ALS. The study wants to find out if CNM-Au8 is safe to take without causing too many side effects and can help people with ALS.

Participants will have a visit to see if they qualify to participate. Following this visit, they will return to the clinic for visits every 12 weeks and these visits will continue in 144-week periods until the treatment plan is discontinued. Participants will have one last visit 4 weeks after their last dose of the investigational medicine.

Yes
 

Xiaowei Su
nervemuscle@pennstatehealth.psu.edu 717-534-8257
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06408727
STUDY00025011
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Inclusion Criteria:
Able to understand and give written informed consent
Male or female aged 18 years or greater at time of ALS diagnosis
Participants with a confirmed diagnosis of ALS as determined by a neurologist specializing in ALS
Participant is able to consume up to 240mL of investigational drug without substantial dsyhpagia or can take the investigational drug through a gastronomy tube

Exclusion Criteria:
Participant is eligible for any other interventional ALS drug clinical trial
Participant has a history of clinical significant or unstable medical condition that may interfere with assessment of safety or compromise the study objectives
Based on the investigator’s judgment, participants who may have difficulty complying with the protocol and/or any study procedures.
Within the prior 90-days the participant has had clinically significant findings on standard hepatic, hematologic, or renal safety assays.
Participant is currently involved in another placebo-controlled clinical trial (note: concomitant therapy with other investigational products is permitted with certain restrictions—see concomitant medications section below).
Neurology
Not applicable
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Hershey, PA ,

Examining the relationship between caregiving factors, social determinants of health, and quality of life among parental caregivers of adults with profound autism: A mixed methods study

This is a survey study that will examine factors that impact the quality of life for parental caregivers of an adult child with profound autism.

Participants will be asked to take a survey about their experiences caring for their autistic child and questions about their well-being.

$20

No
 

Jessica Wellington
Jessica Wellington - at jdw6174@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024778
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Inclusion Criteria:
18 years of age or older
Primary parental caregiver for an adult-child (aged 18 and older) with profound autism
Reside in the United States
Able to read and understand English
Are able to provide informed consent

Exclusion Criteria:
The adult-child with profound autism does not live with the parental caregiver
Mental & Behavioral Health
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The Ecology of Infant Emotion-Regulation

This study aims to understand how emotion regulation in infants develops within the context of family and community support. We're particularly interested in the relation between mother-infant synchrony, facilitated by family and community support, and infant emotion regulation. We will use a multi-method approach to collect simultaneous brain activation in mothers and infants, infant's physiological responses, and information about family and community support.

Participants complete questionnaires online, then come in for 1 in-person visit. This research aims to find out how patterns of brain activation in infants and mothers and infant physiological responses relate to the real life, face-to-face interactions that mothers and babies usually engage in.

50

Yes
 

Eunkyung Shin
Eunkyung Shin - at ems7249@psu.edu or 540-200-7894
Psychology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00025290
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Inclusion Criteria:
Infants who are 4 - 9 months and their mother.
Infants born 3 weeks within their due date.
Infants of a birth weight > 2500 g.
Infants with NO serious medical complications.
English-speaking families.

Exclusion Criteria:
Infants who were < 2500 g at birth.
Infants who experienced any serious medical complications.
Infants who were born > 3 weeks before the indicated gestational period.
Families who do not understand and do not speak English
Children's Health, Neurology
Not applicable
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State College, PA ,

Interaction between cocoa and the fecal microbiome

There is a growing body of data demonstrating that polyphenols from foods including cocoa and chocolate are metabolized by the gut microbiome to produce small molecular weight metabolites that have greater systemic bioavailability and a potential role in the health-related effects of the parent compounds. The objective of this protocol is to collect fecal samples from human subjects, aged 18 - 40 years old, with overweight or obesity (BMI = 25 – 40 kg/m2), to use as a source of gut microbiota. These fecal samples will be used in in vitro fermentation experiments where fecal samples will be mixed cocoa powder or cocoa extracts in buffer. Samples from these fermentation experiments will be analyzed by chemical methods to identify the metabolites present and will be tested in bioassays to determine potential health-related bioactivities. Because biological sex can impact the composition of the microbiome, we plan to recruit both biological males and females.

There will be two in-person visits. Screening and consent collection will be done at the first and participants will receive supplies for stool collection. The participant will collect the stool samples at home and then return the sample at the second visit.

25

Yes
 

Joshua Lambert
Joshua Lambert - at jdl134@psu.edu or 814-865-5223
Food Science (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024951
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Inclusion Criteria:
aged 18 – 40 yrs old
BMI of greater than 25 to 40 kg/m2
Free of chronic intestinal/colon diseases
Willingness to abstain from consumption of polyphenol-rich foods for 24 h
Proficiency with English (verbal and written)

Exclusion Criteria:
Active bacterial or viral gastrointestinal infection
Pre-existing chronic gastrointestinal diseases
Use of antibiotics within 30 days
Medical circumstances that prevent participation
Food & Nutrition
Not applicable
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State College, PA ,

Testing the Effect of ENDS Flavors on Neurotransmission

This clinical trial will test the effects of common flavor chemicals in electronic nicotine delivery systems on brain reward function and nicotine use behaviors.

Subjects completing MRIs: Subjects will attend two in person visits with MRIs. where they will complete questionnaires, use e-cigarette devices and complete computer tasks.Subjects not completing MRIs: Subjects will attend two in person visits where they will complete questionnaires, use e-cigarette devices and complete computer tasksAll subjects will take a study E-cigarette device home to use for 10 days between their two in person visits.

If completing MRI - up to $400; If not completing MRI - up to $250

Yes
 

Andrea Hobkirk
abl@pennstatehealth.psu.edu
Psychiatry and Behavioral Health (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05836051
STUDY00024844
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Inclusion Criteria:
Regular users of inhaled tobacco products
No plan to quite tobacco in the next month
Able to read or write in English
Age 21 or older

Exclusion Criteria:
MRI Contraindications
Unstable or Significant Medical Conditions
Uncontrolled serious mental illness
Current substance abuse
Smoking, Vaping, Nicotine and Tobacco, Addiction & Substance Abuse, Mental & Behavioral Health
Prefer not to display
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Hershey, PA ,

PSCI 24-040 A NON-RANDOMIZED PROSPECTIVE CLINICAL TRIAL COMPARING THE NON-INFERIORITY OF SALPINGECTOMY TO SALPINGO-OOPHORECTOMY TO REDUCE THE RISK OF OVARIAN CANCER AMONG BRCA1 CARRIERS [SOROCk]

This protocol is comparing two types of surgery, one with the removal of the ovaries, fallopian tubes and uterus against removal of the fallopian tubes and uterus in subjects how are between 35 and 50 with the BRCA1 mutation..

Participants must be carriers of the BRCA1 gene mutation. This trial involves going to the operating room to have either their fallopian tubes removed or their ovaries and fallopian tubes removed. A vaginal ultrasound will be done. you will have blood drawn and a pregnancy test done. This will happen before surgery.

Yes
 

Shaina Bruce
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04251052
STUDY00025098
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Inclusion Criteria:
Individuals 35-50 years of age, inclusive.
At least one intact ovary and fallopian tube
Positive CLIA-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient.
Patients may be premenopausal or menopausal.
Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration.

Exclusion Criteria:
Individuals with a history of any prior cancer
Prior history of ovarian cancer,
Patients medically unfit for the planned surgical procedure.
Patients with abnormal screening tests
Cancer
Not applicable
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Hershey, PA ,

Randomized Placebo-controlled Trial of Nicotine Pouches in Smokers

The purpose of this research study is to understand the health effects of a new oral nicotine pouch, and also to understand if this product can help reduce traditional cigarette smoking. Participants will be asked to reduce their cigarette smoking by at least 50% with the help of the nicotine pouches.

After smoking your usual brand cigarettes for one week, you will be randomly assigned to one of six nicotine pouch groups to use over 16 weeks and asked to reduce your cigarette smoking over that time by at least 50% by using a nicotine pouch in place of your cigarettes. During the 16 weeks, there will be 2 phone call contacts and 4 in-person study contacts. During in-person contacts you will complete study questionnaires and you will be asked to provide urine, exhaled carbon monoxide, mouth cell samples, and other health measurements. You will record your cigarette and nicotine pouch use every day through a daily text message. Lastly, you will be followed up for a last study contact (virtual) 4 weeks later.

$375

Yes
 

Jonathan Foulds
Nicolle Krebs - at smokingresearch@pennstatehealth.psu.edu or 717-585-0416
Public Health Sciences (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT06043362
STUDY00023056
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Inclusion Criteria:
Ages 21-70
Commonly smoke ≥ 5 cigarettes or little cigars/cigarillos per day (at least 2 days/week) for at least the prior 12 months
Smoke cigarettes daily
Must be interested in reducing cigarette consumption by at least 50% and willing to try nicotine pouches
Access to e-mail and a smartphone/computer that has reliable internet connection

Exclusion Criteria:
Has a firm plan to quit within the next 30 days when assessed at screening
Use of a nicotine pouch or other non-cigarette nicotine product (e-cigarette, pipe, cigar, chew, snus, hookah, IQOS) for 5 or more days in the past 28 days
Currently pregnant, breastfeeding, or planning to become pregnant
Use of any FDA-approved smoking cessation medication (including any nicotine replacement therapy or varenicline, bupropion or nortriptyline used specifically as a smoking cessation aid) in the prior month
Use of illegal drugs daily or weekly in the past 3 months
Smoking, Vaping, Nicotine and Tobacco, Addiction & Substance Abuse, Women's Health
Not applicable
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Hershey, PA ,

A Multicenter, Randomized, Double-blind, 2-Part Phase 2 Study to Evaluate the Efficacy and Safety of GS-1427 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC) Part 1: Placebo-Controlled, Dose-Ranging Study of GS-1427; Part 2: Active-Controlled, Combination Study Evaluating the Efficacy and Safety of GS-1427 in Combination With Ustekinumab versus GS-1427 or Ustekinumab monotherapy

The study will test GS-1427 for treatment of ulcerative colitis (UC). Adults diagnosed with UC can participate if otherwise eligible.The study has two parts; the first part lasts 12 weeks. Participants will be randomly assigned to either a treatment or a placebo arm. At 12-week evaluation the participants can be further assigned to an active treatment lasting 40 weeks. The second part of the study is for new participants. Eligible participants will be randomized to the treatment with GS-1427, Stelara, or both drugs.The study procedures include blood tests, endoscopy with biopsies, vitals, and physical exam, EKG testing, providing urine and stool samples, and completion of symptom-related diary questionnaires.

Participants will be required to sign the informed consent and show that they understand the study requirements. They will be required to complete in-person clinic visits. During the visits, the participants will have their vitals checked, and we will ask them about any problems they may have or adverse events. During the screening periods, participants will undergo endoscopy with biopsies and provide stool and urine samples. Blood draws will also be done, and we will teach them to complete the questionnaires about the disease symptoms. If eligible for the study, screened subjects will be randomized for either tone of the three drug dose or placebo treatment (blinded). They will attend at least five clinic visits over the twelve-week treatment period. At that time, the endoscopy evaluation will be done again, and the participants will be eligible to enter the next study phase. They will again be randomized to one of the four possible treatment arms using different drug doses. In the part 2, investigational drug, standard of care biologic Stelara, or concomitant treatment of both medicines. During part 2 of the study, subjects are required to attend at least ten clinic visits every four weeks. When the treatment is completed, the participants will be followed for four weeks and attend the end of the therapy visit. The final endoscopy will be done at week 52 of treatment. Participants will have an ECG done at selected study visits and a pregnancy check for WOCBA at every visit. Blood draws and a review the study diary will be done at every visit.

Part 1 total $1765 ($75 per visit, $20 meal cards v2 and v12); Part 2 TBD

Yes
 

Kofi Clarke
Zvjezdana Chroneos - at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06290934
STUDY00024299
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Inclusion Criteria:
age18-75 years
diagnosed UC at least three months prior
active disease inspite of one of the standard therapies
loss of response, or intolerant to not more than one therapy
negative TB test and HIV at screening

Exclusion Criteria:
diagnosis of Crohn's disease
history of ileostomy, colostomy or stenosis
history of extensive colonic resection
past treatment with vedolizumab
past treatment with ustekinumab
Digestive Systems & Liver Disease
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Hershey, PA ,

PSCI-23-089: CAFs (Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC): a Phase I/II study

Researchers in this trial will be using a combination of two drugs to determine if the combination will help in treating cancer by shrinking tumors and controlling cancer growth.

You will need to come to the clinic for at least six visits while you are taking the study medication. Those visits will include see the study doctor, having blood drawn, and giving you the study drug. When you are no longer taking the study drug you will be seen about 2 months after that followed by phone follow ups between 6 and 8 months after stopping the study drug and then every year for 2 years. Those yearly visits can also be done by looking at you medical record.

Yes
 

Takefumi Komiya
CI CTO at PSCI-CTOPennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04467723
STUDY00024667
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Inclusion Criteria:
Participant or legal representative is able to provide written informed consent prior to performing any protocol-related procedures.
Men or women at least 18 years of age with histologically or cytologically confirmed non-small cell lung cancer.
Previous history of other than lung cancer is allowed if no active treatment for that cancer within 1 year
Life expectancy of at least 6 months
Recurrent Unresectable stage III NSCLC treated with prior chemoradiation followed by maintenance PD1/PDL1 inhibitor with measurable disease.

Exclusion Criteria:
Has a known hypersensitivity to atezolizumab or pirfenidone.
Has uncontrolled diabetes.
Has a history of any Grade 3 or 4 toxicities to a prior checkpoint inhibitor treatment.
Is pregnant or breast feeding.
Has drug-induced pneumonitis ( e.g. from amiodarone, methotrexate or nitrofurantoin)
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Opioid Use and Criminal Justice: Intervening to Improve the Outcomes of Women

The new program will help women who have recently been involved in the criminal justice system and use opioids (heroin, fentanyl, prescription pain medications nonmedically) to join treatment programs for opioid addiction. The program will also assist women in finding and getting access to the social services they may need and provide opioid response training. Half of the recruited participants will be randomly selected to be in a trauma support group for women with addiction issues. The program will also help women with common barriers to staying in treatment, such as childcare and transportation.

Participants will be connected to drug treatment programs that offer medications to stop or reduce drug use. Participants will be assigned a peer recovery specialist; these are women in long-term recovery who will help the enrolled women with transportation, childcare, and completing any tasks they may have due to criminal justice involvement or child welfare. Half of our participants will be assigned to a support group of other women in recovery. Participants will complete surveys at three time points and will be paid $50 each time. Participants will also be given overdose response training and take-home-naloxone.

$575

Yes
 

Abenaa Jones
Abenaa Jones - at avj5462@psu.edu or 202-956-8557
Human Development and Family Studies (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00023933
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Inclusion Criteria:
Female
Use heroin, fentanyl, or prescription opioids without a prescription
interested in medications to reduce opioid use
18 years or older
live in Harrisburg area

Exclusion Criteria:
Not interested in medications to stop opioid use
not female
not older than 17
Addiction & Substance Abuse, Mental & Behavioral Health, Women's Health
Survey(s)
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Carlisle, PA ,
Harrisburg, PA ,
York, PA ,

Pain and the Brain in Different Virtual Reality Environments

Research has shown that exposure to different environments alters perceived pain intensity. To explore whether pain differs in various VR environments, we are going to use virtual reality to immerse participants in different settings. At the end of every immersion, we are going to induce controlled experimental thermal pain to participants (like holding a hot cup of coffee) to understand whether their pain differs. We are also going to measure their stress, affect and brain activity using behavioral, electrophysiological (skin conductance and heart rate) and functional Near-Infrared Spectroscopy (fNIRS) methodology. The results have the potential to improve pain treatment in medical settings, where virtual reality is regularly used as a non-pharmacological analgesic, but also to inform architectural design and urban planning, so our cities and homes promote improved pain outcomes.

There will be one in-person visit that will last ~3.5 hours. During the visit you will be immersed in Virtual Reality environments, you will experience painful (but tolerable) heat stimulations, like holding a hot cup of coffee, and you will be asked to rate your pain intensity. We will record your brain activity using functional Near Infrared Spectroscopy (fNIRS) as well as your palm sweatiness and pulse. You will be compensated $25 per hour for your time.

~$85

Yes
 

Elizabeth Losin
Theoni Varoudaki - at tvaroudaki@psu.edu
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00024939
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Inclusion Criteria:
Adults 18-55 years old.
Fluent English speakers.
Living in the U.S.
Born in the United States or moved to the United States prior to 10 years of age.
Do not have a history of vertigo, motion or simulation sickness.

Exclusion Criteria:
Wear glasses and cannot wear contacts.
Pregnancy.
Current presence of pain.
Self-reported color blindness.
Recent history (within two years) of myocardial infarction.
Pain Management
Not applicable
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State College, PA ,

A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)

Participants in the PIVOT-006 study will either receive surgical treatment plus cretostimogene or surgical treatment alone.This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by CG0070 vs TURBT for the treatment of patients with IR-NMIBC.The purpose of this study is to see if cretostimogene can reduce the risk of your bladder cancer returning, or coming back as quickly as if you did not receive cretostimogene. People in the study will continue to be monitored by cystoscopy and pathology to see how long it takes for thecancer to return.Who May Be Eligible to Take Part In This Study:People with:• Bladder Cancer that has not invaded the muscle (Non-Muscle Invasive Bladder Cancer) • Intermediate-Risk Disease • Over 18AllTreatment:18All patients will receive surgical treatment on study as part of Standard-of-Care. 50% of patients will receive cretostimogene in addition to surgical treatment. For patients who do not receive cretostimogene, you will be offered cretostimogene if your bladder cancer recurs. The treatment will be instilled into the bladder through a thin tube called a catheter. This will be done 14 times over an 12-month period.Main Meausure:Patients who have recurrence of bladder cancer after receiving surgery plus cretostimogene compared to patients who receive surgery alone.

if you decide to take part in this study and meet all of the requirements, all patients will receive surgical treatment on study as part of Standard-of-Care. 50% of patients will receive cretostimogene in addition to surgical treatment. For patients who do not receive cretostimogene, you will be offered cretostimogene if your bladder cancer recurs. You will receive 6 treatments, once per week for 6 weeks in a row. The treatment will be instilled into the bladder through a thin tube called a catheter. This will be done 14 times over an 12-month period. There will be up to 16 visits with blood draw and/or urine colelction. As a part of screening, efficacy and follow up for this study, you might have to have cystoscopy ( up to 6), urine cytology (up to 6), TUBRT or vladder mapping or CT urogram over a 3 year month period.

Yes
 

Hong Truong
Seyma Demirsoy - at sdemirsoy@pennstatehealth.psu.edu or 717-531-0003, ext=282616
Urology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06111235
STUDY00024123
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Inclusion Criteria:
Bladder Cancer that has not invaded the muscle (Non-Muscle Invasive Bladder Cancer)
Intermediate-Risk Disease
Is ≥18 years of age on day of signing informed consent.
Demonstrates adequate organ function
Is willing to comply with study mandated cystoscopies, urine cytology, CT urograms, TURBTs/biopsies, and other procedures

Exclusion Criteria:
Has current or prior evidence of high-risk Non-Muscle Invasive Bladder Cancer (NMBIC)
Has disease that cannot be completely resected.
Has current or history of muscle-invasive cancer or locally advanced or metastatic bladder cancer
Has a history of High-grade or Low-Grade urothelial cancer
Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks of randomization.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Augmented Reality: Perceptions, Performance, and Language Enhancement

This is a single-center feasibility study assessing the Apple Vision Pro as a device for augmentative and alternative communication in patients with Amyotrophic Lateral Sclerosis who are experiencing impaired communication.Participants in this study will visit the study site once for approximately 1.5 hours. During the session, participants will complete questionnaires about their medical history, undergo an eye exam, and use an augmented reality headset that tracks the motion of the eyes to communicate.

Participants and their caregivers will complete a single visit at the Hershey Medical Center lasting approximately 1.5 hours. During this time, they will undergo an eye exam, answer a set of questionnaires, and use an augmented reality (AR) headset that tracks eye-gaze to communicate.

$25

Yes
 

James Grogan
Andrew Geronimo - at ageronimo@pennstatehealth.psu.edu or 717-531-0003, ext=282576
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00024666
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Inclusion Criteria:
Diagnosis of motor neuron disease (ALS, PLS, PMA, or progressive bulbar palsy)
Use of augmentative and alternative communication device device (including but not limited to: eye tracking, switch control, scanning interface, written or typed communication).
Score of 1 or 0 on the ALS Functional Rating Scale (ALSFRS-R, Cedarbaum1999) speech sub-score and/or score of 2, 1, or 0 ALSFRS-R handwriting sub-score.

Exclusion Criteria:
Preexisting ocular or medical condition that would inhibit eye tracking or headset use.
Continuous use of face-mask noninvasive ventilator that would impair comfortable wearing of AVP headset for at least 60 minutes
History of visual impairment incompatible with device use
History of medical diagnoses that could be exacerbated by use of the augmented reality headset: uncontrolled migraines or chronic headache, dizziness, vertigo, or other inner ear conditions, dry eyes, skin allergies, seizures
Diagnosis of frontotemporal dementia or other severe cognitive impairment that is sufficient, in the opinion of the study neurologist, to interfere with the subject’s ability to provide informed consent and reliably complete questionnaires
Neurology
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Hershey, PA ,

ALL ALS-ASSESS

This study will follow symptomatic ALS participants and control participants for 2 years, measuring a wide range of ALS outcome measures and gathering long term survival data.

Study visits will be conducted both in an in-clinic setting (on-site) and remotely (off-site) over the course of 24 months (2 years). The symptomatic ALS cohort participants can either participate in on-site or off-site visits, depending on their location and ease of access to one of the participating sites.During this 2-year period, symptomatic ALS participants will complete a screening visit (2-3 hours to complete), a total of 7 in-person study visits (1-3 hours to complete) and 24 remote self-assessment activities (completed each month, takes 35-45 minutes to complete). Participants and will need access to a personal device (i.e. a computer and/or smartphone or tablet) and an internet connection to participate in this study. All control participants will participate on-site, completing their on-site visits every 12 months.Biospecimens will be collected at regular intervals to support biofluid biomarker analyses. Biospecimens will include plasma, serum, whole blood for generation of induced pluripotent stem cells (iPSCs) and DNA for whole genome sequencing, and cerebrospinal fluid (CSF). For on-site symptomatic ALS and control participants, CSF will be collected through optional Lumbar Puncture (LP) procedure. Only plasma, serum and whole blood will be collected for off-site participants through home phlebotomy collection process.

Up to $350

Yes
 

Zachary Simmons
nervemuscle@pennstatehealth.psu.edu 717-531-8257
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00024206
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Inclusion Criteria:
Age 18 years or older
Capable of providing informed consent
Willing to follow study procedures
Diagnosis of ALS by a physician
Access to a smartphone, computer or tablet, and internet (need not be in the home – access to a public library or other available computer with internet connection is sufficient)

Exclusion Criteria:
Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression that would interfere with the study procedure.
Clinically significant unstable medical condition (other than ALS) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator’s judgment.
Optional Lumbar Puncture - Medically unable to undergo LP; allergy to Lidocaine or other local anesthetic agents; use of anticoagulant medication or antiplatelet medications (aside from aspirin 81mg) that cannot be safely withheld prior to LP.
Neurology
Not applicable
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Hershey, PA ,

ALL ALS-PREVENT

The primary purpose of this study is to collect samples and health information from individuals who are genetically at risk for ALS to better understand ALS and how the disease progresses.

Study visits will be conducted both in an in-clinic setting and remotely with 14 visits over the course of 36 months (3 years). Participants will complete a total of 10 visits over the course of 36 months (3 years). There will be a screening visit onsite in the clinic; 3 in-person onsite clinic visits once a year; and 6 remote visits once every 4 months. Participants and will need access to a personal device (i.e. a computer and/or smartphone or tablet) and an internet connection to participate in this study.Biospecimens will be collected alongside COA to support biofluid biomarker analyses. Biospecimens will include plasma, serum, RNA, whole blood for generation of induced pluripotent stem cells (iPSCs) and DNA for whole genome sequencing, and cerebrospinal fluid (CSF) via lumbar puncture (LP). To supplement annual in-person visits, participants will undergo additional biofluid collection (plasma, serum and whole blood) which will be remotely collected through home phlebotomy.

Up to $780

Yes
 

Zachary Simmons
nervemuscle@pennstatehealth.psu.edu 717-531-8257
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00024446
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Inclusion Criteria:
Age 18 years or older.
Capable of providing informed consent and willing to follow study procedures.
First-degree relative of known carrier of ALS gene OR First-degree relative of individual with ALS and/or FTD in a family with a “compelling family history” of ALS/FTD, regardless of whether genetic testing has occurred in symptomatic family members.
Access to a smartphone, computer, or tablet, and internet (need not be in the home – access to a public library or other available computer with internet connection is sufficient)
Genetic Testing Sub-Study: Currently enrolled in the PREVENT ALS Study

Exclusion Criteria:
Evidence of neurological signs or symptoms concerning for ALS of FTD, at the discretion of the site investigator which will be communicated to the applicant along with referral for appropriate clinical follow-up.
Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression that would interfere with the study procedure.
Clinically significant, unstable medical condition that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator's judgment.
Optional Lumbar Puncture: Medically unable to undergo LP; allergy to Lidocaine or other local anesthetic agents; use of anticoagulant medication or antiplatelet medications (aside from aspirin 81mg) that cannot be safely withheld prior to LP.
Genetic Testing Sub-Study: Presence of unstable psychiatric illness (psychosis, active suicidal ideation, suicide attempt, or untreated major depression) in whom predictive genetic testing would confer a high risk of harm.
Neurology
Not applicable
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Hershey, PA ,

A randomized, open-label, multicentric, two-arm pivotal trial of SonoCloud-9 combined with carboplatin (CBDCA) vs standard of care lomustine (CCNU) or temozolomide (TMZ) in patients undergoing planned resection for first recurrence glioblastoma

We are asking you to take part in this voluntary research study because you have a brain tumor (glioblastoma) that has gotten worse despite first treatment.The purpose of this voluntary research study is to is to learn if the SonoCloud-9 (SC9) implantable device can be used in combination with Carboplatin chemotherapy to help control glioblastoma at recurrence. Neither Sonocloud-9 (SC9) in combination with Carboplatin chemotherapy is not FDA approved.

As part of your routine care, you will be asked to undergo surgery to remove the tumor that has come back. You will be randomized into one of the treatment groups. If you are in the study drug group the surgeon will insert the SonoCloud-9 device (SC9) implant into the skull bone at the end of the tumor resection surgery. If you are in the routine treatment group, the surgeon will close the wound without implanting the SC9 device.The treatment itself will start within 12 to 21 days after the randomization.-If you are in the study drug group you will receive up to 7 doses (every 3 weeks) of Carboplatin at the same time the SonoCloud-9 device is being activated. Further details on the procedures are described below. A brain MRI (Magnetic Resonance Imaging) scan will be performed after the first cycle as part of the research to evaluate opening of the BBB (blood-brain barrier). -If you are in the routine treatment group, you will receive up to 4 doses of Lomustine (every 6 weeks), or, if considered as best appropriate, up to 6 doses of Temozolomide (every 4 weeks). Additional in-person hospital visits or telehealth consultations by video or phone will be performed at regular intervals.

Yes
 

Brad Zacharia
Micaiah Grien - at mgrien@pennstatehealth.psu.edu or 717-531-0003, ext=283063
Neurosurgery (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05902169
STUDY00023862
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Inclusion Criteria:
Candidate for surgical resection (craniotomy)
Received prior first line therapy
First disease progression
Proven glioblastoma
At least 18 years old

Exclusion Criteria:
Contra-indication to Carboplatin, lomustine or temozolomide
Medical need to be on continued anti-platelet aggregation therapy or coagulation
Peripheral neuropathy
Uncontrolled epilepsy
Known sensitivity/allergy to gadolinium
Cancer
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Hershey, PA ,