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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
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 ,

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 ,

Examine Three Different Functional Analysis Methods Using Innovative Measurements to Identify Their Properties

This study compares three different functional analysis methods using the same measurements to find the better method. Each participant will be assigned one method to produce a diagram using the given method and one online survey after the in-person experiment. Each participant will be given detailed instructions and information regarding the method to ensure there are no knowledge gaps. 

For the experiment, participants will be assigned to a group of four people from different engineering subfields to evaluate a product using one of three functional analysis methods. Each group will be randomly assigned a product to evaluate and a functional analysis method to use. After the experiment, each participant will be asked to complete an online survey asking for their experiences and thoughts. 

Yes
 

Kathryn Jablokow
Haixing Piao - at hbp5181@psu.edu or 856-796-6269
Engineering (GREAT VALLEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023656
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Inclusion Criteria:
Junior, Senior, Graduate Stduents
Chemical Engieering
Electrical Engineering
Industrial Engineering
Mechanical Engineering

Exclusion Criteria:
Freshmen
Sophmore
Education
Not applicable
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State College, PA ,

Human-Centric Non-Invasive Physiological Sensing System for Early Detection of Workers’ Heat Stress in the Field

This study will examine different structural designs of stretchable, skin-like sensors on the surface of human skin for workers.

There will be one in person visit;Subjects will first be asked to sit still for 3 minutes and then move their skin by the research team for another 3 minutes.

Yes
 

Huanyu Cheng
Huanyu Cheng - at huc24@psu.edu or 814-863-5945
Engineering Science and Mechanics (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00020880
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Inclusion Criteria:
no existing skin conditions or open wounds, or other disorders that make them have altered temperature responses
be over 18 years old
must understand English
resources from Penn State, University Park

Exclusion Criteria:
people with a metal allergy
Men's Health, Women's Health
Prefer not to display
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State College, PA ,

Self-Help for Stress Related to COVID-19

This is a study on internet-based self-help for stress related to the COVID-19 pandemic. College and university students who screen high on perceived stress or measures of risk for anxiety, depression, or eating disorders during the COVID-19 pandemic will be invited to participate in this study. Participants will be randomly assigned to receive access to an internet-based self-help program for stress resilience and coping with the COVID-19 pandemic or care as usual. Symptoms of stress, anxiety, depression, and eating disorders, as well as secondary outcomes, will be assessed via questionnaire at baseline (pre-randomization), one month post-randomization, and three months post-randomization.

Participants will be randomly assigned to receive access to an internet-based self-help program for stress resilience and coping with the COVID-19 pandemic or care as usual. Symptoms of stress, anxiety, depression, and eating disorders, as well as secondary outcomes, will be assessed via questionnaire at baseline (pre-randomization), one month post-randomization, and three months post-randomization.

Up to $50 (raffle-based)

No
 

Gavin Rackoff
Gavin Rackoff - at gnr18@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT04762173
STUDY00015766
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Inclusion Criteria:
Experiencing significant stress related to COVID-19 pandemic
Fluent in English
Current college or university student

Exclusion Criteria:
Unable to provide informed consent
Under 18 years of age
Not a college or university student
Not fluent in English
Mental & Behavioral Health
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Voice Perception Study

This is a voice perception study that asks participants to listen to voices and rate on various attributes such as attractiveness, social status, health, and others.

No
 

Toe Aung
Toe Aung - at txa96@psu.edu or 775-225-1747
Anthropology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00009763
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Inclusion Criteria:
Age 18-40
Gender/Sex: Men/Male; Women/Female
Education: PSU students and participants recruited online

Exclusion Criteria:
Uncorrected severe defects of hearing
Participants who already completed the survey
Participants who took the survey on the mobile phone
Men's Health, Women's Health
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A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients

Study of the safety of unlicensed cord blood units for stem cell transplant of children and adults.

For the treatment arm of this study you will no receive the total body radiation (TBI) as typically given before transplant. In this study you will have various research procedures such as a Blast sample at the screening part of the study, and MRD testing of your bone marrow and blood at screening and through the course of the study. Participation in the treatment arm (Non-TBI) of the study will last up to 5 years.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT01656603
STUDY00015052
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Inclusion Criteria:
You have a disorder affecting your hematopoietic system (the organs and tissues that produce your blood) that is inherited, acquired, or from previous chemotherapy

Exclusion Criteria:
You are receiving licensed cord blood products
You are receiving unlicensed CB products from other CB banks
Blood Disorders, Cancer
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Hershey, PA ,

Emotion in Motion: Behavior and Mental State Analysis on Human Visual Data

The main purpose of the proposed study is to examine the relationship between emotional body expression and internal emotional and psychophysiological processes among individuals with mental disorders in social interaction situations.

In this study, participants will be asked to answer structured questions. After this, participants will be asked to engage in emotional induction tasks, communicate with another person, and walk. During the interview and experimental procedures, your motion will be video recorded. 

40

Yes
 

James Wang
Adam Calderon - at afc6160@psu.edu or 814-863-0115
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00006792
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Inclusion Criteria:
You are at least 18 years old
Fluent in English
Able to walk at a leisurely pace on a treadmill without assistance

Exclusion Criteria:
Under 18 years old
Not fluent in English
Unable to walk at a leisurely pace on a treadmill without assistance
Experiencing cognitive impairments
Mental & Behavioral Health
Not applicable
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State College, PA ,

A prospective examination of TAC features as predictors of consequences and alcohol use disorders

The study aims to use a longitudinal design that combines transdermal alcohol concentration (TAC) sensors and ecological momentary assessment (EMA) in a sample of college and non-college young adults to examine the associations between TAC features (such as rise rate and duration), alcohol-related consequences, and alcohol use disorder (AUD), when adjusting for EMA self-reported indicators (such as drink counts, estimated BAC).

If eligible, participants will be invited to be part of a study that will take place over two years. Every 6 months, participants will be asked to wear a small biosensor on their wrist and complete mobile phone surveys for three consecutive weeks. Participants will also be asked to complete a 20-minute survey and a 15-minute interview at baseline, 12-month, and 24-month follow-ups. Participants can earn up to $776 over the course of the two-year period. 

776

Yes
 

Michael Russell
Sarah Ackerman - at psuprohealth@psu.edu
Human Development and Family Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00025265
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Inclusion Criteria:
Must be aged 19-20 years old
Must have a working iPhone (biosensor app is iOS compatible only)
Must be willing and able (ex. no app store issues such as expired payment method, have space on phone) to download and install two free apps from app store
Must live/work/attend school in the State College, PA area (biosensor pick up on University Park campus)
Must not be participating in another study with mobile phone survey currently or planning to participate in another study with mobile phone survey in next 30 days

Exclusion Criteria:
Not aged 19-20 years
Dot not have a working iPhone
Not able/willing to download and install two free study apps from app store
Do not live, work, or attend school in the State College, PA area
Are participating or plan to participate in the next 30 days in another study with mobile phone surveys
Addiction & Substance Abuse
Not applicable
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State College, PA ,

Muscular Dystrophy Association Neuromuscular Observational Research (MOVR) Data Hub Protocol

The Muscular Dystrophy Association (MDA) wants to collect information about individuals with neuromuscular disease to better understand the disease progression and ultimately improve the medical care, quality of life, and survival of those with neuromuscular disease. To collect this information, MDA has created a data registry called the Neuromuscular Observational Research Data Hub (referred to as the “MOVR Data Hub”). The MOVR Data Hub is a kind of database — a way of collecting and storing information.

Each person who participates in the MOVR Data Hub will have his/her information collected for as long as the person is being seen at an MDA Care Center and information is still being collected, unless and until the person requests that the information no longer be provided to the MOVR Data Hub.

Yes
 

Mansoureh Mamarabadi
Neurology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
STUDY00012883
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Inclusion Criteria:
Diagnosed with a neuromuscular condition

Exclusion Criteria:
Unwilling to provide informed consent
Neurology
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Hershey, PA ,

Phase III Trial of Concurrent Chemoradiotherapy with or without Atezolizumab (PSCI# 19-044)

The purpose of this study is to compare the effects, good and/or bad, of chemotherapy and radiation therapy with or without the use of atezolizumab, which is used to treat bladder cancer. The combination of chemotherapy, radiation therapy and the immunotherapy atezolizumab is considered experimental.

The purpose of this study is to compare the effects, good and/or bad, of chemotherapy and radiation therapy with or without the use of atezolizumab, which is used to treat bladder cancer. The combination of chemotherapy, radiation therapy and the immunotherapy atezolizumab is considered experimental.If you decide to take part in this study, you will receive combined chemotherapy and radiation therapy which is called “chemoradiotherapy” either with or without the study drug. The chemoradiotherapy you will receive is standard of care and what your doctor thinks is best. You will receive chemoradiotherapy for up to 7 weeks. If you are assigned to the group receiving study drug, you will take the drug for up to 6 months in addition the chemoradiotherapy.Your doctor will continue to follow your condition for up to 5 years after you register to the study, even though you have finished treatment in the first year. Your doctor will watch you for side effects and to see how your cancer affects you. You will have clinic visits at 3 months from the time you stop taking treatment for the first two years and then twice a year for the third year and once a year thereafter until 5 years after you register to the study

Yes
 

Monika Joshi
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03775265
SITE00000631
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Inclusion Criteria:
Patients must have histologically proven, T2-T4a N0M0 urothelial carcinoma of the bladder within 70 days prior to randomization.
Patients must undergo radiological staging within 70 days prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI. Patients must not have evidence of T4bN1-3 disease.
Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meets criteria specified.
Female patients of childbearing potential must have a serum pregnancy test prior to randomization.
Patients must be ≥ 18 years of age.

Exclusion Criteria:
Patient must not have received any systemic chemotherapy for their bladder cancer.
Patients must not have received prior treatment for muscle invasive bladder cancer including neoadjuvant chemotherapy for the current tumor.
Patients must not have a major surgical procedure within 28 days prior to randomization.
Patients must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Patients must have adequate bone marrow function as evidenced by all of the following: ANC ≥ 1,500/microliter (mcL); platelets ≥ 100,000/mcL; Hemoglobin ≥ 9 g/dL. These results must be obtained within 28 days prior to randomization.
Cancer
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Hershey, PA ,

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY OF SIRNA GENE SILENCING FOR THE TREATMENT OFNON-ALCOHOLIC STEATOHEPATITIS (NASH) IN PARTICIPANTS WITH GENETIC RISK FACTORS

This is a Phase 2 drug study, using a precision medicine approach to treat a chronic liver disease called Non-Alcoholic Steatohepatitis (NASH) in individuals at increased genetic risk for this condition. The primary objective of the study is to evaluate the effect of the study drug, ALN-HSD, on the histopathologic (liver biopsy) assessment of liver fibrosis. The study has a screening period of up to 16 weeks (day -113 to -1),a double-blind placebo-controlled treatment period of 52 weeks (day 1 to 365), and an off-drug safety follow-up period of 32 weeks (day 366 to 589). In total, the study duration is approximately 100 weeks.The study drug, or placebo, would be administered subcutaneously (through a fine needle in the belly) every 4 weeks, for a total of 13 doses. During the course of the study, there will be approximately 20 visits, which will take place in the clinical research center of our hospital. At these visits, participants will receive the injections, and be evaluated for vital signs, have regular bloodwork, receive a physical, and answer questions about their well being.

There will be up to 20 in person visits. The screening visits will include bloodwork, vitals, body measurements, and some additional scans. After randomization, each visit will occur approximately every two weeks and will include blood work and a physical at each visit, in addition to the administration of the study drug.

$2000

Yes
 

Jonathan Stine
Wes Heinle - at jheinle@pennstatehealth.psu.edu
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05519475
STUDY00025117
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Inclusion Criteria:
Adult male or female ≥18 years and ≤75 years of age.
A diagnosis of NASH with fibrosis (F) stage 2 or 3

Exclusion Criteria:
Cirrhosis from any cause, including cirrhosis due to NASH
Alcoholic liver disease
History of Type 1 diabetes
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Ecological Decision-Making of COVID-19 Vaccination

This is an online survey study that examines factors impacting people’s COVID-19 vaccination decision-making. In the survey, participants will answer various questions about COVID-19 and COVID-19 vaccines, such as their personal experience, their perception and knowledge of COVID-19 vaccines.

No
 

Aiping Xiong
axx29@psu.edu
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00017483
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Inclusion Criteria:
18 years or order
An active undergraduate student or graduate student enrolled in classes at University Park campus
currently is residing in the United States

Exclusion Criteria:
Younger than 18 years old
not a currently enrolled undergraduate student or graduate student, of PSU, University Park
currently is not residing in the United States
COVID-19
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A comparison of VR and MR in Human-ECA interaction

We are conducting this study to investigate whether different platforms of immersive technology influence the experiences of users when interacting with an embodied conversational agent. We are particularly interested in studying the effects of platform on users’ feelings of presence and social presence when comparing virtual and mixed reality environments.

Yes
 

Pejman Sajjadi
Pejman Sajjadi - at sfs5919@psu.edu
Geography (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013361
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Inclusion Criteria:
Corrected to near corrected vision
English speaking

Exclusion Criteria:
Hearing impairment
Education
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State College, PA ,

HEALEY -RSA F

We are doing this research to find out if ABBV-CLS-7262 can help with Amyotrophic Lateral Sclerosis (ALS). We also want to find out if ABBV-CLS-7262 is safe to take without causing too many side effects.

•Ask you to complete questionnaires about your general health and well-being [Baseline Visit and Weeks 4, 8, 16 and 24/Early Termination (ET) Visits] •Collect a blood sample for:oTesting the amount of study drug in your body [Weeks 4, 8, 16, and 24/ET]oTest certain hormone levels [Regimen Screening, Week 4, 16, and 24/ET]oTest for a bleeding disorder prior to lumbar puncture [Regimen Screening if not done at Master Protocol Screening Visit, Week 16] oBiomarker (including RNA) testing [Baseline Visit, Week 8, 16, and 24/ET]oOver the course of the placebo-controlled portion of this research study, total blood draw volume for the samples listed above will be approximately 32mL or 2 tablespoons per visit •Collect a urine sample for:oRoutine safety testing [Baseline Visit, Week 4, Week 8, 16, and 24/ET]oBiomarker testing [Baseline Visit, Week 8, 16, and 24/ET]•Collect electrocardiogram (ECG) to assess for cardiovascular safety [Baseline Visit, Week 8, 16, and 24/ET]•Collect your vital signs (blood pressure, breathing & heart rate, blood oxygen level, and temperature)•Perform a lumbar Puncture to collect spinal fluid [Baseline and Week 24 Visit]•If you are a woman of childbearing potential, you will be asked to complete a Menstrual Cycle Questionnaire throughout the duration of this regimen

You will receive payment for the following: 1.stipend of $50 per on-site visit; 2.stipend of $100 per lumbar puncture (LP requested Weeks 28 and 52); 3.reimbursement for travel of $65 per on-site visit.

Yes
 

Zachary Simmons
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05740813
SITE00001309
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Inclusion Criteria:
Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria
Age 18 years or older
Capable of providing informed consent and complying with study procedures, in the SI’s opinion
Time since onset of weakness due to ALS ≤ 36 months at the time of the Master Protocol Screening Visit

Exclusion Criteria:
Use of any moderate or strong CYP3A4 inhibitor or inducer within 10 days or 5 half- lives (whichever is longer) prior to Baseline and throughout the study
Abnormal adrenal function, defined as confirmed abnormal random cortisol (<5 μg/dL) or ACTH (>2x upper limit of normal) at Regimen Specific Screening.
Any clinically significant ECG abnormalities, including QT interval corrected for heart rate using Fridericia’s correction formula (QTcF) of > 450 msec for males or > 470 msec for females at Master Protocol Screening.
Neurology
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

The Ketogenic Diet, Blood Lipids, and Heart Health in Healthy Adults with Differing BMI

The purpose of this feeding study is to examine if there is a difference in the effect of feeding a very low carbohydrate diet to people with normal weight and people with obesity. Participants will be asked to eat a very low carbohydrate diet, also known as a ketogenic diet, for 28 days. This diet will be provided to participants and includes 3 meals, some snacks, and beverages daily. Measurements of blood markers (fats, sugar, insulin, cholesterol), blood pressure, heart health, and body composition will be done at the start and end of the study.

In this study, you will be asked to consume a ketogenic diet for 28 days. This diet will be provided to you and includes 3 meals, some snacks, and beverages daily. This diet will meet your energy and nutrient needs. You will be asked to not eat any foods outside of what is provided by the study and consume no alcohol. Testing will be conducted on two consecutive days at the start of the study and the end of the study (a total of 4 testing days). For these visits, you will need to fast for 12 hours prior and avoid alcohol for 48 hours prior. At these visits, we will take a blood draw, measure your body weight, body composition, and preform non-invasive tests to assess your heart health.

$150

Yes
 

Kristina Petersen
Zachary DiMattia - at dchlab@psu.edu or 866-778-3438
Nutritional Sciences (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00000000
STUDY00024970
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Inclusion Criteria:
Age: 25 to 45 years
BMI: 18.5-22 or 30-35 kg/m^2
LDL cholesterol: <100 mg/dL
Blood glucose: <126 mg/dL
Triglycerides: <350 mg/dL

Exclusion Criteria:
Diagnosis of heart disease, stroke, kidney or liver disease
Current use of tobacco-containing products or (≤6 months) cessation
Pregnant or nursing individuals
Allergy or unwilling to eat study foods
Previously consumed a ketogenic diet for > 1 week
Food & Nutrition, Heart & Vascular, Prevention
Not applicable
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State College, PA ,

Social Values for Bird Conservation in PA

The purpose of this study is to examine public attitudes and willingness to pay for bird conversation activities on private forest lands.

No
 

Melissa Kreye
Melissa Kreye - at mxk1244@psu.edu
Ecosystem Science and Management (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013358
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Inclusion Criteria:
lives in Pennsylvania

Exclusion Criteria:
Does not live in Pennsylvania
Education
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Pictorial Influence on Sentence Comprehension

This behavioral study will examine the influence of pictorial primes on general knowledge questions. A participant will be shown a cartoon-type picture prior to the presentation of a question. They will be asked to answer the question verbally. This study aims to determine the influence of pictorial primes on memory recall and retrieval.

Yes
 

Marissa Scotto
Marissa Scotto - at mxs2620@psu.edu or 814-867-3033
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00010406
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Inclusion Criteria:
Must be over the age of 18
Must be a native English speaker

Exclusion Criteria:
Under the age of 18
Not a native English speaker
Education, Language & Linguistics
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State College, PA ,

Evaluation of the Immune Response and Antigenic Signature of Patients with Babesia Infection in Pennsylvania with the Aim of Developing a Rapid Diagnostic Test

We are evaluating patients who have been infected with Babesia. Babesia is a blood parasite that is acquired from ticks. The number of cases seen in Pennsylvania every year has been increasing. We intend to evaluate the blood of patients acutely infected with Babesiosis and review for possible simultaneous co-infections. We will compare those infected patients with the blood of healthy individuals. The goal is to identify proteins in the blood of acutely infected patients that are specific for Babesia and also evaluate the prevalence of patient's who have contracted a co-infection from the tick vector that transmitted the Babesia infection. The identification of the specific bacterial/parasitic antigens could then be used to create rapid diagnostic tests and help clinicians increase awareness of these tick-borne diseases.

We will obtain basic demographic information and past medical history. We will obtain two 10ml samples of blood. The blood will then be stored and ultimately sent to Antigen Discovery, Inc for proteomic array screening.

Yes
 

David Ingram
David Ingram - at dingram@pennstatehealth.psu.edu or 717-531-8881
Medicine: Infectious Diseases and Epidemiology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00011530
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Inclusion Criteria:
Healthy
18 years or older

Exclusion Criteria:
Active Cancer
History of having your spleen removed
History of liver or kidney disease
HIV
Diabetes
Infectious Diseases & Immune System
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Hershey, PA ,
Reading, PA ,
Wilkes-Barre/Scranton Area, PA ,

A151216-Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (Alchemist)

Purpose of study is to examine lung cancer patients' surgically removed tumors for certain genetic changes and to possibly refer these patients to a treatment study with drugs that may specifically these tumors.

Patients will be registered to the trial after surgical intervention. One vial of peripheral blood and a tissue block (or scrolls) will be submitted to the study. Once testing is completed, subject is notified if they are eligible for one of the sub protocols.

Yes
 

Marc Rovito
Michelle Eschbach - at meschbach@pennstatehealth.psu.edu or 610-378-2336
Cancer Institute (ST. JOSEPH)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02194738
AFFIL0A151216
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Inclusion Criteria:
Surgically resected non-small cell lung cancer
Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size ≥4 cm).
Tissue available for the required analyses

Exclusion Criteria:
No patients with recurrence of lung cancer after prior resection
No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD1/PD-L1/CTLA-4.
Cancer
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Reading, PA ,

Rapid Motor Regulation Mechanism for Arm Movement in Response to Visual Motion

This study looks at the relationship between motor control via. arm movement and visual stimuli. After participating in brief calibration protocol for the eye tracking system, participants will be moving a robotic handle to interact with visual stimuli during various tasks. Participants will spend approximately 2 hours in the lab.

There will be one approximately 2-hour visit. They will then be asked to complete 20-25 blocks of hand movements while looking at a moving virtual stimulus with a large visual background. Participants will receive regular breaks during the experiment.

$20

Yes
 

Tarkeshwar Singh
Tarkeshwar Singh - at tsingh@psu.edu or 814-865-7851
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023522
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Inclusion Criteria:
Between 18-65 years old
Right-hand dominant
Normal or corrected-to-normal vision
Able to sit upright in a chair for long periods
Able to grasp and move objects with both hands

Exclusion Criteria:
Any history of neurological disorders
Any history of musculoskeletal disorders
Eye or vision problems (e.g., cataracts, glaucoma, a detached retina or macular degeneration)
Cognitive impairment such that informed consent cannot be obtained, or that participant would not be safe with the protocol
Medication that could make the participant drowsy or tired during the experiment
Neurology, Vision & Eyes
Not applicable
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State College, PA ,

Understanding healthcare workers perception and knowledge of dysphagia

The purpose of this study is to gain a greater understanding of healthcare workers’ knowledge of and perception of dysphagia in older adults. Study participants will fill out a survey/questionnaire in a single study session. This is expected to take 15-20 minutes.

You will be asked to complete a single, brief survey. It will take no more than 15-20 minutes.

No
 

Aarthi Madhavan
Aarthi Madhavan - at aarthi@psu.edu
Communication Sciences and Disorders (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT00000000
STUDY00024236
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Inclusion Criteria:
Age 18 and older
Active healthcare workers or care providers for community dwelling older adults over 60 years old
Working with older adults
English proficiency at 8th grade level

Exclusion Criteria:
Never worked with older adults
Not working clinically currently
Diagnosed mild cognitive impairment or dementia
Infectious Diseases & Immune System, Food & Nutrition, Prevention
Not applicable
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Evaluation of Patellar Tendon Biomechanics

The objective of the study is to evaluate the condition of the patellar tendon with Ultrasound imaging. Ultrasound imaging will be explored as an accessible and non-invasive imaging modality to quantify tendon parameters (length, thickness, width, and neovascularization). Participants will sign informed consent and participate in an imaging session that will last approximately two hours. If the Ultrasound measurements prove feasible, they will provide insight into the biomechanical and biological mechanisms that contribute to tendon injury. It is important to understand how these parameters change among patients and healthy individuals with varying degrees of activity levels.

There will be one ultrasound session that will last approximately 2 hours. Ultrasound imaging will be performed at 342 Leonhard Building.

$20

Yes
 

Daniel Cortes Correales
Amanda Sargen - at ajs9367@psu.edu or 717-673-4218
Mechanical and Nuclear Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00026075
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Inclusion Criteria:
Age 18 - 35

Exclusion Criteria:
Prior knee surgery
Arthritis & Rheumatic Diseases, Sports Medicine, Pain Management
Not applicable
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State College, PA ,

Perception of English sentences in context

This study tracks the eye movements of 30 adults to gather information on how they process sentences when presented in a context.

Yes
 

Frances Blanchette
Frances Blanchette - at fkb1@psu.edu or 814-863-7392
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00007476
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Inclusion Criteria:
adult (18+)
native speaker of American English
grew up mainly in the US

Exclusion Criteria:
under 18 years of age
not a native speaker of American English
did not grow up mainly in the US
Language & Linguistics
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State College, PA ,

Genetics of Aromatase Inhibitor Musculoskeletal Syndrome (AIMSS)

This is a case-control biospecimen collection study of 1,000 breast cancer patients with survey and retrospective chart review components to study the possible genetic, clinical and demographic/lifestyle predictive factors of AIMSS.

If you decide to participate, we will ask you to send us a sample of your saliva (“spit”) and ask you to fill out a survey on a computer or on paper, whichever you prefer. The survey will ask questions about risk factor data, demographics, and questions about side effects of cancer treatments. We will also ask you for permission to collect data from your electronic medical record.

$25

No
 

Cheryl Thompson
Cheryl Thompson - at cthompson11@pennstatehealth.psu.edu
Public Health Sciences (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00024358
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Inclusion Criteria:
Breast cancer (stage 0-IV) diagnosis within the last 5 years
Prescribed at least one AI as part of breast cancer treatment at least one year ago
Female aged 21 and older
English or Spanish speaking

Exclusion Criteria:
Previous diagnosis of rheumatoid arthritis
Diagnosis and systemic chemotherapy and/or hormonal treatment from cancer diagnosed prior to the index breast cancer
Those currently incarcerated
Under age 21 years old
Cancer
Survey(s)
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PSCI: 24-010: Evaluate Safety and Efficacy of Daily oral Angelica gigas Nakai (AGN)-INM176 in Prostate Cancer Patients with Rising Plasma PSA (Phase I/II trial)

The purpose of this voluntary research study is to evaluate the safety and assess the efficacy of the daily INM176 herbal supplement in managing prostate cancer-specific PSA levels in prostate cancer patients.

This research study involves two phases: Phase I and Phase II. The procedures and treatments may vary depending on the phase the participant is in. Study Drug is administered daily by mouth. Pharmacokinetic (PK) and Pharmacodynamic (PD) blood tests are research procedures. Other research procedures include physical exams, vital signs, and blood tests.

total of $1300 and $1200, respectively

Yes
 

Monika Joshi
Meredith Belga - at Mbelga@pennstatehealth.psu.edu or 717-531-5232
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06600698
STUDY00026143
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Inclusion Criteria:
Agree to comply with all study procedures and attend all study visits to the best of their ability.
Male aged >=40 years.
History of prostate cancer diagnosis
Subjects with treated prostate cancer are eligible.
ECOG performance status 0-2.

Exclusion Criteria:
Subjects who are receiving any other investigational agents.
Any active secondary malignancy requiring treatment.
Chronic kidney disease with calculated GFR <30 mL/min/1.73 m2 using Cockcroft-Gault formula, or measured GFR <30 mL/min/1.73 m2 using a 24-hour urine collection.
Subjects who are taking Warfarin/coumadin.
Cancer
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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
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
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Hershey, PA ,

Mindful Moms study

This study (Mindful Moms) is being done to understand how an 8-week app-based mindfulness program called Calm impacts breastfeeding and maternal well-being. Eligible participants will be asked to complete three online surveys (each survey will take about 20 minutes) and take part in an 8-week app-based mindfulness program. Eligible participants will also be asked to take part in one online interview that will take about 25-30 minutes once the mindfulness program is over.

Participants will take part in one of two groups: A group asked to take part in a free 8-week app-based mindfulness program on their smartphone starting when they are 36 weeks pregnant or 4 weeks after delivery. The program will teach participants about mindfulness and breathing strategies to assist with calming their mind and body. or A group asked to take part in a free 8-week app-based mindfulness program on your smartphone starting 4 weeks or 12 weeks after they deliver. The program will teach participants about mindfulness and breathing strategies to assist with calming their mind and body. Participants will also be asked to complete three online surveys (each survey will take about 20 minutes) and take part in one online interview that will take about 25-30 minutes once the mindfulness program is over.

$130

No
 

Amy Moore
Amy Moore - at amm9107@psu.edu or 814-865-6714
Nutritional Sciences (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00018380
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Inclusion Criteria:
18 years of age or older
currently pregnant (12 to 34 weeks) or recently delivered (within the past 4 weeks)
intend to or are currently breastfeeding
daily access to a smartphone
willing to download a free mobile app

Exclusion Criteria:
have a current daily meditation practice
Food & Nutrition, Pregnancy & Infertility, Women's Health
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KEYSTROKE: A RANDOMIZED PHASE II STUDY OF PEMBROLIZUMAB (KEYTRUDA®) PLUS STEREOTACTIC RE-IRRADIATION VERSUS SBRT ALONE FOR LOCOREGIONALLY RECURRENT OR SECOND PRIMARY HEAD AND NECK CARCINOMA

Study of Pembrolizumab (KEYTRUDA®) Plus non-surgical radiation therapy Versus non-surgical radiation therapy alone for Recurrent or Second Primary Head and Neck Cancer. This study is evaluating the safety of the addition of pembrolizumab to non-surgical radiation therapy.

The purpose of this voluntary research study is to compare any good and bad effects of using the study drug, pembrolizumab, plus radiation therapy to using radiation therapy alone. The addition of the study drug to radiation could shrink your cancer/prevent it from returning but it could also cause side effects.

Yes
 

Mitchell Machtay
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03546582
STUDY00017112
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Inclusion Criteria:
Confirmed diagnosis of recurrent or any new primary squamous cell carcinoma of the head and neck
Patients for whom resection would be medically contraindicated and/or would impose excessive surgical risk
Patients must have had prior radiation to the head and neck

Exclusion Criteria:
Patients with distant metastases
Tumors that involve more than 180 degrees of the carotid artery
Patients with tumor ulceration through the skin
Disease that requires two or more discontiguous target volumes will be ineligible.
Cancer
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Hershey, PA ,

Phase II Trial of Palbociclib with Fulvestrant in Individuals withHormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer who have Progressed on Treatment with Palbociclib and an Aromatase Inhibitor

In this phase II trial, we will determine the progression-free survival (PFS) of the cyclin dependent kinase 4/6 inhibitor (CDK4/6i) palbociclib with fulvestrant in women and men with estrogen or progesterone receptor (ER/PR) positive, HER2-negative metastatic breast cancer (MBC) who progressed on treatment with palbociclib and an aromatase inhibitor (AI). We will also determine the prevalence rate of estrogen eceptor α (ESR1) and phosphatidylinositol-3-kinase (PI3K) mutations in the study population.

Participants will be required to come to the clinic every three weeks for evaluation and fulvestrant injections, take medication correctly, keep all appointments.

Yes
 

Cristina Truica
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02738866
STUDY00010878
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Inclusion Criteria:
Men and women, 18 years of age or older
Histologically or cytologically confirmed adenocarcinoma of the breast with evidence of metastatic disease (stage IV) or locally advanced disease,
ER-positive and/or PR-positive tumor (≥1% positive stained cells) • HER2-negative tumor
Progressed on and following at least 6 months of combined treatment with palbociclib and AI therapy for advanced/metastatic breast cancer, and be able and willing to receive additional palbociclib treatment
Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:
Women who are pregnant or breast-feeding
Concurrent use of any of the following medications during study participation: • Inhibitors or inducers of CYP3A4 that may affect serum concentrations of palbociclib
Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 2 weeks before registration.
Any other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
Prior hematopoietic stem cell or bone marrow transplantation.
Cancer
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Hershey, PA ,