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SNAC Study

This is a multi center clinical trial to test the efficacy of N-acetylcysteine for treatment of patients with active systemic lupus Erythematosus. Healthy control subjects who do not receive treatment are also recruited to serve as controls for the laboratory assays.

This is a clinical trial to be carried out in patients who have systemic lupus erythematosus. Participants will be asked to attend seven study visits over a period of 13 months. After an initial period where it will be determined that the patient can tolerate the medication, N-acetyl cysteine, then there will be a three-month double blind phase where the participant receives either the active treatment or a placebo. At each visit the participant will be asked to complete several questionnaires and blood and urine samples will be obtained. Healthy control individuals will be also enrolled for blood samples only; not for any treatment intervention.

$20 per visit completed

Yes
 

Nancy Olsen
Jamie Carter - at jcarter3@pennstatehealth.psu.edu or 717-531-4921
Medicine: Rheumatology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00775476
SITE00001115
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Inclusion Criteria:
Diagnosis of Systemic Lupus Erythematosus
Age 18 years or older
On stable medications
Experiencing flare of disease

Exclusion Criteria:
pregnant or lactating
regular daily use of Tylenol (acetaminophen)
active chronic infections
current treatment with cyclophosphamide or rituximab
current use of anti-oxidants
Arthritis & Rheumatic Diseases
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

AIDP

The purpose of this study is to test the performance of a web-based system for automated review of MRI images across 21 sites in the Parkinson Study Group. Each site will perform imaging, clinical scales, diagnosis, and will upload the data to the web-based software tool. The clinical diagnosis will be blinded to the diagnostic algorithm and the imaging diagnosis will be compared to the movement disorders trained neurologist diagnosis.

Participants will attend two study visits that will include questionnaires, a physical exam and motor exams and an MRI (during one of the visits).

300

Yes
 

Sol De Jesus
Autumn Collier - at acollier3@pennstatehealth.psu.edu or 717-531-5233
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
SITE00001044
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Inclusion Criteria:
40-80 years old at baseline
Diagnosed with a Parkinsonism (PD, MSA or PSP)

Exclusion Criteria:
Unable to undergo an MRI
Neurology
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Hershey, PA ,

A Survey of the Sex Differences in Taking Selfies while Driving

This study aims to understand peoples’ selfie-taking behavior and how, if at all, they relate to their driving behavior and gender difference. The participants will participate the study by completing an online survey.

No
 

Yiqi Zhang
Josh Avalos - at jqa5409@psu.edu or 610-716-7976
Industrial and Manufacturing Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00016045
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Inclusion Criteria:
Subjects who are 18 years of age or older
Subjects have a valid U.S. driver license or are allowed to drive in the US

Exclusion Criteria:
Subjects who under 18 years of age
Subjects who do not have a valid U.S. driver license or are not allowed to drive in the US
Education, Language & Linguistics
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Olfactory tools for COVID-19 screening and surveillance

This a collaborative multisite NIH funded project to develop smell tests as a rapid low cost way to screen for Covid19 infections. The lead institution is the University of Florida, and this project is being entered into CATS to create a Reliance Agreement under the NIH single IRB rules (sIRB).

No
 

John Hayes
Elisabeth Weir - at efw5195@psu.edu
Food Science (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
SITE00000951
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Inclusion Criteria:
Aged 18 to 99
COVID19 negative
COVID19 positive
Able to Consent in English

Exclusion Criteria:
Inability to provide consent
History of known pre-existing olfactory or taste disorder
History of head trauma with loss of consciousness
History of neurodegenerative disease
COVID-19
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Predicting Concussion Outcomes with Salivary miRNA

The purpose of this study is to identify changes in salivary micro ribosomal nucleic acid (miRNA) expression that are predictive of symptom duration and severity following mild traumatic brain injury (mTBI) in children. The primary endpoints of this study are as follows:1)Characterization of brain-related miRNA in the saliva of 250 children with mTBI and 200 age- and gender-matched controls between the ages of five and twenty-three years.2)Identification of a set of salivary miRNAs that is predictive of duration and severity of mTBI symptoms.

Saliva collection and surveys at baseline, 7 days, and 30 Days

$20

Yes
 

Jayson Loeffert
Brennen Harding - at bharding@pennstatehealth.psu.edu or 717-531-5656
Family and Community Medicine (HERSHEY)
 

All
All
This study is also accepting healthy volunteers
NCT02901821
STUDY00003729
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Inclusion Criteria:
5 to 23 years of age
Seen in the Penn State Pediatric Concussion Clinic within 2 weeks of most recent concussion

Exclusion Criteria:
Does not speak english
Periodontal disease
Ongoing seizure disorder, or other neurologic disorder
Drug or alcohol dependency
clinical diagnosis of severe TBI
Children's Health, Neurology, Sports Medicine
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Hershey, PA ,

Observations of Family Mealtime Routines

The purpose of this study is to gather information about what family mealtimes look like for families with children between the ages of 3 and 8. Families will be asked to video record their family mealtime, in addition to answer some questions and to complete some questionnaires, some about body image and dieting.

On one occasion, your family's mealtime will be recorded via Zoom. You and your family will be asked some questions and to complete some questionnaires online.

$20

No
 

Hannah Mudrick
Hannah Mudrick - at hxm99@psu.edu or 717-948-6404
Behavioral Sciences and Education (HARRISBURG)
 

All
All
This study is also accepting healthy volunteers
STUDY00015339
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Inclusion Criteria:
At least one adult who is the caregiver of at least one child between age 3 and 8 (e.g., at least one parent-child dyad)
Adults age 18 and older
Children, ages 3-8
Individuals fluent in English

Exclusion Criteria:
Non-family members, as defined individually by each family
Caregivers who are under the age of 18
Individuals who are not fluent in English
Families without at least one child age 3 to 8
Children's Health, Food & Nutrition
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Human-robot interaction study

We are interested in developing robots that can interact with humans. We hope that to develop robots that can interact with people and be used in a variety of different situations such as schools, offices, and homes. This study investigates human-robot interaction.

Yes
 

Alan Wagner
Alan Wagner - at alan.r.wagner@psu.edu or 814-865-3136
Aerospace Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00010270
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Inclusion Criteria:
Ability to read and see

Exclusion Criteria:
Under 18
Education
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State College, PA ,

Behavior, Voice, and Sex Hormones Study

Hormones are molecules that deliver signals throughout the body. They influence behavior, sleep, hunger, stress, and virtually all other aspects of life. This study seeks to better understand several of these functions, specifically how hormones affect specific aspects of human behavior and psychology, as well as speech production. Following an initial lab visit, subjects will participate in the remainder of the study (~5 weeks) at home via the internet. On a daily basis, they will collect urine samples for hormone analysis, saliva samples for analysis of oral micro-organisms, and will submit voice samples for analysis of speech (e.g. measuring voice pitch and loudness). They will then complete an online survey designed to collect information about their behavior, and attitudes over the previous 24 hours. Subjects receive compensation for their participation.

- Compensation $330 at maximum- Pre-sampling lab visit to sign a consent form and receive training- A series of ~42 daily at-home sample (urine, saliva) collection & online surveys- Weekly lab visits for sample drop-off

$330

Yes
 

David Puts
Sojung Baek - at research1871@psu.edu or 814-321-5541
Anthropology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013693
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Inclusion Criteria:
Between 18 and 30 years of age
Normal menstrual cycles
Available for daily at-home session for approximately 5 weeks
Female/Identifying as a woman
Predominantly or exclusively heterosexual sexual orientation

Exclusion Criteria:
On hormonal birth control
Uncorrected severe defects of hearing, speech, or vision
Bisexual or predominantly homosexual sexual orientation
Very heavy smoking or alchohol consumption
Medications that affect levels of ovarian hormones (e.g. anti-depressants, anti-psychotics)
Language & Linguistics, Diabetes & Hormones, Women's Health
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State College, PA ,

PSCI-22-063: NRG-GU011 NRG Promethean

This trial is comparing radiation therapy with or without hormone therapy in men with prostate cancer.

Patients must come in for all radiation treatments. Patients must take their androgen therapy as prescribed.

Yes
 

Joseph Miccio
psci-cto@pennstatehealth.psu.edu 717-531-5471
Radiation Oncology (HERSHEY)
 

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05053152
SITE00001224
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of prostate adenocarcinoma at any anatomical location (for example, prostate, metastatic site), including intraductal or ductal carcinoma, at any time before registration.
Age ≥ 18 years.
ECOG Performance Status 0-2 within 120 days prior to registration.
External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites.
Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes.

Exclusion Criteria:
Evidence of local tumor recurrence in the prostate and/or periprostatic/seminal vesicle region after radiotherapy, or in the prostate bed after prostatectomy.
Currently on androgen deprivation or anti-androgen therapy.
Osseous metastasis on 99mTc radionuclide bone scan
Extra pelvic nodal/soft tissue disease (> 1.5cm in short axis) on CT or MRI pelvis +/- abdomen
Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis
Cancer
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Understanding Prenatal Hydration Behaviors

To examine women’s self-reported pregnancy hydration behaviors, especially during a global pandemic. This study will also examine other lifestyle behaviors (e.g., weight gain, exercise, eating behaviors, sleep, pain management). It is hypothesized that hydration behaviors will decrease due to lifestyle changes related to the pandemic. Secondary outcomes will also be influenced by hydration behaviors and pandemic lifestyle changes.

No
 

Danielle Downs
Abigail Pauley - at amp34@psu.edu
Kinesiology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00016174
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Inclusion Criteria:
Pregnant
Women
18-45
English speaking

Exclusion Criteria:
Non-pregnant
Men
Younger than 18
Non-English speaking
Food & Nutrition, Mental & Behavioral Health, Women's Health
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AYA-CONNECT: A qualitative study to inform creation of a social network-based peer intervention for adolescent/young adult cancer survivors

In this study, in Aim 1 we will conduct focus groups of adolescent/young adult cancer survivors (AYACS) (at least 15 total AYACS) 15-25 years old to understand their perspectives on the importance of peer connection and social connectedness during and after cancer treatment, the role of an intervention to foster peer connections, and suggestions/feedback on designing AYA-CONNECT (an AYACS-peer network intervention) including delivery format, structure, and content to promote life goals and health-related behaviors. In Aim 2 we will further explore ways to design AYA-CONNECT through interviews of pairs of AYACS and a nominated peer.

You will participate in one focus group and/or interview that will last about 1 hour.

$40

No
 

Pooja Rao
Pooja Rao - at prao2@pennstatehealth.psu.edu
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
STUDY00024174
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Inclusion Criteria:
Participant age 15-25 years old at time of cancer diagnosis and within 5 years of initial cancer diagnosis
Participant is receiving or has received any oncologic care at Penn State Health Children’s Hospital or Penn State Cancer Institute
Participant fluency in written and spoken English for participants > 18 years old

Parent and participant fluency in written and spoken English for participants < 18 years old
Access to computer or smartphone

Exclusion Criteria:
Non-English speaking
Participants with cognitive or physical inability to participate in study
Cancer
Not applicable
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Understanding the effect of drivers’ profile information on riders’ feedback in ride-sharing context

This study aims to understand ways to affect how riders perceive and provide feedback to drivers through technology intervention. Particularly, we investigate how presenting drivers’ personal profile under different trip conditions may lead to differences in the ways riders may provide feedback. We hypothesize that riders will provide positive feedback when provided drivers’ personal information when the trip goes well, and that riders will provide less negative feedback when provided drivers’ personal information when the trip goes bad due to uncontrollable reasons.

Yes
 

Benjamin Hanrahan
Ning Ma - at nzm37@psu.edu
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013808
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Inclusion Criteria:
Taken at least 10 Uber/Lyft ride in the last 12 months.
You are willing to share several of your past Uber/Lyft trip records in the app with us.

Exclusion Criteria:
You are a current or past employee with one of the ride-sharing corporations (Uber/Lyft)
Education
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State College, PA ,

Skin pathophysiology of Hidradenitis Suppurativa

The purpose of this research study is to collect skin samples from volunteers with HS and volunteers with healthy skin. The collected skin samples will be processed and compared to each other to see if there are specific differences in the skin between the HS volunteer group and the healthy skin volunteer group.

Participants will need to come to a one-time, in-person visit where biopsies (small skin samples) will be collected.- For participants with HS: Up to 4 biopsies will be collected - For participants with healthy skin: Up to 2 biopsies will be collected

Yes
 

Amanda Nelson
Samantha Gettle - at sgettle2@pennstatehealth.psu.edu or 717-531-5136
Dermatology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00020589
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Inclusion Criteria:
Diagnosis of hidradenitis suppurativa (HS)
HS lesions present in the armpits and/or groin

Exclusion Criteria:
Participants who are pregnant or are planning to become pregnant
Certain medications are not allowed in this study- the study team will provide details
Skin Conditions
Not applicable
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Hershey, PA ,

Evaluation of the reliability and convergent validity of the Pain Competency Evaluation in Dementia (PACED) Rating Scale

This study establishes the reliability and convergent validity of the PACED rating scale. 15 undergraduate nursing students and registered nurses will be recruited to complete 2 clinical scenarios related to nursing home residents with dementia experiencing pain and symptoms of distress. Participants will use their clinical judgment to conduct assessments and provide interventions and treatments.

Participants (nurses and nursing students) will be asked to complete a demographic survey, a pain management knowledge survey (POAKS), and complete 2 clinical scenarios followed by pain management notes related to persons with dementia experiencing symptoms of distress. It may take about an hour to complete the study procedure mentioned above. You can choose to complete the 2 clinical scenarios in one setting or at different times.

$25 gift card for Registered Nurses (RN) and nursing students.

No
 

Yo-Jen Liao
Yo-Jen Liao - at yzl541@psu.edu or 814-826-8603
Nursing (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022937
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Inclusion Criteria:
English Speaking
18-years old or older
Undergraduate nursing students or Registered Nurses (RN)

Exclusion Criteria:
None
Pain Management
Not applicable
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Metabolic Alterations of the Semitendinosus Muscle After Tendon Harvest for Anterior Cruciate Ligament Reconstruction

This is a cohort study examining the changes in the muscle that occur following ACL injury and reconstruction. This study aims to determine if significant changes to the muscles properties occur as a result of the graft taken for ACL reconstruction, and whether or not these changes serve as a risk factor for further injuries. This study will examine the muscles ability to use oxygen non-invasively, an important determinant of muscle endurance and allow for comparisons of this between individuals with ACL-reconstruction surgery and healthy, non-injured adults.

Participants will have their leg muscle strength and endurance measured using common clinical techniques used in physical medicine and rehabilitation sciences. They will also have their mitochondrial capacity assessed through the skin using a non-invasive procedure.

$60.00

Yes
 

Giampietro Vairo
Jigar Gosalia - at jzg691@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00010623
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Inclusion Criteria:
ACL tear within last 12-36 months
Full rehabilitation
autograft taken from hamstring tendon
other autografts may be considered
Recreationally active

Exclusion Criteria:
Other major knee injury (i.e. MCL tear)
Muscle & Bone
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State College, PA ,

ABTECT-2 Induction-A randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of ABX464 once daily for induction treatment in subjects with moderately to severely active ulcerative colitis

This is a multicenter, randomized, placebo-controlled Induction study to evaluate the efficacy and safety of oral ABX464 given daily in inducing clinical remission in subjects with moderately to severely active ulcerative colitis (UC) who have inadequate response, no response, a loss of response, or an intolerance to either conventional or advanced therapies.The screening period is 28 days long, and a 28-day follow-up follows 8 weeks of induction treatment. Approximately 612 subjects (only adults at our site) will be randomized in this study. On Day 1, subjects will be randomized to one of the three arms. On Day 56, subjects can either continue participation in the maintenance study (ABX464-107) or end the study by entering four-week safety follow-up. Colonoscopy procedures will include biopsies of the most severely affected areas. The subjects will complete daily electronic Diaries. Blood samples will be collected at some visits. A cardiac safety sub-study is optional for eligible subjects.

Participants will be asked to sign the informed consent. There are at least five in-person visits, approximately every four weeks. There are two colonoscopy procedures with biopsies: first during the screening period and second evaluation at week 56 at the end of the study. Physical examination and vital signs will be taken at every visit. Stool sample for pathogens will be collected at screening. Blood tests will be taken to test for infectious diseases and other tests. There is an optional cardiac safety study. Pregnancy testing is required for eligible female subjects at every visit. Subjects will complete e-Diary questionnaires. There will be two eye exam visits. Participation in the study is voluntary.

Subjects will receive a flat amount per completed visit, up to maximum of $425.

Yes
 

Kofi Clarke
Zvjezdana (Stella) 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
NCT05507216
STUDY00023472
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Inclusion Criteria:
Age ≥ 18 years and weight ≥ 40 kg
must understand, sign and date the written voluntary informed consent.
Documented diagnosis of UC confirmed by endoscopy and histology
Inadequate response to immunosuppressants or treatment with biologics
Male partners and women WOCBP must agree to use highly effective contraception methods.

Exclusion Criteria:
Subjects with ulcerative colitis limited to an isolated proctitis.
Subjects with CD or subjects with heart disease, or history of malignancy
History or current evidence of toxic megacolon, fulminant colitis, bowel perforation.
Recent or planned bowel surgery.
Subjects on antidiarrheals and probiotics.
Digestive Systems & Liver Disease
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 ,

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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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)
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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 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
Annisha Chhetri - 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
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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 ,