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22-061 Relugolix Versus Leuprolide in Patients with Prostate Cancer: A Randomized, Open-Label Study to Assess Major AdverseCardiovascular Events (REPLACE-CV)

The purpose of this research study is to compare and see if medications used in ADT treatment, either relugolix or leuprolide acetate, lower the risk of cardiovascular events in patients with prostate cancer. You (or your caregiver) will be asked to complete questionnaires electronically (such as computer, tablet, or smartphone) and/or share information via phone calls every three months until the end of your participation in the study. You will receive the study medications for treatment (either relugolix or leuprolide acetate)

Participants will be required to complete questionnaires electronically (such as computer, tablet, or smartphone) and/or share information via phone calls every three months until the end of your participation in the study. You will receive the study medications for treatment (either relugolix or leuprolide acetate)

$150 per year

Yes
 

Megan Wheelden
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05605964
SITE00001315
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Inclusion Criteria:
Has voluntarily signed and dated the informed consent form prior to baseline visit;
Is a male and 18 years of age or older on the day of signing and dating the informed consent form;
Patient has sufficient cognitive function in the investigator’s opinion to complete the questionnaires and other activities related to the study
Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
Is, in the opinion of the investigator, a candidate for at least 1 year of continuous ADT for the management of prostate cancer with one of the following clinical disease state presentations:Evidence of biochemical (prostate-specific antigen

Exclusion Criteria:
Any significant cardiovascular conditions per the investigator within 1 month before study entry
Any major cardiovascular or cerebrovascular procedures planned within 1 month after enrollment;
Patients with QT interval corrected for heart rate (QTc) determined using Fridericia’s formula (QTcF; QTcF = QT/[R-R interval {RR}^0.33]) > 470 msec within 6 months of screening
Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg) at the time of screening
Previously received GnRH receptor agonist
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Characterizing resilience to food-cue induced overeating in children

This is a behavioral and neuroimaging study that will examine how food commercials affect the way a child eats and responds to food. Children enrolled in the study will complete 5 in-lab sessions that include eating meals and snacks, watching TV, and playing computer games. For one of these sessions, children will complete an fMRI scan. On the first and last visit to the lab, children will receive a DXA scan to assess their body composition.

We are looking for children to help us learn about how kids respond to different types of foods and food advertisements. The study consists of 5 visits to our facilities in Noll and Chandlee Labs, located on the University Park Campus. For 3 visits your child will eat test meals and snack buffets in our laboratory. On 1 visit we will use fMRI to take pictures of your child’s brain. We will use a DXA to scan for lean muscle and conduct an IQ test. These procedures are not harmful. You and your child will fill out questionnaires.Your child will also play computer games and watch commercials.

$250.00-450.00

Yes
 

Kathleen Keller
Ben Baney - at bab349@psu.edu or 814-753-1005
Nutritional Sciences (UNIVERSITY PARK)
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
NCT05073185
STUDY00015835
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Inclusion Criteria:
In order to be enrolled, children must be of good health based on parental self-report.
Be 7-9 years-old at enrollment.
Not be taking any medications known to influence body weight, taste, food intake, behavior, or blood flow.
Have no learning disabilities (e.g., ADHD).
The biological mother must have a body mass index either between 18.5 - 25 kg/m2 (low-risk group) or greater than or equal to 30 kg/m2 (high-risk group).

Exclusion Criteria:
They are not within the age requirements (< than 7 years old or > than 9 years-old at baseline).
If they have a learning disability, ADD/ADHD, language delays, autism or other neurological or psychological conditions.
If they have a pre-existing medical condition such as diabetes, rheumatoid arthritis, Cushing’s syndrome, Down’s syndrome, severe lactose intolerance, Prader-Willi syndrome, HIV, cancer, renal failure, cerebral palsy, or can't engage in moderate exercise.
If they don’t speak English.
Biological mother must have a body mass index either between 18.5 - 25 kg/m2 (low-risk group) or greater than or equal to 30 kg/m2 for mothers (high-risk group), or they are excluded.
Children's Health, Food & Nutrition, Prevention
Not applicable
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State College, PA ,

Emotion dynamics and alcohol use in NIAAA-defined recovery from alcohol use disorder

This study uses a baseline assessment and 28 days of ecological momentary assessment to examine the association of emotion dynamics to craving and alcohol use among people in the first year of cessation of heavy drinking and remission from DSM-5 AUD.

There will be one in person visit. Participants will be asked to complete baseline questionnaires. After the baseline assessment, participants will complete 28 days of daily diary questions on their cell phone. A prompt will be sent to the phone 3 times per day. It should take 5 minutes (15 minutes total/day) to complete the questions.

189

Yes
 

Brad Linn
Brad Linn - at blinn1@pennstatehealth.psu.edu or 717-531-0003, ext=321641
Family and Community Medicine (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00024054
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Inclusion Criteria:
Aged between 18-68
Have a history of a previous (AUD) in the past year
Live within commuting distance of the Penn State Clinical Research Center

Exclusion Criteria:
Acute psychosis
Bipolar disorder
Cognitive impairment
Active drug use disorder other than nicotine or cannabis dependence
Lack of sufficient familiarity with the English language to comprehend recruitment and consent procedures
Men's Health, Addiction & Substance Abuse, Mental & Behavioral Health
Not applicable
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Hershey, PA ,

The Sexual Relationships Study

The purpose of this study is to examine the sexual relationships among heterosexual female college students (ages 18-22) via Qualtrics (a web-based survey). Utilizing latent class analysis with a distal outcome, the proposed cross-sectional study seeks to do the following: Aim 1. Examine the heterogeneity in relationship quality among female college students. Research question 1: Is there a latent class structure that adequately represents the heterogeneity in relationship quality among female undergraduate students participating in penile-vaginal sex? If so, what are the types and their corresponding prevalence?Aim 2. Examine the association between relationship characteristics and latent class membership.Research question 2: Are relationship characteristics (partner type, relationship duration, exclusivity/monogamy, and frequency of sex) predictive of membership in latent classes of relationship quality?Aim 3. Examine the association between latent classes of relationship quality and condom use.Research question 3: Which identified latent class of relationship quality is significantly associated with condom use at last penile-vaginal sex?Please note that the indicators measuring relationship quality will include the following variables: 1) trust, 2) love, 3) passion, 4) commitment, 5) relationship satisfaction, 6) sexual satisfaction, 7) intimacy, and 8) decision-making dominance.

No
 

Jessica Salas
Jessica Salas-Brooks - at jis5940@psu.edu or 704-249-4252
Biobehavioral Health (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00006941
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Inclusion Criteria:
Be enrolled at Pennsylvania State University (University Park Campus)
Be between the ages of 18-22 years
Be a female college student
Be sexually active with male partners in the previous 3 months

Exclusion Criteria:
Are not enrolled at Pennsylvania State University (University Park Campus)
Are under the age of 18 or over the age of 22.
Are not a female college student
Are not sexually active with male partners in the previous 3 months
Women's Health
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NMTRC014: NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

A study of DFMO for patients with neuroblastoma in remission.

Participating in this study requires that you visit the Penn State health Medical Center multiple times over the course of the full study for evaluations (physical exam, blood draw, urine analysis, etc.) and scans (MRI/CT, MIBG).If you agree to take part, you will receive treatment on this study for about 2 years and will be followed for survival for 5 years after the last dose of study drug. You will be asked to return to the research site approximately 15 times.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT02679144
STUDY00004295
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Inclusion Criteria:
A confirmed diagnosis of neuroblastoma.
Must be in complete remission (CR).
Tests and scans will be required to confirm remission.

Exclusion Criteria:
Patients below the defined minimum of height and weight.
Patients who are currently receiving another study drug may not participate.
Patients who are currently receiving other anticancer agents may not participate.
Children's Health, Cancer
Prefer not to display
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Hershey, PA ,

Contempt as a Mixed Emotion

This study will investigate whether contempt is a positive, negative, or mixed emotion.

No
 

Michelle Yarwood
Victor Ellis - at vde5011@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00016610
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Inclusion Criteria:
age 18 years or older

Exclusion Criteria:
younger than 18 years of age
Mental & Behavioral Health
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Human intent recognition using surface cues in physically dynamic tasks

Prediction of a subject's goal in a task based on patterns in their body language, speech, facial expressions, reaction to outcome, in short any observable measure.

Yes
 

Alan Wagner
vus133@psu.edu
Aerospace Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00016376
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Inclusion Criteria:
can throw a ball
provides consent to record video of the experiment

Exclusion Criteria:
cannot throw a ball
does not consent to experiment being recorded
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State College, PA ,

A Phase 3 RandOmized Study Comparing PERioperative Nivolumab Vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC) (EA8143) (PSCI 18-025)

This study is a phase 3 study that will be comparing recurrence-free survival (RFS) between patients withlocally advanced renal cell carcinoma randomly assigned toperioperative nivolumab in conjunction with radical or partialnephrectomy with patients randomized to surgery alone.

You are being asked to take part in this research study because you have cancer in your kidney, which is planned to be removed by a surgeon. The standard treatment for your disease is to remove the kidney or part of the kidney that contains the cancer by surgery. You are then monitored after surgery with imaging scans and exams to watch for any possiblesigns of recurrence (close observation)

Yes
 

Monika Joshi
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03055013
SITE00000234
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Inclusion Criteria:
Newly Diagnosed higher risk RCC of any histology
No clinical or radiological evidence of distant metastases
No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted
Age must be greater than or equal to 18 years old
ECOG Performance status must be 0 or 1

Exclusion Criteria:
Women must not be pregant or breast feeding
History of RCC that was resected with curative intent within the past 5 years
Prior or current prostate cancer is excluded
Active known or suspected autoimmune disease
Uncontrolled adrenal insufficiency
Kidney & Urinary System, Cancer
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Hershey, PA ,

PSCI 22-156 HCRN BRE17-141

The purpose of this voluntary research study is to see if neratinib, endocrine therapy, and trastuzumab completely shrink breast tumors before having breast cancer surgery. You will need to have the following exams, tests, or procedures: blood draws, ECG, Echo or MUGA, ultrasound, MRI, receive study treatment, and breast biopsy.

Participants will be required to receive study treatments, laboratory assessments, undergo breast biopsy, and radiologic assessments,

Yes
 

Monali Vasekar
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04987203
SITE00001343
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Inclusion Criteria:
Anatomic, clinical stage I-III, invasive breast cancer, greater than 10mm.
HER2-positive (by most recent ASCO-CAP criteria)
ER > 50% and PR > 50%.
Resectable breast cancer in which pre-operative therapy is appropriate (T > 10mm and/or node-positive).
Archival tissue from the diagnostic pre-treatment biopsy is required.

Exclusion Criteria:
Locally advanced or inflammatory breast cancer.
Evidence of metastatic disease.
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial:
Active infection requiring systemic therapy.
Requirement for use of a moderate or strong CYP3A4 inhibitor or inducer during the study
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Collective Punishment and Identity Fusion: An Examination

This study, part of a broader dissertation on terrorism and radicalization, aims to experimentally determine how collective punishment fuses individual identities to that of an ingroup, expanding extant knowledge of identity fusion theory.

Yes
 

Connor Somgynari
Connor Somgynari - at cjs72@psu.edu
Political Science (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00012346
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Inclusion Criteria:
Over age 18
Identification as Republican or Democratic
English Speaker

Exclusion Criteria:
Under age 18
Political identification as independent (not republican or democrat)
Non-English Speakers
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State College, PA ,

A Multicenter, Randomized, Double-blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Gel 2% for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects with Gorlin Syndrome

Participants 18 years and older who meet the diagnostic criteria for the basal cell nevus (Gorlin) syndrome will be assigned to receive either Patidegib Gel 2% or Placebo (no active medicine) to apply twice daily for 12 months. The assignment will be made according to sex assigned at birth, age, and number of BCC lesions at the treatment area at Baseline. The primary endpoint is a comparison between the 2 treatment arms of the number of new BCCs at Month 12 compared to Baseline. The BCCs will be imaged and tracked consistently throughout the study to identify new BCCs and to confirm their diagnosis by dermoscopy (handheld instrument with a 15x magnification lens and a cross-polarized light source).

Participants will participate in 15 visits over approximately 14 months (attend 6 in person visits along with 9 phone call visits). In addition, participants will receive study medication to apply twice a day for 12 months and undergo clinical tests at various time points, which include blood tests, ECG, complete questionnaires/diary, skin exam and skin photographs.

Compensation is provided for eligible participants.

Yes
 

Elizabeth Billingsley
Samantha Gettle - at dermatologyclinicaltrials@pennstatehealth.psu.edu or 717-531-5136
Dermatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06050122
STUDY00023809
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Inclusion Criteria:
Must be confirmed to have a PTCH1 mutation
Diagnostic criteria present for Gorlin Syndrome
10 BCCs present on face at Randomization (Baseline/Day 1)

Exclusion Criteria:
Certain medications are not allowed during study; study coordinator will discuss
uncontrolled systemic disease
uncontrolled skin disease on the face.
Skin Conditions
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Participants with Chronic Rhinosinusitis Without Nasal Polyps – The BiRCh Study

The purpose of this study is to find out if the experimental drug (brensocatib) improves symptoms of Chronic Rhinosinusitis Without Nasal Polyps and is safe. Study treatments include the study drug and mometasone furoate nasal spray (referred to as mometasone). The study drug will either be brensocatib (“active” drug that contains “real” drug) or placebo (looks like brensocatib but does not have any “real” drug in it). Mometasone will be taken by all participants throughout the study as routine care.

If you choose to participate in the study, the following main activities and procedures are required.•Complete questionnaires asking about your chronic rhinosinusitis symptoms and quality of life•Measure the amount of air you can breathe in through both sides of your nose (nasal airflow)•Electrocardiogram (ECG) and vital signs•Physical examination, including examinations of your mouth and skin•Provide blood and urine samples•Sinus computed tomography (CT) scan•Attend 9 study visits•Nasal endoscopy

Unknown at this time

Yes
 

Timothy Craig
Kara Grim - at kgrim@pennstatehealth.psu.edu or 717-531-4513
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06013241
STUDY00023061
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Inclusion Criteria:
Ages 18 to 75
Participants who have at least a 12-week history before Screening Visit of Chronic Rhinosinusitis without nasal polyps
Received a course of antibiotics or steroids to treat symptoms of Chronic Rhinosinusitis within 1 year or previous surgery for Chronic Rhinosinusitis

Exclusion Criteria:
Diagnosis of nasal polyps
Diagnosis of Cystic Fibrosis or Primary Ciliary Dyskinesia
Scheduled sinus surgery at any time during the study or have had nasal surgery within 4 weeks of the first study visit
Participants with seasonal allergic rhinitis whose symptoms occur during the treatment period of the study
Current smoker
Allergies
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Observational Study for Pediatric Rheumatic Diseases: The CARRA Registry

The original Childhood Arthritis &amp; Rheumatology Research Alliance (CARRA) Registry was first established in 2010 to advance alliance infrastructure,facilitate expanded clinical and translational pediatric research, and transform the culture of pediatric rheumatology toward universal participation in research. Continuation of the CARRA Registry as described in the protocol attached to this IRB submission will support data collection onpatients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressingquestions about therapeutics used to treat pediatric rheumatic diseases, including examining safety questions. The Duke Clinical Research Institute (DCRI) is serving as the CARRA Clinicaland Data Coordinating Center (CDCC) for this protocol.

In addition to allowing the researchers to collect data on you from your medical record, we will ask you and your parents/caregivers to complete a short survey that takes about 15 minutes to completeThe research team will follow up every 6 months by reviewing your medical record and asking you and your parents/caregivers to complete a short survey that takes about 15 minutes to complete.If you agree to take part, you will be in the study for 10 or more years.

Yes
 

Timothy Hahn
Meredith Buckley - at mbuckley@pennstatehealth.psu.edu
Pediatrics: General Pediatrics (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
STUDY00008987
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Inclusion Criteria:
Onset of rheumatic disease prior to age 16 years for Juvenile Idiopathic Arthritis
Onset prior to age 19 years for all other rheumatic diseases
Willing to participate in a registry you will be followed during your treatment and have information about you disease and treatment collected.

Exclusion Criteria:
More than 21 years of age.
Arthritis & Rheumatic Diseases
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Hershey, PA ,

Interpersonal contrast avoidance of anxiety and depression

This research aims to learn more about your daily thoughts, behaviors, and their impact on social relationships. We want to understand the different qualities of day-to-day thoughts, how these might affect your mood, and how this may influence how you behave in social interactions. We will first ask you to complete a set of structured questionnaires and a brief 30-minute psychological interview via Zoom. This will be followed by a training session in which you will learn how to use your smartphone to track your social interactions and related daily thoughts and behaviors eight times a day for eight days.

You will undergo an initial assessment visit conducted on Zoom, where you will provide informed consent and undergo screening through a brief 30-minute clinical interview. Based on your responses, we will know if you can participate in the study. If eligible, you will be invited to the second part of the study. If so, during the same session, you will then receive a brief half-hour training session reviewing instructions on using a mobile application to complete daily surveys and then complete a series of online questionnaires.When you leave this session, for the next eight days, you will complete eight (approximately 2-minute) questionnaires daily between 10 a.m. and 10 p.m. On the third day, you will attend a compliance check via Zoom to review your progress in the present study.

$20

Yes
 

Adam Calderon
Adam Calderon - at afc6160@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022977
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Inclusion Criteria:
At least 18 years of age
Scores on self-report questionnaires suggest person does or does not struggle with anxiety and/or depression
Owns a smartphone
Fluent in the English language in terms of speaking, listening, reading, and writing.

Exclusion Criteria:
Younger than 18 years of age
Does not own a smartphone
Unable to speak, read, listen, and write English fluently.
Men's Health, Mental & Behavioral Health, Women's Health
Not applicable
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State College, PA ,

A Phase 2A, Double-blind, Randomized, Placebo-ControlledClinical Trial to Evaluate the Efficacy and Safety ofSaroglitazar Magnesium 4 mg Tablets for Treating NonalcoholicFatty Liver Disease (NAFLD) in Women WithPolycystic Ovary Syndrome (PCOS)

The purpose of this study is to evaluate the efficacy and safety of Saroglitazar Magnesium 4 mg Tablets once-daily in women with well characterized Polycystic ovary syndrome (PCOS) diagnosed with nonalcoholic fatty liver disease (NAFLD).

There will be 9 in person visits, various procedures will be completed such as a fibroscan, endometrial biopsy, blood draws and surveys. You will be randomly assigned by chance (like the flip of a coin) to receive either Saroglitazar 4 mg or placebo (inactive substance).

Yes
 

Jonathan Stine
Gloriany Rivas - at grivas@pennstatehealth.psu.edu or 717-531-0003, ext=320223
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03617263
STUDY00020411
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Inclusion Criteria:
Adults age >18-75 years old
NAFLD diagnosis
Stage 2 or 3 fibrosis

Exclusion Criteria:
causes of chronic liver disease other than NAFLD
pregnancy
Cirrhosis
Inability to provide informed consent
history of liver transplant
Digestive Systems & Liver Disease, Women's Health
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Robots that Learn Games by Asking People Questions

The study goal is to develop robots that can learn simple games by interviewing humans. The robot interview strategies are represented as Markov Decision Process policies, and are developed offline through robot interactions with simulated interviewees. The investigator can set the simulated interviewee to respond to the robot's queries with different amounts of information. The games include board games like Connect 4, Quarto, and Checkers. The communication between the robot and simulated interviewee is in a formal language like first order logic. After a simulated dialogue, the robot will have more or less knowledge of the game, depending on the conditions of the simulated interviewee. Human subjects will interact with the robots in two ways. First, to test the utility of the new knowledge, human subjects will participate in experiments where they play the game with virtual robots that have learned the game under different conditions. Second, to investigate the kinds of misunderstandings of questions and answers that might arise if the robot could interview a human, we will present subjects with extracts from the formal language dialogues that we have mapped to English in different ways, and ask subjects to imagine how they would express the same meaning in English, or answer questions in different ways, or what sorts of misunderstandings they might imagine in a real dialogue.

Yes
 

Rebecca Passonneau
Maryam Zare - at muz50@psu.edu
Computer Science and Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00014432
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Inclusion Criteria:
Over 18 years of age
Ability to communicate in written and spoken English
Able to give informed consent

Exclusion Criteria:
Below 18 years of age
Unable to communicate in written and spoken English
Unable to give informed consent
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State College, PA ,

PSCI 22-114: A PHASE 2/3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF NKTR-255VS PLACEBO FOLLOWINGCD-19 DIRECTED CAR-T THERAPYIN PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA.

This is a drug study that will evaluate how well the investigational drug works compared to a placebo following CAR-T cell therapy. Participants will be required to keep all your scheduled visits, receive drug treatment, blood draws, imaging, and possibly a tumor biopsy.

Participants will be required to receive the study treatments including CAR-T infusion, blook tests, imaging, tumor biopsy, and study medications.

Yes
 

Shin Mineishi
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05664217
SITE00001327
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Inclusion Criteria:
Male or female ≥ 18 years of age at the time of consent.
Received standard of care therapy with axi-cel or liso-cel (Stage 1 and Stage 2), or tisa-cel (Stage 2 only)
Received lymphodepleting chemotherapy regimen according to the respective FDA (or SmPC) label for CAR-T cell therapy.
Fluorodeoxyglucose (FDG)-avid disease on PET imaging within 30 days prior to CAR-T cell infusion
FDG avid lesion(s) on PET/CT scan following bridging therapy and prior to lymphodepletion, where applicable.

Exclusion Criteria:
Use of therapeutic doses of corticosteroids (≥ 5mg/day prednisone or equivalent) or other systemic immunosuppression within 7 days prior to leukapheresis or within 72 hours prior to CAR-T cell infusion. Topical and/or inhaled steroids are permitted
Prior treatment with any CD19-directed CAR-T cell therapy other than the treatment planned per Inclusion Criterion 2.
For allogeneic hematopoietic cell transplant recipients, active graft versus host disease (GVHD) and/or systemic GVHD therapy during screening or up to 30 days prior to leukapheresis.
Known active hepatitis B (detectable hepatitis B DNA) or hepatitis C (detectable hepatitis C RNA).
Known human immunodeficiency virus (HIV) infection
Cancer
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

VIBRANT: VIB4920 for Active Lupus Nephritis

A randomized placebo-controlled study to evaluate the efficacy and safety of VIB4920 in study participants with active lupus nephritis

Patients come for in-person visits at the Penn State Hershey main hospital location. There will be blood draws, physical exams, and questionnaires spread out across 60 weeks.

Yes
 

Nancy Olsen
Peri Newman - at pnewman@pennstatehealth.psu.edu or 717-531-0003, ext=287327
Medicine: Rheumatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05201469
SITE00001277
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Inclusion Criteria:
Lupus nephritis
Systemic lupus erythematosus

Exclusion Criteria:
Pregnant
Transplant
Kidney & Urinary System, Arthritis & Rheumatic Diseases, Muscle & Bone
Experimental drug compared to a placebo/”sugar pill”
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What’s in a grammar? A microcomparative study of negation in American Englishes

In contexts where people speak different dialects of the same language, how much overlap is there between the dialects, and what are the genuine grammatical differences? This study explores this question through a series of three experiments examining how people from three different dialects understand a variety of negative sentences (e.g., I didn't eat nothing). The results will contribute to our understanding of linguistic diversity.

Participants will sit at a computer and have their eye movements tracked by a camera as they read or listen to sentences and look at pictures on the screen.

$15 per hour

Yes
 

Frances Blanchette
fkb1@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00022446
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Inclusion Criteria:
native speaker of American English

Exclusion Criteria:
non-native speaker
not 18 or older
Language & Linguistics
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State College, PA ,

A Phase Ib/II Study of APG-115 as a Monotherapy or in Combination with Pembrolizumab in Patients with Unresectable or Metastatic Melanomas or Advanced Solid Tumors

Part 1 (Phase Ib): To determine the safety and ability for subjects to tolerate APG-115 when combined with pembrolizumab, as well as the maximum tolerated dose in subjects with metastatic melanomas or solid tumors.Part 2 (Phase II): To determine the overall response rate of APG-115 when combined with pembrolizumab in the treatment of patients with unresectable or metastatic melanomas. To assess APG-115 as a monotherapy in patients with unresectable or metastatic melanomas and MPNST cohorts only.

If you are eligible and agree to receive the study drug combination, you will need to come to the study site at various times to have procedures done. These procedures may include collection of vital signs, blood andurine samples, electrocardiogram, physical exam, tumor biopsy, imagingscans, and x-ray. At each visit, you will be asked about your current medicines, including over-the-counter medications, and about any symptoms or side effects you might be having. You will receive the study drug orally on Days 1, 3, 5, 7, 9, 11, 13 of every 21-day cycle. Pembrolizumab is given as a 30-minute intravenous (IV – through a needle into a vein) infusion on Day 1 of every 21-day cycle.

Yes
 

Joseph Drabick
Irina Geier - at igeier@pennstatehealth.psu.edu
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03611868
STUDY00014555
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Inclusion Criteria:
Male or non-pregnant, non-lactating female patients age ≥18 years on day of signing the informed consent
Histologically confirmed, unresectable or metastatic melanoma, and refractory or relapse after PD1 antibody treatment and ineligible for other standard of care therapy
ECOG Performance scale of 0-2
Life expectancy of equal to or greater than 3 months
Adequate bone marrow and organ functionAdequate

Exclusion Criteria:
Any prior systemic MDM2-p53 inhibitor treatment Received chemotherapy within 21 days (42 days for nitrosoureas or mitomycin C) prior to first dose.
Prior loco-regional treatment with intralesional therapy (e.g. talimogene laherparepvec) for unresectable or metastatic melanoma in the last 6 months prior to start of study treatment.
Received hormonal and biologic (<1 half-lives), small molecule targeted therapies or other anti-cancer therapy within 21 days prior to first dose Radiation or surgery within 14 days of study entry, thoracic radiation within 28 days prior to first dose.
Has known active central nervous (CNS) metastases and/or carcinomatous meningitis. Or has neurologic instability per clinical evaluation due to tumor involvement of the CNS.
Requirement for corticosteroid treatment, with the exception of megestrol, local use of steroid: i.e.: topical corticosteroids, inhaled corticosteroids for reactive airway disease, ophthalmic, intraarticular, and intranasal steroids.
Cancer
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Hershey, PA ,

Vernacular Feature Comprehension and Perception in Persons with Aphasia

This study investigates whether persons with aphasia understand and process sentences with vernacular features in a manner similar to more typical populations. Participants will rate sentences on their naturalness and on whether they make sense, and they will also read sentences while we track their eye movements.

Yes
 

Frances Blanchette
Frances Blanchette - at fkb1@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00014402
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Inclusion Criteria:
1.Diagnosis of aphasia
2.Sustained stroke more than 6 months prior to consent
3.Native speakers of English
4.Completed at least a high school education
5.Normal or corrected-to-normal vision and hearing

Exclusion Criteria:
1.History of degenerative neurological disorders (e.g., Alzheimer’s disease), acquired neurological disorders other than aphasia from stroke (e.g., traumatic brain injury), developmental neurological disorders (e.g., autism), or psychiatric disorders
2.An active medical condition that could compromise participation (e.g., cancer undergoing acute treatment)
3.Taking medications that are known to exert significant effects on cognitive processes
4.Do not meet the above inclusionary criteria
Language & Linguistics
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Hershey, PA ,
State College, PA ,

Using ERPs and eye-tracking to study language learning and processing in adult learners.

In an increasingly global environment, both within the US and abroad, the ability to rapidly gain native-like linguistic competence is a critical asset. The ability to use an L2 in a way that is both expected and recognized by its native speakers is important both to the broad public, and to specific sectors, such as military personnel, that must develop native-like competence in a foreign language in a limited amount of time. The studies conducted under this IRB protocol will examine how learners/speakers of a second language acquire and process multi-word units (e.g., carry a business; run a store) in their second language, and how knowledge from the first language might influence the learning and processing of multi-word units in a second language.

Participants will complete a number of simple tasks on a computer in English and/or in Spanish (depending on language background).

$12/hour (behavioral sessions); $18/hour (EEG sessions); $20 bonus at completion of study when at least 3 behavioral sessions or 2 EEG sessions are required.

Yes
 

Manuel Pulido
Manuel Pulido - at mfp149@psu.edu
Spanish, Italian and Portuguese (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00011115
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Inclusion Criteria:
Be a native speaker of English or Spanish
Not fluent in other languages
No history of neurological or language disorders
Normal or normal-to-corrected vision
Right-handed

Exclusion Criteria:
Native speaker of a language different from English or Spanish
Older than 45 years old
Left-handed or ambidextrous
A history of neurological disorders or language disorders
Education, Language & Linguistics
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State College, PA ,

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

This study seeks to verify the findings of the CHARM I pilot study by conducting a multi-center clinical trial. We hypothesize that:•Pancreatic cyst infusion with a specifically designed drug therapy cocktail following normal saline lavage will result in cyst destruction rates that do not significantly differ from those achieved by alcohol-based cyst treatment (ethanol lavage followed by infusion of the same chemotherapeutic cocktail).•The removal of alcohol from the procedure will decrease both serious and minor adverse event rates associated with pancreatic cyst treatment.•There may be molecular markers contained within the fluid of these cystic tumors which identify cysts that are favorable to or resistant to EUS-guided fine needle infusion using this drug combination. As such, we will test all treated cysts for 10 of the best known molecular markers for evaluation in post study analysis. We expect that administering a specifically designed chemotherapeutic cocktail without prior alcohol lavage will result in an equivalent rate of cyst resolution with fewer complications when compared to alcohol. The results of this study will provide important information about the most efficient and safest method for treating premalignant pancreatic cysts, an important step for treating these lesions with a minimally invasive technique and preventing their progression to cancer. Standard alternative treatment options for this patient group (if not taking part in this study) would be ongoing periodic radiographic monitoring with MR or CT imaging waiting for signs of cancer to develop or to consider surgical removal of the affected tissue.

Patients will have to sign the consent form to participate in the trial

Yes
 

Matthew Moyer
Matthew Moyer - at mmoyer@pennstatehealth.psu.edu or 717-531-0003, ext=287992
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03085004
STUDY00005206
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Inclusion Criteria:
Adult subjects over the age of 18.
Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which are consistent with a mucinous type cyst as per ASGE guidelines including indeterminate type cysts.
Ability to give written informed consent.
Capable of safely undergoing endoscopy with deep sedation or general anesthesia.

Exclusion Criteria:
Lesions which are consistent with a benign cyst by clinical, cytological, chemical, and radiographic evaluation as per ASGE guidelines37 (i.e., consistent with a pseudocyst or serous cystadenoma).
Known or suspected pancreatic cancer or pathologic lymphadenopathy.
Cysts with the following high risk features: main pancreatic duct dilation of > 5mm,epithelial type mural nodules , pathologically thick wall/septation (> 2mm)..
Septated cysts with > 4 compartments.
Confirmed acute pancreatitis within the last 3 months.
Digestive Systems & Liver Disease, Cancer
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Effects of Individualist and Collectivist Culture on Emotional Empathy in Counselor Trainees

This research is an attempt to understand the components of empathy and the cultural factors that shape its development. I am seeking about 200 Master's-level counseling students in the U.S. to complete the online survey. The survey takes about 15 minutes to complete, and participants will have chances to win Amazon gift cards and to learn the study results.

No
 

Qu Chen
Qu Chen - at qbc5002@psu.edu
Counselor Education, Counseling Psychology, and Rehabilitation Service (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00011860
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Inclusion Criteria:
Currently enrolled in a counseling program at the Master's level
over 18-year-old

Exclusion Criteria:
Not a Master's-level counseling student
under 18-year-old
Education, Mental & Behavioral Health
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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF RIFAXIMIN SOLUBLE SOLID DISPERSION (SSD) TABLETS FOR THE DELAY OF ENCEPHALOPATHY DECOMPENSATION IN CIRRHOSIS (RED-C)

Hepatic encephalopathy (HE) is a complication of liver cirrhosis (liver damage). It affects nearly half of people with cirrhosis. Because of the damage, the liver doesn’t work as well as it should, and some toxins stay in the body. HE occurs when too many toxins build up in the bloodstream and reach the brain. It can cause symptoms like confusion, personality changes, lack of energy, inappropriate behavior, sleep problems, loss of small hand movements and tremors in hands and arms.This study is looking to see if a study medicine, rifaximin, can safely delay or prevent HE. Adults who have been diagnosed with liver cirrhosis, but who don’t have yet HE may be eligible to join.•Participants will be in the study will up to 80 weeks. They will attend up to 21 study visits, including 14 visits to the clinic and 7 telephone check-ins.•If participants are eligible and choose to participate, they will be randomly (like a flip of a coin) assigned to one of two treatment groups: the study medicine or placebo (which contains no active ingredients). This means participants have a 50/50 chance of receiving the study medicine.•Both study groups will take their assigned study medicine study medicine as a pill twice a day.•The study is double-blind, which means neither the participant nor the study team will know which treatment they are receiving.

There will be 14 in person visits. Safety assessments will be done at each visit including blood tests and urine tests. Participants will need to take study drug as directed.

$1050.00

Yes
 

Karen Krok
Laurie Peiffer - at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05297448
STUDY00022899
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Inclusion Criteria:
liver cirrhosis
Conn score <2
Mini Mental State Exam score >24

Exclusion Criteria:
active COVID-19
allergic to rifaximin
history of Spontaneous bacterial peritonitis (SBP)
history of neurological disorder
substance abuse
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Pilot evaluation of a multisensory evoked potential brain-computer interface

A brain-computer interface (BCI) is a device that has the potential to restore communication by translating voluntarily controlled brain signals of intent. The P300 speller, a popular BCI paradigm, relies on the generation of a P300 evoked potential when a user is presented a rare and unpredictable target stimulus amidst a larger pool of non-target stimuli. This evoked potential is used to control a spelling interface. Those with advanced ALS experiencing the loss of voluntary muscular control may also experience cognitive changes that result in decreased capacity for BCI control using the P300 speller.With this pilot study, we aim to validate the performance of a combination of eye tracking and standard sensory testing to quantify intact sensory and cognitive processes necessary for the generation of a P300 response. Additionally, we will evaluate the association of these correlates with performance on a multisensor P300 spelling task, where brain potentials are evoked using a combination of visual, auditory, and tactile stimuli. The goal is to demonstrate the viability of this system for future use in a patient group.

A brain-computer interface (BCI) is a device that has the potential to restore communication by direct translation of brain signals into computer commands. The BCI used in this study, the P300 Speller, relies on the generation of a P300 evoked potential when a user is presented a rare and unpredictable target stimulus amidst a larger pool of non-target stimuli. During this 2-hour, single session study, we aim to use a combination of eye tracking and sensory testing to quantify sensory and cognitive processes necessary for the generation of a P300 response. We will test the performance of a multisensory P300 spelling task, where brain potentials are evoked using a combination of visual, auditory, and tactile stimuli.

Yes
 

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

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00018219
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Inclusion Criteria:
18 years of age or older
Fluent in written and spoken English.

Exclusion Criteria:
Those unable to undergo electroencephalography (EEG) due to either allergies to lotions, cuts on the scalp or active infections.
History of seizure disorder
Co-existing neurological or psychiatric illness that, in the opinion of the research team, exclude the subject from participation.
Neurology
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Hershey, PA ,

A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination with Combined Oral Contraceptives in Premenopausal Women with Documented Endometriosis and Associated Moderate to Severe Pain

18 month trial of elagolix and combined oral contraceptives for women with moderate to severe endometriosis related pain

Subjects will have a screening period of approximately 45 days. If eligible, there will be a 3 month double blind placebo controlled treatment period followed by an open label period of 15 months where all subjects will receive the study medication. Total treatment period is 18 months followed by a one month follow up.Onsite visits are once a month during screening and up until Month 3 when onsite visits will be every 3 months through Month 18.Tests include blood draws at each onsite visit, one ultrasound, an EKG, and 4 DXA scans.

$1475.00

Yes
 

Stephanie Estes
Barbara Scheetz - at bscheetz@pennstatehealth.psu.edu or 717-531-4483
Medicine: Endocrinology, Diabetes and Metabolism (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04333576
STUDY00015216
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Inclusion Criteria:
premenopausal females aged 18-49
diagnosed with endometriosis with moderate to severe pain
regular menstrual cycles
willing to use non hormonal contraception throughout the study

Exclusion Criteria:
currently pregnant, breastfeeding or planning a pregnancy in the next 18 months
osteoperosis or other chronic bone disease
other active chronic pain not related to endometriosis
history of hysterectomy or removal of both ovaries
current or former nicotine user if over age 33
Women's Health
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Hershey, PA ,

Active Men's Study

Description: This research study is to assess energetic status, reproductive health, and bone health in a population of young exercising men. Secondarily, this study will also explore how diet, fitness, cardiovascular function, eating behaviors, stress, cognitive function, and sleep related to energy and reproductive outcomes in exercising men. Eligible young men (age 18-35) are those who are generally healthy and either a) exercising or b) not exercising.

There will be essentially 5 study visits - The first visit will include informed consent to take part in the study &amp; completion of questionnaires and measurement of anthropometrics. Visit 2 will include tests of your metabolism, a blood draw, a saliva collection, and assessment of diet and physical activity. Visit 3 will be a short visit for a saliva collection. Visit 4 will include tests of stress (a hair sample), body composition, bone health, aerobic and anaerobic fitness, cognitive testing, and reproductive function. Visit 5 will consist of a results meeting and return of wearable devices and logs.

Yes
 

Mary Jane De Souza
Ana Carla Salamunes - at whel@psu.edu
Kinesiology (UNIVERSITY PARK)
 

Male
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00017681
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Inclusion Criteria:
Age 18-35 years
BMI between 16-29.9 kg/m2
Non-smoker
For sedentary participants: less than 150 minutes of purposeful exercise per week
For exercising participants: at least 150 minutes of purposeful exercise per week (moderate to high intensity aerobic and/or resistance training).

Exclusion Criteria:
BMI >29.9 kg/m2 or <16 kg/m2
Procedures using contrast material within the past 7 days, including X-rays, MRI scans, CT scans, barium studies, nuclear medicine exams.
Currently a smoker or history of regular smoking
Prostheses
Vasectomy
Men's Health, Sports Medicine, Muscle & Bone
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State College, PA ,

NRG-GU007, Randomized Phase II Trial of Niraparib with Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (With Initial Phase I) (NADIR*) (NCT 04037254) (PSCI# 20-104)

The purpose of this study is to compare the usual treatment alone to using the study drug niraparib plus the usual treatment. The addition of niraparib to the usual treatment could prevent your cancer from growing or returning. But, it could also cause side effects, which are described in the risks section below. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To be better, the study approach should increase the chance of remaining cancer free to 50 out of 100 participants after 2 years, or a 20% improvement compared to the usual approach.

This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To be better, the study approach should increase the chance of remaining cancer free to 50 out of 100 participants after 2 years, or a 20% improvement compared to the usual approach.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04037254
SITE00000907
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Inclusion Criteria:
ECOG performance status of 0 or 1 within 180 days prior to registration
Age is greater than or equal to 18 years old
Pretreatment serum PSA, obtained prior to any androgen suppression therapy and within 180 days of registration
Adequate hematologic, renal, and hepatic function within 90 days prior to registration
Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards

Exclusion Criteria:
PSA > 150 ng/mL
Definitive clinical or radiologic evidence of metastatic disease
Pathologically positive lymph nodes or nodes > 1.5 cm short axis on CT or MR imaging
Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
Prior systemic therapy for prostate cancer; note that prior therapy for a different cancer is allowable
Cancer
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Hershey, PA ,

Exercise pressor reflex in peripheral artery disease patients with leg revascularization

The purpose of this research study is to better understand how leg blood flow is regulated in healthy people and patients with Peripheral Arterial Disease (PAD). It is also being done to examine if a standard-of-care peripheral intervention procedure to improve blood flow to the leg in PAD patients will improve the oxygen delivery and blood flow response to exercise in their legs.

Healthy subjects will participate in 1 visit and perform handgrip and foot (plantar flexion) exercises while several non-invasive measurements are recorded.

You will receive $25 per hour for your participation in this research study

Yes
 

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

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023729
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Inclusion Criteria:
Men and women at least 21 years of age
All races and ethnicities welcome
Can speak and understand spoken English
Healthy status as defined by history and physical
Females may be on oral contraceptives, but will be excluded if they are pregnant or lactating

Exclusion Criteria:
less than 21 years of age
Pregnant or nursing women
Have a major disease (heart, lungs, kidney, diabetes, cancer)
Have resting blood pressure of 150/100 or higher
current smoker
Heart & Vascular
Not applicable
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Hershey, PA ,