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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 ,

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 & 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
Prefer not to display
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Hershey, 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 ,

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 ,

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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Hershey, PA ,

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 ,

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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Hershey, PA ,

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

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

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

$350.00

Yes
 

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

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

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

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
Amyee McMonagle - at amcmonagle@pennstatehealth.psu.edu or 717-531-4484
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 & 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 ,

PSCI-24-092 A PHASE 1, OPEN-LABEL, MULTICENTER STUDY OF JANX007 IN SUBJECTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

This trial will examine different doses of JANX007 to find the safest dose to treat metastatic castration resistant prostate cancer (mCRPC)

Participants will be required to come to all clinic visits, report any symptoms they are having and all medications they are taking, including over the counter medications.

Yes
 

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

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05519449
STUDY00025910
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Inclusion Criteria:
Male subjects ≥18 years of age at the time of signing informed consent
Histologically or cytologically confirmed adenocarcinoma of the prostate
Serum testosterone <50 ng/dL
Documented progression
Progressive mCRPC or intolerance to the most recent therapy

Exclusion Criteria:
Prior treatment with PSMA-targeted CAR-T cell therapy
Prior treatment with PSMA-CD3, PSMA-CD28, or other CD3-T cell engaging bispecific antibodies.
Prior solid organ transplant
Use of any herbal products that could decrease PSA levels
Cancer
Not applicable
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Hershey, PA ,

Threat of infection, social decision-making, and the autonomic nervous system

The purpose of the study is to test how social decisions are affected by possible risk of infection. We aim to examine how choices in a risky social decision-making situation can influenced by viewing images of infection threat (e.g., person with runny nose) vs. images of neutral scenes or other threatening scenes.

There will be one 90-minute in-person visit. Participants will be asked to have electrodes placed on their skin to record their physiological signals, answer questionnaires, and complete a decision-making task on the computer while looking at different images.

$30

Yes
 

Derek Spangler
Eva Li - at eql5351@psu.edu
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019072
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Inclusion Criteria:
Adult over 18 years of age
Student at Penn State University Park
English-speaking
No cardiovascular, metabolic, or neurological condition
No diagnosis of COVID-19 within the last 14 days

Exclusion Criteria:
Under the age of 18
Not a student at Penn State University Park
Does not speak English
Has cardiovascular, metabolic, or neurological condition
Has/had diagnosis of COVID-19 within the last 14 days
Infectious Diseases & Immune System, COVID-19, Heart & Vascular
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State College, PA ,

Interoception and eating behaviors in children

The purpose of this study is to examine how individual differences in interoception (the ability to sense, interpret, and act on bodily feelings like hunger, fullness, thirst, hot, cold, etc.) relate to eating behaviors in children ages 7-10 years. Findings will inform whether interventions targeting interoceptive awareness may be helpful for prevention of obesity and related chronic diseases.

Child and parent will attend 2 visits at the Clinical Research Center, about 1-3 weeks apart.At visit 1 (~3 hours)- Your child's height and weight will be measured- Your child's percent body fat will be measured using an x-ray based technology- Your child will wear a heart rate monitor and will complete tasks where they are asked to notice or count their heartbeat- Your child will complete questionnaires via an interview with a researcher- Your child will be asked to drink several glasses of water to measure their stomach sensations- You will complete questionnairesAt visit 2 (~2.5 hours)- We will collect 4 saliva samples from your child- Your child will eat a meal and taste snacks- Your child will play brain games on an iPad- You will complete questionnaires

$100

Yes
 

Emily Hohman
Francisca Dungula - at ieatstudy@psu.edu or 814-865-5246
Center for Childhood Obesity Research (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
NCT00650465
STUDY00024712
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Inclusion Criteria:
Age 7-10 years old
Able to understand and answer questions in English

Exclusion Criteria:
Child BMI <5th percentile
Any medical conditions impacting growth, eating, or heart function
Developmental delay
Autism/autism spectrum disorder
Taking medications that impact appetite
Children's Health, Food & Nutrition
Not applicable
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State College, PA ,

Perceptions of online learning and well-being of medical students during the COVID-19 pandemic – a multicenter international study

This study will allow us to explore the influence of the COVID-19 pandemic as well as sociodemographic factors on undergraduate and graduate medical students’ mental health measured by stress, anxiety, and resilience, and to study their online learning experience during the pandemic.

No
 

Philip Ratnasamy
Philip Ratnasamy - at ppr5082@psu.edu or 717-649-6009
Biochemistry and Molecular Biology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00016639
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Inclusion Criteria:
Medical Student at the Penn State College of Medicine
English Speaking
Undergraduate & Graduate Medical Students
Adult who is 18 years of age or older

Exclusion Criteria:
Non-medical undergraduate and graduate students and non-traditional university students
Adults unable to provide consent
Individuals who are not yet adults
Pregnant women
Prisoners
COVID-19, Education, Mental & Behavioral Health
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A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)

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

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

Yes
 

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

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

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

PSCI 23-099 NRG-BR009: A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancerand an Oncotype Recurrence Score ≤ 25 (OFSET)

To determine if chemotherapy added to ovarian suppression and endocrine therapy is better than endocrine therapy and ovarian supression alone.

Subjects will be required to keep all study appointments, take the medications as required, have an annual mammogram, inform the study of any over the counter medications they may be taking.

Yes
 

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

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05879926
STUDY00023629
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Inclusion Criteria:
Female patients must be ≥ 18 years of age.
Patients must be premenopausal
The patient must have an ECOG performance status of ≤ 2
Patients may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
Patients may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.

Exclusion Criteria:
Definitive clinical or radiologic evidence of metastatic disease.
pT4 tumors, including inflammatory breast cancer.
History of ipsilateral or contralateral invasive breast cancer.
Life expectancy of < 10 years due to co-morbid conditions in the opinion of the investigator.
Cancer
Approved drug(s)
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Hershey, PA ,

Acute to Chronic Pain Signatures in Traumatic Injury

The goal of the proposed project is to identify biosignatures that predict resilience or vulnerability to the transition from acute to chronic pain in a cohort of patients recovering from an acute musculoskeletal trauma.

There is one in person visit that will include a 30-min MRI scan, sensory testing, and blood draw. Two follow-up surveys will be sent to the participants at 3- and 6-months following their injury.

$200

Yes
 

Jennifer Nyland
Aimee Cauffman - at acauffman@pennstatehealth.psu.edu or 717-531-1617
Neuroscience and Experimental Therapeutics (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00017713
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Inclusion Criteria:
Age 18-70 years old
Presence of acute traumatic blunt chest trauma with multiple (≥ 2) closed fractures of the ribs
Non-surgical treatment of rib fractures
Able and willing to provide informed consent
Must be able to read and communicate in English sufficiently to complete all study requirements

Exclusion Criteria:
Surgical procedures on the chest during current admission (with exception of placement chest tube or rib platting)
Open rib fractures
Pregnant women
Single, isolated rib fractures
Presence of implanted ferromagnetic materials or devices
Pain Management
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Hershey, PA ,

22-124 Main-CAV

To evaluate the effect of cabozantinib in combination with avelumab on OS compared to avelumab alone in patients with mUC who did not progress during first-line platinum-based chemotherapy therapy, i.e. patients who had CR, PR or SD after completion of first line platinum-based chemotherapy.

Patients will be expected to come to all clinic appointments, have labs drawn on the first day of every cycle, take medications as prescribed, return all empty pill bottles and diary, and call the clinic with questions.

Yes
 

Monika Joshi
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
NCT05092958
SITE00001285
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Inclusion Criteria:
Histologically or cytologically-confirmed diagnosis of advanced or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra
Prior first-line treatment must have consisted of 4-6 cycles of 1st-line therapy (platinum-based chemotherapy; gemcitabine-cisplatin, gemcitabine-carboplatin, MVAC or ddMVAC).
No prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PDL2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
ECOG Performance Status of 0 or 1
Age ≥ 18 years

Exclusion Criteria:
Active autoimmune disease that might deteriorate when receiving the anti PD-L1 agent, avelumab.
No known symptomatic central nervous system (CNS) metastases.
No major surgery within 4 weeks prior to randomization.
No palliative radiotherapy within 48 hours prior to patient randomization.
No known cavitating pulmonary lesion(s) or known endobronchial disease manifestation.
Kidney & Urinary System, Cancer
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Harrisburg, PA ,
Hershey, PA ,

A more naturalistic interaction: using back-channeling in smart-speakers to indicate active listening

In this project, we aim to extend the capabilities of smart-speakers (such as Amazon Alexa, Google Home, Siri, etc.) to support more engaging interactions with their users. Specifically, we would like to make the future of smart-speakers more conversational. One of the key aspects in developing a conversation is to be an active listener; showing interest in the speaker and allowing them to extend their turn in talk. In this study we investigate how smart-speakers can become better listeners by incorporating some of the human-human conversational features of active listening. Our question is, how can smart-speakers extend the users' turn in talk by being better listeners?

Yes
 

Nasim Motalebi
Nasim Motalebi - at nfm5140@psu.edu or 814-753-2081
Architecture (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00011534
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Inclusion Criteria:
18 years of age and older
English speaking individuals

Exclusion Criteria:
under 18 years old
non english-speaking individuals
Mental & Behavioral Health
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State College, PA ,

Elucidating the Necessary Active Components of Training (ENACT) Study

This study will examine the effects of different brain games on cognitive and everyday activities in middle-aged and older adults. Participants will play either 20 or 40 hours of ENACT brain games on a study provided laptop. They will also complete daily surveys on a study-provided mobile phone for the duration of the study. These surveys will take approximately 5-6 minutes to complete per day. The study will last either 6 or 9 months depending on the brain game training time. The study will be done remotely from the comfort of home using study-provided mobile devices. Participants are compensated for their time.

Participants will play either 20 or 40 hours of ENACT brain games on a study provided laptop. They will also complete daily surveys on a study-provided mobile phone for the duration of the study. These surveys will take approximately 5-6 minutes to complete per day. The study will last either 6 or 9 months depending on the brain game training time. The study will be done remotely from the comfort of home using study-provided mobile devices.

$230

No
 

Martin Sliwinski
Jordan Solt - at jvs6276@psu.edu or 814-865-4773
Human Development and Family Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00010760
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Inclusion Criteria:
Age 55-85
Strong English writing and comprehension
Willing to participate for 5 to 9 months

Exclusion Criteria:
Involved in brain training, such as Lumocity or BrainHQ
History of dementia or Alzheimer's Disease
Use of video games for more than 2 hours/week over the previous 2 years
Prevention, Mental & Behavioral Health
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