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A011801 THE COMPASSHER2 TRIALS (COMPREHENSIVE USE OF PATHOLOGIC RESPONSE ASSESSMENT TO OPTIMIZE THERAPY IN HER2-POSITIVE BREAST CANCER): COMPASSHER2 RESIDUAL DISEASE (RD), A DOUBLE-BLINDED, PHASE III RANDOMIZED TRIAL OF T-DM1 AND PLACEBO COMPARED WITH T-DM1 AND TUCATINIB (PSCI# 21-155)

The purpose of this study is to compare the usual treatment with T-DM1 alone to T-DM1 plus tucatinib. The addition of tucatinib to the usual treatment could prevent the breast cancer from returning

The purpose of this study is to compare the usual treatment with T-DM1 alone to T-DM1 plus tucatinib. The addition of tucatinib to the usual treatment could prevent the breast cancer from returning.

Yes
 

Cristina Truica
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
NCT04457596
SITE00001048
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Inclusion Criteria:
Age = 18 years or older (male or female)
ECOG Performance Status 0-1
Patients must have received neoadjuvant chemotherapy with one of the following regimens: THP, TMP, AC-TH(P); TCH(P); FAC-TH(P), or FEC-TH(P).
HER2-positive breast cancer per pathology
Prior treatment must have consisted = 6 cycles of chemotherapy and HER2-directed therapy, with a total duration of = 12 weeks, including at least 9 weeks of preoperative taxane and trastuzumab with or without pertuzumab (or FDA-approved biosimilars).

Exclusion Criteria:
Prior receipt of T-DM1 in the neoadjuvant setting is not allowed.
Patients with known active and/or untreated Hepatitis B or Hepatitis C or chronic liver disease are ineligible.
Stage IV (metastatic) breast cancer
History of any prior (ipsi- or contralateral) invasive breast cancer within 3 years of registration
Patients with ER+ HER2+ residual invasive disease that is lymph node-negative per the surgical pathology report
Cancer
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Hershey, PA ,

Nurse Situation Awareness in ICUs

This is an interview and survey study that will examine how the design of ICU warning information system influence nurses situation awareness.

This study aims to understand how the design factors of warning information system influence nurse situation awareness in ICUs. You will participate an online interview study and fill out two questionnaires. The study takes 1-2 hours.

$30

No
 

Yiqi Zhang
Yiqi Zhang - at yuz450@psu.edu
Industrial and Manufacturing Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00020979
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Inclusion Criteria:
Be a practicing nurses or a nursing student who has clinical experience in ICU settings

Exclusion Criteria:
NA
Children's Health, Education, Mental & Behavioral Health
Not applicable
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Phase 1/2 Study to Evaluate Palbociclib (IBRANCE®) in Combination with Irinotecan and Temozolomide or in Combination with Topotecan and Cyclophosphamide in Pediatric Patients with Recurrent or Refractory Solid Tumors

A study of the safety of palbociclib with irinotecan and temozolomide and palbociclib with topotecan and cyclophosphamide for children with solid tumors that returned or did not respond to previous treatment.

If you join the study, you will be assigned to receive either palbociclib in combination with backbone chemotherapy of IRN and TMZ or the backbone chemotherapy (IRN and TMZ). You may be asked to provide biological samples (such as blood or urine or tumor tissue sample) and undergo procedures that might be different from a regular medical examination. This study will involve screening, treatment, and follow up period. During screening, the study doctor will determine whether you are eligible for the study. If you are eligible and are enrolled into the study, you will be required to visit the study doctor on days 1 to 5 of each 21-day cycle and on day 14 for the first 2 cycles to undergo study assessments and to provide information about your health.

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
NCT03709680
STUDY00012769
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Inclusion Criteria:
Have a solid tumor that has returned or did not respond to previous treatment
Ages ≥2 and <21

Exclusion Criteria:
Prior intolerability to the chemo drugs used in this study
Cancer
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Hershey, PA ,

A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib

The main purpose of the study is to find out if patients treated with remibrutinib may experience fewer MS relapses (also called clinical attacks, exacerbations or flare ups) than patients treated with teriflunomide (also known as Aubagio®). Teriflunomide is an approved medication for the treatment of relapsing MS

This study requires you to take a medication. This study consists of a core part (21 in person visits over 2.5 years) and an extension part (18 in person visits over 5 years). Study activities consist of blood draws for labs every 3 months, vitals (blood pressure readings, heart rate, height and weight), physical exam, electrocardiogram (ECG), clinical outcome assessments, a participant diary that will be filled out during treatment, and an optional magnetic resonance imaging (MRI) sub-study. All study activities will be done at the Penn State Health Hershey Medical Center in the neurology clinic at 30 Hope Drive and clinical research center (CRC) in the main hospital.

$3960

Yes
 

Jikku Zachariah
Erin King - at eking9@pennstatehealth.psu.edu
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05156281
STUDY00023527
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Inclusion Criteria:
18-55 years of age
Diagnosed with remitting relapsing multiple sclerosis (RRMS) with a documented relapse within the previous year, two documented relapses within previous two years, or one documented Gd enhancing lesion on an MRI scan within the previous year.
Must be neurologically stable for 1 month prior to joining the study (including no MS relapse in this time period)
Must agree to use contraception for both male and female participants
Must be able to sign informed consent or have a legally authorized representative to sign.

Exclusion Criteria:
Diagnosis with primary progressive multiple sclerosis (PPMS)
MS disease duration of more than 10 years
Any history or presence of significant concomitant illness.
Treatment with some common MS medications such as cladribine, cyclophosphamide, remibrutinib or other BTKi, alemtuzumab
Optional sub-study: contraindication for MRI: any metal in the body or history of metal fragments, claustrophobia, known allergy to contrast medium.
Neurology
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Hershey, PA ,

Cabazitaxel with Abiraterone versus Abiraterone alone Randomized Trial for Extensive Disease following Docetaxel: the CHAARTED2 Trial

To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel and ADT for HSPC can improve PFS compared toabiraterone acetate alone.

To assess whether the addition of 6 cycles of cabazitaxel toabiraterone acetate in patients with CRPC that have previouslyreceived docetaxel and ADT for HSPC can improve PFS compared toabiraterone acetate alone.

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
NCT03419234
SITE00000449
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Inclusion Criteria:
Age ≥ 18 years
Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate).
Previous chemotherapy with at least 3 cycles of docetaxel for hormone-sensitive metastatic prostate cancer.
Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (CT/MRI of abdomen/pelvis, bone scintigraphy or NaF PET/CT).
Ability to swallow abiraterone acetate tablets as a whole.

Exclusion Criteria:
Any prior chemotherapy or AR-directed therapy for CRPC, (e.g. docetaxel, cabazitaxel, mitoxantrone, abiraterone
Pure small cell or other variant (non-adenocarcinoma) prostate cancer histology for which treatment with abiraterone would not be considered appropriate.
Patients may not be receiving other therapeutic investigational agents or be receiving concurrent anticancer therapy other than standard androgen deprivation therapy.
Any medical condition for which prednisone (corticosteroid) is contraindicated.
Active infection requiring treatment with antibiotics.
Cancer
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Hershey, PA ,

Children's appetite regulation study

The purpose of this study is to determine whether girls and boys regulate their appetites differently. Children will attend 1, 3 hour session in the laboratory, complete some surveys and health measures, donate saliva, and eat pizza.

Children will come to the lab for a 3.5 hour session where they will wear a heart rate monitor, conduct some surveys, have their veggie intake measured, provide some saliva, and eat some pizza. Parents will attend the lab visit with the child and complete questionnaires about feeding and the home environment.

$50 plus travel costs for &gt; 20 miles from lab

Yes
 

Kathleen Keller
Rhea Sarma - at rvs6115@psu.edu
Nutritional Sciences (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
NCT00000000
STUDY00025564
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Inclusion Criteria:
Age 4-6 years
Healthy without food allergies
Parent in charge of feeding able to attend with child

Exclusion Criteria:
Younger than age 4 or older than age 6 years
Children with medical problems or taking a prescription medication that may affect appetite
Children who are not willing to eat pizza in the laboratory
The parent in charge of feeding decisions cannot attend with the child
Children's Health, Food & Nutrition
Not applicable
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State College, PA ,

The efficacy and safety of a CCT-102 regimen versus expectant management in the treatment of first trimester pregnancy loss

This study will compare the use of CCT-102 with expectant management to promote uterine evacuation in first trimester non-progressing Delayed Pregnancy Loss (DPL). Eligible participants will be randomly assigned to active treatment or expectant management and will undergo ultrasound, physical examination, sample collection and complete daily diaries.for six days. Participants will be monitored up to 208 days until a negative urine hCG test is achieved.

There are 3 visits and a screening visit which may be combined with visit 1. A physical examination, ultrasound and blood draw will take place at screening and visit 2. Urine pregnancy tests will be taken at screening, visit 1, visit 2 and at home on days 14, 21 and 28 or until a negative result occurs. Electronic diaries will be logged days 1 through 7

595

Yes
 

Stephanie Estes
Robinn Moyer - at rmoyer3@pennstatehealth.psu.edu or 717-531-6272
Medicine: Endocrinology, Diabetes and Metabolism (HERSHEY)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT06121063
STUDY00023711
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Inclusion Criteria:
Age 18-50
Hemodynamically stable
Closed cervical os
If fetus exists, gestation <10 weeks by clinical observation
Diagnosis of delayed pregnancy loss based on embryonic demise or anembryonic pregnancy

Exclusion Criteria:
Diagnosis of incomplete or inevitable abortion including more than slight bleeding and or open os
Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
Hemoglobin <10 g/dL, coagulation disorder, chronic adrenal failure
History of allergy or contraindications to use of mifepristone, misoprostol or prostaglandins
Current presence of an IUD
Women's Health
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Hershey, PA ,

ALL ALS-PREVENT

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

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

Up to $780

Yes
 

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

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

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

20-099, EA1181 (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete response

The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.

The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.

Yes
 

Cristina Truica
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
NCT04266249
SITE00000861
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Inclusion Criteria:
Histologically confirmed HER2-positive primary invasive breast carcinoma
Patents must have a left ventricular ejection fraction (LVEF) within normal institutional parameters (or > 50%).

Exclusion Criteria:
Patient must not have a history of any prior (ipsilateral or contralateral) invasive breast cancer.
Patient must not have Stage IV (metastatic) breast cancer
Patient must not have T4 and/or N3 disease, including inflammatory breast cancer.
Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy.
Patient must not have a concurrent serious medical condition that would preclude completion of study therapy.
Cancer
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Hershey, PA ,

Functional magnetic resonance imaging (fMRI) and psychophysical studies of sensory perception and cognition

The purpose of this study is (1) to understand how the brain processes sensory information and (2) how this is affected by factors like blindness or synesthesia. In addition to behavioral testing, the study will use functional magnetic resonance imaging (fMRI) which enables us to take pictures of the brain while you are doing a task, using an instrument called an MRI scanner.

Participants will perform simple behavioral tasks either stand-alone or while being scanned; they may also complete questionnaires or rating scales.

Amount varies depending on the study

Yes
 

Krishnankutty Sathian
Simon Lacey - at sathianlab@pennstatehealth.psu.edu
Neuroscience and Experimental Therapeutics (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00012238
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Inclusion Criteria:
Healthy adults over 18 years old
Normal or corrected-to-normal vision
No other sensory deficits
Adults who experience synesthesia
Must pass MRI safety screen (if applicable)

Exclusion Criteria:
Pregnant women (excluded from fMRI studies)
Minors under the age of 18
Individuals who fail the MRI safety screen (may still do behavioral studies)
Neurology, Language & Linguistics, Vision & Eyes
Not applicable
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Hershey, PA ,
State College, PA ,

Characterization and Exploration of Cognitive Assistants in the Space of Knowledge and Social Demands

The objective of this study is to investigate the effects of artificial intelligence on ideation in groups (specifically the process of brainstorming). Facilitation and facilitator/participant perceptions will also be analyzed. This study collects qualitative data through surveys, interviews, and audio/video recording.

Yes
 

Jessica Menold
Torsten Maier - at torstennamaier@psu.edu or 812-781-0014
Mechanical and Nuclear Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00010263
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Inclusion Criteria:
Individuals must be 18 years of age or older
Individuals must be an undergraduate OR graduate student at Penn State

Exclusion Criteria:
Individuals under the age of 18
Individuals who are not an undergraduate OR graduate student at Penn State
Education, Language & Linguistics
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State College, PA ,

Central Pennsylvania Rural Birth Cohort

This study is being conducted to understand what strategies are most successful: 1) in building and retaining a cohort of families from rural communities in Central Pennsylvania with recruitment beginning in pregnancy, infant/toddler age, and preschool age using a cohort sequential design; 2) for collecting clinical and semi-invasive, remote-based biobehavioral measurements to better characterize synergistic factors associated with obesity and substance use in this high risk population; and 3) for identifying points for future intervention, treatment, prevention, and policy efforts to reduce health disparities in maternal-child morbidity and promote positive family processes.

Cohort 1 (Pregnancy Cohort) will follow the assessment schedule as described below:Visit 1 will occur around 16-weeks gestation. You will complete online surveys. The surveys should take 1 hour or less.. Visit 2 will occur around 32-weeks gestation. You will complete online surveys, and a semi-structured health behaviors interview via Zoom. You may also be asked to collect hair and/or nail samples. The visit should take 2 hours or less. Visit 3 will occur around 6 months post-delivery. You will complete online surveys. The surveys should take 1 hour or less. Visit 4 will occur around 12 months post-delivery. You will complete online surveys and a parent-child interaction observation (one session). This visit should take 1 hour or less.Cohort 2 (12 month old child Cohort) will follow the assessment schedule as described below:Visit 1 will occur around 12 months post-delivery. You will complete online surveys, and a parent-child interaction observation (one session). You may also be asked to provide hair and/or nail samples. This visit should take 2 hours or less. Visit 2 will occur around 24 months post-delivery. You will complete online surveys. This visit should take 1 hour or less.Cohort 3 (24 month old child Cohort) will follow the assessment schedule as described below:Visit 1 will occur around 24 months post-delivery. You will complete online surveys. You may also be asked to provide hair and/or nail samples. This visit should take 1 hour or less.Visit 2 will occur around 36 months post-delivery. You will complete online surveys. This visit should take 1 hour or less.All electronic health record data will be extracted at the end of study participation.

$100-200

No
 

Danielle Downs
Birth Cohort Team at birthcohort@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00020841
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Inclusion Criteria:
Pregnant person over age of 18 with a singleton pregnancy
Over the age of 18
Families with toddlers that are either 12 or 36 months of age
Live in rural Pennsylvania
Have smartphone/wifi access

Exclusion Criteria:
Not pregnant or multiple pregnancy
Pregnant person or parents under age of 18
Families without toddlers that are either 12 or 36 months of age or a multiple (twin, triple, etc.)
Live outside of rural Pennsylvania
Do not have smartphone/wifi access
Children's Health, Pregnancy & Infertility, Women's Health
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ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED)

Upper tract urothelial cancer (UTUC) is a recurrent disease. The current standard treatment for most UTUC patients requires surgery either removing some of the ureter in each operation or radical nephroureterectomy (RNU-removal of kidney and ureter) but the role of minimally invasive &amp; kidney- preserving methods is increasing. The use of TOOKAD (padeliporfin) was investigated in a Phase 1 clinical study in the minimally-invasive treatment of UTUC with the goal of identifying safe laser/light exposure and signs that the tumor has been reduced or eliminated. Early results from this study have been highly promising, revealing the effects of tumor removal with a positive safety profile, indicating the potential role of TOOKAD (padeliporfin) in the treatment of low-grade UTUC disease.This Phase 3 study is designed to provide confirmation of the observed Phase 1 findings. Patients are expected to remain in the study for 25 to 28 months. Participation in this study will include up to 9 study visits to Hershey Medical Center and 2 phone visits.

There are 4 stages to this study: screening phase, induction study treatment phase, maintenance study treatment phase and long-term follow-up phase.In screening you can expect to be asked questions about your medical history, MRI or CTU, blood and urine samples, physical exam, vitals, tumor assessment by ureteroscopy and biopsy under anesthesia.Induction Treatment Phase (1-3 months)•Participants undergo anesthesia and receive the study therapy 1 to 3 times, about 4 weeks apart. If a participant does not achieve Complete Response (CR)* after 3 treatments (or if their disease has progressed as defined in the protocol), the participant will be discontinued from the Treatment Phases and enter the Long-term Follow-up Phase.Maintenance Treatment Phase (12 months)•Participants who achieve CR* from Induction Treatment Phase will be followed for 12 months. Up to 3 repeated study therapy doses will be provided for participants who have treatable tumor recurrence as determined by the study doctor.Long-term Follow-up Phase (48 months)•Patients who achieve CR and then enter the maintenance treatment phase and who have a CR after the end of maintenance treatment phase will enter the Long-term Follow-up Phase and will be followed up for up to an additional 48 months in the Long-term Follow-up Phase or until recurrence, progression, death or loss to follow up, to document safety and ongoing response.•Patients discontinued from the treatment phases and who have received at least one study treatment will be followed up for additional 12 months in the long-term follow-up phase of the study from last VTP treatment.

Yes
 

Jay Raman
Amogh Pande - at UrologyResearch@pennstatehealth.psu.edu or 717-531-5930
Urology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04620239
SITE00000972
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Inclusion Criteria:
New or recurrent low-grade, non-invasive UTUC disease
Biopsy-proven disease. A concurrence of the central pathology reader will be required for eligibility.
Up to 2 biopsy-proven sites of low-grade involvement. Please contact site for tumor dimension criteria.
Karnofsky Performance Status ≥ 50%
Adequate organ function defined by baseline Lab testing

Exclusion Criteria:
Current high-grade or muscle invasive (>pT1) urothelial carcinoma of the bladder
Carcinoma in situ (CIS) current or previous in the upper urinary tract
History of invasive T2 or higher urothelial cancer in past 2 years
Participation in another clinical study involving an investigational product within 1 month before study entry
BCG or local chemotherapy treatment in the upper urinary tract within 2 months prior to inclusion
Kidney & Urinary System, Cancer
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Hershey, PA ,

Evaluation of Health State Utilities for a Chronic Medical Condition

The goal of this research study is to understand how society perceives a chronic illness and the lifestyle outcomes that result from various treatments. Assessing this information will provide more insight on the quality of life for patients of that disease. This information will also help to guide medical decisions and assess the value of a health care intervention. The research team created descriptions of different lifestyle outcomes, called “health states,” and these are designed to reflect the burden of disease. You will be surveyed on your perception of these health states.

No
 

Debarati Bhanja
Debarati Bhanja - at dbhanja@pennstatehealth.psu.edu or 614-849-2866
Student Affairs (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00017700
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Inclusion Criteria:
18 years of age or older
Access to a computer and internet connection
Full English literacy, including reading and writing ability
Permanent residents or citizens of the United States

Exclusion Criteria:
Diagnosed, treated or in remission of cancer
Drug or alcohol dependent
Primary language is not English
Cognitively impaired
Permanently residing outside of the United States
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Trust in Machine Agents Under Realistic Threat

Measures of actual human-machine interaction are required to generate ecologically valid, translatable discoveries that enhance human-systems integration and performance. Here, the proposed methods center on human-robot decision tasks to assess key determinants of human trust in robot recommendations (e.g., factors such as threat-salience and/or robot appearance), and the concomitant impacts of trust on performance.

There will be one in person visit, you will be asked to interact with a robot in a virtual environment.

10

Yes
 

Alan Wagner
azw78@psu.edu
Aerospace Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00016538
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Inclusion Criteria:
An adult over the age of 18
Must not be suffering from anxiety disorders and/or panic attacks.
Must not be suffering from any known heart conditions.
Must not, to your knowledge, be prone to nausea when experiencing VR

Exclusion Criteria:
Anyone under the age of 18 will be excluded.
Suffers from anxiety disorders, suffers from heart conditions, prone to nausea when experiencing VR
Prevention, Mental & Behavioral Health
Not applicable
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State College, PA ,

Identification of Neural Markers of Aggression and Irritability and Their Capacity to Predict Treatment Response to CNS Stimulants in Youth with ADHD

This is a drug study for children between 7-12 years old with ADHD that will examine how central nervous system (CNS) stimulants improve anger and irritability in children. It uses only meds that are already FDA approved for ADHD. After intake, families will meet with study doctors to determine an ideal stimulant dose (no placebos in this phase) over 6 visits spaced 1-2 weeks apart. All youth showing improved ADHD and stable or reduced levels of irritability/aggression will advance to a 2 week blinded crossover trial. Participants will complete computer tasks while hooked up to EEG to measure how CNS stimulants impact processing of reward and loss. Participants will complete two EEG visits one week apart - one visit will occur while the child is on the optimal active dose of CNS stimulant from the prior phase, and the other will occur while the child is on a placebo pill. Parents will complete 3 cell phone surveys per day of their child's behavior over these 14 days. This study is expected to take an average of 10 visits over 3 months.

Parent and child will first complete an intake up two hours (30 minutes for child) to verify that child has ADHD and issues with temper problems at home. Then over 6 visits spaced 1-2 weeks apart study doctors will find the best dose of ADHD medication for the child that also helps their anger, with parents filling out weekly ratings of child behavior. All medicines used in the study are already approved to treat ADHD in children and commercially available. At least half of these visits need to occur at the study site at 22 NE Drive in Hershey, PA. For the last two weeks, there will be one in office visit per week at the Hershey office. Children will complete 3 computer games while undergoing EEG testing to measure their brain wave activity. For each of these 14 days, parents will fill out 3 cell phone surveys per day about their child’s behavior. During one of these two weeks, children will take the dose of ADHD medication that worked the best for them. For the other week, it will be replaced with placebo (fake pill). Neither parent or child will know which week is real and which week is fake medication. The total study takes between 10 to 12 visits over an average of 3 months.

child is $100 parent is $105

Yes
 

James Waxmonsky
Thresia Casanova - at tcasanova@pennstatehealth.psu.edu or 717-531-0003, ext=285966
Psychiatry and Behavioral Health (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT06871488
STUDY00026311
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Inclusion Criteria:
ADHD (suspected or diagnosed)
ages 7 to 12
problems with anger or irritability at home

Exclusion Criteria:
Autism Spectrum Disorder
Current Major Depression
Not interested in using medicine for ADHD
Mental & Behavioral Health
Approved drug(s)
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Hershey, PA ,

Eye-tracking of Aging and Language

We are interested in how adults understand language, and how this changes across the lifespan. Participants will complete paper and pencil tasks, computer-based tasks, and we will monitor how they move their eyes.

Yes
 

Michele Diaz
Victoria Gertel - at vhg2@psu.edu or 814-865-2912
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00011840
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Inclusion Criteria:
Native English Speaker
Right Handed
Monolingual
Minimum High School Education or GED
Normal or corrected to normal vision (20/20, not color blind)

Exclusion Criteria:
History of Neurological or Psychological Disease
Left Handed
<18 years old
speaking more than 1 language
less than 12 years education and no GED
Language & Linguistics
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State College, PA ,

Identification of Emotion in Music in Autism Spectrum Disorders

The purpose of the project is to learn more about reactions to music by adults with and without autism spectrum disorders. Participants will listen to short pieces of music and answer some questions on a computer. They will also complete some formal testing and answer some interview questions.

Yes
 

Diane Williams
Diane Williams - at dlw81@psu.edu or 814-865-3177
Communication Sciences and Disorders (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00009952
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Inclusion Criteria:
Speak sentence length English as primary language
Normal or corrected to normal vision
Normal hearing
Individuals with and without an autism spectrum disorder or Asperger syndrome
Willing to consent and complete study requirements

Exclusion Criteria:
Cannot speak sentence length English
Vision problems (uncorrected)
Hearing problems
Significant learning problems
Unwilling to consent or complete study requirements
Mental & Behavioral Health, Language & Linguistics
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Greater Pittsburgh Area, PA ,
State College, PA ,

Interactions between the olfactory, auditory, visual, and trigeminal systems

The purpose of this study is to use fMRI to identify and characterize the olfactory, auditory, visual and trigeminal-related brain networks. This research will then be use to enhance human health by laying the foundation to develop sensitive biomarkers to identify people who are at risk of developing brain disorders such as Alzheimer’s disease and Parkinson’s disease, where olfactory deficits are known preclinical symptoms.

Yes
 

Prasanna Karunanayaka
Lauren Spreen at lms553@psu.edu or 717-531-5857
Radiology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
PRAMS042765EP
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Inclusion Criteria:
Healthy subjects with normal olfactory, visual, and hearing abilities
Clear sinuses

Exclusion Criteria:
Non-English speaking
Pregnant or lactating
Presence of a pacemaker, aneurysm clips or any metal in the body
A history of welding, grinding, and or claustrophobia
Neurological disease (stroke, tumor, Parkinson's) or Psychiatric disorder (bipolar, schizophrenia, etc)
Neurology
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Hershey, PA ,

Defining the cellular and molecular signatures that are associated with the clinical heterogeneity of hidradenitis suppurativa

Patients with the clinical diagnosis of mild, moderate to severe Hidradenditis Suppurativa or normal healthy volunteers ages 18 and older to participate in a 1 time study visit. There is no treatment provided but we may gain information for the treatment of HS.

Eligible participants will attend a one time in person visit. During the visit, the study team will ask you to participate in the following activities: collect skin sample, blood sample and cheek swab. Take photographs of your HS lesions.

study coordinator will discuss.

Yes
 

Amanda Nelson
Amy Longenecker - at alongenecker@pennstatehealth.psu.edu or 717-531-1513
Dermatology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00012908
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Inclusion Criteria:
18 years and older
Hidradentitis Suppurativa diagnosis for 3 months
Normal skin participants

Exclusion Criteria:
Patients who are Pregnant
Normal skin participants do not have an autoimmune disease
Participants who do not want to have any of the lesion sampling performed
Skin Conditions
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Hershey, PA ,

Understanding the Relationship between Education and Well-being among College Students with Disabilities

The purpose of the study is to gain an understanding of students’ experiences in college and their engagement help-seeking and healthy behaviors. Participation in the study involves completing a brief online-survey on Qualtrics, which we anticipate will take approximately 20 minutes to complete.

No
 

Amber O'Shea
Amber O'Shea - at amo5208@psu.edu or 814-867-5721
Educational Psychology, Counseling and Special Education (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00011286
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Inclusion Criteria:
Currently enrolled as a college student
18 years of age or older
Capable of providing informed consent
Diagnosis of a disability
Able to understand written English

Exclusion Criteria:
Adults unable to provide legal consent
Individuals who are not yet legal adults
Pregnant women
Prisoners
Education, Mental & Behavioral Health, Women's Health
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Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)

Polycystic ovary syndrome (PCOS) is the most common endocrine abnormality in women in the U.S. and is characterized by both reproductive (anovulation and androgen excess) and metabolic dysfunction (insulin resistance). PCOS lacks a simple, safe and effective treatment for women of all ages and all weights. Recentlya dietary supplement, inositol, has been used widely to treat women with PCOS. However there are no well designed trials to address the risk/benefit ratio and identify the mechanism of action. In this study we propose a 3 month double blind (of both patients and investigators) randomized controlled trial of inositol supplementation compared to placebo. We hypothesis that women with PCOS who receive inositol supplementation will have a significantly greater reduction in serum total testosterone than women on placebo as well has improvement in glucose tolerance and decrease in fasting insulin.

There will be 4 in person visitsHave a physical exam and other evaluations, including ultrasoundTake study drug as directedHave bloodwork taken throughout studyComplete questionnaires and a daily diary

$300

Yes
 

Richard Legro
Amyee McMonagle - at amcmonagle@pennstatehealth.psu.edu or 717-531-4484
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03864068
STUDY00010252
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Inclusion Criteria:
Women 18-45 years old
Diagonosed with Polycystic Ovary Sydrome
8 or less periods per year
Periods of greater than or equal to 45 days
Not seeking pregnancy

Exclusion Criteria:
High protactin levels
Uncorrected thyroid disease
Suspected adrenal or ovarian tumor screting androgens
Suspected Cushing's syndrome
Contraindications to the study drug or placebo
Women's Health
Prefer not to display
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Hershey, PA ,

Phase III Study of Daratumumab/RHuPH20 + Lenalidomide or Lenalidomide in Patients with Multiple Myeloma Using MRD to Direct Therapy Duration (PSCI# 19-079) (S1803)

This study is being done to answer the following questions: 1.Will adding the drug daratumumab/rHuPH20 to the usual maintenance treatment with lenalidomide after stem cell transplant help multiple myeloma patients survive longer?2.For patients who have no evidence of multiple myeloma in their bone marrow (patients who do not have “minimum residual disease” [MRD-negative]), should maintenance therapy be stopped after 2 years? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your multiple myeloma. The usual approach is defined as care most people get for multiple myeloma.

Phase III Study of Daratumumab/rHuPH20 (NSC-810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration

Yes
 

Kevin Rakszawski
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
NCT04071457
SITE00000688
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Inclusion Criteria:
Patients must have had a confirmed diagnosis of symptomatic multiple myeloma (See Section 4.1) that required systemic induction therapy prior to autologous stem cell transplantation (ASCT).
Patients with disease measurable by serum light chain assay alone are eligible (defined as ≥ 100 mg/L on involved light chain).
Patients must be ≥ 18 and ≤ 75 years of age at time of registration to Step 1.
Patients must have history and physical exam within 28 days prior to registration.
Patients must have Zubrod Performance Status ≤ 2.

Exclusion Criteria:
Patients with smoldering myeloma are not eligible
Patients must not have any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction.
Patients must not have progressive disease at any time prior to registration.
Patients must not be refractory or intolerant to either lenalidomide or daratumumab/rHuPH20.
Patients must not have moderate or severe persistent asthma within the past 2 years and must not have currently uncontrolled asthma of any classification.
Cancer
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Hershey, PA ,

The role of middle temporal and frontoparietal areas in limb motor control

The goal of this research is to understand the role of motion-processing areas on limb motor control. We will be using behavioral studies and combining that with functional brain imaging, EEG, and non-invasive brain stimulation using transcranial magnetic stimulation (TMS). TMS has been used in thousands of studies and is a very safe method to understand brain function for eye hand coordination.

There will be three visits. Participants will under go brain scanning. They will perform eye-hand coordination tasks by grabbing a robotic manipulandum. During the eye-hand coordination tasks, participants' brain activity will be measured using electroencephalography (EEG) and muscle activity using surface electromyography (EMG). Researchers will also apply transcranial magnetic stimulation (TMS) to temporarily inhibit and excite different brain areas. TMS is a noninvasive procedure that uses magnetic fields to stimulate nerve cells

50

Yes
 

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

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00018993
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Inclusion Criteria:
Participants should be between 18-50 years old
Participants should be right-hand dominant individuals
Participants should be able to sit upright in a chair for long periods (up to 2 and a half hours) with rest
Participants should be able to grasp and move objects with both hands
Participants should be able to lie still and perform behavioral tasks inside a magnetic scanner for up to 60 minutes

Exclusion Criteria:
History of neurological disorders (e.g., Seizures, Parkinson’s or Alzheimer’s disease, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Friedreich's ataxia, aneurism, brain tumor, epilepsy, traumatic brain injury, a concussion in the last five years)
Any history of musculoskeletal disorders (e.g., carpal tunnel syndrome, any form of arthritis, fibromyalgia, tendinitis, or previous injury or surgery to the bones or joints in your neck, upper back, arms or hands in the last six months)
Eye or vision problems (e.g., cataracts, glaucoma, a detached retina, or macular degeneration)
Individuals with metallic implants will be excluded from the study. The metallic implant will make participation in a magnetic scanner impossible
Medication that could make the participant drowsy or tired during the experiment
Neurology, Vision & Eyes
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State College, PA ,

PSCI# 23-137 NRGF-001: ACTIVITY MONITORING TO IMPROVE PATIENT CARE DURING CHEMORADIOTHERAPY FOR LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER (LA-NSCLC)

this trial looks at the difference in health between lung cancer subjects who do deliberate exercise measured by a fit bit and those who do not.

Participants will need to commit to all appointments. All those assigned to the fit bit arm must agree to wear it as instructed. You will wear the activity monitor for approximately 4 months. There are approximately 13 visits in total that you would need to come to the clinic.

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
NCT04878952
STUDY00024680
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of NSCLC
Planned initiation (within the 30 days after study registration) of fractionated (≥15 treatments) thoracic radiotherapy with concurrent chemotherapy.
Age ≥ 18
Ambulates independently or with a cane (use of a walker not permitted)

Exclusion Criteria:
Patients with a history of another cancer that is expected to affect the toxicity profile of thoracic chemoradiotherapy for NSCLC
Patients receiving concurrent treatment for another cancer that is expected to affect the toxicity profile of thoracic chemoradiotherapy
Cancer
Approved device(s)
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Hershey, PA ,

Can Twitter be the platform that leads to the rise of ’Crisis Reporters’?

Citizen journalism refers to production of journalistic content by ordinary citizens such as ‘current affairs-based blogging, photo and video sharing, and posting eyewitness commentary on current events’. In our study we try to redefine ‘citizen journalism’ to ‘crisis reporting’ that includes sharing updates and actionable news using Twitter. To this end we wish to propose a study where we interview people to understand the feasibility of the same. In addition, as supporting data, we would use historical data from Twitter. This would be done keeping in mind a particular event which would be the Texas snowstorm.

No
 

Sanjana Gautam
Sanjana Gautam - at sqg5699@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00017565
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Inclusion Criteria:
Above 18 years of age
Present in Texas during the snowstorm
Have an active Twitter account

Exclusion Criteria:
Below 18 years of age
Not present in Texas during the snowstorm
Do not have an active Twitter account
Mental & Behavioral Health
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A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study toAssess the Efficacy and Safety of Barzolvolimab in Patients withChronic Spontaneous Urticaria Who Remain Symptomatic DespiteH1 Antihistamine Treatment (EMBARQ – CSU2)

A clinical research study called EMBARQ-CSU, which seeks to assess an investigational study medicine that has the potential to expand treatment options for Chronic Spontaneous Urticaria (CSU). CSU is a skin condition also known as chronic hives or long-term hives that is characterized by raised itchy welts on the skin that persist for six weeks or longer with no known cause.

If you decide to take part in this research study, you will have a screening phase where you will have procedures to determine if you meet the requirements to be in the study. These include a physical exam and an electrocardiogram (ECG) which will measure the electrical activity of your heart. You will also be required to give blood and urine samples. If you are a woman who can have children, you will also need to take pregnancy tests.If you qualify and agree to take part in the study, you will receive injections of barzolvolimab or placebo (the placebo contains the same ingredients but without barzolvolimab) under your skin every 4 weeks for 6 months. After 6 months, everyone will receive barzolvolimab for an additional 6 months, involving visits every 4 weeks. During the study, you will continue to have physical exams, blood taken for testing, and urine tests.You will need to complete a daily diary.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06455202
STUDY00025517
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Inclusion Criteria:
Male or female, ≥ 18 years of age at the time of signing the informed consent.
Diagnosis of CSU ≥ 6 months prior to Screening.
CSU remains despite a stable dose and regimen containing a second-generation antihistamine.
Agree to use highly effective contraception.
Willing and able to comply with all study requirements and procedures, including the completion of a daily symptom diary during screening and throughout of the study.

Exclusion Criteria:
Receipt of a live vaccine within 2 months prior to Screening (participants must agree to avoid live vaccination during study treatment and within 3 months thereafter).
Diseases with possible symptoms of urticaria or angioedema.
Phototherapy with ultraviolet (UV) A or UVB within 4 weeks of Screening.
Diagnosis of idiopathic anaphylaxis or a history of anaphylaxis.
Women who are pregnant or nursing.
Infectious Diseases & Immune System, Allergies
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A Phase Ib/II Study of Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia (EA9152) (PSCI 18-047)

This study is being done to determine what effects (good and bad) the therapy venetoclax has on your type of cancer (acute lymphoblastic leukemia, also known as ALL). This investigational therapy will be added to what is a standard, liposomal vincristine, to treat relapsed acute lymphoblastic leukemia. It is hoped that venetoclax will help liposomal vincristine work better to kill your ALL, but it has not yet been proven.

venetoclax will be given orally in a tablet formulation once daily in 3 dose arms with a fixed, standard dose of intravenous (IV) liposomal vincristine 2.25mg/m2 weekly starting after a 2 week lead-in phase of venetoclax

Yes
 

Joseph Cioccio
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
NCT03504644
SITE00000009
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Inclusion Criteria:
Relapsed or refractory B-cell or T-cell ALL after multi-agent chemotherapy(≥ 5% marrow lymphoblasts, assessed by morphology and flow cytometry
ECOG performance status 0-2
Creatinine clearance of at least 50 mL/min within 7 days prior to first dose of study agent
Adequate liver function with AST/ALT less than 3X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent
Circulating WBC count must not be above 20 x10^9/L within 7 days prior to first dose of study agent

Exclusion Criteria:
Pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol
Evidence of isolated extramedullary relapse (i.e., testicular or CNS)
Serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
Poorly controlled HIV, or CD4 < 400. HIV positive patients are allowed on this study if they have a CD4 count greater than or equal to 400, and are on a stable antiviral regimen
Patients with NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
Cancer
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Hershey, PA ,

Comparing Interactions Between Heterogeneous and Homogeneous Pairs of Building Designers

This study considers how building designers work together on a design task. During the 1-hour long study, participants will be assigned a design partner and given a design task with specific goals to address. The entire study will take place over a computer and the design process will be recorded through the computer's video and audio.

No
 

Nathan Brown
Stephanie Bunt - at s.bunt@psu.edu
Architectural Engineering (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00016546
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Inclusion Criteria:
Architecture Students
Architectural Engineering Students
4th or 5th year undergrads with internship experience
Graduate students

Exclusion Criteria:
First, Second, or Third year students
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UroGen UR001

This study is being done is to test the safety of a drug called UGN-301 at different dose levels, either alone or with another drug called UGN-201, and to understand how these drugs interact with the bladder and body

If you decide to take part in this study and meet all of the requirements, you will receive 6 treatments, once per week for 6 weeks in a row. The medication treatments will be instilled via catheter into your bladder. There will be 11 total visits with blood draws at all of the visits. As part of screening for this study you will have to have a CT scan, a cystoscopy, and a bladder biopsy. At 3 months you will be required to return for a cystoscopy and bladder biopsy if necessary. Finally, there will be a follow up cystoscopy and bladder biopsy at 6 months.

Yes
 

Jay Raman
Urology Research - at urologyresearch@pennstatehealth.psu.edu
Urology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05375903
SITE00001313
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Inclusion Criteria:
Have confirmed recurrent NMIBC with HG Ta disease and/or CIS or recurrent IR LG Ta disease
Have confirmed recurrent NMIBC with HG Ta disease and/or CIS
Has a life expectancy > 12 months.
Be post menopausal, surgically sterile, or using a combination of 2 methods of birth control for maximally effective birth control
Have adequate organ and bone marrow function within 14 days of treatment initiation as determined by routine laboratory tests

Exclusion Criteria:
Intravesical therapy within 4 weeks before starting study treatment.
Current or previous evidence of muscle invasive, locally advanced nonresectable, or metastatic urothelial carcinoma (ie, T2, T3, T4 and/or stage IV). High or low grade T1 disease.
Current systemic therapy for bladder cancer.
History of malignancy of other organ system within the past 5 years. Patients with genitourinary cancers other than urothelial cancer or prostate cancer that are under active surveillance
Prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD-L1 agent, or with an agent directed to another co-inhibitory T-cell receptor.
Cancer
Not applicable
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Hershey, PA ,