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Understanding the user experience of using consumer-facing digital symptom checkers

This is an interview study that examines how people use online symptom checker platforms or apps (e.g., WebMD, Ada, K health app, Your.MD) to self-diagnose or support the decision of whether and when to do a medical visit. The research procedure involves: 1) a short screening survey which helps us determine who are eligible to participate; 2) an audio‐taped interview with each eligible participant that will last approximately 30‐60 minutes online or offline near Penn State University Park. Each participant will be compensated with a $20 Amazon gift card for completing the interview.

Yes
 

Xinning Gui
yxy340@psu.edu
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00013312
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Inclusion Criteria:
Live in US
Speak English or Chinese
At least 18 years of age
Have used online symptom checker platforms or apps

Exclusion Criteria:
Less than 18 years old
Have never used any symptom checker
Vulnerable populations such as children, pregnant women, cognitively impaired adults, and prisoners
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Altoona, PA ,
Hershey, PA ,
State College, PA ,

Decision-Making in ADHD: An Evaluation of the Subjective Value of Rewards and Costs

Children with attention and behavior problems often need external rewards to motivate them to perform challenging tasks, but we don’t yet know much about how children weigh potential rewards and the effort required to obtain the rewards. This research is being done to find out how children with varying levels of ADHD symptoms value rewards and costs when making decisions about whether or not to perform a difficult task.

There will be one in-person visit. Children will complete two computerized cognitive tasks (thinking games), and will be able to earn prizes from the points they earn on these tasks. Parents will also be asked to complete a few questionnaires that should take about 25 minutes to finish. Children can earn up to $50 in compensation for completing the study.

$50

Yes
 

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

All
Younger than 18 years old
This study is also accepting healthy volunteers
STUDY00018076
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Inclusion Criteria:
Children ages 8 to 12 years old
Children with normal or corrected vision
Caregiver and child must be fluent in written and spoken English
Willing to stop stimulant medications, when appropriate, for research testing

Exclusion Criteria:
Children who are younger than 8 years of age and children who are older than 12 years of age.
Current or past diagnosis of autism spectrum disorder, schizophrenia or other psychotic disorders.
Current use of non-stimulant medication due to its extended washout period.
Physical disabilities that are incompatible with completing laboratory tasks such as hearing impairments, or visual impairments that cannot be corrected with visual aids (i.e., glasses, contacts).
Children's Health, Mental & Behavioral Health
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Harrisburg, PA ,
Hershey, PA ,

PHASE I SAFETY ASSESSMENT OF HYPOFRACTIONATED POSTOPERATIVE RADIOTHERAPY (H-PORT) FOR INTERMEDIATE-RISK HEAD AND NECK CANCER

The purpose of this study is to test the good and bad effects of using hypofractionated radiation therapy. Hypofractionated radiation therapy could shrink or stabilize your cancer, but it could also cause side effects. The study doctors hope to learn if hypofractionated radiation therapy is safe and tolerable in patients with your type of cancer. You will receive radiation therapy for 4 weeks. You may also receive chemotherapy.

Participants will be required to receive radiation therapy for 4 weeks. Participants may also receive chemotherapy with cisplatin, carboplatin, or cetuximab.

Yes
 

Mitchell Machtay
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
NCT05540899
STUDY00022103
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Inclusion Criteria:
Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS, etc.) of the head/neck
Clinical stage II, III or IVA squamous cell carcinoma of the oral cavity, oropharynx or larynx (AJCC 8th edition), including no distant metastases.
Total resection of the patient’s cancer (i.e. no residual disease after total resection of the patient’s cancer ).
One or more indications for postoperative radiotherapy, based upon pathologic findings: • Perineural invasion; • Lymphovascular invasion;
Zubrod Performance Status 0-1

Exclusion Criteria:
Recurrence of the study cancer.
History of systemic lupus erythematosus or systemic sclerosis (scleroderma).
Pregnancy and individuals unwilling to discontinue nursing.
Feeding tube (gastric or jejuno) at the time of registration.
Anticipated need for high-dose systemic chemotherapy (e.g. high dose q3-week cisplatin), multiple systemic therapy agents or immunotherapy. Weekly single-agent systemic therapy with cisplatin, carboplatin, or cetuximab is allowable.
Cancer
Not applicable
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Hershey, PA ,

Master Protocol of Two Independent, Randomized, Double-Blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) To Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis

A study that looks at the efficacy of Frexalimab compared to standard of care drug, Teriflunomide, for adults with relapsing forms of MS.

The purpose of this clinical trial is to compare the efficacy and safety of investigational products in adult participants with relapsing forms of multiple sclerosis. There will be about 22 in person visits over 3.5 years that consist of monthly IV medication administration, monthly oral tablet medication dispensation, Magnetic resonance imaging (MRI) roughly every 6 months, monthly blood draws for lab work, vitals, ECG, and clinical outcome assessments. 13 of these visits are within the first 12 months of the study. All study activities will be done at the Penn State Health Hershey Medical Center in the Neurology Clinic at 30 Hope Drive and the Clinical Research Center (CRC) in the main hospital.

Up to $4300

Yes
 

Jikku Zachariah
Kasey Schutt - at klong10@pennstatehealth.psu.edu or 717-531-0003, ext=289869
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06141473
STUDY00025586
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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 two years, or one documented Gd enhancing lesion on an MRI scan within the previous year.
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 or with secondary progressive multiple sclerosis without activity.
History of infectious disease/serious psychiatric illness/active substance use disorder/cirrhosis, acute liver disease/malignancy/autoimmune, cardiovascular, neurological disorders/any other history or presence of significant other concomitant illness.
Treatment with lymphoid irradiation, bone marrow transplantation, mitoxantrone, alemtuzumab, cladribine, daclizumab, cyclophosphamide, other strongly immunosuppressive treatments with very long-lasting effects, equal to or over 3 months of teriflunomide.
Previous exposure to frexalimab, other investigational drug trials, allergy or sensitivity to any of the study interventions.
Contraindication for MRI: pacemaker, metallic implants/presence of metallic material in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.
Neurology
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Hershey, PA ,

PSCI 23-092 EA8192 A Phase II/III trial of Durvalumab and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

This trial is comparing outcomes of cisplatin eligible vs cisplatin ineligible high grade urothelial cancer patients treated with accelerated therapy vs gemcitabine and durvalumab followed by surgery.

Participants will need to complete all study visits, agree to having surgery and to make sure to tell the study team if they are having any side effects.

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
NCT04628767
STUDY00023370
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Inclusion Criteria:
Patient must be ≥18 years of age.
Patient must have the ability to understand and the willingness to sign a written informed consent document
Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy
Patients must not have any component of small cell/neuroendocrine carcinoma
Patients must not be pregnant or breast-feeding

Exclusion Criteria:
Patients must have no evidence of metastatic disease
Patient must not have another active (or within two years) second malignancy
Patient may have a history of resectable urothelial cancer
Patient must not have any uncontrolled illness
Patient must not have received prior systemic anthracycline therapy
Cancer
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Hershey, PA ,

Cognitive and Social Factors Underlying Spoken Language Use

The central purpose of this research is to understand how language users produce and comprehend speech. To do this we ask participants to record speech, make judgments on the speech they hear, and work with a partner on simple language tasks.

Yes
 

Navin Viswanathan
Navin Viswanathan - at splaco@psu.edu
Communication Sciences and Disorders (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00011708
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Inclusion Criteria:
English Speakers
Between 18 and 65 years of age

Exclusion Criteria:
Those with diagnosed speech, hearing or language Issues
Language & Linguistics
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State College, PA ,

A Phase 1/2, Open-label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects with Advanced or Metastatic Malignancies Harboring ALK, ROS1, or NTRK1-3 Alterations (CARE)

Repotrectinib for cancer that has returned or is not responding to treatment

If you agree to take part in this study, you will need to visit the study site regularly and follow the study procedures listed later in this document. You will be told what these procedures are and why they are needed. These procedures include interviews, exams, heart testing, tumor assessments, and blood and urine samples. You will be asked to take the study drug Repotrectinib. This is a capsule to be taken orally.

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
NCT04094610
STUDY00014715
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Inclusion Criteria:
You have cancer that has returned or is not respondin g to treatment
You are positive for certain changes in your genes which we will test you for as needed

Exclusion Criteria:
1. You have gastrointestinal disease, such as Crohn’s disease,
Cancer
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Hershey, PA ,

The naturalistic reinforcement of obsessions and compulsions: An ecological momentary assessment study

The purpose of this study is to examine the relationship between sleep patterns, thoughts, behaviors, and emotions in obsessive-compulsive disorder (OCD). In the screening visit, participants will complete a brief interview and questionnaire to determine if they are eligible to participate in our study. Eligible participants will complete additional questionnaires and a training session on study procedures. Following this visit, for the next 7 days, participants will complete daily questionnaires and (for those selected to be in the sleep monitoring group) monitor their sleep by wearing a sleep watch. On day 4, participants will attend a brief compliance check Zoom visit where they will be informed about their overall compliance rate. Participants will be compensated with course credit. Findings from this research may help improve understanding of OCD symptoms and sleep.

Screening Visit: This can be conducted in person or over Zoom. During this visit, we will administer a short questionnaire and an interview to determine if you are eligible to participate in the study. If you are eligible, you will complete questionnaires and a training session on study procedures. You will also receive a sleep watch, which you will be asked to wear consequently for 7 days. This visit will take approximately 1 hour and 25 minutes.7 Day Monitoring: For the next 7 days, you will complete several, brief daily questionnaires (7 questionnaires/per day) on your smartphone. Questionnaires will take place generally every 2 hours starting from 10 a.m. to 10 p.m. You will also monitor your sleep by wearing a sleep watch and maintaining a daily sleep diary.Compliance Check (Day 4): On day 4, there will be a 5 minute compliance check Zoom meeting where you will be informed about your overall study compliance rate. Return and Debrief: At the end of the 7 days, you will be asked to return the sleep watch to our lab location (Moore Building) or schedule a pick-up time with a study team member. You will also receive an educational debriefing handout over email.

No
 

Valerie Swisher
Valerie Swisher - at vss5199@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00024470
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Inclusion Criteria:
Meets criteria for Obsessive-Compulsive Disorder
Owns an iPhone or Android Smartphone
Fluency in English
Age 18 or older

Exclusion Criteria:
Younger than 18
Not able to consent or commit to study duration
Does not meet criteria for Obsessive-Compulsive Disorder
Meets criteria for certain conditions (e.g., schizophrenia)
Not fluent in English
Sleep Management, Mental & Behavioral Health
Not applicable
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Gaming Communities as Virtual Third Places: A Quantitative Assessment

This study will collect information about the use of gaming communities for social interaction.

Participants will be asked to complete a short survey.

No
 

Jeffrey Stone
Jeffrey Stone - at stonej@psu.edu or 610-285-5003
Information Sciences and Technology (LEHIGH VALLEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00021668
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Inclusion Criteria:
Adults 18 years of age and older.

Exclusion Criteria:
Individuals under 18 years of age.
Mental & Behavioral Health
Not applicable
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One Talk at a Time - Anti-Racism

This is a psychological study to examine the effect of a new intervention that provides parents with tools to speak with their kids about race, racism, and privilege.Participants will complete a 2-3 hour long program and answer questionnaires over the course of 6-8 weeks. The total time required for this study is approximately 4.5 hours for parents and 2 hours for children. Parents can earn up to $165 and children can earn up to $50.

Parents and children will both be asked to participate, and all participation will be remote.Over the course of 6-8 weeks, parents will answer 3 sets of questionnaires in addition to completing 2-3 hour long interactive program. Parents will also be asked to participate in a recorded discussion task with their child, and will be invited back for a short interview as the final task.Children will answer 2 sets of questionnaires at the beginning and end of the study, and will also participate in the recorded discussion task with their parents.

215

No
 

Chardee Galan
Chardee Galan - at dreamlab@psu.edu or 626-205-5563
Psychology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00023214
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Inclusion Criteria:
Non-Hispanic, White parent and child
Child between the ages of 10-14 years old
Child in 5th through 8th grade
Parent and youth are fluent in English
Parent and youth have access to devices with WiFi

Exclusion Criteria:
Parent or youth identify as any race/ethnicity other than non-Hispanic White, including multiracial individuals that identify as White
Family does not have reliable internet access or access to a device that can appropriately display the virtual program.
Parent or children does not speak or read sufficient English
Youth or parent/caregiver has an intellectual disability, autism spectrum disorder, or other disorder that may limit ability to complete study (surveys and interviews require sustained attention, mental processing, and comprehension)
Children's Health, Education, Mental & Behavioral Health
Not applicable
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Effects of increased interstitial pressure on venous distension reflex

The purpose of this study is determine if an increase in interstitial pressure has an effect on the venous distension reflex.

This study involves a single visit with 2 trials.You will receive an infusion of saline in your arm before and after a procedure to cause a temporary swelling in your arm.

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

Yes
 

Takuto Hamaoka
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
STUDY00019302
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Inclusion Criteria:
Men and women of any race or ethnicity
Healthy (no major disease)
Between 21-60 years old
Weigh over 110 punds

Exclusion Criteria:
Are not between 21-60 years old
Pregnant or nursing women
Have a major disease (heart, lungs, kidney, diabetes, cancer)
High blood pressure
metal implants or claustrophobic
Men's Health, Heart & Vascular, Women's Health
Not applicable
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Hershey, PA ,

A Phase III, Randomised, Double-blind Study to Evaluate theEffect of Balcinrenone/Dapagliflozin, Compared withDapagliflozin, on the Risk of Heart Failure Events andCardiovascular Death in Patients with Heart Failure and ImpairedKidney Function (BalanceD-HF, D6402C00012))

The study is being done to determine whether dalcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of cardiovascular death and heart failure events with and without hospitalization

Sign consent form, attend scheduled study visits, undergo an echocardiogram (if applicable) and electrocardiogram, complete pregnancy test (if applicable), undergo physical examination, vital signs, height and weight measurements, complete study questionnaires, provide urine and blood samples for the study, take study medication as directed.

up to $1,600

Yes
 

Umar Farooq
PSHVIResearchCoordinators@pennstatehealth.psu.edu 717-531-5967
Medicine: Nephrology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06307652
STUDY00024754
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Inclusion Criteria:
recent heart failure event
being treated for heart failure
undergoing treatment for decreased kidney function

Exclusion Criteria:
chest discomfort, heart attack or stroke within last 3 months
major heart surgery within the past 3 months
complicated heart defects at birth or severe uncorrected valve disease
Kidney & Urinary System, Heart & Vascular
Experimental drug compared to an approved drug
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Hershey, PA ,

Student Housing Assessment

The primary objectives are to identify why students choose where they live; what is their perception of value for housing; is this value based on their home city/state/country; how are they paying for housing costs; if their parents are paying for the housing, what perception of value do the parents have, what is their economic status, what is their home owning status, etc.

No
 

Mallory Meehan
Mallory Meehan - at mmm446@psu.edu
Institute for Real Estate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00010798
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Inclusion Criteria:
Undergraduate Student
Graduate Student
Enrolled and living at University Park

Exclusion Criteria:
Non-student
Education
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Expanding Family Foundations to 2nd-Time Parenthood - Focus Group

This focus group study, funded by Penn State's Social Science Research Institute, brings together couples with preschool-aged firstborns who are pregnant with their 2nd child or who have given birth to their 2nd child within the last 12 months. Couples will be interviewed about how they worked together as a team (as coparents) to prepare their firstborn for the birth of the second child and to prepare themselves for 2nd-time parenthood.

Yes
 

Douglas Teti
Douglas Teti - at dmt16@psu.edu or 814-863-9570
Human Development and Family Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00015968
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Inclusion Criteria:
1.Two-caregiver families, any race or ethnicity, with one or two children: a.One subgroup with one child < 6 years of age and pregnant with a 2nd child b.One subgroup with one child < 6 years of age and an infant between 1-to-12 months of age.
2.Each caregiver is over 18 years of age.
3.Caregivers are living together in the same household and are either married or living with a partner.
4.Families living independent of parents’ families of origin.
5.Both caregivers fluent in communicating in English.

Exclusion Criteria:
1.One or the other caregiver cannot understand or speak English
2.Caregivers are under 18 years of age.
3.Caregivers not living together
4.Caregivers not living independently of their families of origin
5.Single-parent families with no live-in partner.
Children's Health, Prevention, Mental & Behavioral Health
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Altoona, PA ,
Carlisle, PA ,
DuBois, PA ,
Erie, PA ,
Greater Philadelphia Area, PA ,
Greater Pittsburgh Area, PA ,
Harrisburg, PA ,
Hazleton, PA ,
Hershey, PA ,
Mont Alto, PA ,
Reading, PA ,
Schuylkill Haven, PA ,
Sharon, PA ,
State College, PA ,
Wilkes-Barre/Scranton Area, PA ,
Williamsport, PA ,
York, PA ,

A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2002 in Participants With Hereditary Angioedema

This study will investigate the effects of NTLA-2002 on people with Hereditary Angioedema (HAE). NTLA-2002, which consists of a CRISPR/Cas9 gene editing system, is designed to limit production of plasma kallikrein in the liver cells by acting on the KLKB1 gene. This means NTLA-2002 would permanently change the DNA in the liver cells so less plasma kallikrein would be produced. Lower levels of plasma kallikrein may result in fewer HAE attacks.

During part 1 of the study, participants will either be given NTLA-2002 or placebo (no active ingredients) as an intravenous infusion. Participants will have the option to receive the opposite infusion about 28 weeks later. This study involves getting pre-medications to reduce the chance of an HAE attack and a reaction to the infusion. Study assessments will be preformed to monitor safety. Daily electronic diaries will be completed to monitor for HAE attacks. Also quality of life questionnaires will be completed. If part 1 and part 2 are completed, there are 22 visits. Some of those visits can occur over the phone.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT06634420
STUDY00025612
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Inclusion Criteria:
Males or females 16 years of age or older and Ability to understand and the willingness to sign a written informed consent document
Diagnosis of Hereditary Angioedema Type 1 or Type 2
Access to rescue treatment for Hereditary Angioedema

Exclusion Criteria:
Liver cirrhosis
history of drug or alcohol abuse in the past 3 years
history of active cancer in the past 3 years
Infectious Diseases & Immune System, Allergies
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Stepping and Balance in Young and Older Healthy Adults Walking on Winding Paths

As we walk, we have to stay balanced to avoid falling while also being able to maneuver along various paths that are most often not straight. This study will test younger and older healthy adults walking on paths of varying complexity and difficulty to determine how they negotiate achieving these various task goals. We predict that older adults will have greater difficulty successfully completing these tasks and will use different motor control strategies to do so.

There will be one in-person visit (easy free parking is available). This visit should last no more than 2 hours total.We will ask you to complete a health history questionnaire, do some basic visual assessments, and physical assessments. Your height, weight, and blood pressure will also be taken. After screening, you will walk on a treadmill in a virtual reality environment. We will ask you to walk on various different paths. Your task will be to stay on a path that may be windy and/or difficult to see. Treadmill walking will take less than an hour and you can take rest breaks as needed.

$30.00

Yes
 

Jonathan Dingwell
Sarah Overby - at seo5285@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00025096
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Inclusion Criteria:
Age 18-35, or 65 or older
No medications or health conditions that significantly impair your walking ability.
Body Mass Index (BMI) more than 18 and less than 30
Normal corrected vision (≥ 20/40)
Able to walk un-assisted for at least 5 minutes without shortness of breath, chest pain, or joint pain in the legs, neck, or back

Exclusion Criteria:
Not meeting any of the above
Prevention
Not applicable
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State College, PA ,

PSCI 24-139 NRG-BN013: PHASE III TRIAL OF SINGLE FRACTION STEREOTACTIC RADIOSURGERY (SRS) VERSUS FRACTIONATED

This trial will examine if disease progression improves with Fractionated vs. Steriotactic Radiosurgery.

Participants must agree to the type of radiation they are randomized, keep all appoiintments and rpoert any side effects.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06500455
STUDY00026009
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of one of the following solid tumor malignancies within 5 years prior to registration:
Patients must have at least 1 and up to 8 total intact brain metastases
All brain metastases must be located outside of the brainstem
No more than 2 lesions planned for resection
No known leptomeningeal disease

Exclusion Criteria:
Not Pregnant and Not Nursing
No prior radiotherapy to the brain
No active infection
No hepatic insufficiency
No chronic obstructive pulmonary disease exacerbation
Cancer
Not applicable
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Hershey, PA ,

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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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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