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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@pennstatehelath.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 ,

A Phase 2, Double-Blind, Placebo-Controlled Trial of Mycophenolate Mofetil alone or with Voclosporin for Systemic Lupus: Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment

Treatment of Systemic Lupus with mycophenolate mofetil alone or with voclosporin

There will be 16 visit over a years time, physical exam, blood work, ECG, questionnaires

Yes
 

Nancy Olsen
Jamie Carter - at jcarter3@pennstatehealth.psu.edu or 717-531-0003, ext=283833
Medicine: Rheumatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05306873
SITE00001147
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Inclusion Criteria:
18 years and older
Systemic Lupus

Exclusion Criteria:
Pregnant or breast feeding
Arthritis & Rheumatic Diseases
Approved drug(s)
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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 either course credit or an Amazon e-giftcard. 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.

$50

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 Randomised, Double-blind, Placebo-controlled, Multi-centrePhase 2b Study to Evaluate the Efficacy, Safety and Tolerability ofAZD2693 in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) with Fibrosis Who Are Carriers of thePNPLA3 rs738409 148M Risk Allele

This study is a Phase 2b, 52-week randomised, double-blind, placebo-controlled, multi-centre, multinational trial comparing once monthly subcutaneous (SC) administration of AZD2693 in participants with non-cirrhotic NASH (F2-F3) who are homozygous for the PNPLA3 rs738409 148M risk allele. Over the course of the approximately year long protocol, study participants will be screened to determine whether they carry the allele, which is known to place those with the allele at an increased risk for fatty liver disease. Screening will further take place to evaluate a participant's inclusion in the study, to make sure they are an eligible candidate. This screening includes blood work, a physical, and some additional diagnostic tests. If a patient is determined eligible to be randomized, the participant will complete approximately bi-weekly visits for up to a year. These visits will include bloodwork and additional evaluations to make sure they are doing well, as they receive their injections. At the completion of the study, participants will complete a final work up to see if the treatment was safe and effective.

There will be a genetic screening for an allele of the PNPLA3 gene.There will be a further screening period to determine eligibility.There will then be up to 24 visits with up to 10 injections of the study drug or placebo. Visits will require various blood work, biopsies of the liver, ECG's, and questionnaires.

$1600

Yes
 

Jonathan Stine
stinelaboratory@pennstatehealth.psu.edu
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05809934
STUDY00023755
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Inclusion Criteria:
Participants who consent to give blood and buccal swab samples for genetic testing and diagnostic test development for PNPLA3 rs738409 148M who are homozygous carriers (G / G genotype) for the PNPLA3 rs738409 148M risk allele,
Participants who accept to have one liver biopsy performed during the screening period and one at 54 weeks. of PCOS by Rotterdam criteria
Participants with histological evidence of NASH based on central pathologist evaluation of a liver biopsy obtained up to 6 months before randomisation

Exclusion Criteria:
Clinical, imaging, or histological evidence of cirrhosis
Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis, cholestatic liver disease, Wilsons disease, hemochromatosis, etc.).
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Exploring the Concreteness Effect in Expressive and Receptive Language Measures in Healthy Aging as a Comparison for Persons with Aphasia

The concreteness effect is the finding that individuals are faster and more efficient at processing concrete words (e.g., "dog") than abstract words (e.g., "wisdom"). The study will investigate the presence and strength of the concreteness effect in neurologically intact older adults. This data will be used as a control comparison for a group of people with aphasia, a language disorder that commonly results from left hemisphere stroke.

Participants will be asked to complete language and cognition tests that measure attention, memory, problem solving, and language processing on the computer. Participants will be asked to complete two Zoom sessions, each lasting approximately 1.5 hours.

30

No
 

Anna Serrichio
Anna Serrichio - at acs36@psu.edu
Division of Graduate Studies (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023820
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Inclusion Criteria:
Native English Speaker
At least a high school education
40 years of age or older
Access to device with keyboard and internet connection to participate in Zoom sessions

Exclusion Criteria:
History of neurological, developmental, or psychiatric disorders
Below 40 years of age
Language & Linguistics
Not applicable
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Examining Maternal Reward Responsiveness and the Intergenerational Risk for Depression

Children of depressed mothers are at high risk for developing depression, particularly as youth age into adolescence, yet relatively little is known about the mechanism underlying risk for depression in youth with depressed mothers. The present study examines maternal reward responsiveness, measured across neurophysiological, behavioral, and self-report measures as a marker of depression in mothers of adolescents. Associations between maternal reward responsiveness and parenting difficulties often associated with maternal depression, as well as adolescent functioning will be examined, to explore the clinical impact of maternal reward responsiveness on the intergenerational transmission of depression.

Yes
 

Dahlia Mukherjee
Sarah Shahriar - at sshahriar1@pennstatehealth.psu.edu or 717-531-0003, ext=285189
Psychiatry and Behavioral Health (HERSHEY)
 

All
All
This study is also accepting healthy volunteers
STUDY00009643
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Inclusion Criteria:
Female adults 18 years and above with an adolescent child aged 13-16 years
Capacity for informed consent
Fluent in verbal and written English
Adolescent between the ages of 13 and 16 years (inclusive)

Exclusion Criteria:
Diagnosis of autism spectrum disorder, substance use disorders, schizophrenia or other psychotic disorder
Any hearing or visual impairments
Investigator discretion regarding ability to participate in the study
Children's Health, Mental & Behavioral Health, Women's Health
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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 ,

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 ,

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 ,

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Safety and Efficacy of IGV-001, an Autologous Cell Immunotherapy With Antisense Oligonucleotide (IMV-001) Targeting IGF 1R, in Newly Diagnosed Patients With Glioblastoma

The purpose of this study is to see how safe the study medicine, IGV-001 plus standard of care (SOC), is and to compare IGV-001 with placebo (only standard of care) to see if it works in slowing GBM tumor regrowth.SOC refers to the usual medicine(s) or procedures used to treat this cancer.

You will be randomly assigned by chance, like rolling a pair of dice - to receive either IGV-001 or placebo (inactive substance) that will be placed into biodiffusion chambers [dime-sized containers] and surgically implanted in your belly area for approximately 48 hours and then removed. You will have a 66.6% (2 in 3) chance of receiving IGV-001 and a 33.3% (1 in 3) chance of receiving placebo. There is a small chance that you may not receive treatment with IGV-001 or placebo after the abdominal incisions have been made.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04485949
STUDY00016975
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Inclusion Criteria:
Is willing and able to give written informed consent for participation in the study
Is between 18 and 70 years of age at screening
Has a diagnosis of malignant glioma based on the treating neurosurgeon’s best clinical judgement defined using the patient’s symptomology, MRI scan results, and intraoperative frozen section verbal confirmation of malignant glioma.
Has adequate bone marrow and organ function at screening

Exclusion Criteria:
Has bi-hemispheric disease, multicentric disease, or disease burden involving the brain stem or cerebellum based on MRI post-gadolinium enhancement
Has received any previous surgery for tumor removal of GBM
Has recurrent glioma, a concurrent malignancy
Has any severe immunocompromised condition
Is receiving any other investigational agent(s) or has received an investigational agent within 30 days prior to screening
Cancer
Experimental drug compared to a placebo/”sugar pill”
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Hershey, 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
Prefer not to display
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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
Neurology (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 ,

Pilot study examining adherence to and efficacy of the quitSTART smoking cessation smartphone application

The goal of this pilot study is to collect preliminary information about the effectiveness of a smoking cessation app called quitSTART, which is a product of Smokefree.gov created by the Tobacco Control Research Branch at the National Cancer Institute. The app is available to the public for download at no cost. The aims of the project are: 1) to measure how participants respond to the app and how they use it during an attempt to quit smoking; and 2) receptivity and adherence rates to the app; 2) to examine whether participants reduce or discontinue smoking while using the app.

The study is designed to test the efficacy of a smoking cessation smartphone app and has three parts. For the first part, participants are asked to watch an orientation video about the study, fill out questionnaires, and watch a video tutorial explaining how to use a smartphone app. Then, for the second part of the study, participants are asked to use the smoking cessation app to help them with their quit attempt for 30 days. Finally, for the third part of the study, participants are asked to complete an exit survey about their experience using the app after 30 days.

$20

No
 

Stephen Wilson
Stephen Wilson - at sjw42@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00021797
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Inclusion Criteria:
Must be 21-65 years old
Must smoke cigarettes everyday
Must own and regularly use a smartphone
Must be planning a quit attempt within the next month
Must be willing to use a smartphone app to assist them during a quit attempt

Exclusion Criteria:
Meet criteria for current dependence on a substance other than nicotine
Previously used the quitSTART smartphone app
Smoking, Vaping, Nicotine and Tobacco
Survey(s)
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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 ,

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
I'm interested
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