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583 Study Matches

Phase 2 Study of Bladder-SparIng ChemoradiatioN with Durvalumab (PSCI# 19-072) (EA8185)

The purpose of this study is to compare the usual treatment of chemotherapy and radiation to adding MEDI4736 (durvalumab) immunotherapy to the usual treatment. The addition of MEDI4736 (durvalumab) immunotherapy to the usual treatment may help shrink your cancer better than the current standard of care or usual approach for bladder cancer. But, it could also cause side effects, which are described in the risks section.This study will help determine if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the life of patients by 6 months or more compared to the usual approach.

If you decide to take part in this study, you will either get chemotherapy and radiation for 6-8 weeks, or you will get durvalumab immunotherapy in addition to chemotherapy and radiation for 6.5-8 weeks. After you finish your study treatment, your doctor will continue to follow you for up to 3 years. The follow-up will consist of visits to his or her office and CT scans of the bladder.

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
NCT04216290
SITE00000823
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Inclusion Criteria:
Patient must have an ECOG Performance Status of 0-2 at the time of registration.
Patient must have histologically proven pure or mixed urothelial cancer of the bladder.
Patient must be ≥ 18 years of age.
Must have adequate renal function as evidenced by calculated (Cockcroft’s formula) creatinine clearance or 24 hours actual creatinine clearance ≥ 30mL/min.
Patient must have a life expectancy of at least 12 weeks, as determined by the treating physician.

Exclusion Criteria:
Patients with clinical N3 disease are ineligible.
Patient must not have received any previous radiation therapy to the pelvic area.
Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
Patients with a negative biopsy of nodes determined to be suspicious on imaging are not eligible.
Small cell carcinoma is excluded, however other variant histologies are permitted provided a component of urothelial carcinoma is present.
Cancer
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Hershey, PA ,

A Multicenter, Open-Label, Single Group Clinical Trial to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab (CD14152) in Pediatric Subjects (aged 2 to 11 years) with Moderate-to-Severe Atopic Dermatitis

Atopic Dermatitis: Open Label, 64 weeks study. Injectable medicine. Males/Females 2-11 years with moderate to severe atopic dermatitis. The goal of the study is assess the uptake of the drug by the body and safety of nemolizumab administered with topical corticosteroids.

Participants will attend in person visit at the Dermatology Clinical Trial office. Dr. Zaenglein is the pediatric dermatologist in charge of this research study and will do all skin evaluations. In addition at different time points there will be blood that is drawn, questionnaires to be completed, and ECGs will be performed.

Study coordinator will discuss.

Yes
 

Andrea Zaenglein
Amy Longenecker - at alongenecker@pennstatehealth.psu.edu or 717-531-5136
Dermatology (HERSHEY)
 

Female
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT04921345
SITE00001016
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Inclusion Criteria:
Ages 2-11 years old
Diagnosed with Moderate to Severe Atopic Dermatitis
Willing to attend all study visits and follow directions

Exclusion Criteria:
Certain treatments for atopic dermatitis are not allowed; study coordinator will discuss
Had a documented asthma exacerbation requiring hospitalization in the past 12 months.
Weigh less than 22 pounds
Skin Conditions
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Hershey, PA ,

A PHASE 2, MULTICENTER, PLACEBO-CONTROLLED,RANDOMIZED, DOUBLE-BLIND, 48-WEEK STUDY TOEVALUATE THE EFFICACY AND SAFETY OF COMBINATIONTHERAPY OF K-877-ER AND CSG452 IN PATIENTS WITHNONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH)WITH LIVER FIBROSIS

This is a Phase 2, multicenter, double-blind, randomized, 52-week study to assess the efficacy and safety of K-001 medication compared with placebo in subjects with noncirrhotic NASH with liver fibrosis. This study will look at a study drug, called K-001, for participants with a liver condition called noncirrhotic nonalcoholic steatohepatitis (NASH). This condition is defined by a build-up of fat in the liver, which causes liver damage and inflammation. Due to this damage, the liver does not work as well. If left untreated, NASH can lead to liver fibrosis (scarring of the liver), liver cancer, or liver failure. K-001 is a once daily pill that contains combination of two medicines: K-877-ER and CSG452. The purpose of the study is to find out whether the study drug works and how safe it is in participants diagnosed with NASH with liver fibrosis. To answer these questions, the study drug will be compared with a placebo.

There will be 10 in person visits over 52-week study period. Various procedures will be completed such as a fibroscan, ECG, liver MRI, liver biopsy, blood draws. You will be randomly assigned by chance (like the flip of a coin) to receive the study drugs or placebo (inactive substance). You will be taking a pill once daily.

$1310

Yes
 

Jonathan Stine
Nataliya Smith - at nsmith9@pennstatehealth.psu.edu or 717-531-0003, ext=320223
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05327127
STUDY00023757
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Inclusion Criteria:
Age ≥18 years
NASH diagnosis
Stage 1, 2 or 3 fibrosis

Exclusion Criteria:
Causes of liver disease other than NAFLD
Chronic alcohol or drug abuse
Cirrhosis
History of liver transplant, or subjects listed for liver transplantation
Inability to provide informed consent
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Mental wellbeing during the Covid-19 pandemic: a study of essential workers and social media use

Through in-depth interviews, we examine how the Covid-19 pandemic has impacted the daily lives and mental well-being of essential workers, as well as their use of social media.

No
 

Saeed Abdullah
Johnna Blair - at jlb883@psu.edu
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00015851
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Inclusion Criteria:
Considered an “essential worker”---working outside of their homes during the Covid-19 pandemic (e.g. front line medical professionals, paramedics, hospital workers, grocery store employees, delivery drivers, factory workers, etc.)
Social media users (e.g. Twitter, Instagram, Facebook)
Adults 18 or older
Social media users

Exclusion Criteria:
Considered "non-essential" workers during the Covid-19 pandemic
those working from home during the Covid-19 pandemic
minors (those under 18)
those who do NOT use social media
Men's Health, Mental & Behavioral Health, Women's Health
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A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects with Relapsed/Refractory Follicular Lymphoma

The purpose of this study is to determine how effective and safe axi-cel is compared to standard of care, specifically chemo-immunotherapies, and use this information to determine the best choice of treatment in Subjects with Relapsed/Refractory Follicular Lymphoma

Attend all study visits receive study drug or SOChave blood drawn for various testsECHO or MUGA, ECG, PET/CT, and MRI if neededbone marrow biopsy if neededComplete questionnaires

Yes
 

Shin Mineishi
PSCI-CTO ONeal - at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471, ext=343429
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05371093
SITE00001300
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Inclusion Criteria:
Histologically-confirmed FL (Grade 1, 2, or 3a) per local diagnosis.
R/r disease as defined as one of the following options: a) First-line systemic chemoimmunotherapy and high-risk disease, defined as relapse or progression within 24 months of initiation of the initial course of chemoimmunotherapy (ie, POD24)
Clinical indication for treatment local symptoms due to progressive or bulky disease, systemic B symptoms, compromised organ function due to disease progression, cytopenias due to marrow involvement, or symptomatic extranodal disease.
At least 1 measurable lesion per the Lugano Classification
No known history or suspicion of central nervous system (CNS) lymphoma involvement

Exclusion Criteria:
History of large B cell lymphoma or history of transformed FL at any time during the subject’s lifetime including at the time of screening
FL Grade 3b
Small lymphocytic lymphoma
Lymphoplasmacytic lymphoma
Full-thickness involvement of the gastric wall by lymphoma
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis

Restrictive (vs liberal) fluid treatment strategy during the first 24 hours of resuscitation for sepsis-induced hypotension will reduce 90-day in-hospital mortality.

Yes
 

Lawrence Kass
Nancy Campbell RN - at ncampbell1@pennstatehealth.psu.edu or 717-531-1707, ext=3
Emergency Medicine (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT00343402
SITE00000005
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Inclusion Criteria:
Age > 18 years
Suspected or confirmed infection
Sepsis induced hypotension

Exclusion Criteria:
> 4 hours from start of hypotension
> 3 L intravenous fluids
Pregnancy
Severe volume depletion
Immediate surgical intervention planned
Infectious Diseases & Immune System, Heart & Vascular
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Hershey, PA ,

Smart Connected Water Bottle and Lighting Devices: A Prenatal Pilot Study

We will conduct a pilot study to test feasibility of an innovative light device and blue-light glasses for promoting better sleep and a novel, smart water bottle for proper hydration. We will also examine women’s sleep and hydration behaviors in relation to their perceptions of pain, and obtain feedback from the participants on the overall patient intervention content to reduce prescription opioid use and promote behavioral pain management strategies after delivery.

Currently recruiting pregnant women who are in their 2nd or 3rd trimester.Attend a pre-session (in person OR remote) to explain the use of the water bottle, lighting devices, activity monitors, and weight scaleUse the devices for 22 days and complete surveys in your own homeAttend a post-session (in person OR remote) to return devices and participate an interview about the last 22 days

$100

Yes
 

Danielle Downs
Abigail Pauley - at amp34@psu.edu
Kinesiology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019938
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Inclusion Criteria:
Pregnant
2nd or 3rd trimester
18-45
Reside around State College, PA

Exclusion Criteria:
Sleep apnea/diagnosed sleep disorders
Diagnosed eating disorders/extreme dietary restrictions
Currently diagnosed with gestational diabetes
Currently diagnosed with pre-eclampsia
Not pregnant
Pregnancy & Infertility, Sleep Management, Women's Health
Survey(s)
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State College, PA ,

The Effects of Aircraft Seat Width on Passenger Comfort

The objective of this research is to determine the relationship between aircraft seat width and passenger comfort. Airlines are reducing the sizes of seats and improving their ability to fly planes at or near capacity. The combined effect is to decrease the quality of the experience of passengers. This work will help us to understand the degree to which comfort has been reduced.

Yes
 

Matthew Parkinson
Ritwik Biswas - at AirplaneResearch@psu.edu
School of Engineering Design and Innovation (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00012135
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Inclusion Criteria:
We are particularly interested in small and large participants.
You must be a healthy adult aged 18 years or older.

Exclusion Criteria:
Individuals under 18 years of age are not eligible.
Muscle & Bone, Mental & Behavioral Health
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State College, PA ,

PSCI 21-158 Radiopaque Hydrogel Rectal Spacer for Prostate Cancer Radiation Image Guidance

Prior to enrollment, potential subjects will be evaluated during the Screening Period to determine eligibility. The following assessments will be performed during the Screening Period:●Review of eligibility ●Placement of hydrogel spacer and fiducial marker after eligibility is determined Visit 2 or Day 2 or Post-test - Radiotherapy per standard of care.

Prior to enrollment, potential subjects will be evaluated during the Screening Period to determine eligibility. The following assessments will be performed during the Screening Period:●Review of eligibility ●Placement of hydrogel spacer and fiducial marker after eligibility is determinedVisit 2 or Day 2 or Post-test - radiotherapy per standard of care

Yes
 

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

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05650021
STUDY00022554
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Inclusion Criteria:
Untreated cT1 – cT3 prostate cancer
N/A
N/A
N/A
N/A

Exclusion Criteria:
Extracapsular extension
Prior prostate surgery
Prior prostate radiotherapy
N/A
N/A
Cancer
Approved device(s)
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Hershey, PA ,

Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients with Nonalcoholic Steatohepatitis

This study will be a pilot study to evaluate the workability, safety and acceptability of Exercise and Liver FITness (EL-FIT), a mHealth exercise training program previously confirmed in patients with cirrhosis,(1) in patients with Nonalcoholic Steatohepatitis (NASH)

El-Fit NASH (Nonalcoholic Steatohepatitis) is a 9-week intervention trial for patients with NASH. Our goal is to evaluate the workability, safety and acceptability of Exercise and Liver FITness (EL-FIT), a mHealth exercise training program. The El-FIT application allows for participants to access to a library of guided workouts. All patients will be asked to complete a screening visit that includes a physical exam, height, and weight measurements & surveys. Participants will be asked to download the EL-Fit NASH application and use it for 8 weeks. In addition to using the application, participants will be asked to complete 3 check-in phone calls through-out the 8 weeks.

Yes
 

Jonathan Stine
Stine Laboratory at StineLaboratory@pennstatehealth.psu.edu or 717-531-0003, ext=320222
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06195943
STUDY00022771
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Inclusion Criteria:
18 years or older
Evidence of NASH
Posission of a Smart Phone

Exclusion Criteria:
Active cardiac Symptoms
Active or recent participation in exercise training program within the last 90 years
Active or recent weight-loss supplement use within the last 90 days
Active illicit substance use
Cancer that is active
Digestive Systems & Liver Disease, Sports Medicine
Not applicable
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Hershey, PA ,

Phase II Study of Bendamustine and Rituximab plus Venetoclax in Untreated Mantle Cell Lymphoma over 60 Years of Age

This study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination .

This study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination .

Yes
 

Seema Naik
CI-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
NCT03834688
STUDY00013967
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Inclusion Criteria:
Must have histologically confirmed (biopsy-proven) diagnosis of mantle cell lymphoma (MCL)
Must have measurable or evaluable disease as defined as a lymph node measuring >1.5 cm in any dimension or splenomegaly with spleen >15 cm in craniocaudal dimension
ECOG performance status of 0-2
Adequate organ function as measured by the criteria
Total Bilirubin ≤ 1.5x upper limit of normal (ULN) or ≤ 3x ULN with documented Gilbert’s syndrome

Exclusion Criteria:
Should not have known evidence of central nervous system (CNS) lymphoma
Should not have prior chemotherapy, radiotherapy or immunotherapy for lymphoma
Must not have received a prior allogeneic stem cell transplant or solid organ transplant (except for cornea) for any indication
Must have no active, uncontrolled infections
Must not have active hepatitis B or be chronic carriers of hepatitis B.
Cancer
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Hershey, PA ,

A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer (NRG-BR004) (PSCI# 20-136)

The purpose of this study is to compare the usual treatment plus placebo to the usual treatment plus atezolizumab. The addition of atezolizumab to the usual treatment could stabilize your cancer. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the atezolizumab lengthens the time during and after the treatment of your cancer that you live with your cancer and it is stable. Atezolizumab is already approved by the FDA for use in non-small cell lung cancer and urinary cancer. Its use in this study is considered experimental. There will be about 600 people taking part in this study.

pt will initially get the chemotherapy drug paclitaxel or docetaxel along with trastuzumab, pertuzumab, and either placebo or atezolizumab.

Yes
 

Monali Vasekar
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
NCT03199885
SITE00000916
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Inclusion Criteria:
Patient must have an ECOG Performance Status of 0 or 1
Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease, or metastatic disease
Adequate hematologic function within 14 days prior to randomization
Localized palliative radiation therapy is allowed for symptom management if completed 14 days or more prior to randomization
Adequate renal function determined within 14 days prior to randomization

Exclusion Criteria:
Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded
History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body surface area or its equivalent
Prior treatment with mTOR inhibitors or CDK 4/6 inhibitors in combination with endocrine therapy for treatment of metastatic disease
History of asymptomatic LVEF decline to < 40% during or after prior HER2-targeted therapy
Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including antiCD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Cancer
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Hershey, PA ,

Psychopathy and Affective Priming

This is a study which examines whether priming for fear can influence affective empathy in persons high in psychopathic traits.

No
 

Daniel Komar
Daniel Komar - at dzk231@psu.edu
Behavioral Sciences and Education (HARRISBURG)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00015164
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Inclusion Criteria:
Adults over the age of 18
Able to read and write in English

Exclusion Criteria:
Persons unable to read and write in English
Persons under the age of 18
Mental & Behavioral Health
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Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin

The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment drug (durvalumab), to the usual therapy of radiation plus the drug (cetuximab) in patients with head and neck cancer who cannot take the drug cisplatin.

The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment drug (durvalumab), to the usual therapy of radiation plus the drug (cetuximab) in patients with head and neck cancer who cannot take the drug cisplatin.

Yes
 

Mitchell Machtay
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
NCT03258554
SITE00000527
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Inclusion Criteria:
squamous cell carcinoma
18 or older
Adequate hematologic function
Adequate hepatic function
Adequate renal function

Exclusion Criteria:
invasive malignancy within the past 3 years
Prior radiotherapy
Prior immunotherapy
Major surgery within 28 days prior to Step 1 registration
Uncontrolled hypertension
Cancer
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Hershey, PA ,

Hand Action and Perception in Parkinson's Disease

The purpose of this research study is 1.) to determine if Parkinson’s Disease (PD) causes changes in the way that people sense the movements of and forces produced by their bodies, and to connect any of these changes in sensation to changes in the brain, and 2.) to identify how changes in movement might come from different parts of the nervous system. This study will use a combination of electromyography, via electrodes placed on the skin, and finger force recordings to infer how PD affects patients' sense of force production, and the neural mechanisms underlying this change.

This study requires a single in-person visit. We will use adhesive skin sensors on the forearms to measure muscle activity. At the same time, we test the participant's finger strength and then ask them to press with moderate force on piano-key-like sensors. Participants will be asked to match force levels between hands and to move an on-screen cursor into a target.

$40.00

Yes
 

Janina Prado Rico
Janina Prado-Rico - at jpradorico@pennstatehealth.psu.edu
Neurology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00020063
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Inclusion Criteria:
Persons diagnised with Parkinson's disease or Essential Tremor, age 40-85, or subjects without Parkinson's disease, age 21-85
No history of earning disability, neurodevelopmental disorder, seizures, multiple concussion (> 3), cerebrovascular disease, brain tumor, hydrocephalus, or any CNS disease other than PD.
No present carpal tunnel syndrome, cervical myelopathy, brachial plexopathy, hand pain, or another neuromusculoskeletal disorder affecting hand function
No history of alcohol and/or drug abuse.

Exclusion Criteria:
History of specialized hand training such as professional musicianship.
Neurology
Not applicable
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Hershey, PA ,

Effects of fasting on blood protein levels

Up to 50 older adults (age 60+ years) will participate in a two-visit CRC study with blood sampling (40 ml per visit) occurring before and after a breakfast meal. Specifically, there will be four (10 ml) blood draws during each of the visits, with each blood draw timed one hour apart (T1 to T4). The two visits (short- and long-fasting) will be randomly assigned and counterbalanced for the order in which they occur and will occur at least a week apart. During the short-fasting visit, participants will arrive fasting and be given breakfast after the second blood draw (T2). During the long-fasting visit, participants will arrive fasting and be given breakfast after the fourth blood draw (T4). Aside from blood draws, and vitals obtained at the start of each visit, participants will be seated comfortably in a chair in a small room by themselves. They will be checked upon periodically to ensure they are not falling asleep, they are comfortable, etc. They will also be given a small packet of written questionnaires to complete after T1 and after T3 (i.e., after the 1st and 3rd blood draws). Each visit will be between 3.5 and 4 hours.

There will be two in-person visits both will include four blood draws.

$100 total

Yes
 

Christopher Engeland
Abigail Smith - at ajs8854@psu.edu or 814-867-5428
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00021531
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Inclusion Criteria:
Men and women between the ages of 60-90
Fluent in English
Vaccinated for COVID-19

Exclusion Criteria:
Non-ambulatory
Having current severe psychiatric symptoms that interfere with testing
Alcohol or substance abuse, chronic medicinal use of opioids, glucocorticoids, anti-inflammatories, or active cancer treatment in the last 12 months
Education
Survey(s)
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State College, PA ,

PSCI 23-012 THE JANUS RECTAL CANCER TRIAL: A RANDOMIZED PHASE II TRIAL TESTING THE EFFICACY OF TRIPLET VERSUS DOUBLET CHEMOTHERAPY TO ACHIEVE CLINICAL COMPLETE RESPONSE IN PATIENTS WITH LOCALLY ADVANCED RECTAL CANCER

This trial is using long course chemoradiation in combination with three different chemotherapy treatments to treat rectal cancer. Once therapy is completed patients will either have surgery or watch and wait. The goal is to see which therapy is better in achieving a complete response, if any.

Patients will be expected to come to the clinic for all radiation treatments and all chemotherapy treatments.

Yes
 

Mitchell Machtay
PSCI-CTO@pennstatehealth.psu.edu
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05610163
SITE00001341
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Inclusion Criteria:
Clinical stage II or III rectal adenocarcinoma defined as T4N0 or any T with node positive disease (any T, N+); also T3N0 requiring APR or coloanal anastomosis
Tumor Site: Rectum; ≤ 12cm from the anal verge
No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed.
Not pregnant and not nursing,
Age ≥ 18 years

Exclusion Criteria:
No upper rectal tumors (distal margin of tumor >12 cm from the anal verge)
No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis
No known mismatch repair deficient rectal adenocarcinoma
Cancer
Approved drug(s)
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Hershey, PA ,

AWS-PSU: Active Women's Study at Penn State University

AWS-PSU: Active Women's Study at Penn State University This research study is being conducted to evaluate the impact of exercise and reproductive function on bone strength. Eligible young women (age 18-30) are those that are generally healthy and either a) exercising and experiencing regular or irregular menstrual cycles, or b) not exercising and experiencing regular menstrual cycles.

Yes
 

Mary Jane De Souza
Nicole Aurigemma - at nca11@psu.edu or 814-863-4488
Kinesiology (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
PRAMS00043507
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Inclusion Criteria:
Regular or irregular menstrual cycles
Age 18-30
BMI between 16-29.9
No hormonal contraception for 6 months

Exclusion Criteria:
Smoking
Currently using medication impacting bone
Food & Nutrition, Muscle & Bone, Women's Health
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State College, PA ,

PLS Natural History Study

This study will provide a strong basis and foundation for future clinical trials that use historical controls. The study will collect clinical data and biological specimens to create a dataset and biorepository to be shared with other researchers as a foundation for future clinical trials.

This is a volunteer study for participants diagnosed with Primary Lateral Sclerosis (PLS) or suspected to have PLS by a neurologist. You will be expected to attend scheduled visits in person or by telephone, complete study testing and audio/video recordings. The study includes clinical measurements to assess disease status and motor function, a number of questionnaires, collection of biospecimens including DNA, blood, and urine, and an electromyography (EMG) test. There will be 6 visits over 24 months, of these 6 three will be in-person visits (2-3 hours) and the other three will be telephone calls (lasting about 45 minutes to an hour). Blood and urine samples will be collected during these visits.

$100 per in person visit (three) and $50 for telephone visit (three) completed.

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
STUDY00018274
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Inclusion Criteria:
Adult participants (≥ 25 years of age)
Symptom onset was no more than 15 years prior to baseline
Ability to independently walk with or without an assistive device (e.g., walker) at the baseline evaluation
In cases where a molecular test has been done prior to enrollment in this study, HSP or HSP-related mutations are negative
Expected to have at least some bulbar symptoms (dysarthria, dysphagia, drooling or pseudobulbar affect); however, the absence of these symptoms will not exclude participants when molecular testing is negative for known HSP

Exclusion Criteria:
Unwilling or unable to give informed consent
UMN symptoms and signs only in the legs
Unwilling or unable to visit the study site asrequired
Clinically obvious cognitive impairment that precludes obtaining informed consent, as determined by the site PI
Participating in clinical treatment trials
Neurology, Muscle & Bone, Mental & Behavioral Health
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Hershey, PA ,

Phase III Trial of MEDI4736 (durvalumab) as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 NSCLC (EA5181) (PSCI# 21-041)

The purpose of this study is to compare the usual approach of chemo/radiation followed by one year of MEDI4736 (durvalumab) to chemo/radiation with MEDI4736 (durvalumab) followed by one year of MEDI4736 (durvalumab). The addition of MEDI4736 (durvalumab) during chemo/radiation could prevent your cancer from returning and extend your life. But, it could also cause side effects.This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study drug extends the life of patients and/or prevents the tumor from coming back as compared to the usual approach.This drug, MEDI4736 (durvalumab), is already approved by the FDA for use in other cancers, and for use in your type of cancer after the completion of chemotherapy and radiation. At this time MEDI4736 (durvalumab) is not yet approved (experimental) when given with chemotherapy and radiation. There will be about 660 people taking part in this study.

The purpose of this study is to compare the usual approach of chemo/radiation followed by one year of MEDI4736 (durvalumab) to chemo/radiation with MEDI4736 (durvalumab) followed by one year of MEDI4736 (durvalumab). The addition of MEDI4736 (durvalumab) during chemo/radiation could prevent your cancer from returning and extend your life. But, it could also cause side effects.This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study drug extends the life of patients and/or prevents the tumor from coming back as compared to the usual approach.This drug, MEDI4736 (durvalumab), is already approved by the FDA for use in other cancers, and for use in your type of cancer after the completion of chemotherapy and radiation. At this time MEDI4736 (durvalumab) is not yet approved (experimental) when given with chemotherapy and radiation. There will be about 660 people taking part in this study.

Yes
 

Patrick Ma
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
NCT04092283
SITE00000978
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Inclusion Criteria:
Patient must be = 18 years old.
Patient must have an ECOG Performance Status of 0 or 1.
Body weight > 30 kg of patients.
Patient must not have unintentional weight loss > 10% within 30 days prior to registration.
Patient must have a baseline ECG obtained within 6 weeks of registration.

Exclusion Criteria:
Patient must not have any active, known or suspected autoimmune disease and neuromuscular paraneoplastic syndromes
Patient must not have a history of active hepatitis B (chronic or acute) or hepatitis C infection.
Patient must not have a known active tuberculosis infection.
Patient must not have any severe infections within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
Patient must not have signs or symptoms of severe infection (sepsis) within 2 weeks prior registration.
Cancer
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CAREER: No Time to Explain: Developing Robots that Actively Prevent Overtrust during Emergencies

The overall goal of this proposal is to develop robots that can help people correctly calibrate their trust in the robot. We look at this problem within the context of robot-guided emergency evacuation. We believe that robots stationed inside of buildings can serve as instantaneous first responders helping people safely evacuate during an emergency, thus saving lives. Participants will be asked to interact with an emergency guidance robot and decide whether to follow the robot to an exit.

Yes
 

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

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00016965
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Inclusion Criteria:
Over 18
Reasonable ability to see

Exclusion Criteria:
Under 18
Cannot see or read the consent form
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State College, PA ,

GPRPL Study

The purpose of this study is to find genetic causes of recurrent pregnancy loss (RPL). RPL is defined by two or more miscarriages under 20 weeks gestation and affects approximately 5% of women.The causes of RPL are not well understood. After all the currently recommended testing for RPL has been done, about half of women with RPL will still have no identifiable cause. This lack of knowledge makes it difficult to provide effective medical care for couples with RPL.This study will compare reading about 20000 genes in the entire human genetic library by whole genome sequencing in the miscarriage material and also your and your partner’s DNA from blood samples. The DNA in a person is a combination of the DNA from each of their biological parents. If you have healthy children we may ask your consent for them to give a blood sample for DNA extraction and testing. Similarly, we may ask the same for other family members such as grandparents if necessary. We may also request your permission to use stored DNA or miscarriage material from previous pregnancy loss if available. Testing of family members or previous miscarriage materials may help to understand DNA sequence variants or changes identified in the miscarriage sample.

There will be a one time collection of blood samples.

Yes
 

Sarah Horvath
OBGYNResearch@pennstatehealth.psu.edu
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
SITE00001050
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Inclusion Criteria:
Women with current pregnancy loss
Two or more prior losses of clinically recognized pregnancies
Prior losses are unexplained

Exclusion Criteria:
Known cause for pregnancy loss and/or prior losses
Pregnancy & Infertility
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Hershey, PA ,

Examine Three Different Functional Analysis Methods Using Innovative Measurements to Identify Their Properties

This study compares three different functional analysis methods using the same measurements to find the better method. Each participant will be assigned one method to produce a diagram using the given method and one online survey after the in-person experiment. Each participant will be given detailed instructions and information regarding the method to ensure there are no knowledge gaps. 

For the experiment, participants will be assigned to a group of four people from different engineering subfields to evaluate a product using one of three functional analysis methods. Each group will be randomly assigned a product to evaluate and a functional analysis method to use. After the experiment, each participant will be asked to complete an online survey asking for their experiences and thoughts. 

Yes
 

Kathryn Jablokow
Haixing Piao - at hbp5181@psu.edu or 856-796-6269
Engineering (GREAT VALLEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00023656
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Inclusion Criteria:
Junior, Senior, Graduate Stduents
Chemical Engieering
Electrical Engineering
Industrial Engineering
Mechanical Engineering

Exclusion Criteria:
Freshmen
Sophmore
Education
Not applicable
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State College, PA ,

Human-Centric Non-Invasive Physiological Sensing System for Early Detection of Workers’ Heat Stress in the Field

This study will examine different structural designs of stretchable, skin-like sensors on the surface of human skin for workers.

There will be one in person visit;Subjects will first be asked to sit still for 3 minutes and then move their skin by the research team for another 3 minutes.

Yes
 

Huanyu Cheng
Huanyu Cheng - at huc@psu.edu or 814-863-5945
Engineering Science and Mechanics (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00020880
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Inclusion Criteria:
no existing skin conditions or open wounds, or other disorders that make them have altered temperature responses
be over 18 years old
must understand English
resources from Penn State, University Park

Exclusion Criteria:
people with a metal allergy
Men's Health, Women's Health
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State College, PA ,

Self-Help for Stress Related to COVID-19

This is a study on internet-based self-help for stress related to the COVID-19 pandemic. College and university students who screen high on perceived stress or measures of risk for anxiety, depression, or eating disorders during the COVID-19 pandemic will be invited to participate in this study. Participants will be randomly assigned to receive access to an internet-based self-help program for stress resilience and coping with the COVID-19 pandemic or care as usual. Symptoms of stress, anxiety, depression, and eating disorders, as well as secondary outcomes, will be assessed via questionnaire at baseline (pre-randomization), one month post-randomization, and three months post-randomization.

Participants will be randomly assigned to receive access to an internet-based self-help program for stress resilience and coping with the COVID-19 pandemic or care as usual. Symptoms of stress, anxiety, depression, and eating disorders, as well as secondary outcomes, will be assessed via questionnaire at baseline (pre-randomization), one month post-randomization, and three months post-randomization.

Up to $50 (raffle-based)

No
 

Gavin Rackoff
Gavin Rackoff - at gnr18@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT04762173
STUDY00015766
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Inclusion Criteria:
Experiencing significant stress related to COVID-19 pandemic
Fluent in English
Current college or university student

Exclusion Criteria:
Unable to provide informed consent
Under 18 years of age
Not a college or university student
Not fluent in English
Mental & Behavioral Health
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Voice Perception Study

This is a voice perception study that asks participants to listen to voices and rate on various attributes such as attractiveness, social status, health, and others.

No
 

Toe Aung
Toe Aung - at txa96@psu.edu or 775-225-1747
Anthropology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00009763
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Inclusion Criteria:
Age 18-40
Gender/Sex: Men/Male; Women/Female
Education: PSU students and participants recruited online

Exclusion Criteria:
Uncorrected severe defects of hearing
Participants who already completed the survey
Participants who took the survey on the mobile phone
Men's Health, Women's Health
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A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients

Study of the safety of unlicensed cord blood units for stem cell transplant of children and adults.

For the treatment arm of this study you will no receive the total body radiation (TBI) as typically given before transplant. In this study you will have various research procedures such as a Blast sample at the screening part of the study, and MRD testing of your bone marrow and blood at screening and through the course of the study. Participation in the treatment arm (Non-TBI) of the study will last up to 5 years.

Yes
 

Robert Greiner
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT01656603
STUDY00015052
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Inclusion Criteria:
You have a disorder affecting your hematopoietic system (the organs and tissues that produce your blood) that is inherited, acquired, or from previous chemotherapy

Exclusion Criteria:
You are receiving licensed cord blood products
You are receiving unlicensed CB products from other CB banks
Blood Disorders, Cancer
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Hershey, PA ,

Emotion in Motion: Behavior and Mental State Analysis on Human Visual Data

The main purpose of the proposed study is to examine the relationship between emotional body expression and internal emotional and psychophysiological processes among individuals with mental disorders in social interaction situations.

In this study, participants will be asked to answer structured questions. After this, participants will be asked to engage in emotional induction tasks, communicate with another person, and walk. During the interview and experimental procedures, your motion will be video recorded. 

40

Yes
 

James Wang
Adam Calderon - at afc6160@psu.edu or 814-863-0115
Information Sciences and Technology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00006792
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Inclusion Criteria:
You are at least 18 years old
Fluent in English
Able to walk at a leisurely pace on a treadmill without assistance

Exclusion Criteria:
Under 18 years old
Not fluent in English
Unable to walk at a leisurely pace on a treadmill without assistance
Experiencing cognitive impairments
Mental & Behavioral Health
Not applicable
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State College, PA ,

Muscular Dystrophy Association Neuromuscular Observational Research (MOVR) Data Hub Protocol

The Muscular Dystrophy Association (MDA) wants to collect information about individuals with neuromuscular disease to better understand the disease progression and ultimately improve the medical care, quality of life, and survival of those with neuromuscular disease. To collect this information, MDA has created a data registry called the Neuromuscular Observational Research Data Hub (referred to as the “MOVR Data Hub”). The MOVR Data Hub is a kind of database — a way of collecting and storing information.

Each person who participates in the MOVR Data Hub will have his/her information collected for as long as the person is being seen at an MDA Care Center and information is still being collected, unless and until the person requests that the information no longer be provided to the MOVR Data Hub.

Yes
 

Mansoureh Mamarabadi
Cristie Crawford - at ccrawford5@pennstatehealth.psu.edu or 717-531-0003, ext=322992
Neurology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
STUDY00012883
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Inclusion Criteria:
Diagnosed with a neuromuscular condition

Exclusion Criteria:
Unwilling to provide informed consent
Neurology
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Hershey, PA ,

Phase III Trial of Concurrent Chemoradiotherapy with or without Atezolizumab (PSCI# 19-044)

The purpose of this study is to compare the effects, good and/or bad, of chemotherapy and radiation therapy with or without the use of atezolizumab, which is used to treat bladder cancer. The combination of chemotherapy, radiation therapy and the immunotherapy atezolizumab is considered experimental.

The purpose of this study is to compare the effects, good and/or bad, of chemotherapy and radiation therapy with or without the use of atezolizumab, which is used to treat bladder cancer. The combination of chemotherapy, radiation therapy and the immunotherapy atezolizumab is considered experimental.If you decide to take part in this study, you will receive combined chemotherapy and radiation therapy which is called “chemoradiotherapy” either with or without the study drug. The chemoradiotherapy you will receive is standard of care and what your doctor thinks is best. You will receive chemoradiotherapy for up to 7 weeks. If you are assigned to the group receiving study drug, you will take the drug for up to 6 months in addition the chemoradiotherapy.Your doctor will continue to follow your condition for up to 5 years after you register to the study, even though you have finished treatment in the first year. Your doctor will watch you for side effects and to see how your cancer affects you. You will have clinic visits at 3 months from the time you stop taking treatment for the first two years and then twice a year for the third year and once a year thereafter until 5 years after you register to the study

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
NCT03775265
SITE00000631
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Inclusion Criteria:
Patients must have histologically proven, T2-T4a N0M0 urothelial carcinoma of the bladder within 70 days prior to randomization.
Patients must undergo radiological staging within 70 days prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI. Patients must not have evidence of T4bN1-3 disease.
Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meets criteria specified.
Female patients of childbearing potential must have a serum pregnancy test prior to randomization.
Patients must be ≥ 18 years of age.

Exclusion Criteria:
Patient must not have received any systemic chemotherapy for their bladder cancer.
Patients must not have received prior treatment for muscle invasive bladder cancer including neoadjuvant chemotherapy for the current tumor.
Patients must not have a major surgical procedure within 28 days prior to randomization.
Patients must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Patients must have adequate bone marrow function as evidenced by all of the following: ANC ≥ 1,500/microliter (mcL); platelets ≥ 100,000/mcL; Hemoglobin ≥ 9 g/dL. These results must be obtained within 28 days prior to randomization.
Cancer
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Hershey, PA ,