Search Results

The purpose of this study is to find out if gene expression signatures are different in people with cancer associated dermatomyositis (CAM) and CAM negative (CAM-) patients. Dermatomyositis (DM) participants will provide up to 3 blood samples and 2 skin samples for testing, including testing that has to do with genes. Control participants (those who do not have a skin condition) will provide up to 2 skin samples for testing, including testing that has to do with genes.

Only control subjects are being recruited through StudyFinder. There will be one in-person visit where up to 2 skin samples will be collected using a punch biopsy.

$50.00 per skin sample

Ewing sarcoma (EWS) and osteosarcoma primarily affect adolescents and young adults. Common treatments include chemotherapy, surgery and radiation, however, there have been few recent advancements in the standard of care. By incorporating eflornithine (DFMO) as an additional therapy and/or maintenance therapy we hope to safely observe improved event-free survival and overall survival. There are 5 cohorts covered under this master protocol.

Patients will come in for screening and at the start of the study, and then approximately once a month during chemotherapy (if applicable). Patients may need to be seen more often for standard of care. During the DFMO alone phase, patients will come in once a month for the first 3 months, and then once every 3 months until the end of study treatment. During these visits patients will have tests done which may include a physical exam, blood tests, cardiac tests, hearing tests, or tumor evaluations.

Participants will be asked to use a nicotine pouches, with either 3, 6, or 9mg of nicotine, in the laboratory while blood samples are collected. The study will measure the nicotine delivery and related effects of using nicotine pouches among current tobacco product users.

Participants will be asked to attend one study visit lasting approximately 1.5 hours. Participants will be asked to use a nicotine pouch in either 3, 6, or 9mg of nicotine while blood samples are collected.

175

The purpose of this Expanded Access Program is to determine the safety of cretostimogene in patients with BCG -unresponsive high-risk Non Muscle Invasive Bladder Cancer and to determine the Complete Response rate at any time of cretostimogene in patients with BCG-unresponsive CIS with or without HG Ta/T1 papillary NMIBC

Eligible participants will receive the study drug, Cretostimogene every week for 6 treatments, followed by a maintenance period as directed by the Investigator. There are 3 phases in the study: Screening Phase, Treatment Phase, and Follow-Up Phase. The Screening Phase will last up to 16 weeks (4 months). The Treatment Phase can continue for up to 2 years from the start of study treatment unless your cancer gets worse or recurs. The Follow-Up Phase will include one visit every 3 months after the last study treatment. If your cancer has not come back but you stop treatment before the end of the Treatment Phase, you will also have a study visit every 3 months in the Follow-Up Phase to confirm whether your cancer gets worse or recurs, until 2 years after the start of treatment. If your cancer has gotten worse or recurs at any point during the study, you will not be scheduled to return to the clinic/hospital for the study after the final visit, but you will be contacted approximately every 6 months.

This trial will examine if the dose of drug determined in the Phase `1 portion can stop the cancer from growing.

There will be a screening period after you sign consent. You will have labs drawn and scans done to make sure it is safe for you to participate in this study. During the first 2 cycles, you will need to come to the clinic a total of 6 times. We do this to make sure you are feeling ok while taking these study medications. From C3 onward you will only need to come into the clinic twice. You will need to keep all of your clinic appointments, tell the study doctor how you are feeling and make sure that you tell them about any and all medications you are taking.

This trial are looking at GIREDESTRANT to see if that combined with another drug, will work better and keeping breast cancer in remission after progressing on a CDK inhibitor.

Participants must come into the clinic to learn about the study and sign consent. Once it has been determined that it is safe to participate, participants must come to the clinic every other week for the first two cycles for a check up to see how they are feeling. This way the study doctors knows that it is safe to continue the study drugs. After the first two cycles you will come to the clinic once a month. You will have a physical exam, blood drawn and periodically through the study, scans to see how your cancer is responding to the study treatment. You will continue on the study therapy until your cancer no longer responds to it, you do not want to take the treatment any more or the study doctor feels it is unsafe for you to continue the study treatment.

The purpose of this voluntary research study is to find out if cemiplimab and fianlimab with or without ipilimumab can shrink or stop advanced or metastatic clear cell kidney cancer from growing. This research study will include a screening period, a treatment period, and a follow up period, and participation may last up to five years

Participant will need to complete several screening tests. If participant qualifies for the study, participant will be asked to receive one of the study treatment combinations. Cemiplimab, fianlimab, and ipilimumab, or Cemiplimab and fianlimab, or Ipilimumab and nivolumab. Participant will continue receiving assigned combination for up to 96 weeks (about 22 months). Have regular tests and assessments, which may include physical exams, blood tests, imaging scans, and other procedures needed for your safety and for study purposes.

This is a Phase 3 study for Induction treatment of ulcerative colitis to evaluate safety and efficacy of duvakitug. The subjects are going to be enrolled in either the open label induction (Study-1), or placebo controlled induction (Study-2) across the study sites. All the participants who respond to treatment can be randomized into maintenance treatment.. The participants who do not respond to treatment will be eligible for an extended induction. The subjects must sign the informed consent before any procedures. the screening period will be for 5 weeks, and the Induction treatment will last 12 weeks. There will be six drug administrations in the induction treatment by subcutaneous injections. The participants will have in person visits, and will have procedures done such as blood draws, physical examination, endoscopy with biopsies, and completing questionnaires.

Participants will attend in person visit at the research clinical facility in Hershey, PA. If they sign the informed consent and want to participate, they will have vital checked, physical examination done. They will provide specimens such as blood and stool. They will answer questionnaires at home and in the clinic. The endoscopy will be done with biopsy to evaluate the disease response to the treatment. The drug will be administered by subcutaneous injection in the clinic. There will be a compensation for every completed visit.

$1400

Everyday actions like typing, playing an instrument, or reaching for a series of objects require the brain to hold a plan in memory and then carry it out as a smooth sequence of movements. This study examines how people use vision, short-term (working) memory, and attention to plan and coordinate sequences of reaching movements. Participants memorize short sequences of targets shown on a screen and then reach to them in order on a robotic device while the researchers record their eye movements and hand movements (and, in some sessions, brain activity using a non-invasive EEG cap). The goal is to better understand how memory and movement work together — knowledge that may help improve training, rehabilitation, and assistive technology.

1) Participants complete a brief phone screening, then attend one or more in-person sessions of up to two hours each. 2) At each session, they give consent, answer short readiness and demographic questions, and perform a reaching task on a robotic device — memorizing sequences of targets and reaching to them — while their eye and arm movements (and, in some sessions, their brain activity via a non-invasive EEG cap) are recorded. 3) Some sessions also include brief visual distractions on the screen or gentle forces applied to the hand by the robot.

$30

The purpose of this study is to find out if full-fat dairy and low-fat dairy have similar effects on risk factors for heart disease and diabetes. The study will take approximately 4 months to complete. During the study, participants will consume two types of dairy products: low-fat dairy (milk, yogurt, and cheese) and full-fat dairy (milk, yogurt, and cheese). Each type of dairy will be consumed for 6 weeks with a ≥4-week break between. Participants will be provided with all the dairy products. Testing will be conducted on two separate days at the beginning and end of each 6-week study period (a total of 8 testing days).

• The total time commitment for this study is approximately 4 months. It may take up to 7 months to complete the study from the time that you do the clinic screening visit. • During the study, you will be asked to consume two types of dairy products: low-fat dairy (milk, yogurt, and cheese) and full-fat dairy (milk, yogurt, and cheese). We will provide you with the dairy products. • Each type of dairy will be consumed for 6 weeks with a ≥4-week break between. • You will be asked to come to the Penn State Research Kitchen on campus every 7 days during each 6-week period to pick up your dairy products. • We will draw blood from you several times during the study, once at screening, and on two consecutive days at the start and end of each study period (total 9 times). • At the start and end of each period, we will also measure your blood pressure and perform non-invasive tests of artery health. • You will also be asked to collect a stool sample at the beginning and end of each study period (4 total).

$400

The potential participants must have Crohn's disease diagnosis. They should have had previous standard or advanced therapies for CD and have been intolerant or have lost response. They will be asked to sign and understand the informed consent. The volunteers will provide biological specimens blood, urine, stool, and the biopsy during endoscopy. They will answer daily diary questions about the symptoms, and complete questionnaires in the clinic. The screening will involve at least two visit and will last five weeks. They will be treated in the open label sub-study 1, or double-blinded randomization with placebo in the sub-study 2. The non-responders will be eligible for extended induction in sub-study 3. Each sub-study is 12 weeks long.

Participants will attend in person visit at the research clinical facility in Hershey, PA. If they sign the informed consent and want to participate, they will have vitals checked, and physical examination done. They will provide specimens such as blood and stool. They will answer questionnaires at home and in the clinic. The endoscopy will be done with biopsy to evaluate the disease response to the treatment at screening and week 12, or week 24 for the extended induction if applicable. The drug will be administered by subcutaneous injection in the clinic or at home. There will be a compensation for every completed clinic visit.

TBD

Exercise conducted above the shoulders (i.e., overhead exercise) can reduce blood flow and oxygen delivery to the exercising muscle due to the effects of gravity. This ultimately leads to greater muscle fatigue during overhead exercise tasks which can lead to fatigue-related injuries in occupational settings. Cold-water exposure increases blood pressure (i.e., cold pressor response) and could increase blood flow to exercising muscle by increasing muscular perfusion pressure (i.e., pressure that pushes blood into the muscle) during overhead exercise. This has the potential to reduce muscle fatigue during overhead exercise. However, no studies to date have investigated the effect of cold-water exposure on muscle fatigue during overhead exercise.

There will be 4 in person visits at Penn State Altoona for this study. The first visit will be ~1 hour and the other 3 visits will be ~30 minutes. Participants will complete questionnaires, undergo body composition measurements, and resting blood pressure and heart rate measurements during visit 1. Participants will complete a handgrip exercise test during each visit and their arm will be placed in different positions (overhead or straight in front) during the exercise test. Blood pressure, muscle oxygen levels, and blood flow will be measured during the exercise test. During two of the visits, the participant's foot will be exposed to cold water (~40 degrees F) with a cold-water foot sleeve for a brief period of time (1-3 minutes).

$25

This is a behavioral and biological research study that will examine how first-time parents’ interactions, brain activity, and hormone levels during pregnancy are related to later parenting and infant development. Participants will complete questionnaires, take part in video-recorded interaction tasks, wear a non-invasive brain activity monitor, and provide saliva samples. At a follow-up visit, parents and their infant will participate in similar activities together.

There will be two in-person lab visits for first-time expectant father–mother couples: one during pregnancy and one when the baby is about 8 months old. During both visits, participants will complete questionnaires, take part in interaction tasks, wear a soft headband to measure brain activity, and provide saliva samples. At the second visit, parents will complete similar activities together with their baby, including parent–infant interaction tasks.

Up to $375 per family (including travel reimbursement)

SPK-8011QQ is a one time IV infusion gene therapy drug. The purpose is providing an adeno-associated viral vector (a non-disease vector transport) to carry a human FVIII gene to the liver in order to increase the production of FVIII. This study will assess the safety & tolerability of SPK-8011QQ. Patients will receive a single dose of SPK-8011QQ & will then be followed for approx. 5 years. Total visits (all on-site) will be approx. 52.

SPK-8011QQ is a one-time IV infusion gene therapy drug. The purpose is providing an adeno-associated viral vector (a non-disease vector transport) to carry a human FVIII gene to the liver in order to increase the production of FVIII. This study will assess the safety & tolerability of SPK-8011QQ. Patients will receive a single dose of SPK-8011QQ & will then be followed for approx.5 years. Total visits (all on-site) will be approx. 52.

$75.00 travel reimbursement, $180.00 for the screening visit & day of infusion visit. A $130.00 stipend for each in person visit is also included.

The LAAOS-4 study is to determine if closure of the left atrial appendage using a closure device called the WATCHMAN, in addition to taking oral anticoagulant medications, is more effective at reducing strokes and blood clots in the body, than taking oral anticoagulant medications on their own.

The research study involves eleven visits, one being in person and ten being completed by telephone. A review of your medical history, current medications, and questionnaires at each visit. If you are randomly chosen to have the WATCHMAN closure device, this will involve an overnight stay in the hospital after the device implant.

Multidisciplinary clinic (MDC) care is the standard for Amyotrophic Lateral Sclerosis (ALS) and is associated with better symptom control, quality of life, and longer survival. Patients with ALS and their caregivers attend MDC visits every 3 months and spend 4-5 hours meeting with multiple healthcare providers. Each provider gives recommendations that are important for the patient to remember and implement on their own at home. But sometimes it can be a lot to take in. The purpose of this study is to evaluate two ways to provide MDC visit information to people with ALS: video recordings plus written visit notes (new method being explored) or written visit notes alone (current method). This study examines whether providing video recordings of the clinic visits can help patients with ALS and the people who care for them.

WHO CAN TAKE PART IN THIS STUDY? People with Amyotrophic Lateral Sclerosis (ALS) who are cognitively able to consent, anticipate attending multidisciplinary clinic (MDC) visits for 12 or more months, and who have a non-professional caregiver who is also willing to take part in the study. WHAT WILL PARTICIPANTS BE ASKED TO DO? Study participants will be randomly assigned by a computer to either the NOTES Group or the VIDEO Group. All participants will be asked to review their visit notes on their online Penn State “My Health” patient portal account. All participants will be asked to complete 4 short surveys over 12 months, first at the index multidisciplinary clinic (MDC) visit before assigned to a group, then again at 1 month, 6 months, and 12 months after the index MDC visit. Surveys may be done online or on paper at home or in the clinic and participants will be compensated for completing them. The VIDEO Group participants will be videorecorded at all of their planned MDC visits for 12 months and asked to watch the video recordings after their visits on a secure mobile and online application. Patients can watch these private videos at any time or share them with someone else.

Up to a maximum possible total of $200

The purpose of this study is to see how well a treatment that includes amivantamab, pembrolizumab and carboplatin works compared to a different treatment that includes 5-FU, pembrolizumab and platinum (carboplatin or cisplatin) therapy. 5-FU, pembrolizumab and platinum (carboplatin or cisplatin) are already used together to treat recurrent/metastatic head and neck squamous cell carcinoma.

Participants must come to all study visits, take the medication as instructed, tell the study how you are feeling and tell the study team about any medications you are taking, especially over the counter medications.

130.00 per completed visit

This trial is a randomized, open-label, active treatment in adult participants with moderate to severe Crohn's disease. The study consists of a screening period up to 5 weeks long. Baseline visit and randomization which is 52-weeks long, open-label treatment, and post-intervention safety follow-up. The study drug will be administered in the research clinic during the induction phase at Weeks 0, 4, 8 and for the first maintenance injection at week 12. The participants will then be trained if they are willing to self-administer study drug. Randomization ratio is 1:1 or one arm per treatment group, first guselkumab and second, risankizumab. Participants who leave the study early will return for EOT/Early withdrawal. Treatment extension for subjects on guselkumab treatment who completed week 52 will continue same treatment through week 148, and will complete safety follow up until week 160. Subjects receiving risankizumab treatment for 52-weeks will transition to a standard of care. From the week 24 and through week 52, participants who meet rescue criteria will be eligible to receive guselkumab rescue treatment.

Participants will have to sign the informed consent. They will be asked to have blood drawn, TB testing and x-rays at screening, have the endoscopy procedure with biopsy. They will be asked to give urine specimen for pregnancy testing, and stool specimen for infection testing. They will have in-person visits, five during the induction and two endoscopies (first 12 weeks). They will be treated per study randomization, with either medication.

$100 per completed visit

The purpose of this clinical trial is to learn more about the effectiveness and safety of sonesitatug vedotin (sone-ve) in combination with capecitabine alone or in combination with rilvegostomig (rilve) and also to better understand the studied disease and associated health problems.

Participants will have Screening Part 1 (optional), Screening Part 2, study treatment, and a follow-up period. The participant will have approximately 1 to 2 visits at the study site during Screening Part 2. Each visit may be different in length (up to 8 hours), depending on which tests and examinations are scheduled. The screening period can last up to 28 days before the first planned dose of the study drug. Before starting the study treatment they will undergo a series of tests.

Patients will be reimbursed $100.00 per visit

The purpose of this study is to look at the effect of consuming peanut butter at breakfast on blood sugar control, cognitive function, and heart disease risk factors in middle-aged adults with prediabetes.

• The total time commitment for this study is approximately 8 months. It may take up to 11 months to complete the study from the time that you do the clinic screening visit. • During the study, you will undergo the following two conditions for 12 weeks each: 1) eat 1.5 oz. of peanut butter (Simply Jif® Creamy Unsweetened peanut butter) each day with your breakfast (or the first food you consume each day); 2) continue your usual diet with provision of a gift card to a local grocery store of equal value to the peanut butter ($5/month). • There will be a minimum 8-week break between the two conditions. • You will be asked to come to the Penn State Research Kitchen on campus every month during each 12-week period to pick up your study products (peanut butter or gift card). • We will draw blood from you several times during the study, once at screening, and on two consecutive days at the start and end of each study period (total 9 times). • At the start and end of each period, we will also measure your blood pressure and perform non-invasive tests of artery health. • You will also be asked to wear a continuous glucose monitor (CGM) for 7 days before the first testing visit and for 7 days at the end of each 12-week study period (3 times in total). A CGM is a small sensor worn on your arm that measures your blood sugar every 15 minutes. • During the time you are wearing the CGM, you will also be asked to complete brief surveys 4 times per day using your smartphone (or a smartphone provided to you by the study) about your daily experiences and play brief cognitive games to measure your memory and attention. • You will also be asked to collect a stool sample at the beginning and end of each study period (4 total). • Compensation for this study is up to $300

$300

This study is looking at whether adding a medicine called ribociclib to standard hormone therapy, with or without chemotherapy, can help prevent breast cancer from returning in people with hormone receptor-positive, HER2-negative early breast cancer. Participants will receive study treatment and be monitored regularly for side effects and signs that the cancer has come back. Researchers will follow participants for up to 10 years to learn more about the long-term safety and effectiveness of these treatments.

If participants choose to join this study, they will receive either chemotherapy followed by endocrine therapy plus ribociclib, or endocrine therapy plus ribociclib alone. Treatment will be determined by the participant and their physician. Participants may receive ribociclib for up to 3 years and endocrine therapy for at least 5 years. Following treatment, participants will be followed for up to 10 years with regular visits to monitor for cancer recurrence and side effects.

Compare radiation therapy with cetuximab against radiation and carboplatin/paclitaxel to see if radiation carboplatin/paclitaxel increases progression free survival vs radiation and cetuximab

Participants will get radiation 5 days a week for 7 weeks, will get drug intravenous in the arm weekly for 7-8 weeks and 8 cycles of cetuximab and each cycle lasts 7 days or 8 cycles of cetuximab and each cycle lasts 7 days. Participants fill out a symptoms survey 5 times About 2 tablespoons of blood will be collected from start of treatment, week 4 of radiation, and 4 months after the end of your treatment Imaging of the head and neck with a neck CT or MRI (with contrast, unless contraindicated) or PET/CT which includes diagnostic-quality CT of the neck (with contrast, unless contraindicated); Chest imaging: Chest CT (with contrast, unless contraindicated) or PET/CT

The purpose of this study is to evaluate whether a comic-based educational booklet can reduce anxiety and support coping during a simulated diagnostic mammography callback experience. We aim to assess participants’ emotional responses to the simulated callback process, evaluate whether the booklet improves confidence in managing uncertainty during the waiting period, and gather feedback on the booklet’s clarity, usefulness, and acceptability.

What participation involves: Participants complete two brief surveys remotely—one before and one 1–2 weeks after attending an in-person study session at a date and time convenient for you. The in-person session will take place in a comfortable, non-clinical area at Penn State and is completely independent of your imaging appointment. During the in-person session, you will: - Read and sign an informed consent form. - Complete three brief surveys. - Watch a simulated mammography video. - Read through and use a brief (and fun) activity booklet designed to support patients during the waiting period. - Participate in a brief focus group with a member of the research team and several other participants. Your total participation time, including the remote surveys and in-person session, is approximately 75 minutes.

Participants will receive a $25 Greenphire ClinCard.

Orthostatic hypertension is a condition in which blood pressure rises abnormally when a person stands up. The purpose of this study is to better understand why this happens. In particular, this study will examine whether signals from the leg muscles to the nervous system play a role in causing this increase in blood pressure when standing.

This study consists of three visits to the Penn State Hershey Medical Center. We encourage you to complete the entire study by participating in all visits, but you are not required to do so. The order of the visits as well as the order of interventions during each visit may be changed and some may be eliminated due to time constraints or participant comfort. Each visit lasts about 3-3.5 hours. Various physiological measurements will be recorded during the visits including microneurography, blood pressure, heart rate and blood flow.

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

Subject will either get zanubrutinib for up to 10 years, or zanubrutinib plus sonrotoclax for an initial 15 months, with the possibility that subject will be assigned to receive an additional 12 months depending on response. After subject finishes treatment, study doctor and study team will watch for side effects. They will see subjects for follow up clinic visits every 3 months for a total of 3 years from when treatment was started. After that, the subjects will have clinic visits every 6 months for up to 10 years from when treatment was started. If subjects cancer grows or they start another treatment for their leukemia, the study doctor will follow up with the subject by phone call every 6 months for up to 10 years from when the subject started treatment.

Subjects will receive either: Zanubrutinib for up to 10 years, or Zanubrutinib plus sonrotoclax for 15 months, with a possible additional 12 months depending on response. After treatment ends, subjects will be monitored for side effects. Follow-up visits: Every 3 months for the first 3 years from treatment start Then every 6 months up to 10 years from treatment start If the cancer progresses or the subject starts another leukemia treatment, follow-up will switch to phone calls every 6 months for up to 10 years from treatment start.

Subjects will receive immunotherapy-based drug treatment until their disease gets worse or side effects become too severe or liver stereotactic body radiation therapy (SBRT) for up to 3 weeks plus immunotherapy-based drug treatment until their disease gets worse or the side effects become too severe. After study treatment, subjects will be checked every 3 months for 2 years, then every 6 months for 3 years, then once every year for their lifetime. 

Subjects will receive standard immunotherapy-based drug treatment or standard immunotherapy-based drug treatment with liver stereotactic body radiation therapy (SBRT) over a period of up to three weeks. Subjects may receive one of three approved drug combinations: atezolizumab plus bevacizumab, tremelimumab plus durvalumab, or ipilimumab plus nivolumab, with treatment continuing until the cancer worsens or side effects become unacceptable.  After study treatment, subjects will be checked every 3 months for 2 years, then every 6 months for 3 years, then once every year for their lifetime.

This study involves adding the drug letermovir to standard therapy after HCT. The overall goal of this study is to determine whether taking letermovir will reduce the likelihood of infection with CMV in children and adolescents after HCT.

In this study, participants will take the drug letermovir for 14 weeks (about 3 ½ months) after undergoing a planned, standard-of-care HCT. . All subjects will have a blood test to check for CMV infection during the week before the date of their HCT procedure and after the HCT procedure to check for CMV infection will be part of your regular care. After the study treatment, study follow-up lasts for about 9 months and is coordinated with your other regular medical care

This study is evaluating whether a blood-based circulating tumor DNA (ctDNA) test (Signatera) can help guide treatment and monitoring for patients with urothelial cancer following surgery. Participants will undergo Signatera blood testing to determine whether urothelial cancer DNA is detectable in their blood. Based on the Signatera result, participants will be assigned to a study cohort and randomized to receive either immunotherapy (nivolumab alone or nivolumab plus relatlimab) or close monitoring with serial Signatera blood tests. Patients receiving immunotherapy will receive treatment by intravenous infusion every 28 days for up to 12 doses. Patients assigned to monitoring will undergo regular blood testing and may begin immunotherapy if ctDNA becomes detectable during follow-up. All participants will undergo routine clinical assessments, imaging studies, and blood tests, with follow-up for disease monitoring and safety for up to 5 years and additional Signatera testing for up to 2 years.

This study will look at whether a blood test called Signatera can help guide treatment and follow-up care after surgery for patients with bladder and related urinary tract cancers (urothelial cancer). After surgery, participants will have a Signatera blood test to check for small amounts of cancer DNA in their blood. Based on the test results, eligible participants will be assigned to a study group by chance. Some participants will receive immunotherapy through an IV every 4 weeks for up to 12 treatments, while others will be closely monitored with regular Signatera blood tests and routine follow-up care. Participants in the monitoring group may begin immunotherapy later if the blood test shows signs that the cancer may have returned. All participants will have regular clinic visits, lab tests, and imaging scans as required by the study. Researchers will follow participants' health and safety for up to 5 years, and additional Signatera testing may continue for up to 2 years.