Search Results
Pilot Study to Assess Medication Adherence, Health Literacy, and Technological Literacy among African Americans and Latinos with Hypertension
This pilot study aims explore the health literacy and medication adherence found among African Americans and Latinos with hypertension receiving care at Hamilton Health Center in Harrisburg PA. We also aim to determine the feasibility of the iPad or smartphone as a tool for accessing health related information among African American and Latino patients with hypertension receiving care at clinics at Hamilton Health Center in Harrisburg PA. The expected outcomes of this project are to obtain a better understand of the literacy levels and adherence behaviors of African Americans and Latinos in Harrisburg, Pennsylvania. The findings from this study will provide valuable insights into the health management behaviors of this community and determine if there is a need to develop a mobile health application for the management of hypertension.
Prescribed medication for high blood pressure
African American/Black (Hispanic or Non-Hispanic) or White (Hispanic)
21 years and older
Able to speak and read English
Angiotensin-(1-7) and Energy Expenditure in Human Obesity
We will investigate the effects of the hormone angiotensin-(1-7) on energy expenditure in patients with obesity.
This is an outpatient study that requires a screening visit, and if eligible, one study visit in the Clinical Research Center within the Penn State Health Milton S. Hershey Medical Center. The screening visit will take about one hour and includes a brief physical examination and medical history, urine pregnancy test if female and of childbearing potential, measurement of heart rhythm, collection of blood samples, and measurements of body composition. If eligible based on the results of the screening visit, participants will be invited to participate in one study visit that will take about four hours. Participants will complete food recall and activity questionnaires prior to the study visit and asked not to change eating or physical activity patterns. A urine pregnancy test will be given for females of childbearing potential. Participants will lie down on a bed and a catheter (small plastic tube) will be placed in a vein in each arm to draw blood samples and to give study medications. Equipment will then be placed to measure heart rate, blood pressure, breathing rate, and the amount of oxygen in the blood. After placing this equipment, participants will be allowed to rest for at least 20 minutes. Resting energy expenditure will then be measured by asking participants to breathe through a canopy placed over their head that is connected to a metabolic cart for 45 minutes. Blood samples will be taken to measure hormones influencing resting energy expenditure. Participants will then receive either angiotensin-(1-7) or normal saline (salt water) through the catheter in the arm for up to two hours. Angiotensin-(1-7) is a substance that the body produces naturally; however, in this form, it is considered experimental, which means the Food and Drug Administration has not approved it for this use. Participants will receive either angiotensin-(1-7) or normal saline. The treatment will be randomly assigned meaning that it is determined purely by chance, and neither the participant nor study investigators will know which treatment is received. Blood pressure, heart rate, breathing rate, and oxygen in the blood will be measured continuously while giving angiotensin-(1-7) or normal saline. During the last 45 minutes of the treatment, resting energy expenditure will be measured again and additional blood samples taken. Participants will also have the option of allowing for a small piece of fat to be taken from under the skin in the abdominal region (fat tissue biopsy). Participants will then be allowed to recover for at least 20 minutes and then all equipment will be removed. After the study visit, a nurse will contact participants to check on general well-being and answer any questions.
$25 per hour; additional $75 for fat tissue biopsy
Age 18-60 years
Body mass index between 30-40 kg/m2
Capable of giving informed consent
Pregnant or nursing women
Current smokers
Type I or type II diabetes
History of major cardiovascular or cerebrovascular disease, immune diseases, impaired kidney or liver function
Cardiovascular Effects of Angiotensin 1-7 in Obesity Hypertension
The purpose of this study is to see if the hormone angiotensin-(1-7) lowers blood pressure and sympathetic activity and improves the function of blood vessels and in obese subjects with hypertension.
This is an outpatient study that requires a screening visit, and if eligible, two study visits in the Clinical Research Center within the Penn State Health Milton S. Hershey Medical Center. The screening visit will take about one hour and includes a brief physical examination and medical history, a urine pregnancy test if female and of childbearing potential, measurement of heart rhythm, collection of blood samples, and measurements of body composition. If eligible based on the results of the screening visit, participants will be invited to participate in two study visits that are about four hours and are separated by at least one week. Participants will complete food recall and activity questionnaires prior to each study visit. A urine pregnancy test and ovulation test will be given for females of childbearing potential. Participants will lie down on a bed and a catheter will be placed in a vein in each arm to draw blood samples and to give study medications. Equipment will then be placed to measure heart rate, blood pressure, and the amount of oxygen in the blood. A blood pressure cuff on the arm will be inflated for up to five minutes to measure blood flow in the arm using ultrasound and blood samples will be collected. Small electrodes will then be inserted into a nerve and just under the skin on one leg to measure nerve activity, which will remain in place until the end of the study. Participants will then receive either angiotensin-(1-7) or normal saline through the catheter in the arm for up to 120 minutes. Angiotensin-(1-7) is a substance that the body produces naturally; however, in this form, it is considered experimental, which means the Food and Drug Administration has not approved it for this use. Participants will receive angiotensin-(1-7) at one study visit and normal saline at the other study visit. The treatments will be randomly assigned so that the order in which they receive each treatment will be determined purely by chance, and neither the participant nor study investigators will know which treatment is received at each study visit. Blood pressure, heart rate, oxygen in the blood, and leg nerve activity will be measured continuously while giving angiotensin-(1-7) or normal saline. Near the end of treatment, blood flow in the arm will be measured again. At the end of the last dose, another blood sample will be taken. Participants will then be allowed to recover for at least 20 minutes and then all equipment will be removed. After the study visit, participants will be asked to complete a questionnaire if they had the nerve activity measurements, and a nurse will contact them to check on general well-being and answer any questions.
$25 per hour
Obesity (defined as body mass index between 30-40 kg/m2)
Hypertension (defined as seated blood pressure greater than 130/80 mmHg)
Able and willing to give informed consent
Fluent in written and spoken English
Current smokers
Type I or type II diabetes
History of major cardiovascular disease, immune or liver diseases, impaired renal or liver function
Morbid obesity (body mass index greater than 40 kg/m2)
Prospective Cohort Assessing Novel Biomarkers of Early Pregnancy
The purpose of this research is to take and store blood, urine samples from pregnant women diagnosed by a positive pregnancy test or by ultrasound imaging. The purpose of this study is to determine a better way to diagnose the location and/or viability (chance of survival) of a pregnancy, as compared to current clinical care. Many women are found to be pregnant by a hCG (human chorionic gonadotropin) test which detects a hormone that is indicative of pregnancy. However, in early pregnancy, it is often difficult to see the pregnancy by ultrasound, which is called a pregnancy of unknown location (PUL). In early pregnancy, doctors do many tests (including blood tests and ultrasounds) to try to determine how far along the pregnancy is, whether it is healthy, and most importantly whether the pregnancy is growing in the right place. The doctors running this research project are trying to see if there are substances (biomarkers) in the blood or urine of a pregnant woman that can tell whether the pregnancy is a normal, healthy pregnancy, an ectopic pregnancy, or if pregnancy is not viable (miscarriage). To do this, blood and/or urine samples are being collected from women who have a pregnancy of unknown location, an ectopic pregnancy, women who are having a miscarriage, and women with a healthy growing pregnancy. The study will then look at a pre- determined panel of biomarkers that have been shown to be elevated (higher) or decreased (lower) in different types of pregnancy to determine the effectiveness and accuracy of this test in earlier diagnosing the viability and location of early pregnancy.
There will be one visit at the visit participants will be consented and following consenting blood and urine will be collected.
$25.00
Live intrauterine pregnancy through 14 weeks, diagnosed by ultrasound demonstrating fetal heart motion
Diagnosed ectopic pregnancy
Pain or bleeding or at risk for ectopic pregnancy
Women seeking confimation of a pregnancy with a urine or serum pregnancy test (less than 14 weeks)
STEEL: A Randomized Phase II Trial of Salvage Radiotherapy with Standard vs Enhanced Androgen Deprivation Therapy (with Enzalutamide) in Patients with Post-Prostatectomy PSA Recurrences with Aggressive Disease Features
Radiation treatment and hormonal therapy vs. Radiation treatment, hormonal therapy plus Enzalutamide in post-prostatectomy cancer recurrences.
Radiation treatment and hormonal therapy vs. Radiation treatment, hormonal therapy plus Enzalutamide in post-prostatectomy cancer recurrences
PSA level (≥0.2 ng/mL) within 90 days prior to registration.
Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to registration.
At least 1 of the following features: • Gleason score of 8-10 • Seminal vesicle invasion • Locoregional node involvement at radical prostatectomy • Persistently elevated PSA post-RP nadir
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
A Phase III De-escalation of Breast Radiation for Stage I, Hormone Sensitive, HER2 Negative Breast Cancer (PSCI# 21-098) (NRG-BR007)
This study is being done to answer the following question:Is treatment with hormonal therapy as good as the usual treatment of radiation and hormonal therapy in women with low-risk breast cancer who have had lumpectomy? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your breast cancer. The usual approach is defined as care most people get for low-risk, early stage breast cancer that is sensitive to hormones.
Pt will either have radiation therapy to the breast and take a hormonal drug for at least five years or you will only take a hormonal drug for at least five years.
The patient must have recovered from surgery with the incision completely healed and no signs of infection
The patient must have an ECOG performance status of 0 or 1
The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines
pT2 - pT4 tumors including inflammatory breast cancer
Patient had a mastectomy
Non-epithelial breast malignancies such as sarcoma or lymphoma
Paget's disease of the nipple
Parallel Phase III Randomized Trials For High Risk Prostate Cancer Evaluating De-Intensification For Lower Genomic Risk and Intensification for Higher Genomic Risk with Radiation (NRG-GU009) (PSCI# 20-141)
This study is being done to answer the following questions: If you have high risk prostate cancer, a low gene risk score and plan to receive radiation therapy, is a shorter hormone therapy treatment as effective at controlling your cancer compared to the usual 24 month hormone therapy treatment? If you have high risk prostate cancer, a high gene risk score and plan to receive radiation therapy, does adding two new hormone therapy drugs to the usual treatment increase the length of time without your prostate cancer spreading as compared to the usual treatment?We are doing this study because we want to find out if these approaches are better, similar, or worse than the usual approach for your type of prostate cancer. The usual treatment is defined as the care most people get for prostate cancer.
This study is being done to answer the following questions:If you have high risk prostate cancer, a low gene risk score and plan to receive radiation therapy, is a shorter hormone therapy treatment as effective at controlling your cancer compared to the usual 24 month hormone therapy treatment?If you have high risk prostate cancer, a high gene risk score and plan to receive radiation therapy, does adding two new hormone therapy drugs to the usual treatment increase the length of time without your prostate cancer spreading as compared to the usual treatment?We are doing this study because we want to find out if these approaches are better, similar, or worse than the usual approach for your type of prostate cancer. The usual treatment is defined as the care most people get for prostate cance
High-risk disease
ECOG Performance Status of 0-2 within 120 days prior to registration
Adequate hematologic function within 120 days prior to registration
Adequate hepatic function within 120 days prior to registration
Prior systemic chemotherapy within ≤3 years prior to registration
Current use of 5-alpha reductase inhibitor
Didanosine (DDI) antiretroviral therapy is not permitted
History of seizure disorder or current severe or unstable angina
Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer (PSCI# 21-217) (NRG-GU010)
The purpose of this study is to use the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient’s cancer aggressiveness. The study will test your tumor tissue for many different genes that all together indicate the risk of your cancer spreading; this is called the Decipher risk score. If you have a higher Decipher risk score, you will be assigned to the part of the study that compares the use of 6 months of hormone therapy and radiation treatment (usual treatment) to the use of darolutamide (BAY 1841788) plus the usual treatment. The purpose of this study is to determine whether the additional drug can reduce the chance that your cancer will come back and spread.
The purpose of this study is to use the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient’s cancer aggressiveness.The study will test your tumor tissue for many different genes that all together indicate the risk of your cancer spreading; this is called the Decipher risk score.If you have a higher Decipher risk score, you will be assigned to the part of the study that compares the use of 6 months of hormone therapy and radiation treatment (usual treatment) to the use of darolutamide (BAY 1841788) plus the usual treatment. The purpose of this study is to determine whether the additional drug can reduce the chance that your cancer will come back and spread.
ECOG Performance Status of 0-2 within 120 days prior to registration;
For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured.
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
Previous bilateral orchiectomy
Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields.
Active testosterone replacement therapy; any replacement therapy must be stopped at least 30 days prior to registration
Inability to swallow oral pills.
Using Exercise to Relieve Arthralgia (Joint Pain) and Improve AI Adherence in Older Survivors (REJOIN): A Pilot Study
Briefly, the purpose of this study is to use a self-management approach (combining education and exercise) to help older breast cancer survivors manage joint pain, a common side effect of aromatase inhibitors (AIs), a medication used to reduce hormones that might increase risk of recurrence and mortality following primary cancer treatment. We believe that reducing joint pain might help survivors take their medication longer and thus improve survival outcomes, compared to standard care.
Attend 4 in person visits, blood will be drawn at each visit.Complete physical function tests and surveys.Wear accelerometer for 7 days following each visit.Randomly selected participants will attend group exercise sessions twice a week for eight weeks via video call and record exercise activities between visits.
$160
Female
Breast Cancer Survivor
Preparing to Start AI medication
ER+ diagnosis
Gross Cognitive Impairment
Recent Joint Surgery
Cardiac event/Stroke within last 6 months
Not willing to come to HMC for Exercise Sessions
Pathway to Prevention Study
This study will help us learn more about how type 1 diabetes occurs and provides monitoring to individuals at risk. In addition, the study will help us identify people who may be eligible for prevention trials. The study is divided into two parts: Screening and Monitoring. During screening, participants with a 1st degree relative who has type 1 diabetes will be tested for diabetes-related autoantibodies in the blood. Autoantibodies are proteins that are made by the body’s immune system. If autoantibodies are present, it could mean that cells in the pancreas which produce insulin are damaged. Certain kinds of autoantibodies can be found in the blood years before type 1 diabetes occurs. If the screening blood tests show that a participant has the autoantibodies, they will be asked to have an Eligibility visit to determine if you can participate in the Monitoring part of the study.
screened for Type 1 diabetes antibodies
aged 1-20 years and a niece, nephew, aunt, uncle, grandchild, cousin, or half sibling of an individual with Type 1 diabetes
willing to have blood drawn
Currently use immunosuppressive or immunomodulatory therapies
Has diabetes
Exploring the Immediate Psychosocial and Self-Management Support Needs of Individuals Newly Diagnosed with Type 2 Diabetes (T2D)
To find out the kind of support someone newly diagnosed with type 2 diabetes will need following diagnosis.
Age 20 years or older
agree to participate in online focus group
individuals below 20 years
diagnosed with other types of diabetes
A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF ADJUVANT GIREDESTRANT COMPARED WITH PHYSICIAN'S CHOICE OF ADJUVANT ENDOCRINE MONOTHERAPY IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE EARLY BREAST CANCER (PSCI# 20-133) (GO42784)
The purpose of this study is to compare the effects, good or bad, of giredestrant versus an approved endocrine therapy (a treatment that blocks or removes hormones), on patients with breast cancer. In this study, subjects will get either giredestrant or a drug chosen specifically by the study doctor. Subjects can participate in this study based on breast cancer characteristics, current condition, and how well previous anti-cancer therapies were tolerated.
• You should not join another research study.• For women: If you can become pregnant, you must use a reliable non-hormonal birth control method during the study and for 9 days after your final dose of giredestrant or, if you are in the group receiving approved endocrine therapy prescribed by the study doctor, a period of time that your study doctor will discuss with you. This will be 21 days after if you are prescribed letrozole or anastrozole, 30 days after if you are prescribed exemestane, and 60 days after if you are prescribed tamoxifen. Talk with your study doctor about what birth control method may be best for you. Depending on the study treatment you receive, you might be restricted from donating eggs during this same period. Tell your study doctor right away if you get pregnant during this period. If you get pregnant, the study doctor will want to follow up with you on the outcome of the pregnancy and collect information on the baby.• For men: you must agree to take precautions as outlined below for each treatment arm:–If you are in the group receiving approved endocrine therapy prescribed by the study doctor, you study doctor will discuss with you what precautions you will need to take.–If you are in the group receiving giredestrant, and your partner is pregnant or able to become pregnant, you must use a condom during the study and for 9 days after your final dose of giredestrant. This will be 21 days after if you are prescribed letrozole or anastrozole, 30 days after if you are prescribed exemestane, and 90 days after if you are prescribed tamoxifen. You must not donate sperm during this same period. Tell your study doctor right away if your partner becomes pregnant during these periods. The study doctor or research staff will advise you of the possible risks to your unborn child and will make an effort to contact your partner to get her permission to collect information about the pregnancy and the baby. No matter what your partner decides, you can continue to take part in this study.• You should not use certain medications during this study. Your study doctor will talk to you about these medications.
Participants who have documented ER+ tumor by immunohistochemistry, as assessed locally on a primary disease specimen and defined as 1% of tumor cells stained positive according to the ASCO/College of American Pathologists (CAP) guidelines
Participants who have documented HER2- tumor, as assessed locally on a primary disease specimen and defined according to ASCO/CAP guidelines
Participants must have undergone definitive surgery of the primary breast tumor(s)
Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization
Participants who have received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research
Participants receiving or planning to receive a CDK4/6i as adjuvant therapy
Participants who have active cardiac disease or history of cardiac dysfunction
Participants who have been diagnosed with Stage IV breast cancer
Insulitis, Inflammation, Dietary intake and Omega-3 Biostatus of Youth with Partial Remission of Type 1 Diabetes
Only 50% of patients with type 1 diabetes (T1D) recover insulin secretion function after 3 months of initial diagnosis, and this phase is called partial remission (PR) of T1D, also called "Honeymoon phase". During this PR phase of T1D, patients recover the ability to secrete more than 50% of their insulin secretion function. This phase of PR typically lasts no longer than 6 or up to12 months, and has been frequently defined as requiring exogenous insulin below 0.5 units per kilogram per day, and hemoglobin A1C is typically below 7.5%. Most recently the use of a coefficient called IDAA1C ≤ 9 has became more accepted as the methodology to determine the development of partial clinical remission of T1D (honeymoon phase). Prior data published by the SEARCH study (national epidemiological study) showed that youth with prolonged honeymoon phase had higher intake of omega -3 fatty acids, vitamin D intake and leucine intake than those youth without prolonged honeymoon phase of T1D. Currently, there are not approved medications to prolong this phase of partial remission of type 1 diabetes, however inducing PR in youth with T1D could potentially decrease the risk of multi-organ damage caused by chronic severe hyperglycemia associated to the chronic hyperglycemia related to T1D.We aim to perform a case- multiple control study between youth with prolonged partial remission phase of T1D after one year of diagnosis, and compare these youths with multiple controls matched by age, gender, race, and puberty stage to study the potential protective factors associated to the development of prolonged partial remission of T1D.
Participants will be approached at their routine Pediatric diabetes clinic appointment. If participants agrees to be in the research, informed consent/assent will be reviewed and signed by all parties. Participant's parent/guardian will be asked to complete a questionnaire. The participant's glucose machine/insulin pump will be downloaded for study purposes. Participant will undergo a fingerstick and a blood draw to collect specific lab values as outlined in the consent.
$35.00
Age 1-17 years old, any gender
Attendance to the Pediatric diabetes clinic at Penn State Health in Hershey, PA
Most recent hemoglobin A1C below 7.5%
History of seafood allergies and/or milk/dairy related allergies
Medical conditions (such as severe cerebral palsy, etc.) that could make patients unable to communicate with the study team
Existence of other autoimmune diseases in addition to T1D requiring regular treatment with immunosuppressive or anti-inflammatory treatment
Diagnosis of type 2 diabetes, monogenic diabetes (MODY), secondary diabetes, pregnancy, compromised kidney function, or liver diseases
The perception and experiences of newly diagnosed type 2 diabetes patients (T2D) on the impact of patient-provider communication on subsequent decision to engage in diabetes self-management education (DSME).
This study seeks to explore the perception and experiences of newly diagnosed type 2 diabetes patients about how their interaction with their provider at diagnosis led to their uptake of diabetes education.
Any gender
Newly diagnosed type 2 diabetes patient within the past 12 months
Have attended at least one diabetes education after diagnosis
Able to provide consent in English
Patients who have a different type of diabetes either than type 2
Patients diagnosed with Type 2 diabetes more than 12 months
Newly diagnosed diabetes patients who have not attended diabetes self-management education
EA8183 A Phase III Study of Early Intervention after RADICAl ProstaTEctomy with Androgen Deprivation Therapy with Darolutamide vs. Placebo in Men at Highest Risk of Prostate Cancer Metastasis by Genomic Stratification (ERADICATE) (PSCI# 21-122)
This study is being done to answer the following question:Will the addition of a new drug, darolutamide, to standard Androgen Deprivation Therapy (ADT) (a hormonal therapy that is a usual approach to treatment) after surgery cure more men with prostate cancer than using Androgen Deprivation Therapy alone?We are doing this study because we want to find out if this approach is better or worse than the usual approach for your prostate cancer. The usual approach is defined as care most people get for prostate cancer.
This study is being done to answer the following question:Will the addition of a new drug, darolutamide, to standard Androgen Deprivation Therapy (ADT) (a hormonal therapy that is a usual approach to treatment) after surgery cure more men with prostate cancer than using Androgen Deprivation Therapy alone?We are doing this study because we want to find out if this approach is better or worse than the usual approach for your prostate cancer. The usual approach is defined as care most people get for prostate cancer.
Patient must have undergone a radical prostatectomy (RP) and must be preregistered to Step 0 of this study at least 6 weeks after but not more than 12 weeks after their radical prostatectomy.
Patient must not have any previous treatment with androgen deprivation therapy (ADT), chemotherapy, or other physician prescribed systemic therapy for treatment of their prostate cancer.
Patient must have an ECOG performance status of 0-2.
Patient must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III and IV heart failure).
Examining views associated with physical exercise and its connection to diet, social connectivity, and stress reduction: Online Focus Groups
The primary objective of this study is to examine, via online focus groups, the perceptions that are held by potentially-eligible subjects in the PSH DPP program in regard to the importance of physical exercise, particularly within the context of diet, social connectivity, and stress reduction. These perspectives will then be used to help develop, test, and refine additional motivational text messages that can be used in a text messaging intervention. Participants will receive a $25.00 gift card.
Body Mass Index ≥25 kg/m2 (≥23 kg/m2 if Asian)
Have no previous diagnosis of type 1 or type 2 diabetes
Fluent in English
Body Mass Index <25 kg/m2 (<23 kg/m2if Asian)
Previous diagnosis of type 1 or type 2 diabetes
Not fluent in English
An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic hormone Sensitive Prostate Cancer (mHSPC)
The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with mHSPC.
At the study visits, the following procedures should happen:• Your study eligibility will be determined• There will be a review of your current medications and medical history• You will undergo a physical examination that includes measuring your height, weight, taking your vital signs, checking your heart with an electrocardiogram, and determining your ECOG performance status (a measure of your daily functional activity)• You may undergo tumor biopsy if clinically feasible according to your doctor or may be asked for a previously collected sample. You will be asked for a previously collected tumor biopsy if clinically feasible by your doctor• Blood and urine will be taken to determine the function of your liver, kidneys, and bone marrow function.• Blood samples will also be collected to assess potential changes in biological molecules in the blood such as certain proteins and pieces of DNA shed from tumor cells • You will receive a variety of imaging procedures to determine the status of your cancer throughout the study. These will include CT and PET scans, bone scans and may include other scans like X-rays and MRI scans.• On repeat visits, your doctor will ask you about any changes in the way you feel
Patients must have an ECOG performance status of 0 to 2
Patients must be adults >= 18 years of age
Patients must have evidence of PSMA-positive disease as seen on a 68Ga-PSMA-11 PET/CT scan
Patients with CNS metastases that are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity
Patients with a history of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
Patients with symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
Patients who received transfusion for the sole purpose of making a subject eligible for study inclusion
PSCI-22-063: NRG-GU011 NRG Promethean
This trial is comparing radiation therapy with or without hormone therapy in men with prostate cancer.
Patients must come in for all radiation treatments. Patients must take their androgen therapy as prescribed.
Age ≥ 18 years.
ECOG Performance Status 0-2 within 120 days prior to registration.
External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites.
Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes.
Currently on androgen deprivation or anti-androgen therapy.
Osseous metastasis on 99mTc radionuclide bone scan
Extra pelvic nodal/soft tissue disease (> 1.5cm in short axis) on CT or MRI pelvis +/- abdomen
Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis
Randomized Phase III Trial Incorporating Abiraterone Acetate with Prednisone and Apalutamide (NRG-GU008) (PSCI# 20-087)
The purpose of this study is to compare the use of hormone therapy and radiation therapy (usual treatment) to the use of apalutamide and abiraterone acetate with prednisone plus the usual treatment. The addition of apalutamide and abiraterone acetate with prednisone to the usual treatment could stabilize your cancer and prevent it from spreading. But it could also cause side effects, which are described in the risks section below.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 approach increases the time without prostate cancer spreading compared to the usual approach. The study drugs, apalutamide and abiraterone acetate with prednisone, are already approved by the FDA for use in prostate cancer. But, most of the time abiraterone acetate with prednisone is not used until hormone drugs stop working and apalutamide is not used until hormone drugs stop working and after prostate cancer has spread. There will be about 586 people taking part in this study.
The purpose of this study is to compare the use of hormone therapy and radiation therapy (usual treatment) to the use of apalutamide and abiraterone acetate with prednisone plus the usual treatment. The addition of apalutamide and abiraterone acetate with prednisone to the usual treatment could stabilize your cancer and prevent it from spreading. But it could also cause side effects, which are described in the risks section below.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 approach increases the time without prostate cancer spreading compared to the usual approach.The study drugs, apalutamide and abiraterone acetate with prednisone, are already approved by the FDA for use in prostate cancer. But, most of the time abiraterone acetate with prednisone is not used until hormone drugs stop working and apalutamide is not used until hormone drugs stop working and after prostate cancer has spread. There will be about 586 people taking part in this study.
History/physical examination within 90 days prior to registration
ECOG Performance Status of 0-1 within 90 days prior to registration
Any T-stage is eligible (AJCC 8th ed)
Adequate hepatic function within 90 days prior to registration
Seizure or known condition that may pre-dispose to seizure
Severe or unstable angina, myocardial infarction, arterial or venous thromboembolic events within 6 months prior to registration
Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily
Patients with inflammatory bowel disease.
Angiotensin-(1-7) Cardiovascular Effects in Aging
We will investigate the effects of acute intravenous infusion of the hormone, angiotensin-(1-7), on cardiovascular function in healthy older adults in a randomized, double blind, placebo-controlled, crossover study.
Participation in this study will include three separate visits to the Clinical Research Center within the Penn State Milton S. Hershey Medical Center. Participants will first have a screening visit to determine if they are able to participate in this study. If eligible based on the screening visit, they will participate in two study visits separated by at least one week. At each study visit, they will be infused with doses of a placebo or angiotensin-(1-7) for about two hours. Before and at the end of the infusion, we will measure blood pressure and blood flow, nerve activity with an acupuncture-type needle in your leg, and collect blood samples from a small plastic tube (catheter) placed in the arm. Cells will also be collected from inside the vein using the catheter if the participant is willing.The study visits will include intravenous infusion of angiotensin-(1-7) or saline for approximately two hours, starting with increasing doses and holding at a steady-state dose. Endothelial function will be measured and blood samples and endothelial cells (if willing) will be collected at baseline and at the end of infusions. Blood pressure, heart rate, and muscle sympathetic nerve activity via microneurography will be measured throughout the study.
$25 per hour; additional $25 per study visit for cell collection
Body Mass Index between 18.5-30 kg/m2
Blood pressure less than 130/80 without medication
No serious chronic medical problems
Fluent in written and spoken English
History of cardiovascular, liver, or kidney disease
Taking certain medications (such as SNRIs, NET inhibitors, anticoagulants, glucocorticoids)
Women who are pregnant, nursing, or taking hormone replacement therapy
Evidence of diabetes
Behavior, Voice, and Sex Hormones Study
Hormones are molecules that deliver signals throughout the body. They influence behavior, sleep, hunger, stress, and virtually all other aspects of life. This study seeks to better understand several of these functions, specifically how hormones affect specific aspects of human behavior and psychology, as well as speech production. Following an initial lab visit, subjects will participate in the remainder of the study (~5 weeks) at home via the internet. On a daily basis, they will collect urine samples for hormone analysis, saliva samples for analysis of oral micro-organisms, and will submit voice samples for analysis of speech (e.g. measuring voice pitch and loudness). They will then complete an online survey designed to collect information about their behavior, and attitudes over the previous 24 hours. Subjects receive compensation for their participation.
- Pre-sampling lab visit to sign a consent form and receive training- A series of ~42 daily at-home sample (urine, saliva) collection & online surveys- Weekly lab visits for sample dropoff- The expected amount of time for participating in the study is 12 hours and 30 minutes in total (~5 to 6 weeks).
$212
Normal menstrual cycles
Available for daily at-home session for approximately 5 weeks
Female/Identifying as a woman
Predominantly or exclusively heterosexual sexual orientation
Uncorrected severe defects of hearing, speech, or vision
Bisexual or predominantly homosexual sexual orientation
Very heavy smoking or alchohol consumption
Medications that affect levels of ovarian hormones (e.g. anti-depressants, anti-psychotics)
A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)
Participants in this study will receive a drug called ribociclib with the endocrine therapy of your physician’s choice. Ribociclib is taken as a pill. Endocrine therapy is taken as a pill or given as a shot. You will have tests, exams and procedures that are part of your regular care and for study purposes. Also, as part of routine care, you will be checked every 4 to 12 weeks to make sure your cancer hasn’t come back. You will receive ribociclib combined with endocrine therapy for up to 3 years. After that you will continue endocrine therapy alone for another 2 years (5 years total) as part of your regular care.
Participants will be required to: - receive ribociclib along with standard endocrine therapy drugs - have blood drawn - imaging scans (CT, PET-CT, bone scans, mammograms, MRI) - keep a medication diary - optional biopsy - ECG-a test that looks at the way your heart beats - ECHO-a test that looks at the way your heart pumps
Male or female age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
If patient is receiving tamoxifen or toremifene, a washout period of 28 days prior to registration is required.
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory.
Patient who has received prior CDK4/6 inhibitor for recurrent disease. Patients who received a CDK4/6 inhibitor in the adjuvant setting may participate if they have been off therapy for at least 1 year prior to diagnosis of recurrent disease.
Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
Pregnant or breastfeeding or planning to become pregnant during the trial
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety