Search Results
PSCI 24-077 A Phase 1b/2 Study Assessing the Safety and Efficacy of Evexomostat (SDX-7320) in Combination with a PI3K Pathway Inhibitor plus Fulvestrant in Postmenopausal Women with Advanced Breast Cancer and PI3K Pathway Alterations Who Have Progressed on or Following Endocrine Therapy plus a CDK4/6 Inhibitor
this trial is looking at introducing a medication to control blood sugars elevations caused by CDK inhibitors.
Participants must agree to come to all study visits, report any new medications to the study team, agree to having blood work done at least 8-12 hours after eating something, take study medication as directed.
Patient with histologically and/or cytologically confirmed diagnosis of HR+, HER2- breast cancer, as determined by the local laboratory.
Patient has identified PI3K pathway
Patient has locally advanced (not amenable to curative therapy or metastatic) breast cancer meeting any of the following categories:
Patient has measurable disease
Patient has known primary brain malignancy,
Patient has a known hypersensitivity to evexomostat, fulvestrant, alpelisib or capivasertib, or to any of their excipients.
Patient has had major surgery within 30 days
Patient has uncontrolled human immunodeficiency virus (HIV) infection.
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
Fluent in English
Vaccinated for COVID-19
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
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.
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
No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis
No known mismatch repair deficient rectal adenocarcinoma
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.
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.
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.
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.
Reasonable ability to see
Cannot see or read the consent form
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.
Two or more prior losses of clinically recognized pregnancies
Prior losses are unexplained
ALL ALS-ASSESS
This study will follow symptomatic ALS participants and control participants for 2 years, measuring a wide range of ALS outcome measures and gathering long term survival data.
Study visits will be conducted both in an in-clinic setting (on-site) and remotely (off-site) over the course of 24 months (2 years). The symptomatic ALS cohort participants can either participate in on-site or off-site visits, depending on their location and ease of access to one of the participating sites. During this 2-year period, symptomatic ALS participants will complete a screening visit (2-3 hours to complete), a total of 7 in-person study visits (1-3 hours to complete) and 24 remote self-assessment activities (completed each month, takes 35-45 minutes to complete). Participants and will need access to a personal device (i.e. a computer and/or smartphone or tablet) and an internet connection to participate in this study. All control participants will participate on-site, completing their on-site visits every 12 months. Biospecimens will be collected at regular intervals to support biofluid biomarker analyses. Biospecimens will include plasma, serum, whole blood for generation of induced pluripotent stem cells (iPSCs) and DNA for whole genome sequencing, and cerebrospinal fluid (CSF). For on-site symptomatic ALS and control participants, CSF will be collected through optional Lumbar Puncture (LP) procedure. Only plasma, serum and whole blood will be collected for off-site participants through home phlebotomy collection process.
Up to $350
Capable of providing informed consent
Willing to follow study procedures
Diagnosis of ALS by a physician
Access to a smartphone, computer or tablet, and internet (need not be in the home – access to a public library or other available computer with internet connection is sufficient)
Clinically significant unstable medical condition (other than ALS) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator’s judgment.
Optional Lumbar Puncture - Medically unable to undergo LP; allergy to Lidocaine or other local anesthetic agents; use of anticoagulant medication or antiplatelet medications (aside from aspirin 81mg) that cannot be safely withheld prior to LP.
Endometriosis and microvascular dysfunction
Endometriosis, is a disorder that occurs in women, is when tissue that should be normally found inside the womb is also found in sites outside of the womb. This disorder impairs the function of the endothelium, the cells that line the body’s blood vessels (endothelium). The endothelium helps to control blood flow in healthy vessels. Women with this disorder not only have an increased risk for high blood pressure and high cholesterol, they also have an increased risk for cardiovascular disease. They have a higher risk for cardiovascular disease, too. With this study, we will learn how endometriosis impairs the lining of blood vessels and increases the risk for disease. We will test two different intervention strategies to reduce long-term cardiovascular disease risk in women with endometriosis.
There will be 3 in person visits, blood draws will occur at all visits. On 2 of the visits blood flow experiments will be conducted. Participants will take oral medications.
390
Endometriosis
Pregnant and/or breastfeeding
Taking blood pressure medication
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.
be over 18 years old
must understand English
resources from Penn State, University Park
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.
Gender/Sex: Men/Male; Women/Female
Education: PSU students and participants recruited online
Participants who already completed the survey
Participants who took the survey on the mobile phone
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.
You are receiving unlicensed CB products from other CB banks
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
Fluent in English
Able to walk at a leisurely pace on a treadmill without assistance
Not fluent in English
Unable to walk at a leisurely pace on a treadmill without assistance
Experiencing cognitive impairments
A prospective examination of TAC features as predictors of consequences and alcohol use disorders
The study aims to use a longitudinal design that combines transdermal alcohol concentration (TAC) sensors and ecological momentary assessment (EMA) in a sample of college and non-college young adults to examine the associations between TAC features (such as rise rate and duration), alcohol-related consequences, and alcohol use disorder (AUD), when adjusting for EMA self-reported indicators (such as drink counts, estimated BAC).
If eligible, participants will be invited to be part of a study that will take place over two years. Every 6 months, participants will be asked to wear a small biosensor on their wrist and complete mobile phone surveys for three consecutive weeks. Participants will also be asked to complete a 20-minute survey and a 15-minute interview at baseline, 12-month, and 24-month follow-ups. Participants can earn up to $776 over the course of the two-year period.
776
Must have a working iPhone (biosensor app is iOS compatible only)
Must be willing and able (ex. no app store issues such as expired payment method, have space on phone) to download and install two free apps from app store
Must live/work/attend school in the State College, PA area (biosensor pick up on University Park campus)
Must not be participating in another study with mobile phone survey currently or planning to participate in another study with mobile phone survey in next 30 days
Dot not have a working iPhone
Not able/willing to download and install two free study apps from app store
Do not live, work, or attend school in the State College, PA area
Are participating or plan to participate in the next 30 days in another study with mobile phone surveys
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
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.
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.
Ecological Decision-Making of COVID-19 Vaccination
This is an online survey study that examines factors impacting people’s COVID-19 vaccination decision-making. In the survey, participants will answer various questions about COVID-19 and COVID-19 vaccines, such as their personal experience, their perception and knowledge of COVID-19 vaccines.
An active undergraduate student or graduate student enrolled in classes at University Park campus
currently is residing in the United States
not a currently enrolled undergraduate student or graduate student, of PSU, University Park
currently is not residing in the United States
A comparison of VR and MR in Human-ECA interaction
We are conducting this study to investigate whether different platforms of immersive technology influence the experiences of users when interacting with an embodied conversational agent. We are particularly interested in studying the effects of platform on users’ feelings of presence and social presence when comparing virtual and mixed reality environments.
English speaking
The Ketogenic Diet, Blood Lipids, and Heart Health in Healthy Adults with Differing BMI
The purpose of this feeding study is to examine if there is a difference in the effect of feeding a very low carbohydrate diet to people with normal weight and people with obesity. Participants will be asked to eat a very low carbohydrate diet, also known as a ketogenic diet, for 28 days. This diet will be provided to participants and includes 3 meals, some snacks, and beverages daily. Measurements of blood markers (fats, sugar, insulin, cholesterol), blood pressure, heart health, and body composition will be done at the start and end of the study.
In this study, you will be asked to consume a ketogenic diet for 28 days. This diet will be provided to you and includes 3 meals, some snacks, and beverages daily. This diet will meet your energy and nutrient needs. You will be asked to not eat any foods outside of what is provided by the study and consume no alcohol. Testing will be conducted on two consecutive days at the start of the study and the end of the study (a total of 4 testing days). For these visits, you will need to fast for 12 hours prior and avoid alcohol for 48 hours prior. At these visits, we will take a blood draw, measure your body weight, body composition, and preform non-invasive tests to assess your heart health.
$150
BMI: 18.5-22 or 30-35 kg/m^2
LDL cholesterol: <100 mg/dL
Blood glucose: <126 mg/dL
Triglycerides: <350 mg/dL
Current use of tobacco-containing products or (≤6 months) cessation
Pregnant or nursing individuals
Allergy or unwilling to eat study foods
Previously consumed a ketogenic diet for > 1 week
Social Values for Bird Conservation in PA
The purpose of this study is to examine public attitudes and willingness to pay for bird conversation activities on private forest lands.
Pictorial Influence on Sentence Comprehension
This behavioral study will examine the influence of pictorial primes on general knowledge questions. A participant will be shown a cartoon-type picture prior to the presentation of a question. They will be asked to answer the question verbally. This study aims to determine the influence of pictorial primes on memory recall and retrieval.
Must be a native English speaker
Not a native English speaker
Evaluation of the Immune Response and Antigenic Signature of Patients with Babesia Infection in Pennsylvania with the Aim of Developing a Rapid Diagnostic Test
We are evaluating patients who have been infected with Babesia. Babesia is a blood parasite that is acquired from ticks. The number of cases seen in Pennsylvania every year has been increasing. We intend to evaluate the blood of patients acutely infected with Babesiosis and review for possible simultaneous co-infections. We will compare those infected patients with the blood of healthy individuals. The goal is to identify proteins in the blood of acutely infected patients that are specific for Babesia and also evaluate the prevalence of patient's who have contracted a co-infection from the tick vector that transmitted the Babesia infection. The identification of the specific bacterial/parasitic antigens could then be used to create rapid diagnostic tests and help clinicians increase awareness of these tick-borne diseases.
We will obtain basic demographic information and past medical history. We will obtain two 10ml samples of blood. The blood will then be stored and ultimately sent to Antigen Discovery, Inc for proteomic array screening.
18 years or older
History of having your spleen removed
History of liver or kidney disease
HIV
Diabetes
A151216-Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (Alchemist)
Purpose of study is to examine lung cancer patients' surgically removed tumors for certain genetic changes and to possibly refer these patients to a treatment study with drugs that may specifically these tumors.
Patients will be registered to the trial after surgical intervention. One vial of peripheral blood and a tissue block (or scrolls) will be submitted to the study. Once testing is completed, subject is notified if they are eligible for one of the sub protocols.
Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size ≥4 cm).
Tissue available for the required analyses
No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD1/PD-L1/CTLA-4.
Rapid Motor Regulation Mechanism for Arm Movement in Response to Visual Motion
This study looks at the relationship between motor control via. arm movement and visual stimuli. After participating in brief calibration protocol for the eye tracking system, participants will be moving a robotic handle to interact with visual stimuli during various tasks. Participants will spend approximately 2 hours in the lab.
There will be one approximately 2-hour visit. They will then be asked to complete 20-25 blocks of hand movements while looking at a moving virtual stimulus with a large visual background. Participants will receive regular breaks during the experiment.
$20
Right-hand dominant
Normal or corrected-to-normal vision
Able to sit upright in a chair for long periods
Able to grasp and move objects with both hands
Any history of musculoskeletal disorders
Eye or vision problems (e.g., cataracts, glaucoma, a detached retina or macular degeneration)
Cognitive impairment such that informed consent cannot be obtained, or that participant would not be safe with the protocol
Medication that could make the participant drowsy or tired during the experiment
Understanding healthcare workers perception and knowledge of dysphagia
The purpose of this study is to gain a greater understanding of healthcare workers’ knowledge of and perception of dysphagia in older adults. Study participants will fill out a survey/questionnaire in a single study session. This is expected to take 15-20 minutes.
You will be asked to complete a single, brief survey. It will take no more than 15-20 minutes.
Active healthcare workers or care providers for community dwelling older adults over 60 years old
Working with older adults
English proficiency at 8th grade level
Not working clinically currently
Diagnosed mild cognitive impairment or dementia
Perception of English sentences in context
This study tracks the eye movements of 30 adults to gather information on how they process sentences when presented in a context.
native speaker of American English
grew up mainly in the US
not a native speaker of American English
did not grow up mainly in the US
Genetics of Aromatase Inhibitor Musculoskeletal Syndrome (AIMSS)
This is a case-control biospecimen collection study of 1,000 breast cancer patients with survey and retrospective chart review components to study the possible genetic, clinical and demographic/lifestyle predictive factors of AIMSS.
If you decide to participate, we will ask you to send us a sample of your saliva (“spit”) and ask you to fill out a survey on a computer or on paper, whichever you prefer. The survey will ask questions about risk factor data, demographics, and questions about side effects of cancer treatments. We will also ask you for permission to collect data from your electronic medical record.
$25
Prescribed at least one AI as part of breast cancer treatment at least one year ago
Female aged 21 and older
English or Spanish speaking
Diagnosis and systemic chemotherapy and/or hormonal treatment from cancer diagnosed prior to the index breast cancer
Those currently incarcerated
Under age 21 years old
PSCI: 24-010: Evaluate Safety and Efficacy of Daily oral Angelica gigas Nakai (AGN)-INM176 in Prostate Cancer Patients with Rising Plasma PSA (Phase I/II trial)
The purpose of this voluntary research study is to evaluate the safety and assess the efficacy of the daily INM176 herbal supplement in managing prostate cancer-specific PSA levels in prostate cancer patients.
This research study involves two phases: Phase I and Phase II. The procedures and treatments may vary depending on the phase the participant is in. Study Drug is administered daily by mouth. Pharmacokinetic (PK) and Pharmacodynamic (PD) blood tests are research procedures. Other research procedures include physical exams, vital signs, and blood tests.
Phase I Total: $1,200. Phase II Total: $1,300. Phase II Subjects crossing over from Phase I: Total: $900. All phases: Each additional unscheduled visit will be compensated for $100.
Male aged >=40 years.
History of prostate cancer diagnosis
Subjects with treated prostate cancer are eligible.
ECOG performance status 0-2.
Any active secondary malignancy requiring treatment.
Chronic kidney disease with calculated GFR <30 mL/min/1.73 m2 using Cockcroft-Gault formula, or measured GFR <30 mL/min/1.73 m2 using a 24-hour urine collection.
Subjects who are taking Warfarin/coumadin.
Mindful Moms study
This study (Mindful Moms) is being done to understand how an 8-week app-based mindfulness program called Calm impacts breastfeeding and maternal well-being. Eligible participants will be asked to complete three online surveys (each survey will take about 20 minutes) and take part in an 8-week app-based mindfulness program. Eligible participants will also be asked to take part in one online interview that will take about 25-30 minutes once the mindfulness program is over.
Participants will take part in one of two groups: A group asked to take part in a free 8-week app-based mindfulness program on their smartphone starting when they are 36 weeks pregnant or 4 weeks after delivery. The program will teach participants about mindfulness and breathing strategies to assist with calming their mind and body. or A group asked to take part in a free 8-week app-based mindfulness program on your smartphone starting 4 weeks or 12 weeks after they deliver. The program will teach participants about mindfulness and breathing strategies to assist with calming their mind and body. Participants will also be asked to complete three online surveys (each survey will take about 20 minutes) and take part in one online interview that will take about 25-30 minutes once the mindfulness program is over.
$130
currently pregnant (12 to 34 weeks) or recently delivered (within the past 4 weeks)
intend to or are currently breastfeeding
daily access to a smartphone
willing to download a free mobile app
Phase II Trial of Palbociclib with Fulvestrant in Individuals with Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer who have Progressed on Treatment with Palbociclib and an Aromatase Inhibitor
In this phase II trial, we will determine the progression-free survival (PFS) of the cyclin dependent kinase 4/6 inhibitor (CDK4/6i) palbociclib with fulvestrant in women and men with estrogen or progesterone receptor (ER/PR) positive, HER2-negative metastatic breast cancer (MBC) who progressed on treatment with palbociclib and an aromatase inhibitor (AI). We will also determine the prevalence rate of estrogen eceptor α (ESR1) and phosphatidylinositol-3-kinase (PI3K) mutations in the study population.
Participants will be required to come to the clinic every three weeks for evaluation and fulvestrant injections, take medication correctly, keep all appointments.
Histologically or cytologically confirmed adenocarcinoma of the breast with evidence of metastatic disease (stage IV) or locally advanced disease,
ER-positive and/or PR-positive tumor (≥1% positive stained cells) • HER2-negative tumor
Progressed on and following at least 6 months of combined treatment with palbociclib and AI therapy for advanced/metastatic breast cancer, and be able and willing to receive additional palbociclib treatment
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Concurrent use of any of the following medications during study participation: • Inhibitors or inducers of CYP3A4 that may affect serum concentrations of palbociclib
Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 2 weeks before registration.
Any other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
Prior hematopoietic stem cell or bone marrow transplantation.
SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 in the Treatment of Microcystic Lymphatic Malformations
Microcystic lymphatic malformations (mLMs) are masses of spongy tissue that may have small fluid-filled cysts. They are made of abnormally large or misshapen lymph vessels that do not work correctly. They are usually present at birth and get worse over time. Complications of mLMs include infection, bleeding, leaking of lymphatic fluid, disfigurement, and impaired mobility. The purpose of this study is to find out if the study medicine, sirolimus 3.9% topical gel, can help with the treatment of mLMs.
Total duration of the study is approximately 14 months, with up to 8 visits (approximately 1 visit per month). 5 visits will occur in person and 3 visits will be phone call visits. You will also complete 2 interviews. After the first 14 months, you will have phone call visits every 84 days until either the study is discontinued, or you decide to no longer participate. Procedures involved in the study include: medical history collection, physical exams, skin assessments, patient interviews, photographs, blood draws (at 3 visits), urine tests, and questionnaires.
At least 3 years old
Willing to follow all study guidelines
History of HIV or other immunodeficiency
Depressive Symptomatology and Inflammation
The purpose of this research is to investigate the associations between depressive symptoms and inflammation. The researchers are studying how specific symptoms of depression (such as fatigue, sadness, impaired concentration, and loss of pleasure) are related to markers of inflammation, which is a key component of our immune system. Volunteers with depressive symptoms, as well as volunteers without depressive symptoms are needed for this research study. This study includes an online survey to determine eligibility and one in-lab visit. Participants who are eligible will be scheduled for one in-lab visit (2.5-3h for participants with depressive symptoms & 1-2h for participants without depressive symptoms), where they will be asked to answer surveys with questions related to depressive symptoms and complete a number of tasks (using an iPad and a touch screen phone) that measure thinking skills including attention, memory and reaction time. Participants will also undergo a single blood draw to assess inflammatory markers.
Participation will require one in person visit at the CRC that takes from 1 to 1.5 hours total where they will have their blood drawn, fill out surveys about their mood, and complete cognitive tests.
30
No history of depression
Free of chronic inflammatory or autoimmune disorders
If female, not pregnant or nursing
Taking non-steroidal anti-inflammatory agents or statins everyday within the past month
Taking antipsychotics or mood stabilizers
If female, are post-menopausal or pregnancy/lactation