Search Results
HERMES: Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation.
To see how ziltivekimab taken once monthly versus placebo works in reducing the risk of cardiovascular death and heart failure events in participants with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation.
Return for on-site visits 14 times, participate in 6 phone calls, complete questionnaires via electronic study app, blood samples taken at each on-site visit, electrocardiogram (EKG) completed at 5 visits, monthly injection of study medication.
Up to approximately $1,120
Age 18 years or above
Use of long-term oral or IV antibiotics, antivirals, antifungals, or prescription oral/IV anti-rheumatics such as Methotrexate
Active hepatitis B or C, or active infection treated with antibiotics/antivirals
Females with active or planned pregnancy, currently breastfeeding, or females not able to use highly effective contraceptive
Inflammatory bowel disease within the last 12 months
Validation of Cell-free mitochondrial DNA (cf-mtDNA) Saliva Collection Methods
The reproducibility, reliability, and validity of saliva collection techniques is an important issue that needs to be addressed to achieve consistency in the emerging field of mitochondrial psychobiology. The objective of the current study is to increase scientific rigor by utilizing robust and well-controlled methods in the collection and testing of saliva samples. Given the non-invasive and convenient nature of saliva collection, it is likely that research using saliva-derived cell-free mitochondrial DNA (cf-mtDNA) will increase. Therefore, to ensure that the results obtained from the current study are trustworthy and meaningful, we are proposing a small, highly controlled randomized study design that will integrate three methods of saliva collection. The study will adopt a rigorous and systematic approach to data collection, analysis, and interpretation. Through the implementation of these methods, we seek to achieve a higher degree of accuracy and reliability in cf-mtDNA saliva-based measurements.
Each participant will be asked to collect 3 randomized saliva samples (i.e., one static Salivette®, one active Salivette®, and either a second active Salivette® or a passive drool) upon awakening for 10 business days. All collection materials be pre-labeled with the day, type of sample, and order to make it easy for participants to quickly and accurately deposit samples upon awakening. Once saliva samples are collected, participants will be asked to promptly return the samples to the provided plastic bag and store the bag in their at-home freezers. All samples will be stored there until the end of the 10-day study. After the saliva is returned to the freezer, participants will complete a short (3-5 min) morning survey on the provided mobile device which has been pre-loaded with the M2C2 application. The morning survey asks questions about sleep, morning outlook, and anticipatory stress and positive experiences. In the evenings, participants will be prompted (via banner notification on screen and audible beep) to complete a slightly longer (8-10 min) survey. This survey asks questions about the respondent’s daily experiences (stressors, mood, physical symptoms). Within the application, there are three brief, objective cognitive tasks. Upon completion of the 10-day protocol, respondents will return the mobile device and saliva samples. Participants may bring all saliva samples back to the lab during regular business hours, or they may schedule a time for a member of the study team to pick up the samples. Depending on the distance between the laboratory and the participant’s home, the need for ice packs will be assessed on an individual basis.
50
between the age of 18-50 years
must be English speaking
cannot be pregnant or breastfeeding
must not use tobacco
Individuals who work nightshift
Individuals who do not have access to an at-home freezer
Individuals who have an irregular sleep-wake cycle
Individuals who currently use tobacco
PSCI 22-082 Tropion-Breast03
This is an investigational drug study comparing the Investigational treatment with treatments called capecitabine and pembrolizumab as stand-alone treatment agents or in combination. Study participants will be required to attend all study visits, complete the tests and procedures, receive study treatment, and complete questionnaires.
Participants must attend all visits, receive study treatment, have blood drawn, complete questionnaires, have imaging scans done (ECG, ECHO or MUGA, CT, mammogram or breast MRI), keep a diary, have an eye exam, and provide a tumor sample.
Histologically confirmed invasive TNBC.
Residual invasive disease in the breast and/or axillary lymph node(s) at surgical resection following neoadjuvant therapy.
Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or a taxane with or without carboplatin, with or without pembrolizumab.14
No evidence of locoregional or distant relapse. Radiological scans before treatment are not required and should be obtained as per local institutional practice.
History of prior invasive breast cancer, or evidence of recurrent disease following preoperative therapy and surgery.
As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including history of allogeneic organ transplant and active bleeding diseases, ongoing or active infection,
History of another primary malignancy except for adequately resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ disease that has undergone potentially curative therapy
Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
22-111 A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple Myeloma
This study involved testing a drug for the treatment of relapsed/refractory multiple myeloma. The trial consists of three parts: the first part looks at the safety of the drug when given to patients; the second and third part looks the dose of the drug at how the drug is used through the body and how it acts on multiple myeloma.
Participants will need to attend the scheduled visits, provide medical history, blood samples, complete questionnaires, radiology exams, bone marrow aspirate and/or biopsy, and take study medication
Aged 18 years or older.
For patients in Parts 2 and 3 only: Measurable disease defined as one of the following: a) Serum M-protein ≥500 mg/dL (≥5 g/L).
During Part 1 only, patients not meeting the above criteria for measurable disease should, at least, have measurable bone marrow plasmacytosis (≥10%) and/or plasmacytoma (≥1 cm in diameter) detected by physical examination or imaging.
ECOG performance status of ≤2.
Patients who have received autologous SCT 60 days before first infusion of modakafusp alfa or patients who have received allogeneic SCT 6 months before first infusion.
Graft-versus-host disease that is active or requires ongoing systemic immunosuppression.
Part 1: Until the MTD/OBD is defined, patients who have received daratumumab (or other investigational anti-CD38 antibody) for at least 5 months (steady state) require a 90-day wash-out period before receiving modakafusp alfa.
Patient has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade ≤1 or baseline,
The effect of repetitive thinking on emotional reactivity to daily events in depression and generalized anxiety disorder: Application of the contrast avoidance model
This is an ecological momentary assessment study that will examine the relationship between daily events, emotion, and repetitive thinking using a mobile application. The participants will be required to answer 2 minutes questionnaire and monitor their heart rate 8 times a day for 8 consecutive days.
If you are eligible based on the screening survey, there will be one Zoom study session where you will complete a brief videotaped clinical interview to further determine your eligibility to participate in the study. If you are eligible and decide to continue in the study, you will complete a brief questionnaire and be trained on how to complete the study. Starting the next day, you will complete eight 2-minutes questionnaires per day and monitor your heart rate using smartphone application for 8 days.
Up to $20 (Amazon gift card)
Owns iPhone.
Scores high or low on depression and anxiety symptoms measure
Fluent in the English language in terms of speaking, listening, reading, and writing
Meets diagnostic criteria for bipolar disorder or schizophrenia-related disorders
Has suicidal thoughts
Unable to speak, read, listen, and write English fluently.
PACE – Development of an Eating Behavior Risk Score
The prevention of obesity is a far more effective approach than treating obesity after it has developed. Researchers and medical providers need better tools to identify risk factors for developing obesity, so families and their physicians can work to reduce a child's risk. This proposed study tests whether a novel risk score (PACE) is good at predicting if children will develop obesity. The PACE Score combines the measures of sensitivity to portion size, behavior while hungry or craving, loss of control during eating, and eating speed. This study will follow children in middle childhood through four visits, followed by two visits one year later. We will identify the components of PACE as well as biological and environmental factors that may work with or against the PACE factors to predict how children's body composition changes over a year.
Four baseline visits followed by two follow-up visits one year later Children will be provided meals at each visit Children and parents will complete questionnaires Children will have a DXA scan and an MRI scan Children will play learning games on the computer Children will wear an activity monitor for one week Children will perform brief and moderate exercise while wearing a heart rate monitor
$300
The biological mother must have a BMI between 18.5 – 25 or greater than 30. The parent primarily in charge of feeding must be able to accompany children to the visits.
children must speak English fluently
children should have no learning disabilities or developmental delays (e.g., ADHD, Autism, dyslexia)
children generally healthy with a BMI-for-age percentile less than 85 or greater than 95 to be enrolled.
Child medical condition affecting digestion, cardio, etc.
Child not fluent in English
Child should not be taking a medication that affects blood flow, appetite, behavior, etc.
Child should not have any unremovable metal in their body (e.g. steel dental work) or be claustrophobic
A Randomized Phase II Trial of Adjuvant Pembrolizumab versus Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) with Primary Tumors Between 1-4 cm:Big Ten Cancer Research Consortium BTCRC-LUN18-153 (PSCI# 20-043)
This is a research study to find out if giving a drug called pembrolizumab after lung cancer surgery does a better job at keeping the cancer from coming back than surgery alone. The usual approach for patients who are not in a study is to be followed closely by their doctor to watch in case the cancer returns. Participants in this study will be assigned by chance (flip of a coin) to be watched closely by their doctor or to receive a drug called pembrolizumab. Pembrolizumab is given as an infusion in the clinic once every six weeks. . You will have tests, exams and procedures that are part of your regular care and for study purposes. You will have scans every 12 weeks to make sure the cancer hasn’t come back. If you are assigned to receive pembrolizumab, you can continue to receive it for up to 1 year.
If you decide to take part in this study, you will be assigned to one of two groups. This is called randomization. A computer will assign you to a group in the study by chance. This is done by chance because no one knows if one study group is better or worse than the other. You will have an equal chance (50/50) of being assigned to either group.
Patients must have undergone complete surgical resection of their stage I non-small cell lung cancer between 4-12 weeks prior to registration.
Pathological tumor size must be 1.0 – 4.0 cm in size.
ECOG Performance Score 0-1
Baseline CT chest must be performed within 28 days of randomization
No prior PD-1 or PD-L1 inhibitors are permitted.
No prior neo-adjuvant or adjuvant chemotherapy is permitted for this lung cancer.
Patients with a history of (non-infectious) pneumonitis that required steroids
Has active autoimmune disease that has required systemic treatment in the past 2 years.
A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency–Associated Liver Disease With METAVIR Stage F1 Fibrosis
The goal of treatment with fazirsiran is to prevent and improve the build up of these abnormal proteins that cause liver injury and fibrosis by shutting down the production of Z-AAT. Decreasing Z-AAT build up in liver cells is important, as this protein has been clearly identified as the cause of liver injury in AATD. In this study, fazirsiran is being compared with a placebo for patients with AATD LD. A placebo is a liquid like fazirsiran but does not contain any active ingredients.
You will visit the study site approximately 12 times for blood sampling, computed tomography (CT) lung densitometry, lung function tests, FibroScans, ultrasounds, liver biopsy, esophagogastroduodenoscopy (EGD) study drug administration, and questionnaire completion.
The participant must have a diagnosis of the PiZZ genotype AATD
The participant has evidence of METAVIR stage F1 liver fibrosis
An adult participant must have a body mass index (BMI) between 18.0 and 39.0 kg/m2, inclusive.
The participant is a nonsmoker
The participant has a history of varices based on a previous esophagogastroduodenoscopy.
The participant has portal vein thrombosis.
The participant has HIV infection as shown by the presence of anti-HIV antibody (seropositive).
The participant is pregnant or breastfeeding or intending to become pregnant before participating in this study, during the study.
Convergence of online machine learning policies for haptic feedback
The purpose of this study is to determine whether a machine-learning based algorithm for generating on-skin feedback can be trained quickly and can adapt quickly to changes in the environment. Participants will have an armband with vibration motors and microcontroller fitted to their right arm. They will provide indication about where around the circumference of their arm, they feel the vibration using a joystick. The joystick responses will be used to update a machine learning policy online such that the desired joystick responses match the actual ones by adjusting the levels of vibration in each motor.
There will be one in-person visit. You will have an armband with vibration motors and microcontroller fitted to your right arm. You will grasp a small joystick and move the stick around following the indications given by the vibration and/or visual display.
15
Right-handed
neuromotor disorder
PSCI# 24-028 NRG-BR008: A PHASE III RANDOMIZED TRIAL OF RADIOTHERAPY OPTIMIZATION FOR LOW-RISK HER2-POSITIVE BREAST CANCER (HERO*)
This study will look at the differences in recurrence between patients who receive breast radiation after surgery to those who don't.
Participants will be required to come to all study visits, complete their radiation and chemotherapy treatments.
The patient must have an ECOG performance status of 0 ,1,
Histologically or cytologically confirmed invasive breast carcinoma.
The tumor must have been determined to be HER2-positive by current ASCO/CAP guidelines based on local testing results.
The tumor must have ER and PgR status assessed locally using current ASCO/CAP Guidelines.
patients with a primary tumor >2 cm on pathologic examination of the surgical specimen
Patient planning for or status-post mastectomy.
Non-epithelial breast malignancies such as sarcoma or lymphoma.
Multicentric carcinoma (invasive cancer or DCIS)
Understanding the user experience of using consumer-facing digital symptom checkers
This is an interview study that examines how people use online symptom checker platforms or apps (e.g., WebMD, Ada, K health app, Your.MD) to self-diagnose or support the decision of whether and when to do a medical visit. The research procedure involves: 1) a short screening survey which helps us determine who are eligible to participate; 2) an audio‐taped interview with each eligible participant that will last approximately 30‐60 minutes online or offline near Penn State University Park. Each participant will be compensated with a $20 Amazon gift card for completing the interview.
Speak English or Chinese
At least 18 years of age
Have used online symptom checker platforms or apps
Have never used any symptom checker
Vulnerable populations such as children, pregnant women, cognitively impaired adults, and prisoners
PHASE I SAFETY ASSESSMENT OF HYPOFRACTIONATED POSTOPERATIVE RADIOTHERAPY (H-PORT) FOR INTERMEDIATE-RISK HEAD AND NECK CANCER
The purpose of this study is to test the good and bad effects of using hypofractionated radiation therapy. Hypofractionated radiation therapy could shrink or stabilize your cancer, but it could also cause side effects. The study doctors hope to learn if hypofractionated radiation therapy is safe and tolerable in patients with your type of cancer. You will receive radiation therapy for 4 weeks. You may also receive chemotherapy.
Participants will be required to receive radiation therapy for 4 weeks. Participants may also receive chemotherapy with cisplatin, carboplatin, or cetuximab.
Clinical stage II, III or IVA squamous cell carcinoma of the oral cavity, oropharynx or larynx (AJCC 8th edition), including no distant metastases.
Total resection of the patient’s cancer (i.e. no residual disease after total resection of the patient’s cancer ).
One or more indications for postoperative radiotherapy, based upon pathologic findings: • Perineural invasion; • Lymphovascular invasion;
Zubrod Performance Status 0-1
History of systemic lupus erythematosus or systemic sclerosis (scleroderma).
Pregnancy and individuals unwilling to discontinue nursing.
Feeding tube (gastric or jejuno) at the time of registration.
Anticipated need for high-dose systemic chemotherapy (e.g. high dose q3-week cisplatin), multiple systemic therapy agents or immunotherapy. Weekly single-agent systemic therapy with cisplatin, carboplatin, or cetuximab is allowable.
Master Protocol of Two Independent, Randomized, Double-Blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) To Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis
A study that looks at the efficacy of Frexalimab compared to standard of care drug, Teriflunomide, for adults with relapsing forms of MS.
The purpose of this clinical trial is to compare the efficacy and safety of investigational products in adult participants with relapsing forms of multiple sclerosis. There will be about 22 in person visits over 3.5 years that consist of monthly IV medication administration, monthly oral tablet medication dispensation, Magnetic resonance imaging (MRI) roughly every 6 months, monthly blood draws for lab work, vitals, ECG, and clinical outcome assessments. 13 of these visits are within the first 12 months of the study. All study activities will be done at the Penn State Health Hershey Medical Center in the Neurology Clinic at 30 Hope Drive and the Clinical Research Center (CRC) in the main hospital.
Up to $4300
Diagnosed with remitting relapsing multiple sclerosis (RRMS) with a documented relapse within the previous year, two documented relapses within two years, or one documented Gd enhancing lesion on an MRI scan within the previous year.
Must agree to use contraception for both male and female participants.
Must be able to sign informed consent or have a legally authorized representative to sign.
History of infectious disease/serious psychiatric illness/active substance use disorder/cirrhosis, acute liver disease/malignancy/autoimmune, cardiovascular, neurological disorders/any other history or presence of significant other concomitant illness.
Treatment with lymphoid irradiation, bone marrow transplantation, mitoxantrone, alemtuzumab, cladribine, daclizumab, cyclophosphamide, other strongly immunosuppressive treatments with very long-lasting effects, equal to or over 3 months of teriflunomide.
Previous exposure to frexalimab, other investigational drug trials, allergy or sensitivity to any of the study interventions.
Contraindication for MRI: pacemaker, metallic implants/presence of metallic material in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.
PSCI 23-092 EA8192 A Phase II/III trial of Durvalumab and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy
This trial is comparing outcomes of cisplatin eligible vs cisplatin ineligible high grade urothelial cancer patients treated with accelerated therapy vs gemcitabine and durvalumab followed by surgery.
Participants will need to complete all study visits, agree to having surgery and to make sure to tell the study team if they are having any side effects.
Patient must have the ability to understand and the willingness to sign a written informed consent document
Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy
Patients must not have any component of small cell/neuroendocrine carcinoma
Patients must not be pregnant or breast-feeding
Patient must not have another active (or within two years) second malignancy
Patient may have a history of resectable urothelial cancer
Patient must not have any uncontrolled illness
Patient must not have received prior systemic anthracycline therapy
Cognitive and Social Factors Underlying Spoken Language Use
The central purpose of this research is to understand how language users produce and comprehend speech. To do this we ask participants to record speech, make judgments on the speech they hear, and work with a partner on simple language tasks.
Between 18 and 65 years of age
A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared with Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients with Heart Failure and Impaired Kidney Function (BalanceD-HF, D6402C00012))
The study is being done to determine whether dalcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of cardiovascular death and heart failure events with and without hospitalization
Sign consent form, attend scheduled study visits, undergo an echocardiogram (if applicable) and electrocardiogram, complete pregnancy test (if applicable), undergo physical examination, vital signs, height and weight measurements, complete study questionnaires, provide urine and blood samples for the study, take study medication as directed.
up to $1,600
being treated for heart failure
undergoing treatment for decreased kidney function
major heart surgery within the past 3 months
complicated heart defects at birth or severe uncorrected valve disease
Expanding Family Foundations to 2nd-Time Parenthood - Focus Group
This focus group study, funded by Penn State's Social Science Research Institute, brings together couples with preschool-aged firstborns who are pregnant with their 2nd child or who have given birth to their 2nd child within the last 12 months. Couples will be interviewed about how they worked together as a team (as coparents) to prepare their firstborn for the birth of the second child and to prepare themselves for 2nd-time parenthood.
2. Each caregiver is over 18 years of age.
3. Caregivers are living together in the same household and are either married or living with a partner.
4. Families living independent of parents’ families of origin.
5. Both caregivers fluent in communicating in English.
2. Caregivers are under 18 years of age.
3. Caregivers not living together
4. Caregivers not living independently of their families of origin
5. Single-parent families with no live-in partner.
A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2002 in Participants With Hereditary Angioedema
This study will investigate the effects of NTLA-2002 on people with Hereditary Angioedema (HAE). NTLA-2002, which consists of a CRISPR/Cas9 gene editing system, is designed to limit production of plasma kallikrein in the liver cells by acting on the KLKB1 gene. This means NTLA-2002 would permanently change the DNA in the liver cells so less plasma kallikrein would be produced. Lower levels of plasma kallikrein may result in fewer HAE attacks.
During part 1 of the study, participants will either be given NTLA-2002 or placebo (no active ingredients) as an intravenous infusion. Participants will have the option to receive the opposite infusion about 28 weeks later. This study involves getting pre-medications to reduce the chance of an HAE attack and a reaction to the infusion. Study assessments will be preformed to monitor safety. Daily electronic diaries will be completed to monitor for HAE attacks. Also quality of life questionnaires will be completed. If part 1 and part 2 are completed, there are 22 visits. Some of those visits can occur over the phone.
Diagnosis of Hereditary Angioedema Type 1 or Type 2
Access to rescue treatment for Hereditary Angioedema
history of drug or alcohol abuse in the past 3 years
history of active cancer in the past 3 years
PSCI 24-139 NRG-BN013: PHASE III TRIAL OF SINGLE FRACTION STEREOTACTIC RADIOSURGERY (SRS) VERSUS FRACTIONATED
This trial will examine if disease progression improves with Fractionated vs. Steriotactic Radiosurgery.
Participants must agree to the type of radiation they are randomized, keep all appoiintments and rpoert any side effects.
Patients must have at least 1 and up to 8 total intact brain metastases
All brain metastases must be located outside of the brainstem
No more than 2 lesions planned for resection
No known leptomeningeal disease
No prior radiotherapy to the brain
No active infection
No hepatic insufficiency
No chronic obstructive pulmonary disease exacerbation
A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib
The main purpose of the study is to find out if patients treated with remibrutinib may experience fewer MS relapses (also called clinical attacks, exacerbations or flare ups) than patients treated with teriflunomide (also known as Aubagio®). Teriflunomide is an approved medication for the treatment of relapsing MS
This study requires you to take a medication. This study consists of a core part (21 in person visits over 2.5 years) and an extension part (18 in person visits over 5 years). Study activities consist of blood draws for labs every 3 months, vitals (blood pressure readings, heart rate, height and weight), physical exam, electrocardiogram (ECG), clinical outcome assessments, a participant diary that will be filled out during treatment, and an optional magnetic resonance imaging (MRI) sub-study. All study activities will be done at the Penn State Health Hershey Medical Center in the neurology clinic at 30 Hope Drive and clinical research center (CRC) in the main hospital.
$3960
Diagnosed with remitting relapsing multiple sclerosis (RRMS) with a documented relapse within the previous year, two documented relapses within previous two years, or one documented Gd enhancing lesion on an MRI scan within the previous year.
Must be neurologically stable for 1 month prior to joining the study (including no MS relapse in this time period)
Must agree to use contraception for both male and female participants
Must be able to sign informed consent or have a legally authorized representative to sign.
MS disease duration of more than 10 years
Any history or presence of significant concomitant illness.
Treatment with some common MS medications such as cladribine, cyclophosphamide, remibrutinib or other BTKi, alemtuzumab
Optional sub-study: contraindication for MRI: any metal in the body or history of metal fragments, claustrophobia, known allergy to contrast medium.
Cabazitaxel with Abiraterone versus Abiraterone alone Randomized Trial for Extensive Disease following Docetaxel: the CHAARTED2 Trial
To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel and ADT for HSPC can improve PFS compared to abiraterone acetate alone.
To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel and ADT for HSPC can improve PFS compared to abiraterone acetate alone.
Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate).
Previous chemotherapy with at least 3 cycles of docetaxel for hormone-sensitive metastatic prostate cancer.
Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (CT/MRI of abdomen/pelvis, bone scintigraphy or NaF PET/CT).
Ability to swallow abiraterone acetate tablets as a whole.
Pure small cell or other variant (non-adenocarcinoma) prostate cancer histology for which treatment with abiraterone would not be considered appropriate.
Patients may not be receiving other therapeutic investigational agents or be receiving concurrent anticancer therapy other than standard androgen deprivation therapy.
Any medical condition for which prednisone (corticosteroid) is contraindicated.
Active infection requiring treatment with antibiotics.
Children's appetite regulation study
The purpose of this study is to determine whether girls and boys regulate their appetites differently. Children will attend 1, 3 hour session in the laboratory, complete some surveys and health measures, donate saliva, and eat pizza.
Children will come to the lab for a 3.5 hour session where they will wear a heart rate monitor, conduct some surveys, have their veggie intake measured, provide some saliva, and eat some pizza. Parents will attend the lab visit with the child and complete questionnaires about feeding and the home environment.
$50 plus travel costs for > 20 miles from lab
Healthy without food allergies
Parent in charge of feeding able to attend with child
Children with medical problems or taking a prescription medication that may affect appetite
Children who are not willing to eat pizza in the laboratory
The parent in charge of feeding decisions cannot attend with the child
ALL ALS-PREVENT
The primary purpose of this study is to collect samples and health information from individuals who are genetically at risk for ALS to better understand ALS and how the disease progresses.
Study visits will be conducted both in an in-clinic setting and remotely with 14 visits over the course of 36 months (3 years). Participants will complete a total of 10 visits over the course of 36 months (3 years). There will be a screening visit onsite in the clinic; 3 in-person onsite clinic visits once a year; and 6 remote visits once every 4 months. 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. Biospecimens will be collected alongside COA to support biofluid biomarker analyses. Biospecimens will include plasma, serum, RNA, whole blood for generation of induced pluripotent stem cells (iPSCs) and DNA for whole genome sequencing, and cerebrospinal fluid (CSF) via lumbar puncture (LP). To supplement annual in-person visits, participants will undergo additional biofluid collection (plasma, serum and whole blood) which will be remotely collected through home phlebotomy.
Up to $780
Capable of providing informed consent and willing to follow study procedures.
First-degree relative of known carrier of ALS gene OR First-degree relative of individual with ALS and/or FTD in a family with a “compelling family history” of ALS/FTD, regardless of whether genetic testing has occurred in symptomatic family members.
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)
Genetic Testing Sub-Study: Currently enrolled in the PREVENT ALS Study
Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression that would interfere with the study procedure.
Clinically significant, unstable medical condition 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.
Genetic Testing Sub-Study: Presence of unstable psychiatric illness (psychosis, active suicidal ideation, suicide attempt, or untreated major depression) in whom predictive genetic testing would confer a high risk of harm.
20-099, EA1181 (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete response
The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.
The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.
Patents must have a left ventricular ejection fraction (LVEF) within normal institutional parameters (or > 50%).
Patient must not have Stage IV (metastatic) breast cancer
Patient must not have T4 and/or N3 disease, including inflammatory breast cancer.
Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy.
Patient must not have a concurrent serious medical condition that would preclude completion of study therapy.
Functional magnetic resonance imaging (fMRI) and psychophysical studies of sensory perception and cognition
The purpose of this study is (1) to understand how the brain processes sensory information and (2) how this is affected by factors like blindness or synesthesia. In addition to behavioral testing, the study will use functional magnetic resonance imaging (fMRI) which enables us to take pictures of the brain while you are doing a task, using an instrument called an MRI scanner.
Participants will perform simple behavioral tasks either stand-alone or while being scanned; they may also complete questionnaires or rating scales.
Amount varies depending on the study
Normal or corrected-to-normal vision
No other sensory deficits
Adults who experience synesthesia
Must pass MRI safety screen (if applicable)
Minors under the age of 18
Individuals who fail the MRI safety screen (may still do behavioral studies)
Characterization and Exploration of Cognitive Assistants in the Space of Knowledge and Social Demands
The objective of this study is to investigate the effects of artificial intelligence on ideation in groups (specifically the process of brainstorming). Facilitation and facilitator/participant perceptions will also be analyzed. This study collects qualitative data through surveys, interviews, and audio/video recording.
Individuals must be an undergraduate OR graduate student at Penn State
Individuals who are not an undergraduate OR graduate student at Penn State
ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED)
Upper tract urothelial cancer (UTUC) is a recurrent disease. The current standard treatment for most UTUC patients requires surgery either removing some of the ureter in each operation or radical nephroureterectomy (RNU-removal of kidney and ureter) but the role of minimally invasive & kidney- preserving methods is increasing. The use of TOOKAD (padeliporfin) was investigated in a Phase 1 clinical study in the minimally-invasive treatment of UTUC with the goal of identifying safe laser/light exposure and signs that the tumor has been reduced or eliminated. Early results from this study have been highly promising, revealing the effects of tumor removal with a positive safety profile, indicating the potential role of TOOKAD (padeliporfin) in the treatment of low-grade UTUC disease. This Phase 3 study is designed to provide confirmation of the observed Phase 1 findings. Patients are expected to remain in the study for 25 to 28 months. Participation in this study will include up to 9 study visits to Hershey Medical Center and 2 phone visits.
There are 4 stages to this study: screening phase, induction study treatment phase, maintenance study treatment phase and long-term follow-up phase. In screening you can expect to be asked questions about your medical history, MRI or CTU, blood and urine samples, physical exam, vitals, tumor assessment by ureteroscopy and biopsy under anesthesia. Induction Treatment Phase (1-3 months) • Participants undergo anesthesia and receive the study therapy 1 to 3 times, about 4 weeks apart. If a participant does not achieve Complete Response (CR)* after 3 treatments (or if their disease has progressed as defined in the protocol), the participant will be discontinued from the Treatment Phases and enter the Long-term Follow-up Phase. Maintenance Treatment Phase (12 months) • Participants who achieve CR* from Induction Treatment Phase will be followed for 12 months. Up to 3 repeated study therapy doses will be provided for participants who have treatable tumor recurrence as determined by the study doctor. Long-term Follow-up Phase (48 months) • Patients who achieve CR and then enter the maintenance treatment phase and who have a CR after the end of maintenance treatment phase will enter the Long-term Follow-up Phase and will be followed up for up to an additional 48 months in the Long-term Follow-up Phase or until recurrence, progression, death or loss to follow up, to document safety and ongoing response. • Patients discontinued from the treatment phases and who have received at least one study treatment will be followed up for additional 12 months in the long-term follow-up phase of the study from last VTP treatment.
Biopsy-proven disease. A concurrence of the central pathology reader will be required for eligibility.
Up to 2 biopsy-proven sites of low-grade involvement. Please contact site for tumor dimension criteria.
Karnofsky Performance Status ≥ 50%
Adequate organ function defined by baseline Lab testing
Carcinoma in situ (CIS) current or previous in the upper urinary tract
History of invasive T2 or higher urothelial cancer in past 2 years
Participation in another clinical study involving an investigational product within 1 month before study entry
BCG or local chemotherapy treatment in the upper urinary tract within 2 months prior to inclusion
Trust in Machine Agents Under Realistic Threat
Measures of actual human-machine interaction are required to generate ecologically valid, translatable discoveries that enhance human-systems integration and performance. Here, the proposed methods center on human-robot decision tasks to assess key determinants of human trust in robot recommendations (e.g., factors such as threat-salience and/or robot appearance), and the concomitant impacts of trust on performance.
There will be one in person visit, you will be asked to interact with a robot in a virtual environment.
10
Must not be suffering from anxiety disorders and/or panic attacks.
Must not be suffering from any known heart conditions.
Must not, to your knowledge, be prone to nausea when experiencing VR
Suffers from anxiety disorders, suffers from heart conditions, prone to nausea when experiencing VR
Eye-tracking of Aging and Language
We are interested in how adults understand language, and how this changes across the lifespan. Participants will complete paper and pencil tasks, computer-based tasks, and we will monitor how they move their eyes.
Right Handed
Monolingual
Minimum High School Education or GED
Normal or corrected to normal vision (20/20, not color blind)
Left Handed
<18 years old
speaking more than 1 language
less than 12 years education and no GED
Interactions between the olfactory, auditory, visual, and trigeminal systems
The purpose of this study is to use fMRI to identify and characterize the olfactory, auditory, visual and trigeminal-related brain networks. This research will then be use to enhance human health by laying the foundation to develop sensitive biomarkers to identify people who are at risk of developing brain disorders such as Alzheimer’s disease and Parkinson’s disease, where olfactory deficits are known preclinical symptoms.
Clear sinuses
Pregnant or lactating
Presence of a pacemaker, aneurysm clips or any metal in the body
A history of welding, grinding, and or claustrophobia
Neurological disease (stroke, tumor, Parkinson's) or Psychiatric disorder (bipolar, schizophrenia, etc)