Search Results
Metabolic biomarkers in ALS
Our overall objective is to recruit a case control study of metabolic profiles. We are hoping to learn more about metabolic profiles for people with ALS (Amyotrophic lateral sclerosis - Lou Gehrig’s Disease) and the changes that occur during disease progression. Study participants will be divided into two cohorts: ALS patients and healthy volunteers. The ALS patients will provide blood samples every 6 months, as long as possible. The healthy volunteers will only provide one blood sample upon enrollment in the study.
ALS patients will: - Review and sign informed consent - Attend a study visit lasting 15-30 minutes every 6 months - Provide blood sample every 6 months - Allow study team to access electronic medical record to collect ongoing clinical data at each study visit Healthy volunteers will: - Review and sign informed consent - Attend a single study visit lasting 15-30 minutes - Provide blood sample at enrollment - Provide height & weight - Provide information about Medcial history & medications as they pertain to diabetes and high cholesterol
ALS diagnosis using Gold Coast Criteria or healthy controls
Cognitive ability to consent or legally authorized represenative
PSCI# 25-059: Consolidative Use of Radiotherapy to Block (CURB2) Oligoprogression in Patients With Metastatic Non-Small-Cell Lung Cancer – A Randomized Phase 3 Trial
The purpose of this study is to compare the usual approach to a new technique in radiotherapy delivery called stereotactic body radiotherapy (SBRT) while continuing the current treatment of immunotherapy with or without chemotherapy.
Participants will meet with the study team to discuss the study. After it has been determined that is save for them to enroll, they will need to attend all appointments. Participants will be coming to the clinic at least monthly for infusion therapy and daily for radiation. It is important that participants let the study team know how they are feeling.
Oligoprogression on first-line ICI +/- chemotherapy systemic therapy after at least 3 cycles
All sites of oligoprogression can be safely treated with SBRT or ablative radiotherapy
ECOG performance status of 0, 1 or 2.
Participants must be ≥ 18 years of age.
Pregnancy
Serious medical conditions in which radiotherapy of target lesions is contraindicated
Participants who are not actively on ICI alone or ICI + chemotherapy.
Concurrent treatment with other anti-cancer therapy, including investigational agents.
AREN2231: Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)
The purpose of this study is to improve the treatment of children and young adults with all stages of FHWT, so that more patients are cured without relapse, and that side effects from treatment are lessened without decreasing cure rates. This study will use information on higher or lower risk features of FHWT to adjust the treatment of each subject based on their risk of relapse.
All patients will receive chemotherapy (regardless of stratum assignment) starting with 1 cycle (3 weeks) of VA (vinCRIStine, DACTINomycin) chemotherapy. Some patients will have changes in treatment based on information learned after enrollment. For all patients, at least one callback is required to be completed prior to randomization and/or prior to any change in treatment or continuation of the same treatment.
Patients must have newly diagnosed Stage I-IV Favorable Histology Wilms Tumor
Patients who in the opinion of the investigator are not able to comply with the study procedures are not eligible
Patients with any uncontrolled, intercurrent illness including but not limited to symptomatic congestive heart failure
Patients with known Charcot-Marie-Tooth syndrome
Patients receiving concurrent chemotherapy for a different diagnosis.
PSCI 23-146 A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery
this trial will compare Pembrolizumab with and without MK-2870 in participants with lung cancer for disease free survival.
Participants will be required to com to all study visits, report all medications they are taking, including over the counter medications and tell the study team how they are feeling.
$50 for each completed visit
Able to undergo surgery based on opinion of investigator after consultation with surgeon.
Able to receive pembrolizumab and platinum-based chemotherapy
Has not achieved pathologic Complete Response at surgery
18 years of age
Has history of documented severe dry eye syndrome,
Has active inflammatory bowel disease
Has active inflammatory bowel disease
Characterizing the effect of an electrolyte and carbohydrate-based hydration beverage on hydration status in young adults.
This study will determine how well water, an electrolyte and carbohydrate based drink, and an electrolyte only drink hydrate the body. This study will measure how long the water from these drinks stay in your body. We will look at different hormones and electrolytes in the blood and urine to determine which drink keeps fluid in your body the longest.
There will be 4 in person visits. The first is a screening visit which will take about an hour. During the next three visits we will have you drink 1 L of a beverage and we will measure your blood and urine for a few hours after you drink it to determine how well it hydrates you. There will be a blood draw at each of the 4 visits.
150
Regularly Active
18-40 yrs old
Men and women
Pregnancy and breastfeeding
smoking
diuretics
prostate issues interfering with urination
PSCI 24-076 A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN (I-DXD) IN SUBJECTS WITH PRETREATED ADVANCED OR METASTATIC ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ESCC) (IDeate-Esophageal01) (A PHASE 3 STUDY OF I-DXD IN SUBJECTS WITH PRETREATED ESCC)
This trial will be examining the use of a drug, ifinatamab in the treatment of patients with advanced or metastatic esophageal squamous cell cancer.
After signing consent, participants will have blood tests and scans to see if they are well enough to participate. If the participate, they will need to come to the clinic to see the study team then get the experimental treatment. Participants will continue treatment until the medication no longer works, they no longer want to participate, or the study doctor feels it is not safe for them to continue.
Has histologically or cytologically documented unresectable locally advanced (Stage II to IVA if T2-T4 or N1-3 M0), or metastatic (Stage IVB) ESCC
Has disease progression post platinum-based and ICI treatment
Has received any topoisomerase inhibitor.
Has histologically or cytologically confirmed adenosquamous carcinoma subtype.
PSCI # 25-038 A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
This trial will examine which combination is better in treating Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Sorotoclax or Venatoclax.
There are three parts to this study. Screening, when you will meet the study team, sign the consent for and have tests performed to make sure that it is safe for you to participate in the study. If you join the study you will be chosen to participate in one of four arms, each with different medication to treat you disease. During the first cycle of treatment you will need to be seen by the study team between 4 and 7 times, depending upon the treatment. You will continue on the study medication until it no longer works, you have finished the trial or the doctor feels that it is no safe for your to continue ( among other reasons). The third part of the study is follow up. you will have a study visit in the clinic 30 after the last day of taking the study drug. That will be followed by after treatment follow up visits every three months until your cancer returns, if it returns. Then you will be followed every three months to see how you are doing.
Must have confirmed diagnosis of CLL/SLL
Must have received ≥ 1 prior therapy for CLL/SLL
Must not have received any maintenance therapy.
Patients with a history of confirmed progressive multifocal leukoencephalopathy
Prior allogeneic stem cell transplant with active GVHD
Received a live, attenuated vaccine within 4 weeks
A Phase 3, External and Synthetic Placebo-Controlled Randomized Study with Dose-Up for Non-Responders to Investigate Safety and Efficacy of Ritlecitinib 50 mg and 100 mg Once Daily in Adult and Adolescent Participants 12 Years of Age and Older with Alopecia Areata
Alopecia areata (AA) is an autoimmune disease that causes non-scarring hair loss that can be relapsing and chronic. It affects patients of all ages, races, and genders. Symptoms can range from patchy hair loss usually affecting the scalp, to complete scalp hair loss (alopecia universalis) or complete loss of hair on the scalp, face, and body (alopecia totalis). AA has a detrimental impact on patients' emotional wellbeing, self-esteem, social interactions, and quality of life, and psychiatric conditions such as anxiety and depression are more common in patients with AA compared to healthy controls. The purpose of this study is to find out if the study medicine, Ritlecitinib, can help with the treatment of AA.
Study participation will last approximately 57weeks. During the study, participants will attend 9 in person visits in the research office. At different timepoints the participant will have their hair examined, blood drawn, have an ECG and chest x-ray done, have photos taken of their scalp and face, answer questionnaires, and take study medication as directed by the study team.
At least 50% hair loss on the scalp with no regrowth for at least 6 months
Current episode of hair loss no longer than 10 years
Other scalp conditions that could interfere with alopecia assessment
Certain medications are not allowed; study coordinator will discuss
A Community-Based Pickleball Program for Adults with Autism Spectrum Disorder
This study will test whether playing pickleball, a fun and easy-to-learn paddle sport, can improve physical coordination and reduce core autism symptoms in adults with autism spectrum disorder (ASD). Participants will be placed in either an early start group or a delayed start group using a delayed control trial design. The early start group will attend two 90-minute pickleball classes per week for the first 8 weeks and then resume regular activities for the next 8 weeks. The delayed start group will continue regular activities for the first 8 weeks and then transition into the pickleball classes for 8 weeks. All participants will complete pickleball skill assessments at their first and last class to measure improvement, and three testing sessions during the study will assess sensory-motor processing, autism symptoms, mental health, and quality of life. By comparing the two groups, this study aims to determine whether pickleball supports better physical and emotional health for autistic adults and whether it can help participants feel more confident, connected, and engaged in social settings.
Participants will attend two or three in-person testing sessions (baseline, mid-study, and post-study) where they will complete surveys and a videogame-based sensory-motor assessment. They will also participate in two 90-minute coach-led pickleball classes per week for 8 weeks. Pickleball skill assessments will be completed during their first and last pickleball class.
$100
Clinical diagnosis of autism spectrum disorder (ASD)
Able to participate in group activities without caregiver support
Able to understand and communicate in English
Available and able to attend at least two pickleball sessions per week during the 8-week program
Use of mobility aids that limit court-based movement
Moderate-to-severe joint pain
Neurological conditions (e.g., cerebral palsy, epilepsy, severe head injury)
Clinical diagnosis of intellectual disability
Platform Wars: Evaluating postural and strength adaptations with Wii Fit Balance vs. Whole-body vibration in college students.
This study will aim to see if there is a difference in strength and balance changes among college students when comparing the Wii Fit Balance and whole-body vibration training.
The study duration will be six-weeks, in which study participants will be involved in either a gaming training group or a vibration platform training group. Participants will complete a baseline session and post-training assessment, each lasting two hours. During both of these visits measures of balance, strength, and walking ability will be acquired. In the six weeks of the study,18 individual vibration or gaming training sessions will be completed. The respective training sessions will take place three times a week for 6 weeks and will last 10-minutes each.
$20.00
Male and female between the ages of 18 and 25.
Known history of musculoskeletal, neurological, cardiovascular, or pulmonary impairment that may affect ability to perform the testing procedures.
Use of a pacemaker.
Major general medical disorders, such as recent surgeries, implants in trained body parts (i.e., artificial joints), acute hernias, discopathies (i.e., slipped disks), rheumatoid arthritis, epilepsy, and/or acute thrombosis.
Using sedatives of any type upon enrollment to the study.
Glycemic Effects of a Mediterranean-Style Dietary Pattern Containing Potatoes in Adults with Prediabetes
The purpose of this research study is to determine if a healthy Mediterranean diet containing one medium potato/day has equivalent or non-different effects on risk factors for type 2 diabetes and heart disease as a healthy Mediterranean diet without potatoes. Participants will be randomly assigned to one of the test diets and be asked to consume this diet for 12 weeks (84 days). Testing will be conducted at the beginning and end of the study.
This study runs for about 3 months. During this time, you will be randomly assigned to one of the test diets and be asked to consume this diet for 12 weeks (84 days). We will provide you with all of the food you need to follow this diet. This will include 3 meals, snacks and some beverages prepared in the Penn State Research Kitchen, which will meet your energy and nutrient needs. During the study, we will ask you not to eat any foods outside of those provided by the study. You may have up to 5 days off the diet during the 12 week period. Testing will take place on two separate days at the beginning and end of the study (4 testing days total). For these visits, you will need to fast for 12 hours prior and avoid alcohol for 48 hours. At these visits, we will collect a blood sample, measure your weight, and perform non-invasive tests to assess your vascular health. You will also be asked to wear a continuous glucose monitor (CGM) for 14 days—7 days before the first testing visit and 7 days at the end of the study. The CGM is a small sensor worn on your arm that measures your blood sugar every 15 minutes. You will need to attend a visit to have the CGM fitted (2 visits total). Additionally, we will ask you to collect a stool sample twice during the study.
500
BMI 25-40 kg/m2
Current use of tobacco-containing products or (≤6 months) cessation
Pregnant or nursing individuals
Allergy to study foods
Alcohol intake > 14 drinks/week
Mechanisms of Action: The Impact of Emotional Well-Being Intervention in Increasing Optimism and Biological Markers
This study aims to support midlife adults by enhancing their emotional well-being and reducing psychological stress, which may affect cardiometabolic health. We are evaluating a novel 4-week program that integrates three components—emotional well-being–enhancing writing, chair-assisted squats, and slow-paced breathing—using a factorial design. Eighty adults aged 40–65 with a sedentary lifestyle will be randomly assigned to one of eight groups that include different combinations of these activities. Participants will engage in their assigned activities via Zoom five times per week over four weeks. Emotional well-being and stress will be assessed through self-report at multiple time points, and physiological health (e.g., blood pressure, heart rate, heart rate variability, inflammation) will be measured during in-person visits before and after the program. The study will also evaluate the feasibility, acceptability, and preliminary effects of each intervention component and their combinations.
Participants will engage in a four-week program involving three components: EWB-enhancing writing exercises, chair assisted squat, and slow-paced breathing. They will complete these activities five times per week, with each session lasting 30 minutes.Participants will undergo cardiovascular assessments at Penn State University’s Biobehavioral Health (BBH) Building at baseline and post-intervention. These assessments will include heart rate variability measured via a standard three-lead electrocardiogram (ECG) and continuous blood pressure measured non-invasively using a finger cuff device that captures beat-to-beat waveforms.
$300
Sedentary lifestyle
Able to engage in chair assisted squat
Willingness to participate in all study components
Ability to provide informed consent
Physical limitations preventing chair assisted squat
Lack of technology or access – no computer/laptop and stable internet for Zoom and Qualtrics participation.
Inability to provide informed consent
Significant medical conditions that could be exacerbated by the intervention (e.g., severe cardiovascular disease)
PSCI# 25-001 TITLE PAGE A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)
This study is comparing using rilvegostomig or pembrolizumab with a platinum based chemotherapy. The doctor, subject and study team will not know if the subject is receiving rilvegostomig or pembrolizumab.
After signing consent to agree to join the study, the subject will have lab work and scans of their body to see if they are wll enough to participate. If they begin study treatment, they must come to all study visits. It is important that the subject tell the study team if there has been a change in their medications and how they are feeling. Subjects will continue treatment until the treatment no longer is working, they no longer want to participate of the study doctor feels it is not safe for them to participate any further. Once study treatment is finished, subjects will be followed to see how they are feeling and what new treatments for their cancer they are getting.
$75.00 for each visit completed for a minimum of $300. Compensation may be more if additional visits are completed.
Histologically or cytologically documented squamous NSCLC
Minimum life expectancy of 12 weeks
Minimum body weight of 30 kg.
History of organ transplant
Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF EFRUXIFERMIN IN SUBJECTS WITH COMPENSATED CIRRHOSIS DUE TO NONALCOHOLIC STEATOHEPATITIS (NASH)/METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS (MASH)
This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the clinical benefit and safety of EFX in subjects with compensated cirrhosis due to NASH/MASH. The study will enroll in 2 cohorts. Cohort 1 will enroll approximately 450 subjects with biopsy-proven compensated cirrhosis due to NASH/MASH. Cohort 2 will enroll approximately 1700 subjects with a clinical diagnosis of compensated cirrhosis due to NASH/MASH.
You will be required to visit the study clinic at specific times points. Laboratory and safety assessments will be completed at each visit. You will need to take the study drug as directed. Study procedures that will be performed include Liver Imaging scans, Liver Stiffness Exams, Electrocardiogram, Bloodwork, Liver Biopsy and an Endoscopy.
Previous history or presence of type 2 diabetes
Body mass index (BMI) ≥ 25.0 kg/m2
Poorly controlled high blood pressure
Any current or prior history of decompensated liver disease
A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate The Safety a Efficacy of Cretostimogene Grenadenorepvec In Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
The purpose of this Phase 2 clinical trial is to study treating patients with non-muscle invasive bladder cancer (NMIBC) with an investigational drug, Cretostimogene and DDM. Participants will be assigned to either Cohort A or Cohort B depending on whether they have previously been treated with BCG (Bacillus Calmette-Guerin) for NMIBC.
Eligible participants will receive the study drug, Cretostimogene every week for 6 treatments, followed by a maintenance period as directed by the Investigator. For the first 2 years after treatment initiation, participants will be assessed for disease status every 3 months by urine cytology and cystoscopy, with directed TURBT/biopsy (if indicated). CT urogram or MRU will be performed every 6 months. Thereafter, efficacy assessments will be performed at 6-month intervals for up to an additional 2 years
Validation of Biomechanics Technology in Golf
The purpose of this study is to compare accuracy and repeatability of biomechanical metrics between technologies during golf swings. This study also aims to identify differences in swing characteristics between various skill levels and environments.
You will be screened with a Health History Questionnaire via email, online survey, or in-person. You will come to either the Suzy and Jim Broadhurst Golf Teaching and Research Center (GTRC) or the Penn State Golf Courses with your golf clubs to provide consent, collect blood pressure and heart rate, answer golf-related questions, and perform golf-related tasks (full swing shots with various clubs). Various technologies will be used to measure the biomechanics of your swing. The total time of participation is expected to be about 60-90 minutes.
When you have finished the golf-related activites, you will be provided with a brief piece of instruction from one of the Center’s two Class-A PGA Professionals.
18-55 years old
Physically capable of playing a full round of golf (18 holes)
A known or estimated handicap less than 35 and/or average score less than 120
Healthy and active (> 75 minutes of moderate exercise weekly)
2 or more cardiovascular risk factors according to the Health History Questionnaire
A musculoskeletal injury within the past 3 months
Experiencing pain during a golf swing
The effect of input conditions on language learning: The roles of salience, modality and context.
The present study will examine the role of different input conditions on the learning of words and morphosyntactic units in a new language. We specifically aim to examine the effects of variables researched in the field: type of knowledge (explicitly stated via pre-training, or incidental; Pellicer-Sánchez et al., 2021), salience (manipulated via input properties; Ellis & Sagarra, 2010) and modality (visual or auditory; Borro, 2021) play on learning outcomes. Our goal is to examine how cognitive processes underlying learning are affected by our manipulations, and the impact on learning outcomes. We hypothesize that pre-training will enhance speakers' ability to detect target vocabulary and structures to be learned. While the literature is mixed on the role of salience, across the experiments described below, we will explore the impact of low-level salience (e.g., text enhanced visually) and psychological salience (the amount of repetition / expectedness of a target items. We will also investigate the less investigated effect of modality.
This is a language learning study. There will be up to two visits to the research lab. Sessions will consist of simple tasks consisting of readings sentences, remembering words, and completing memory tasks. EEG data will be collected via a wearable EEG cap; eye-tracking data will be collected while reading and completing some of the tasks are on a computer.
18 / hour
Must be between 18 and 45 years old.
Right handed
Normal or corrected-to-normal vision
No history of neurological disorders or language disorders, or current condition requiring psychoactive medication (e.g. antidepressants, antianxiety medications, ADHD stimulants, etc.)
Speakers with low English proficiency.
Left-handed or ambidextrous
Uncorrected vision
A history of neurological disorders or language disorders, or current condition requiring psychoactive medication (e.g. antidepressants, antianxiety medications, ADHD stimulants, etc.)
A Phase 1 Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Healthy Participants (Part A) and the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SR604 in Participants with Hemophilia A or Hemophilia B or Factor VII deficiency (Part B)
SR604 is a monoclonal antibody that blocks anticoagulant activity, which improves clotting in patients with the clotting disorders of Hemophilia A & B. This study is looking at treatment options for Hemophilia A & B. There will be 4 cohorts (1B, 2B, 3B & 4B). Our site will be starting study drug SR604 dose escalation with 0.1mg/kg (2B), then 0.2mg/kg (3B) with the final dose 0.4mg/kg (4B). Lower doses will start in the first cohort & dose escalation will continue in subsequent cohorts after a 3-month monitoring period in each cohort. See page 44 of the protocol for patient numbers in each cohort.
Participants will receive subcutaneous SR604 every 4 weeks for 3 months. Total visits to site will be 15. Blood draws will be obtained at each of these 15 visits.
$75.00 per visit travel reimbursement & $145.00 per in person visit
Severe congenital Hemophilia A or FVII deficiency
Severe and/or moderate congenital Hemophilia B
Patients with or without inhibitors
Ages 18-60
Hemophilia A pts. currently treated with hemlibra must have 20-week washout period
Active infections requiring antibiotic/antiviral therapy
Producing code-switched speech
Bilinguals frequently mix languages, even mid-sentence, when communicating with other bilinguals, a practice known as code-switching. This study aims to understand how bilinguals weave together different ways of producing the same sounds, corresponding to the languages they use, when code-switching. Participants will read aloud a list of sentences in Spanish, or in Spanish with switches to English partway through. They will also complete English and Spanish proficiency tasks and a questionnaire about their language background.
Participants will participate in a single session in our lab, lasting about an hour. During this time participants will: Produce words and sentences in Spanish and English. These will be audio recorded. Read and make decisions about words in Spanish and English. Name pictures in Spanish and English. These will be audio recorded. Complete a questionnaire about your language background.
$15
Speaker of Puerto Rican Spanish
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) with Low-Dose Post-Transplant Cyclophosphamide for Prophylaxis of Graft-versus-Host Disease in Hematological Malignancies
This study is testing whether a lower dose of a medicine called cyclophosphamide (25 mg per kg), given after an allogeneic stem cell transplant, can reduce serious side effects and improve outcomes. We are enrolling people who are receiving a reduced-intensity or non-myeloablative (less intensive) stem cell transplant. We will follow participants for one year after their transplant to see if they stay free from severe graft-versus-host disease (GVHD), cancer relapse, or death. We will also look at overall survival, rates of GVHD, infections, donor cell recovery, and other side effects.
You must attend all scheduled study visits, tell the study doctor about all medications you are taking (including over-the-counter medicines), and let the study team know how you are feeling. Before joining the study, you will have routine health checks. These include breathing tests (called pulmonary function tests, or PFTs) to see how well your lungs work, and a heart scan (MUGA scan or echocardiogram) to see how well your heart is pumping. As part of this study, you will be given a low dose of cyclophosphamide (25 mg/kg) on day +3 and +4 after your stem cell transplant. You will be carefully monitored for any side effects, and the study team will evaluate your risk for graft-versus-host disease (GVHD) and disease relapse.
Patients with acute leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, mixed phenotype acute leukemia) or chronic myeloid leukemia with no circulating blasts and less than 5% blasts in the bone marrow.
Patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia with no circulating blasts and less than 10% blasts in the bone marrow (exception allowed due to lack of difference in outcomes with <5% vs 5-10% blasts in this disease).
Patients with secondary acute myeloid leukemia progressing from pre-existing myelodysplastic syndrome, myeloproliferative disease (MPN), or MDS/MPN overlap syndrome.
Patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma who are indicated for allogeneic stem cell transplantation.
Active central nervous system (CNS) involvement by malignant cells.
Uncontrolled bacterial, viral, or fungal infections (currently taking medication with progression or no clinical improvement).
A Pilot Randomized Trial of a Mother-Child Dyadic Positive Affect Prevention Program for Reducing Mental Health Symptoms in Youth Exposed to Deprivation
The purpose of this voluntary research study is to test the effectiveness of the Positive Affect Intervention Program in reducing mental health symptoms for families experiencing financial hardship.
In this study, you and your child will attend some virtual and in-person study visits over 8 months. You will complete some interviews and questionnaires virtually. You will be randomly assigned to either an 8-session prevention program or to receive weekly educational materials to read. You and your child will come to the lab for in-person visits both pre and post program. During these visits, your child will complete some EEG tasks, and you and your child will complete some interaction tasks where your respiratory and heart rate data will be collected. You and your child will also be asked to complete some short daily phone surveys at home.
480 dollars
Child and biological mother can read and speak in English.
Child and mother have access to a computer or tablet with a video camera and internet that can be used for study appointments by Zoom.
Family is experiencing financial hardship.
Children or mothers with intellectual disabilities.
Children or mothers with a diagnosis of mania or bipolar disorder
Children or mothers with a diagnosis of a psychotic disorder (e.g., schizophrenia); or with visual or hearing impairments that interfere with completing study measures and sessions.
Children currently taking psychotropic medications for at least two weeks prior to study participation (except use of stimulant medication which has to be discontinued for 36-hours prior to the EEG visit).
PSCI# 24-172 TITLE PAGE A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients with BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy with Androgen Deprivation Therapy (EvoPAR-Prostate02)
This study will see if participants who have the addition of saruparib to their treatment will have a longer time period before/if their cancer spreads.
Before participating in the trial, p[otential; participants will need to sign a consent form to have their tumor tested for the BRCA mutation. If the participants have this mutation in their tumor, they will be invited to participate in this trial. While you are receiving treatment you will need to come to the clinic on certain days for treatment, getting safety assessments, collection of blood samples and to see how you are feeling. You will come to the clinic every four weeks. The treatment will last for 24 months
Participants with newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer
Confirmed BRCA1 or BRCA2 mutation
Participants with any known predisposition to bleeding
Refractory nausea and vomiting
PSCI # 24-026 EA8231 A Phase III Randomized Trial of Pembrolizumab in Combination with Sacituzumab Govitecan vs Standard of Care in Anti-PD(L)1-Resistant Advanced Urothelial Cancer
This study is comparing Pembrolizumab in combination with Sacituzumab Govitecan vs. standard treatment for individuals who have drug resistant advanced urolethial cancer
Participants will need to come to the clinic to meet with the study team and to sign a consent form. Once it has been determined that it is safe for you to participate, you will come into the clinic for treatment every 21 days, or depending upon the treatment arm you are assigned. You will continue to come into the clinic for treatment until the medication stops working, you no longer want to participate in the study or the document feels it is not safe for you to continue. You will be followed for up to five years to see how you are doing.
Patient must have ECOG Performance Status 0-2.
Patient must have locally advanced (unresectable or not amenable to curative intent therapy) or metastatic urothelial cancer.
Patient must have histologically proven conventional urothelial carcinoma (UC) of any urinary tract origin [any histologic subtype except neuroendocrine (small or large cell)] are permitted so long as tumors include ≥ 1% urothelial histology).
Patient must not be on systemic immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily).
Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial Comparing Standard of Care Adjuvant Temozolomide With or Without 5-Aminolevulinic Acid (5-ALA) With Concomitant Low Intensity Diffuse Ultrasound (LIDU) Sonodynamic Therapy (SDT) System In Patients With Newly Diagnosed Glioblastoma After Completion of Chemoradiotherapy
This is a Phase 2b clinical research study, which is investigating the use of 5-Aminolevulinic Acid (5-ALA) combined with a Low-Intensity Diffuse Ultrasound (LIDU) system for Sonodynamic Therapy (SDT) in patients with newly diagnosed glioblastoma. LIDU is the name of the investigational SDT device developed by Alpheus Medical. SDT includes the combination of a sonosensitizing drug, also known as a sonosensitizer, that will only be absorbed by tumor cells, and ultrasound to activate the sonosensitizer and cause damage to the tumor cells. The SDT tested in this study includes the oral drug 5-Aminolevulinic Acid (5-ALA) as an investigational sonosensitizer. This investigational treatment is being tested as a potential treatment for your cancer, SDT has been shown in previous cell and animal studies to potentially have an anti-cancer effect.
In this research study there will be two treatment groups. One treatment group will receive standard of care maintenance temozolomide with 5-ALA + SDT, you will have a 50% of receiving this treatment group. The other treatment group wll receive standard of care maintenance temozolomide with placebo, an oral solution that will look like and taste like 5-ALA but will have no active ingredients in it, and sham SDT, a program will be run on the SDT device that will look and sound the same, but will not deliver ultrasound, you will have a 50% chance of receiving this treatment group. If you are eligible for the study, and agree to participate you will be randomized, like the flip of a coin, to one of the two treatment groups, neither you nor your doctors will know which treatment group you have been assigned.
≥ 18 and ≤ 80 years of age at time of signing informed consent
Newly diagnosed Histologically proven glioblastoma
Completion of chemoradiation consisting of radiotherapy
Adequate bone marrow and organ function,
Bihemispheric disease or tumors that involve the bilateral corpus callosum,
Multi-centric disease (enhancing or non-enhancing) or multi-focal disease
Leptomeningeal disease
A diagnosis of gliosarcoma by histopathology
PSCI 24-072 A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-DR) versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial Therapy MajesTEC-7
This trial is designed for patients who are newly diagnosed with multiple myeloma (MM) but who do not want or cannot have an autologous stem cell transplant. Teclistamab and talquetamab have been used alone along with other drugs in the treatment of MM. this study hopes to add either drug to a standard treatment for MM at time of diagnosis to see how effective it is in keeping the MM quiet conpared to standard treatment alone.
Participants must be willing to come to all clinic study visits. The first cycle of treatment the participant will be hospitalized to make sure they do not have any side effects. You will be treated every four weeks as an outpatient until the treatment no longer works. You should tell your study team all side effects you feel and all medication you are taking.
$54.00 per completed visit. A caregiver may receive compensation of the same amount.
Have a diagnosis of multiple myeloma
Be newly diagnosed and not considered a candidate for high-dose chemotherapy with ASCT
Received any prior therapy for multiple myeloma
Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization.
Glycemic effects of substituting pecans for snacks higher in saturated fat and added sugars in individuals with prediabetes
The purpose of this study is to investigate the effects of replacing snacks high in saturated fats and added sugars with a snack low in saturated fat and added sugar with blood sugar control, heart health and diet quality in individuals with prediabetes. Participants will be randomized into one of two groups. Group 1 will consume a daily provided snack in place of normally consumed snacks high in saturated fat and added sugars for 16 weeks. Group 2 will be asked to continue consuming their current diet for 16 weeks. Measures will be taken to evaluate blood sugar, heart health and dietary intake at the beginning and 16 weeks later.
• The total time commitment for this study is approximately 4 months. It may take up to 7 months to complete the study from the time that you do the clinic screening visit. • During the study, we will ask you to consume a provided nutrient-dense snack daily for 16 weeks, or to use provided gift cards to purchase and consume your usual snacks/diet. • You will be asked to come to the Penn State Research Kitchen on campus once a month for 16 weeks to pick up your pecans or gift cards. • We will draw blood from you several times during the study, once at screening, and on two consecutive days at the start and end of the study (total 5 times). • At the start and end of the study, we will also measure your blood pressure and perform non-invasive tests of artery health. • You will also be asked to wear a continuous glucose monitor (CGM) for 14 days—7 days before the first testing visit and 7 days at the end of the study. The CGM is a small sensor worn on your arm that measures your blood sugar every 15 minutes. You will need to attend a non-fasting visit to have the CGM fitted (2 visits total). • At the start and end of the study, we will ask you to collect 12 saliva samples over two days at home. • At the start and end of the study, we will collect a small hair sample from the back of your head. • You will also be asked to collect a stool sample at the beginning and end of the study (2 total). • Compensation for this study is up to $150
150
Prediabetes (HbA1c 5.7-6.4%)
BMI 25-40 kg/m2
Low intake of nuts and nut butters
Usually eat snacks (eat food between main meal times)
Current use of tobacco-containing products or (≤6 months) cessation
Pregnant or nursing individuals
Allergy to study foods
Alcohol intake > 14 drinks/week
PSCI 24-147 A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE 3 TRIAL OF TRASTUZUMAB DERUXTECAN (ENHERTU®) PLUS CHEMOTHERAPY PLUS OR MINUS PEMBROLIZUMAB VERSUS CHEMOTHERAPY PLUS TRASTUZUMAB PLUS OR MINUS PEMBROLIZUMAB AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC HER2-POSITIVE GASTRIC OR GASTROESOPHAGEAL JUNCTION (GEJ) CANCER (DESTINY-GASTRIC05)
To see if the combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus SoC chemotherapy plus trastuzumab plus pembrolizumab is better in treating gastric or gastroesophageal junction cancer
Participants will need to come to the clinic twice before they are able to start study treatment. The first time is to sign a consent form allowing their tumor tissue that has been stored to be spent for testing. This test will look to see if the tissue has changes in it to see if the medication will work. If the tissue has the receptive changes a second consent form will be signed to participate in the study. You will need to have tests done to make sure it is safe for you to participate in the study. If the tests results determine that is it safe, you will begin treatment. The first month of treatment you will need to come to the clinic every week for blood tests and to see how you are feeling. After that you will need to come to the clinic once a month for treatment and blood tests. You will also have scans done at certain time in the study. Those scans will tell the doctor if the study treatment is working to make your cancer go away. You will stay on this treatment until it stops working. After that, you will come back to the clinic for two more visits to see how you are feeling.
Is willing and able to comply with scheduled visits, trial intervention plan, laboratory tests, other trial procedures, and trial restrictions.
Medical history of myocardial infarction within 6 months
PSCI 25-083 Long-term Follow-up of AAV2-hAQP1 Gene Therapy in Participants with Radiation-Induced Late Xerostomia
To evaluate the long-term safety of AAV2-hAQP1 in participants with radiation-induced late xerostomia
Participants who were on the parent trial and did not receive actual drug will be invited to be treated and then rolled over into long term follow up. For those who were treated with actual drug will roll over into a long term follow up. Long term follow up participants will be followed up monthly for 5 years.
$60 per visit
AALL1821: A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 147294) in Combination with Nivolumab (NSC# 748726, IND# 147294), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/=1 to <31 Years Old with First Relapse
This is a drug study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL).
All subjects on study will be treated with the medicine blinatumomab. Some subjects will also receive an additional medicine, nivolumab. Subjects will receive treatment on this study for about 1.5-2.5 months. Treatment is divided into 1-2 cycles. Before the start of therapy, patients will have a bone marrow evaluation for Immunophenotyping and will have their bone marrow tested for MRD on Day 36 of cycle 1 and Day 36 of cycle 2 during treatment.
Patients 18 years or older with first marrow relapse of B-ALL
Lactating females are not eligible unless they agree to not breastfeed their infants.
A Multi-Center, Double-Blind, Randomized, Placebo Controlled Trial to Assess Efficacy and Safety of Omecamtiv Mecarbil in Patients with Symptomatic Heart Failure with Severely Reduced Ejection Fraction (COMET-HF)
To evaluate the effectiveness of omecamtiv mecarbil in reducing the number of heart failure events or hospitalizations in patients with severely reduced left ventricular ejection fraction <30%.
Participate in about 13 in-person visits over 3 years with bloodwork at each in-person visit, participate in about 9 brief remote phone call visits, questionnaires at 5 of the in-person visits over the first year, first visit electrocardiogram (EKG), first visit Echocardiogram (ECHO) if not completed within the last 6 months, willing to be randomized to take oral study medication or placebo for the duration of the study (about 3 years).
Up to $1,500
Severely reduced ejection fraction less than 30%
Age is between 18 and 85
Acute cardiac issue such as a heart attack, heart surgery, or implant in the last 3 months
Active or planned pregnancy or breastfeeding
Current participation in another research study
History of any solid organ transplant