Search Results
Comparing the Impact of Video Integration to Traditional Amyotrophic Lateral Sclerosis Visit Communication on Patient and Caregiver Quality of Life (VITALS trial)
Multidisciplinary clinic (MDC) care is the standard for Amyotrophic Lateral Sclerosis (ALS) and is associated with better symptom control, quality of life, and longer survival. Patients with ALS and their caregivers attend MDC visits every 3 months and spend 4-5 hours meeting with multiple healthcare providers. Each provider gives recommendations that are important for the patient to remember and implement on their own at home. But sometimes it can be a lot to take in. The purpose of this study is to evaluate two ways to provide MDC visit information to people with ALS: video recordings plus written visit notes (new method being explored) or written visit notes alone (current method). This study examines whether providing video recordings of the clinic visits can help patients with ALS and the people who care for them.
WHO CAN TAKE PART IN THIS STUDY? People with Amyotrophic Lateral Sclerosis (ALS) who are cognitively able to consent, anticipate attending multidisciplinary clinic (MDC) visits for 12 or more months, and who have a non-professional caregiver who is also willing to take part in the study. WHAT WILL PARTICIPANTS BE ASKED TO DO? Study participants will be randomly assigned by a computer to either the NOTES Group or the VIDEO Group. All participants will be asked to review their visit notes on their online Penn State “My Health” patient portal account. All participants will be asked to complete 4 short surveys over 12 months, first at the index multidisciplinary clinic (MDC) visit before assigned to a group, then again at 1 month, 6 months, and 12 months after the index MDC visit. Surveys may be done online or on paper at home or in the clinic and participants will be compensated for completing them. The VIDEO Group participants will be videorecorded at all of their planned MDC visits for 12 months and asked to watch the video recordings after their visits on a secure mobile and online application. Patients can watch these private videos at any time or share them with someone else.
Up to a maximum possible total of $200
Plan to attend MDC visits for 12 months
Presence of a non-professional caregiver who is also participating in the VITALS trial
Projected life expectancy of at least 12 months as determined by the site investigator
Speak English or Spanish
Do not wish to create a patient portal account, if they do not already have one
Unable to access the internet
Do not have access to a personal or shared email and are not interested in creating a personal or shared email
Significant cognitive impairment, clinical dementia, or unstable psychiatric illness as determined by the site PI
A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants with Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
The purpose of this study is to see how well a treatment that includes amivantamab, pembrolizumab and carboplatin works compared to a different treatment that includes 5-FU, pembrolizumab and platinum (carboplatin or cisplatin) therapy. 5-FU, pembrolizumab and platinum (carboplatin or cisplatin) are already used together to treat recurrent/metastatic head and neck squamous cell carcinoma.
Participants must come to all study visits, take the medication as instructed, tell the study how you are feeling and tell the study team about any medications you are taking, especially over the counter medications.
130.00 per completed visit
Have an ECOG performance status of 0 or 1.
Have histologically or cytologically confirmed R/M HNSCC that is considered incurable by local therapies.
Be treatment-naïve for systemic therapy in the R/M setting.
Have measurable disease according to RECIST v1.1.
Has untreated brain metastases or history ofknown presence of leptomeningeal disease.
Has a history of (non-infectious) ILD/pneumonitis/pulmonary fibrosis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening.
Has a history of clinically significant cardiovascular disease
Renal function:Have an estimated glomerular filtration rate <50mL/min, based on the MDRD 4-variable formula during the screening period and on the day of the start of study treatment.
CHARGE-CD: A Phase 3b, Multicenter, Open-label, Active-Controlled Study to compare the Efficacy and Safety Guselkumab versus Risankizumab in the Treatment of Participants with Moderately to Severely Active Crohn's Disease
This trial is a randomized, open-label, active treatment in adult participants with moderate to severe Crohn's disease. The study consists of a screening period up to 5 weeks long. Baseline visit and randomization which is 52-weeks long, open-label treatment, and post-intervention safety follow-up. The study drug will be administered in the research clinic during the induction phase at Weeks 0, 4, 8 and for the first maintenance injection at week 12. The participants will then be trained if they are willing to self-administer study drug. Randomization ratio is 1:1 or one arm per treatment group, first guselkumab and second, risankizumab. Participants who leave the study early will return for EOT/Early withdrawal. Treatment extension for subjects on guselkumab treatment who completed week 52 will continue same treatment through week 148, and will complete safety follow up until week 160. Subjects receiving risankizumab treatment for 52-weeks will transition to a standard of care. From the week 24 and through week 52, participants who meet rescue criteria will be eligible to receive guselkumab rescue treatment.
Participants will have to sign the informed consent. They will be asked to have blood drawn, TB testing and x-rays at screening, have the endoscopy procedure with biopsy. They will be asked to give urine specimen for pregnancy testing, and stool specimen for infection testing. They will have in-person visits, five during the induction and two endoscopies (first 12 weeks). They will be treated per study randomization, with either medication.
$100 per completed visit
Previously failed treatment, 1or 2 ADT
Willing to use contraception
Complications of CD, i.e. strictures, stomashort gut
Anticipating surgery
Adenomatous colon polyps not removed before randomization
A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug vedotin in Combination with Fluoropyrimidine with or without Rilvegostomig in First-line Claudin18.2-positive, HER2-negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)
The purpose of this clinical trial is to learn more about the effectiveness and safety of sonesitatug vedotin (sone-ve) in combination with capecitabine alone or in combination with rilvegostomig (rilve) and also to better understand the studied disease and associated health problems.
Participants will have Screening Part 1 (optional), Screening Part 2, study treatment, and a follow-up period. The participant will have approximately 1 to 2 visits at the study site during Screening Part 2. Each visit may be different in length (up to 8 hours), depending on which tests and examinations are scheduled. The screening period can last up to 28 days before the first planned dose of the study drug. Before starting the study treatment they will undergo a series of tests.
Patients will be reimbursed $100.00 per visit
Previously untreated histologically documented unresectable, locally advanced, or metastatic gastric, GEJ, or distal esophagus (distal third of the esophagus) adenocarcinoma
Provision of a FFPE tumour sample (newly acquired or archival) adequate to assess the CLDN18.2 and PD-L1 expression prior to randomisation by central testing.
The FFPE sample must be an archival sample taken ≤ 3 months prior to start of screening or a fresh tumour biopsy obtained during Screening Part 1 or Screening Part 2.
Positive CLDN18.2 expression defined as ≥ 25% TCs with membranous IHC staining at any intensity, as determined prospectively by central IHC testing using the validated investigational VENTANA CLDN18.2 (SP455) RxDx assay.
History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
Participants with known HER2-positive status as defined as IHC 3+ or IHC 2+/ISH+ (Cases with HER2: CEP17 ratio ≥ 2 or an average HER2 copy number ≥ 6.0 signals/cell are considered positive by ISH).
Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers.
Active or history of autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment or assessed by investigator as not appropriate to participate due to undue risk are excluded.
Peanut butter glycemic control, cognition and cardiovascular health
The purpose of this study is to look at the effect of consuming peanut butter at breakfast on blood sugar control, cognitive function, and heart disease risk factors in middle-aged adults with prediabetes.
• The total time commitment for this study is approximately 8 months. It may take up to 11 months to complete the study from the time that you do the clinic screening visit. • During the study, you will undergo the following two conditions for 12 weeks each: 1) eat 1.5 oz. of peanut butter (Simply Jif® Creamy Unsweetened peanut butter) each day with your breakfast (or the first food you consume each day); 2) continue your usual diet with provision of a gift card to a local grocery store of equal value to the peanut butter ($5/month). • There will be a minimum 8-week break between the two conditions. • You will be asked to come to the Penn State Research Kitchen on campus every month during each 12-week period to pick up your study products (peanut butter or gift card). • We will draw blood from you several times during the study, once at screening, and on two consecutive days at the start and end of each study period (total 9 times). • At the start and end of each period, we will also measure your blood pressure and perform non-invasive tests of artery health. • You will also be asked to wear a continuous glucose monitor (CGM) for 7 days before the first testing visit and for 7 days at the end of each 12-week study period (3 times in total). A CGM is a small sensor worn on your arm that measures your blood sugar every 15 minutes. • During the time you are wearing the CGM, you will also be asked to complete brief surveys 4 times per day using your smartphone (or a smartphone provided to you by the study) about your daily experiences and play brief cognitive games to measure your memory and attention. • You will also be asked to collect a stool sample at the beginning and end of each study period (4 total). • Compensation for this study is up to $300
$300
Pre-diabetes (HbA1c 5.7-6.4%)
BMI 25-40 kg/m2
Low habitual intake of peanut butter (<0.5 Tablespoons/day on average)
Have a smartphone device or be willing to use one provided by the study
Diabetes type 1 or type 2 diabetes
Current use of tobacco-containing products or (≤6 months) cessation
Pregnant or nursing individuals
Allergic to peanuts
PSCI 26-065: A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment For High Anatomic Stage ER-pos/HER2-neg Breast Cancer with RS<25 (RxFINE-Low) (NCT#) EA1242
This study is looking at whether adding a medicine called ribociclib to standard hormone therapy, with or without chemotherapy, can help prevent breast cancer from returning in people with hormone receptor-positive, HER2-negative early breast cancer. Participants will receive study treatment and be monitored regularly for side effects and signs that the cancer has come back. Researchers will follow participants for up to 10 years to learn more about the long-term safety and effectiveness of these treatments.
If participants choose to join this study, they will receive either chemotherapy followed by endocrine therapy plus ribociclib, or endocrine therapy plus ribociclib alone. Treatment will be determined by the participant and their physician. Participants may receive ribociclib for up to 3 years and endocrine therapy for at least 5 years. Following treatment, participants will be followed for up to 10 years with regular visits to monitor for cancer recurrence and side effects.
Patient must have an ECOG Performance Status of 0-2 within 28 days prior to Step 0 Pre-Registration.
Patient must be a postmenopausal woman or a man
Patient must have a primary breast tumor that is HER2-negative by current ASCO/CAP guidelines utilizing immunohistochemistry and/or FISH.
For patients who have undergone mastectomy, the margins must be free of residual gross tumor. Patients with microscopic positive margins are eligible if post-mastectomy RT of the chest wall will be administered.
Patient must not have received prior CDK4/6 inhibitor
Patient must not have a known contraindication to ribociclib per current FDA indication
Patient must not have received prior chemotherapy for this malignancy.
Patient must not have a contraindication to adjuvant chemotherapy based on treating physician’s discretion.
PSCI 26-073 HN-016 - Radiotherapy with Concurrent Cetuximab vs. Carboplatin and Paclitaxel in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin: A Pragmatic Phase III Randomized Trial (CONCISE)
Compare radiation therapy with cetuximab against radiation and carboplatin/paclitaxel to see if radiation carboplatin/paclitaxel increases progression free survival vs radiation and cetuximab
Participants will get radiation 5 days a week for 7 weeks, will get drug intravenous in the arm weekly for 7-8 weeks and 8 cycles of cetuximab and each cycle lasts 7 days or 8 cycles of cetuximab and each cycle lasts 7 days. Participants fill out a symptoms survey 5 times About 2 tablespoons of blood will be collected from start of treatment, week 4 of radiation, and 4 months after the end of your treatment Imaging of the head and neck with a neck CT or MRI (with contrast, unless contraindicated) or PET/CT which includes diagnostic-quality CT of the neck (with contrast, unless contraindicated); Chest imaging: Chest CT (with contrast, unless contraindicated) or PET/CT
cal evaluation of p16 status is required for all oropharynx patients prior to registration.
Local evaluation of p16 status is recommended for non-oropharynx patients prior to registration.
No prior systemic therapy for the study cancer; note that prior systemic therapy for a different cancer is allowable
No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
No prior surgery for the study cancer
Evaluating the Efficacy of a Comic-Based Activity Booklet for Reducing Mammography Anxiety
The purpose of this study is to evaluate whether a comic-based educational booklet can reduce anxiety and support coping during a simulated diagnostic mammography callback experience. We aim to assess participants’ emotional responses to the simulated callback process, evaluate whether the booklet improves confidence in managing uncertainty during the waiting period, and gather feedback on the booklet’s clarity, usefulness, and acceptability.
What participation involves: Participants complete two brief surveys remotely—one before and one 1–2 weeks after attending an in-person study session at a date and time convenient for you. The in-person session will take place in a comfortable, non-clinical area at Penn State and is completely independent of your imaging appointment. During the in-person session, you will: - Read and sign an informed consent form. - Complete three brief surveys. - Watch a simulated mammography video. - Read through and use a brief (and fun) activity booklet designed to support patients during the waiting period. - Participate in a brief focus group with a member of the research team and several other participants. Your total participation time, including the remote surveys and in-person session, is approximately 75 minutes.
Participants will receive a $25 Greenphire ClinCard.
Individuals who have had a mammogram callback after routine screening within the last 2 years.
Able to read and understand English, as the booklet and questionnaires will be provided in English.
Non-English speaking (due to language limitations of materials used in the study).
Individuals unable to demonstrate an understanding of the study procedures or who decline to provide informed consent.
Individuals who have previously participated in this study.
Autonomic dysfunction in orthostatic hypertension
Orthostatic hypertension is a condition in which blood pressure rises abnormally when a person stands up. The purpose of this study is to better understand why this happens. In particular, this study will examine whether signals from the leg muscles to the nervous system play a role in causing this increase in blood pressure when standing.
This study consists of three visits to the Penn State Hershey Medical Center. We encourage you to complete the entire study by participating in all visits, but you are not required to do so. The order of the visits as well as the order of interventions during each visit may be changed and some may be eliminated due to time constraints or participant comfort. Each visit lasts about 3-3.5 hours. Various physiological measurements will be recorded during the visits including microneurography, blood pressure, heart rate and blood flow.
You will receive $25 per hour for your participation in this research study
Capable of giving informed consent
Are of any race or ethnicity
No history of chronic hypertension and do not take antihypertensive medications
Non-smokers
Have any history of chronic diseases including heart failure, severe lung diseases, renal failure, peripheral neuropathy, epilepsy or seizure disorders and other chronic diseases.
Have orthostatic hypotension or a history of syncope
Pregnant or nursing woman
Decisional impairment or unable to consent
PSCI-26-038 Phase III Evaluation of Fixed Duration Zanubrutinib Plus Sonrotoclax-Based Therapy Compared to Continuous Zanubrutinib in Previously Untreated Older Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).
Subject will either get zanubrutinib for up to 10 years, or zanubrutinib plus sonrotoclax for an initial 15 months, with the possibility that subject will be assigned to receive an additional 12 months depending on response. After subject finishes treatment, study doctor and study team will watch for side effects. They will see subjects for follow up clinic visits every 3 months for a total of 3 years from when treatment was started. After that, the subjects will have clinic visits every 6 months for up to 10 years from when treatment was started. If subjects cancer grows or they start another treatment for their leukemia, the study doctor will follow up with the subject by phone call every 6 months for up to 10 years from when the subject started treatment.
Subjects will receive either: Zanubrutinib for up to 10 years, or Zanubrutinib plus sonrotoclax for 15 months, with a possible additional 12 months depending on response. After treatment ends, subjects will be monitored for side effects. Follow-up visits: Every 3 months for the first 3 years from treatment start Then every 6 months up to 10 years from treatment start If the cancer progresses or the subject starts another leukemia treatment, follow-up will switch to phone calls every 6 months for up to 10 years from treatment start.
No prior therapy for CLL
Age ≥ 65 years
No active systemic anticoagulation with warfarin
Treatment with rituximab and/or high-dose corticosteroids for autoimmune complications of CLL must be completed prior to enrollment
No major surgery within 7 days of enrollment, or minor surgery within 5 days of enrollment
No known medical condition causing an inability to swallow oral formulations of agents
PSCI-26-053 Phase III Randomized Trial Of IO-Based Systemic Treatment +/- Liver SBRT In Hepatocellular Cancer With Macrovascular Invasion (HELIO-RT)
Subjects will receive immunotherapy-based drug treatment until their disease gets worse or side effects become too severe or liver stereotactic body radiation therapy (SBRT) for up to 3 weeks plus immunotherapy-based drug treatment until their disease gets worse or the side effects become too severe. After study treatment, subjects will be checked every 3 months for 2 years, then every 6 months for 3 years, then once every year for their lifetime.
Subjects will receive standard immunotherapy-based drug treatment or standard immunotherapy-based drug treatment with liver stereotactic body radiation therapy (SBRT) over a period of up to three weeks. Subjects may receive one of three approved drug combinations: atezolizumab plus bevacizumab, tremelimumab plus durvalumab, or ipilimumab plus nivolumab, with treatment continuing until the cancer worsens or side effects become unacceptable. After study treatment, subjects will be checked every 3 months for 2 years, then every 6 months for 3 years, then once every year for their lifetime.
For patients with known HIV, HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
No medical contraindication to the standard of care immunotherapy.
No history of allergic reaction to the systemic therapy agent(s), compounds of similar chemical or biologic composition to the systemic therapy agent(s) (or any of its excipients).