Search Results
STARSCAPE-1: A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn’s Disease
The potential participants must have Crohn's disease diagnosis. They should have had previous standard or advanced therapies for CD and have been intolerant or have lost response. They will be asked to sign and understand the informed consent. The volunteers will provide biological specimens blood, urine, stool, and the biopsy during endoscopy. They will answer daily diary questions about the symptoms, and complete questionnaires in the clinic. The screening will involve at least two visit and will last five weeks. They will be treated in the open label sub-study 1, or double-blinded randomization with placebo in the sub-study 2. The non-responders will be eligible for extended induction in sub-study 3. Each sub-study is 12 weeks long.
Participants will attend in person visit at the research clinical facility in Hershey, PA. If they sign the informed consent and want to participate, they will have vitals checked, and physical examination done. They will provide specimens such as blood and stool. They will answer questionnaires at home and in the clinic. The endoscopy will be done with biopsy to evaluate the disease response to the treatment at screening and week 12, or week 24 for the extended induction if applicable. The drug will be administered by subcutaneous injection in the clinic or at home. There will be a compensation for every completed clinic visit.
TBD
Diagnosis of Crohn's disease at least for 3 months
Inadequate response to conventional therapy
Must be at least 40 kg in weght (88.2 lb)
Females must use contraceptive if WOCBP
Complications of CD (abscess, strictures, fulminant colitis, short bowel syndrome)
Current ostomy
Two missing segments of colon
Active tuberculosis, cardiovascular disease
The Influence of Cold-Water Exposure on Arterial Perfusion Pressure and Muscular Fatigability During Overhead Exercise
Exercise conducted above the shoulders (i.e., overhead exercise) can reduce blood flow and oxygen delivery to the exercising muscle due to the effects of gravity. This ultimately leads to greater muscle fatigue during overhead exercise tasks which can lead to fatigue-related injuries in occupational settings. Cold-water exposure increases blood pressure (i.e., cold pressor response) and could increase blood flow to exercising muscle by increasing muscular perfusion pressure (i.e., pressure that pushes blood into the muscle) during overhead exercise. This has the potential to reduce muscle fatigue during overhead exercise. However, no studies to date have investigated the effect of cold-water exposure on muscle fatigue during overhead exercise.
There will be 4 in person visits at Penn State Altoona for this study. The first visit will be ~1 hour and the other 3 visits will be ~30 minutes. Participants will complete questionnaires, undergo body composition measurements, and resting blood pressure and heart rate measurements during visit 1. Participants will complete a handgrip exercise test during each visit and their arm will be placed in different positions (overhead or straight in front) during the exercise test. Blood pressure, muscle oxygen levels, and blood flow will be measured during the exercise test. During two of the visits, the participant's foot will be exposed to cold water (~40 degrees F) with a cold-water foot sleeve for a brief period of time (1-3 minutes).
$25
Individuals with Reynaud’s Syndrome
Women who are pregnant
Cigarette smoking within the past 6 months
Diagnosed hypertension and/or prescribed antihypertensive medication
Biobehavioral Synchrony and Hormonal Correlates of Parenting from Pregnancy to Toddlerhood: A Longitudinal, Multi-Method Study of First-Time Fathers and Mothers
This is a behavioral and biological research study that will examine how first-time parents’ interactions, brain activity, and hormone levels during pregnancy are related to later parenting and infant development. Participants will complete questionnaires, take part in video-recorded interaction tasks, wear a non-invasive brain activity monitor, and provide saliva samples. At a follow-up visit, parents and their infant will participate in similar activities together.
There will be two in-person lab visits for first-time expectant father–mother couples: one during pregnancy and one when the baby is about 8 months old. During both visits, participants will complete questionnaires, take part in interaction tasks, wear a soft headband to measure brain activity, and provide saliva samples. At the second visit, parents will complete similar activities together with their baby, including parent–infant interaction tasks.
Up to $375 per family (including travel reimbursement)
Both partners 18 years or older
Expecting a single baby (singleton pregnancy)
Able to complete study activities in English
Willing to attend two in-person lab visits (during pregnancy and when the baby is about 8 months old)
High-risk pregnancy
Expecting more than one baby (e.g., twins)
Unable or unwilling to attend two in-person lab visits
PSCI 26-021 NRG-GY035: A RANDOMIZED PHASE III TRIAL OF CARBOPLATIN, PACLITAXEL, PEMBROLIZUMAB VERSUS CARBOPLATIN, PACLITAXEL, BEVACIZUMAB VERSUS CARBOPLATIN, PACLITAXEL, PEMBROLIZUMAB, BEVACIZUMAB IN THE TREATMENT OF pMMR, TP53 MUTATED ADVANCED OR RECURRENT ENDOMETRIAL CANCER
This trial will see if bevacizumab, in combination with carboplatin, paclitaxel, and pembrolizumab is better than carboplatin, paclitaxel, and pembrolizumab (the control arm) or carboplatin, paclitaxel, and bevacizumab in prolonging survival.
After it has been determined that it is safe for you to participate, you will be randomized to one of three treatment combinations. All of the arms will use real drug to treat your cancer. You will need to come to the clinic every three or every six weeks for treatment. You will continue treatment until your cancer comes back, you do not want treatment any more or the doctor feels it is not safe for you to continue. You will then be followed for five years once you complete all treatment.
Stage IVB endometrial cancer (with or without measurable disease
Recurrent endometrial cancer (with or without measurable disease
NO prior chemotherapy for treatment of endometrial cancer
Prior adjuvant chemotherapy (e.g., paclitaxel/carboplatin alone or as a component of concurrent chemotherapy and radiation therapy [with or without cisplatin]) provided adjuvant chemotherapy was completed ≥ 12 months prior to registration
No current evidence of intra-abdominal abscess
No uncontrolled hypertension
No major surgery within 28 days of initiation of bevacizumab
Exploring the Lived Experiences of First-Generation Adult and Non-Traditional Learners in Fully Online College Programs: An Interpretative Phenomenological Analysis
This qualitative research study uses the Interpretative Phenomenological Analysis (IPA) method to explore the lived experiences of first-generation adult students who have graduated from fully online college degree programs. The primary goal is to gain a deeper understanding of how these individuals made meaning of their academic journeys, the challenges they faced as first-generation students, and the factors that contributed to their success in an online learning environment. Participants will engage in one-hour open-ended interviews with the researchers held via Zoom videoconference
All participants will complete a brief 5-minute screening process via Zoom to determine eligibility. If participants meet the study criteria and are interested in moving forward with the study, an approximately 60-minute Zoom interview will be conducted. The interview will discus their experiences as first-generation adult graduates of fully online bachelor’s degree programs. A brief follow-up interview may be requested if clarification is needed.
$50 Amazon Gift Card
Completed a fully online degree program
Graduated from an accredited college or university
Able and willing to participate in a Zoom interview for 1 hour in English
Individuals who completed primarily face-to-face or hybrid degree programs
Individuals who were younger than 25 throughout their enrollment
Individuals who did not complete a bachelor’s degree program
Individuals unwilling or unable to participate in a Zoom interview
Growing Healthy Hearts: A randomized controlled trial of a multicomponent gardening intervention for adults with cardiovascular disease risk and their families.
The purpose of this study is to evaluate the effectiveness of the Growing Healthy Hearts (GHH) program, a remotely delivered gardening, nutrition, and cooking intervention, on cardiovascular health behaviors and outcomes among adults with cardiovascular disease (CVD) risk factors who have a child living in the home. Participants will be randomized to either the GHH intervention or a waitlist control group. The intervention is designed to promote sustained improvements in fruit and vegetable intake and physical activity by leveraging interest in gardening as an entry point for behavior change and by providing integrated education in gardening, nutrition based on the Dietary Approaches to Stop Hypertension (DASH) eating pattern, and cooking skills.
2 arm randomized controlled trial (intervention and waitlist control) Intervention group will be required to meet virtually 5 times for the study visits and attend two zoom sessions a month for 6 months.
$410
At least one risk factor for CVD
Internet access
Recent heart attack or stroke
Planned surgery
A Phase 2b, Single-Arm, Open-Label, Multicenter Study of the Safety of SPK-8011QQ in Adults With Severe or Moderately Severe Hemophilia A
SPK-8011QQ is a one time IV infusion gene therapy drug. The purpose is providing an adeno-associated viral vector (a non-disease vector transport) to carry a human FVIII gene to the liver in order to increase the production of FVIII. This study will assess the safety & tolerability of SPK-8011QQ. Patients will receive a single dose of SPK-8011QQ & will then be followed for approx. 5 years. Total visits (all on-site) will be approx. 52.
SPK-8011QQ is a one-time IV infusion gene therapy drug. The purpose is providing an adeno-associated viral vector (a non-disease vector transport) to carry a human FVIII gene to the liver in order to increase the production of FVIII. This study will assess the safety & tolerability of SPK-8011QQ. Patients will receive a single dose of SPK-8011QQ & will then be followed for approx.5 years. Total visits (all on-site) will be approx. 52.
$75.00 travel reimbursement, $180.00 for the screening visit & day of infusion visit. A $130.00 stipend for each in person visit is also included.
Documented Treatment of 6 Months Prophylaxis Dosing or On Demand Dosing
> 150 Exposure Days to FVIII Product
Negative Inhibitor Test Against FVIII
NegativeAnti-Spark200 Antibodies
Thromboembolic Disease
Prior Treatment with a Vector or Gene Transfer Agent
History of Malignancy Other Than Basal/Squamous of the Skin within 5 yrs.
Have a Major Surgical Procedure Prior to the 15 Month Period after SPK-8011QQ Infusion
The Fourth Left Atrial Appendage Occlusion Study (LAAOS-4) Same as approved submission STUDY00025327 closed
The LAAOS-4 study is to determine if closure of the left atrial appendage using a closure device called the WATCHMAN, in addition to taking oral anticoagulant medications, is more effective at reducing strokes and blood clots in the body, than taking oral anticoagulant medications on their own.
The research study involves eleven visits, one being in person and ten being completed by telephone. A review of your medical history, current medications, and questionnaires at each visit. If you are randomly chosen to have the WATCHMAN closure device, this will involve an overnight stay in the hospital after the device implant.
History of stroke due to clot
History of clot anywhere in the body
Must be on an oral anticoagulant medication for at least 90 days
Prior atrial fibrillation ablation without recurrence of atrial fibrillation
Must be willing to use effective birth control methods throughout study, if of childbearing age
A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L Platinum-Based Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)
The purpose of this voluntary research study is to learn how well the study drug works against ovarian cancer when it is given together with the current standard treatment. The study will also help researchers understand how safe the study drug is when used in this combination.
The study begins with a screening period that lasts about 28 days. During screening, tests will be done to make sure subjects qualify for the study. If Subjects are eligible, they will start receiving the study treatment. The subject will continue treatment until their cancer grows or they have a side effect that makes it unsafe to stay in the study. After treatment stops, they take part in follow up visits.
Must have PSOC defined as progressive disease > 6 months (ie, 183 days) from the last dose of primary (1L) platinum therapy.
Must have completed platinum-based chemotherapy in the 2L treatment for recurrent PSOC.
Participants with response of stable disease (SD) at time of screening must have received bevacizumab in combination with 2L platinum-based chemotherapy and be eligible to continue treatment with bevacizumab.
Must be randomized no later than 8 weeks from the last dose of the 2L platinum-based therapy
More than 2 prior lines of systemic therapy
Progression while on or following 2L platinum-based regimen prior to randomization.
Known active central nervous system metastases or carcinomatous meningitis
Has a past or current malignancy other than the inclusion diagnosis before the planned first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy
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.
A Phase 2 Study of Blinatumomab in Combination with Chemotherapy for Infants with Newly Diagnosed Acute Lymphoblastic Leukemia with Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax
A Phase 2 Study of Blinatumomab in Combination with Chemotherapy for Infants with Newly Diagnosed Acute Lymphoblastic Leukemia with Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax
Part 1 of the study is necessary to help decide the best treatment and to determine which arm in Part 2 you will be eligible for. The treatment in Part 1 involves the administration of steroids, which help decrease the amount of leukemia in your body. The treatment in Part 1 of the study takes about 7 - 10 days. If your leukemia worsens in Part 1 of the study, you may consent to Part 2 and the total treatment will last about 2.5 years from diagnosis. You may receive blinatumomab and venetoclax with standard chemo to help treat your leukemia.
Enrollment on APEC14B1
Newly diagnosed with B-ALL or ALAL
Patients with secondary B-ALL
Prior therapy with cytotoxic chemo