Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction
This is a Phase 3 study, which means that BIIB093 (study drug) has already been investigated in previous clinical research studies with a small number of people with large hemispheric infarction (LHI). These studies suggested that the study drug was safe, did not cause serious side effects or discomfort, and may reduce brain swelling, disability, and death in subjects with LHI. In this study, we want to investigate the study drug in a larger number of subjects (hundreds) to know more about it.
LHI is a type of stroke. An ischemic stroke occurs when blood flow to parts of the brain is blocked, such as by a blood clot. This can cause damage to the brain. In LHI a large portion of the brain is damaged. People who have LHI can develop swelling of the brain called cerebral edema, which can worsen the symptoms and outcomes of LHI.
Currently, there are no medications available to specifically reduce brain swelling caused by LHI. In this study, we want to investigate how well the study drug works to improve functional outcomes (the ability to do normal daily activities, such as walking and getting dressed) in subjects with LHI. This study will also look at the long-term effects of the study drug over time and see how safe the study drug is.
All
18 year(s) or older
NCT02864953
Neurology
Immersive Virtual Reality Storm Surge: Scale and Risk Perception
Evaluating if an immersive virtual reality experience of storm surge flooding gives people an understanding of the scale of the flooding and increases their risk perception of such flooding compared to a non-immersive desktop experience.
Mark Simpson at marksimpson@psu.edu or 575-491-5512
All
18 year(s) or older
N/A
Education
Creative Thinking and Problem Solving
This is a behavioral study that will examine cognitive processes relevant for creative thinking. Participants will be asked to complete a series of cognitive tasks and self-report measures on a computer.
James Lloyd-Cox at jll487@psu.edu
All
18 year(s) or older
N/A
Efficacy of Virtual Reality Exposure Therapy Scripts for Social Phobia
This research is conducted to test if virtual reality technology is effective to help people face their social fears and promote the use of adaptive social skills in various settings. You will be immersed in a range of virtual reality environments and work with a research therapist to learn certain skills, such as managing fears of negative evaluation during job interviews, and interacting with peers in common social settings (e.g., classrooms, cafeterias).
Hani Zainal at nvz5057@psu.edu or 814-863-0115
All
18 year(s) or older
N/A
Men's Health, Mental & Behavioral Health, Women's Health
Story Circles as a Methodology: Exploring Illness Perceptions in Advanced Heart Failure
We will utilize Story Circles with persons living with advanced heart failure to explore their experiences, their illness perceptions, and how these perceptions might influence goals of care and decision making. There is a gap in our current understanding of how persons living with an advanced life-limiting illness such as heart failure perceive their illness and how this might influence decision-making. New knowledge regarding a person’s illness perceptions has important implications for future work including goals of care conversations and decision making for heart failure throughout the illness trajectory and especially at the end of life.
Lisa Kitko at lkitko@psu.edu or 814-863-2228
All
18 year(s) or older
N/A
Heart & Vascular
Site for 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.
Kathleen Rizzo at kar23@psu.edu
All
18 year(s) or older
NCT03419234
Cancer
Understanding the Relationship between Education and Well-being among College Students with Disabilities
The purpose of the study is to gain an understanding of students’ experiences in college and their engagement help-seeking and healthy behaviors. Participation in the study involves completing a brief online-survey on Qualtrics, which we anticipate will take approximately 20 minutes to complete.
Amber O'Shea at amo5208@psu.edu or 814-867-5721
All
18 year(s) or older
N/A
Education, Mental & Behavioral Health, Women's Health
A more naturalistic interaction: using back-channeling in smart-speakers to indicate active listening
In this project, we aim to extend the capabilities of smart-speakers (such as Amazon Alexa, Google Home, Siri, etc.) to support more engaging interactions with their users. Specifically, we would like to make the future of smart-speakers more conversational. One of the key aspects in developing a conversation is to be an active listener; showing interest in the speaker and allowing them to extend their turn in talk. In this study we investigate how smart-speakers can become better listeners by incorporating some of the human-human conversational features of active listening. Our question is, how can smart-speakers extend the users' turn in talk by being better listeners?
Nasim Motalebi at nfm5140@psu.edu or 814-753-2081
All
18 year(s) or older
N/A
Mental & Behavioral Health
A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE).
This is a drug study that will examine the drug Ribociclib with endocrine therapy versus just endocrine therapy in patients with early breast cancer.
Kathleen Rizzo at krizzo@pennstatehealth.psu.edu
All
18 year(s) or older
NCT03701334
Cancer
Site for EA9161: A Randomized Phase III Study of the addition of Venetoclax to Ibrutinib and Obinutuzumab versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)
The is a drug study to compare the progression free
survival of the three drug combination Ibrutinib-Obinutuzumab-Venetoclax (IOV) to Ibrutinib-Obinutuzumab (IO) in untreated CLL patients younger than 70 years of age.
Michelle Stojanovic at mstojanovic1@pennstatehealth.psu.edu
All
18 year(s) or older
NCT03701282
Cancer
Storytelling on Snapchat
This study will examine via ethnographic observation the Story feature on social media. Participants will be asked to provide their Snapchat or Instagram username and must be willing to let the researcher observe the Stories that they post. The primary aims are to illuminate how and why people are using the Story feature on social media, and to analyze how this feature is changing how we relate to and understand the world around us.
Michael Krieger at mlk75@psu.edu or 646-430-0117
All
18 year(s) or older
N/A
Education, Mental & Behavioral Health, Language & Linguistics
Site for A RANDOMIZED PHASE III DOUBLE BLINDED PLACEBO CONTROLLED TRIAL OF ASPIRIN AS ADJUVANT THERAPY FOR HER2 NEGATIVE BREAST CANCER: THE ABC TRIAL.
This is a drug study with a primary outcome of testing aspirin as therapy versus a placebo pill for patients for breast cancer.
Lea Russell at lmay1@psu.edu
All
18 year(s) or older
NCT02927249
Cancer
Coparenting, Infant Sleep, and Infant Development: An Intervention Study
This application proposes a randomized clinical trial (RCT) to evaluate the effects of a sleep-enhanced adaptation of an evidence-based transition-to-parenting coparenting intervention program [Family Foundations - FF). The study has three arms. In one arm, families will experience FF as originally formulated; in the second, families will receive an adapted FF that emphasizes coparenting in infant sleep contexts; the third arm will serve as controls. Assessments of coparenting and parenting in infant sleep contexts, parental adjustment to infant sleep behavior, choices about sleep arrangements, infant and parent sleep quality, and infant socio-emotional functioning, will serve as outcomes.
Morgan Loeffler at FF@psu.edu or 717-695-7050
All
18 year(s) or older
NCT03187561
Pregnancy & Infertility, Sleep Management, Women's Health
Walking through the forests of the future: Using data-driven iVR to visualize forests under climate change
We used a combination of ecological modeling, procedural modeling, and virtual reality to provide an embodied experience of “walking through the forests of the future”. This study will provide empirical evidence of the effectiveness of this immersive experience based on users’ feedbacks on different kinds of tools we developed.
Jiawei Huang at jzh87@psu.edu or 734-355-5327
All
18 year(s) or older
N/A
Education, Language & Linguistics
"Alexa, I’m in pain! "A Real-Time Mindfulness Intervention to Control Pain: Delivery Through a Conversational Agent
We are interested in learning about people’s experiences with using the Amazon Alexa for delivery of a real-time mindfulness intervention to help with chronic pain management. Participation will include a free day-long introductory mindfulness training followed by daily use of mindfulness practices using the Amazon Alexa to establish a habit of use.
The participants will use our developed Amazon Alexa app ("skill") and provide assessments. We will ask participants to complete short daily surveys and a follow-up interview.
Sebrina Doyle at sld40@psu.edu
All
18 year(s) or older
N/A
Pain Management
Describing your voice: Viewpoints from pre-professional voice users
The purpose of this study is to conduct semi-structured interviews with students at Penn State who are working towards degrees in fields that require a high vocal demand (e.g. teachers, lawyers, singers, actors, etc). The purpose is to learn more about what students think about their voice, what they know about protecting their voice, and what they would do if they had a voice disorder. This information can be used to design interventions and preventative outreach programs for these students.
Nicole Etter at oppal@psu.edu or 814-863-2021
All
18 year(s) or older
N/A
Prevention, Education, Language & Linguistics
Randomized trial of low nicotine cigarettes plus electronic cigarettes in smokers
This study will examine the health effects of lowering the nicotine content in cigarettes while having access to an electronic cigarette.
Candace Bordner at cbordner@pennstatehealth.psu.edu or 717-531-0003, ext=282798
All
18 year(s) or older
NCT04058717
Smoking, Vaping, Nicotine and Tobacco, Addiction & Substance Abuse, Mental & Behavioral Health
Site for A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects with Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa: Phase 2 Subject and Investigator Blinded, 68 week study with phone call 20 weeks after last dose.
Hidradenitis Suppurativa (HS) is a chronic recurrent and debilitating skin condition that typically presents with deep and painful lesions. The most common areas affected are the armpits, the groin, and the anus and genitals area.
The purpose of the study is to find out if risankizumab is beneficial and well tolerated in patients with HS. Each subject will be assigned to 1 of 3 treatment groups, reassigned to a different treatment at week 16, and then receive risankizumab at week 20.
Amy Longenecker at alongenecker@pennstatehealth.psu.edu or 717-531-5136
All
18 year(s) or older
NCT03926169
Skin Conditions
Physical Therapists Role in Promoting Physical Activity for People with Chronic Physical Disabilities
We plan to conduct a qualitative study exploring perspectives of physical therapists and people with disability regarding physical activity promotion
Jacob Corey at jjc6062@psu.edu or 814-865-1691
All
18 year(s) or older
N/A
Arthritis & Rheumatic Diseases, Neurology, Muscle & Bone
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Crohn's Disease
This study is for patients with moderate to severely active Crohn's disease to measure how effective and safe an experimental medication is in treating this condition.
Laurie Peiffer at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
All
18 year(s) or older
NCT03599622
Digestive Systems & Liver Disease
Assessing cognitive and psychosocial mechanisms of Useful Field of View cognitive training using ecological momentary assessment
We are interested in how brain games impact everyday life in healthy older adults. Participants will play 20 hours of brain games on a study-provided laptop, and we will examine how the brain games impact everyday life. This study will be performed remotely in participants homes using study-provided laptops. Some participants may also participate in 2 optional visits with brain MRI scans at Penn State University and at home sleep monitoring.
Michelle Huerbin at mlh5955@psu.edu or 814-865-4773
All
18 year(s) or older
NCT00000000
Mental & Behavioral Health
Cardio-metabolic effects of diets including pecans
The purpose of the study is to examine how the inclusion of 2 oz./day of pecans into a typical American diet and a healthy diet affect risk factors for heart disease and diabetes.
Philip Sapp at pzs5199@psu.edu or 866-778-3438
All
18 year(s) or older
N/A
Food & Nutrition
A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy, and Safety Study in Prurigo Nodularis with Nalbuphine ER Tables for Pruritus Relief Through Itch Scratch Modulation (PRISM Study)
Prurigo Nodularis: Phase 2b/3 Subject and Investigator Blinded, 56 Week study. Oral medication taken twice daily, Males/Females 18 years and older with Prurigo Nodularis
Prurigo Nodularis (PN) is a skin disease that causes hard, itchy lumps (nodules) to form on the skin. The itching (pruritus) can be intense, cause people to scratch themselves to the point of bleeding or pain.
The goal of this study is to evaluate the change of itch with using Nalbuphine ER.
Amy Longenecker at alongenecker@pennstatehealth.psu.edu or 717-531-5136
All
18 year(s) or older
NCT03497975
Skin Conditions
Understanding the effect of drivers’ profile information on riders’ feedback in ride-sharing context
This study aims to understand ways to affect how riders perceive and provide feedback to drivers through technology intervention. Particularly, we investigate how presenting drivers’ personal profile under different trip conditions may lead to differences in the ways riders may provide feedback. We hypothesize that riders will provide positive feedback when provided drivers’ personal information when the trip goes well, and that riders will provide less negative feedback when provided drivers’ personal information when the trip goes bad due to uncontrollable reasons.
Ning Ma at nzm37@psu.edu
All
18 year(s) or older
N/A
Education
A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit in Subjects with Hypertension
The purpose of this study is to evaluate the safety and effectiveness of renal denervation while still on blood pressure medications. Renal denervation is the destruction of nerve fibers that run along the kidney blood vessels. This causes an interruption of nerve signals that may cause high blood pressure. Therefore, the effectiveness of the study catheter and the alcohol (Peregrine Kit) will be assessed by how well the treatment reduces blood pressure.
Paula Trump at PSHVIResearchCoordinators@pennstatehealth.psu.edu or 717-531-5967
All
18 year(s) or older
NCT02910414
Heart & Vascular
The Daily Reflections Study
This 14-day daily diary study is being conducted to better understand how young adults' thoughts and feelings about their bodies influence their health behaviors, and how their daily experiences and characteristics contribute to their health behaviors. Participants will be asked to complete a 10-20 minute baseline survey and a brief (5-8 minutes) daily survey each day for 14 consecutive days. Surveys will include questions about participants' mental and physical health, emotions, relationships, health behaviors, thoughts, and experiences.
Anna Hochgraf at akh7@psu.edu
All
18 year(s) or older
N/A
Smoking, Vaping, Nicotine and Tobacco, Mental & Behavioral Health, Women's Health
EXALT: EXercise Attenuates Liver Tumors Trial
Our goal is to better understand how exercise impacts patients with liver cancer in order to identify treatments that can improve outcomes and access to liver transplantation.
Gloriany Rivas at grivas@pennstatehealth.psu.edu or 717-531-0003, ext=320223
All
18 year(s) or older
NCT03979547
Cancer
Neural Correlates of Cognitive Dysfunction in Postural Tachycardia Syndrome
Postural tachycardia syndrome (POTS) is a chronic syndrome in which the heart beats too quickly when standing. POTS primarily affects young women. People with POTS also experience symptoms such as feeling faint, fatigue, nausea, and mental clouding or "brain fog." “Brain fog” is one of the most bothersome symptoms of POTS and it is unknown why people with POTS experience this symptom. Some studies have shown that POTS patients have problems with attention, memory and executive function (ability to plan, organize information, and adapt to changes) while seated and when upright. In this study, we will evaluate how brain function during mental tasks is affected in people with POTS compared to healthy volunteers. All volunteers will complete mental tasks while lying down and standing. If eligible, we will measure brain activity using functional magnetic resonance imaging (fMRI).The findings from this study will increase our understanding of the mental complaints in people with POTS, to hopefully help with development of new treatments.
Amanda Miller at aross1@pennstatehealth.psu.edu or 717-531-7676
All
18 year(s) or older
NCT04137757
Heart & Vascular, Neurology
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis
The primary purpose of this phase 3 clinical trial is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).
Anne Haulman at ahaulman@pennstatehealth.psu.edu or 717-531-0003, ext=289123
All
18 year(s) or older
NCT03920293
Neurology
Collaborative Research: Measuring and Enhancing Scientific Creative Thinking for STEM Education and Research: Classroom-Aligned Assessment and Network Neuroscience-Based Mechanisms
The project is interested in understanding how the brain supports creative thinking in the context of solving scientific problems. During functional magnetic resonance imaging (fMRI) and behavioral experiments, participants will be presented with open-ended scientific questions and asked to produce responses.
Brendan Baker at brendan.baker@psu.edu
All
18 year(s) or older
N/A