BMN 331 is an experimental drug that is being tested for the treatment of patients with HAE. This study is the first time BMN 331, which is a gene therapy, is being used in humans. BMN 331 is given only once during this research study and it is given as an infusion. The purpose of this study is to find out what effects, good and/or bad, the Study Drug has on you and your HAE.

You will have a total of 68 in person visits over 68 months where there will be blood drawn and other lab tests. You will have to travel to an off site location to receive the drug once and travel will be paid for by the sponsor of the trial.

The overall goals of this study are to identify how measurement of carbon dioxide during sleep can improve recognition of respiratory distress in neuromuscular disease and thus improve timely access to respiratory therapies which prolong survival. Subjects in this study will participate for up to one year, during which their carbon dioxide levels will be measured in clinic and in their homes during sleep.

Subjects in this study will participate for up to one year, during which their carbon dioxide levels will be measured using deviced attached to the skin while in clinic and in their homes during sleep. Subjects will also complete surveys at the time of clinic visits.

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The purpose of this study is to analyze the strengths, outcomes, adversity, and resilience, as indicated by self-reported experiences in college students who may or may not be childhood cancer survivors. We are asking college students aged 18-23 years attending 4 year universities in the United States to report on their childhood health experiences and their current mental, physical, and social well being during college using a confidential survey. We plan to recruit students who have or have not had a childhood history of cancer and will also ask questions about their demographic information and health habits.

The participants will be asked to complete a confidential online survey that will take 10-15 minutes to complete.

Participants are eligible to earn a $75 Amazon gift card through a random drawing that they can choose to enter after submitting their survey responses

This study is designed to compare biological markers of mood in participants with bipolar disorder to individuals without bipolar disorder. Participants will answer questions, give blood, and undergo a clinical interview. This study is a 1 time appointment lasting no longer than 1.5 hours and participants will be compensated $50.

One in person visit with interviews, questionnaires, and a blood sample.

$50

The community of remote learners is on the rise. With the trends of application and skill based knowledge, more and more people are migrating to the learn while you work paradigm. People value flexibility and comfort increasingly. Penn State is one of the few Universities propagating the cause of spreading knowledge via all modalities. The 33,302 students spread across its 19 commonwealth campuses are further a testimony to the prevalent trends. It is important that all these students receive an integrated and cohesive student experience. This also covers the need for the students to feel a sense of social belongingness. The work will focus on bringing together the Penn State community to achieve the true essence of it’s chant WeAre!

The purpose of this study is to compare two usual treatment approaches to your head and neck cancer: high-dose cisplatin given every 3 weeks with radiation to low-dose cisplatin given weekly with radiation. The first part of this study will help the study doctors find out if the low-dose cisplatin approach is better tolerated than the high-dose cisplatin approach. To decide if it is better, the study doctors will be looking to see if there are fewer side effects for patients who receive low-dose cisplatin weekly compared to patients who receive high-dose cisplatin every 3 weeks. The second part of this study will also help the study doctors find out if the low-dose cisplatin approach will extend your life by at least the same amount of time as the high-dose cisplatin approach. There will be 464 people in the first part of the study. If the study goes on to the second part, there will be 786 additional people. Overall, there will be a total of up to 1250 people taking part in this study.

he first part of this study will help the study doctors find out if the low-dose cisplatin approach is better tolerated than the high-dose cisplatin approach. To decide if it is better, the study doctors will be looking to see if there are fewer side effects for patients who receive low-dose cisplatin weekly compared to patients who receive high-dose cisplatin every 3 weeks.The second part of this study will also help the study doctors find out if the low-dose cisplatin approach will extend your life by at least the same amount of time as the high-dose cisplatin approach.There will be 464 people in the first part of the study. If the study goes on to the second part, there will be 786 additional people. Overall, there will be a total of up to 1250 people taking part in this study.

This study investigates users’ experience with smart devices. This study makes further implications for designing more user-friendly devices for better user experience. We aim to make such contributions by answering these questions:1.How do users interact with smart devices?2.What challenges do users face when using smart devices?3.What strategies do users apply to adapt themselves to smart devices?4.What service do smart device producers provide for users to get a better user experience?5.When does user experience break down when interacting with smart devices?The study methods are social media data analysis, interview, survey, and focus group.

Trying to understand how humans alter their behavior when presented with new information regarding privacy rules.

This is a pilot study on the impact of switching from cigarettes to Electronic Cigarettes on disease-related clinical symptoms and biomarkers of harm in smokers with preexisting COPD

You will be asked to reduce your cigarette smoking and use study-provided e-cigarettes for 3 months. You will be asked to attend 2 in-person visits at the Hershey Medical Center and participate in 4 telephone visits. Throughout the study you will be asked to complete questionnaires, have heart rate, blood pressure and pulse oximetry taken, electrocardiograms (ECGs), height and weight measured, provide medical history, perform pulmonary function tests, complete a 6-minute walk, have your exhaled carbon monoxide measured, provide urine specimen and have blood drawn.

The purpose of the dose-escalation part is to evaluate GEN1046 in subjects with solid malignant tumors to determine the maximum tolerated dose (MTD) or maximum administered dose and/or the recommended phase 2 dose (RP2D). The purpose of the expansion part is the further evaluate the safety, tolerability, PK and antitumor activity of the selected dose(s) in select solid tumors.

The participants will be required to follow the trial doctor's instructions, have tests and checks done as part of the trial, inform the trial doctor of any changes in how they are feeling, be open and honest about their health history, inform the study team of all concomitant medications, and inform the trial doctor if you decide not to participate in the trial anymore.

The purpose of this study is to compare the usual treatment (surgery plus chemotherapy after) to using chemotherapy both before and after surgery. Receiving gemcitabine/cisplatin chemotherapy both before and after surgery could extend your life and prevent your cancer from returning. But, it could also cause side effects, which are described in the risks section below. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will look to see if the chemotherapy increases the time to disease recurrence and if it increases a patient’s overall survival compared to the usual approach given both before and after surgery.

We are asking you to take part in a research study. This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer. We are asking you to take part in this research study because you have recently been diagnosed with gallbladder cancer that was found after your gallbladder was removed during surgery.

This study investigates how the interaction affects how well 3D graphs are understood and remembered in virtual reality, and how individual differences in spatial ability affect and interact with memory and understanding.

The purpose of this study is to investigate psychobiological factors that impact the development and manifestation of eating disorder (ED) pathology in elite male and female athletes before and during their competitive season.

The purpose of this voluntary research study is to assess how changes in stress, cognitive flexibility, response inhibition, and reward delay predict the trajectory of eating disorder behaviors and associated side effects of energy deficiency from the off-season compared to the competitive season. Your participation in this study will last approximately the duration of one season of your sport, specifically 4-weeks of data collection prior to season commencement (baseline), 4-weeks of data collection during peak competition season, and 4-weeks of data collection during off-season. The total time spent in the lab will be approximately 10-14 hours. Procedures will occur three times and measurements will be taken twice following baseline measures (once during the peak competition season, once during off-season), if you agree to do so.

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The goal of this study is to measure emotional and brain responses related to the motivation to smoke cigarettes. The study uses a method called functional magnetic resonance imaging, or fMRI, which is a research method for measuring activity in the brain. The study also involves measuring moment-to-moment changes in emotion by coding facial expressions. A primary goal of the project is to examine how changes in brain activity are related to changes in emotion over time. If successful, the project will help to demonstrate the usefulness of combining fMRI and facial coding to study cigarette smoking and other harmful behaviors.

There will be two in-person visits. Brain imaging scans (using functional magnetic resonance imaging) will be completed at one of these visits.

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The purpose of this study is to examine the sexual relationships among heterosexual female college students (ages 18-22) via Qualtrics (a web-based survey). Utilizing latent class analysis with a distal outcome, the proposed cross-sectional study seeks to do the following: Aim 1. Examine the heterogeneity in relationship quality among female college students. Research question 1: Is there a latent class structure that adequately represents the heterogeneity in relationship quality among female undergraduate students participating in penile-vaginal sex? If so, what are the types and their corresponding prevalence?Aim 2. Examine the association between relationship characteristics and latent class membership.Research question 2: Are relationship characteristics (partner type, relationship duration, exclusivity/monogamy, and frequency of sex) predictive of membership in latent classes of relationship quality?Aim 3. Examine the association between latent classes of relationship quality and condom use.Research question 3: Which identified latent class of relationship quality is significantly associated with condom use at last penile-vaginal sex?Please note that the indicators measuring relationship quality will include the following variables: 1) trust, 2) love, 3) passion, 4) commitment, 5) relationship satisfaction, 6) sexual satisfaction, 7) intimacy, and 8) decision-making dominance.

The original Childhood Arthritis & Rheumatology Research Alliance (CARRA) Registry was first established in 2010 to advance alliance infrastructure,facilitate expanded clinical and translational pediatric research, and transform the culture of pediatric rheumatology toward universal participation in research. Continuation of the CARRA Registry as described in the protocol attached to this IRB submission will support data collection onpatients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressingquestions about therapeutics used to treat pediatric rheumatic diseases, including examining safety questions. The Duke Clinical Research Institute (DCRI) is serving as the CARRA Clinicaland Data Coordinating Center (CDCC) for this protocol.

In addition to allowing the researchers to collect data on you from your medical record, we will ask you and your parents/caregivers to complete a short survey that takes about 15 minutes to completeThe research team will follow up every 6 months by reviewing your medical record and asking you and your parents/caregivers to complete a short survey that takes about 15 minutes to complete.If you agree to take part, you will be in the study for 10 or more years.

Part 1 (Phase Ib): To determine the safety and ability for subjects to tolerate APG-115 when combined with pembrolizumab, as well as the maximum tolerated dose in subjects with metastatic melanomas or solid tumors.Part 2 (Phase II): To determine the overall response rate of APG-115 when combined with pembrolizumab in the treatment of patients with unresectable or metastatic melanomas. To assess APG-115 as a monotherapy in patients with unresectable or metastatic melanomas and MPNST cohorts only.

If you are eligible and agree to receive the study drug combination, you will need to come to the study site at various times to have procedures done. These procedures may include collection of vital signs, blood andurine samples, electrocardiogram, physical exam, tumor biopsy, imagingscans, and x-ray. At each visit, you will be asked about your current medicines, including over-the-counter medications, and about any symptoms or side effects you might be having. You will receive the study drug orally on Days 1, 3, 5, 7, 9, 11, 13 of every 21-day cycle. Pembrolizumab is given as a 30-minute intravenous (IV – through a needle into a vein) infusion on Day 1 of every 21-day cycle.

In an increasingly global environment, both within the US and abroad, the ability to rapidly gain native-like linguistic competence is a critical asset. The ability to use an L2 in a way that is both expected and recognized by its native speakers is important both to the broad public, and to specific sectors, such as military personnel, that must develop native-like competence in a foreign language in a limited amount of time. The studies conducted under this IRB protocol will examine how learners/speakers of a second language acquire and process multi-word units (e.g., carry a business; run a store) in their second language, and how knowledge from the first language might influence the learning and processing of multi-word units in a second language.

Participants will complete a number of simple tasks on a computer in English and/or in Spanish (depending on language background).

$12/hour

This study will examine the effects of different brain games on cognitive and everyday activities in middle-aged and older adults. Participants will play either 20 or 40 hours of ENACT brain games on a study provided laptop. They will also complete daily surveys on a study-provided mobile phone for the duration of the study. These surveys will take approximately 5-6 minutes to complete per day. The study will last either 6 or 9 months depending on the brain game training time. The study will be done remotely from the comfort of home using study-provided mobile devices. Participants are compensated for their time.

Participants will play either 20 or 40 hours of ENACT brain games on a study provided laptop. They will also complete daily surveys on a study-provided mobile phone for the duration of the study. These surveys will take approximately 5-6 minutes to complete per day. The study will last either 6 or 9 months depending on the brain game training time. The study will be done remotely from the comfort of home using study-provided mobile devices.

$230

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.

Clinical trial on the treatment of persons who are diagnosed with Lung Cancer.

Participants in this study will undergo screening tests and procedures to determine whether you are eligible to participate with the research study. If you meet the requirements to participate with the study, you be given Brigatinib by mouth each day for 7 days. If you do not experience any intolerable side effects while taking Brigatinib, you will receive an increased dose starting on Day 8 and take Brigatinib continuously each day thereafter. Bevacizumab will be given intravenously (IV) on Day 8 in combination with Brigatinib. The first 28 days of treatment is called Cycle 1. Starting Cycle 2 and thereafter, one cycle will consist of 21 days. Bevacizumab will be given on Day 1 every 21 days starting Cycle 2. Participation is expected to last until your disease worsens or you decide you no longer want to participate in the study. There will be a follow-up visit within 30 days of treatment discontinuation. The study team will check in with you every three months after this final visit to see how you are doing.If you decide to take part, this is what will happen: Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have Anaplastic Lymphoma Kinase (ALK) Rearranged Non-Small Cell Lung Cancer (NSCLS), not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses. If you take part in this research study, you will be given a drug diary. You will be asked to document information in the drug diary about the study drug you are being asked to take.If you take part in this research, study you will be given a study calendar. Information about what to expect during and between study visits will be included in the study calendar.

Only 50% of patients with type 1 diabetes (T1D) recover insulin secretion function after 3 months of initial diagnosis, and this phase is called partial remission (PR) of T1D, also called "Honeymoon phase". During this PR phase of T1D, patients recover the ability to secrete more than 50% of their insulin secretion function. This phase of PR typically lasts no longer than 6 or up to12 months, and has been frequently defined as requiring exogenous insulin below 0.5 units per kilogram per day, and hemoglobin A1C is typically below 7.5%. Most recently the use of a coefficient called IDAA1C ≤ 9 has became more accepted as the methodology to determine the development of partial clinical remission of T1D (honeymoon phase). Prior data published by the SEARCH study (national epidemiological study) showed that youth with prolonged honeymoon phase had higher intake of omega -3 fatty acids, vitamin D intake and leucine intake than those youth without prolonged honeymoon phase of T1D. Currently, there are not approved medications to prolong this phase of partial remission of type 1 diabetes, however inducing PR in youth with T1D could potentially decrease the risk of multi-organ damage caused by chronic severe hyperglycemia associated to the chronic hyperglycemia related to T1D.We aim to perform a case- multiple control study between youth with prolonged partial remission phase of T1D after one year of diagnosis, and compare these youths with multiple controls matched by age, gender, race, and puberty stage to study the potential protective factors associated to the development of prolonged partial remission of T1D.

Participants will be approached at their routine Pediatric diabetes clinic appointment. If participants agrees to be in the research, informed consent/assent will be reviewed and signed by all parties. Participant's parent/guardian will be asked to complete a questionnaire. The participant's glucose machine/insulin pump will be downloaded for study purposes. Participant will undergo a fingerstick and a blood draw to collect specific lab values as outlined in the consent.

$35.00

This research is being done to find out more about changes in the brain as we age and to determine if MRI, genetic (DNA) variations, and neuropsychological tests can be used to evaluate memory loss and cognitive impairment.

The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain. Participants will complete surveys, record pain, medication use and bleeding in an online diary during endometriosis flare ups for 3 months without using the TENS unit. After the first 3 month period of time, a TENS unit will be given to participants to wear and again, record pain, medication use and bleeding in the online diary during endometriosis flare ups for and additional 3 months while using the TENS unit.

There will be one in person enrollment visit, involving being consented and completion of 2 surveys. The first 3 months, the "baseline period" will include filling out pain scores online on days of endometriosis flare without TENS unit use. The next 3 months, the "treatment period" will include filling out pain scores online on days of endometriosis flare with TENS unit. At end of study completion of 2 surveys.

This is an investigational drug study comparing the Investigational treatment with treatments called capecitabine and pembrolizumab as stand-alone treatment agents or in combination. Study participants will be required to attend all study visits, complete the tests and procedures, receive study treatment, and complete questionnaires.

Participants must attend all visits, receive study treatment, have blood drawn, complete questionnaires, have imaging scans done (ECG, ECHO or MUGA, CT, mammogram or breast MRI), keep a diary, have an eye exam, and provide a tumor sample.

This is a self-report survey and questionnaire study that examines whether members of marginalized groups are more motivated than members of dominant groups to give referent power to high status others in attempts to belonging.

Children with attention and behavior problems often need external rewards to motivate them to perform challenging tasks, but we don’t yet know much about how children weigh potential rewards and the effort required to obtain the rewards. This research is being done to find out how children with varying levels of ADHD symptoms value rewards and costs when making decisions about whether or not to perform a difficult task.

There will be one in-person visit. Children will complete two computerized cognitive tasks (thinking games), and will be able to earn prizes from the points they earn on these tasks. Parents will also be asked to complete a few questionnaires that should take about 25 minutes to finish. Children can earn up to $50 in compensation for completing the study.

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Children of depressed mothers are at high risk for developing depression, particularly as youth age into adolescence, yet relatively little is known about the mechanism underlying risk for depression in youth with depressed mothers. The present study examines maternal reward responsiveness, measured across neurophysiological, behavioral, and self-report measures as a marker of depression in mothers of adolescents. Associations between maternal reward responsiveness and parenting difficulties often associated with maternal depression, as well as adolescent functioning will be examined, to explore the clinical impact of maternal reward responsiveness on the intergenerational transmission of depression.

The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.

The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.

The goal of this research is to understand the role of motion-processing areas on limb motor control. We will be using behavioral studies and combining that with functional brain imaging, EEG, and non-invasive brain stimulation using transcranial magnetic stimulation (TMS). TMS has been used in thousands of studies and is a very safe method to understand brain function for eye hand coordination.

There will be three visits. Participants will under go brain scanning. They will perform eye-hand coordination tasks by grabbing a robotic manipulandum. During the eye-hand coordination tasks, participants' brain activity will be measured using electroencephalography (EEG) and muscle activity using surface electromyography (EMG). Researchers will also apply transcranial magnetic stimulation (TMS) to temporarily inhibit and excite different brain areas. TMS is a noninvasive procedure that uses magnetic fields to stimulate nerve cells

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