Search Results
E4512- A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
Purpose of this study is to compare any good and bad effects of using the study drug, crizotinib after completeion of surgery and in some cases after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer.
You will need to have the following extra exams and tests to find out if you can be in the research study:•Electrocardiogram (EKG) to check your heart rhythm•Blood or urine pregnancy test, if you are a woman of child-bearing potential•Smoking status survey•ALK Fusion Status test using tissue from your previous surgery and/or biopsiesToxicity assessment will be done every 3 weeks for the first 6 weeks, then every 6 weeks for the next 12 weeks, then every 12 weeks until treatment is completed.
Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE
ALK positive
Patients must have completed any prior adjuvant chemotherapy or
Examining responses to rewards in the laboratory and during daily life in individuals who smoke cigarettes
The goal of this study is to learn more about how people who smokecigarettes respond to rewards, such as winning money, under different conditions. The study uses a method called functional magnetic resonance imaging, or fMRI, which is a research method for measuring activity in the brain. In this study, we are using fMRI to measure how brain activity changes in people who smoke when they receive rewards. The fMRI measures are collected during two separate visits. Participants are also asked to fill out questionnaires and complete computer tasks while in the lab. In addition, the study involves measuring thoughts and behaviors in people who smoke in real life by asking them to fill out surveys on a smartphone. Participants are asked to carry a smartphone for a total of 10 days and answer several surveys throughout each day. In order to be eligible for the study, individuals must be between 18 and 55 years old and you must smoke on a daily basis.
Right Handed
Smokes cigarettes
Left Handed
non-smokers
Future of Construction Workplace Health Monitoring
This study will examine different structural designs of stretchable, skin-like sensors on the surface of human skin for construction workplace health monitoring.
There will be one in person visit, you will be asked to sit still for 3 minutes and then move your skin for another 3 minutes.
be over 18 years old.
must understand English.
from Penn State, University Park
cannot understand English
under 18 years old
Application of graph theory to both resting-state and task-based fMRI data to uncover brain-behavior relationships related to therapy outcomes in aphasia
This project will use fMRI to examine changes in the brain related to behavioral therapy outcomes in persons with aphasia. We aim to recruit twenty persons with aphasia. Each participant will receive 4 MRI scans. Between scan 1 and scan 2, no therapy will be provided (10 week break). Between scan 2 and scan 3, ten weeks of word finding therapy will be provided. Between scan 3 and scan 4, no therapy will be provided (10 week break). The therapy used is abstract word retrieval training. The results of this project will help inform rehabilitation practices in aphasia.
There will be 4 fMRI scans. After the first and third fMRI scans, there will be an assessment. After the second fMRI scan, there will be 10 weeks of treatment.
$460
Sustained stroke at least 6 months ago
Right-handed
Native English speaker
Completed at least a high school education
History of other acquired neurological disorder (e.g., TBI)
History of developmental disorder (e.g., autism)
History of psychological disorder (e.g., schizophrenia)
Unsafe to receive MRI (e.g., pacemaker)
Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III (PSCI# 20-135) (S1501)
The purpose of this study is to test whether carvedilol can reduce the occurrence of heart problems during your cancer treatment. Carvedilol (Coreg®) is a medication that is FDA approved and used to treat congestive heart failure and high blood pressure and is not a new medication. It has been shown in small studies to protect the heart from side effects of chemotherapies such as doxorubicin (Adriamycin®) and trastuzumab (Herceptin®). The effects of carvedilol will be compared to the usual approach. Previously, people who were already taking a beta blocker, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitor were able to take part in the study. The study has reached the maximum number of people allowed who are already on those treatments now, so, you must not be taking these types of drugs in order to be part of the study. There will be about 817 people taking part in this study.
The purpose of this study is to test whether carvedilol can reduce the occurrence of heart problems during your cancer treatment. Carvedilol (Coreg®) is a medication that is FDA approved and used to treat congestive heart failure and high blood pressure and is not a new medication. It has been shown in small studies to protect the heart from side effects of chemotherapies such as doxorubicin (Adriamycin®) and trastuzumab (Herceptin®). The effects of carvedilol will be compared to the usual approach. Previously, people who were already taking a beta blocker, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitor were able to take part in the study. The study has reached the maximum number of people allowed who are already on those treatments now, so, you must not be taking these types of drugs in order to be part of the study. There will be about 817 people taking part in this study.
Patients must be ≥ 18 years of age.
Patients must have a complete physical examination and medical history within 28 days prior to registration.
Patients must not be dialysis dependent
Patients must be able to swallow tablets.
Patients have uncontrolled asthma.
Patients who are pregnant or nursing
Patients who are unable to swallow tablets.
Patients who do not have adequate hepatic function
Coping with it All from Labor to Maternity
The CALM Project is looking to learn how different birthing classes prepare child-bearers for parenthood. Participants attend a free birthing class between their 20th and 37th weeks of pregnancy with their partners and fill out three questionnaires during pregnancy and postpartum. Three months after their baby is born, they are video-recorded interacting with their baby in their home and have their brain scanned using MRI. We aim to understand how different childbirth classes support mothers' well-being and bonding with their babies.
Women are asked to 1.complete 3 self-report questionnaires online during pregnancy and after their baby is born (45 minutes each)2.attend a childbirth preparation class (from a few hours to a 9-week class)3.participate in 2 in-person sessions (1.5 hours each): a videorecording with their baby in the home and a brain scan using MRI at Penn State Hershey Medical Center.
$160 + free birthing class
At least 18 years old
Speaks English
Pregnancy complications that would prevent you from participating in an online class
Protocol NRG-LU007: RAndomized Phase II/III Trial Of Consolidation Radiation + Immuno-therapy for ES-SCLC: RAPTOR trial (NCT # NCT04402788) (PSCI# 20-118)
The purpose of this study is to compare the usual treatment of the immune therapy drug atezolizumab alone, to using radiation therapy plus the usual treatment. The addition of radiation to the usual treatment could shrink your cancer or prevent it from returning. This study will help the study doctors find out if this different approach is better, the same or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the life of patients or extends your time without disease compared to the usual approach.
The purpose of this study is to compare the usual treatment of the immune therapy drug atezolizumab alone, to using radiation therapy plus the usual treatment.
measurable disease (per RECIST) and 3 or fewer observable liver metastases and no evidence of progressive disease at enrollment
Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody
ECOG Performance Status of 0-2 at the time of registration
Age ≥ 18
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 5 years prior to randomization
Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration
Patients who have had immunotherapy-induced pneumonitis
History of recent myocardial infarction within 6 months prior to registration
Understanding rideshare passengers’ awareness and attitudes toward Rideshare drivers’ safety
In prior research, it was found that the major source of drivers’ feelings of lack of safety is the passenger (Almoqbel and Wohn, 2020); in this research, we aim to understand the perceptions of rideshare passengers of the drivers’ safety. We plan to interview 30 rideshare passengers from the U.S. We ask them questions about their behavior in the rideshare cars and their perception of the driver's safety. The results will provide insights into passengers’ behaviors that could be influenced by platforms to enhance the safety of both app users, the driver, and the passenger.
We are researchers to work on understanding users’ rideshare experience. If you often use rideshare apps (e.g., almost every week), such as Uber or Lyft, please consider participating in our 30 mins to 1 hours interview to share your rideshare and app usage experience. We can have a remote interview with Zoom, Discord, phone call, or Skype.
$15
English-Speaking
Non-English speaking
A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease
This is a phase 2/3, multi-center, randomized, double-blind, study for patients with moderate to severe Crohn's disease. Subjects with refractory CD or who are intolerant to at least one current therapy will be considered. The study consists of four substudies. They are designed to investigate efficacy, safety, tolerability of etrasimod as therapy for CD.
The study consists of a screening period, a 14-week induction period, a 6-week extended induction period (if applicable), and a follow-up period. •The subject will have to go to the study center for the visits and follow the instructions the study doctor and the study team give them, and take the study medication, as directed.They are required to bring all unused study medication and packaging to each study visit. The subject should complete their eDiary every day and bring it with you to all visits. They also must remember to return your Holter monitor to the study clinic.Other tests that the subject is required to complete will include ECG, drug test, TB test at screening. Also urine and blood tests at all induction visits except day 1 extension, vital signs and physical at every visit, eye and pulmonary function tests will be done at screening.
$600
Crohn's disease >3 months
Inadequate response, LOR or intolerance to more than one therapies
Females must not be/intent to be pregnant
Use of certain therapies less than 2 weeks prior to randomization
Hypersensitivity to Entrasimod
Have UC diagnosis
Has infection
A Phase 2A, Double-blind, Randomized, Placebo-ControlledClinical Trial to Evaluate the Efficacy and Safety ofSaroglitazar Magnesium 4 mg Tablets for Treating NonalcoholicFatty Liver Disease (NAFLD) in Women WithPolycystic Ovary Syndrome (PCOS)
The purpose of this study is to evaluate the efficacy and safety of Saroglitazar Magnesium 4 mg Tablets once-daily in women with well characterized Polycystic ovary syndrome (PCOS) diagnosed with nonalcoholic fatty liver disease (NAFLD).
There will be 9 in person visits, various procedures will be completed such as a fibroscan, endometrial biopsy, blood draws and surveys. You will be randomly assigned by chance (like the flip of a coin) to receive either Saroglitazar 4 mg or placebo (inactive substance).
NAFLD diagnosis
Stage 2 or 3 fibrosis
pregnancy
Cirrhosis
Inability to provide informed consent
history of liver transplant
Robots that Learn Games by Asking People Questions
The study goal is to develop robots that can learn simple games by interviewing humans. The robot interview strategies are represented as Markov Decision Process policies, and are developed offline through robot interactions with simulated interviewees. The investigator can set the simulated interviewee to respond to the robot's queries with different amounts of information. The games include board games like Connect 4, Quarto, and Checkers. The communication between the robot and simulated interviewee is in a formal language like first order logic. After a simulated dialogue, the robot will have more or less knowledge of the game, depending on the conditions of the simulated interviewee. Human subjects will interact with the robots in two ways. First, to test the utility of the new knowledge, human subjects will participate in experiments where they play the game with virtual robots that have learned the game under different conditions. Second, to investigate the kinds of misunderstandings of questions and answers that might arise if the robot could interview a human, we will present subjects with extracts from the formal language dialogues that we have mapped to English in different ways, and ask subjects to imagine how they would express the same meaning in English, or answer questions in different ways, or what sorts of misunderstandings they might imagine in a real dialogue.
Ability to communicate in written and spoken English
Able to give informed consent
Unable to communicate in written and spoken English
Unable to give informed consent
Vernacular Feature Comprehension and Perception in Persons with Aphasia
This study investigates whether persons with aphasia understand and process sentences with vernacular features in a manner similar to more typical populations. Participants will rate sentences on their naturalness and on whether they make sense, and they will also read sentences while we track their eye movements.
2.Sustained stroke more than 6 months prior to consent
3.Native speakers of English
4.Completed at least a high school education
5.Normal or corrected-to-normal vision and hearing
2.An active medical condition that could compromise participation (e.g., cancer undergoing acute treatment)
3.Taking medications that are known to exert significant effects on cognitive processes
4.Do not meet the above inclusionary criteria
Active Men's Study
Description: This research study is to assess energetic status, reproductive health, and bone health in a population of young exercising men. Secondarily, this study will also explore how diet, fitness, cardiovascular function, eating behaviors, stress, cognitive function, and sleep related to energy and reproductive outcomes in exercising men. Eligible young men (age 18-35) are those who are generally healthy and either a) exercising or b) not exercising.
There will be essentially 5 study visits - The first visit will include informed consent to take part in the study & completion of questionnaires and measurement of anthropometrics. Visit 2 will include tests of your metabolism, a blood draw, a saliva collection, and assessment of diet and physical activity. Visit 3 will be a short visit for a saliva collection. Visit 4 will include tests of stress (a hair sample), body composition, bone health, aerobic and anaerobic fitness, cognitive testing, and reproductive function. Visit 5 will consist of a results meeting and return of wearable devices and logs.
BMI between 16-29.9 kg/m2
Non-smoker
For sedentary participants: less than 150 minutes of purposeful exercise per week
For exercising participants: at least 150 minutes of purposeful exercise per week (moderate to high intensity aerobic and/or resistance training).
Procedures using contrast material within the past 7 days, including X-rays, MRI scans, CT scans, barium studies, nuclear medicine exams.
Currently a smoker or history of regular smoking
Prostheses
Vasectomy
Computer-Human Team Problem-Solving
This project examines team problem solving. Participants will work individually or in small groups to solve problems alone or in collaboration with a computer (AI) program, presented either as puzzles or in case studies. Participants may be occasionally asked to self-report concerning the problem, their own or their group's progress, and/or other aspects of their solving.
Must be at least 18 years of age
Must be at least 18 years of age
Effects of acid sensing ion channels blockade with amiloride on exercise pressor reflex in patients with peripheral artery disease
The purpose of the study is to determine the effects of amiloride on the blood pressure response during exercise, and exercise tolerance in patients with PAD and healthy controls.
There will be 3 in-person visits. You will take a capsule of amiloride or placebo before visits 2 and 3 and blood pressure, heart rate and other physiological measurements will be recorded.
You will receive $25 per hour for your participation in this research study
Any race or ethnicity
Healthy: Free of acute medical conditions
PAD: Diagnosis of PAD, no pain at rest
Resting blood pressure of 150/100 or higher
Already taking amiloride
Recent heart attack or epilepsy
Peripheral neuropathy
Identifying and Predicting Inflection Points in Human-Agent Action Teams Using Relational Event Modeling
The purpose of this study is to better understand how human teams with non-human virtual agent team members operate and function.
If you agree to be in this study, you will be fitted to sensors that will measure your neurophysiological (i.e., brain, cardiac, and respiratory) signals while you complete group tasks in person or in virtual reality. This interaction will be recorded and coded. You will also be asked to complete several questionnaires about your demographics, behaviors, and emotions.
$50
English-speaking
Willing/able to travel to Penn State University Park location research site
No cardiovascular, metabolic, or neurological condition
Willing to wear EEG sensors
Report or diagnosis of a neurological injury or disorders related to cardiovascular-respiratory, metabolic or brain function
Cannot speak or read English
Unable to provide informed consent
Not willing to wear EEG sensors
DFMO for Medullo
This is a study of the drug DFMO (difluoromethylornithine) for medulloblastoma that has returned or not responded to treatment. DFMO is an oral drug that inhibits a certain enzyme (protein) in blood which is associated with a bad outcome in neuroblastoma cases. Cancer cells have pathways that drive the cancer to grow and DFMO targets the specific pathway of this enzyme to turn these cells off.
You will have exams, tests, and procedures while on the study to evaluate whether you can participate in the study and how you are doing while on the study. These include physical exams, blood tests, urine tests, bone marrow aspirate and biopsies, heart tests, hearing tests, and imaging evaluations such as MRI of your brain and spine. You will receive treatment on this study for a total of about 2 years. After treatment, you will have follow-up examinations and medical tests. We would like to continue to find out about your health for about 5 years after you complete the study.
You are 21 years old or younger
You must have no evidence of disease at this time
HEALEY ALS Platform Trial - Master Protocol
The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. The trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. The Master Protocol describes the overall framework of the platform trial, including the target population, inclusion and exclusion criteria, randomization scheme, study endpoints, schedule of assessments, trial design, the mechanism for adding and removing interventions, and the statistical methodology and recommended statistical methods for evaluating interventions.
The HEALEY ALS Platform Trial is a research trial that tests the safety and effectiveness of multiple treatments in ALS. A regimen is a specific course of treatment, each with a different study drug.The following things will happen in this research study: Blood and urine sample collection; Completion of questionnaires; Physical and neurological exams; Vital signs, current and historical review of medical information about general health and medication use review; Muscle strength testing; Measurement of the electrical activity of the heart with an electrocardiogram (ECG); and Measurement of respiratory (breathing) function.Participants will also take either the study drug, or placebo, according to the study schedule
Slow vital capacity (SVC) at least 50% predicted
Time since onset of weakness due to ALS within 36 months
Able to swallow pills and liquids
Clinically significant unstable medical condition (other than ALS) that would pose a risk to you
Investigating Design Aspects of Immersive Virtual Field Trips and Site Experiences
This study investigates the effects and effectiveness of different options for designing immersive virtual reality tours of real-world places. Participants will wear a Virtual Reality headset and watchseveral short tours featuring different environments (museum, forest, harbor, Mayan site). After each tour, participants will be asked for their opinion on certain design aspects of the tour app.
English speaking
able to wear a VR headset + sit and turn in a swivel chair while watching the short VR tours
able to listen to the tour's audio commentary
non-English speaking
22-111 A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple Myeloma
This study involved testing a drug for the treatment of relapsed/refractory multiple myeloma. The trial consists of three parts: the first part looks at the safety of the drug when given to patients; the second and third part looks the dose of the drug at how the drug is used through the body and how it acts on multiple myeloma.
Participants will need to attend the scheduled visits, provide medical history, blood samples, complete questionnaires, radiology exams, bone marrow aspirate and/or biopsy, and take study medication
Aged 18 years or older.
For patients in Parts 2 and 3 only: Measurable disease defined as one of the following: a)Serum M-protein ≥500 mg/dL (≥5 g/L).
During Part 1 only, patients not meeting the above criteria for measurable disease should, at least, have measurable bone marrow plasmacytosis (≥10%) and/or plasmacytoma (≥1 cm in diameter) detected by physical examination or imaging.
ECOG performance status of ≤2.
Patients who have received autologous SCT 60 days before first infusion of modakafusp alfa or patients who have received allogeneic SCT 6 months before first infusion.
Graft-versus-host disease that is active or requires ongoing systemic immunosuppression.
Part 1: Until the MTD/OBD is defined, patients who have received daratumumab (or other investigational anti-CD38 antibody) for at least 5 months (steady state) require a 90-day wash-out period before receiving modakafusp alfa.
Patient has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade ≤1 or baseline,
Couples' Daily Lives with Chronic Back Pain
The purpose of this study is to learn more about the daily experiences of people with back pain and their spouse/partner. Participants and their spouse/partner will be interviewed by video using a tablet computer every 6 months for 2 years and will be asked to complete daily surveys twice a day for 30 days using the provided tablet computer. The daily surveys will take about 5 to 10 minutes to complete. Questions for the interviews and daily surveys focus on physical symptoms, feelings, activities, and interactions.
Video interviews using a tablet computer every 6 months for 2 years. Complete daily surveys twice a day for 30 days using a tablet computer.
295.00
Experienced moderate or severe back pain for at least 3 months
Married or in a long-term relationship AND living with spouse or partner
Pattern Learning in Human Adults
We are interested in what adults notice about stimuli that are presented to them. These stimuli typically consist of novel objects, abstract images, or made-up words.
Fluent in English
Minimum High School Education
Normal or corrected-to-normal vision/ hearing
Those unable to consent, pregnant women, children, and prisoners will be excluded.
A Phase 2, Double-Blind, Placebo-Controlled Trial of Mycophenolate Mofetil alone or with Voclosporin for Systemic Lupus: Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment
Treatment of Systemic Lupus with mycophenolate mofetil alone or with voclosporin
There will be 16 visit over a years time, physical exam, blood work, ECG, questionnaires
Systemic Lupus
Nurse Situation Awareness in ICUs
This is an interview and survey study that will examine how the design of ICU warning information system influence nurses situation awareness.
This study aims to understand how the design factors of warning information system influence nurse situation awareness in ICUs. You will participate an online interview study and fill out two questionnaires. The study takes 1-2 hours.
$30
ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED)
Upper tract urothelial cancer (UTUC) is a recurrent disease. The current standard treatment for most UTUC patients requires surgery either removing some of the ureter in each operation or radical nephroureterectomy (RNU-removal of kidney and ureter) but the role of minimally invasive & kidney- preserving methods is increasing. The use of TOOKAD (padeliporfin) was investigated in a Phase 1 clinical study in the minimally-invasive treatment of UTUC with the goal of identifying safe laser/light exposure and signs that the tumor has been reduced or eliminated. Early results from this study have been highly promising, revealing the effects of tumor removal with a positive safety profile, indicating the potential role of TOOKAD (padeliporfin) in the treatment of low-grade UTUC disease.This Phase 3 study is designed to provide confirmation of the observed Phase 1 findings. Patients are expected to remain in the study for 25 to 28 months. Participation in this study will include up to 9 study visits to Hershey Medical Center and 2 phone visits.
Biopsy-proven disease. A concurrence of the central pathology reader will be required for eligibility.
Up to 2 biopsy-proven sites of low-grade involvement. Please contact site for tumor dimension criteria.
Karnofsky Performance Status ≥ 50%
Adequate organ function defined by baseline Lab testing
Carcinoma in situ (CIS) current or previous in the upper urinary tract
History of invasive T2 or higher urothelial cancer in past 2 years
Participation in another clinical study involving an investigational product within 1 month before study entry
BCG or local chemotherapy treatment in the upper urinary tract within 2 months prior to inclusion
Eye-tracking of Aging and Language
We are interested in how adults understand language, and how this changes across the lifespan. Participants will complete paper and pencil tasks, computer-based tasks, and we will monitor how they move their eyes.
Right Handed
Monolingual
Minimum High School Education or GED
Normal or corrected to normal vision (20/20, not color blind)
Left Handed
<18 years old
speaking more than 1 language
less than 12 years education and no GED
Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)
Polycystic ovary syndrome (PCOS) is the most common endocrine abnormality in women in the U.S. and is characterized by both reproductive (anovulation and androgen excess) and metabolic dysfunction (insulin resistance). PCOS lacks a simple, safe and effective treatment for women of all ages and all weights. Recentlya dietary supplement, inositol, has been used widely to treat women with PCOS. However there are no well designed trials to address the risk/benefit ratio and identify the mechanism of action. In this study we propose a 3 month double blind (of both patients and investigators) randomized controlled trial of inositol supplementation compared to placebo. We hypothesis that women with PCOS who receive inositol supplementation will have a significantly greater reduction in serum total testosterone than women on placebo as well has improvement in glucose tolerance and decrease in fasting insulin.
There will be 4 in person visitsHave a physical exam and other evaluations, including ultrasoundTake study drug as directedHave bloodwork taken throughout studyComplete questionnaires and a daily diary
$300
Diagonosed with Polycystic Ovary Sydrome
8 or less periods per year
Periods of greater than or equal to 45 days
Not seeking pregnancy
Uncorrected thyroid disease
Suspected adrenal or ovarian tumor screting androgens
Suspected Cushing's syndrome
Contraindications to the study drug or placebo
Phase III Study of Daratumumab/RHuPH20 + Lenalidomide or Lenalidomide in Patients with Multiple Myeloma Using MRD to Direct Therapy Duration (PSCI# 19-079) (S1803)
This study is being done to answer the following questions: 1.Will adding the drug daratumumab/rHuPH20 to the usual maintenance treatment with lenalidomide after stem cell transplant help multiple myeloma patients survive longer?2.For patients who have no evidence of multiple myeloma in their bone marrow (patients who do not have “minimum residual disease” [MRD-negative]), should maintenance therapy be stopped after 2 years? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your multiple myeloma. The usual approach is defined as care most people get for multiple myeloma.
Phase III Study of Daratumumab/rHuPH20 (NSC-810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration
Patients with disease measurable by serum light chain assay alone are eligible (defined as ≥ 100 mg/L on involved light chain).
Patients must be ≥ 18 and ≤ 75 years of age at time of registration to Step 1.
Patients must have history and physical exam within 28 days prior to registration.
Patients must have Zubrod Performance Status ≤ 2.
Patients must not have any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction.
Patients must not have progressive disease at any time prior to registration.
Patients must not be refractory or intolerant to either lenalidomide or daratumumab/rHuPH20.
Patients must not have moderate or severe persistent asthma within the past 2 years and must not have currently uncontrolled asthma of any classification.
Can Twitter be the platform that leads to the rise of ’Crisis Reporters’?
Citizen journalism refers to production of journalistic content by ordinary citizens such as ‘current affairs-based blogging, photo and video sharing, and posting eyewitness commentary on current events’. In our study we try to redefine ‘citizen journalism’ to ‘crisis reporting’ that includes sharing updates and actionable news using Twitter. To this end we wish to propose a study where we interview people to understand the feasibility of the same. In addition, as supporting data, we would use historical data from Twitter. This would be done keeping in mind a particular event which would be the Texas snowstorm.
Present in Texas during the snowstorm
Have an active Twitter account
Not present in Texas during the snowstorm
Do not have an active Twitter account
Randomized Phase III Trial Incorporating Abiraterone Acetate with Prednisone and Apalutamide (NRG-GU008) (PSCI# 20-087)
The purpose of this study is to compare the use of hormone therapy and radiation therapy (usual treatment) to the use of apalutamide and abiraterone acetate with prednisone plus the usual treatment. The addition of apalutamide and abiraterone acetate with prednisone to the usual treatment could stabilize your cancer and prevent it from spreading. 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, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the time without prostate cancer spreading compared to the usual approach. The study drugs, apalutamide and abiraterone acetate with prednisone, are already approved by the FDA for use in prostate cancer. But, most of the time abiraterone acetate with prednisone is not used until hormone drugs stop working and apalutamide is not used until hormone drugs stop working and after prostate cancer has spread. There will be about 586 people taking part in this study.
The purpose of this study is to compare the use of hormone therapy and radiation therapy (usual treatment) to the use of apalutamide and abiraterone acetate with prednisone plus the usual treatment. The addition of apalutamide and abiraterone acetate with prednisone to the usual treatment could stabilize your cancer and prevent it from spreading. 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, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the time without prostate cancer spreading compared to the usual approach.The study drugs, apalutamide and abiraterone acetate with prednisone, are already approved by the FDA for use in prostate cancer. But, most of the time abiraterone acetate with prednisone is not used until hormone drugs stop working and apalutamide is not used until hormone drugs stop working and after prostate cancer has spread. There will be about 586 people taking part in this study.
History/physical examination within 90 days prior to registration
ECOG Performance Status of 0-1 within 90 days prior to registration
Any T-stage is eligible (AJCC 8th ed)
Adequate hepatic function within 90 days prior to registration
Seizure or known condition that may pre-dispose to seizure
Severe or unstable angina, myocardial infarction, arterial or venous thromboembolic events within 6 months prior to registration
Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily
Patients with inflammatory bowel disease.