All Clinical Trials

Normally, white blood cells are produced in a controlled way by the bone marrow. In someone with AML or ALL, this production process is abnormal and immature cells are produced and sent into the blood stream. In this immature state, the cells affect the production of other normal cells and these cannot perform their usual functions. Therefore patients with AML or ALL are vulnerable to infection, anemia, and bleeding.

The purpose of this study is to understand what causes the white blood cells to grow abnormally, and to determine if there are novel agents that can be used to stop this abnormal growth. In this research project, a sample of blood and bone marrow will be studied in the laboratory to learn more about the nature of the disease, and to understand what causes the defect in the growth of these cells.

The purpose of this research study is to better understand posture control in able-bodied individuals and in individuals who have had a stroke. Participants will be asked to sit in a chair and maintain various muscle contractions while a motor moves their arm.

Share your health data and a little blood to help with studies on all kinds of diseases— cancer, diabetes, heart disease. A ready pool of samples and treatment histories speeds up research. It’s simple to help. And your info is so important to the search for new ways to prevent and treat illnesses.

Want to make an impact in just 20 minutes? Give some blood, answer some questions, and share your health records with your study team’s database. Researchers use it to find disease patterns and search for new ways to prevent and treat illnesses.

Recruiting Research Participants for a New Study on the “Genetics of Prostate Cancer”

At the time of conception, fertilization of the egg by the sperm brings together the genetic material (DNA) from both parents, half from the mother and half from the father, producing the embryo. In the very early stages of embryonic development, the embryo is made up of cells that have the potential to develop into all types of cells, like skin, muscle, liver, brain, pancreas, breast, ovary, fallopian tube, or prostate cells. Because of this ability, these cells are called “pluripotent” embryonic stem cells (ESCs). However, about a week after fertilization, the embryonic cells lose their ability to develop into all of the different cells and tissues of the body and gradually “differentiate” into the various tissues and organs that have different specific functions. So, there is a relatively narrow window during which pluripotent ESCs exist in the embryo.

At the end of the in vitro fertilization (IVF) process for couples undergoing subfertility treatment, the doctors are usually left with one-week-old embryos. In 1998, using such embryos for research, scientists figured out how to grow pluripotent ESCs in the lab that can stay in their pluripotent state if the right growth conditions are present. Changing the growth conditions in certain ways, scientists learned how to stimulate the ESCs to go through a process called “differentiation,” in which the stem cells can develop into any of the different cell types present in the body. ESCs were used in the early animal cloning experiments that produced the cloned ewe named “Dolly;” however, cloning human cells is illegal. While ESCs offer promising and exciting opportunities, like the possibility of growing organs in the lab, because their production involves technical and ethical problems, efforts were directed to produce pluripotent stem cells from mature cells to avoid the use of embryos.

In 2007, Japanese researchers found an amazing way (for which they received a Nobel Prize) to transform mature cells, like regular skin or blood cells, directly into stem cells without using human eggs. They found a combination of proteins that, if injected into mature cells, gradually reprogrammed them into induced pluripotent stem cells, abbreviated iPSCs.

Research Project

Drs. Dan Theodorescu and Clive Svendsen, the Principal Investigators at the Cedars-Sinai Medical Center in Los Angeles, California in collaboration with Dr. William Catalona, the Principal Investigator at Northwestern University are engaged in research using iPSCs to develop a model of human prostate cancer using iPSCs from men who carry BRCA2 mutations that are related to a higher risk for developing aggressive prostate cancer (the Cedars-Sinai team has already accomplished this for ovarian cancer in women who carry BRCA1 mutations). As study controls, they will also enroll men with non-BRCA2-related prostate cancer and those without prostate cancer. They will not use embryos.

In the laboratory, the researchers will take the white blood cells from a blood sample back in time to when they were capable of making any cell type in the body and differentiate them forward into prostate cells carrying (or for non-BRCA2-mutation carriers, not carrying) the BRCA2 mutation in a petri dish. Using these transformed prostate cells, they will use current genetic engineering and molecular biology research methods to study the mechanisms of the transformation of normal prostate cells into aggressive prostate cancer cells. This model also can be used in cell-signaling studies and drug screening studies for designing future therapies. The bank of prostate iPSCs that they will create may be shared with research institutions around the world.

These researchers are now recruiting men and their male family members who carry a BRCA2 mutation and other prostate cancer patients and controls without prostate cancer to participate in this study. This research is being performed to discover the causes of prostate cancer and how it is passed down in families using the BRCA2 mutation as a model system and also can be applied to non-BRCA2-related cancers.

This study is called “The genetics of prostate cancer” and is approved by the Institutional Review Boards at Northwestern University (STU00018651) and Cedars Sinai, whose function is to protect the rights of research subjects and to oversee ethical issues. Participation in this study will involve having up to 50 ml of your blood drawn (10 teaspoons), and completing family history questionnaires (baseline and follow-ups) and clinical follow-up questionnaires, if applicable. The time involved includes the time required to read the 10-page consent form, and the time required to travel to Northwestern Memorial Hospital, Galter Pavilion, 675 North St. Clair Street, Chicago, IL 60611 for the research blood draw.If it is not convenient for you to come to our clinic you may be able to get blood drawn at a clinic of your choice and we will arrange to have it shipped to Cedars-Sinai in Los Angeles, California. It will take about 20 to 40 minutes to complete the questionnaire. In the case that your family history suggests familial prostate cancer, Dr. Catalona may want your family members to participate in the study as well. You may be asked to contact your relative(s) about the study. We will follow up with a family history follow-up questionnaire annually, which takes 15 to 30 minutes to finish, to update the file. If you develop prostate cancer, we will want you to fill out a clinical follow-up questionnaire about prostate cancer and follow you up with the questionnaire annually as well, which takes 10 minutes to finish.

In addition, we may request up one or more additional blood samples of 10 to 20 ml (2-4 teaspoons) from you at a later date, depending on the evolving needs of the study. You may refuse to provide these follow-up blood samples without affecting your participation in this study. The blood sample(s) will be saved for future analysis. Efforts will be made to limit the use and disclosure of your personal information, including research studies and medical records, to people who have a need to review this information. We cannot promise complete secrecy. Organizations that may inspect and copy your information include the IRB and other representatives of this institution.

Research results will not be available to you or your physician except under extraordinary circumstances. These are situations in which a life-threatening medical disorder is discovered for which medical treatment is available to prevent or alleviate long-term medical complications. If such a situation should occur, we will contact you via phone, email or mail.

Those interested in participating may contact Dr. Catalona at 312 695-4471 or william.catalona@nm.org.

Further background information on stem cells is available from the author who created the background information for this article: Meshorer E (2020) What Are Embryonic Stem Cells and How Can They Help Us?. Front. Young Minds. 8:32. doi: 10.3389/frym.2020.00032. Copyright © 2020 Meshorer

The main purpose of this project is to collect samples for research. The samples will be stored at the Pathology Core Facility (PCF) of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School (NUMS). PCF serves as the centralized resource that addresses the sample collection needs for the research community. The samples collected can be used by researchers at Northwestern University and third party commercial and non-profit institutions who have approval from their Institutional Review Board (a committee which is responsible for the ethical oversight of the study) for their projects.

You will be asked to donate a sample of blood. In addition, any extra tissue or fluid from what has been collected from you for your routine care will be used. Examples of samples include but are not limited to tissue, blood, urine, and bone marrow.

The observational primary progressive aphasia (PPA) research program at Northwestern University seeks to study individuals living with PPA over time using neuropsychological testing and advanced imaging techniques. Participants are asked to come to Chicago in order to help:

The purpose of the Northwestern University Alzheimer’s Disease Research Center (NUADRC) study is to support clinical and basic research on memory and aging by collecting, storing, and disseminating clinical data. These data and samples include memory and thinking tests, brain imaging scans, blood samples, and brain donations. We collect these data and samples from study participants who are experiencing healthy aging and those who suffer from dementia or Mild Cognitive Impairment. This study is a longitudinal, observational trial meaning that research participants will be observed over time, and data will be collected, but there is no attempt to alter the symptoms or course of disease (an intervention). Participants attend annual visits that typically last one to three hours. If participants can no longer attend in-person visits, we will continue to follow them through telephone visits with a designated study partner.

This study is a multi-site study meaning Northwestern University is one of 33 sites in the United States. Research data is shared with a national database. There are currently over 15,000 participants in this study nationally with approximately 500 of them enrolled at Northwestern University. Once they enroll, most participants are referred to other research studies being led by investigators within the Mesulam Center or the greater Northwestern University scientific community.

The purpose of this research study is to help advance the scientific understanding of breast cancer. A portion of breast or skin tissue and a sample of blood, along with clinical information, will be collected and stored in a database for research purposes only.

Only tissue or fluid in excess of that required for clinical diagnosis and/or staging will be collected. Specific clinical data will include: treatment for cancer (surgical procedures, chemo or hormone therapy, radiation), cancer outcome (recurrence, metastases, death due to disease, and death without disease, alive, alive with disease).

Our project examines pragmatic (social) language skills in families. We enroll both children (ages 12- adult) and their parents. Eligible participants include autistic individuals and their parents, individuals with fragile X syndrome and their mothers, and families who do not have these conditions. Participation includes completing different types of activities, including conversational activities, saying and listening to different sounds, puzzles, and answering questions about yourself. Participation in our research is flexible, as we have several options to choose from depending on the amount of time you would like to spend. There is n virtual only option (~1-2 hours), as well as an additional opportunity to come to our laboratory in Evanston for additional activities (~3-4 hours).

Participants agree to allow the collection of information from the medical record for research purposes and agree to allow us to contact them about future studies. Participants may also complete questionnaires during their standard of care visits, participate in an optional frailty study by taking a brief physical ability test at the time of standard of care visits, give optional blood for research, and optionally allow us to contact them about their health on an annual basis.

In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells in the laboratory. The purpose of this study is to understand how these new drugs stop leukemia cells from growing. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future.

The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it was developed to replace older paper methods for collecting and storing information.

The purpose of this study is to allow researchers involved with the NBTIDB to use data stored in it for future research studies and projects. The NBTIDB also allows researchers to track whether or not patients have agreed to allow their information to be linked to their leftover tissue samples, which are kept in the hospital’s pathology department, for future research studies.

Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a problem, and can be as high as 80% in some types of AML patients. Therefore, it would be beneficial to identify specific treatment approaches for patients at a high risk for relapse. One characteristic associated with high relapse rates is an increase in proteins that are referred to as Hox proteins in the leukemia cells. Increase in Hox proteins prevents production of some other proteins, including a protein referred to as Triad1. An increase in Triad1 protein in bone marrow cells may be important to control the growth of such cells. Decreased Triad1 in leukemia cells may therefore promote their growth, but this has not been previously studied.

The purpose of this study is to investigate if the lack of Triad1 in leukemia cells contributes to resistance of some leukemias to chemotherapy drugs. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future.

At a time when you are having a bone marrow biopsy and aspirate performed as part of your standard medical care, about an additional 2.5 teaspoons (12.5 mL) of bone marrow will be collected for this research study.

Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be about how genes affect the development of cancer, response or resistance to treatment as well as prognosis (course of disease and overall outcome including survival). Other studies may aim to identify measurable substances in the blood and/or urine (known as biomarkers) that can indicate early development of cancer, worsening or relapse of disease and response to treatment. Some studies may lead to new products, such as drugs or tests for detection of cancer.

The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct studies to learn more about the subtypes of head and neck cancers and determine the most effective treatments. The registry will also allow us to identify possible subjects for future studies.

The aim this study is to collaboratively advance knowledge about epidermolysis bullosa (EB) by collecting clinical data from patients with EB from multiple EB centers in the United States and Canada. As EB is a rare disease, coordination and collaboration between multiple centers will help our understanding of disease manifestations, course, and complications, with the aim of improving future care, expanding clinical and translational research, and finding an eventual cure for individuals with EB.

2GETHER is a relationship education program and study designed to help male couples navigate the complexities of being in same-gender loving and gay relationships. 2GETHER provides participants with relationship tools to help them in the years to come.

2GETHER participants will be asked to complete one of two different relationship programs, both of which focus on couples-specific skills and gay relationship coaching.

Each relationship program involves:

2 group sessions with other male couples.

2 individual couples sessions with a trained 2GETHER facilitator

Participant couples will then be tracked for the following year and will receive surveys at 3, 6, 9, and 12 months. As an incentive for participating in the clinical trial of the relationship program, each member of the couple has the potential to make up to $250.

This study is being done to help improve the knowledge on the biology of breast cancer in the future. Blood specimens from patients with breast cancer will be collected and utilized for future research projects known as biomarker studies. These blood based laboratory tests will ultimately evaluate molecules present in the blood of patients with breast cancer. These molecules could be, for example, a protein, tumor DNA, or tumor cells circulating in the blood. As research technology advances, blood samples from patients with breast cancer may help in understanding the course of disease and to check as to how effective a treatment is.

The purpose of the study is to gather information about your cancer and the treatment you receive as a part of your routine clinical care. In this study, we are developing a research registry, which is a bank of information about many patients.

We are interested in learning about the relationship between your cancer and the different types of tests available to identify the best treatment option for you. That is, we are interested in the tests that identify possible ‘mutations’ (e.g., changes) or ‘drivers’ within your tumor, what treatments you receive after getting these tests, and how your cancer responds to the treatments.

The tests known as next generation sequencing or “NGS” are usually done on your cancer tissue or blood samples as a part of your routine clinical care. Your doctor can use the information to identify the best treatment option for you after discussing it with other doctors. These routine tests will be performed whether you participate in this study or not, but we want to collect the information about this process for this study.

If you participate in this study, extra samples of your blood will be collected and stored, and your health information from your medical record and NGS lab results will be collected and stored.

Participation involves:

• monthly 30min checkups,
• expert evaluation, mood assessments, and blood draws,
• validation of on-site parking, and
• to compensate for your time and effort, $25 for each completed checkup.

Este estudio tiene el fin de entender como ciertos cambios fisiológicos durante el embarazo y postparto afectan el metabolismo de medicamentos como lamotrigine (Lamictal), lithium (Lithium Carbonate), risperidone (Risperdal), aripiprazole (Abilify), lurasidone (Latuda), y olanzapine (Zyprexa). Cambios en el nivel del medicamento en sangre tienen el potencial de inducir un nivel terapeutico del medicamento menor al estándar lo cual puede llevar a un incremento en cambios de ánimo o recurrencia de episodios anímicos.

El estudio incluye:

• consultas mensuales de 30min,
• la evaluación de un experto, cuestionarios del estado de ánimo, y muestras de sangre,
• pago por el parqueo en el hospital, y
• para compensar su tiempo y esfuerzo, por cada visita completada usted recibirá $25.

1 year, 2 visits.

This research study involves the use of Magnetic Resonance Imaging (MRI) to study the effects

of COVID-19 on the heart. Since COVID-19 is a new disease, we do not yet understand the

different ways that it may effect the body. There is some evidence that individuals with COVID-

19 are at higher risk for heart complications. The purpose of this study is to use recently

developed MRI techniques to compare heart health of individuals with COVID-19 to people who

were asymptomatic or are healthy. The new MRI techniques used in this experiment may also allow researchers and health care providers to take clearer pictures of the heart in other

individuals.

WHATARE THE BENEFITS OF JOINING?

· · ·

WHATWOULD I NEED TO DO?

· · · Visit an All of Us Participant Center for physical measurements (bloodpressure, height, weight, waist/hip, & heart rate) and biosamples (blood& urine)

Participants receive a $25 payment for completing all researchcomponents.You will also receive a voucher for free parking.

Since 2005, a group of scientists and clinicians from around the world have identified and are studying hundreds of persons with MacTel Type 2. Progress has been made to find ways to help prevent the condition from developing and to find potential treatment(s) but more work is needed. Special scientists (geneticists) are working to understand if this disorder is inherited (passed down from your parents) and basic scientists are working to understand what happens to the eye tissue inside a MacTel eye.

The purpose of this study is to identify persons with MacTel Type 2, and their affected family members to create a Registry of persons with MacTel Type 2. This Registry will be used to study participants with MacTel Type 2 now and may be used in the future to identify persons to be in a study that may help find a way to prevent or treat this eye condition. We also wish to keep in contact with persons who have told by their MacTel doctor that they have MacTel Type 2.

In this document, the word “affected” means that it has been confirmed that you have MacTel Type 2. These persons may also be referred to as “Probands” when they are the first person in the family to be diagnosed with the disorder.

“Unaffected” means that at this time, there is no evidence of MacTel Type 2.

The purpose of this study is to collect information to help us understand how doctors treat and manage people with severe asthma and how the health of people with severe asthma changes with those treatments.

At least 75 doctors in the United States will provide information on their patients for the study. There will be at least 1500 patients in this study. The length of each patient's participation will vary but the goal is to have patients involved for 3 or more years.

If you decide to participate in the study, the study team will:

1. Ask you to sign a consent form that you are agreeing to participate in the study

2. Review your health history and collect a small amount of blood to check your general health

3. Perform a physical exam and measure your leg

4. Perform imaging to assess your blood flow in your leg

5. Ask you to complete questionnaires

6. Ask you to come in for follow-up visits at 2 months, 4 months, 6 months, 12 months, 18 months and 24 months.

Treatment assignment:

1. If you are randomly assigned to the low-risk stent procedure, you will return about 1 week after you consent to participate in the study to have the procedure

If you participate in the study, you will receive $100.00 after completion of each follow-up visit. Enrolled participants will also receive compression stockings at enrollment and every six months during their participation.

Volunteers are needed for a study on the microbiome of subjects with and without vitiligo. For patients with vitiligo and without vitiligo, the study will include an initial visit, at which time samples of the skin and swab samples of stool will be collected. All subjects will be asked to complete questionnaires about their skin care regimen and dietary habits.

Join the LEADS Study Waitlist

The Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a non-randomized, natural history, non-treatment study designed to look at disease progression in individuals with early onset Alzheimer's disease (EOAD). Clinical/cognitive, imaging, biomarker, and genetic characteristics will be assessed across two cohorts: (1) individuals with EOAD and (2) cognitively normal (CN) control participants.

The primary objectives of the LEADS study are to: collect longitudinal assessments and biomarker data; to compare baseline and longitudinal cognitive and functional characteristics between cognitively impaired and cognitively normal individuals, and EOAD and Late Onset Alzheimer's Disease (LOAD) individuals from the Alzheimer's Disease Neuroimaging Initiative (ADNI); and to study the associations of longitudinal clinical and cognitive assessments with multimodal imaging and biofluid markers that capture different elements of the AD pathophysiological cascade.

Patients who participate in this study will:

• donate fluid collected from their lungs during a bronchoscopy (taken at the time they are already scheduled to have a bronchoscopy or during their scheduled endoscopy)
• give a blood sample
• give esophageal biopsies (taken during their scheduled endoscopy)
• as an option, give skin biopsies

We would like to reach about 250 – 500 people. Our eligibility criteria: (1) 18 – 29 years old, (2) HIV-negative, (3) male assigned at birth & currently identify as male, (4) live in one of 22 counties (please see counties below) in the USA.

state

county

AZ

Maricopa County

TX

Dallas County

TX

Bexar County

TX

Travis County

MI

Wayne County

PA

Allegheny County

MA

Suffolk County

CA

San Bernardino County

NJ

Essex County

NY

Nassau County

AL

Jefferson County

VA

Arlington County

WA

Snohomish County

CA

Fresno County

TN

Shelby County

CT

Hartford County

MO

Jackson County

OH

Hamilton County

WA

Pierce County

MO

St. Louis city

DE

New Castle County

FL

Lee County

The purpose of this study is to test flexible body-worn sensors and video technology to provide high-resolution measures of motor development in infants, starting from a very young age and continuing up to 2 years of age.

This study will enroll up to 200 infants: 100 infants expected to have typical motor development and 100 infants at risk of atypical motor development (based on clinician diagnosis or risk factors such as prematurity, neonatal hypoxic ischemic encephalopathy, neonatal stroke, etc.).

During each study visit, sensors will be placed on the legs, arms, chest, and head using soft bandage wraps or a gentle adhesive. The sensors will record the child’s movements in various postures and tasks. Their movements will also be recorded on video.

These measurements will be completed at the approximate ages of 1-2 weeks, 1 months, 3 months, 6 months, 9 months, 1 year, and 2 years old. Each study visit will take about 1-2 hours.

Compensation will be provided.

If ever it’s too difficult to travel to one of these locations, another option is that we can come to you, and do a study visit at your home.

The CONQUER Registry will enable researchers to:

This study aims to capture a better image of the heart using MR imaging. This enables comprehensive evaluation of the heart, including cardiac function, perfusion, edema, and scar/fibrosis.

The purpose of this study is to learn about the factors that most influence participants in their ability to perform specific daily activities with varying intensity, while also measuring calorie expenditure. Using self-report questionnaires, we will collect a participant's medical history and determine their perceived ability to perform certain activities. We will also use data collected from wearable sensors to build a more accurate energy expenditure estimator. Participants are asked to put on two wearable devices as well as a mask to measure breathing and perform 12 specific physical activities in the lab. The in-lab session lasts 3 hours. Lastly, participants will be asked their opinion about the wearability of the devices.

The purpose of this research is to observe patients with skin conditions in a ‘real world’ setting and to create an patient registry of skin conditions, to better understand these diseases and how they are treated. A patient registry is a collection of information about a group of patients who share a condition or experience.

Additionally, researchers are interested in:

• Observing how skin condition treatments work and understand side effects caused by these medicines and how these are managed
• Identifying other types of conditions associated with skin disorders
• Collecting patient reported outcomes to better understand the patient perspective and feelings patients have about having a skin condition
• Assessing the impact of Patient Support Programs for individuals with skin conditions and how these programs affect skin condition outcomes
• Creating a “Biorepository Specimen Bank” with blood and saliva samples

The purpose of this study is to test your tumor tissue for certain biomarker (which may be the cause of your cancers, such as specific mutations in certain proteins). This will help determine your eligibility to participate in either matched sub-studies involving investigational agents that targets the specific mutated protein or alternatively to un-matched sub-studies.

A study is available for persons with aphasia

The Shirley Ryan AbilityLab is conducting a research study that will help us understand how to better schedule speech and language therapy.

If you should qualify, you will receive 10 hours of speech and language therapy.

Therapy will be scheduled for either:

a)two weeks (1 hour a day, 5 days a week)

or

b)five weeks (1 hour a day, 2 days a week)

Thepurpose of this study is to test the good and bad effects of the combination ofdrugs called inotuzumab ozogamicin and blinatumomab. The study doctors hope tolearn if the combination of study drugs will cause cancer to go away andprevent leukemia from coming back.

Inotuzumabozogamicin and blinatumomab have already been approved by the FDA to treatrelapsed or refractory ALL as well as other cancers. The combination ofinotuzumab ozogamicin and blinatumomab is considered investigational for thisstudy.

Participantswith ‘untreated ALL’ or ‘relapsed or refractory ALL’, will get a combination ofdrugs called inotuzumab ozogamicin and blinatumomab. This combination of drugsis known to be effective in patients with relapsed or refractory leukemia, butit is not the usual chemotherapy for patients with ‘untreated ALL.’Participants will also get a drug called methotrexate to prevent cancer cellsfrom entering the central nervous system.

Non-Alcoholic Steatohepatitis (NASH) is a liver disease that isassociated with an increased amount of fat and inflammation in the liver. Having NASH increases the chances of gettingheart disease. In time, liver cells may be so badly damaged that scar tissueforms (fibrosis) within the liver where healthy cells used to be. When this happens, your doctor might diagnoseyou with “NASH fibrosis”. When enoughscarring happens and the liver gets even more diseased, the liver becomescirrhotic and stops working which causes serious complications in your body. NASHfibrosis can only be accurately diagnosed by taking a sample of tissue called a“biopsy” directly from the liver. There are currently no approved medicines forNASH.

MadrigalPharmaceuticals, Inc. (the Sponsor of the study) is running this medical researchstudy to see if a test medicine named MGL-3196 (resmetirom), will help in thetreatment of NASH fibrosis and also to find out how safe it is to use in peoplewith NASH. MGL-3196 is an ‘investigational’ drug, i.e., it is not approved foruse by the U.S. Food and Drug Administration (FDA) MGL-3196 was previouslytested in a 9-month study in patients with NASH and was found to be safe andwell-tolerated, caused a decrease in the amount of fat in the liver, and causeda decrease in NASH compared with placebo patients (placebo patients arepatients that did not receive MGL-3196 (“active drug”) in the 9-month study).

In the study, there will be many patients, like you, with hepatocellular carcinoma (HCC) who are eligible to receive a treatment called Y90 radioembolization and who may also be liver resection candidates.

Y90 radioembolization is a non-invasive, out-patient treatment that uses radioactive beads (microspheres), which are tiny glass particles that are loaded with radiation. The beads are injected into an artery of the liver that supplies blood to the tumor(s). The beads flow to the tumor(s) and become trapped inside. The beads release the Y90 radiation inside the tumor(s).

Liver resection is used to remove the part of the liver that has the liver tumor(s). It has been shown that Y90 radioembolization can increase the untreated liver’s size and volume. Patients with HCC may be liver resection candidates if they have a large enough liver.

The purpose of this research is to determine if there is an ideal Y90 dose to increase liver volume. This research may help determine the best Y90 dose for future patients who need a larger liver to have a liver resection.

If you participate in this study, you will have standard-of-care Y90 radioembolization as well as study-specific imaging and two optional liver biopsies. You will participate in the study for up to 3 months. Your health status will continue to be followed for up to 5 years.

Patients enrolled in the study will receive up to $195.00 for their participation.

This is one of the largest non-interventional observational study of patients with ALS and other motor neuron disorders. It is both prospective and retrospective. It does not require blood sampling.

The purpose of this study is to compare the treatment of carboplatin/paclitaxel and letrozole hormonal therapy to letrozole alone. The use of the hormonal therapy drug letrozole without chemotherapy may shrink or stabilize cancer in the same way that chemotherapy also does, but without the added side effects of chemotherapy. Letrozole is a drug called an aromatase inhibitor, which indirectly stops the body from producing estrogen.

This study will investigate if this approach is better, the same, or worse than the usual approach. In order to determine if the use of letrozole alone helps to improve treatment for patients with low-grade serous ovarian or peritoneal cancer compared to combined chemotherapy and letrozole, half of patients in this study will receive letrozole with paclitaxel/carboplatin and the other half will receive letrozole alone. The study doctors will be looking to see if the letrozole alone prolongs the time cancer is in remission, or the duration of time participants are alive after treatment.

Letrozole is approved by the FDA for breast cancer, but is not FDA approved for ovarian cancer and is therefore considered experimental in this setting.

Participants will get either the combination of paclitaxel and carboplatin for four and a half months followed by letrozole or letrozole alone. Patients who are assigned to letrozole monotherapy will continue taking the letrozole for as long as they are tolerating the drug (i.e., have not developed any allergies or severe side effects with the medication) and have not experienced a recurrence or progression of their disease.

After participants finish their study treatment, their doctor and study team will continue to follow their condition and watch for side effects during clinic visits or by phone. Participants will be checked every 3 months for the first 3 years after treatment. After that, this will happen every 6 months for two years.

Patients age 6-17 years old with moderate to severe plaque psoriasis with at least one of: facial/scalp, genital, palm/sole, axillary involvement, candidate for systemic treatment or photo therapy or photochemotherapy.

The purpose of this study is to test good and bad effects of different drugs against metastatic brain tumors with altered genes. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients such as you. Researchers have looked at the DNA material (genes) that can be affected in brain metastases and have found several genes that are altered, or mutated. There are medications that target these genes.

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your metastatic cancer. The usual approach is defined as care most people get for your metastatic cancer.

Heart failure (HF) and chronic kidney disease (CKD) commonly coexist and increase risks of hospitalizations and mortality. Insights into mechanisms of concurrent HF and CKD are urgently needed to improve outcomes.

Critical barriers to therapeutic breakthroughs for patients with CKD and HF include lack of in-depth understanding of early changes in cardiac function and poor knowledge of CKD-specific mechanisms for both HF and heart failure with preserved ejection fraction (HFpEF).

Participate in a paid research study at Northwestern University Feinberg School of Medicine! We are actively recruiting for study on mood and phone use. Teens age 13-18 who use iPhones or Androids may be eligible. Teens may earn up to $519. Parents will also be compensated $25 for their time.

The study will consist of four total sessions – three virtual and one in person. The initial video call and in-person visit will take about 4 hours each. The remaining two video calls will take place approximately 6 and 12 months after the start of the study and will take about 2 hours each. Participation will also involve the use of a study-specific smartphone app throughout the 12-month study period.

Interested teens/parents can email us directly at NUCU@northwestern.edu or complete the contact form at https://sites.northwestern.edu/nearlab/participate/.

IRB Study Code: STU00211494 /Principal Investigator: Stewart Shankman, Ph.D.

For this study a cardiac magnetic resonance imaging (MRI) stress test (also known as stress CMR) will be done to look at the RV in patients with CTEPH before and 6 months after treatment. A stress CMR is a specialized scan of the heart that examines fibrosis (scarring) and blood flow (perfusion) both at rest and under stress. A gadolinium contrast agent (MRI dye) is given to highlight the heart muscle in areas receiving a good blood supply. Areas receiving less blood do not highlight as well as the good areas, which can be an indicator of ischemic heart disease (undersupply of blood and oxygen to the heart).

Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office based procedure in under 15 minutes. The precision of biopsy has improved over the last decade with the introduction of MRI guidance/targeting of suspicious lesions within the prostate.

However, significant limitations remain with this approach, including a significantly increasing risk of post-biopsy infection. This arises because more than 97% of all prostate biopsy are performed via a transrectal approach that introduces rectal bacteria with each pass of the biopsy needle into the sterile urinary tract. The current risk of post-transrectal biopsy infection, even with antimicrobial prophylaxis, is high at approximately 7% overall with 3% (30,000 men) requiring hospitalization annually.

Transperineal biopsy is an alternate approach that eliminates the direct introduction of bacteria from the rectum to the prostate. This approach, which is perfomed without antimicrobial prophylaxis, instead passes the biopsy needle through the perineal skin and pelvic floor.

Transperineal biopsy has not been widely adopted for several reasons. Historically, it has been considered too painful for patients in the clinic and thus was traditionally performed under general anesthesia. The added time, inconvenience and cost has limited its national adoptance. Second, when transrectal biopsy was initially adopted over 40 years ago, antibiotic resistance of rectal flora was not a challenge.

Beyond the potential for in-office transperineal biopsy to significantly reduce or eliminate biopsy infections, transperineal biopsy may also improve cancer detection: studies of transperineal biopsy (performed under general anesthesia) demonstrate higher detection rates for prostate cancer, particularly for anterior zone tumors, compared to transrectal biopsy. This is notable, as anterior tumors are difficult to sample with transrectal. Anterior tumors are also twice as likely to occur in African American men. In fact, our research demonstrates that some of the outcomes disparities in African American men may stem from an underdiagnosis of anterior prostate cancers.

Although transrectal biopsy is used widely, it is associated with a significant and increasing risk of biopsy infections due to growing antibiotic resistance, highlighting the urgent need for a safer alternative approach to prostate biopsy. The study investigators have refined a transperineal approach under local anesthesia with MRI-targeting/guidance without the need for antibiotic prophylaxis. The investigators hypothesize that transperineal MRI targeted biopsy will: (1) largely eliminate post-biopsy infections and costly hospitalizations for urosepsis; (2) be performed in the office with similar discomfort and non-infectious complications compared to transrectal MRI targeted biopsy; and (3) have significantly better detection of prostate cancer.

This multi-center randomized controlled trial will be conducted to evaluate in-office transperineal MRI targeted vs. transrectal MRI targeted biopsy, the current gold standard. This has transformative impact to change current standard of practice.

Join the ALLFTD Study Waitlist

ALLFTD (ARTFL-LEFFTDS Longitudinal Frontotemporal Lobar Degeneration) Study is a comprehensive study targeting most varieties of frontotemporal lobar degeneration (FTLD). FTLD is a neurological disease that causes Frontotemporal Dementia (FTD) syndromes including Primary Progressive Aphasia (PPA) and Behavioral Variant Frontotemporal Dementia (bvFTD), among others.

Participating in the longitudinal arm of ALLFTD involves annual visits to an ALLFTD clinical site.

Annual visits usually span 2-3 days, and involve a neurological exam; tests of memory, behavior, and judgement; a blood draw, imaging of your brain (MRI), and an optional lumbar puncture (LP). All participants enrolled in ALLFTD will have their DNA (from the blood draw) tested for FTLD-associated genetic mutations, but you do not have to learn this information. Participation may last up to 5 years.

The goals of the study are: To identify the best clinical measurements and biomarkers for following patients with FTLD in treatment trials. To identify clinical measurements and biomarkers that indicate when a person with a high risk of developing FTLD due to a mutation will begin to have symptoms. Sharing clinical data, images and biological samples from participants affected by FTLD with the scientific community to address additional scientific questions about FTLD.

https://www.allftd.org/

Due to the amazing contributions of our research participants, we have met our site's enrollment goals.

If you are interested, we can add you to the ALLFTD waitlist and as sites have availability, we will offer openings to those on our waitlist. If you would like to be placed on our waitlist, please complete this inquiry survey. We strongly encourage you to review additional research opportunities here and we encourage you to join the FTD Disorder Registry

This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the MDS-UPDRS Part III score at 12 months. Subjects will be randomly assigned to 2 endurance exercise groups: 1) moderate intensity exercise: 60-65% HRmax or 2) high intensity exercise: 80-85% HRmax. The endurance exercise will be 4 days per week for approximately 30 minutes per session for 18 months.

The purpose of this research study is to determineif the experimental therapy called JCAR017 is effective and safe to treatFollicular Lymphoma or Marginal Zone Lymphoma.

This study will have 4 cohorts or patientgroups. Assignment to one of these patient groups depends on if you haveFollicular Lymphoma or Marginal Zone Lymphoma and the number and type oftreatments that you have received in the past, as well as how long it took foryour lymphoma to return after your last treatment. Everyone in all 4 patientgroups will receive the same dose of JCAR017 T cells. JCAR017 is a type oftherapy known as chimeric antigen receptor (CAR) T cell therapy which isco-developed with Juno Therapeutics. The visit schedule will also be the samefor all 4 patient groups. At the time you decide to take part in the study andgo through the screening procedures, it will be determined which patient groupyou will be assigned to.

In this study, your immunecells will be collected from your blood in a procedure called leukapheresis.The T cells will be separated from the collected immune cells and will bemodified in a laboratory. In the laboratory, a new gene will be put into your Tcells using genetic modification techniques. After they have been modified, thecells will be grown in the laboratory to reach the expected dose for thetreatment. Adding in the new gene may enable your T cells (now called JCAR017 Tcells) to bind to the CD19 protein, which your type of cancer cells carry ontheir surface. Binding to these cells activates the JCAR017 T cells, and theyattack the cancer cells. The JCAR017 T cells will persist in your body afterattacking the cancer cells, you will be monitored during the study to evaluatehow long these JCAR017 T cells persist. The JCAR017 T cells will be given backto you via infusion (IV).

Note:This is only a partial description of treatment. Please contact the Robert H.Lurie Comprehensive Cancer Center of Northwestern University if you areinterested in the trial.

Subjects are asked to participate in this Study because they have moderate-to-severe or severe MR and it has been determined to have symptoms due to heart failure despite being treated with currently available therapies. MR occurs when the leaflets of the mitral valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart needs to pump more blood with each beat to push the same amount of blood forward.

The Study will enroll approximately 500 subjects at up to 60 sites in Europe, United States, and Canada. The Study consists of two arms: Device Arm and Control Arm.

We are only recruiting patients who have not started their edaravone treatment.

Location of study: Les Turner ALS Center at Northwestern Medicine, 259 E. Erie St., Lavin 19, Chicago, IL 60611.

Finding a way to reduce pain is consistently named as one of the top priorities for patients with RA. Previous research has found that this ongoing pain may in part be caused by problems in the way the brain processes pain signals. This is called pain centralization. This study will identify factors that lead to the development of pain centralization, so that in future studies we can learn more about how to prevent the development of this kind of chronic pain in RA.

Participants will complete a total of 3 study visits (baseline, 3 months and 12 months). At each study visit, participants will have a physical exam, have blood drawn, answer questionnaires, and undergo quantitative sensory testing to assess responses to pressure and coldness. A subset of patients who are interested and eligible will undergo a brain MRI at baseline and the 12-month study visit. Participants will receive $50 for the completion of each study visit and an additional $100 for completing each MRI.

Healthy Participants:

The Shirley Ryan AbilityLab is seeking healthy adults to study the effect and ability of muscle stimulation to reduce tremor. We are seeking Healthy adults to participate as a comparison group.

During the study, participants will be stimulated with non-invasive muscle electrostimulation and/or transcranial magnetic stimulation (TMS) while seated in a comfortable chair. To measure muscle activity, electrodes will be attached to the forearm.

In one visit, magnetic resonance imaging (MRI) will be used to observe your brain.

Clinical Participants:

The Shirley Ryan AbilityLab is seeking patients with Parkinson’s disease or Essential Tremor, to study the effect and ability of muscle stimulation to reduce tremor. Exclusion criteria include epilepsy/seizures and incompatibility with MRI or transcranial magnetic stimulation (TMS).

During the study, participants will be stimulated with non-invasive muscle electrostimulation and TMS while seated in a comfortable chair. To measure tremors, sensors will be placed over the wrist, elbow and shoulder and in some visits to the head.

In two visits, magnetic resonance imaging (MRI) will be used to observe the brain.

Cure Glomerulonephropathy (CureGN) is an NIH-sponsored cohort study of patients with biopsy-proven glomerular disease. Participants will be followed longitudinally with annual blood/urine collection to better understand the causes of disease, response to therapy, and disease progression. There is no study drug/intervention.

Primary Aim:

To determine the 28-daymortality rate from the time of COVID 19 diagnosis for CLL patients infectedwith SARS-CoV2 at MSKCC and other institutions.

Secondary Aims:

To describe baseline characteristics, prior and current CLL directed therapies, COVID19 clinical course and outcomes for CLL patients infected with SARS-CoV2.

To examine relationships between CLL directed therapy and COVID19 disease course and outcomes.

To examine current practices regarding management of CLL directed therapy in CLL patients infected with SARS-CoV2.

All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. A computer will by chance assign patients to one of the two arms in the study. This is called randomization.

•Arm A: Carboplatin + Pemetrexed + Avastin + Tecentriq

•Arm B: Carboplatin + Pemetrexed + Avastin

Arm A: Participants will receive carboplatin, pemetrexed, Avastin and Tecentriq for 4 cycles in the treatment phase, followed by pemetrexed, Avastin and Tecentriq for the rest of the cycles, called the maintenance phase.

Arm B: Participant will receive carboplatin, pemetrexed and Avastin for 4 cycles in treatment phase, followed by pemetrexed and Avastin during the following cycles of the maintenance phase.

Participants will be asked to take the study drugs as long as they are benefitting from the treatment or their disease does not get worse. Participants will be removed from the study if the study doctor thinks that they have unacceptable toxicities due to the study drug/s and it is in their best interest to stop participating in the study.

All the drugs will be administered intravenously on Day 1 of each cycle. Each cycle is made of 21 days. The number of cycles will depend on how participants respond to treatment. During the study, participants will have a CT scan every 6 weeks (every 9 weeks during the maintenance phase). Participants will also undergo a physical exam, blood tests, performance status, and vital signs. Blood will be collected during the study. A biopsy for tissue will be collected if the participant agrees.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

In this trial, multiple investigational products for ALS will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. Each regimen consists of a placebo-controlled trial, meaning that the active investigational product and matching placebo will be tested in each regimen.

The additional details that govern the testing of each investigational product will be summarized in separate regimen-specific appendices (RSAs). Each regimen will have a separate ClinicalTrials.gov posting, which will include specific information about the regimen. All regimen-specific outcome measures will be detailed in each regimen posting.

Participants will have an equal chance to be randomized to all regimens that are active at the time of screening. Once randomized to a regimen, participants will be randomized in a 3:1 ratio to either study drug or placebo.

The following regimens are active in the trial:

Regimen A - Zilucoplan Regimen B - Verdiperstat Regimen C - CNM-Au8 Regimen D - Pridopidine Regimen E - Trehalose

New regimens will be continuously added as new investigational products become available. The HEALEY ALS Platform Trial will enroll additional participants as each new regimen is available.

This study will examine different proteins and cell types in blood and cerebrospinal fluid (CSF) of patients with systemic lupus (SLE) who may or may not currently be experiencing neuropsychiatric manifestations of the disease. We aim to identify specific factors that affect the regulation of genes to help explain what goes wrong in systemic lupus. Then, we hope to develop treatments that will target these factors.

This study will characterize immune responses specific to the virus that causes COVID-19 and how they contribute to favorable or poor outcomes. We hope to identify factors that predict the development of long COVID to improve medical care of COVID-19 and related complications. The visit itself will consist of reviewing and signing the consent form, a blood draw of approximately 2 tablespoons of blood, optional stool/nasal samples and a brief questionnaire to review demographics, medications, and medical conditions. You will receive a gift card of $20 for your participation and donation. Individual results generated from this study cannot be shared with the study participant.

The AHEAD 3-45 Study is closed for enrollment.

Alzheimer’s disease (AD) is a progressive, neurodegenerative disorder characterized by cognitive decline with loss of memory. The biological hallmarks of AD include the buildup of an abnormal form of a protein called amyloid, but not every person with amyloid accumulation will develop memory problems or AD. Amyloid plaques are composed of β-amyloid peptide (Aβ) and research suggest that Aβ can begin to accumulate 10 to 20 years before the onset of clinical symptoms. “Preclinical AD” is defined as the accumulation of amyloid in the brain, before clinical symptoms.

The purpose of the AHEAD study is to determine if an investigational drug (lecanemab) reduces the risk of developing AD dementia through early intervention targeting the amyloid pathway before significant and irreversible neurodegeneration. Lecanemab is a novel humanized immunoglobulin G1 (IgG1) monoclonal antibody that preferentially binds to Aβ protofibrils.

This study includes a 216-week treatment period (about 4 years) with an optional open-label extension phase for participants with Preclinical AD. Participants will receive either monthly or bi-weekly depending on their treatment arm (A3 vs. A45). Throughout the study longitudinal cognitive, clinical, safety, fluid biomarker, and imaging biomarker assessments will be performed.

https://www.aheadstudy.org/about/

This research is being done to compare treatmentsfor knee osteoarthritis pain.

Knee osteoarthritis (KOA) occurs when the cartilagethat cushions your knee joint wears down over time or from trauma. Symptoms of KOA include pain, swelling,tenderness, stiffness, and loss of flexibility in the knee. People with KOA pain are often treated withopioids, which can lead to opioid addiction. In this study, we are comparing non-opioid treatments in an effort tolessen your pain and improve knee function.

If you qualify for this study your participation will last between 18 and 48 months

The Shirley Ryan AbilityLab is seeking healthy adults to study how humans interact with robots to program human-like behavior.

This study involves an ankle robot and a lower limb robotic suit that track movements; participants may test only one robot or both.

If testing the ankle robot, participants will wear the robot on their dominant foot and move their ankle while sitting.

If testing the robotic suit, the participants will wear the robotic suit on both legs and the hips, and perform various movements like standing, squatting, or walking.

The purpose of this Managed Access Program(MAP), which is an intermediate size patient

population Expanded Access, is to allowtreatment with tisagenlecleucel (CTL019) for eligible

patients diagnosed with B-cell acutelymphoblastic leukemia (ALL) or large B-cell lymphomas who meet all of thefollowing criteria: are 1) consistent with the approved prescribing information,2) unable to receive commercially manufactured product due to failure of the incomingapheresis material to meet acceptance specifications or final outgoing productto meet the commercial release specifications or other specification within theprescribing information, and 3) where no overwhelming safety concerns has beenidentified for manufacture and release of the out of specification product.

Participation inthis treatment plan involves an experimental approach called gene transfer forALL or large B-cell lymphoma that involves cells in your blood called B cells(your tumor cells and also normal antibody-producing cells). During thistreatment, some of your own white blood cells (T cells) will be taken andchanged to turn against your tumor cells. T cells from your body will bechanged in a way that may allow them to identify and kill your tumor cells.This change may allow your T cells to go to the tumor cells, turn"on" and potentially kill the tumor cells. The modification is doneby gene transfer and results in a genetic change to your T cells. This mayallow the changed T cells to recognize your tumor cells but also normalantibody-producing cells called B cells. These changed cells are calledtisagenlecleucel cells.

If you are eligible andchoose to participate in this MAP, you will be asked to come to the doctor’soffice/clinic/study site at least 3 times in order to make sure you areeligible to receive the tisagenlecleucel cells, and to prepare you for theexperimental treatments. Once you receive the tisagenlecleucel cells, acaregiver, relative, or friend should be in your presence at all times for thefirst 10 days to monitor your well-being and contact your study physician incase of fever or changes in your condition. If you become ill, immediatelycontact your study physician. Additionally, you may be required to spend about4 weeks after you have received tisagenlecleucel cells in close proximity tothe trial treatment center while the doctor and study team see how thetreatment is working and monitor your safety.

Note:This is only a partial description of treatment. Please contact the Robert H.Lurie Comprehensive Cancer Center of Northwestern University if you areinterested in this Managed Access Plan (MAP).

The purpose of this study is to test the safety of a drugcalled M3814 in combination with avelumab and hypofractionated radiation. This combination of drugs has been tested inanimals but has not been tested in people. This study tests different doses of the drug to see which dose is saferfor people.

Participants enrolled in Phase 1 will get standard dose ofradiation therapy every other day over 10 days. This will be followed by a combination of avelumab and M3814 for as long as your doctor feels that the combination ishelping you and you are not experiencing too many side effects.

Phase 2:

Phase 2 has twostudy groups:

Group 1 Participants in Group 1 will receive radiation therapy and the study drugsavelumab and M3814. These drugs are not approved by the FDA for treatment of your disease.

Group 2 Participants in Group 2 will receive radiation therapy and the study drug avelumab.Avelumab is not approved by the FDA for treatment of yourdisease.

All participants, regardless of which phase they areenrolled in, will be followed for 12 months and watched for side effects.Participants will be asked to return to the clinic approximately 30 days aftertheir last dose of study treatment. Afterthat time, participants will be contacted by telephone at regular intervals forup to five years.

This study is being done to answer the following question:

Can we increase the chance of your pancreatic cancer staying away by giving you chemotherapy before and after surgery?

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your pancreatic cancer. The usual approach is defined as care most people get for removable pancreatic cancer.

About the Study

Opt2Move is a 6-month smartphone-based study to help adolescent and young adult cancer survivors become more active.

What’s involved?

Assessments

Complete before starting study and at 3 and 6 months:

• 45-min online survey
• Wear activity monitor 24/7 for 7 days
• You will be compensated for assessment completion

Physical Activity Program

All Participants

• Receive Fitbit, Opt2Move app, exercise prescription, 15-min orientation call
• Track physical activity with Fitbit and use Opt2Move app daily
• Additionally, you may receive 0-4 additional Opt2Move features focused on mindfulness and/or social support.

How can I learn more?

For questions: Phone: 312-503-3465; Email: O2M@nm.org

To complete online screening: https://redcap.link/O2M