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Displaying 1 - 200 of 254

OptimICE-PCR: Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Currently Recruiting
This study is being done to answer the following question: Among patients with early-stage triple-negative breast cancer (TNBC) who achieve a pathologic complete response (pCR) after preoperative chemotherapy in combination with pembrolizumab, will observation after surgery be as effective as completing 6 more months of pembrolizumab after surgery at…
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Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies

Condition: Cancer / Leukemia
Investigator: Nobuko Hijiya, MD
Status: Currently Recruiting
This study is for 1 to 21-year-olds whose hematologic cancer has relapsed to take medication called Tagraxofusp. Relapse means that cancer has come back after treatment. Tagraxofusp is a drug approved by the FDA (Food and Drug Administration) but is not approved to treat the cancers of people in this study. This study is being done to find out if…
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Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

Condition: Cancer / Leukemia
Investigator: Nobuko Hijiya, MD
Status: Currently Recruiting
This study will enroll with children, adolescents and young adults that are less than 22 years old that have returned or 'relapsed' acute myeloid leukemia (AML) diagnoses. Within this group, the study is also targeting those are also unable to receive additional chemotherapy treatments containing anthracycline, which is a type of antibiotic that…
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A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML

Condition: Cancer / Leukemia
Investigator: Nobuko Hijiya, MD
Status: Currently Recruiting
This is a phase 1 study for participants with relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or juvenile myelomonocytic leukemia (JMML) diagnosis. This study will observe the safety, side effects, and best dose of Imetelstat as an investigational drug, or drug that is not approved by the Food and Drug Administration (FDA…
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Pathway to Prevention of Type 1 Diabetes (T1D)- Pediatrics

Condition: Pediatrics
Investigator: Robin Goland, MD
Status: Currently Recruiting
A future without Type 1 Diabetes (T1D) starts with you. Get screened! Thanks in large part to T1D family members, we understand T1D as a disease that progresses in three distinct stages. This new definition in conjunction with TrialNet's Pathway to Prevention screening, allows for earlier detection and intervention.
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Learn more about Lock & Protect: Reducing Adolescent Access to Lethal Means for Suicide

Condition: Pediatrics
Investigator: Ashley Blanchard, MD
Status: Currently Recruiting
The purpose of the study is to study how to make the home safer for youth at risk of suicide. Our goal is to learn how to better help families whose children are seen in the emergency room for self-injury or suicidal thoughts or actions.
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TReatment for ImmUne Mediated PathopHysiology (TRIUMPH)

Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
TReatment for ImmUne Mediated PathopHysiology (TRIUMPH) is a multi-center, three-arm clinical trial of immunosuppressive therapy for children with acute liver failure. This is a double-blind study, so the study doctors and participants will not know to which arm the participants are assigned. The study will determine if corticosteroids or equine anti-…
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Impact of Aromatase Inhibitors on Daily Activities for Individuals with Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Rochelle Mendonca, PhD
Status: Currently Recruiting
The Department of Occupational Therapy at Columbia University will be conducting research to understand the impact of aromatase inhibitors (AIs) on performing everyday activities, like bathing and making meals, for women diagnosed with breast cancer. The purpose of this study is to understand how functional performance is impacted by the use of AIs, and its…
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Study of Focused Ultrasound (FUS) with DEFINITY Microbubbles in Children and Young Adults with Progressive Diffuse Midline Glioma (DMG)

Condition: Pediatrics / Cancer
Investigator: James Hinkley Garvin Jr, MD
Status: Currently Recruiting
Children and young adults with diffuse midline glioma will be treated with Focused Ultrasound (FUS) with DEFINITY microbubbles and neuro-navigator-controlled sonication. The overall goal of this study is to see if the study treatment plan will improve the outcome of participants with diffuse midline glioma, for which no known cure exists, and determine…
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Learn More About PRoMPT BOLUS!

Condition: Pediatrics
Investigator: Maria Kwok, MD, MPH
Status: Currently Recruiting
What's fast-moving, all-encompassing, and plays no favorites? Sepsis, an indiscriminate systemic condition that escalates so rapidly, national guidelines recommend treatment begin within 20 minutes of arrival to the emergency department. Crystalloid resuscitation with normal saline or balanced fluids (including lactated Ringers and Plasma-Lyte) is the…
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Study of BLU-263 in Patients with Indolent Systemic Mastocytosis (ISM) or Monoclonal Mast Cell Activation Syndrome (mMCAS)

Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Currently Recruiting
You are being asked to participate in this study because you have indolent SM (ISM) or because you have Monoclonal mast cell activation syndrome (mMCAS). Currently, there are no available targeted therapies for patients with ISM or mMCAS. The study will test the drug BLU-263. BLU-263 is a new study drug that is being developed for treating people like you,…
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CAUSE: Childhood Asthma in Urban Settings

Condition: Pediatrics
Investigator: Meyer Kattan, MD
Status: Currently Recruiting
We are interested in learning more about these diseases and how to treat them. Our research program is conducting several studies including: a study to learn if treatment with a drug named dupilumab can help reduce asthma attacks in children, a study to observe a specific type of irritation in the lungs and how it relates to asthma symptoms, and more! If…
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Study of Polatuzumab Vedotin in Combination with Chemotherapy in Subjectswith Richter's Transformation

Condition: Cancer / Leukemia
Investigator: Andrew Lipsky, MD
Status: Currently Recruiting
This research is being done because Richter's transformation, which is a life-threatening complication of chronic lymphocytic lymphoma (CLL), and is associated with poor overall survival rate. The study drug administration is a combination of the investigational drug, Polatuzumab vedotin, in combination with Rituximab, Etoposide, Prednisone,…
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Study of Alogabat in Children and Adolescents with Angelman Syndrome (AS)

Condition: Pediatrics
Investigator: Jennifer Bain, MD
Status: Currently Recruiting
This is a Phase IIA Multicenter, open-label, 12-week study to investigate the pharmacokinetics and safety and to provide proof of mechanism of the drug, Alogabat (RO7017773) in children and adolescents aged 5-17 years old with Angelman Syndrome with the deletion genotype.
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Study to Predict Your Therapeutic Response (I-SPY 2 Trial)

Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Currently Recruiting
The primary purpose of this trial is to determine whether adding new drugs to the standard initial cancer treatments for breast cancer increases the probability there will be no residual disease (cancer cells left after many attempts to remove the cancer), compared to the initial cancer treatment alone. The intervention includes different drugs to determine…
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Pediatric Type 1 Diabetes and Bone Health Study

Condition: Pediatrics
Investigator: Mishaela Rubin, MD
Status: Currently Recruiting
We are looking for children between the ages of 8-14 with Type 1 diabetes and without Type 1 diabetes who are interested to participate on a research study to find out how bones are affected in children and adolescents with Type 1 diabetes as compared to people without Type 1 diabetes.
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ChANGE HD

Condition: Pediatrics
Investigator: Ashwini Rao, EdD, OTR
Status: Currently Recruiting
Child to Adult Neurodevelopment in Gene Expanded Huntingtons Disease (ChANGE HD) HD has long been considered an adult-onset disease. However, research has shown that brain changes are evident before motor symptoms begin. In fact, the gene responsible for HD plays a role in brain development and is present throughout the lifespan. With gene knockdown therapy…
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Study of SEA-CD70 in Patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Currently Recruiting
You are being asked to participate in this study because you have Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) and we are testing the study drugs, SEA-CD70, to find out what its side effects are and to see if the study drug is safe for people with these types of cancer are testing to see if SEA-CD70 is safe for people, and its side effects…
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Study of GLSI-100 in Female Patients with Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Currently Recruiting
The purpose of this research is to test how well an investigational study drug (medication), GLSI-100, can prevent your cancer from coming back. The research study will also collect information about the safety of the medication. The research will also study how the medication works and who responds the best to the medication. GLSI-100 is a combination of a…
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Kids MoD PAH Trial

Condition: Pediatrics
Investigator: Usha Krishnan, MD
Status: Currently Recruiting
This study is being done to determine whether early combination therapy with two study drugs called sildenafil (REVATIO) and bosentan (TRACLEER) can improve pulmonary hypertension when compared to using sildenafil alone. Pediatric pulmonary arterial hypertension (PAH) is a severe medical problem that often worsens with time. It is caused by problems with…
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Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias (Children and Young Adults)

Condition: Cancer / Childhood Leukemia
Investigator: Nobuko Hijiya, MD
Status: Currently Recruiting
This study is called a screening study and the purpose of this study to find better ways to diagnose and treat leukemia that has come back after treatment or difficult to treat. Bone marrow, blood, and medical information about cancer and treatment will be collected. The results from this screening study may give other information about leukemia that is…
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Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias (Children and Young Adults)

Condition: Cancer / Leukemia
Investigator: Nobuko Hijiya, MD
Status: Currently Recruiting
This study is called a screening study and the purpose of this study to find better ways to diagnose and treat leukemia that has come back after treatment or difficult to treat. Bone marrow, blood, and medical information about cancer and treatment will be collected. The results from this screening study may give other information about leukemia that is…
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Study Comparing Survival of Patients Monitored with Serum Tumor Marker Directed Disease Versus Usual Care in Metastatic Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Melissa Accordino, MD
Status: Currently Recruiting
The purpose of this study is to determine if overall survival of patients monitored with serum tumor marker direct disease monitoring (STMDDM) is as good as the overall survival of patients monitored with the usual care.
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DHREAMS: A genetic study of congenital diaphragmatic hernia (CDH).

Condition: Pediatrics
Investigator: Yufeng Shen, PhD
Status: Currently Recruiting
Each year more than 1,000 babies in the United States are born with a Congenital Diaphragmatic Hernia (CDH). For the majority of these babies, the cause of the CDH is unknown. The DHREAMS (Diaphragmatic Hernia Research & Exploration; Advancing Molecular Science) study was created to improve the understanding of the molecular genetic basis of CDH. This…
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STARZL Network for Excellence in Pediatric Transplantation (SNEPT)

Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
In this research, we want to learn more about how to improve care for children who are listed for or who have received a liver transplant. The goal of this research is to look at how different hospitals treat these children and to look at their outcomes to help improve care, decrease complications, shorten length of hospital stay, reduce hospital re-…
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Safety Planning Study for Elementary School-Aged Children (Ages 6-12)

Condition: Pediatrics
Investigator: Liat Itzhaky, PhD
Status: Currently Recruiting
Your child is invited to participate in a research study. Participation in the study includes one meeting at Washington Heights. Results from this study will assist in modifying an existing behavioral intervention to fit children of this age. For more details, please contact Dr. Liat Itzhaky at 646-774-7634 or e-mail: li2185@cumc.columbia.edu. Participants…
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Study for Children with Excessive Worries and Fears

Condition: Pediatrics
Investigator: Rachel Marsh, PhD
Status: Currently Recruiting
To learn more, click the blue box "Do you qualify" and our study team will contact you. This research study will examine how an iPad-based cognitive training game combined with cognitive behavioral therapy (CBT) helps children with excessive worries and related repetitive behaviors (obsessive compulsive disorder). After completing the training,…
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Assessment of Pruritis (Itch) in Children with Primary Sclerosing Cholangitis

Condition: Pediatrics
Investigator: Mercedes Martinez, MD
Status: Currently Recruiting
The purpose of this study is to better understand how common and how severe pruritis (itching) is in children and adults under 21 years of age with Primary Sclerosing Cholangitis (PSC). The study involves the completion of two short online surveys. If you have any questions regarding this study, please contact the Transplant Clinical Research Center ( TCRC).
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Study of Relatlimab and Nivolumab in Patients Under 30 Years Old with Classical Hodgkin Lymphoma (cHL) and Non-Hodgkin Lymphoma (NHL)

Condition: Pediatrics / Cancer
Investigator: Nobuko Hijiya, MD
Status: Currently Recruiting
This study will utilize an investigational drug combination (also known as the study drugs) called relatlimab and nivolumab as a possible treatment for recurrent/relapsed (returned) or refractory (treatment-resistant) cHL and NHL. An investigational drug combination is one that has not been approved by regulatory agencies, such as the United States (US)…
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The Mindful Brain Project in Teens

Condition: Pediatrics
Investigator: Randy Auerbach, PhD
Status: Currently Recruiting
We are recruiting depressed adolescents ages 13-18 years. As a participant in our study, we will: (1) interview your child about current and past thoughts, feelings, and behaviors, (2) teach your child mindfulness strategies, (3) collect brain activity data with MRI (non-invasive) while your child practices mindfulness, and (4) send short surveys to your…
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Live-Viral Vaccination after Pediatric Liver Transplantation

Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
In this study, we will collect information from the medical record of pediatric liver transplant recipients who received live vaccines as part of their routine post-transplant care. This data will be combined with data from other centers across the United States and Canada to help give us a better understanding of the safety and efficacy of live vaccines in…
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Kids with Iron Deficiency and Scoliosis (KIDS) Study

Condition: Pediatrics / Child and Adolescent Health
Investigator: Lisa Eisler, MD
Status: Currently Recruiting
We are studying the effects of iron supplementation in patients undergoing surgery for scoliosis. If you are scheduled or are planning to schedule a scoliosis surgery in greater than 3 months, please contact us to determine eligibility.
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A Study for Patients with Advanced Melanoma, Solid Tumors or Lymphoma Using Study Drug Pembrolizumab

Condition: Pediatrics / Cancer
Investigator: Nobuko Hijiya, MD
Status: Currently Recruiting
The purpose of this study is to determine if a study drug called pembrolizumab is safe and effective in the treatment of children and adolescents who have advanced melanoma, or advanced, relapsed, or refractory PD-L1 positive malignant solid tumor or other lymphoma, relapsed or refractory classical Hodgkin lymphoma (rrcHL), advanced, relapsed or refractory…
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CHORD Clinical Trial - Gene Therapy DB-OTO for Children with Hearing Loss from Otoferlin (OTOF) Gene Mutation

Condition: Pediatrics
Investigator: Lawrence Lustig, MD
Status: Currently Recruiting
The CHORD clinical trial, sponsored by Decibel Therapeutics, is looking at the use of the gene therapy DB-OTO for children born with hearing loss related to changes in the OTOF gene. The goal of this trial is to assess different doses of DB-OTO to find out if it is safe, well-tolerated, and its effect on improving hearing. DB-OTO is a gene therapy that has…
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Congenital Anomalies Research Exploration - CARE study

Condition: Pediatrics
Investigator: Yufeng Shen, PhD
Status: Currently Recruiting
Study examining the genetic causes of birth defects.
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Cognition and Psychosocial Functioning During Puberty Blocking

Condition: Pediatrics / Child and Adolescent Health
Investigator: Ilene Fennoy, MD
Status: Currently Recruiting
We know that puberty is a major time of change! Adolescents develop new decision-making skills and independence. It is possible that some of these changes are due to the hormonal changes during puberty. One of the ways we treat transgender and gender non-conforming teens is to suppress or "block" puberty. We know that this is a safe thing to do…
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Genetics of Early Childhood Obesity (GECO) Study at Columbia

Condition: Pediatrics
Investigator: Vidhu Thaker, MD
Status: Currently Recruiting
We will enroll children with severe early onset obesity (BMI 99th percentile) diagnosed prior to 6years of age or other endocrine disorders. We will ask questions about their health, eating behavior and perform a brief physical examination. We will collect saliva or blood to perform genetic testing. We will also invite family members to participate in the…
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Study of RLY-2608 in Patients with Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Currently Recruiting
This research study is designed to learn about the safety of an experimental (investigational) drug called RLY-2608, also called the study drug, when given to individuals who have been diagnosed with metastatic (spread to other areas of the body) or unresectable (cannot be removed surgically) cancers and have at least one mutation in a gene called PIK3CA.…
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Study of TSC 100 & TSC 101 in Patients with Leukemia Undergoing Haploidentical Allogeneic Blood Stem Cell Transplantation (HCT)

Condition: Cancer / Leukemia
Investigator: Ran Reshef, MD
Status: Currently Recruiting
The study involves research of two study drugs (TSC 100 and TSC 101), given in combination with the standard of care (SOC). The purpose of the study is to see if TSC 100 and TSC 101 are safe and effective in treating your blood cancer. The study also is measuring the effect of these study drugs on your immune system (immunogenicity of study drugs). TSC 100…
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Program for Overweight Education and Reduction (POWER)

Condition: Pediatrics
Investigator: Ilene Fennoy, MD
Status: Currently Recruiting
We are doing this research study to find out what happens to children who are overweight and how the things we recommend as a part of routine clinical care affect your child. The purpose of this study is to understand what happens to children as a result of being overweight, to link these outcomes to specific clinical measures, and to determine how…
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Addinex-Opioid Dispenser for Post-Op Pain in Cancer Patients

Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Currently Recruiting
The purpose of this study is to evaluate the use of the Addinex device, a time-release medication dispenser designed to assist with medication adherence, in cancer patients undergoing cancer-related surgery that require pain control with opioids after the surgery.
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Family Nurture Intervention in the NICU

Condition: Pediatrics
Investigator: Martha Welch, MD
Status: Closed
The purpose of this study is to compare neurodevelopment and activity in infants born very preterm (26 to 33 6/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU). This study investigator hypothesizes that FNI will improve: i) neonatal electroencephalographic activity ii…
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Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia

Condition: Cancer / Leukemia
Investigator: Nobuko Hijiya, MD
Status: Closed
The purpose of this study is to find the best dose of Asciminib that can be given safely in children with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) having previously been treated with one or more tyrosine kinase inhibitors (TKIs). Tyrosine kinase inhibitors are a group of medications that block chemical…
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Study of Radiotherapy in Patients with Low-Risk HER2-Positive Breast Cancer (HERO*)

Condition: Cancer / Breast Cancer
Investigator: Eileen Connolly, MD, PhD
Status: Closed
This study is being done to answer the following question: Is treatment with HER2-targeted therapy without radiation therapy as good as the usual treatment of radiation and HER2-targeted therapy in patients with HER2-positive breast cancer who have had surgery, chemotherapy, and HER2-targeted therapy? This study is being done to find out if this approach is…
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Study of T-DM1 in Combination with Tucatinib for Patients with HER2-Positive Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Closed
This study is being done to answer the following question: Is the combination of T-DM1 and a newer drug tucatinib, better than usual treatment with T-DM1 alone at preventing your cancer from returning? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your breast cancer. The usual approach is…
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Bone Marrow Transplant (BMT) Study in Patients with Acute Leukemia

Condition: Cancer / Leukemia
Investigator: Markus Mapara, MD
Status: Closed
The purpose of the study is to learn if a transplant using bone marrow recovered from deceased organ and tissue donors is safe and effective in patients undergoing bone marrow transplant (BMT). This study treatment does not include any investigational drugs. The medicines and procedures in this study are standard of care for transplant. Bone marrow cells…
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Study of Breast Cancer in Black Women

Condition: Cancer / Breast Cancer
Investigator: Lauren Houghton, PhD
Status: Closed
We are conducting a series of focus group sessions to investigate the attitudes and opinions of young Black women regarding breast cancer, breast cancer risk, and biomarker-based screening to inform current breast cancer screening guidelines.
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Study of Symptom Monitoring using Young, Empowered & Strong (YES) Web Portal for Breast Cancer Survivors

Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
The Young, Empowered & Strong (YES) study is opened to women who were diagnosed with breast cancer between the ages of 15 and 39 years. Women will need to be within 3 years of the end of early active treatment (e.g. surgery, chemotherapy not including HER2-directed therapy, radiation), and have no know evidence of breast cancer recurrence. The study…
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Study Evaluating KTE-C19 in Subjects With Acute Lymphoblastic Leukemia or B-Cell Non-Hodgkin Lymphoma (ZUMA-4)

Condition: Pediatrics / Cancer
Investigator: Prakash Satwani, MD
Status: Closed
The main purpose of this research study is to determine if the experimental product, KTE-C19, when administered after you receive 3 days of chemotherapy, is safe and effective in treating your leukemia or non-Hodgkin lymphoma.
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Study Evaluating KTE-C19 in Pediatric Subjects With Acute Lymphoblastic Leukemia or B-Cell Non-Hodgkin Lymphoma (ZUMA-4)

Condition: Pediatrics
Investigator: Prakash Satwani, MD
Status: Closed
The main purpose of this research study is to determine if the experimental product, KTE-C19, when administered after you receive 3 days of chemotherapy, is safe and effective in treating your leukemia or non-Hodgkin lymphoma.
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Studies of Pediatric Liver Transplantation (SPLIT)

Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Closed
The purpose of the study is to collect scientific data on pediatric liver transplantation to learn more about how children do after liver transplant. Collecting these data is expected to help researchers learn more about liver transplant in children. This information may improve medical care of your child and other children who need and who have received…
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Study of Drug - DSP-5336 in Patients with Leukemia

Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
You are being asked to participate in this study because you have acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or leukemia of mixed lineage (the leukemia cells cannot be classified as AML or ALL or where both types of AML and ALL cells are present). Because you have already received standard therapy that is no longer helping, or there is…
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REST: Sleep Study for High School Students

Condition: Pediatrics
Investigator: Brooke Aggarwal, EdD, MS, FAHA
Status: Closed
High school students ages 14-18 and their parent(s) may be eligible to participate in a 12-week (consisting of a 6-week pre-pilot and 6-week pilot) sleep health education program.
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PEPN2113: Study of Uproleselan in Children with AML, MDS, or MPAL

Condition: Cancer / Childhood Leukemia
Investigator: Nobuko Hijiya, MD
Status: Closed
This is a Phase 1 study of a drug called uproleselan. We are testing new experimental drugs such as uproleselan in the hopes of finding a treatment that may be effective against acute myeloid leukemia, myelodysplastic syndrome or mixed phenotype acute leukemia that has come back or that has not responded to standard therapy. This study looks at how well…
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Study of Panzyga in Primary Infection Prophylaxis (Prevention) in Patients with Chronic Lymphocytic Leukemia (PRO-SID)

Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
This study will be performed to determine if Panzyga (the study drug) can help with preventing infections in patients who have chronic lymphocytic leukemia (CLL). Panzyga is a study drug administered via injection into the vein, which contains human antibodies also called immunoglobulins. It is manufactured by Octapharma. Your participation in this clinical…
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Study of Radiation Therapy Alone or in Combination With Olaparib for Patients with Inflammatory Breast Cancer (IBC)

Condition: Cancer / Breast Cancer
Investigator: Eileen Connolly, MD, PhD
Status: Closed
This study is being done to answer the following question: Can we lower the chance of your cancer returning by adding the drug olaparib to the usual radiation therapy for your cancer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your inflammatory breast cancer. The usual approach is…
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Natural History Study of Children with SCID (Severe Combined Immunodeficiency)

Condition: Pediatrics
Investigator: Olatundun Williams, MD
Status: Closed
This study is being done to identify the best outcomes for hematopoietic cell transplantation (HCT) or other treatment (enzyme replacement or gene therapy), which is life-saving therapy for children with SCID (severe combined immunodeficiency), leaky SCID, Omenn syndrome and reticular dysgenesis.
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Learn More About How We Decide Which Children With Headaches Need to Have a Picture of Their Brain Taken While They Are in the ED

Condition: Pediatrics
Investigator: Daniel Tsze, MD
Status: Closed
The purpose of this research study is to create a decision-making tool that will help doctors decide which children with headaches require a CT ("CAT scan," "computed tomography") or MRI scan of their head as part of their emergency department care.
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Impact on Learning and Development in Down Syndrome(CHILD-DS)

Condition: Pediatrics / Down Syndrome
Investigator: Michael DiLorenzo, MD
Status: Closed
Down syndrome (DS) occurs in roughly 1 out of 700 births in the U.S. Half of all children with Down syndrome have congenital heart disease (CHD), often requiring corrective heart surgery. Even though CHD in children without DS is known to be associated with developmental problems, few studies have explored how CHD can affect the development and behavior of…
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Understanding the Life Course of Primary Immune Regulatory Disorders (PIRD) Patients and Their Family Members

Condition: Pediatrics
Investigator: Olatundun Williams, MD
Status: Closed
The purpose of this study is to understand the life course of PIRD patients and their family members that have the same gene change but do not have the same symptoms. PIRD is mostly due to inherited changes in the genes that normally have immune cells fight infections and regulate the immune system. There are many types of problems that patients with PIRD…
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Study of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)

Condition: Pediatrics
Investigator: Dana Goldner, MD
Status: Closed
This study evaluates whether odevixibat is safe and effective compared to placebo in children with biliary atresia who have recently undergone a Kasai procedure. This is a double-blind study, so the study doctors and the child/parent will not know whether the child is receiving odevixibat or placebo. Participation will involve several research visits over…
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Study of VOR33 in Patients with Acute Myeloid Leukemia (AML)

Condition: Cancer / Leukemia
Investigator: Markus Mapara, MD
Status: Closed
You are being asked to take part in this study because you have acute myeloid leukemia (AML). Vor Biopharma, is a company that is testing a possible new treatment for AML. This possible new treatment, is VOR33. In this study, your blood-forming stem cells will be genetically modified to become VOR33. VOR33 has not been approved by the Food and Drug…
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Study of Etavopivat in Patients with Myelodysplastic Syndromes (MDS)

Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this study is to evaluate the effects of etavopivat, good and bad, in individuals with myelodysplastic syndrome (MDS).
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Study of Quizartinib in Combination with Chemotherapy for Children and Young Adults with Recurrent /Refractory Acute Myeloid Leukemia (AML)

Condition: Cancer / Childhood Leukemia
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to find the best dose of Quizartinib that can be given safely with chemotherapy in children and young adults with acute myeloid leukemia (AML) which has come back or has not responded to the standard therapy. Quizartinib will be given by mouth once a day from Day 6 through Day 28. It will be given in combination with…
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Study of Quizartinib in Combination with Chemotherapy for Children and Young Adults with Recurrent /Refractory Acute Myeloid Leukemia (AML)

Condition: Cancer / Leukemia
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to find the best dose of Quizartinib that can be given safely with chemotherapy in children and young adults with acute myeloid leukemia (AML) which has come back or has not responded to the standard therapy. Quizartinib will be given by mouth once a day from Day 6 through Day 28. It will be given in combination with…
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MiChoice: Making Informed Choices on Incorporating Chemoprevention Into Care

Condition: Cancer / Breast Cancer
Investigator: Katherine Crew, MD
Status: Closed
The study is being done to answer the following question: How can we best help women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) and their healthcare providers make informed decisions about whether to take breast cancer risk-reducing pills (drugs to slow or prevent breast cancer from developing)? Participants in this study will learn…
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Study of Pirtobrutinib (LOXO-305) Alone or in Combination With Chemotherapy in Patients with Chronic Lymphocytic Leukemia (CLL)

Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
The purpose of this study is to test the safety and effectiveness of an investigational treatment called pirtobrutinib (LOXO-305) plus venetoclax and rituximab (PVR) versus venetoclax and rituximab (VR). Pirtobrutinib is an investigational (or experimental) drug that may treat your Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).
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Learn About Nasal Spray Medication That Helps Children Stay Calm and Hold Still When They Have a Cut in Their Skin That Needs to be Fixed

Condition: Pediatrics
Investigator: Daniel Tsze, MD
Status: Closed
The purpose of this research study is to find out what is the best dose of intranasal midazolam for children to help them stay calm and hold still while they are having a cut in their skin fixed.
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Study of Sacituzumab Govitecan in Combination with Pembrolizumab vs. Chemotherapy in Patients with Advanced Triple-Negative Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The purpose of this study is to see if sacituzumab govitecan in combination with pembrolizumab can improve lifespans of patients with advanced triple-negative breast cancer (TNBC) and their tumor does not grow or spread when compared to chemotherapy (paclitaxel, or nab-paclitaxel, or the combination of gemcitabine and carboplatin), a commonly used treatment…
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FAST TRIAL REGISTRY - Study for Female, Pregnant Patients Affected by Atrial Flutter (AF) or Supraventricular Tachycardia (SVT)

Condition: Pediatrics
Investigator: Stephanie Levasseur, MD
Status: Closed
Although supraventricular tachycardia (SVT), including atrial flutter (AF), are the most common causes of intended in-utero fetal therapy, none of the medication used to date has been evaluated for their effects on the mother and her baby in a randomized controlled clinical trial (RCT). In the absence of such evidence, there is no consensus for the optimal…
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Study of Sacituzumab Govitecan (TRODELVY) in Patients with Triple-Negative Breast Cancer (TNBC)

Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The purpose of this study is to see if sacituzumab govitecan can improve lifespans of patients with advanced triple-negative breast cancer (TNBC) and their tumor does not grow or spread when compared to chemotherapy (paclitaxel, or nab-paclitaxel, or the combination of gemcitabine and carboplatin), a commonly used treatment for previously untreated advanced…
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Study of Nivolumab in Combination with 5-Azacytidine in Acute Myeloid Leukemia (AML) - Children and Adults Age 1 to 30

Condition: Cancer / Leukemia
Investigator: Nobuko Hijiya, MD
Status: Closed
The purpose of this study is to find out if the drugs called Nivolumab and 5-Azacytidine can be given safely in children and young adults with Acute Myeloid Leukemia (AML) which has come back after treatment or has not responded to standard therapy. These drugs are thought to work by turning on genes that limit the growth of cancer cells. The study drugs…
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Study of Nivolumab in Combination with 5-Azacytidine in Acute Myeloid Leukemia (AML) - Children and Adults Age 1 to 30

Condition: Cancer / Childhood Leukemia
Investigator: Nobuko Hijiya, MD
Status: Closed
The purpose of this study is to find out if the drugs called Nivolumab and 5-Azacytidine can be given safely in children and young adults with Acute Myeloid Leukemia (AML) which has come back after treatment or has not responded to standard therapy. These drugs are thought to work by turning on genes that limit the growth of cancer cells. The study drugs…
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Study for Patients with Chronic Lymphocytic Leukemia (CLL) who are Currently Receiving Treatment with Venetoclax

Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
The purpose of this study is to find out whether people who are currently receiving treatment with venetoclax can stop treatment and remain off-treatment for at least 12 months, if they are free of residual disease (MRD- negative) when they stop treatment.
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A Study for Children with Acute Lymphoblastic Leukemia Using Study Drug Carfilzomib

Condition: Pediatrics / Cancer
Investigator: Nobuko Hijiya, MD
Status: Closed
The purpose of this study is to learn more about the treatment of children and teenagers whose leukemia has come back (has relapsed) or has not gone away after other treatments (is refractory). Participants will receive the study drug, called carfilzomib in combination with standard chemotherapy, that are dexamethasone, daunorubicin, vincristine and PEG-…
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ICON3: A Phase 3 Study of Eltrombopag vs. Standard Therapy for Newly Diagnosed Immune Thrombocytopenia (ITP) in Children

Condition: Pediatrics
Investigator: Cindy Neunert, MD
Status: Closed
The purpose of this study is to investigate the safety and effectiveness of eltrombopag (investigational drug) in treating children and adolescents with newly-diagnosed immune thrombocytopenia (ITP), which is a rare blood disorder.
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Study of Eribulin in Combination with Copanlisib in Patients with Metastatic Triple-Negative Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
This study is being done to answer the following question: How does the combination of copanlisib and eribulin compare to eribulin alone to lengthen the time you can live with your metastatic triple-negative breast cancer without your cancer getting worse? We are doing this study because we want to find out if this approach is better or worse than the usual…
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Decreasing Chemotherapy for HER2 Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy

Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Closed
This study is being done to answer the following question: Can participants with HER2-positive breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after 12 weeks of chemotherapy and two HER-targeted therapies eliminate further chemotherapy after surgery? This would be a decrease in the total number of…
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Fetal Atrial Flutter & Supraventricular Tachycardia (FAST) Therapy Trial (Fetus diagnosed with a fast heart rate)

Condition: Pediatrics / Cardiology
Investigator: Stephanie Levasseur, MD
Status: Closed
Although supraventricular tachycardia (SVT), including atrial flutter (AF), are the most common causes of intended in-utero fetal therapy, none of the medication used to date has been evaluated for their effects on the mother and her baby in a randomized controlled clinical trial (RCT). In the absence of such evidence, there is no consensus for the optimal…
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Study of STK-009 in Combination with SYNCAR-001 in Patients with Lymphoma or Leukemia

Condition: Cancer / Leukemia
Investigator: Ran Reshef, MD
Status: Closed
The purpose of this study is to find the highest dose of STK-009 that is safe in combination with a dose of SYNCAR-001 and to learn what side effects are experienced in people with certain lymphomas or leukemias. This study will also evaluate how much SYNCAR-001 and STK-009 is in your blood at various times, whether your immune system becomes activated,…
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Study of Drug - LY3484356 in Patients with Breast Cancer (ER+, HER2-)

Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
This study is being done to see how safe an investigational drug, LY3484356 is and how well it will work to help people with estrogen receptor-positive (ER+), HER2 negative (HER2-) locally advanced or metastatic breast cancer previously treated with endocrine therapy. The main reason for you to take part in this study is not to treat you for your condition…
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Study of Venetoclax and Azacitidine After Allogeneic Stem Cell Transplantation in Patients with Acute Myeloid Leukemia (AML)

Condition: Cancer / Leukemia
Investigator: Ran Reshef, MD
Status: Closed
The purpose of this study is to evaluate the safety and efficacy of venetoclax and azacitidine compared to Best Supportive Care in patients with Acute Myeloid Leukemia (AML) after an allogeneic stem cell transplant (SCT). This is the first randomized study comparing venetoclax in combination with azacitidine versus best supportive care in subjects with AML…
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Study of Fedratinib in Combination with Chemotherapy in Patients with Myeloproliferative Neoplasm (MPN) in Accelerated and Blast Phase

Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
You are being asked to participate in this study because you have a myeloproliferative neoplasm (MPN) that has transformed to accelerated or blast phase. MPN is a group of diseases in which the bone marrow makes too many blood cells. The different types of MPN are myelofibrosis (MF), essential thrombocythemia (ET), or polycythemia vera (PV). Over time,…
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Study of Magrolimab in Combination with Chemotherapy in Patients with Acute Myeloid Leukemia (AML)

Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
You are being asked to participate in this study because you have been diagnosed with a blood cancer called Acute Myeloid Leukemia (AML) with or suspected to have a specific gene mutation (TP53 mutation) for which you have not received any prior AML treatment. Tumor protein p53 (TP53) is a gene that codes for a tumor suppressor protein, which is normally…
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Study of Niraparib in Patients Who Have Been Previously Treated for Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Closed
The purpose of this study is to evaluate if the study drug, niraparib will help patients delay or prevent their breast cancer from returning. This study will compare niraparib to placebo in study participants who have been treated for breast cancer and were then found to have breast cancer ctDNA (Circulating tumor DNA (ctDNA) is found in the bloodstream and…
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Learn More About Positive Pressure Ventilation for Asthma

Condition: Pediatrics / Child and Adolescent Health
Investigator: Maria Kwok, MD, MPH
Status: Closed
The purpose of this study is to evaluate the effectiveness and adverse reactions of the various types of noninvasive positive pressure supportive use in the management of children with moderate to severe acute asthma exacerbation.
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Study of Olanzapine in Children Receiving Chemotherapy for Hematopoietic Stem Cell Transplant (HSCT)

Condition: Pediatrics / Cancer
Investigator: Diane George, MD
Status: Closed
This research study is to find out whether adding olanzapine to standard antiemetics will be helpful in controlling chemotherapy-induced vomiting (CINV) in children receiving high-dose cyclophosphamide for Blood/Bone Marrow Transplant (BMT) conditioning.
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Study of MTX110 in Combination with Gadolinium in Children with Newly Diagnosed Brain Cancer (Diffuse Midline Gliomas)

Condition: Pediatrics / Cancer
Investigator: James Hinkley Garvin Jr, MD
Status: Closed
The purpose of this study is to find the best dose of a drug called MTX110 and a contrast agent called gadolinium that can be given safely in children with newly diagnosed diffuse midline gliomas, which is a kind of brain tumor. All patients enrolled in the study will receive infusion of MTX110 and Gadolinium delivered with a pump directly into the tumor…
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Study of TL-895 Alone or in Combination with KRT-232 for Patients with Myelofibrosis (MF)

Condition: Cancer / Leukemia
Investigator: Mark Heaney, MD, PhD
Status: Closed
The purpose of the study is to determine an appropriate dose of KRT-232 in combination TL-895 or KRT-232 alone for treatment of myelofibrosis (MF). There are 2 parts planned for this study, the Phase 1b that will test different doses of TL-895 given with KRT-232 and it will also test KRT-232 alone, to identify the recommended dose for Phase 2. The Phase 2 (…
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Study of CGT9486 in Patients with Advanced Systemic Mastocytosis (AdvSM)

Condition: Cancer / Leukemia
Investigator: Mark Heaney, MD, PhD
Status: Closed
The purpose of this study is to determine the optimal dose of oral CGT9486 in patients with Advanced Systemic Mastocytosis (AdvSM) and to determine the efficacy of CGT9486 at the selected optimal dose in patients with Advanced Systemic Mastocytosis (AdvSM). This includes Aggressive Systemic Mastocytosis, Advanced Systemic Mastocytosis with an Associated…
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Study of Bendamustine/Rituximab Induction Followed by Venetoclax and Rituximab Consolidation for Treatment of Chronic Lymphocytic Leukemia

Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
The purpose of this study is to determine the effectiveness of the study treatment- bendamustine and rituximab (BR) followed by venetoclax for 12 months. The combination of the drugs bendamustine and rituximab is a commonly used treatment for your disease. Venetoclax is an oral drug that blocks a protein called BCL-2 which is present on CLL cells. With this…
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Study of Improving Patient-Centered Communication in Patients with Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Bret Taback, MD
Status: Closed
This study is being done to answer the following question: How can we best help patients and their clinicians make decisions about breast cancer treatment (surgery and other treatments, like radiation and chemotherapy)? We are doing this study because we want to better understand how to support patients in making decisions about breast cancer treatment. We…
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A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy

Condition: Cancer / Leukemia
Investigator: Ran Reshef, MD
Status: Closed
Patients who will be receiving immune effector cell (IEC) therapy for the treatment of their cancer (leukemia) are being asked to participate in this study. IEC can produce a harmful side effect called Cytokine Release Syndrome (CRS). CRS involves a release of a large amount of proteins into the bloodstream. This may cause changes in blood pressure and…
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ARM: Axillary Reverse Mapping - Lymph Node Surgery Technique in Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Bret Taback, MD
Status: Closed
The purpose of this study is to compare usual lymph node surgery to an added procedure during the surgery to help surgeons see the lymph node system better. During usual surgery, the lymph node system may be disrupted, which can cause swelling in the arm. This research study will use a new lymph node surgery technique to look at how fluid drains through the…
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Study of Cabergoline in Adolescents and Adult Women with Endometriosis

Condition: Pediatrics
Investigator: Jin Hee Kim, MD
Status: Closed
In this research study we want to learn more about a potential new therapy for pain associated with endometriosis. We want to determine if a non-hormonal medication, cabergoline, will help patients with endometriosis. Cabergoline is a medication that is approved by the Food and Drug Administration (FDA) for treatment of other medical conditions. In this…
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Study of the role of lymph node dissection in breast cancer patients after neoadjuvant chemotherapy

Condition: Cancer / Breast Cancer
Investigator: Bret Taback, MD
Status: Closed
The purpose of this study is to examine whether removing some of the lymph nodes from the armpit, but not removing them all followed with radiation therapy (experimental) will be as good as having the majority of the lymph nodes from the armpit removed during breast surgery followed with radiation(standard of care). Patients will be randomized to either of…
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Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS) (ENHANCE)

Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this study is to compare the effects, both good and bad, of magrolimab in combination with azacitidine, to those of azacitidine in combination with placebo, to find out which is better for treating patients with MDS (Myelodysplastic Syndrome). Other purposes of this study include determining the quantity of magrolimab in the blood, aspects of…
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Study of Imprime PGG and Pembrolizumab (Keytruda) in Patients with Metastatic Breast Cancer (mBCA)

Condition: Cancer / Breast Cancer
Investigator: Julia McGuinness, MD
Status: Closed
The purpose of this study is to find out, good and/or bad, the effects of the investigational drug, Imprime PGG, when given together with pembrolizumab (also known as Keytruda, a type of checkpoint inhibitor) in the treatment of your type of cancer. Checkpoint inhibitors are a type of immunotherapy that block immune checkpoint proteins from binding with…
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Study of PMD-026 in Patients with Metastatic Breast Cancer with Expansion in Metastatic Triple Negative Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
This is a first-in-human, phase 1/1b, open-label study of single-agent PMD-026 conducted in participants with metastatic breast cancer. PMD-026 will initially be administered orally on a once-daily schedule. Part 1 of the study will evaluate PMD-026 in participants with metastatic breast cancer that have not responded to treatment, which may involve…
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Teens' Thoughts About Depression and Mental Health Related Discrimination

Condition: Pediatrics
Investigator: Doron Amsalem, MD
Status: Closed
We are conducting a research study to explore discrimination around depression and barriers to care in youth ages 14-18. We will use what we learn to create videos to reduce such discrimination. Parental permission is required for this study. Adolescents (ages 14-18) will participate in an individual interview that will be approximately 45 minutes long. We…
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A Study of GFH009 in Patients With Hematologic Malignancies

Condition: Cancer / Leukemia
Investigator: Andrew Lipsky, MD
Status: Closed
The purpose of this study is to assess the safety, effectiveness, pharmacokinetic (PK how long the drug is in your body and how it is metabolized) and pharmacodynamics (PD where does the drug go in your body and what is its biological effect) of the study drug, GFH009, in patients with relapsed or refractory hematologic malignancies including acute myeloid…
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Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients (6 months-17 years)

Condition: Pediatrics / Cancer
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to find out the effects and safety of an investigational (experimental) new drug called copanlisib in pediatric patients from 6 months to 21 years of age. This study consists in two-phase, Phase I part will determine which is the right dose of copanlisib to be used in children/adolescents/adults with relapsed (has returned) or…
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ASPIRE: Study of Anastrozole, Palbociclib, Trastuzumab and Pertuzumab Metastatic Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Melissa Accordino, MD
Status: Closed
The purpose of this study is to assess the safety and effectiveness of giving anastrozole, palbociclib, trastuzumab, and pertuzumab to women with hormone receptor-positive, HER2-positive metastatic breast cancer. This combination of medications represents an all-biologic approach and avoids chemotherapy as first-line treatment of this disease.
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A Study of CYNK-001 in Adults with Newly Diagnosed Acute Myeloid Leukemia

Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this clinical research study is to evaluate the safety (any good or bad effects) of CYNK-001 and to assess the effects of CYNK-001 on your Acute Myeloid Leukemia (AML). Also, the study plans to determine the maximum tolerated dose (highest safe dose) of CYNK-001 and assess whether CYNK-001 can eliminate your residual (leftover) disease.…
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Study of Drug Injection with Chemotherapy in Children, Adolescents, and Young Adults with Relapse of Actue Lymphoblastic Leukemia

Condition: Pediatrics / Cancer
Investigator: Nobuko Hijiya, MD
Status: Closed
This is a Phase 1 multicenter study of Vincristine Sulfate Liposome Injection (Marqibo) in combination with UK ALL R3 induction chemotherapy. The study treatment is considered experimental because it is not approved by the United States (US) Food and Drug Administration (FDA) for treating children with acute lymphoblastic leukemia (ALL) who have relapsed…
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Study of Flotetuzumab for Children, Adolescents, and Young Adults with Relapsed or Refractory Acute Myeloid Leukemia (AML)

Condition: Pediatrics / Cancer
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to find the highest dose of Flotetuzumab that can be given safely to patients who have a certain type of leukemia called Acute Myeloid Leukemia (AML) that has relapsed (has come back after treatment) or is refractory (never responded to treatment). Flotetuzumab is an experimental treatment that works by targeting certain…
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Study of Selinexor in Pediatric Solid Tumors, including CNS Tumors

Condition: Cancer / Pediatric Solid Tumors
Investigator: Nobuko Hijiya, MD
Status: Closed
We are testing new experimental drugs such as selinexor in the hopes of finding a treatment that may be effective against tumors that have come back or that have not responded to standard therapy. The goals of this study are: To find the highest safe dose of selinexor that can be given without causing severe side effects; To learn what kind of side effects…
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Study of efficacy of ribociclib plus fulvestrant in patients with metastatic breast cancer

Condition: Cancer / Breast Cancer
Investigator: Melissa Accordino, MD
Status: Closed
The purpose of this study is to determine whether there is clinical benefit to continue therapy beyondprogression for metastatic or unresectable breast cancer. The treatment that is being investigated in this clinical trial, ribociclib (LEE011), is part of a family of oral medications (pills) that are called Cyclin Dependent Kinase 4 and 6 inhibitors, which…
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Study of Maralixibat in Infants with Biliary Atresia Who Have Had Kasai Surgery

Condition: Pediatrics
Investigator: Jennifer Vittorio, MD
Status: Closed
The purpose of this study is to see how effective and safe the drug maralixibat is when compared to placebo in infants with biliary atresia who have had Kasai surgery within 3 weeks before participation. This is a 26-week, multicenter, double-blind, placebo-controlled, randomized parallel-group study, followed by an open-label extension (OLE). Approximately…
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Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

Condition: Pediatrics / Cancer
Investigator: Gary Schwartz, MD
Status: Closed
The purpose of this study is to find out if an investigational drug, called ADP-A2M4, is safe and how well it works in attacking Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (MRCLS) cancer cells. The study involves taking certain types of immune cells from the blood, called T cells, and changing them in a laboratory before putting them back into the…
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Study of Ablation in Breast Cancer Patients

Condition: Cancer / Breast Cancer
Investigator: Eileen Connolly, MD, PhD
Status: Closed
The purpose of the study is to determine whether ablation, which is the removal or destruction of a tumor (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients improves progression-free survival (PFS) and overall survival (OS).
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Cannabinoids for Taxane-Induced Peripheral Neuropathy in Women Undergoing Breast Cancer Treatment

Condition: Cancer / Breast Cancer
Investigator: Diana Martinez, MD
Status: Closed
Paclitaxel is frequently used to treat breast cancer, but it can also cause neuropathy where the nerves of the hands and feet stop working properly. The symptoms of neuropathy can include pain, numbness, and difficulty with everyday activities like walking or typing. Paclitaxel-induced neuropathy is common and there are few treatment options. Our study will…
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A Study of ZN-c5 in Subjects With Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Katherine Crew, MD
Status: Closed
This research study involves receiving an experimental drug referred to as ZN-c5. This is the first study in humans using ZN-c5. The purpose of this research study is to test the safety of ZN-c5 at different dose levels. This study is designed to find out what effects, good and/or bad, ZN-c5 has on participants with breast cancer. Participants in both…
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Study of Drug in Patients with B-Cell Lymphoid Malignancies

Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
This research study is evaluating an investigational drug, called cirmtuzumab, in combination with astandard drug, called ibrutinib (Imbruvica), as a possible treatment for patients with CLL/SLL or MCL. All cells in the body receive signals to grow and survive, but sometimes these signals get out of control, causing too much cell growth. When the growth of…
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Social and Contextual Impact on Children Undergoing Liver Transplant

Condition: Pediatrics
Investigator: Jennifer Vittorio, MD
Status: Closed
The social determinants of health have a large impact on health. We have previously demonstrated that an index of neighborhood socioeconomic deprivation was associated with an increased risk of medication non-adherence in children after liver transplant and an increased risk of graft failure and death in children after transplant. The present proposal seeks…
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Glucose Monitoring to Determine Rates of Hyperglycemia During Chemotherapy for Early Stage Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Melissa Accordino, MD
Status: Closed
The purpose of this study is to identify if blood sugar elevations during chemotherapy may be related to the development of side effects from chemotherapy. This study will help us find out if blood sugar goes up during the course of chemotherapy, and if so, for the amount of time the blood sugar is elevated after a chemotherapy treatment. Results of this…
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Study of Experimental Drug for Triple Receptor-Negative Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The purpose of this study is to compare the usual approach (i.e. no more treatment or additional post-operative chemotherapy), to any effects, good and/or bad, of the experimental drug MK-3475 (also called pembrolizumab) after surgery. This study will allow the researchers to know whether treatment with MK-3475 (pembrolizumab) is better, the same, or worse…
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Study of Metronomic and Targeted Anti-Angiogenesis Therapy For Children with Medullobastoma (Brain Tumor)

Condition: Pediatrics / Cancer
Investigator: Stergios Zacharoulis, MD
Status: Closed
The purpose of this study is to learn more about the treatment of children and young adults patient with relapsed (has returned) and progressive medulloblastoma (brain tumor). This study is being done to find out if bevacizumab can be safely given in combination with five study drugs given by mouth, thalidomide, fenofibrate, celecoxib and alternating every…
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Dose-Finding Study of Pacritinib in Patients With Leukemia Previously Treated With Ruxolitinib

Condition: Cancer / Leukemia
Investigator: Mark Heaney, MD, PhD
Status: Closed
The purpose of this study is to find out what dose of pacritinib is safest and works best for participants. Pacritinib is an experimental drug, which is a drug that is being tested and is not currently approved by the Food and Drug Administration (FDA) in the US. The study will be conducted at about 85 study clinics in North America, Europe, Israel and…
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Study of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia

Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this study is to: Test if the lifespan of study participants is increased when uproleselan is added to standard chemotherapy medicines compared to standard chemotherapy alone; test if the number of study participants achieving disease remission is increased when uproleselan is added to standard chemotherapy medicines compared to standard…
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Olaparib With or Without Atezolizumab in Treating Patients With Locally Advanced or Metastatic Non-HER2-Positive Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The purpose of this study is to compare any good and bad effects of using olaparib and atezolizumab in combination compared to olaparib alone. The use of olaparib alone or in combination with atezolizumab could shrink your cancer but could also cause side effects. This study will allow the researchers to know whether the combination approach is better, the…
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A study for patients with Acute Myelogenous Leukemia using study drug ABT-199

Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this study is to evaluate the safety, and effectiveness of ABT-199 in combination with decitabine and ABT-199 in combination with azacitidine in subjects who have not been treated for their AML. In addition, substances (biomarkers) found in the blood and bone marrow that may indicate the effects or progress of the leukemia and the activity of…
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Study Evaluating Everolimus with Endocrine Therapy in Breast Cancer Patients

Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without the subjects cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney…
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Evaluation of Biomarkers in Subjects with Estrogen Receptor-Positive, HER2-Negative Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Katherine Crew, MD
Status: Closed
The purpose of this study is to determine the effect of different doses of ZN-c5 on levels of hormone (estrogen) receptors in breast cancer and how large that effect is for each dose level. The amount of reduction in hormone receptors may indicate that the drug is doing what it intends to do and how effective it is. The results will help define what an…
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Study of New Drug with Radiation Therapy in Children with Diffuse Intrinsic Pontine Gliomas (DIPG) Brain Stem Cancer

Condition: Pediatrics / Cancer
Investigator: Luca Szalontay, MD
Status: Closed
This is a phase I, multicenter, dose escalation study of MK-1775 in combination with radiation. The study treatment is considered experimental because it is not approved by the United States (US) Food and Drug Administration (FDA) for treating children and young adults with newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG). MK-1775 is an oral…
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A study for women with invasive breast cancer or DCIS undergoing mastectomy using study drug Faslodex

Condition: Cancer / Breast Cancer
Investigator: Sheldon Feldman
Status: Closed
The main purpose of this study is to determine the safety and tolerability of Faslodex given directly into thebreast ducts of women with invasive breast cancer or Ductal Carcinoma In Situ (DCIS). This study is for women who have been diagnosed with invasive breast cancer or DCIS. DCIS is the presence of abnormal cells inside a milk duct in the breast, and…
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Study of Imetelstat in Subjects With Myelodysplastic Syndrome (MDS)

Condition: Cancer / Leukemia
Investigator: Azra Raza, MD
Status: Closed
The purpose of the study is to evaluate the efficacy and safety of imetelstat for the treatment of patients with myelodysplastic syndrome (MDS). All patients participating in Part 1 of this study will get 7.5 mg/kg of imetelstat as a 2-hour intravenous infusion once every 4 weeks. The dose of imetelstat may be increased, held or decreased depending on how…
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A study in children, adolescents, and young adults recurrent or refractory solid tumors using study drug nivolumab

Condition: Cancer / Pediatric Solid Tumors
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to learn what kind of side effects nivolumab as a single agent and nivolumab in combination with ipilimumab can cause and if these treatments are beneficial for solid tumors. Nivolumab (Dose Level 1) will be given as an intravenous infusion every 14 days of a 28 day cycle. If Dose Level 1 is not tolerable, then it will be…
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Study to Help Develop Tailored Breast Cancer Screening Strategies

Condition: Cancer / Breast Cancer
Investigator: Allison Borowski, MD
Status: Closed
We are currently recruiting women to TMIST, a clinical trial that will help us develop strategies that tailor breast cancer screening to the risks of individual women. This is a screening trial. The purpose of this trial is to determine if tomosynthesis (3-D) mammography detects breast cancer at earlier stage than current method of 2-D digital mammography.
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Study of Entrectinib in Children and Adolescents with Solid Tumors and Primary CNS Tumors

Condition: Cancer / Pediatric Solid Tumors
Investigator: Stergios Zacharoulis, MD
Status: Closed
The purpose of this study is to find out more about how the study drug called entrectinib will be used in children, adolescents and young adults with treatment-resistant solid tumor in brain or body. This is a phase 1/1b study, divided into a dose escalation portion (different dose will be tested) and a dose expansion portion (one dose will be tested) in…
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A study for patients with Richter's Transformation (RT) using study drug PNT2258

Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
This study is for patients with Richter's transformation (RT). The purpose of this study is to see if a new type of investigational drug called PNT2258 that may be effective in blocking the "on" signal to cancer cells, eventually causing them to die. We are trying to see if PNT2258 provides evidence of anti-tumor effect by measuring what…
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Breathe Easy Early ORBEX Study

Condition: Pediatrics
Investigator: Meyer Kattan, MD
Status: Closed
The Breathe Easy Early ORBEX Study is a three -year study to identify if a daily capsule of Broncho-Vaxom may help prevent or delay young children from developing wheezing or asthma- like symptoms. Other studies have found that Broncho-Vaxom can help prevent upper respiratory infections and stimulate immune defenses, and has been safely and effectively used…
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Study of Combination Treatment to Reduce Occurrence and Severity of Chronic Graft Versus Host Disease (GVHD)

Condition: Cancer / Leukemia
Investigator: Monica Bhatia, MD
Status: Closed
The purpose of this study is to compare two different combinations of treatment plans to a standard transplant procedure in order to see whether one or both of them are better at reducing the occurrence and severity of chronic GVHD. The research portion of this study involves manipulation of your stem cell product by removing T-cells, which cause chronic…
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A study for postmenopausal women with advanced or metastatic breast cancer using study drug MLN0128

Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
This study involves research; it is the first time that MLN0128 will be studied in patients who are also receiving antihormonal medication. The main purposes of the study are to determine: The risks and discomforts of MLN0128 when given with antihormonal medication. Whether giving MLN0128 in combination with antihormonal medication affects the growthof your…
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Mothers' Attitude Towards Breastfeeding in Mothers with Babies with Congenital Heart Disease

Condition: Pediatrics
Investigator: Leonardo Liberman, MD
Status: Closed
The purpose of this study is to investigate how mothers with babies with congenital heart disease feel about breastfeeding. We will ask you to fill out a survey while you are in the hospital at around the time of delivery and another survey approximately three months later to see how you feel about breastfeeding. In addition to the survey data, the study…
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An Efficacy and Safety Trial of Fedratinib in Subjects With Myelofibrosis and Previously Treated With Ruxolitinib (FREEDOM)

Condition: Cancer / Leukemia
Investigator: Mark Heaney, MD, PhD
Status: Closed
You are being asked to take part in this study because you have been diagnosed with Myeloproliferative neoplasm (MPN) Associated Myelofibrosis (your disease) and have received ruxolitinib. The purpose of this study is to confirm how well this study treatment works to reduce your spleen volume, spleen size, what effect the study treatment has on you and…
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A study for patients with spinal muscular atrophy using study drug, ISIS 396443 to test safety and effectiveness

Condition: Neuromuscular / Spinal Muscular Atrophy
Investigator: Claudia Chiriboga, MD, MPH
Status: Closed
The purpose of this study is to evaluate the safety, tolerability and effectiveness of a study drug called ISIS-396443 when using it to treat children with later-onset spinal muscular atrophy (SMA). SMA is a neuromuscular disease that causes a degeneration (a breakdown) of the motor neurons in the spinal cord, resulting in a weakening of the muscles in…
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A study for patients with high-risk Myelofibrosis (MF) using study drug imetelstat

Condition: Cancer / Leukemia
Investigator: Mark Heaney, MD, PhD
Status: Closed
The purpose of this study is to find the dose of imetelstat that best treats myelofibrosis. (A doseis a measured amount of a drug taken at one time.) The effects of imetelstat on myelofibrosis as well as any side effects will be explored.
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TrACER: Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER) for Patients Receiving Chemotherapy

Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
This randomized clinical trial studies prophylactic colony stimulating factor management in patients with breast, colorectal or non-small cell lung cancer receiving chemotherapy and with risk of developing febrile neutropenia. Patients receiving chemotherapy may develop febrile neutropenia. Febrile neutropenia is a condition that involves fever and a low…
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MUPPITS-2: Study of Asthma Medication in Children with Asthma

Condition: Pediatrics
Investigator: Meyer Kattan, MD
Status: Closed
Research funded by the NIH is being done to learn if an asthma medication, given along with standard asthma care, makes children less likely to have asthma attacks.
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Study of Experimental Drug in Patients with Acute Myeloid Leukemia (AML)

Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this study is to test the safety of DCLL9718S at different dose levels, alone or in combination with azacitidine. DCLL9718S is an experimental drug manufactured by Genentech that is designed to inhibit tumor growth. The drug is being tested in clinical trials and has not been approved by the U.S. Food and Drug Administration (FDA) and/or any…
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A study for subjects with chronic lymphocytic leukemia using study drug ABT-199

Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
The purpose of this study is to evaluate how well the study drug ABT-199 works and safety of ABT-199 in subjects with Chronic Lymphocytic Leukemia (CLL) whose cancer has come back (relapsed) after treatment or no response (refractory) to treatment with B-cell receptor signaling pathway inhibitor therapy, namely Ibrutinib and/or Idelalisib. In addition,…
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Optical Tomographic Imaging in Pre-Surgical Women with Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
Tomography (DOT), can help predict how well patients respond to a pre-surgical therapy. This imaging technique uses light to create 3D maps of the blood, fat, and water content of the breast. Based on these measurements taken over 2 time points during therapy (before and after), we will try to determine if this new imaging technique can use early…
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Study of Weekly MOD-4023 Compared to Daily Genotropin Therapy In Pre-Pubertal Children With Growth Hormone Deficiency

Condition: Pediatrics
Investigator: Ilene Fennoy, MD
Status: Closed
Your child has been asked to participate in this study because he/she may have or has growth hormone deficiency (i.e. not enough growth hormone in his/her body) and your doctor has already determined that your child may be suitable to be screened for this study. OPKO Biologics Ltd., the Sponsor of this clinical study, has developed an…
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A study for patients with metastatic breast cancer using study drug Ricolinostat in combination with nab-paclitaxel

Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this study is to determine the MTD of Ricolinostat (ACY-1215) in combination with weekly abraxane as well as evaluate the safety and tolerablility of Ricolinostat (ACY-1215) in combination with weekly abraxane.
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Study of Alvocidib in Patients with Relapsed/Refractory Acute Myeloid Leukemia Following Treatment with Venetoclax Combination Therapy

Condition: Cancer / Leukemia
Investigator: Daniel Lee, MD
Status: Closed
You are being asked to take part in this study because you have acute myeloid leukemia (AML) that has come back after initial treatment (relapsed) with venetoclax combination therapy or because you did not get a complete response from your initial treatment (refractory) with venetoclax combination therapy. The purpose of this research study is to determine…
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A study for infants with pre-symptomatic Spinal Muscular Atrophy (SMA)

Condition: Neuromuscular / Spinal Muscular Atrophy
Investigator: Darryl De Vivo, MD
Status: Closed
This study is for infants that have been genetically diagnosed with Spinal Muscular Atrophy (SMA) and are currently not showing any signs or symptoms of the disease. The purpose of this study is to see whether ISIS 396443 has any effects (good or bad) on infants with SMA (who do not yet show signs or symptoms of the disease) and to see if ISIS 396443 can…
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A study for patients with Acute Myeloid Leukemia (AML) using study drug atezolizumab and guadecitabine

Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this study is to test the safety of the combination of the experimental drugs called atezolizumab and guadecitabine (not yet approved by the U.S. Food and Drug Administration FDA or any other regulatory authority outside the United States) to find out what effects, good or bad, the combination of atezolizumab and guadecitabine has on patients…
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Study of Combination Drug in Patients with Advanced Triple Negative Breast Cancer (TNBC)

Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this trial is to determine whether the study drug, CX-839, reduces tumor size in patients with metastatic triple negative breast cancer when it is used in combination with the standard breast cancer treatment. CX-839 blocks the activity of a certain molecule that is overproduced by some cancer cells.
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Study of MK-1775 in Combination with Irinotecan in Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Tumor

Condition: Cancer / Pediatric Solid Tumors
Investigator: Alice Lee, MD
Status: Closed
This is a phase 1/2 multicenter study of AZD1775 (MK-1775) that will be given in combination with irinotecan. The study treatment is considered experimental because it is not approved by the United States (US) Food and Drug Administration (FDA) for treating children and young adults with solid tumors which have come back or have not responded to standard…
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Determining Changing in Cardiovascular and Metabolic Risks in Patients with Chronic Myeloid Leukemia

Condition: Cancer / Leukemia
Investigator: Mark Heaney, MD, PhD
Status: Closed
This study will see how the treatment you will receive for your chronic myeloid leukemia affects cardiovascular and metabolic risk factors. The treatments that are being studied are called BCR-ABL1 tyrosine kinase inhibitors (TKIs) (i.e., dasatinib, imatinib, nilotinib). Subjects who are eligible for the study will be starting treatment for chronic myeloid…
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Adults with untreated Acute Myeloid Leukemia who are not considered candidates for intensive remission induction using study drug SGI-110

Condition: Cancer / Leukemia
Investigator: Todd Rosenblat, MD
Status: Closed
The purpose of the study is to test how effective and safe the study drug SGI-110 is compared with current standard treatment for AML. The study drug, SGI-110, is changed in the body into a compound called decitabine. Decitabine is an approved drug in the US for treatment of patients with myelodysplastic syndrome (MDS) and in Europe for treatment of…
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Study of using patient's residual tumor to develop a cancer model

Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this research study is to determine if using a piece of the patient's residual tumor to develop a model of her cancer in mice that lack an immune system (also called an immune-deficient mouse) could help in determining which additional drugs or compounds to which an individual breast tumor is sensitive. The tumor implanted in the mouse…
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Study of Combination Therapies in Children with Relapsed Acute Lymphoblastic Leukemia (ALL) or Non-Hodgkins Lymphoma (NHL)

Condition: Pediatrics / Cancer
Investigator: Nobuko Hijiya, MD
Status: Closed
This is a Phase 1 multicenter study of temsirolimus in combination with etoposide and cyclophosphamide. The study treatment is considered experimental because it is not approved by the Unites States (US) Food and Drug Administration (FDA) for treating children with acute lymphoblastic leukemia (ALL) and non-Hodgkins lymphoma (NHL) who have relapsed. The…
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A study for patients with acute myeloid leukemia using study drug Venetoclax in combination with Azacitidine

Condition: Cancer / Leukemia
Investigator: Daniel Lee, MD
Status: Closed
The purpose of this study is to evaluate the efficacy (how well the study drug works) and safety of venetoclax in combination with azacitidine in subjects who have not been treated for their acute myeloid leukemia (AML). The tolerability (the degree to which evident adverse effects can be tolerated by the patient) of venetoclax will also be evaluated.
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A study for children with refractory solid tumors, including CNS tumors using study drug ramucirumab

Condition: Cancer / Pediatric Solid Tumors
Investigator: Alice Lee, MD
Status: Closed
The goals of this study are to find the highest safe dose of ramucirumab that can be given without causing severe side effects, to learn what kind of side effects ramucirumab can cause, to learn more about the effects of ramucirumab on cells and proteins in the blood and to determine whether ramucirumab is a beneficial treatment for patients with solid…
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Study of Select Immunotherapy Combinations in Patients with Triple Negative Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The purpose of this study is to identify the doses of spartalizumab (PDR001) with LAG525 in combination with either NIR178, capmatinib (INC280), MCS110 or canakinumab (ACZ885) that can be given safely. The study will also test how well spartalizumab (PDR001) with LAG525 in combination with either NIR178, capmatinib (INC280), MCS110 or canakinumab (ACZ885)…
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A study for women with metastatic breast cancer using study drug LY2835219 for treatment

Condition: Cancer / Breast Cancer
Investigator: Meghna Trivedi, MD
Status: Closed
The purpose of this study is to see how safe investigational drug, LY2835219 is and how well it will work to help people with advanced hormone receptor (HR) positive, HER2 negative breast cancer. This study will investigate whether the combination of LY2835219 plus fulvestrant improves outcomes compared to fulvestrant alone for women with a certain type of…
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Early Developmental Changes, Risk for Diabetes, and the Microbiome in Children

Condition: Pediatrics
Investigator: Sharon Oberfield, MD
Status: Closed
We are recruiting boys between 3-9 years old and girls between 3-8 years old to participate in a research study. Children who would like to participate must be healthy and not showing signs of puberty. The goal of the study is to understand the relationship between early body development, metabolism (sugars and fats processing), and the saliva microbiome (…
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A Study Evaluating the Safety and Pharmacokinetics of Atezolizumab Administered With Hu5F9-G4 to Patients With Acute Myeloid Leukemia

Condition: Cancer / Leukemia
Investigator: Daniel Lee, MD
Status: Closed
The main purposes of this study are to: 1) understand the safety of atezolizumab given in combination with Hu5F9-G4 and 2) understand the way the body processes atezolizumab and Hu5F9-G4 (pharmacokinetics). This study will also be testing if the combination therapy is effective at treating relapsed or refractory acute myeloid leukemia (R/R AML).…
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Study for children with recurrent or refractory solid tumors using study drug axitinib

Condition: Cancer / Pediatric Solid Tumors
Investigator: Julia Glade Bender, MD
Status: Closed
The purpose of this study is to assess the safety and effectiveness of a study drug called axitinib on treating tumors that have returned (recurrent) or have not responded to standard therapy (refractory). Children will take axitinib twice a day for 28 days (1 cycle). Children may take study drug for up to 24 cycles (2 years).
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A study for patients with Acute Myeloid Leukemia (AML) using study drug decitabine

Condition: Cancer / Leukemia
Investigator: Richard Carvajal, MD
Status: Closed
This study is for patients with Acute Myeloid Leukemia (AML). The purpose of this study is to determine if decitabine plus JNJ-56022473 can be safely combined and is active for your disease. The study drugs used in this study are JNJ-56022473, an experimental drug and DACOGEN ( also known generic as decitabine), a drug already used to treat your type of…
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Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women with Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Bret Taback, MD
Status: Closed
This is a study for patients diagnosed with either breast cancer that is HER-2 positive, or breast cancer that is negative for estrogen, progesterone and HER-2 (triple-negative disease), and whose tumor can be removed by breast-conserving surgery. The purpose of this study is to test whether patients undergoing a breast MRI (magnetic resonance imaging)…
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Study of Drug in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors

Condition: Pediatrics / Cancer
Investigator: Alice Lee, MD
Status: Closed
This is a Phase 1 multicenter study of LY2606368, a CHK1/2 inhibitor, in pediatric patients with refractory solid tumors, including CNS tumors. The study treatment is considered experimental because LY2606368 is not approved by the United States (US) Food and Drug Administration (FDA) for treating pediatric patients with refractory solid tumors, including…
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Study of Drug in Patients with Acute Myeloid Leukemia (AML)

Condition: Cancer / Leukemia
Investigator: Daniel Lee, MD
Status: Closed
The purpose of this study is to measure the effectiveness and safety of an investigational drug called "alovicidib" in combination with cytarabine and daunorubicin in the treatment of AML. Investigational means that this drug has not been approved by the FDA. Cytarabine and daunorubicin are both standard of care treatments for patients with AML.…
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Using New Imaging Technique in Women with Breast Cancer to predict response to Neoadjuvant Chemotherapy

Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
This study examines diffuse optical tomography (DOT) as a way to monitor the progress of the breast cancer therapy. Specifically, it looks at DOTs ability to detect non-responders early in treatment and then adjust the therapy to improve response and overall survival. DOT is favorable to more conventional forms of cancer monitoring, such as physical exams,…
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Study of Combination Treatment to Reduce Occurrence and Severity of Chronic Graft Versus Host Disease (GVHD)

Condition: Pediatrics / Cancer
Investigator: Monica Bhatia, MD
Status: Closed
The purpose of this study is to compare two different combinations of treatment plans to a standard transplant procedure in order to see whether one or both of them are better at reducing the occurrence and severity of chronic GVHD. The research portion of this study involves manipulation of your stem cell product by removing T-cells, which cause chronic…
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A registry to investigate certain breast cancer diagnosis tests and treatment decisions in Chinese breast cancer patients

Condition: Cancer / Breast Cancer
Investigator: Margaret Chen-Seetoo, MD
Status: Closed
The purpose of this registry study is to assess information obtained from the Agendia Breast Cancer Suite of diagnostic tests and other clinical information to study ways to assist in breast cancer diagnosis and treatment decisions in Chinese patients. The Agendia Breast Cancer Suite includes MammaPrint, TargetPrint, BluePrint, and TheraPrint which are…
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Study of Acalabrutinib (ACP-196) in Combination with Venetoclax with and without Obinutuzumab in Subjects with Chronic Lymphocytic Leukemia

Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
The purpose of this study, which involves research, is to determine if giving an experimental drug called acalabrutinib in combination with venetoclax with and without obinutuzumab is safe and effective for treating people with CLL compared to a combination of bendamustine and rituximab (BR) or a combination of Fludarabine, Cyclophosphamide and Rituximab (…
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A study for patients with chronic lymphocytic leukemia (CLL) using study drug TDR-1202

Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
This study is being done to see how well tolerated the investigational drug TGR-1202 is in comparison to other similar therapeutics agents in treating patients with chronic lymphocytic leukemia (CLL).
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Biomarker Study of Philadelphia Chromosome Negative Myeloproliferative Neoplasms (MPN)

Condition: Cancer / Leukemia
Investigator: Mark Heaney, MD, PhD
Status: Closed
The purpose of this study is to provide samples for biomarker testing for the different MPD-RC treatment studies. As part of the treatment study you currently participating in, this is an additional research study in which you we will ask for you to donate blood and/or bone marrow samples, two nail clippings, and buccal (cheek) swab. In order to…
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MLN4924 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome (18 to 21 years old)

Condition: Cancer / Leukemia
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to find the best dose of pevonedistat that can be given safely with chemotherapy in young adults with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) that has either come back or has not responded to the standard therapy. Pevonedistat works by blocking some of the enzymes that are needed for cell growth.
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A study for patients with Thrombocytopenia and Primary Myelofibrosis using study drug pacritinib

Condition: Cancer / Leukemia
Investigator: Mark Heaney, MD, PhD
Status: Closed
This is a clinical research study for subjects with Myelofibrosis (Primary, Post-Polycythemia Vera, and Post-Essential Thrombocytopenia) and thrombocytopenia. The purpose of this study is to determine if pacritinib is better at reducing spleen size and a reduction in symptoms than the best available therapy. This is a randomized, controlled study.…
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Study of Radiation Therapy in Female Patients with Breast Cancer who Have Undergone Surgery

Condition: Cancer / Breast Cancer
Investigator: Eileen Connolly, MD, PhD
Status: Closed
The main purpose of this clinical trial is to study women like you who have cancer cells in the lymph nodes at the time that the breast cancer is diagnosed and have chemotherapy before surgery that clears the cancer cells from the lymph nodes. This study asks 1) if, after lumpectomy, radiation to the breast and lymph nodes will be better than radiation only…
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Study for Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Melissa Accordino, MD
Status: Closed
This a Phase III study designed to compare the efficacy and the safety of the triplet combination of GDC-0077 plus palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in patients with PIK3CA-mutant, HR-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of…
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Flex CMT Muscle Cramps Study

Condition: Pediatrics / Neuromuscular
Investigator: Thomas Brannagan, MD
Status: Closed
Moving forward in Charcot-Marie-Tooth disease. A clinical research study assessing the safety and effectiveness of an investigational product in people with Charcot-Marie-Tooth (CMT) disease experiencing muscle cramps is now enrolling. Participation is entirely voluntary. Contacting us does not mean that you are required to take part in this study. If you…
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A study of adding study drug Sorafenib to the usual treatment in children and teens with AML (Acute Myeloid Leukemia)

Condition: Cancer / Leukemia
Investigator: Alice Lee, MD
Status: Closed
This study is for children and teens who have been diagnosed with Acute Myeloid Leukemia (AML). AML is a cancer of the bone marrow, the spongy tissue inside the large bones of the body where blood cells are made. In AML, the bone marrow makes large numbers of immature white blood cells called blasts. These blast cells crowd out the normal cells of the bone…
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Test of an inhaled medicine (Aerosurf) to treat premature lung disease in babies born at 26 to 28 weeks gestation.

Condition: Pediatrics
Investigator: Tina Leone, MD
Status: Closed
Babies born prematurely frequently have difficulty breathing because of immature lung development. A substance called surfactant is usually present in mature lungs to help keep the lungs inflated normally. The treatment for breathing problems in premature infants can include giving surfactant as a medicine. When surfactant is given as a medicine a…
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The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL (in Breast Cancer Patients)

Condition: Cancer / Breast Cancer
Investigator: Melissa Accordino, MD
Status: Closed
This is a research study of cryotherapy (cold therapy) vs. compression therapy for the prevention of taxane-induced neuropathy. This study will assess the effect of a wearing frozen garments or compression garments on preventing neuropathy pain and discomfort that can be caused by taxane chemotherapy. Cryotherapy involves wearing frozen garments on both…
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Brave Trial, A Clinical Research Study for Duchenne Muscular Dystrophy (DMD)

Condition: Pediatrics / Neuromuscular
Investigator: Darryl De Vivo, MD
Status: Closed
Our clinic is currently participating in the Brave Trial, a clinical research study for Duchenne muscular dystrophy (DMD). This study is being conducted to learn whether a study drug can improve motor functions in boys with DMD. If your child takes part, he'll receive at no cost: study drug or placebo, study-related procedures, reimbursement for…
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Study of PTC299 in Relapsed/Refractory Acute Leukemias

Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this study is to find if PTC299 is safe to treat people with relapsed/refractory acute myeloid leukemia (AML) as well to determine the dose of PTC299 that can be given without causing severe side effects. AML is a cancer of the blood and bone marrow (spongy tissue inside bones where blood cells are made). PTC299 is being developed to…
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A study for patients with Leukemia using study drug acalabrutinib

Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
The purpose of this study, which involves research, is to determine if an experimental drug: acalabrutinib is safe and effective in the treatment of this patients with High Risk Chronic Lymphocytic Leukemia (CLL). Acalabrutinib is an investigational drug, which means that it is still being tested in people and has not been approved by government agencies in…
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Study of Escalating Doses of Study Drug in Patients with HER2 Positive Breast Cancer

Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this study is to test the safety, tolerability, and the behavior of the drug in your body of an experimental study drug, DHES0815A. The goal is to determine a safe and tolerable dose in patients with cancer and to measure how the body processes the study drug at different dose levels.
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Body Composition Changes after Bariatric Surgery in Adolescents

Condition: Pediatrics
Investigator: Wei Shen, MD
Status: Closed
This is a study of body changes that take place in teenagers who undergo bariatric surgery as a treatment for obesity and obesity-related conditions. Changes will be measured by serial MRI andmetabolomic profiling.
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Study of Experimental Drug in Patients with Elevated Thrombocythemia (Too Many Platelets, Leading to Abnormal Blood Clotting or Bleeding)

Condition: Cancer / Leukemia
Investigator: Mark Heaney, MD, PhD
Status: Closed
The purpose of this study is to compare the safety, tolerability, and effectiveness of ruxolitinib, an investigational drug, compared to anagrelide, an FDA approved drug. Investigational means that the study drug has not been approved by the FDA for treatment of ET. Patients will be assigned to one of two groups. Group A will receive ruxolitinib and placebo…
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Study of Sacituzumab Govitecan in patients with triple-negative breast cancer

Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this study is to determine the effectiveness of the study drug, sacituzumab govitecan, to the treatment of physicians choice, in patients with metastatic, triple negative breast cancer.
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Effects of varying bubble nasal continuous airway pressure in very low birth weight infants

Condition: Pediatrics
Investigator: Rakesh Sahni, MD
Status: Closed
The purpose of this study is to see if the use of bubble nasal continuous positive airway pressure (NCPAP) at a pressure of 6-7 centimeters of water (cm H2O) in very low birth weight (VLBW) infants is associated with improved gas exchange without any related changes in vital signs.
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A study for women who are undergoing breast reconstruction surgery using a new device called the AeroForm Tissue Expander System

Condition: Cancer / Breast Cancer
Investigator: Jeffery Ascherman, MD
Status: Closed
The purpose of this study is to assess the performance and ease of use of the AeroDorm Tissue Expander System in women who are undergoing breast reconstruction surgery. This device is for use in women who are having or have had a mastectomy procedure to remove their breast(s) because of breast cancer (or to decrease their risk of breast cancer). The study…
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Study of Vedolizumab in Subjects Undergoing Stem Cell Transplantation

Condition: Cancer / Leukemia
Investigator: Ran Reshef, MD
Status: Closed
The main purpose of this research study is to investigate if a drug called Vedolizumab is safe and effective in preventing acute graft-versus-host disease (attack of donor cells on recipient healthy organs after transplant) of the gut in comparison to placebo (dummy drug). This will be studied in patients undergoing Allogeneic Hematopoietic Stem Cell…
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Evaluating the safety and effectiveness of study drug AMG 228 in patients with Advanced Solid Tumors

Condition: Cancer / Pediatric Solid Tumors
Investigator: Yvonne Saenger, MD
Status: Closed
This study is for patients with the following cancers: advanced non-small cell lung cancer, head and neck cancer, melanoma, colon cancer, or bladder cancer. The purpose of this study is to find out more about the effects of AMG 228 in people and on their cancer. AMG 228 is an experimental drug that is being developed to stimulate the bodys immune system to…
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A study for patients with MDS, Chronic Myelomonocytic Leukemia (CMML) or Acute Myelogenous Leukemia (MDS) using study drug pevonedistat

Condition: Cancer / Leukemia
Investigator: Mark Frattini, MD, PhD
Status: Closed
Pevonedistat is currently being studied in humans with advanced solid tumors and acute myelogenous leukemia (AML). The current study is designed to evaluate pevonedistat in combination with azacitidine in patients with myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and low-blast AML. This study will assess whether taking…
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Study of Posaconazole (POS) in Immunocompromised Pediatric Subjects with Neutropenia (Low Neutrophils Type of White Blood Cell Count)

Condition: Pediatrics / Cancer
Investigator: Monica Bhatia, MD
Status: Closed
The purpose of this study is to: 1) Test the safety and tolerability of the research study drug, MK-5592 posaconazole (POS), intravenously (IV) and in powder for oral suspension (PFS), 2) Evaluate the pharmacokinetics (how the study drug is absorbed and broken down in the body), of POS IV solution and POS PFS, and 3) Evaluate the taste and reaction to the…
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Study of JCAR017 in Subjects with Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Condition: Cancer / Leukemia
Investigator: Nicole Lamanna, MD
Status: Closed
The overall purpose of this part of the study is to determine the best dose of JCAR017 for treating adult participants with relapsed or refractory B-cell Chronic Lymphocytic Leukemia (CLL), and Small Lymphocytic Lymphoma (SLL) and to understand the side effects that participants with your disease may have when they are treated with JCAR017.
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A study for patients with myelodysplastic syndrome or chronic myelomonocytic leukemia using study drug birinapant

Condition: Cancer / Leukemia
Investigator: Joseph Jurcic, MD
Status: Closed
The purpose of this part of the study is to obtain further information about the safety and effectiveness(how well it works) of azacitidine plus birinapant (the investigational drug), in people with higher-risk myelodysplastic syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMMoL). One of the standard drugs for these diseases is azacitidine which all…
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A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)

Condition: Cancer / Breast Cancer
Investigator: Dawn Hershman, MD
Status: Closed
This is a cohort study looking at the effects of anastrozole (an aromatase inhibitor) on patients, and specifically at Aromatose Inhibitor Musculoskeletal Symptoms (AIMSS). The genetic predictors of AIMSS will also be evaluated. Participants will take daily anastrazole and will be followed for 12 months. The study will enroll 35 patients at Columbia…
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Small Fiber Neuropathy in Juvenile Fibromyalgia

Condition: Pediatrics
Investigator: Alexis Boneparth, MD
Status: Closed
Juvenile fibromyalgia (JFM) is a cause of chronic, whole-body pain. The cause of JFM is unknown. One of the possible causes of JFM is a problem with nerves called "small fiber neuropathy." This is a problem where small nerve fibers in the skin are not working properly and patients can have pain as a result. Recent studies have found evidence of…
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A study for patients with LIV-1-positive metastatic breast cancer using study drug SGN-LIV1A

Condition: Cancer / Breast Cancer
Investigator: Kevin Kalinsky, MD, MS
Status: Closed
The purpose of this study is to find out what side effects (unwanted effects) are caused in patients with breast cancer who are given SGN-LIV1A (single therapy). This study will also look at other effects of SGN-LIV1A, including its effect on this type of cancer. This study is also being done to find out what side effects (unwanted effects) are caused in…
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MLN4924 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome (1 month to 17 years old)

Condition: Cancer / Childhood Leukemia
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to find the best dose of pevonedistat that can be given safely with chemotherapy in children with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) that has either come back or has not responded to the standard therapy. Pevonedistat works by blocking some of the enzymes that are needed for cell growth.
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A study for children with high-risk neuroblastoma using study drug unituxin

Condition: Pediatrics / Cancer
Investigator: Alice Lee, MD
Status: Closed
The purpose of this research study is to collect information about the percentage of people that develop HACA when they are treated with Unituxin and determine if HACA affects the blood levels of Unituxin. Unituxin is a type of antibody. Antibodies are made by the body to attack tumors and fight infections. Unituxin is a chimeric antibody which means it is…
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Study of Radiation Therapy After Mastectomy

Condition: Cancer / Breast Cancer
Investigator: Eileen Connolly, MD, PhD
Status: Closed
This study is for women who have been diagnosed with stage 2 or stage 3 breast cancer whose doctor has recommended that you receive radiation therapy after your mastectomy to prevent your breast cancer from coming back. Radiation uses particles of energy to kill any remaining cancer cells where your breast was removed or in the lymph nodes. Radiation after…
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