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…
Columbia University researchers want to hear from current IVF patients about which patient experiences they think should be studied and how. Participation includes a ~1 hour interview on Microsoft Teams about your notable IVF patient experiences and how you might want to share it for future research purposes. Participants will receive $30 for their…
The purpose of this registry is to keep track of people who are undergoing therapy for ductal carcinoma in situ (DCIS) and who are having molecular testing known as DCISionRT. A Registry is a databank of people who have something in common. Molecular testing looks at how certain genes are used by your tumor cells. The goal of this Registry is to help…
During pregnancy, a baby's heart rate can tell us a lot about how their brain and body develop. Our team is testing a new, easy-to-use device that you can wear at home to track the baby's heartbeat for up to 24 hours. By using the monitor in your everyday environment, we can learn more about your baby's development in a natural setting,…
The Lugo Lab at Columbia University's Department of Psychiatry is conducting a study to better understand experiences related to extreme heat during pregnancy and to inform the development of heat preparedness resources for perinatal care. We are recruiting English-speaking participants who are 18 years of age or older and reside in New York State and…
We are conducting a research trial to determine if low dose Aspirin either 81 or 162 mg will prevent preterm birth in patients who have had a previous preterm birth, still birth, or complications of pregnancy including preeclampsia, small for gestational age baby, fetal growth restriction, or placental abruption. You will be randomized to 81 or 162 mg and…
Columbia University researchers are looking to interview people for a study on patient decisions about whether to remove the fallopian tubes when having a hysterectomy, tubal ligation, or other sterilization surgery. If you are a woman 30-49 years of age, speak English, and have had a hysterectomy (for non-cancer reasons), tubal ligation, or another type of…
You are invited to participate in a research study to understand how environmental exposures during pregnancy influence the health and development of children. This study will begin at pregnancy and follow your child through age 11. A trained research worker will work with you and your child, administering questionnaires to you and developmental evaluations…
The Lugo Lab at Columbia University's Department of Psychiatry is conducting a study of stress and sleep in childhood and pregnancy, which will take place over the next year. We are recruiting pregnant people who identify as Latinx/Hispanic. You will be compensated for your time! We are flexible in scheduling convenient times for you to come in. The…
Our team is looking at the relationship between a mother and her baby to see how different prenatal and infant experiences affect a baby's brain development. Specifically, we are looking at maternal immune activation (MIA) and how prenatal exposure to MIA can affect a baby's development. For our study, we ask participants to come in for up to 3…
The Center for Intergenerational Psychiatry at Columbia University is recruiting pregnant individuals. We want to learn how feeling worried or anxious (or not having these feelings) may impact pregnant individuals and their babies. We would like to invite people from a wide-range backgrounds who are in between 12 to 34 weeks of their pregnancy to…
We are doing this study to test the use of a drug called bromocriptine for women with a condition called Peripartum cardiomyopathy (PPCM). The study will look at how the heart muscle improves in women taking bromocriptine compared to a group of women given a placebo or inactive pill.
This research study is being done to understand how CPAP for sleep apnea may affect hypertensive disorders of pregnancy and other complications of pregnancy such as gestational diabetes. The purpose of the home sleep test is to find women with sleep apnea. Sleep apnea is when you have one or more pauses in breathing or shallow breaths while you sleep.…
This study is being done to test the orally administered study drug, CA-4948 alone, in combination with ibrutinib, or ibrutinib alone in adult patients ages 18 and over diagnosed with relapsed or refractory (RR) Primary Central Nervous System Lymphoma (PCNSL). This study will take place at multiple centers globally. The study drug, CA-4948, is thought to…
The purpose of this study is to find out if performing Magnetic Resonance Image (MRI) scans of your brain with adaptive planning during your radiation treatment of your high-grade glioma will help determine how sensitive the images collected of the brain are at detecting the response of the tumor to the cancer treatment. In this study, four or seven MRI…
This study will enroll participants who did or did not receive a SARS-CoV-2 vaccine during their pregnancy and have a child who is now 18-30 months of age. In order to assess the long-term outcomes of the offspring of those who received SARS-CoV-2 vaccine in pregnancy, a cohort study examining child developmental outcomes is needed. There are a number of…
The purpose of the study is to evaluate the safety of Lutathera alone in patients with recurrent glioblastoma and the combination of Lutathera with radiotherapy with temozolomide (TMZ) in patients with newly diagnosed glioblastoma (GB) and to establish the appropriate dose of this combination. Lutathera is a radioligand therapy, which is a targeted…
Women will be enrolled at or prior to prenatal visit at 34-40 weeks gestation with follow-up visits within 48 hours of delivery, and 6 and 12 months postpartum among the mother and infant. Maternal and infant measurements will be conducted at each visit. The purpose of the study is to estimate cardiovascular disease risk in healthy and medically complicated…
Researchers at Columbia are looking at the changes that happen in the placenta when people become pregnant. Participation in this study involves a blood draw at three time points. Participants will be paid $50 at each time point. Participants who complete all three time points will receive bonus compensation.
Researchers at Columbia are looking into possible viral causes of stillbirth or late-term miscarriages in patients. We are looking for people who have recently had a late-term pregnancy loss (within the past week). Participation in this research involves a one-time blood draw. Participants will receive $50.
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…
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.
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…
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…
The purpose of this study is to test good and bad effects of these two different drugs against meningioma tumors with altered genes. Today, therapy for meningioma is the same for all patients and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients with meningioma.…
The purpose of this study is to find out if REC-2282, an investigational new drug, is an effective and safe treatment in patients with progressive NF2 mutated meningiomas who have either NF2 disease-related meningioma or recurrent sporadic meningiomas that have NF2 mutation. Investigational new drug means a drug that has not been approved as a marketed…
Are you currently pregnant or were you pregnant in the last 2 years? We want to hear from you! We are conducting interviews to understand how we can support physical and mental health during pregnancy and postpartum. Interviews will take place virtually over Zoom or via telephone and last about 60 minutes. There are also options to participate in person (…
The purpose of this study is to see how safe and effective Safusidenib erbumine, the study drug, is in treating brain glioma and to find the recommended dose of the study drug for clinical studies. Safusidenib is not Food and Drug Administration (FDA) approved.
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…
GO MOMs is an observational study designed to characterize the glycemic profile of pregnancy using continuous glucose monitoring (CGM) technology in order to develop criteria using CGM measurements and/or early pregnancy oral glucose tolerance testing (OGTT) at 10w0d-14w0d gestation that are predictive, along with clinical factors, of adverse pregnancy…
Ovaprene, is an experimental monthly non-hormonal intravaginal contraceptive being developed as a possible new method of birth control. It consists of a round piece of woven material surrounded by a soft, flexible rubber ring. The ring itself is made of a silicone rubber combined with the following ingredients: ferrous gluconate (a type of iron), Vitamin C…
The study is looking to evaluate levonogestrel butanoate as a possible new long-acting injectable for birth control. Levonogestrel butanoate is a type of hormone called progestin that has a long history of clinical use in a variety of birth control methods (e.g. pills, intrauterine devices, implants) and its efficacy and safety are well recognized. This…
Researchers at Columbia are looking at new treatments to help delay the start of menopause. This is a randomized trial where some women will receive medication and some will receive a placebo. The study will last approximately 12 weeks, followed by monthly follow-ups for 6 months. Participants will be compensated $1300 for compensation.
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…
The purpose of this study is to evaluate how safe the investigational drug, DSP-0390, is at different doses and to identify a recommended dose that is safe for further study. Investigational means that the study drug is currently being tested and has not been approved for use alone or in combination with any drug by the U.S. Food and Drug Administration (…
The purpose of this study is to see how safe the study medicine, IGV-001 plus standard of care (SOC), is and to compare IGV-001 with placebo see if it works in slowing glioblastoma multiforme (GBM) tumor regrowth. SOC refers to the usual medicine(s) or procedures used to treat your cancer. A placebo looks like the study medicine but does not contain any…
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…
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…
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…
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…
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…
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…
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…
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…
We are doing this study because we want to find out if adding a new immunotherapy drug to the usual combination of chemotherapy drugs is better or worse than the usual approach for your endometrial cancer. The usual approach is defined as care most people get for endometrial cancer.
The purpose of this research study is to see if the combination of medications approved for the treatment of glioblastoma, together with the study drug, selinexor (also known as XPOVIO), has any effects on your cancer. Selinexor works by trapping tumor suppressor proteins within the cell nucleus. This is expected to cause the cancer cells to die or stop…
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.
Nexplanon a contraceptive implant is currently approved for use up to 3 years. This study is looking to evaluate the contraceptive efficacy of Nexplanon during extended use for 2 more years (5 years total). You may be eligible if you are between the ages of 18-35 and are approaching 36 months from placement of your Nexplanon implant. Study participation…
This study is being done to evaluate the safety and usefulness of the study drug, AG-881, as compared to placebo (a medically inactive substance) in residual or recurrent non-enhancing Grade 2 glioma (a type of brain cancer) that has a mutation in the IDH1 or IDH2 metabolic enzyme (a substance produced by the body to assist in breaking down chemicals).…
The purpose of this research study is to test how safe and how well an investigational drug known as ONC201 works in treating high grade glioma (a type of brain cancer). The FDA (the U.S. Food and Drug Administration) has not approved ONC201 as a treatment for this condition.
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…
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).
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…
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…
Protocol is looking to evaluate efficacy of the EVO100 vaginal gel in the prevention of urogenital Chlamydia Trachomatis (CT) and Neisseria gonorrhoeae (GC) infections. You may be eligible if you are between the ages of 18 years or older with a CT and/or GC infectiondiagnosis within the last 16 weeks.
If you are a woman between the ages of 18 and 35, are pre-menopausal, sexually active and do NOT wish to become pregnant, you are invited to see if you may qualify for a research study. The purpose of this research study is to test the effectiveness of an investigational oral birth control pill. If you qualify, you will receive investigational study…
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…
The purpose of this study is to measure how well and how safe eflornithine is in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has come back after radiation and chemotherapy. Safety and how well you can tolerate the drug will be determined on the basis of physical exams, laboratory tests,…
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…
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…
The purpose of this study is to: See if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in patients who have been diagnosed with cancer and are experiencing fatigue. See the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer-related fatigue
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…
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…
The purpose of this study is to find out whether an experimental drug, bevacizumab with temozolomide is safe when given to elderly patients with brain tumors and investigate the side effects of the drug combination and how often they occur. This study will also explore whether bevacizumab and temozolomide can be effective in shrinking tumors when given to…
This research is being done to find out if TOLMAR formulation behaves in the body the same way DOXOrubicin does. This will be done by comparing the amount of doxorubicin in subjects' blood after they are given TOLMAR formulation compared to the amount of doxorubicin in the blood after they are given DOXOrubicin. This is a pharmacokinetic study.…
In this research study, we are looking for Information on how well nivolumab with or without ipilimumab works in combination with TTFields in adult patients with glioblastoma. You will receive the Nivolumab and/or Ipilimumab study treatment until you decide to stop study treatment or your study doctor decides to remove you from the study. This means that…
Do You Have a Mirena IUD? You may qualify for a study on the extended use of the Mirena IUD! You may qualify if you are 18 to 33 years old and had your Mirena placed in 2013. Compensation available for time and effort. Find out if you qualify!
The purpose of this study is to evaluate the safety and effectiveness of ATryn, for the treatment of early onset preeclampsia (high blood pressure during pregnancy). ATryn is is currently approved by the Food and Drug Administration (FDA) and is used to prevent blood clots from forming in patients who are having surgery or giving birth to a child. Eligible…
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)…
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…
The purpose of this study is to determine the safety of directly injecting a tumor chemotherapy drug called Topotecan and a contrast agent called Gadolinium into malignant brain tumors.
This is a research study to test the effects of VB-111 combined with Bevacizumab versus Bevacizumab alone on glioblastoma . This study will enroll 252 subjects age 18 years and older who have recurrent glioblastoma. All subjects will be randomly assigned in a 1:1 ratio to receive either VB-111 combined with Bevacizumab or Bevacizumab alone. Survival, tumor…
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,…
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.
The purpose of this study is to compare the effects, good and/or bad, of study drug cobimetinib and paclitaxel for patients with metastatic truple-negative breast cancer (mTNBC). In this study, you will receive either a combination of cobimetinib and paclitaxel or placebo (no active medication) and paclitaxel. The study will also evaluate what side effects…
The purpose of this research study to find out a new way of treating patients with cervical cancer byactivating their immune system to help their body fight the cancer. VGX-3100 and INO-9012 are aninvestigational drug. This means that the drug has not been approved by the Food and DrugAdministration (FDA) for medical use in patients, but has only been…
The purpose of this study is to test how well the study drug works in recurrent or isocitratedehydrogenase (IDH) mutant high grade gliomas. The study drug is called Nivolumab. Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow your own body's immune system to work against tumor cells. Nivolumab is not…
The purpose of this research study is to learn about the effects of the study drug, PF-06840003,and to find the best dose for treating research subjects/participants with malignant glioblastoma or anaplastic glioma. PF-068400003 is a new investigational drug. A new investigational drug is one that is currently not approved for sale in this country. PF-…
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…
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)…
This study is for women with breast cancer who will be undergoing lumbar puncture to evaluate for the presence of leptomeningeal metastasis, a complication in which the cancer spreads to the membranes (meninges) surrounding the brain and spinal cord. This condition is typically diagnosed by examining the cerebrospinal fluid obtained from the lumbar puncture…
You may be eligible if you are younger than 51 years old, have regular monthly periods with moderate to severe cramping, and are willing to try a NEW hormonal vaginal ring. The ring contains estrogen and progestin which are hormones found in some types of birth control pills, patches and rings.Participation in the study will consist of 6 study visits and 2…
This is a two-part research study of an investigational drug called ABBV-321 in subjects with glioblastoma (brain tumor). This study will be conducted in two-parts: 1) Dose Escalation Phase: The purpose of the first part, called a Dose Escalation Phase, is where we will increase the dose of ABBV-321 until we find the highest dose before unmanageable side…
Columbia University is conducting a contraceptive clinical trial looking at two intrauterine devices, one of which is investigational. Pre-menopausal women ages 16-40 who are generally healthy, sexually active, at risk for pregnancy, and are not at risk for sexually transmitted infections may qualify.
The purpose of this study is to survey study participants to determine their knowledge and attitudes towards fertility, and interest in understanding fertility management options. Recruited participants will be contacted via e-mail and invited to participate in online surveys and have hormone markers measured at the Columbia University Medical Center.
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.
The purpose of this study is to compare any good and bad effects of avoiding the hippocampus during whole-brain radiation plus memantine to using the usual whole-brain radiation plus memantine. The hippocampus is a brain structure that is important for memory. The addition of the hippocampal avoidance technique to the usual whole-brain radiation plus…
This is a Phase 2b/3 study to compare the effectiveness of the study drug ABT-414 against a placebo. Patients will be randomized to either receive the standard-of-care therapy which consists of radiation therapy/TMZ plus adjuvant TMZ which will be followed by eiter the study drug ABT-414 or a placebo monotherapy.
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.
The purpose of this study is to gather information on the safety of TH-302 and its effect on patients with HER2+ breast cancer. This study will also look at how the drug is processed in the body. In addition, this study will collect data from blood, tumor, and imaging studies about this specific cancer such as the level of oxygen that is present. This may…
The purpose of this study, which involves research, is being done to see how well an investigational new drug and study device combination will work to treat people with pre-cancerous cells on the cervix caused by human papillomavirus (HPV). The treatment combination is testing a drug, called VGX-3100, given by injection and used with the study device,…
The purpose of this study is to evaluate a new experimental (investigational) oral combination hormone drug product containing estradiol (a form of the estrogen) and progesterone (a female hormone that regulates the inner lining of the uterus called the endometrium) for postmenopausal women who have hot flushes. The estradiol and progesterone used in this…
The main purpose of this study is to improve treatment of ocular side effects that result from depatuxizumab mafodotin (Depatux-M) use in patients with glioblastoma (GBM). Most people treated with Depatux-M will experience eye side effects. When these side effects are not tolerated, Depatux-M is usually interrupted until symptoms improve and then restarted…
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…
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…
Some people who are treated for breast cancer develop swelling in their arms as a result of their treatment. This swelling is called lymphedema and it can be chronic. The purpose of this study is to see if early detection of arm swelling using a small painless device (called bioelectrical impedance), immediately followed by compression treatment, prevents…
The purpose of this research study is to compare the treatment device (Uphold LITE) to a traditional native tissue repair procedure for the treatment of symptoms for pelvic organ prolapse (POP). Uphold Lite is a non-absorbable synthetic mesh used to support tissue in women with POP. The device is inserted into the body through an incision in the vaginal…
The purpose of this study is to see how well an investigational new drug and study device combination work to treat women with pre-cancerous cells of the vulva caused by human papillomavirus (HPV) and,thereby avoid surgery. To participate in this study you must have high grade squamous intraepithelial lesion (HSIL) of the vulva caused by HPV types 16 or 18.
This randomized phase IIb trial studies how well alternative dosing of exemestane before surgery works in treating postmenopausal patients with stage 0-II estrogen positive breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of exemestane may treat early stage (stage 0-II) breast cancer. Comparing…
The purpose of this study is to see if the newly discovered vaccine drug, DSP-7888, will help your immune system to fight against cancer cells that have a protein called WT1. The study will also compare the effectiveness of treatment with DSP-7888 in combination with Bevacizumab versus Bevacizumab alone in patients with glioblastoma (GBM). Bevacizumab has…
This is a research study to test the effectiveness of ICT-107, an experimental drug, with the standard of care (SOC) for treatment of glioblastoma compared to enriched blood cells (PBMC) with the SOC. The study will enroll 400 subjects age 18 years and older with newly diagnosed glioblastoma. Following an initial SOC radiation treatment, patients will be…
This is a study looking to evaluate how well a new hormone-releasing Intrauterine Contraceptive called LevoCept works in healthy, sexually active women. The study will consist of 6 study visits including a screening visit prior to enrollment and monthly telephone calls over the course of a year. The study visits will vary but mostly consist of physical and…
The purpose of this study is to capture and evaluate clinical data about the long-term safety and effectiveness of Novilasee - a FDA-cleared minimally invasive treatment for benign breast tumors in hopes that tracking and analyzing the safety and effectiveness of Novilase in a real world application will benefit future patients and the breast cancer…
The main purpose of this study is to: Find out if the study vaccine therapies cause any side effects (unexpected or unwanted reactions) and how well they are tolerated in women with persistent HPV types 16 or 18 infection of the cervix. Find out whether your body responds (the immune response). Compare the effects (both good and bad) of the study…
The purpose of this study is test a new investigational vaginally inserted hormone drug product called TX-004HR on postmenopausal women who have symptoms of vulvar and vaginal atrophy (VVA). After menopause, the amount of estrogen circulating throughout a woman's body decreases and can result in changes in their vaginal tissue known as vulvar and…
The purpose of this clinical study is to evaluate safety of the study treatment, its effects on the immune system and on GBM. The study treatment includes several experimental therapies: INO-5401 + INO-9012 delivered by an electroporation device called CELLECTRA 2000 used for delivery of INO-5401 + INO-9012 into your muscle. You will also receive another…
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the bodys immune system to work against tumor cells. The effectiveness of BMS-936558…
The purpose of this study is to determine the effects of combining metformin and atorvastatin treatment in patients with newly diagnosed breast cancer during the interval between breast biopsy and surgery. Metformin is a common treatment for patients with diabetes, and atorvastatin is a common therapy for elevated cholesterol. We will examine the effects of…
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…
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…
The objective of this research study is to compare the treatment success rates and safety of two surgical treatment options: Native Tissue Repair and the Elevate Prolapse Repair System. You maychoose to participate in this research when you and your doctor have determined which surgical treatment option is right for you. The Elevate Prolapse Repair System…
The purpose of this research study is to test whether the advanced perfusion MRI done prior to starting Bevacizumab and a few weeks after starting Bevacizumab can determine your response to the treatment better than the standard MRI performed at typical time points. The researchers want to see if this type of advanced MRI is better or the same as what is…
The goal of the study is to determine whether coming to the hospital and having the labor started with medicine (i.e., labor induction) at 39 weeks of pregnancy can improve the baby's health at birth when compared with waiting for labor to start on its own.
The purpose of this research study is to see if Selinexor (KPT-330) has any effects against glioblastoma, a type of brain cancer. The study will be conducted at 3-5 sites in the United States and Europe and plan to enroll 30 patients with brain cancer. Patients will be screened prior to study participation. If their brain tumor is evaluated to require…
The purpose of this study is to find out what effects, good or bad, the experimental device, NovoTTF-100A has on patients with meningioma. This study is being done because currently there are no proveneffective medical treatments for a progressive meningioma that has failed surgery and/or radiation. The NovoTTF-100A System is a portable medical device. It…
This study will look at the safety and effectiveness of a new hormonal IUD. This IUD is a small device that a clinician will place in your uterus. It contains a progestin (a hormone) that releases a small amount of hormone to prevent pregnancy. Once the device is in, you will come in for periodic study visits over the course of a year.
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…
This clinical research study is for women between the ages of 35 and 42 years who are having difficulty becoming pregnant and who would like to receive treatment within an assisted reproductive technology (ART) program in order to become pregnant. The purpose of this research study is to test the safety and effectiveness of an investigation drug called FE…
The purpose of this study is to find out how safe and effective investigational birth control pill, LF111 may be as a contraceptive, how it affects women's menstrual bleeding patterns, and how long LF111 stays in women's bodies. Participants will take the new experimental birth control pill for one year, and will come to the medical center for 8…
This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when…
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…
The purpose of this study is to look at the effects of an investigational anti-cancer drug (BGB-290) in combination with radiation therapy and/or temozolomide in patients with newly diagnosed or recurring glioblastoma. BGB-290 is expected to work by preventing cancer cells from repairing their damaged genes, causing the progression of cancer to slow down.
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to work against tumor cells.
The purpose of this study is to determine whether the combination of study drugs Ruxolitinib plusTrastuzumab is safe and effective in stopping breast tumor growth in patients with HER2 positivemetastatic breast tumors who have already received Trastuzumab. Trastuzumab (Herceptin) is an FDA-approved treatment for HER2 positive breast cancer.
This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in…
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.
The purpose of this study is to investigate a novel treatment regimen for patients with recurrent Glioblastomas (GBM). In this phase 2 trial, the potentially synergistic action of PARP inhibition and anti-angiogenesis on DNA repair and biomarkers of angiogenesis and DNA repair will be evaluated.
The purpose of this study is to evaluate the effectiveness and safety of eribulin mesylate (eribulin) incombination with pembrolizumab in metastatic (spread of cancer from one part of body to another) triple-negative breast cancer (mTNBC).
The purpose of this study is to determine whether treatment with sacituzumab govitecan could provide a better response and improve survival (the amount of time you live without your cancer growing) than other forms of cancer treatment (either Eribulin, Capecitabine, Gemcitabine, Vinorelbine).
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness ofan investigational drug to learn whether the study drug works in treating a specific disease.Investigational means that the drug is being studied. In this research study, we are looking to compare the effects, good and bad, of the standard of care…
The purpose of this study is to find out whether study drug bortezomib with radiation therapy and Temozolomide is safe when given to patients with brain tumors. This study will also evaluate the side effects and see whether the combination of bortezomib with radiation and Temozolomide can be effective in shrinking tumors. Bortezomib is the investigational…
This study is studying the effectiveness and safety of a new birth control pill. The pill contains two hormones, drospirenone (a progestin) and estetrol (an estrogen), which combine to prevent pregnancy. Scientists think that estetrol may be safer and have more benefits than other estrogen hormones. The study lasts about one year, and you will come in for 7…
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…
We are asking you to participate in this research study because you are a woman of child-bearing age or potential and interested in using an intrauterine device (IUD) for birth control for up to 5 years.
The purpose of this study is to collect blood samples from women who are pregnant with a fetus that has been confirmed by prenatal microarray testing to have a chromosomal abnormality, such as a microdeletion (missing chromosomes) or microduplication (extra chromosomes). The sponsor of this study, Sequenom Laboratories, will use these samples to develop and…
The goal of this study is to determine if ribociclib in combination with letrozole as neoadjuvant endocrine therapy increases the proportion of women with PEPI score of 0 at surgery, compared to patients treated with letrozole alone therefore allowing more patients excellent outcomes without chemotherapy. The PEPI score measures the risk of breast cancer…
New data from the study of ABT-414 and ABBV-221 in patients with recurrent glioblastoma multiforme (GBM) have shown several examples where it seems evidence of disease progression (cancer that continues to grow and spread) was seen in MRI images, but examination of surgically removed tissue under the microscope did not agree with the MRI.
This is a research study to test the effectiveness of Toca 511/Toca FC, an experimental drug, for treatment of recurring brain tumors compared to current standard of care. The study will enroll 370 subjects age 18-85 years who choose to undergo removal of the tumor a second time. At the time of surgery patients will be randomly assigned in a 1:1 ratio to…
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…
To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab-based HER-2 targeted therapy.
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…
The unintended pregnancy rate is rising despite increased availability and use of different types of emergency contraception (EC) pills. Few studies have addressed reasons for EC failure, yet such an investigation may allow researchers to better understand if EC can be used more successfully.Recently studies have shown that EC failure rates are higher in…
The purpose of the research study is to see if selinexor has any effects against your cancer and toevaluate the side-effects of selinexor or selinexor in combination with temozolomide (TMZ ). One specific way cancer cells continue to grow is by getting rid of certain proteins called tumor suppressor proteins that would normally cause cancer cells to die.…
The purpose of this study is to test the effect of a drug called retosiban on stopping preterm labor and delaying the birth of her baby. We will also study the safety of the drug to find out what effects; good or bad, retosiban has on women in preterm labor and their fetuses. A previous small study, involving 93 women with preterm labor, found that…
The reason for this study is to find out if the experimental study drug, tesevatinib, is effective as a possible treatment for recurrent glioblastoma. Certain genetic information about your tumor will also be collected, by drawing blood, to help better understand why tesevatinib did or did not work in treating your recurrent glioblastoma. Although…
The purpose of this study is to find out if SL-701 is safe and tolerable for patients with recurrent glioblastoma multiforme (GBM). The study will also look at what effect SL-701 has on patient's brain tumor. SL-701 is a type of anti-cancer vaccine made up of parts 3 different short proteins called "peptides" which are frequently found on…
The UPA Breast Study will investigate a medication called ulipristal acetate (UPA), which is currently used as an emergency contraceptive and as a treatment for fibroids. The study is designed to investigate 1) whether taking UPA daily can decrease breast cell proliferation compared to traditional combined oral contraceptive pills; and 2) whether MRI can…
This is a study of patients delivering at Columbia University Medical Center-Allen Hospital. The investigators will compare the change in maternal hemoglobin from postpartum day 1 to day 2 and also try to find out if there is a correlation between estimated blood loss and measured blood loss.
The purpose of this study is to assess the effectiveness of AG200-15 which is an investigational birth control patch. AG200-15 is an investigational birth control patch being developed for use by women who wish to use a skin patch to prevent pregnancy. It contains LNG (levonorgestral) and EE (ethinyl estradiol), which are female sex hormones and are active…
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…
The purpose of this research study is to determine if the experimental drug balixafortide combined with eribulin is well tolerated and more effective for treating breast cancer compared with eribulin given alone. Balixafortide (POL6326) interacts with proteins called CXCR4 receptors which may directly suppress tumor growth through disruption of signaling…
Two different studies have been developed to treat people with anaplastic glioma brain tumors. Onetreatment research study requires a tumor that has the 1p/19q co-deletion tumor marker; the other does not. This treatment research study requires that the subject has a certain kind of tumor, one that is missing part of both chromosomes 1 and 19. These missing…
The purpose of this study is to test whether the new drug, ABT-414, given either alone or with a drug called temozolomide, which is commonly used to treat brain tumors like yours, gives a better outcome than the standard therapy and is safe. The standard therapy can be one of two different regimens, either a drug called lomustine or temozolomide.
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…
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.
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…
There are over 62 million US women in their child-bearing years, ages 15-44. Thirty-eight million use some form of contraception which included permanent sterilization (tubal ligation or vasectomyin male partner), contraceptive implants, intrauterine devices, injections, pills, patches, vaginal spermicides, and behavioral methods such as coitus interrupts…