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Displaying 1 - 118 of 118

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 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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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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MOMS - Supporting Physical and Mental Health During Pregnancy and Postpartum

Condition: Obstetrics & Gynecology / Pregnancy
Investigator: Natalie Benda, PhD
Status: Closed
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 (…
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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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Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs)

Condition: Obstetrics & Gynecology / Pregnancy
Investigator: Noelia Zork, MD
Status: Closed
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…
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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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Ovaprene Non-Hormonal Contraceptive Ring Study

Condition: Obstetrics & Gynecology / Contraception
Investigator: Paula Castano, MD, MPH
Status: Closed
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…
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Study Seeking to Evaluate the Effectiveness of LB as a Possible Injection Contraception Method (Females Age 18-40)

Condition: Obstetrics & Gynecology / Contraception
Investigator: Paula Castano, MD, MPH
Status: Closed
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…
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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 Rapamycin in Delaying the Start of Menopause

Condition: Obstetrics & Gynecology / Reproductive & Hormonal Disorders
Investigator: S. Zev Williams, MD, PhD
Status: Closed
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.
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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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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 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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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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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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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 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 Cabergoline in Adolescents and Adult Women with Endometriosis

Condition: Obstetrics & Gynecology
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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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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Study of Pembrolizumab in Combination with Chemotherapy for Patients with Endometrial Cancer

Condition: Obstetrics & Gynecology
Investigator: Jason Wright, MD
Status: Closed
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.
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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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Study About Extended Nexplanon Use in Females 18-35 Years Old

Condition: Obstetrics & Gynecology
Investigator: Paula Castano, MD, MPH
Status: Closed
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…
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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 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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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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Study of Vaginal Gel (EVO100) in Prevention of Chlamydia and Gonorrhea (Ages 18-24)

Condition: Obstetrics & Gynecology
Investigator: Paula Castano, MD, MPH
Status: Closed
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.
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New Birth Control Pill Study

Condition: Obstetrics & Gynecology / Contraception
Investigator: Carolyn Westhoff, MD
Status: Closed
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…
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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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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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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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Study Comparing Two Copper IUDs

Condition: Obstetrics & Gynecology / Contraception
Investigator: Paula Castano, MD, MPH
Status: Closed
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.
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A study evaluating the effect of Ulipristal Acetate (UPA) on breast cell growth in reproductive aged women for breast cancer prevention.

Condition: Obstetrics & Gynecology
Investigator: Carolyn Westhoff, MD
Status: Closed
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…
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Study of Glecaprevir/Pibrentasvir in Pediatric Subjects with Chronic Hepatitis C Virus (HCV) Infection

Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Closed
Open-labeled hepatitis C pediatric treatment trial with a two drug direct acting viral oral combination (already approved in adults) across all genotypes for naive or treatment experienced subjects.
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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 healthy women seeking birth control using Agile contraceptive patch, AG200-15

Condition: Obstetrics & Gynecology / Contraception
Investigator: Paula Castano, MD, MPH
Status: Closed
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…
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Study of Patients Receiving an Allogeneic Stem Cell Transplantation for Non-Malignant Disease

Condition: Pediatrics
Investigator: Diane George, MD
Status: Closed
The purpose of this study is to determine the incidence and severity of acute GVHD following CD34+ selection in children, adolescents and young adults receiving an allogeneic peripheral blood stem cell transplant from a family member or unrelated adult donor for a non-malignant condition.
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VGX-3100 Followed by Electroporation with Cellectra for HPV-related High-Grade Squamous Intraepithelial Lesion of Cervix (REVEAL 2)

Condition: Obstetrics & Gynecology
Investigator: June Hou, MD
Status: Closed
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,…
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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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Birth control research study of an investigational intrauterine copper contraceptive

Condition: Obstetrics & Gynecology / Contraception
Investigator: Carolyn Westhoff, MD
Status: Closed
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…
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Testing combination drugs in children with solid tumors that have come back or are resistant to current anti-cancer therapy

Condition: Cancer / Pediatric Solid Tumors
Investigator: Nobuko Hijiya, MD
Status: Closed
This is a Phase 1 multicenter study of pevonedistat in combination with Temozolomide and Irinotecan in pediatric patients with refractory solid tumors, including CNS tumors and lymphoma. The study treatment is considered experimental because pevonedistat is not approved by the United States (US) Food and Drug Administration (FDA) for treating pediatric…
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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 clinical trial for children with 15Q duplication syndrome or CDKL5 deficiency disorder to help control seizures.

Condition: Pediatrics
Investigator: Wendy Chung, MD, PhD
Status: Closed
The purpose of this research is to determine whether a new investigational drug called TAK-935 is safe and whether it may help treat epilepsy in children with 15q duplication syndrome or CDKL5 deficiency disorder.
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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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Study of VGX-3100 for patients with squamous intraepithelial lesion (HSIL) of the vulva

Condition: Obstetrics & Gynecology
Investigator: Ana Tergas, MD
Status: Closed
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.
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A study for women with ovarian cancer who have failed chemotherapy using study drug Liposome-Encapsulated Doxorubicin Hydrochloride

Condition: Obstetrics & Gynecology
Investigator: June Hou, MD
Status: Closed
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.…
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Study of Entinostat in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors and Lymphoma

Condition: Cancer / Pediatric Solid Tumors
Investigator: Alice Lee, MD
Status: Closed
This study is being carried out by the Childrens Oncology Group (COG) Phase 1 Consortium. COG is an international research group that consists of more than 200 hospitals that treat children with cancer in the United States, Canada, Australia, and Switzerland. The Phase 1 Consortium is the group within COG that consists of 21 hospitals, and participation in…
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A study for pregnant women with high blood pressure using study drug, ATryn

Condition: Obstetrics & Gynecology / Preeclampsia
Investigator: Kirsten Cleary, MD
Status: Closed
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…
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CD34 Stem Cell Selection for Malignant Condition

Condition: Pediatrics / Cancer
Investigator: Diane George, MD
Status: Closed
The purpose of this study is to determine the incidence and severity of acute GVHD following CD34+ selection in children, adolescents and young adults receiving an allogeneic peripheral blood stem cell transplant from a family member or unrelated adult donor for a malignant condition.
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Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score (TEAMMATE) (Pediatric)

Condition: Pediatrics / Cardiology
Investigator: Irene Lytrivi, MD
Status: Closed
This is a Phase 3 multi-center open label randomized clinical trial. The purpose of this study is to learnmore about which anti-rejection (or immunosuppressive) medications best protect infants, children,adolescents, and young adults after they have had a heart transplant. Two different drug regimens will bewill be compared. All of these drugs are FDA-…
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Study of HVP16 and HPV18 Vaccine Components in Overwise Healthy Women with Persistent HPV16 or 18 Infection of the Cervix

Condition: Obstetrics & Gynecology
Investigator: Ana Tergas, MD
Status: Closed
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…
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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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A study for women with cervical cancer using study drugs VGX-3100 and INO-9012

Condition: Obstetrics & Gynecology
Investigator: Ana Tergas, MD
Status: Closed
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…
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Decitabine and Vorinostat Followed by Fludarabine, Cytarabine, and G-CSF (FLAG) in Children & Young Adults with Acute Myeloid Leukemia

Condition: Cancer / Childhood Leukemia
Investigator: Nobuko Hijiya, MD
Status: Closed
This is a Phase 1 multicenter study of Decitabine (DEC) and Vorinostat (VOR) followed by the standard chemotherapy drugs (Fludarabine, Cytarabine and G-CSF (FLAG)). 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 myeloid leukemia (AML)…
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This study is comparing the outcomes of labor induction versus natural delivery for women with the first pregnancy.

Condition: Obstetrics & Gynecology / Pregnancy
Investigator: Cynthia Gyamfi Bannerman, MD
Status: Closed
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.
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A study for women with moderate to severe abdominal cramping during menstruation using a new hormonal vaginal ring

Condition: Obstetrics & Gynecology / Abdominal Cramping
Investigator: Anne Davis, MD
Status: Closed
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…
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Study of EBV-CTLs in Patients with Epstein-Barr Virus-Associated Viremia or Lymphoma

Condition: Pediatrics / Cancer
Investigator: Ran Reshef, MD
Status: Closed
Epstein-Barr Virus (EBV) is the virus that causes mononucleosis, also known as mono. Almost all adults have had EBV. For most people, EBV never causes a health problem. However, when their immune system is not working properly (people who have had a transplant and those who have immune disorders), EBV can cause certain diseases where cells grow abnormally.…
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A study on women and fertility using online surveys to determine knowledge and attitude

Condition: Obstetrics & Gynecology / Fertility
Investigator: Nataki Douglas, MD, PhD
Status: Closed
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.
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Study of Hematopoietic Stem Cell Transplantation (HSCT) in non-cancer disease

Condition: Pediatrics
Investigator: Monica Bhatia, MD
Status: Closed
The overall purpose of this research is to treat diseases that are not cancer but are improved by bone marrow transplantation with mild and safer chemotherapy as pretransplant conditioning. This treatment is chosen because it is milder and is likely to have fewer long and short term side effects unlike older chemotherapy and radiation treatments. Yet, it…
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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 clinical trial investigating the safety and evaluating how well a study drug works in women having difficulty becoming pregnant

Condition: Obstetrics & Gynecology / Fertility
Investigator: Eric Forman, MD, HCLD
Status: Closed
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…
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Study of Experimental Drug in Pediatric Patients with Solid Tumors, including CNS Tumors

Condition: Cancer / Pediatric Solid Tumors
Investigator: Alice Lee, MD
Status: Closed
This is a Phase 1 multicenter study of a drug called ABI-009 (nab-Rapamycin) in combination withtemozolomide and irinotecan in children and young adults with solid tumors (including CNS tumors)which have come back or have not responded to standard therapy. The study is considered experimental because ABI-009 (nab-Rapamycin) is not approved by the United…
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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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A study for Menopausal women using an investigational drug TX004-HR to reduce the frequency of hot flushes.

Condition: Obstetrics & Gynecology / Reproductive & Hormonal Disorders
Investigator: Rogerio Lobo, MD, FACOG
Status: Closed
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…
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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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Study of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Subjects with Central Nervous System Malignancies

Condition: Pediatrics / Cancer
Investigator: Luca Szalontay, MD
Status: Closed
The purpose of this study is to find out more about the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558) when given alone or when combined with ipilimumab in children/ adolescents/ young adults with high grade primary central nervous system (CNS) malignancies (certain…
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A study for women who want permanent birth control without surgery

Condition: Obstetrics & Gynecology / Contraception
Investigator: Paula Castano, MD, MPH
Status: Closed
The purpose of this study is to test the safety of the FemBloc Permanent Contraceptive System as a method to prevent pregnancy.
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A study for women with pelvic organ prolapse using urogynecologic surgical mesh Uphold LITE

Condition: Obstetrics & Gynecology
Investigator: Cara Grimes, MD, FACOG
Status: Closed
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…
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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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A study for male adolecents with muscular dystrophy using study drug Eteplirsen

Condition: Pediatrics / Neuromuscular
Investigator: Jacinda Sampson, MD
Status: Closed
The purpose of this study is to find out if eteplirsen can help people with the muscle disorder called Duchenne Muscular Dystrophy (DMD) and find out if eteplirsen is safe to take without causing too many side effects. Eteplirsen is an investigational (experimental) drug and can only be used in research studies. DMD is caused by a mutation (a change) in the…
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VeraCept Phase III

Condition: Obstetrics & Gynecology / Contraception
Investigator: Paula Castano, MD, MPH
Status: Closed
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.
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A study for healthy, sexually active women using a hormone-releasing intrauterine contraceptive called LevoCept

Condition: Obstetrics & Gynecology / Contraception
Investigator: Carolyn Westhoff, MD
Status: Closed
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…
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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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A study for children and adolescents with relapsed or refractory acute myeloid leukemia using study drug Lenalidomide

Condition: Pediatrics / Cancer
Investigator: Alice Lee, MD
Status: Closed
This study is for children with relapsed or refractory acute myeloid leukemia (rrAML). Acute myeloid leukemia is a fast growing cancer of the blood and bone marrow. This study examines the effects of study drug Lenalidomide on children with rrAML. Lenalidomide is an anti-cancer drug that belongs to a group of drugs known as immunomodulating drugs (IMiDs), a…
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A study for postmenpausal women with symptoms of moderate to severe vaginal pain associated with sexual activity using study drug TX-004HR

Condition: Obstetrics & Gynecology
Investigator: Rogerio Lobo, MD, FACOG
Status: Closed
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…
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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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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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Prolonging pregnancy in women with unexpected early labor using study drug Retosiban

Condition: Obstetrics & Gynecology / Pregnancy
Investigator: Cynthia Gyamfi Bannerman, MD
Status: Closed
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…
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A study for women with Pelvic Organ Prolapse who require surgical treatment using Elevate Anterior and Apical Prolapse repair system

Condition: Obstetrics & Gynecology
Investigator: Cara Grimes, MD, FACOG
Status: Closed
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…
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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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Improvement of exercise capacity in patients with Fontan physiology

Condition: Pediatrics / Cardiology
Investigator: Marc Richmond, MD
Status: Closed
Over time, children and young adults who have had a Fontan operation may find they are more tired, have difficulty breathing and cannot exercise as well as before. Currently, there are no approved medicines to prevent this decline. The purpose of this research study is to learn whether children who have had the Fontan operation can improve their ability to…
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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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A study for children with pediatric acute Lymphoblastic Leukemia using study drug Moxetumomab Pasudotox

Condition: Pediatrics / Cancer
Investigator: Maria Sulis, MD
Status: Closed
The purpose of this study is to determine the effectiveness and safety of the study drug moxetumomab pasudotox in treating children with relapsed or refractory pALL or Lymphoblastic Lymphoma of B-cell origin. Moxetumomab pasudotox is made up of two parts: 1) a modified mouse antibody that attaches to a protein from the immune system, called CD22, which can…
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QUOTABL: Study of Postpartum Hemoglobin Assessment in Patients Delivering at Allen Hospital

Condition: Obstetrics & Gynecology / Pregnancy
Investigator: Rachana Gavara, MD
Status: Closed
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.
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A study looking at the effectiveness and safety of a new hormonal IUD (Intrauterine Device)

Condition: Obstetrics & Gynecology / Contraception
Investigator: Carolyn Westhoff, MD
Status: Closed
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.
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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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A study for pediatric patients with mild to moderate Ulcerative Colitis using study drug MMX Mesalamine/Mesalazine

Condition: Pediatrics
Investigator: Ali Mencin, MD
Status: Closed
This study is evaluating an investigational medication to see if it is safe and if it works well in children andadolescents who have mild to moderate ulcerative colitis (UC) or are in remission. Ulcerative colitis (UC) is a chronic disease of the last section of the intestine, which is also known as the colon. If you have UC, the lining of your colon…
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A study for women using contraceptive study drug LF111

Condition: Obstetrics & Gynecology / Contraception
Investigator: Anne Davis, MD
Status: Closed
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…
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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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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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A study for children with an Inammatory Bowel Disease (IBD) such as Crohn's disease or ulcerative colitis

Condition: Pediatrics
Investigator: Joel Lavine, MD
Status: Closed
Researchers at Columbia University are conducting a clinical research study of children with inammatory bowel disease (IBD). This study will examine the eectiveness and safety of an investigational medication inchildren with IBD.
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Contraceptive Vaginal Ring

Condition: Obstetrics & Gynecology / Contraception
Investigator: Paula Castano, MD, MPH
Status: Closed
Hormonal Vaginal Ring for Contraception
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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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Bowel Prep Study

Condition: Pediatrics
Investigator: Ali Mencin, MD
Status: Closed
This research study is for children age 12 to 16. In this research study, we will evaluate the safety, effectiveness and tolerability of two different doses of a bowel cleansing medication referred to as BLI-800. One group of study participants will receive the larger dose (6 oz.), which dose has been approved by the FDA for use by adults. A second group 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 of children with relapsed or refractory solid tumors and large cell lymphoma using study drug, PF-02341066 for treatment

Condition: Cancer / Pediatric Solid Tumors
Investigator: Julia Glade Bender, MD
Status: Closed
The purpose of this study is to examine the effectiveness and tolerability of a study drug called PF-02341066. Additional goals of this study are to learn how the body handles the study drug as well as determine whether or not PF-02341066 is a beneficial treatment for your tumor This study is for children with a recurrent or progressive tumor or lymphoma…
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Study of Extended Use of Mirena Beyond 5 Years in Women

Condition: Obstetrics & Gynecology / Contraception
Investigator: Paula Castano, MD, MPH
Status: Closed
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!
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E4 Birth Control Pill Study

Condition: Obstetrics & Gynecology / Contraception
Investigator: Carolyn Westhoff, MD
Status: Closed
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…
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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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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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A study for pregnant women to test fetal chromosomal abnormality

Condition: Obstetrics & Gynecology / Prenatal Abnormalities
Investigator: Ronald Wapner, MD
Status: Closed
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…
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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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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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A study for children and adolescents with advanced non central nervous system (CNS) tumors using study drug Talimogene laherparepvec

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 talimogene laherparepvec will be used in children/adolescents/young adults with advanced solid tumors not involving the central nervous system that are available for direct injection. This is a phase 1 study, multicenter, open-label study, that means all subject enrolled in the…
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Help us learn how Emergency Contraception (EC) is absorbed

Condition: Obstetrics & Gynecology / Contraception
Investigator: Carolyn Westhoff, MD
Status: Closed
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…
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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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