315 matching studies

Sponsor Condition of Interest
A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects...
AbbVie Ulcerative Colitis (UC)
This study comprises three sub-studies. The objective of sub-study 1 is to characterize the dose-response, efficacy, and safety of ABT-494 compared to placebo in inducing clinical remission in order to identify the induction dose of ABT-494 for further evaluation in sub-study... expand

This study comprises three sub-studies. The objective of sub-study 1 is to characterize the dose-response, efficacy, and safety of ABT-494 compared to placebo in inducing clinical remission in order to identify the induction dose of ABT-494 for further evaluation in sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of ABT-494 compared to placebo in inducing clinical remission in participants. The objective of sub-study 3 is to evaluate the efficacy and safety of ABT-494 compared to placebo in achieving clinical remission in participants who had a response following induction with ABT-494.

Type: Interventional

Start Date: Sep 2016

open study

A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia...
Rigel Pharmaceuticals Warm Antibody Autoimmune Hemolytic Anemia
The purpose of this study is to evaluate whether fostamatinib is safe and effective in treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA). expand

The purpose of this study is to evaluate whether fostamatinib is safe and effective in treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).

Type: Interventional

Start Date: Apr 2016

open study

Cerebrotendinous Xanthomatosis (CTX) Prevalence Study
Retrophin, Inc. Cerebrotendinous Xanthomatosis (CTX)
This is an observational, multicenter study to determine the prevalence of Cerebrotendinous Xanthomatosis (CTX) in patient populations diagnosed with early-onset idiopathic bilateral cataracts. Patients who are potentially eligible for study participation will be identified through... expand

This is an observational, multicenter study to determine the prevalence of Cerebrotendinous Xanthomatosis (CTX) in patient populations diagnosed with early-onset idiopathic bilateral cataracts. Patients who are potentially eligible for study participation will be identified through a chart review of patients who were seen at each study site prior to that site's initiation, or by entering care at the site while the site is participating in the trial.

Type: Observational

Start Date: Sep 2015

open study

EZN-2279 in Patients With ADA-SCID
Leadiant Biosciences, Inc. ADA-SCID Adenosine Deaminase Deficiency Severe Combined Immunodeficiency
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of EZN-2279 in patients with ADA-deficient combined immunodeficiency currently being treated with Adagen. expand

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of EZN-2279 in patients with ADA-deficient combined immunodeficiency currently being treated with Adagen.

Type: Interventional

Start Date: Dec 2013

open study

Neuropsychological and Behavioral Testing in Younger Patients With Cancer
Children's Oncology Group Chemotherapeutic Agent Toxicity Childhood Cancer Cognitive/Functional Effects Neurotoxicity Psychosocial Effects of Cancer and Its Treatment
This research trial studies neuropsychological (learning, remembering or thinking) and behavioral testing in younger patients with cancer. Collecting information over time from a series of tests may help doctors develop effective tests to measure neuropsychological and behavioral... expand

This research trial studies neuropsychological (learning, remembering or thinking) and behavioral testing in younger patients with cancer. Collecting information over time from a series of tests may help doctors develop effective tests to measure neuropsychological and behavioral function of patients with cancer.

Type: Observational

Start Date: Sep 2008

open study

Collecting and Storing Samples of Bone Marrow and Blood From Patients With Relapsed Acute Lymphoblastic...
Children's Oncology Group Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Non-Hodgkin Lymphoma Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Non-Hodgkin Lymphoma
This research study is collecting and storing samples of bone marrow and blood from patients with relapsed acute lymphoblastic leukemia or relapsed non-Hodgkin lymphoma. Collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory... expand

This research study is collecting and storing samples of bone marrow and blood from patients with relapsed acute lymphoblastic leukemia or relapsed non-Hodgkin lymphoma. Collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and help predict the recurrence of cancer.

Type: Observational

Start Date: Sep 2006

open study

Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa
Montefiore Medical Center Hidradenitis Suppurativa Hidradenitis
To establish the safety of radiotherapy in the treatment of advanced hidradenitis suppurativa. Patients will receive radiotherapy treatment over one week and then they will be followed for the next three months. expand

To establish the safety of radiotherapy in the treatment of advanced hidradenitis suppurativa. Patients will receive radiotherapy treatment over one week and then they will be followed for the next three months.

Type: Interventional

Start Date: Mar 2017

open study

Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
Icahn School of Medicine at Mount Sinai Mild Tricuspid Regurgitation Moderate Tricuspid Regurgitation Tricuspid Regurgitation
The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart health of those who receive it compared to those who... expand

The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart health of those who receive it compared to those who do not. At this point, the medical community is split in their opinion on whether surgeons should routinely repair mild to moderate TR in patients who are undergoing planned mitral valve surgery, and this study will answer this question.

Type: Interventional

Start Date: May 2016

open study

Intravenous Gammaglobulin for Sickle Cell Pain Crises
Albert Einstein College of Medicine, Inc. Sickle Cell Disease Pain
The purpose of this study is to determine whether intravenous immune globulin is safe and effective in the acute treatment of pain crises in sickle cell disease. Funding Source: Food and Drug Administration (FDA), Office of Orphan Products Development (OOPD) expand

The purpose of this study is to determine whether intravenous immune globulin is safe and effective in the acute treatment of pain crises in sickle cell disease. Funding Source: Food and Drug Administration (FDA), Office of Orphan Products Development (OOPD)

Type: Interventional

Start Date: Nov 2008

open study

Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic...
Children's Oncology Group Adult B Lymphoblastic Lymphoma Childhood B Acute Lymphoblastic Leukemia Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1 Childhood B Lymphoblastic Lymphoma Down Syndrome
This partially randomized phase III trial studies different combinations of risk-adapted chemotherapy regimens and their side effects and comparing how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic... expand

This partially randomized phase III trial studies different combinations of risk-adapted chemotherapy regimens and their side effects and comparing how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.

Type: Interventional

Start Date: Aug 2010

open study

Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk...
Children's Oncology Group Ganglioneuroblastoma Localized Resectable Neuroblastoma Localized Unresectable Neuroblastoma Recurrent Neuroblastoma Regional Neuroblastoma
This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring... expand

This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.

Type: Interventional

Start Date: Jul 2014

open study

Impact of Hidradenitis Suppurativa on Quality of Life Functions
Montefiore Medical Center Hidradenitits Suppurativa Quality of Life
The goal of this study is to get a better understanding of the impact of the skin condition, Hidradenitis Suppurativa, on quality of life function of patients with this condition. Patients with HS will be asked questions about demographics including gender, age, and ethnicity.... expand

The goal of this study is to get a better understanding of the impact of the skin condition, Hidradenitis Suppurativa, on quality of life function of patients with this condition. Patients with HS will be asked questions about demographics including gender, age, and ethnicity. They will also be asked to complete questionnaires to determine how their skin condition affects their life. Study participation will last for 1 day, with potential for follow-up in the future.We hope this information will help us improve our treatment for this skin condition.

Type: Observational [Patient Registry]

Start Date: Apr 2015

open study

SNP-based Microdeletion and Aneuploidy RegisTry (SMART)
Natera, Inc. 22q11 Deletion Syndrome DiGeorge Syndrome Trisomy 21 Trisomy 18 Trisomy 13
This multi-center prospective observational study is designed to track birth outcomes and perinatal correlates to the Panorama prenatal screening test in the general population among ten thousand women who present clinically and elect Panorama microdeletion and aneuploidy screening... expand

This multi-center prospective observational study is designed to track birth outcomes and perinatal correlates to the Panorama prenatal screening test in the general population among ten thousand women who present clinically and elect Panorama microdeletion and aneuploidy screening as part of their routine care. The primary objective is to evaluate the performance of Single Nucleotide Polymorphism (SNP)-based Non Invasive Prenatal Testing (NIPT) for 22q11.2 microdeletion (DiGeorge syndrome) in this large cohort of pregnant women. This will be done by performing a review of perinatal medical records and obtaining biospecimens after birth to perform genetic diagnostic testing for 22q11.2 deletion. Results from the follow-up specimens will be compared to those obtained by the Panorama screening test to determine test performance. Specific test performance parameters will include: PPV, specificity, and sensitivity.

Type: Observational [Patient Registry]

Start Date: Apr 2015

open study

Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating...
Children's Oncology Group Childhood Infratentorial Ependymoma Childhood Supratentorial Ependymoma Newly Diagnosed Childhood Ependymoma
This randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine... expand

This randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

Type: Interventional

Start Date: Mar 2010

open study

Randomized On-X Anticoagulation Trial
On-X Life Technologies, Inc. Heart Valve Disease
Various patient groups with the On-X Valve can be maintained safely on lower doses of blood thinner(Coumadin®) or on antiplatelet drugs (aspirin/Plavix®) only rather than the standard dose of Coumadin and aspirin presently recommended by ACC/AHA or ACCP professional societies.... expand

Various patient groups with the On-X Valve can be maintained safely on lower doses of blood thinner(Coumadin®) or on antiplatelet drugs (aspirin/Plavix®) only rather than the standard dose of Coumadin and aspirin presently recommended by ACC/AHA or ACCP professional societies.

Type: Interventional

Start Date: Jul 2006

open study

Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor...
University of North Carolina, Chapel Hill Pediatric Crohn's Disease
The purpose of this study is to determine whether adding low dose methotrexate to anti -TNF therapy is more effective than treatment with anti-TNF therapy alone in inducing and maintaining steroid-free remission for children with Crohn's Disease. expand

The purpose of this study is to determine whether adding low dose methotrexate to anti -TNF therapy is more effective than treatment with anti-TNF therapy alone in inducing and maintaining steroid-free remission for children with Crohn's Disease.

Type: Interventional

Start Date: Oct 2016

open study

A National Registry For Patients With Hidradenitis Suppurativa
Montefiore Medical Center Hidradenitis Suppurativa
The goal of this study is to get a better understanding of the skin condition, Hidradenitis Suppurativa, and to find out how the disease affects quality of life. We hope this information will help us improve our treatment for this skin condition expand

The goal of this study is to get a better understanding of the skin condition, Hidradenitis Suppurativa, and to find out how the disease affects quality of life. We hope this information will help us improve our treatment for this skin condition

Type: Observational

Start Date: Aug 2015

open study

Assessing Compliance With Mercaptopurine Treatment in Younger Patients With Acute Lymphoblastic Leukemia...
Children's Oncology Group Childhood Acute Lymphoblastic Leukemia in Remission
This randomized phase III trial studies compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute lymphoblastic leukemia in remission. Assessing ways to help patients who have acute lymphoblastic leukemia to take their medications... expand

This randomized phase III trial studies compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute lymphoblastic leukemia in remission. Assessing ways to help patients who have acute lymphoblastic leukemia to take their medications as prescribed may help them in taking their medications more consistently and may improve treatment outcomes.

Type: Interventional

Start Date: Feb 2012

open study

Effectiveness of a Patient Decision Aid in Immediate Postpartum Contraceptive Counseling
Montefiore Medical Center Contraception
Effective physician-patient communication in postpartum contraceptive counseling is essential for patients to meet their contraceptive needs and reduce the risk of rapid repeat pregnancies. This project will utilize a patient decision aid to facilitate shared decision making... expand

Effective physician-patient communication in postpartum contraceptive counseling is essential for patients to meet their contraceptive needs and reduce the risk of rapid repeat pregnancies. This project will utilize a patient decision aid to facilitate shared decision making in the immediate postpartum setting, assess the effectiveness of such aid in "decision quality" and "decision-making process quality", and observe its effects on contraceptive choice mix at the time of discharge.

Type: Interventional

Start Date: Jan 2017

open study

Ischemia Care Biomarkers of Acute Stroke Etiology (BASE)
Ischemia Care LLC Ischemic Stroke Atrial Fibrillation Transient Ischemic Attacks Transient Cerebrovascular Events Thrombotic Stroke
The proposed study will validate the clinical use of new biomarker blood tests to identify blood components that may differentiate between diverse stroke etiologies and clinical outcomes as listed below: 1. Differentiate between cardioembolic and large artery atherosclerotic... expand

The proposed study will validate the clinical use of new biomarker blood tests to identify blood components that may differentiate between diverse stroke etiologies and clinical outcomes as listed below: 1. Differentiate between cardioembolic and large artery atherosclerotic ischemic strokes, when hemorrhagic stroke is ruled out. 2. In cases of ischemic strokes of unknown or "cryptogenic" etiology, determine the ability of biomarker blood tests to predict etiology between cardioembolic and large artery atherosclerotic. 3. In cases of cardioembolic ischemic stroke, further differentiation of cardioembolic ischemic strokes into those caused by atrial fibrillation (AF) and those not caused by AF. 4. Differentiate "transient ischemic attacks" (TIAs) from acute ischemic strokes. 5. Differentiate TIAs from non-ischemic "transient neurological events" (TNE) with similar symptoms.

Type: Observational

Start Date: Dec 2013

open study

Management of Reflux After Sleeve Using Stretta
Montefiore Medical Center GERD Morbid Obesity
Gastroesophageal reflux disease (GERD) is a frequently seen entity after sleeve gastrectomy. Management of GERD after sleeve is difficult given limited treatment modalities. Stretta is an endoscopic FDA approved device that improves symptoms of GERD, there is minimal information... expand

Gastroesophageal reflux disease (GERD) is a frequently seen entity after sleeve gastrectomy. Management of GERD after sleeve is difficult given limited treatment modalities. Stretta is an endoscopic FDA approved device that improves symptoms of GERD, there is minimal information about its use on patients after sleeve. This registry will attempt to get information regarding the treatment of reflux using Stretta after sleeve gastrectomy.

Type: Observational [Patient Registry]

Start Date: Apr 2016

open study

Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH
Bellerophon Pulse Technologies Pulmonary Arterial Hypertension
Phase 3, placebo controlled, double-blind, randomized clinical study to determine safety, tolerability, and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH). Part 1 and Part 2 expand

Phase 3, placebo controlled, double-blind, randomized clinical study to determine safety, tolerability, and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH). Part 1 and Part 2

Type: Interventional

Start Date: Apr 2016

open study

Bone Marrow Transplantation vs Standard of Care in Patients With Severe Sickle Cell Disease (BMT CTN...
Medical College of Wisconsin Sickle Cell Disease
This is a clinical trial that will compare survival and sickle related outcomes in adolescents and young adults with severe sickle cell disease after bone marrow transplantation and standard of care. The primary outcome is 2-year overall survival. expand

This is a clinical trial that will compare survival and sickle related outcomes in adolescents and young adults with severe sickle cell disease after bone marrow transplantation and standard of care. The primary outcome is 2-year overall survival.

Type: Interventional

Start Date: Nov 2016

open study

HCV Group Evaluation and Treatment Uptake (HCV GET-UP) Intervention
Montefiore Medical Center Hepatitis C Substance Use Disorders
People who inject drugs (PWID) represent the overwhelming majority of both HCV and HIV/HCV infected people in the United States. Though new, direct-acting HCV medications are highly efficacious and have the potential to end the HCV epidemic, few PWIDs ever initiate treatment.... expand

People who inject drugs (PWID) represent the overwhelming majority of both HCV and HIV/HCV infected people in the United States. Though new, direct-acting HCV medications are highly efficacious and have the potential to end the HCV epidemic, few PWIDs ever initiate treatment. We seek to improve HCV treatment uptake and cure among HCV and HIV/HCV+ PWIDs by testing a primary care based HCV Group Evaluation and Treatment UPtake (HCV GET-UP) intervention. If efficacious, this innovative care intervention could provide a means to reduce the growing mortality from HCV, as well as decrease the current reservoir for HCV transmission.

Type: Interventional

Start Date: Feb 2017

open study

Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients
Montefiore Medical Center Pain, Postoperative
Methadone has several advantages over standard narcotic medications, especially when considering use after a typically painful surgery such as lumbar fusion. Methadone is low cost, has a long half-life, has a convenient dosing schedule, has excellent oral bioavailability, and... expand

Methadone has several advantages over standard narcotic medications, especially when considering use after a typically painful surgery such as lumbar fusion. Methadone is low cost, has a long half-life, has a convenient dosing schedule, has excellent oral bioavailability, and demonstrates slow onset to withdrawal. The literature comparing methadone to more commonly used post-operative narcotics demonstrates that it manages pain better, sustains consistent plasma concentrations, decreases overall narcotic requirement, results in no additional adverse events, and is safe, even in children, across several studies. Since the standard of care is non-methadone narcotic usage to manage the significant pain of complex spinal surgery cases, it is understandable that methadone could be a desirable alternative to promote sustained pain control and early ambulation in these patients. The goal of this study is to compare the effect of a single dose of methadone administered intraoperatively in enrolled spinal fusion patients to their historical controls given fentanyl and morphine, and determine if more sustained pain control during the first few days after surgery provides a better subjective experience for the patient with less pain, which allows them to ambulate and leave the hospital sooner than patients given a standard regimen.

Type: Interventional

Start Date: Jul 2017

open study