313 matching studies

Sponsor Condition of Interest
The REPLACE Registry
Retrophin, Inc. Bile Acid Synthesis Disorders
This is a prospective, observational, non-interventional patient registry designed to document long term safety and clinical outcomes for 10 years in patients treated with Cholbam/Kolbam, including those who have been using Cholbam/Kolbam and those who start Cholbam/Kolbam treatment... expand

This is a prospective, observational, non-interventional patient registry designed to document long term safety and clinical outcomes for 10 years in patients treated with Cholbam/Kolbam, including those who have been using Cholbam/Kolbam and those who start Cholbam/Kolbam treatment at enrollment.

Type: Observational [Patient Registry]

Start Date: Jul 2017

open study

Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain Control
Montefiore Medical Center Pain
To evaluate the efficacy of virtual reality analgesia (VRA) for pediatric patients undergoing Botulinum toxin injections (BTI) for spasticity management. Patients will be assigned to one of three groups; one group of subjects will randomly be assigned to VRA intervention using... expand

To evaluate the efficacy of virtual reality analgesia (VRA) for pediatric patients undergoing Botulinum toxin injections (BTI) for spasticity management. Patients will be assigned to one of three groups; one group of subjects will randomly be assigned to VRA intervention using Google Cardboard Virtual reality head- mounted display powered by a iPod touch, a second group of subjects will receive VRA with Oculus Rift, and a third group of subjects will receive no intervention beyond standard sedation, anesthetic, and/or restraint—this group will serve as the control group.

Type: Interventional

Start Date: Jul 2017

open study

The Selective Personalized Radio-Immunotherapy for Locally Advanced NSCLC Trial.
Albert Einstein College of Medicine Non-small Cell Lung Cancer, NSCLC
The goal of this study is to explore if, for locally advanced non-small cell lung cancer patients whose tumors have high levels of PD-L1 (a marker associated with benefits from immunotherapy), a combination of immunotherapy and a personalized 4-week radiotherapy course could... expand

The goal of this study is to explore if, for locally advanced non-small cell lung cancer patients whose tumors have high levels of PD-L1 (a marker associated with benefits from immunotherapy), a combination of immunotherapy and a personalized 4-week radiotherapy course could be more effective than standard treatment, which is a combination of chemotherapy and radiotherapy.

Type: Interventional

Start Date: Aug 2018

open study

Early Feasibility Study of the AccuCinch® Ventricular Repair System - The CorCinch-FMR Study
Ancora Heart, Inc. Heart Failure Mitral Valve Insufficiency Cardiomyopathies
This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the AccuCinch® Ventricular Repair System in patients with symptomatic heart failure and concomitant functional mitral regurgitation that have stable symptoms on guideline-directed medical... expand

This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the AccuCinch® Ventricular Repair System in patients with symptomatic heart failure and concomitant functional mitral regurgitation that have stable symptoms on guideline-directed medical therapy

Type: Interventional

Start Date: Aug 2016

open study

PRECISION GRX Registry
Corindus Inc. Coronary Artery Disease
To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath GRX System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during... expand

To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath GRX System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.

Type: Observational [Patient Registry]

Start Date: Aug 2017

open study

Platinum Based Chemotherapy or Capecitabine in Treating Patients With Residual Triple-Negative Basal-Like...
ECOG-ACRIN Cancer Research Group Estrogen Receptor Negative HER2/Neu Negative Invasive Breast Carcinoma Progesterone Receptor Negative Stage II Breast Cancer
This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs... expand

This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.

Type: Interventional

Start Date: Apr 2015

open study

Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients...
ECOG-ACRIN Cancer Research Group Castration Levels of Testosterone Castration-Resistant Prostate Carcinoma Metastatic Prostate Carcinoma in the Soft Tissue Prostate Carcinoma Metastatic in the Bone Stage IV Prostate Adenocarcinoma AJCC v7
This randomized phase II trial studies how well abiraterone acetate and antiandrogen therapy, with or without cabazitaxel and prednisone, work in treating patients with castration-resistant prostate cancer previously treated with docetaxel that has spread to other parts of the... expand

This randomized phase II trial studies how well abiraterone acetate and antiandrogen therapy, with or without cabazitaxel and prednisone, work in treating patients with castration-resistant prostate cancer previously treated with docetaxel that has spread to other parts of the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using abiraterone acetate and antiandrogen therapy may fight prostate cancer by lowering and/or blocking the use of androgens by the tumor cells. Drugs used in chemotherapy, such as cabazitaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving abiraterone acetate and antiandrogen therapy with or without cabazitaxel and prednisone may help kill more tumor cells.

Type: Interventional

Start Date: Feb 2018

open study

Phase I Study of Fractionated Stereotactic Radiation Therapy
Albert Einstein College of Medicine Brain Metastases
There is a lack of prospective trial data and consensus guidelines describing the use of Fractionated Stereotactic Radiation Therapy (FSRT) in the treatment of brain metastases. There has been no prospective dose escalation study performed to date to determine the maximum tolerated... expand

There is a lack of prospective trial data and consensus guidelines describing the use of Fractionated Stereotactic Radiation Therapy (FSRT) in the treatment of brain metastases. There has been no prospective dose escalation study performed to date to determine the maximum tolerated dose (MTD) in patients treated with FSRT. Prescription doses in the series described above ranged from 18 Gy to 42 Gy, delivered in 3 to 12 fractions. The results of this study will be used to plan future Phase II/III studies to determine the efficacy of different dose fractionation schedules of FSRT. We thus propose a phase I study to determine the feasibility and safety of FSRT in patients with brain metastases.

Type: Interventional

Start Date: Dec 2017

open study

Regulation of Endogenous Glucose Production by Central KATP Channels
Albert Einstein College of Medicine Type 2 Diabetes Mellitus Glucose Metabolism Disorders Glucose, High Blood
The goal of this study is to understand how activating control centers of the brain with diazoxide can affect how much glucose (sugar) is produced by the liver. This is particularly important for people with diabetes who have very high production of glucose, since this could... expand

The goal of this study is to understand how activating control centers of the brain with diazoxide can affect how much glucose (sugar) is produced by the liver. This is particularly important for people with diabetes who have very high production of glucose, since this could be at least in part due to impaired regulation of the liver by the brain.

Type: Interventional

Start Date: Aug 2018

open study

Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)
Albert Einstein College of Medicine Diabetes Mellitus, Type 1 Hypoglycemia Hypoglycemia Unawareness
The overall goal of this study is to develop a new and practical way to prevent the development of Hypoglycemia Associated Autonomic Failure (HAAF), which is unawareness of hypoglycemia (low blood sugar) in individuals with diabetes. Previous studies suggest that both naloxone... expand

The overall goal of this study is to develop a new and practical way to prevent the development of Hypoglycemia Associated Autonomic Failure (HAAF), which is unawareness of hypoglycemia (low blood sugar) in individuals with diabetes. Previous studies suggest that both naloxone and diazoxide may increase the body's ability to respond to episodes of low blood sugar and prevent the development of HAAF (or hypoglycemia unawareness). Only healthy subjects are being recruited for this study. The study has three distinct phases. In the first phase, healthy, non-diabetic individuals who are susceptible to developing HAAF are identified. Only these individuals will be studied in the second and third phases. The second phase of this study evaluates the effect of using a naloxone nasal spray versus a placebo nasal spray in improving the body's response to episodes of low blood sugar and in preventing the development of HAAF. The third phase of this study evaluates the effect of using naloxone nasal spray and diazoxide in combination, compared to naloxone nasal spray plus a placebo (for diazoxide) or diazoxide plus a placebo (for naloxone) in improving the body's response to episodes of low blood sugar and in preventing the development of HAAF.

Type: Interventional

Start Date: Aug 2018

open study

Dose-Escalation and Expansion Trial of NC-6300 in Patients With Advanced Solid Tumors or Soft Tissue...
NanoCarrier Co., Ltd. Solid Tumor Soft Tissue Sarcoma Metastatic Sarcoma Sarcoma
The goal of this study is to find the highest tolerated dose of NC-6300 that can be given to patients with advanced solid tumors or soft tissue sarcoma. The safety and tolerability of the drug will also be studied. expand

The goal of this study is to find the highest tolerated dose of NC-6300 that can be given to patients with advanced solid tumors or soft tissue sarcoma. The safety and tolerability of the drug will also be studied.

Type: Interventional

Start Date: Jun 2017

open study

The Pediatric Anesthesia Quality Improvement Project
The Society for Pediatric Anesthesia Surgery Anesthesia Children
The Study is designed to collect information about adverse events that occur in children undergoing anesthesia in participating hospitals. Demographic information will be collected on all anesthetics. An analysis of each adverse event will be performed and entered into the database.... expand

The Study is designed to collect information about adverse events that occur in children undergoing anesthesia in participating hospitals. Demographic information will be collected on all anesthetics. An analysis of each adverse event will be performed and entered into the database. From this information we will devise strategies to prevent these adverse events.

Type: Observational [Patient Registry]

Start Date: Feb 2008

open study

Silicone Gel for Postsurgical Scars of the Eyelid
Montefiore Medical Center Scarring Due to Treatment
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery. expand

To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery.

Type: Interventional

Start Date: Aug 2018

open study

Use of Functional MRI to Assess Functional Hypothalamic Activation in Response to Diazoxide
Albert Einstein College of Medicine Diabetes Mellitus, Type 2 Glucose, High Blood Glucose Metabolism Disorders (Including Diabetes Mellitus)
The goal of this study is to determine whether metabolic control centers in the brain can be activated in patients with type 2 diabetes as compared to non-diabetic individuals. This is important since people with diabetes have inappropriately high production of glucose, which... expand

The goal of this study is to determine whether metabolic control centers in the brain can be activated in patients with type 2 diabetes as compared to non-diabetic individuals. This is important since people with diabetes have inappropriately high production of glucose, which could be at least in part due to impaired activation of important brain centers.

Type: Interventional

Start Date: Jun 2018

open study

Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer
Fadoi Foundation, Italy Venous Thromboembolism
Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study expand

Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study

Type: Interventional

Start Date: Apr 2017

open study

Sensory Integration Therapy in Autism: Mechanisms and Effectiveness
Albert Einstein College of Medicine Autism
A common feature of ASD is over or under sensitivity to the environment and difficulty putting sensory information together in an orderly way, referred to here as sensory issues. Building on previous work, this study will test the efficacy of Sensory Integration Therapy (SIT),... expand

A common feature of ASD is over or under sensitivity to the environment and difficulty putting sensory information together in an orderly way, referred to here as sensory issues. Building on previous work, this study will test the efficacy of Sensory Integration Therapy (SIT), a non-invasive intervention to improve functional skills in children with ASD, in comparison to commonly applied ABA behavioral treatments, in the treatment of ASD symptoms. A total of 180 children with ASD and sensory issues in the greater New York City Metropolitan area will complete this study.

Type: Interventional

Start Date: Sep 2015

open study

Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)
Boston Scientific Corporation Left Ventricular Dysfunction
Prospective, multi-center, single arm, post approval study to be conducted in the United States. expand

Prospective, multi-center, single arm, post approval study to be conducted in the United States.

Type: Interventional

Start Date: Dec 2017

open study

Acetaminophen Versus IV Hydromorphone for Pain in the Elderly in the ED
Montefiore Medical Center Acute Pain
Intravenous opioids are the mainstay of acute, severe pain treatment in Emergency Departments (ED) across the country. Acetaminophen, given orally, has also been used for treatment of mild to moderate pain. The more potent intravenous (IV) form of acetaminophen has been widely... expand

Intravenous opioids are the mainstay of acute, severe pain treatment in Emergency Departments (ED) across the country. Acetaminophen, given orally, has also been used for treatment of mild to moderate pain. The more potent intravenous (IV) form of acetaminophen has been widely used in Europe for more than 20 years as post-surgical analgesia and received full FDA approval in the USA in 2010. As part of a continuing set of studies whose goal is to optimize treatment of pain among elderly ED patients, this randomized study will compare efficacy and safety of IV acetaminophen to IV hydromorphone.

Type: Interventional

Start Date: Aug 2018

open study

Dose-escalation Study of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients With Advanced...
Taiwan Liposome Company Cancer
This is a phase I/IIa, Open label, Dose-escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients with Advanced Malignancy. expand

This is a phase I/IIa, Open label, Dose-escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients with Advanced Malignancy.

Type: Interventional

Start Date: Jun 2017

open study

Intravenous Gammaglobulin for Sickle Cell Pain Crises
Albert Einstein College of Medicine 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

Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous...
Southwest Oncology Group Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC v7
This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait... expand

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

Type: Interventional

Start Date: Jun 2014

open study

Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring...
Montefiore Medical Center Fetal Distress Fetal Monitoring Contraction
The EUM (electrical uterine myography) (OB Tools, Israel) was tested and found to be reliable as a non-invasive method for evaluating uterine contractions and the fetal heart rate. It is safe and effective in monitoring uterine contractions. The investigators propose to perform a... expand

The EUM (electrical uterine myography) (OB Tools, Israel) was tested and found to be reliable as a non-invasive method for evaluating uterine contractions and the fetal heart rate. It is safe and effective in monitoring uterine contractions. The investigators propose to perform a series of studies to validate the accuracy and clinical usefulness of the EUM device by simultaneously monitoring patients with current methods (with either external or internal devices) as clinically indicated and with the EUM device. Providers will be blinded to the results of the EUM device. The investigators will continue care as per current guidelines using the information obtained from the current monitoring methods. Information obtained from the EUM devices will not be used to determine the clinical course of action.

Type: Observational

Start Date: Jul 2017

open study

Determining Change in Cardiovascular and Metabolic Risks in Patients With Chronic Phase Chronic Myeloid...
Bristol-Myers Squibb Chronic Phase Chronic Myeloid Leukemia
This non-interventional, prospective study will characterize the impact of three approved first and second generation BCR-ABL1 tyrosine kinase inhibitors on cardiovascular and metabolic risk factors in chronic phase CML (CP-CML) patients who are TKI naive and initiating first-line... expand

This non-interventional, prospective study will characterize the impact of three approved first and second generation BCR-ABL1 tyrosine kinase inhibitors on cardiovascular and metabolic risk factors in chronic phase CML (CP-CML) patients who are TKI naive and initiating first-line TKIs in routine clinical practice in the US. All treatment decisions will be determined at the discretion of the treating physician(s) and data identifying the cardiovascular and metabolic risk factors will be collected. Additional fasting blood samples (collected following 8 hours of fasting) will be collected during standard of care (SOC)/routine office visits. Additional research imaging will be performed and will be reviewed by core imaging laboratory. As the study is collecting data on management of CML, this study will not influence the prescribing or management practices at participating sites.

Type: Observational

Start Date: Mar 2017

open study

Anti-ESO (Cancer/Test Antigen) mTCR-transduced Autologous Peripheral Blood Lymphocytes and Combination...
Albert Einstein College of Medicine HLA-A2 Positive Cells Present Metastatic Malignant Neoplasm Metastatic Malignant Neoplasm in the Brain
This pilot clinical trial studies the side effects of anti-ESO (cancer/test antigen) murine T-cell receptor (mTCR)-transduced autologous peripheral blood lymphocytes and combination chemotherapy with cyclophosphamide and fludarabine phosphate in treating patients with cancer... expand

This pilot clinical trial studies the side effects of anti-ESO (cancer/test antigen) murine T-cell receptor (mTCR)-transduced autologous peripheral blood lymphocytes and combination chemotherapy with cyclophosphamide and fludarabine phosphate in treating patients with cancer that has spread to other places in the body (metastatic) and expresses the gene NY-ESO-1. Donor white blood cells that are treated in the laboratory with anti-cluster of differentiation (CD)3 may help treat metastatic cancer. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, 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) may kill more cancer cells. Aldesleukin may stimulate white blood cells, including natural killer cells, to kill metastatic cancer cells. Giving anti-ESO (cancer/test antigen) mTCR-transduced autologous peripheral blood lymphocytes together with combination chemotherapy and aldesleukin may kill more cancer cells.

Type: Interventional

Start Date: Aug 2016

open study

Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating...
Children's Oncology Group Cellular Ependymoma Childhood Anaplastic Ependymoma Childhood Infratentorial Ependymoma Childhood Supratentorial Ependymoma Clear Cell Ependymoma
This partially 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... expand

This partially 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, by stopping them from dividing, or by stopping them from spreading. 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