307 matching studies

Sponsor Condition of Interest
Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA
NRG Oncology Epstein-Barr Virus Infection Stage II Nasopharyngeal Carcinoma Stage III Nasopharyngeal Carcinoma Stage IVA Nasopharyngeal Carcinoma Stage IVB Nasopharyngeal Carcinoma
There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent... expand

There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel 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 giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.

Type: Interventional

Start Date: Apr 2014

open study

To Evaluate the Safety and Tolerability of Atogepant 10mg, 30 mg and 60 mg Once a Day for the Prevention...
Allergan Episodic Migraine
To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the prevention of migraine in participants with episodic migraine. expand

To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the prevention of migraine in participants with episodic migraine.

Type: Interventional

Start Date: Dec 2018

open study

MarginProbe® System U.S. Post-Approval Study
Dune Medical Devices Breast Cancer
The study objective is to determine the MarginProbe® System's diagnostic accuracy at the margin level and impact on Positive Margin* Presence originating from the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery. *A positive margin is defined in this study... expand

The study objective is to determine the MarginProbe® System's diagnostic accuracy at the margin level and impact on Positive Margin* Presence originating from the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery. *A positive margin is defined in this study as a margin microscopically measured and reported in the histology report to have cancer within 1 mm or less of the inked surface

Type: Interventional

Start Date: Jun 2015

open study

Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
CareDx Kidney Transplant Rejection
This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to... expand

This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making regarding the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment.

Type: Observational

Start Date: Jan 2018

open study

An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently...
Bristol-Myers Squibb Psoriasis
The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis. expand

The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.

Type: Interventional

Start Date: Jul 2018

open study

A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated...
Boston Biomedical, Inc Colorectal Cancer
This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal... expand

This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).

Type: Interventional

Start Date: Jun 2016

open study

Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic...
Jazz Pharmaceuticals Veno-occlusive Disease
This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone in the prevention of hepatic veno- occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant... expand

This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone in the prevention of hepatic veno- occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant who are at high risk or very high risk of developing VOD.

Type: Interventional

Start Date: Sep 2016

open study

Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in...
National Institute of Allergy and Infectious Diseases (NIAID) Influenza A Influenza B
Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is usually mild, but can cause serious illness or death. The purpose of this study is to test the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune... expand

Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is usually mild, but can cause serious illness or death. The purpose of this study is to test the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune immunoglobulin or IVIG) in people who are hospitalized for severe flu.

Type: Interventional

Start Date: Jan 2015

open study

L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary...
Asklepion Pharmaceuticals, LLC Acute Lung Injury
The purpose of this study is to determine whether L-citrulline is effective and safe in the prevention of clinical sequelae of Acute Lung Injury in pediatric subjects undergoing surgery for congenital heart defects. expand

The purpose of this study is to determine whether L-citrulline is effective and safe in the prevention of clinical sequelae of Acute Lung Injury in pediatric subjects undergoing surgery for congenital heart defects.

Type: Interventional

Start Date: Aug 2016

open study

Durvalumab And Radiation Therapy Followed by Adjuvant Durvalumab in Patients With Urothelial Cancer (T2-4...
Monika Joshi, MD Urothelial Cancer
This is an open label, multi-institutional, single arm study of a phase Ib study, followed by a phase II study of durvalumab with radiation therapy (RT) in patients with urothelial cancer (UC). No randomization or blinding is involved. expand

This is an open label, multi-institutional, single arm study of a phase Ib study, followed by a phase II study of durvalumab with radiation therapy (RT) in patients with urothelial cancer (UC). No randomization or blinding is involved.

Type: Interventional

Start Date: Nov 2016

open study

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
Intercept Pharmaceuticals Non Alcoholic Steatohepatitis (NASH)
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis. expand

The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Type: Interventional

Start Date: Sep 2015

open study

Mechanisms Responsible for Hypoglycemia Associated Autonomic Failure
Albert Einstein College of Medicine Diabetes Mellitus Hypoglycemia Autonomic Failure
Intensive glucose control in type 1 diabetes mellitus (T1DM) is associated with clear health benefits (1). However, despite development of insulin analogs, pump/multi-dose treatment and continuous glucose monitoring, maintaining near-normal glycemia remains an elusive goal for... expand

Intensive glucose control in type 1 diabetes mellitus (T1DM) is associated with clear health benefits (1). However, despite development of insulin analogs, pump/multi-dose treatment and continuous glucose monitoring, maintaining near-normal glycemia remains an elusive goal for most patients, in large part owing to the risk of hypoglycemia. T1DM patients are susceptible to hypoglycemia due to defective counterregulatory responses (CR) characterized by: 1) deficient glucagon release during impending/early hypoglycemia; 2) additional hypoglycemia-associated autonomic failure (HAAF) and exercise-associated autonomic failure (EAAF) that blunt the sympathoadrenal responses to hypoglycemia following repeated episodes of hypoglycemia or exercise as well as degrading other CR; and 3) hypoglycemia unawareness (HU), lowering the threshold for symptoms that trigger behavioral responses (e.g. eating). Thus, the risk of hypoglycemia in T1DM impedes ideal insulin treatment and leads to defaulting to suboptimal glycemic control (2). There are two approaches that could resolve this important clinical problem: 1) perfection of glucose sensing and insulin and glucagon delivery approaches (bioengineered or cell-based) that mimic normal islet function and precisely regulate glucose continuously, or 2) a drug to enhance or normalize the pattern of CR to hypoglycemia. Despite much research and important advances in the field, neither islet transplantation nor biosensor devices have emerged as viable long-term solutions for the majority of patients (3, 4). Over the past several years, our lab has explored the approach of enhancing CR by examining mechanisms responsible for HAAF/EAAF and searching for potential pharmacological methods to modulate the CR to hypoglycemia (5-11). Our work has led to a paradigm shift in the field of hypoglycemia, exemplified by the novel hypothesis and published experimental data supporting a role for opioid signaling that resulted in the initiation of exploratory clinical trials by other research groups.

Type: Interventional

Start Date: Mar 2008

open study

Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect
Ampel BioSolutions, LLC Gout
The purpose of this study is to evaluate the effect of a high zone tolerizing regimen of pegloticase on clinical outcome, as defined by an serum uric acid level <6 mg/dL, in patients with chronic, refractory gout. expand

The purpose of this study is to evaluate the effect of a high zone tolerizing regimen of pegloticase on clinical outcome, as defined by an serum uric acid level <6 mg/dL, in patients with chronic, refractory gout.

Type: Interventional

Start Date: Dec 2015

open study

Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy
Duke University Sudden Cardiac Death Heart Failure
VIVID is a prospective, multicenter, randomized clinical trial that will evaluate three specific research questions. In black patients eligible for a primary prevention implantable cardioverter defibrillator (ICD), 1) what is the effect of a patient-centered educational video... expand

VIVID is a prospective, multicenter, randomized clinical trial that will evaluate three specific research questions. In black patients eligible for a primary prevention implantable cardioverter defibrillator (ICD), 1) what is the effect of a patient-centered educational video compared with usual care (UC) on knowledge of SCD (Sudden Cardiac Death), associated risk factors, and ICDs; 2) what is the effect of a patient-centered educational video compared with UC on the decision for ICD implantation, decisional conflict, and receipt of an ICD within 90 days of the decision; 3) what is the effect of racial concordance between study patients and video participants (health care providers/patients) on the decision for ICD implantation, decisional conflict and ICD receipt within 90 days of the decision. In addition, in-depth qualitative interviews (IQI) with a sample of trial participants will be conducted to determine the salient influences on their decision and explore the reasons for their ultimate decision and subsequent implantation or non-implantation of an ICD. Approximately 480 patients eligible for a primary prevention ICD will be enrolled at approximately 12 hospitals in this study. Study sites selected for VIVID will be geographically diverse and provide care to a significant proportion of racial and ethnic minority patients. Patient's will be mailed a letter, regarding the study, prior to their initial visit. At the initial visit, patients will be approached about participation in the trial. For those interested, informed consent will be obtained and patients will be randomized. The investigators will be utilizing electronic consents on an iPad. Black patients will be randomized to one of 3 arms: educational videos presented in the same format; one with black participants (patients and providers) or the other with white participants (patients and providers); The third arm will be usual care (control) and the provider can interact with the patient consistent with their typical/usual care. Notably, for both intervention and control arms, all patient management decisions are completely at the discretion of the care providers.

Type: Interventional

Start Date: Jul 2016

open study

An Investigational Immuno-therapy Study of Nivolumab or Placebo in Patients With Resected Esophageal...
Bristol-Myers Squibb Advanced Cancer
The purpose of this study is to determine whether Nivolumab will improve overall survival, disease-free survival, or both compared with placebo. expand

The purpose of this study is to determine whether Nivolumab will improve overall survival, disease-free survival, or both compared with placebo.

Type: Interventional

Start Date: May 2016

open study

New Onset Type 1 Diabetes: Role of Exenatide
Albert Einstein College of Medicine Type 1 Diabetes
There are many recent advances in insulin treatment of type 1 diabetes, however after a meal sugars are always a concern. There is a drug Exenatide (Byetta) which is FDA approved to treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals. This... expand

There are many recent advances in insulin treatment of type 1 diabetes, however after a meal sugars are always a concern. There is a drug Exenatide (Byetta) which is FDA approved to treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals. This study is going to test whether this drug can improve the after meal sugars in people with new onset type 1 diabetes. To test this you will be given a dose of exenatide (1.25 mcg) and long acting insulin or inulin alone before the boost. There is also a placebo group (healthy subjects) who do not get any medication before the boost. Insulin levels and other hormones that affect blood glucose as well as your sugar will be measured by a series of blood tests. The role exenatide as compared to insulin alone will be examined to prevent low blood sugars which might occur because of food staying longer in the stomach than usual or due to the suppression of a hormone called glucagon which increases blood sugar. If you qualify you will be given exenatide (Byetta 1.25 mcg) along with insulin or insulin alone. You and the researchers will not know which dose you are taking at any single visit. A total of 20 people in which some will be children aged 12- 18 years will participate, being diagnosed within 3 months of having been found to have type 1 diabetes.

Type: Interventional

Start Date: Dec 2010

open study

A Multi-Center Study of Riociguat in Patients With Sickle Cell Diseases
Gregory J. Kato, MD Sickle Cell Disease
The proposed study is a Phase 2 multi-center, randomized, double-blind, placebo-controlled, parallel groups study aimed to evaluate the safety, tolerability and the efficacy of riociguat compared with placebo in patients with sickle cell disease (SCD). expand

The proposed study is a Phase 2 multi-center, randomized, double-blind, placebo-controlled, parallel groups study aimed to evaluate the safety, tolerability and the efficacy of riociguat compared with placebo in patients with sickle cell disease (SCD).

Type: Interventional

Start Date: Apr 2017

open study

Multiple Cardiac Sensors for the Management of Heart Failure
Boston Scientific Corporation Heart Failure, Congestive
The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature. expand

The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature.

Type: Interventional

Start Date: Aug 2017

open study

Novel Mobile Device Application to Improve Adherence
National Institute of Allergy and Infectious Diseases (NIAID) Pediatric Heart Transplant Recipients Pediatric Cardiac Transplantation Pediatric Heart Transplantation
The purpose of this study is to collect and compare information on how and when adolescent heart transplant recipients take their prescribed medication. The investigators want to find out if regular use of 'an app' on cell phones, called the Teen Pocket PATH® (TPP), can help... expand

The purpose of this study is to collect and compare information on how and when adolescent heart transplant recipients take their prescribed medication. The investigators want to find out if regular use of 'an app' on cell phones, called the Teen Pocket PATH® (TPP), can help adolescents take their medication according to their prescribed dosing schedule. This may then help reduce complications of transplant, such as rejection. The investigators also want to find out if how adolescent heart transplant recipients take their medications affects the development of antibodies in their blood. Antibodies are small proteins in the blood that may develop after heart transplantation, and which can sometimes damage a new heart.

Type: Interventional

Start Date: Aug 2017

open study

The MOTION Study - Treatment of LSS With the MILD Procedure
Vertos Medical, Inc. Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Prospective, multicenter, randomized controlled clinical study examining functional improvement in lumbar spinal stenosis (LSS) patients with neurogenic claudication who are treated with the MILD procedure plus conventional medical management (CMM) compared to those treated with... expand

Prospective, multicenter, randomized controlled clinical study examining functional improvement in lumbar spinal stenosis (LSS) patients with neurogenic claudication who are treated with the MILD procedure plus conventional medical management (CMM) compared to those treated with CMM alone, as the control. Subjects in the control group will be allowed to crossover and receive MILD after completion of 12-month follow-up.

Type: Interventional

Start Date: Aug 2018

open study

Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
Flamel Ireland Limited Excessive Daytime Sleepiness Cataplexy Narcolepsy
The purpose of this study is to determine whether FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy. expand

The purpose of this study is to determine whether FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.

Type: Interventional

Start Date: Nov 2016

open study

Endocrine Response in Women With Invasive Lobular Breast Cancer
Rachel Jankowitz Breast Cancer
RATIONALE: Currently, adjuvant endocrine therapy often follows a "one-size-fits- all" approach, with most premenopausal women receiving tamoxifen, and most postmenopausal receiving aromatase inhibitor therapy. In current clinical practice, patients with invasive lobular carcinoma... expand

RATIONALE: Currently, adjuvant endocrine therapy often follows a "one-size-fits- all" approach, with most premenopausal women receiving tamoxifen, and most postmenopausal receiving aromatase inhibitor therapy. In current clinical practice, patients with invasive lobular carcinoma are treated no differently than patients with invasive ductal carcinoma based on the void of information specific to patients with this tumor type. Identification of a biological signal of tamoxifen and/or AI-resistance and/or fulvestrant-sensitivity in ILC patients would have dramatic implications for the future management of this breast cancer subtype. PURPOSE: To study whether fulvestrant is more effective than anastrozole or tamoxifen in reducing Ki67 in ILC and whether that Ki67 reduction will correlate with alterations in expression of ER and ER-regulated genes. Differential Ki67 effect in this study will serve as a surrogate for outcome of ILC patients on endocrine therapy. Primary Objective: To determine the change from baseline to post-treatment Ki67 values in ER-positive, HER2-negative ILC tissue derived from postmenopausal women awaiting definitive surgery or further neoadjuvant treatment who are randomized to 21-24 days of neoadjuvant endocrine treatments with fulvestrant (two 250 mg IM injections given on day 1), anastrozole (1mg given orally daily), or tamoxifen (20mg given orally daily).

Type: Interventional

Start Date: Aug 2015

open study

Exploring Safety & Clinical Benefit of Anti-Influenza Immunoglobulin Intravenous in Hospitalized Adults...
Emergent BioSolutions Influenza A H3N2 Influenza A H1N1
Influenza, or the flu, is an infectious respiratory disease that can range in severity from mild to severe to even death. This study aims to evaluate a treatment for people who are hospitalized with the flu. The study is looking to see if antibodies collected from people who... expand

Influenza, or the flu, is an infectious respiratory disease that can range in severity from mild to severe to even death. This study aims to evaluate a treatment for people who are hospitalized with the flu. The study is looking to see if antibodies collected from people who have recovered from the seasonal flu or who have had the seasonal flu shot can be used safely as a study drug to treat hospitalized patients with severe flu infections. Also, this study will help to find the right dose for this study drug for treatment of severe flu in hospitalized patients. Overall, this study will evaluate if the hospitalized patients receiving standard of care along with the study drug get better more quickly than those treated with standard of care and placebo. The study drug that contains antibodies against the flu is called anti-influenza immunoglobulin intravenous (FLU-IGIV).

Type: Interventional

Start Date: Nov 2017

open study

Respiratory Virus Hospitalization Study (FLU 003 Plus)
University of Minnesota - Clinical and Translational Science Institute Influenza Novel Respiratory Virus-1 Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV) Novel Respiratory Virus-2 Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)
Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to estimate rates of morbidity and mortality and to examine predictors of severity among participants with 2009 H1N1 infection. In 2011, as surveillance... expand

Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to estimate rates of morbidity and mortality and to examine predictors of severity among participants with 2009 H1N1 infection. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. The current version of the protocol (released in August 2013) further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded.

Type: Observational

Start Date: Aug 2009

open study

Multicultural Healthy Diet to Reduce Cognitive Decline
Albert Einstein College of Medicine Diet Modification Cognitive Decline Cognitive Change
This is a pilot randomized controlled clinical trial is designed to investigate whether the Multicultural Healthy Diet (MHD), an anti-Inflammatory diet tailored to a multi-cultural population, can improve cognitive functioning in a middle aged (40-65 yr) urban population in Bronx,... expand

This is a pilot randomized controlled clinical trial is designed to investigate whether the Multicultural Healthy Diet (MHD), an anti-Inflammatory diet tailored to a multi-cultural population, can improve cognitive functioning in a middle aged (40-65 yr) urban population in Bronx, New York compared to a usual diet.

Type: Interventional

Start Date: Oct 2018

open study