313 matching studies

Sponsor Condition of Interest
Novel INXN-4001 Triple Effector Plasmid in Heart Failure
Xogenex, LLC Heart Failure Cardiovascular Diseases Heart-Assist Device
To evaluate the safety of retrograde coronary sinus infusion of a novel triple-effector plasmid (INXN-4001) in outpatient LVAD recipients as assessed by incidence of all study intervention - related adverse events occurring up to 6 months post-treatment expand

To evaluate the safety of retrograde coronary sinus infusion of a novel triple-effector plasmid (INXN-4001) in outpatient LVAD recipients as assessed by incidence of all study intervention - related adverse events occurring up to 6 months post-treatment

Type: Interventional

Start Date: Apr 2018

open study

A Study of Parsaclisib in Participants With Autoimmune Hemolytic Anemia
Incyte Corporation Autoimmune Hemolytic Anemia
The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin and evidence of ongoing hemolysis that requires treatment intervention. expand

The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin and evidence of ongoing hemolysis that requires treatment intervention.

Type: Interventional

Start Date: Jul 2018

open study

Adapting Critical Time Intervention to Support Inpatient Medical Care Transition
New York State Psychiatric Institute Schizophrenia Medical Complication
We are pursuing a pilot study to assess the feasibility and preliminary effectiveness of adapting a critical time intervention (CTI) approach for adults with schizophrenia who have been admitted for the inpatient treatment of ambulatory care sensitive conditions. These are common... expand

We are pursuing a pilot study to assess the feasibility and preliminary effectiveness of adapting a critical time intervention (CTI) approach for adults with schizophrenia who have been admitted for the inpatient treatment of ambulatory care sensitive conditions. These are common health conditions, such as chronic obstructive pulmonary disease or short-term complications from diabetes mellitus, in which appropriate ambulatory care prevents or reduces the need for inpatient treatment. A 2-arm pilot study will randomize 80 eligible inpatients to receive either: 1) treatment as usual (TAU) (N=40); or 2) CTI and TAU (N=40). Participants assigned to CTI will meet with a CTI care manger during their inpatient stay and over a 3-month period following hospital discharge. CTI care managers will assess and address patient needs and barriers to outpatient medical and mental health care and provide support and assistance with health and mental health care management. The primary outcome measure will be all-cause hospital readmissions at 7 and 30 days following discharge. Secondary outcomes will include follow-up with medical and mental health at 7 and 30 days following hospital discharge. Patients receiving CTI will also receive 6 and 12 week assessments to evaluate secondary outcomes including satisfaction with CTI services, psychiatric symptoms, community function, and involvement in medical care decisions.

Type: Interventional

Start Date: May 2019

open study

Identifying, Understanding, and Overcoming Barriers to the Use of Clinical Practice Guidelines in Pediatric...
Children's Oncology Group Acute Lymphoblastic Leukemia B-Cell Non-Hodgkin Lymphoma Chemotherapy-Related Nausea and/or Vomiting Childhood Acute Myeloid Leukemia Childhood Burkitt Lymphoma
This research trial studies the use of clinical practice guidelines by pediatric oncology healthcare providers in order to identify, understand, and overcome barriers to them. The treatments for childhood cancers are intense and result in a high rate of symptoms which require... expand

This research trial studies the use of clinical practice guidelines by pediatric oncology healthcare providers in order to identify, understand, and overcome barriers to them. The treatments for childhood cancers are intense and result in a high rate of symptoms which require support by healthcare providers. By reviewing patients' medical chart records, meeting in focus groups and in one-on-one interviews, healthcare providers may improve how clinical practice guidelines are used to support children undergoing cancer treatment.

Type: Observational

Start Date: Nov 2016

open study

Myocardial Ischemia and Transfusion
Rutgers, The State University of New Jersey Myocardial Infarction Anemia
The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic. expand

The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.

Type: Interventional

Start Date: Apr 2017

open study

Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents
Dana-Farber Cancer Institute Acute Lymphoblastic Leukemia, Pediatric
Acute lymphoblastic leukemia (ALL) is the most common cancer diagnosed in children. The cancer comes from a cell in the blood called a lymphocyte. Normal lymphocytes are produced in the bone marrow (along with other blood cells) and help fight infections. In ALL, the cancerous... expand

Acute lymphoblastic leukemia (ALL) is the most common cancer diagnosed in children. The cancer comes from a cell in the blood called a lymphocyte. Normal lymphocytes are produced in the bone marrow (along with other blood cells) and help fight infections. In ALL, the cancerous lymphocytes are called lymphoblasts. They do not help fight infection and crowd out the normal blood cells in the bone marrow so that the body cannot make enough normal blood cells. ALL is always fatal if it is not treated. With current treatments, most children and adolescents with this disease will be cured. The standard treatment for ALL involves about 2 years of chemotherapy. The drugs that are used, and the doses of the drugs, are similar but not identical for all children and adolescents with ALL. Some children and adolescents receive stronger treatment, especially during the first several months. A number of factors are used to decide how strong the treatment should be to give the best chance for cure. These factors are called "risk factors". This trial is studying the use of a new, updated set of risk factors to decide how strong the treatment will be. The study also will test a new way of dosing a chemotherapy drug called pegaspargase (which is part of the standard treatment for ALL) based on checking levels of the drug in the blood and adjusting the dose based on the levels.

Type: Interventional

Start Date: Mar 2017

open study

Nivolumab in Eliminating Minimal Residual Disease and Preventing Relapse in Patients With Acute Myeloid...
National Cancer Institute (NCI) Acute Myeloid Leukemia in Remission
This randomized phase II trial studies how well nivolumab works in eliminating any remaining cancer cells and preventing cancer from returning in patients with acute myeloid leukemia that had a decrease in or disappearance of signs and symptoms of cancer after receiving chemotherapy.... expand

This randomized phase II trial studies how well nivolumab works in eliminating any remaining cancer cells and preventing cancer from returning in patients with acute myeloid leukemia that had a decrease in or disappearance of signs and symptoms of cancer after receiving chemotherapy. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Type: Interventional

Start Date: May 2015

open study

DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation
EPIX Therapeutics Persistent Atrial Fibrillation Atrial Fibrillation
The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients. expand

The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients.

Type: Interventional

Start Date: Sep 2018

open study

Low Dose Aprepitant for Patients Receiving Carboplatin
Albert Einstein College of Medicine Chemotherapy-induced Nausea and Vomiting
This study evaluates a simple one day prophylaxis of nausea and vomiting for patients who are getting carboplatin based chemotherapy. In addition to standard oral dexmethasone and oral ondansetrone, participants will be given a third neurokinin 1 (NK1) antagonist agent, either... expand

This study evaluates a simple one day prophylaxis of nausea and vomiting for patients who are getting carboplatin based chemotherapy. In addition to standard oral dexmethasone and oral ondansetrone, participants will be given a third neurokinin 1 (NK1) antagonist agent, either Aprepitant or Fosaprepitant (they have been shown to be equally effective) to improve prevention of nausea and vomiting. No medications need to be taken beyond day 1.

Type: Interventional

Start Date: Oct 2018

open study

Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy
National Cancer Institute (NCI) Metastatic Malignant Neoplasm in Lymph Node Metastatic Malignant Neoplasm in the Adrenal Gland Metastatic Malignant Neoplasm in the Lung Metastatic Malignant Neoplasm in the Pancreas Metastatic Malignant Neoplasm in the Skin
This phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with or without nivolumab in treating patients with kidney cancer that is limited to a certain part of the body (localized). Immunotherapy with monoclonal antibodies, such as nivolumab,... expand

This phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with or without nivolumab in treating patients with kidney cancer that is limited to a certain part of the body (localized). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab before nephrectomy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed, and after nephrectomy to increase survival. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with kidney cancer.

Type: Interventional

Start Date: Feb 2017

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

Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease
Texas Scottish Rite Hospital for Children Legg Calve Perthes Disease
Legg-Calvé-Perthes disease is a childhood hip disorder which is common enough to be a significant public health problem (affects 1 in 740 boys between ages 0—14), but uncommon enough to have a sufficient number of patients from a single institution to perform a definitive prospective... expand

Legg-Calvé-Perthes disease is a childhood hip disorder which is common enough to be a significant public health problem (affects 1 in 740 boys between ages 0—14), but uncommon enough to have a sufficient number of patients from a single institution to perform a definitive prospective study comparing the results of current treatments. The present study will establish a database of prospectively identified patients with Legg-Calvé-Perthes (LCP) Disease and collect information regarding their presentation, treatment, and outcomes in the course of receiving currently available treatments. This study seeks to compare the outcomes of current treatments in the management of different age groups (ages 1-6, 6—8, 8—11, >11) of patients with Perthes disease at two- and five-year followup and at skeletal maturity. For each age group, two to three common treatment regimens currently used by practicing pediatric orthopaedic surgeons will be compared. The intervention a patient receives is determined through physician preference. Physicians pick an intervention for each age group and treat each patient with the same intervention.

Type: Observational

Start Date: Aug 2012

open study

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium...
Rigel Pharmaceuticals Warm Antibody Autoimmune Hemolytic Anemia
The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA). expand

The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

Type: Interventional

Start Date: Apr 2019

open study

Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)
Eric Hollander Autism Spectrum Disorder
This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD. expand

This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD.

Type: Interventional

Start Date: Apr 2019

open study

MEMO-Medical Marijuana and Opioids Study
Albert Einstein College of Medicine Opioid Use Marijuana Chronic Pain HIV/AIDS
The study will examine how medical cannabis use affects opioid analgesic use over time, with particular attention to THC/CBD content, HIV outcomes, and severe adverse events. expand

The study will examine how medical cannabis use affects opioid analgesic use over time, with particular attention to THC/CBD content, HIV outcomes, and severe adverse events.

Type: Observational

Start Date: Sep 2018

open study

Comparison of Healthy Diets on Breast Cancer Markers
Albert Einstein College of Medicine Breast Neoplasms
Women post breast mass biopsy with ER+or ER- cancer will be randomized to two diets--goal of 45 of them to a ketogenic insulin inhibiting diet, 20 to a low fat diet with whole grains and fruits and vegetables. The initial biopsy will be evaluated along with the surgical specimen... expand

Women post breast mass biopsy with ER+or ER- cancer will be randomized to two diets--goal of 45 of them to a ketogenic insulin inhibiting diet, 20 to a low fat diet with whole grains and fruits and vegetables. The initial biopsy will be evaluated along with the surgical specimen pathology to compare changes in biomarkers, particularly of proliferation (Ki-67) and apoptosis (TUNEL).

Type: Interventional

Start Date: Jun 2018

open study

Study to Evaluate Performance of LifePort® Liver Transporter System, a Machine Perfusion System, for...
Organ Recovery Systems, Inc. Liver Transplantation
Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage). expand

Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).

Type: Interventional

Start Date: Apr 2019

open study

Problem Adaptation Therapy for Mild Cognitive Impairment and Depression
Weill Medical College of Cornell University Cognitive Impairment Depression
The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs. Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive, affective, and... expand

The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs. Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive, affective, and functioning outcomes.

Type: Interventional

Start Date: Jul 2017

open study

Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer
Albert Einstein College of Medicine Non-small Cell Lung Cancer
The primary objective of this study is to evaluate patient-reported outcomes during and after concurrent chemoradiotherapy for locally-advanced non-small cell lung cancer. Patients will be randomized to a standard 6-week radiotherapy course or a 4-week radiotherapy course using... expand

The primary objective of this study is to evaluate patient-reported outcomes during and after concurrent chemoradiotherapy for locally-advanced non-small cell lung cancer. Patients will be randomized to a standard 6-week radiotherapy course or a 4-week radiotherapy course using dose-painting based on pre-treatment PET findings.

Type: Interventional

Start Date: Aug 2017

open study

Evaluation of the Duration of Therapy for Thrombosis in Children
Johns Hopkins All Children's Hospital Venous Thrombosis
The Kids-DOTT trial is a randomized controlled clinical trial whose primary objective is to evaluate non-inferiority of shortened-duration (6 weeks) versus conventional-duration (3 months) anticoagulation in children with first-episode acute venous thrombosis. The first stage... expand

The Kids-DOTT trial is a randomized controlled clinical trial whose primary objective is to evaluate non-inferiority of shortened-duration (6 weeks) versus conventional-duration (3 months) anticoagulation in children with first-episode acute venous thrombosis. The first stage of the trial has consisted of a pilot/feasibility component, which then continues as the definitively-powered trial.

Type: Interventional

Start Date: Mar 2008

open study

Outcomes of Neonatal Acute Kidney Injury In Premature Infants
Montefiore Medical Center Acute Kidney Injury Chronic Kidney Disease
The objective of this protocol is to investigate the impact of prematurity, with or without associated acute kidney injury (AKI), on the future risk of chronic kidney disease (CKD) by establishing a patient registry and biorepository. Serum and urine samples will be collected... expand

The objective of this protocol is to investigate the impact of prematurity, with or without associated acute kidney injury (AKI), on the future risk of chronic kidney disease (CKD) by establishing a patient registry and biorepository. Serum and urine samples will be collected serially from premature infants admitted to the neonatal intensive care unit (NICU) at Albert Einstein College of Medicine/Weiler Hospital and subsequently followed in the NICU follow-up and pediatric nephrology ambulatory subspecialty clinics. The biorepository will be linked to a comprehensive clinical database.

Type: Observational [Patient Registry]

Start Date: Nov 2014

open study

Early Childhood Obesity Programming by Intrauterine Growth Restriction
Montefiore Medical Center Childhood Obesity Epigenetics
The molecular mechanisms underlying developmental programming of childhood obesity remain poorly understood. Here, the investigators address major questions about early childhood obesity programming by studying CD3+ T-cells from intrauterine growth restricted (IUGR) newborns... expand

The molecular mechanisms underlying developmental programming of childhood obesity remain poorly understood. Here, the investigators address major questions about early childhood obesity programming by studying CD3+ T-cells from intrauterine growth restricted (IUGR) newborns who have an increased risk for obesity and other metabolic disorders in adult life.

Type: Observational

Start Date: Sep 2018

open study

S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle...
Southwest Oncology Group Pancreatic Adenocarcinoma Resectable Pancreatic Carcinoma
This randomized phase II trial studies how well fluorouracil, irinotecan hydrochloride, and oxaliplatin (combination chemotherapy) works and compares to gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients with... expand

This randomized phase II trial studies how well fluorouracil, irinotecan hydrochloride, and oxaliplatin (combination chemotherapy) works and compares to gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, oxaliplatin, gemcitabine hydrochloride, and paclitaxel albumin-stabilized nanoparticle formulation, 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. It is not yet known whether combination chemotherapy is more effective than gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating pancreatic cancer.

Type: Interventional

Start Date: Oct 2015

open study

Adapting and Expanding the Asthma-Educator App
Montefiore Medical Center Asthma
This project seeks to test and refine an adapted/expanded version of a previously created ASTHMAXcel app. expand

This project seeks to test and refine an adapted/expanded version of a previously created ASTHMAXcel app.

Type: Interventional

Start Date: May 2018

open study

The National Myelodysplastic Syndromes (MDS) Study
National Heart, Lung, and Blood Institute (NHLBI) Myelodysplastic Syndromes (MDS)
Multi-center study enrolling patients suspected or newly diagnosed with myelodysplastic syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) overlap disorder, or idiopathic cytopenia of undetermined significance (ICUS). Participants will be followed... expand

Multi-center study enrolling patients suspected or newly diagnosed with myelodysplastic syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) overlap disorder, or idiopathic cytopenia of undetermined significance (ICUS). Participants will be followed long term. Clinical data, blood, and tissue samples will be collected to establish a biorepository to facilitate the study of the natural history of MDS.

Type: Observational

Start Date: Apr 2016

open study