307 matching studies

Sponsor Condition of Interest
Phase I Study of Combination of Gedatolisib With Palbociclib and Faslodex in Patients With ER+/HER2-...
Hoffman Oncology Breast Cancer
This is a dose-escalation Phase Ib clinical trial in 18 patients with newly diagnosed Stage I-IV ER+/HER2- breast cancer, with the primary cancer in place. These patients have not received prior therapy for their breast cancer and intend to undergo surgery after four cycles of... expand

This is a dose-escalation Phase Ib clinical trial in 18 patients with newly diagnosed Stage I-IV ER+/HER2- breast cancer, with the primary cancer in place. These patients have not received prior therapy for their breast cancer and intend to undergo surgery after four cycles of therapy. This is an open-label study, and investigators and subjects are not blinded to the treatment. The reason for using an open-label study design is because this is a dose-escalation trial, and the investigators need to determine the potential toxicity before a decision can be made to continue the dose escalation procedures. The assignment of patients will not be randomized, as this is a dose-escalation trial.

Type: Interventional

Start Date: Jan 2016

open study

The B'N Fit POWER Initiative: A School-Based Wellness Initiative for Bronx Youth
Montefiore Medical Center Overweight and Obesity
The findings of this study will establish the feasibility and efficacy of B'N Fit POWER and given the wide presence of MSHP, MMCC and other afterschool programs, there is significant potential for dissemination of B'N Fit POWER to many other clinic-community partnership sites... expand

The findings of this study will establish the feasibility and efficacy of B'N Fit POWER and given the wide presence of MSHP, MMCC and other afterschool programs, there is significant potential for dissemination of B'N Fit POWER to many other clinic-community partnership sites enabling the development of a larger grant that will test the effectiveness and dissemination process to several schools in the Bronx. The translation of a traditional clinical-based weight-loss intervention to adapting and implementing such an intervention in a real-world school setting is more relevant and sustainable for advancing a culture of health and promoting diabetes risk reduction in Bronx youth.

Type: Interventional

Start Date: Jun 2017

open study

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

Women post breast mass biopsy with ER+ cancer will be randomized to two diets--45 of them to a ketogenic insulin inhibiting diet, 20 to a low fat diet simulating their existing diet, but with added 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

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal...
Eisai Inc. Renal Cell Carcinoma
This is a multicenter, randomized, open-label, Phase 3 study to compare the efficacy and safety of lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) versus sunitinib (Arm C) as first-line treatment in participants with advanced renal cell carcinoma. expand

This is a multicenter, randomized, open-label, Phase 3 study to compare the efficacy and safety of lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) versus sunitinib (Arm C) as first-line treatment in participants with advanced renal cell carcinoma.

Type: Interventional

Start Date: Oct 2016

open study

Necitumumab in the Neoadjuvant Setting With Gemcitabine in Surgically Resectable - 14X-US-I001
Montefiore Medical Center Squamous Cell Lung Cancer
This will be a single-arm study to primarily evaluate the feasibility of administering necitumumab added to gemcitabine and cisplatin as neoadjuvant treatment in treatment-naïve patients with stage IB (tumor size >4cm), II or IIIA squamous NSCLC. Feasibility will be assessed... expand

This will be a single-arm study to primarily evaluate the feasibility of administering necitumumab added to gemcitabine and cisplatin as neoadjuvant treatment in treatment-naïve patients with stage IB (tumor size >4cm), II or IIIA squamous NSCLC. Feasibility will be assessed by the proportion of patients able to proceed to surgery after administering necitumumab in the neoadjuvant setting. These patients would otherwise be offered standard adjuvant chemotherapy (without necitumumab) for squamous cell lung cancer. Determination of surgical resectability will be reviewed at a multidisciplinary thoracic tumor board, attended by surgical oncology, medical oncology, radiation oncology, radiology, and pathology.

Type: Interventional

Start Date: Feb 2018

open study

Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Takeda Ulcerative Colitis Crohn's Disease
The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active UC or CD. expand

The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active UC or CD.

Type: Interventional

Start Date: Nov 2017

open study

Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)
Cumberland Pharmaceuticals Asthma, Aspirin-Induced
The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal... expand

The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs.

Type: Interventional

Start Date: Jul 2017

open study

Pediatric Vasculitis Initiative
University of British Columbia Wegeners Granulomatosis (Granulomatosis With Polyangiitis) Microscopic Polyangiitis Churg Strauss Syndrome (Eosinophilic Granulomatosis With Polyangiitis) Polyarteritis Nodosa Takayasu Arteritis
Childhood chronic vasculitis describes a group of rare life-threatening diseases that have in common inflammation of blood vessels in vital organs such as kidneys, lungs and brain. Most knowledge about them comes from adult patients. Severe disease requires aggressive life-saving... expand

Childhood chronic vasculitis describes a group of rare life-threatening diseases that have in common inflammation of blood vessels in vital organs such as kidneys, lungs and brain. Most knowledge about them comes from adult patients. Severe disease requires aggressive life-saving treatments with steroids and some cancer drugs which can themselves cause damage, and increase risks of cancer and severe infections. Conversely, milder disease can be treated with less toxic drugs. Different classification and "scoring tools" are used to define the types and severity of vasculitis and to measure damage caused by disease or drugs. These in turn help direct how aggressively to treat a patient and to measure outcome. None of these tools however have been assessed in children and the best balance of disease and treatment risks against outcome for children is not known. Although causes of these diseases in children and adults are probably the same, the effects of the disease and the response (good and bad) to drugs will differ in growing children. Because specialists may see only one new child with vasculitis each year, obtaining enough information to learn about childhood vasculitis requires cooperation. We will use an international web-based registry to which doctors from 50 or more centers can contribute patient data. We will determine the features which help better classify and diagnose children compared to adults. Through the web we will collect and analyze information on patients similarly classified and "scored" so that most successful treatments can be identified. Children with vasculitis are less likely to have diseases associated with aging, alcohol and smoking etc., and therefore may be a better group in whom to study the underlying biology of vasculitis. We will use this opportunity and collect spit, blood and tissue from registry patients for laboratory study with an aim to find biomarkers to better classify, define and direct optimal treatment and outcomes.

Type: Observational [Patient Registry]

Start Date: Jan 2013

open study

Pediatric ASTHMA-Educator
Montefiore Medical Center Asthma
This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile application. expand

This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile application.

Type: Interventional

Start Date: Jul 2016

open study

Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced...
Kevin Kalinsky Metastatic Breast Cancer Breast Carcinoma
This is a randomized trial for patients with metastatic hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have progressed on an aromatase inhibitor plus a CDK4/6 inhibitor (either palbociclib or ribociclib) to either fulvestrant... expand

This is a randomized trial for patients with metastatic hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have progressed on an aromatase inhibitor plus a CDK4/6 inhibitor (either palbociclib or ribociclib) to either fulvestrant alone or fulvestrant with ribociclib (LEE-011). The purpose of the trial is to determine whether there is continued benefit for patients to remain on a CDK4/6 inhibitor at the time of switching anti-estrogen therapy. As ribociclib and palbociclib have a similar toxicity and drug profile and mechanism of action, we feel that it is appropriate for patients to receive either drug with an aromatase inhibitor prior to randomization.

Type: Interventional

Start Date: Mar 2016

open study

Comparing Five Oral Analgesics for Treatment of Acute Pain in the ED
Albert Einstein College of Medicine Musculoskeletal Pain
This study compares the efficacy of five oral analgesics: 5 mg oxycodone + 325 mg acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine + 300 mg acetaminophen, 400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000 mg acetaminophen for the treatment... expand

This study compares the efficacy of five oral analgesics: 5 mg oxycodone + 325 mg acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine + 300 mg acetaminophen, 400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000 mg acetaminophen for the treatment of patients with acute musculoskeletal pain who present to the Emergency Department (ED).

Type: Interventional

Start Date: Nov 2017

open study

Transformative Research in Diabetic Nephropathy
University of Pennsylvania Diabetic Nephropathies Diabetic Glomerulosclerosis
This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate... expand

This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol.

Type: Observational

Start Date: Dec 2016

open study

A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery
Albert Einstein College of Medicine Brain Cancer Head and Neck Cancer Lung Cancer Gastrointestinal Cancer Cervical Cancer
By utilizing fitness trackers, this study aims to demonstrate that a simple walking program improves patients' ability to tolerate curative concurrent chemoradiotherapy without treatment interruption. expand

By utilizing fitness trackers, this study aims to demonstrate that a simple walking program improves patients' ability to tolerate curative concurrent chemoradiotherapy without treatment interruption.

Type: Interventional

Start Date: Feb 2017

open study

STRIDE Biorepository
Emory University Anemia, Sickle Cell
The STRIDE Biorepository is an optional substudy available to participants in "Bone Marrow Transplantation vs Standard of Care in Patients with Severe Sickle Cell Disease (BMT CTN 1503) (STRIDE)". expand

The STRIDE Biorepository is an optional substudy available to participants in "Bone Marrow Transplantation vs Standard of Care in Patients with Severe Sickle Cell Disease (BMT CTN 1503) (STRIDE)".

Type: Observational [Patient Registry]

Start Date: Mar 2017

open study

National Collaborative to Improve Care of Children With Complex Congenital Heart Disease
Children's Hospital Medical Center, Cincinnati Hypoplastic Left Heart Syndrome (HLHS)
The purpose of this initiative is to improve care and outcomes for infants with HLHS by expanding the NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, by improving the use of... expand

The purpose of this initiative is to improve care and outcomes for infants with HLHS by expanding the NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, by improving the use of standards into everyday practice across pediatric cardiology centers, and by engaging parents as partners in the process.

Type: Observational [Patient Registry]

Start Date: May 2016

open study

Understanding the Pathophysiology of Migraine Pain
Montefiore Medical Center Migraine Disorders Migraine, Classic Migraine Without Aura
Migraine is the most common headache disorder, prevalent in 18% of females and 6% of males. Emergency room visits, physician consults, hospitalizations, medications, and indirect costs such as lost work days and decreased productivity place the global economic burden of migraines... expand

Migraine is the most common headache disorder, prevalent in 18% of females and 6% of males. Emergency room visits, physician consults, hospitalizations, medications, and indirect costs such as lost work days and decreased productivity place the global economic burden of migraines at over 20 billion dollars. It is prevalent in 28 million people in the US alone. Symptoms include unilateral, throbbing, debilitating headache pain accompanied by nausea, vomiting, photophobia, and phonophobia. Upwards of 75% of migraine patients have reduced functionability, have lost time at work, and 1/3 of patients require bed rest to manage the symptoms. The health-related impact on quality of life was comparable with that experienced by patients with congestive heart failure, hypertension, or diabetes. While the burden of migraines on our society is clear, the pathophysiology of migraines remains largely unknown. The trigeminovascular system, including the external and internal carotid arteries and their associated sensory fibers which subserve the head have long been implicated in the pain and cutaneous allodynia experienced by migraine patients. Wolff in 1953, was the first to posit that migraine headache pain is the caused by dilation or circumferential expansion of the extracranial carotid artery. He demonstrated that migraineurs had twice the pulse amplitude in their external carotid arteries compared to control subjects and these changes were directly correlated to migraine symptoms. In a 2008 study, randomized migraineurs received nitroglycerin via peripheral IV or placebo for 20 minutes prior to obtaining magnetic resonance angiography (MRA). Nitroglycerin, a potent dilator of blood vessels, reliably induced migraine-like pain in up to 80% of patients, and transient dilation of vessels of up to nearly 40%, mostly in the extracranial vessels. Sumatriptan's efficacy in migraine relief provides further evidence for this theory, as it is a selective extracranial vessel constrictor which does not cross the blood brain barrier. The goal of this current work is to utilize the direct, real-time angiography, which provides a high resolution map of vasculature, and demonstrate changes in vessel flow in patients who have migraine headache attacks. This information may guide therapeutic interventions in the future in order to better treat these migraine patients.

Type: Interventional

Start Date: Jan 2017

open study

A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
Merrimack Pharmaceuticals Non-Small Cell Lung Cancer NSCLC Adenocarcinoma Heregulin
The purpose of this study is to determine whether the combination of MM-121 plus docetaxel is more effective than docetaxel alone in regards to PFS in patients with heregulin-positive NSCLC. expand

The purpose of this study is to determine whether the combination of MM-121 plus docetaxel is more effective than docetaxel alone in regards to PFS in patients with heregulin-positive NSCLC.

Type: Interventional

Start Date: Feb 2015

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

RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers
Montefiore Medical Center Tobacco Use Disorder HIV
This trial will compare the efficacy of Positively Smoke Free on the Web+ (a smoking cessation program + social network for HIV-infected smokers) to the American Heart Association Getting Healthy website in promoting abstinence in a group of HIV-infected smokers. All participants... expand

This trial will compare the efficacy of Positively Smoke Free on the Web+ (a smoking cessation program + social network for HIV-infected smokers) to the American Heart Association Getting Healthy website in promoting abstinence in a group of HIV-infected smokers. All participants will be offered a three-month supply of nicotine patches.

Type: Interventional

Start Date: Jul 2016

open study

MRI Only Radiation Therapy With CPAP
Albert Einstein College of Medicine Carcinoma Liver Carcinoma, Pancreatic
The goal of this imaging study is to evaluate and improve the treatment planning techniques for abdominal radiation therapy. To accurately treat a tumor with radiation, Computed Tomography (CT) and Magnetic Resonance Images (MRI) are used to distinguish a tumor from normal, healthy... expand

The goal of this imaging study is to evaluate and improve the treatment planning techniques for abdominal radiation therapy. To accurately treat a tumor with radiation, Computed Tomography (CT) and Magnetic Resonance Images (MRI) are used to distinguish a tumor from normal, healthy tissue. However the quality of these images can be distorted by motion from breathing. To decrease motion, a patient may be asked to hold their breath or compress the abdomen, but currently there is no standard or best management option for all patients. This study will explore the use continuous positive airway pressure (CPAP), a pressurized breathing mask, during MRI or CT imaging to decrease motion in the abdomen and produce higher quality images. With these additional images, we will also explore the feasibility of creating treatment plans using the CPAP MRI images alone.

Type: Interventional

Start Date: Apr 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

Cognitive Remediation to Improve Mobility in Sedentary Seniors
Albert Einstein College of Medicine Mobility Limitation Motor Activity Difficulty Walking Cognitive Ability General
The investigators propose to conduct a single-blind randomized clinical trial to test the efficacy of a computerized cognitive remediation intervention program on improving locomotion in sedentary seniors, a group at an especially high risk for disability. The hypothesis is that... expand

The investigators propose to conduct a single-blind randomized clinical trial to test the efficacy of a computerized cognitive remediation intervention program on improving locomotion in sedentary seniors, a group at an especially high risk for disability. The hypothesis is that executive functions will respond to the cognitive remediation program and in turn enhance locomotion.

Type: Interventional

Start Date: Feb 2016

open study

Metoclopramide for Post Traumatic Headache
Montefiore Medical Center Post-Traumatic Headache
Nearly 1.5 million patients present to US emergency departments annually following head trauma. Headache is a frequent symptom of victims of head trauma. The purpose of this study is to see if an intravenous medication called metoclopramide can improve the symptoms of patients... expand

Nearly 1.5 million patients present to US emergency departments annually following head trauma. Headache is a frequent symptom of victims of head trauma. The purpose of this study is to see if an intravenous medication called metoclopramide can improve the symptoms of patients with acute post-traumatic headache.

Type: Interventional

Start Date: Aug 2017

open study

VasQ External Support for Arteriovenous Fistula
Laminate Medical Technologies Arterio-Venous Fistula ESRD Steal Syndrome Aneurysm Renal Failure
This is a prospective clinical study of the VasQ external support for arteriovenous fistulas. The device is designed to improve fistula outcomes by optimizing the geometrical configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote laminar flow.... expand

This is a prospective clinical study of the VasQ external support for arteriovenous fistulas. The device is designed to improve fistula outcomes by optimizing the geometrical configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote laminar flow. All patients will be implanted with the VasQ device and will be followed up for a duration of 24 months.

Type: Interventional

Start Date: Nov 2017

open study

A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant
Atossa Genetics, Inc. Female Breast Carcinoma Female Ductal Carcinoma In Situ
This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or DCIS. The first subject of each of five groups will receive fulvestrant intramuscularly. The... expand

This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or DCIS. The first subject of each of five groups will receive fulvestrant intramuscularly. The subsequent 5 subjects of each group will receive fulvestrant by intraductal instillation. All subjects will be monitored for systemic and local adverse events during the procedure, and following the procedure until mastectomy or lumpectomy. Subjects that receive fulvestrant will undergo serial blood draws to determine fulvestrant blood concentration levels.

Type: Interventional

Start Date: Mar 2016

open study