306 matching studies

Sponsor Condition of Interest
Beta Adrenergic Receptor Blockade as a Novel Therapy for Patients With Adenocarcinoma of the Prostate
Montefiore Medical Center Prostate Cancer
This will be a single arm, window of opportunity study in men with treatment-naïve prostate cancer who will proceed to prostatectomy. Men will be treated with carvedilol prior to undergoing prostatectomy. expand

This will be a single arm, window of opportunity study in men with treatment-naïve prostate cancer who will proceed to prostatectomy. Men will be treated with carvedilol prior to undergoing prostatectomy.

Type: Interventional

Start Date: Apr 2017

open study

The Effect of AposTherapy on Pain and Function in a Non Specific Low Back Pain
Montefiore Medical Center Low Back Pain
AposTherapy is a home based exercise program utilizing footwear that causes exercise with normal activity that may significantly improve function in patients with back pain since patients with back pain have altered mechanics of motion contributing or due to the presence of the... expand

AposTherapy is a home based exercise program utilizing footwear that causes exercise with normal activity that may significantly improve function in patients with back pain since patients with back pain have altered mechanics of motion contributing or due to the presence of the conditions. Capitalizing on the reported excellent adherence and clinical benefit of ApostTherapy in patients with significant knee and back pain, we propose to evaluate this as a conservative treatment that may supplant/supplement traditional pain medications and physical therapy in an at-risk urban inner city population.

Type: Interventional

Start Date: Aug 2017

open study

A Study of Pembrolizumab With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative...
Fox Chase Cancer Center Carcinoma Breast Stage IV
The main purpose of this study is to see if Pembrolizumab in combination with chemotherapy (carboplatin and gemcitabine) is safe and effective in treating patients with metastatic triple negative breast cancer. Pembrolizumab is a drug which may help the immune system to target... expand

The main purpose of this study is to see if Pembrolizumab in combination with chemotherapy (carboplatin and gemcitabine) is safe and effective in treating patients with metastatic triple negative breast cancer. Pembrolizumab is a drug which may help the immune system to target and destroy cancer cells. Pembrolizumab has been approved by the FDA for the treatment of advanced melanoma and metastatic non-small cell lung cancer. However, it has not been approved as a treatment for breast cancer.

Type: Interventional

Start Date: May 2016

open study

FLT3 Ligand Immunotherapy and Stereotactic Radiotherapy for Advanced Non-small Cell Lung Cancer
Albert Einstein College of Medicine Non-small Cell Lung Cancer (NSCLC)
Based on promising data from our laboratory demonstrating synergy between ablative local radiotherapy and FLT3 ligand immunotherapy in murine NSCLC models, investigators are performing a phase II study combining FLT3L immunotherapy and SBRT for patients with advanced NSCLC that... expand

Based on promising data from our laboratory demonstrating synergy between ablative local radiotherapy and FLT3 ligand immunotherapy in murine NSCLC models, investigators are performing a phase II study combining FLT3L immunotherapy and SBRT for patients with advanced NSCLC that has progressed following standard systemic therapy. All patients will receive daily subcutaneous injections of CDX-301 (75 µg/kg) for 5 days, beginning on the first day of SBRT. SBRT will be delivered to a single pulmonary or extrapulmonary lesion. The SBRT regimen will depend on the size and location of the target lesion. The primary endpoint will be progression-free survival at 4 months, defined using immune-related response criteria (irRC). A total of 29 patients will be enrolled.

Type: Interventional

Start Date: Jul 2016

open study

Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS
Alliance Foundation Trials, LLC. DCIS Ductal Carcinoma in Situ
This study looks at the risks and benefits of active surveillance (AS) compared to guideline concordant care (GCC) in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ... expand

This study looks at the risks and benefits of active surveillance (AS) compared to guideline concordant care (GCC) in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AS approach does not yield inferior cancer or quality of life outcomes compared to GCC.

Type: Interventional

Start Date: Feb 2017

open study

PRimary Care Opioid Use Disorders Treatment (PROUD) Trial
Kaiser Permanente Opioid-use Disorder
Effective treatment for opioid use disorders (OUDs) requires medications. Two medications for treating OUDs—buprenorphine and injectable naltrexone—can be prescribed in primary care (PC). However, despite the current opioid epidemic and expert recommendations that OUDs should be... expand

Effective treatment for opioid use disorders (OUDs) requires medications. Two medications for treating OUDs—buprenorphine and injectable naltrexone—can be prescribed in primary care (PC). However, despite the current opioid epidemic and expert recommendations that OUDs should be treated in PC, most PC clinics do not offer treatment for OUDs. This reflects a lack of consensus among health system leaders and clinicians that OUDs should be treated in PC. The PRimary care Opioid Use Disorders treatment (PROUD) Trial is a pragmatic cluster-randomized, quality improvement trial that evaluates implementation of a team-based approach to PC supported by a full time nurse (the "PROUD intervention"). This type of team-based PC is often referred to as "collaborative care" for management of OUDs in PC, and this type of trial is often referred to as a Hybrid Type III implementation trial. The trial is being conducted in 6 diverse health systems spanning 5 states (New York, Florida, Michigan, Texas, and Washington), with 2 PC clinics in each system randomized. One clinic is randomly selected to implement the PROUD intervention and the other continues usual PC (UPC). The overall objective of the PROUD trial is to provide information to guide health system leaders who are faced with the decision of whether or not to treat OUDs in PC, by evaluating the benefits of implementing the PROUD intervention that integrates high quality OUD treatment (i.e. buprenorphine or injectable naltrexone) into the normal flow of PC. The primary objective of the PROUD trial is to evaluate whether the PROUD intervention increases OUD treatment with buprenorphine or injectable naltrexone, documented in the electronic health records (EHRs) of PC patients, over a 2 year follow-up, as compared to UPC. The primary hypothesis is that there will be a significant increase in the number of patient-days of medication treatment for OUDs documented in the EHR of PC patients in the 2 years after clinics are randomized to the PROUD intervention compared to PC clinics randomized to UPC. This implementation objective reflects whether the PROUD intervention increases initiation of and/or retention in OUD treatment, documented in EHRs within medical settings. The main secondary objective is to test the hypothesis that PC patients with OUDs documented in their EHRs in the 3 years prior to randomization who receive care in PROUD intervention clinics, compared to those who receive care in UPC clinics, will have fewer days of acute care utilization (including urgent care, emergency department [ED] and hospital care) in the 2 years after randomization. This effectiveness objective assesses whether implementation of the MA Model improves patient outcomes.

Type: Interventional

Start Date: Feb 2018

open study

Use of Perioperative Antibiotics in Endoscopic Sinus Surgery
Montefiore Medical Center Chronic Sinus Infection
The objective of this study is to determine whether the use of postoperative antibiotics following ESS decreases postoperative infection rates. This is a multi-institutional prospective study involving Albert Einstein College of Medicine/Montefiore Medical Center, Columbia University... expand

The objective of this study is to determine whether the use of postoperative antibiotics following ESS decreases postoperative infection rates. This is a multi-institutional prospective study involving Albert Einstein College of Medicine/Montefiore Medical Center, Columbia University Medical Center, Weill Cornell Medical College, Mount Sinai Health System, and New York University Langone Medical Center. The study design will be a multi-institutional prospective randomized controlled trial with parallel random groups assigned to receive postoperative antibiotics or no postoperative antibiotics. The investigators hypothesize that patients who receive postoperative antibiotics will have lower postoperative infection rates and improved postoperative sinonasal symptoms and nasal endoscopy scores.

Type: Interventional

Start Date: Aug 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

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

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

Exparel Interscalene vs Indwelling Catheter
Montefiore Medical Center Pain
The investigators are comparing an indwelling catheter with intermediate duration local anesthetic to a single shot peripheral nerve block with long acting a local anesthetic (Exparel). expand

The investigators are comparing an indwelling catheter with intermediate duration local anesthetic to a single shot peripheral nerve block with long acting a local anesthetic (Exparel).

Type: Interventional

Start Date: Jan 2019

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

The Influence of Breakfast on Hormone Responses and Cognitive Performance
Albert Einstein College of Medicine Insulin Resistance
The purpose of this study is to see what effect skipping breakfast versus consuming breakfast has on cognitive performance and the hormones responsible for glucose homeostasis in lean and obese adolescent males. The subjects will be tested on their ability to maintain attention... expand

The purpose of this study is to see what effect skipping breakfast versus consuming breakfast has on cognitive performance and the hormones responsible for glucose homeostasis in lean and obese adolescent males. The subjects will be tested on their ability to maintain attention when given several tasks called continuous temporal expectancy tasks (CTET) and electrophysiological signals using electroencephalogram (EEG) will be monitored. These two study groups will be randomized to one of two orders: (A,B) or (B,A) where A = breakfast intervention and B = no breakfast. There will be a washout period of 7 days in between study visits.

Type: Interventional

Start Date: Jun 2016

open study

Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies
AIDS Malignancy Consortium Anal Cancer Cervical Cancer Lung Cancer Lymphoma
RATIONALE: Collecting and studying tissue samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies collecting tissue samples from patients with... expand

RATIONALE: Collecting and studying tissue samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies collecting tissue samples from patients with HIV-related malignancies.

Type: Observational

Start Date: Jul 2012

open study

Durvalumab and Tremelimumab in Treating Patients With Recurrent Stage IV Lung Cancer
Southwest Oncology Group Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC v7
This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow... expand

This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread.

Type: Interventional

Start Date: Oct 2017

open study

The Effect of Footwear Generated Biomechanical Manipulation on Symptoms of Stress Urinary Incontinence
Montefiore Medical Center Pelvic Floor Disorders Stress Urinary Incontinence
FGBMM (footwear generated biomechanical manipulation) effects neuromuscular patterns of pelvic muscles. While there have been no published studies to our knowledge investigating the effect of FGBMM on urinary incontinence, FGBMM causes perturbations in balance and gait that create... expand

FGBMM (footwear generated biomechanical manipulation) effects neuromuscular patterns of pelvic muscles. While there have been no published studies to our knowledge investigating the effect of FGBMM on urinary incontinence, FGBMM causes perturbations in balance and gait that create dynamics similar to dynamic lumbosacral stabilization exercises. The investigators propose that FGBMM induces the same bio-mechanical improvements as LPSE (lumbopelvic stabilization exercises) which have shown benefit for incontinence. Instead of instructing patients to co-contract the lower trunk and pelvic floor muscles as commonly done for LPSE, the shoes used in FGBMM can be calibrated in a way that causes this co-contraction to occur without the patient realizing. Beneficial pelvis and spine positioning can also be accomplished by strategic placement of the pods without having to instruct the patient on complicated maneuvers. Capitalizing on the excellent adherence and clinical benefits of FGBMM on related conditions, the investigators propose to evaluate the effects of FGBMM in addition to pelvic floor therapy for improving the symptoms of stress urinary incontinence in an urban inner city population.

Type: Interventional

Start Date: Nov 2017

open study

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

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

Type: Observational

Start Date: Sep 2015

open study

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

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

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

Electronic Patient Reporting of Symptoms During Cancer Treatment
Alliance Foundation Trials, LLC. Advanced Cancer Metastatic Cancer
The current study is designed to test nationally whether patients' outcomes and utilization of services can be improved through symptom monitoring via patient-reported outcomes between visits. expand

The current study is designed to test nationally whether patients' outcomes and utilization of services can be improved through symptom monitoring via patient-reported outcomes between visits.

Type: Interventional

Start Date: Oct 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

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in...
NRG Oncology Breast Adenocarcinoma Estrogen Receptor Negative HER2/Neu Negative Progesterone Receptor Negative Stage IB Breast Cancer
This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide,... expand

This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, 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 doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

Type: Interventional

Start Date: Jul 2015

open study

Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma...
ECOG-ACRIN Cancer Research Group Head and Neck Squamous Cell Carcinoma Hypopharyngeal Squamous Cell Carcinoma Laryngeal Squamous Cell Carcinoma Laryngeal Squamous Cell Carcinoma, Spindle Cell Variant Lip and Oral Cavity Squamous Cell Carcinoma
This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.... expand

This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as 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. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.

Type: Interventional

Start Date: Mar 2016

open study

Effect of Angulus on Patient-elevation Compliance
Angulus, LLC Ventilator Adverse Event Ventilator Associated Pneumonia Hospital Acquired Condition Hospital-acquired Pneumonia Recumbency
Ventilator-associated events (VAE) are a scourge of critical care settings and hospital systems at large. There is extensive evidence that ventilator-associated pneumonia (VAP) and related VAEs increase mortality rates in critically ill patients by up to 50%, while simultaneously... expand

Ventilator-associated events (VAE) are a scourge of critical care settings and hospital systems at large. There is extensive evidence that ventilator-associated pneumonia (VAP) and related VAEs increase mortality rates in critically ill patients by up to 50%, while simultaneously increasing cost of care. C Best-practice guidelines state that positioning ventilated patients at an angle between 30-45 degrees significantly reduces the potential for VAP and other VAE to develop. While the intent of the guidelines is to govern patient elevation angle, the lack of a mechanism to accurately measure patient elevation requires that nurses rely on the head-of-bed (HOB) protractor - a tool which reflects the angle of the bed, not the patient - to measure compliance. Depending upon the position and posture of the patient in the bed, a patient's elevation angle may be significantly different from the HOB angle. Critical care teams currently rely on built-in HOB protractors and digital inclinometers that measure the angle of the bed not the patient. Angulus, LLC has developed a dual-component Angulus sensor to fill this gap in critical care technology. Angulus enables critical care practitioners to instantaneously understand a patient's elevation, identify when the patient is outside of the desired 30-45 degree recumbency scope, and efficiently correct the patient's orientation with immediate feedback. Angulus supports real-time minute-to-minute data display as well as longitudinal aggregation of data.

Type: Interventional

Start Date: Jul 2018

open study