91 matching studies

Sponsor Condition of Interest
Fibrinolysis Compared to Thoracoscopy for Pleural Infection
Tulane University Pleural Infection Empyema Pleural Diseases Parapneumonic Effusion
The purpose of this prospective randomized clinical trial is to compare two currently accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant Deoxyribonuclease (DNase)... expand

The purpose of this prospective randomized clinical trial is to compare two currently accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant Deoxyribonuclease (DNase) for the management of empyema or complicated parapneumonic effusion (CPPE) in adults.

Type: Interventional

Start Date: Nov 2017

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

Sodium Lowering and Urinary Protein Reduction Trial
Tulane University School of Public Health and Tropical Medicine Chronic Kidney Disease Albuminuria
The proposed randomized controlled trial will test the effect of dietary sodium reduction on albuminuria in patients with proteinuric chronic kidney disease. Results from this study will clarify the role of dietary sodium reduction in management of patients with proteinuric chronic... expand

The proposed randomized controlled trial will test the effect of dietary sodium reduction on albuminuria in patients with proteinuric chronic kidney disease. Results from this study will clarify the role of dietary sodium reduction in management of patients with proteinuric chronic kidney disease and its potential to halt the progression of chronic kidney disease.

Type: Interventional

Start Date: Nov 2016

open study

Improve PAD PERformance With METformin
Northwestern University Peripheral Artery Disease
The PERMET trial will determine whether metformin daily for six months improves six-minute walk performance in individuals with peripheral artery disease compared to placebo. expand

The PERMET trial will determine whether metformin daily for six months improves six-minute walk performance in individuals with peripheral artery disease compared to placebo.

Type: Interventional

Start Date: May 2017

open study

The Weaving Healthy Families Program to Promote Wellness and Resilience and Prevent Alcohol and Other...
Tulane University Alcohol Abuse Drug Use Violence, Domestic Child Abuse Diet Modification
Alcohol and other drug (AOD) abuse and violence in families are co-occurring risk factors that drive health disparities and mortality among Native Americans (NA), making the long-term goal of this research is to promote health and wellness, while preventing and reducing AOD abuse... expand

Alcohol and other drug (AOD) abuse and violence in families are co-occurring risk factors that drive health disparities and mortality among Native Americans (NA), making the long-term goal of this research is to promote health and wellness, while preventing and reducing AOD abuse and violence in NA families by testing an efficacious, sustainable, culturally-relevant and family-centered intervention for cross-national dissemination. The central hypothesis is that the sustainable and community-based Weaving Healthy Families program, will reduce and postpone AOD use among NA adults and youth, decrease and prevent violence in families, and promote resilience and wellness (including mental health) among NA adults and youth. The expected outcomes of the proposed research are an efficacious, culturally relevant, and sustainable community based program to promote health and wellness that will address the factors that drive health disparities and promote individual, family, and community resilience.

Type: Interventional

Start Date: Jan 2019

open study

Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease
Northwestern University Peripheral Artery Disease
The TELEX trial will establish whether telmisartan alone improves walking performance in people with peripheral artery disease (PAD). The TELEX trial will also determine whether telmisartan plus supervised exercise improves walking performance more than either therapy alone.... expand

The TELEX trial will establish whether telmisartan alone improves walking performance in people with peripheral artery disease (PAD). The TELEX trial will also determine whether telmisartan plus supervised exercise improves walking performance more than either therapy alone. TELEX is a randomized controlled clinical trial (2 x 2 factorial design) of 240 participants with PAD randomized to one of four arms: Group A: telmisartan + supervised exercise therapy; Group B: telmisartan + a "no exercise" control group; Group C: placebo + supervised exercise therapy; and Group D: placebo + a "no exercise" control group.

Type: Interventional

Start Date: Oct 2015

open study

Using D-Galactose as a Food Supplement in Congenital Disorders of Glycosylation
Tulane University Congenital Disorders of Glycosylation
The goal of this study is to better characterize the metabolic alterations and sugar structure alterations (glycosylation abnormalities) in patients diagnosed with Congenital Disorders of Glycosylation. The investigators aim to assess the safety and tolerability of oral galactose... expand

The goal of this study is to better characterize the metabolic alterations and sugar structure alterations (glycosylation abnormalities) in patients diagnosed with Congenital Disorders of Glycosylation. The investigators aim to assess the safety and tolerability of oral galactose treatment in a small pilot group of Congenital Disorders of Glycosylation patients. The investigators will also determine the relationship between simple milk sugar intake (galactose dose) in the diet and the blood and urine markers of protein glycosylation abnormalities.

Type: Interventional

Start Date: Jul 2014

open study

Music Therapy and Dialysis: A Pilot Investigation Into the Effectiveness of Patient-Selected Music Interventions...
Tulane University End Stage Renal Disease Depression Anxiety Major Depressive Disorder Generalized Anxiety Disorder
The objective of this study is to determine the effect of music therapy during dialysis on: depression, anxiety, quality of life, blood pressure, heart rate, medication compliance, compliance with dialysis treatment, number of hospitalizations, pain level, and energy level. expand

The objective of this study is to determine the effect of music therapy during dialysis on: depression, anxiety, quality of life, blood pressure, heart rate, medication compliance, compliance with dialysis treatment, number of hospitalizations, pain level, and energy level.

Type: Interventional

Start Date: Mar 2019

open study

Evaluating Safety & Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Recalcitrant...
Tulane University Dermatomyositis, Adult Type
With limited treatment options available for dermatomyositis, the investigators hypothesize that apremilast, a phosphodiesterase-4 (PDE-4) inhibitor, is a safe and efficacious add-on treatment in patients with refractory cutaneous dermatomyositis. The study will investigate... expand

With limited treatment options available for dermatomyositis, the investigators hypothesize that apremilast, a phosphodiesterase-4 (PDE-4) inhibitor, is a safe and efficacious add-on treatment in patients with refractory cutaneous dermatomyositis. The study will investigate the efficacy, safety and toxicity of apremilast given at 30 mg twice daily to patients with refractory cutaneous dermatomyositis. Clinical response will be assessed at 1 and 3 months. Patients will also be evaluated for durability of their response for up to 6 months. Treatment will be monitored with frequent clinical visits (0, 1, 3 and 6 months) and blood tests (CBC, CMP, creatine kinase, aldolase). Treatment will be discontinued at disease progression or unacceptable adverse events. Disease progression is defined as 4 points increase in the cutaneous dermatomyositis disease area and severity index (CDASI) score, worsening of muscle disease by manual muscle testing (MMT-8) score and 5 points increase in dermatomyositis life quality index (DLQI). 5 mm skin biopsies from lesional skin will be performed before treatment with apremilast and after 3 months of treatment for gene expression profiling and confirmatory immunohistochemical stains.

Type: Interventional

Start Date: Jun 2018

open study

Registry Study of COAGADEX® Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing...
Bio Products Laboratory Factor 10 Deficiency
This is a non-interventional, multicenter, post-marketing registry study in three patients with moderate or severe hereditary FX deficiency, to assess Coagadex administered peri-operatively for hemostatic cover in major surgery during routine post-marketing use. expand

This is a non-interventional, multicenter, post-marketing registry study in three patients with moderate or severe hereditary FX deficiency, to assess Coagadex administered peri-operatively for hemostatic cover in major surgery during routine post-marketing use.

Type: Observational

Start Date: Feb 2018

open study

Helping Stroke Patients With ThermoSuit Cooling
Life Recovery Systems Stroke Brain Ischemia
The aim of this study is to assess the feasibility of using the Life Recovery Systems ThermoSuit Device to induce therapeutic hypothermia (32-34°C) in victims of ischemic stroke. This feasibility clinical study will enroll a total of 30 patients with acute ischemic stroke at... expand

The aim of this study is to assess the feasibility of using the Life Recovery Systems ThermoSuit Device to induce therapeutic hypothermia (32-34°C) in victims of ischemic stroke. This feasibility clinical study will enroll a total of 30 patients with acute ischemic stroke at four clinical centers. Subjects will receive hypothermia plus conventional therapy (such as IV-tPA and/or neurothrombectomy therapies if indicated). Endpoints will include feasibility of cooling, adverse events, and neurological recovery in comparison with matched historical controls.

Type: Interventional

Start Date: Jan 2017

open study

DM-CHOC-PEN Plus Radiation for Brain Tumors
DEKK-TEC, Inc. Advanced Cancer
4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) is a polychlorinated pyridyl cholesterol carbonate that is lipophilic, electrically neural, crosses the blood brain barrier (BBB), ability to localize in intracranial tumor tissue, lacks neurotoxicity and not transported... expand

4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) is a polychlorinated pyridyl cholesterol carbonate that is lipophilic, electrically neural, crosses the blood brain barrier (BBB), ability to localize in intracranial tumor tissue, lacks neurotoxicity and not transported out of the brain via Pgp (p-glycoprotein) (1). DM-CHOC-PEN has completed Phase I/II trials in humans with primary and secondary tumors involving the brain with success. Complete remissions in both primary astrocytoma and metastatic lung and leukemia malignancies. This trial is open for adult subjects with advanced cancer - brain involvement is required.

Type: Interventional

Start Date: Feb 2016

open study

Cooking for Health Optimization With Patients
Tulane University Cardiovascular Diseases Cardiovascular Risk Factor Nutrition Disorders Diabetes Hypertension
Cooking for Health Optimization with Patients (CHOP) is the first known multi-site prospective cohort study with a nested Bayesian adaptive randomized trial in the preventive cardiology field of culinary medicine. It is also the first known longitudinal study to assess the impact... expand

Cooking for Health Optimization with Patients (CHOP) is the first known multi-site prospective cohort study with a nested Bayesian adaptive randomized trial in the preventive cardiology field of culinary medicine. It is also the first known longitudinal study to assess the impact of hands-on cooking and nutrition education on patient outcomes, with those classes taught by medical students and other future and current medical professionals who have first been trained in those classes on how to integrate diet and lifestyle counseling of patients with their respective scopes of clinical practice. CHOP is the primary research study of the world's first known medical school based teaching kitchen, The Goldring Center for Culinary Medicine at Tulane University School of Medicine. Medical trainees and professionals are followed in this study long-term to understand how the classes impact their competencies in patient counseling, attitudes about the counseling, and their own diets. Patients who consent to being randomized to these classes compared to standard of care are studied within the nested Bayesian adaptive randomized trial to understand how the classes impact their health outcomes, clinical and food costs, and the costs of health systems caring for these patient populations. CHOP is designed as a pragmatic population health trial to hopefully improve healthcare effectiveness, equity, and cost by establishing an evidence-based, scalable, sustainable model of healthcare intervention targeting the social determinants of health, while complementing the pharmacological and/or surgical management of patients.

Type: Interventional

Start Date: Feb 2018

open study

Impact of Plasma Soluble Prorenin Receptor in Obese and Type 2 Diabetic Patients
Tulane University Obesity Type2 Diabetes Bariatric Surgery Candidate
Obesity increases the risk for type 2 diabetes mellitus, high blood pressure, and mortality. Obesity is a major health problem in the United States, especially in the Deep South regions. Obesity increases the risk for T2DM, the occurrence of hypertension, and mortality; but the... expand

Obesity increases the risk for type 2 diabetes mellitus, high blood pressure, and mortality. Obesity is a major health problem in the United States, especially in the Deep South regions. Obesity increases the risk for T2DM, the occurrence of hypertension, and mortality; but the efficacy of long-term weight loss medications has been disappointing. There are three options available for patients who want to lose weight: lifestyle modification, pills, or weight loss by bariatric surgery. When we compare the three options available, bariatric surgery is the most effective method to lose weight at present. Bariatric surgery allows patients lose the most weight, be able to sustain the weight reduction over time and, more importantly, diabetes mellitus and other cardiovascular risk factors significantly improve. Understanding the link among obesitydiabetes-hypertension is crucial in order to develop new therapeutic targets to decrease CVD morbidity and mortality. There is less prevalence of coronary artery disease (CAD) in premenopausal women than in men, but, once initiated, the morbidity and mortality due to CAD in women is worse than in men, thus highlighting this sex difference in CVD. Indeed, women with diabetes exhibit a higher risk of myocardial infarction and stroke mortality than men, compared to people without diabetes. In obese subjects, there is inappropriate activation of the systemic and adipose renin-angiotensin system. The prorenin receptor is a molecule expressed in various tissues including fat tissue and part of it, the soluble prorenin receptor, can be secreted into the blood. The prorenin receptor is part of a very important system that regulates blood pressure and fat in our body, the renin-angiotensin system. In this prospective observational human pilot study, we will determine whether the adipose tissue is the major supplier of soluble prorenin receptor levels in the plasma of obese patients and the relationship between blood soluble prorenin receptor and diabetes mellitus, obesity, high blood pressure and other important cardiovascular risk factors. Outcomes from this study will allow a better understanding of the complex factors that link obesity, diabetes mellitus, and other cardiovascular risk factors and designing better therapeutic alternatives to improve patient's health, particularly in obese diabetic women.

Type: Observational

Start Date: Sep 2018

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

Impact of CMS Reimbursement Policy Supporting Care Coordination in Louisiana
Tulane University Diabetes Mellitus, Type 2 Chronic Disease
Investigators propose to use a natural experiment design to examine the impacts of the new CPT code (99490) for chronic care management on health outcomes. The Investigators will collaborate with partners in the Louisiana Clinical Data Research Network (LaCDRN) who serve more... expand

Investigators propose to use a natural experiment design to examine the impacts of the new CPT code (99490) for chronic care management on health outcomes. The Investigators will collaborate with partners in the Louisiana Clinical Data Research Network (LaCDRN) who serve more than 90,000 patients with type 2 diabetes mellitus in Louisiana to examine impacts of the CMS reimbursed care coordination. Now, LaCDRN is renamed as Research Action for Health Network (REACHnet). Patient and stakeholder engagement will be planned and implemented across all phases of this natural experiment. This project will examine outcome differences created by the policy change in a natural experiment framework. The analyses will utilize the RE-AIM framework to identify the critical elements of the programs that will enhance the reach, effectiveness, adoption, implementation, and maintenance of these strategies in the diverse LaCDRN diabetes populations.

Type: Observational

Start Date: Jan 2017

open study