107 matching studies

Sponsor Condition of Interest
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic...
Genfit Nonalcoholic Steatohepatitis (NASH) With Fibrosis
The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. expand

The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.

Type: Interventional

Start Date: Mar 2016

open study

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Center for International Blood and Marrow Transplant Research Hematologic Malignancies Inherited Disorders of Metabolism Inherited Abnormalities of Platelets Histiocytic Disorders Acute Myelogenous Leukemia (AML or ANLL)
This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications. expand

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

Type: Observational

Start Date: Oct 2011

open study

AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults...
Tobira Therapeutics, Inc. Nonalcoholic Steatohepatitis
The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult subjects with NASH. expand

The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult subjects with NASH.

Type: Interventional

Start Date: Apr 2017

open study

Natural History Study Protocol in PMM2-CDG (CDG-Ia)
Glycomine, Inc. Phosphomannomutase 2 Deficiency
Clinical and Basic Investigations into Phosphomannomutase deficiency (PMM2-CDG) This is a natural history (observational) protocol designed to collect clinical and biological information in patients with PMM2-CDG (CDG-Ia). Data from this natural history study will be used to... expand

Clinical and Basic Investigations into Phosphomannomutase deficiency (PMM2-CDG) This is a natural history (observational) protocol designed to collect clinical and biological information in patients with PMM2-CDG (CDG-Ia). Data from this natural history study will be used to determine a set of clinical and biological parameters that will be used for primary and secondary endpoints in a later clinical trial with a new chemical entity, Lipo-M1P.

Type: Observational

Start Date: Jan 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

Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant...
Daniel George, MD Prostate Cancer
The primary goal is to prospectively estimate the median PFS of African American and Caucasian men with mCRPC taking apalutamide, abiraterone acetate, and prednisone. Secondary objectives include: PSA kinetics: to determine the duration of PSA response, time to nadir, and percent... expand

The primary goal is to prospectively estimate the median PFS of African American and Caucasian men with mCRPC taking apalutamide, abiraterone acetate, and prednisone. Secondary objectives include: PSA kinetics: to determine the duration of PSA response, time to nadir, and percent of men who achieve a PSA < 0.1; Radiographic assessments: to estimate the rate of objective response and incidence of bone flares; Safety (NCI CTC v4.0) and tolerability, particularly incidence and grade of hypertension in the two populations. This is a non-comparative pilot open-label, parallel arm, multicenter study of apalutamide and abiraterone acetate in African American and Caucasian men with mCRPC. It is anticipated that 3 additional sites will be needed to accrue 100 subjects (50 African American and 50 Caucasian) over a 24 month accrual period. The study agents will be administerd at the following doses: apalutamide 240mg orally once daily, abiraterone acetate 1000mg orally once daily, and prednisone 5 mg BID in 4-week cycles throughout the treatment period. Fifty (50) patients will be enrolled in each group (AA and Caucasians). The proportion of patients who experience PSA decline of 30%, 50% and 90% will be estimated with exact 95% confidence intervals based on the binomial distribution will be computed. In addition, post therapy changes in PSA will be explored as a continuous outcome. The Kaplan-Meier product limit method will be used to estimate the rPFS, biochemical PFS and overall survival distributions.

Type: Interventional

Start Date: Jul 2017

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

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer
Endocyte Prostate Cancer
The primary objective of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone.... expand

The primary objective of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone. Key secondary objectives are an arm-to-arm comparison of the following: - Radiographic progression-free survival (rPFS) - Response Evaluation Criteria in Solid Tumors (RECIST) response - Time to a first symptomatic skeletal event (SSE) Additional Secondary Objectives: - Safety and tolerability of 177Lu-PSMA-617 - Health-related quality of life (HRQoL; EQ-5D-5L, FACT-P and Brief Pain Inventory - Short Form (BPI-SF)) - Health economics - Progression-free survival (PFS) (radiographic, clinical, or prostate-specific antigen [PSA] progression-free survival) - Biochemical response as measured by PSA. Alkaline phosphatase [ALP] levels and lactate dehydrogenase [LDH] levels will also be measured.

Type: Interventional

Start Date: May 2018

open study

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

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

Type: Interventional

Start Date: Sep 2015

open study

Avelumab Plus 2nd-generation ADT in African American Subjects With mCRPC
Jodi Layton, MD Metastatic Castration-resistant Prostate Cancer
This is a nonrandomized, open-label trial of avelumab in subjects with metastatic castration-resistant prostate cancer (mCRPC) experiencing PSA or radiographic progression while receiving 2nd generation ADT (abiraterone / enzalutamide/ apalutamide or darolutamide). Metastases... expand

This is a nonrandomized, open-label trial of avelumab in subjects with metastatic castration-resistant prostate cancer (mCRPC) experiencing PSA or radiographic progression while receiving 2nd generation ADT (abiraterone / enzalutamide/ apalutamide or darolutamide). Metastases must be radiographically evident by whole body bone scintigraphy or CT/MRI scan. Thirteen African American subjects will be enrolled into the initial cohort. If at least one positive response (PSA decrease by >50% and or radiographic per RECIST 1.1) is found, the study will be expanded to accrue a total of 27 patients. The trial will be conducted in accordance with Good Clinical Practices. Subjects enrolled in the study will receive avelumab 10 mg/kg every 2 weeks (Q2W) and continue their previously started 2nd generation ADT (abiraterone or enzalutamide). Treatment with avelumab will continue until documented confirmed disease progression, unacceptable AEs, intercurrent illness that prevents further administration of treatment, Investigator's decision to withdraw the subject, subject discontinuation from the study, noncompliance with trial treatment or procedure requirements, subject receives 52 administrations of avelumab (approximately 2 years), or administrative reasons requiring the cessation of treatment. After the end of treatment, each subject will be followed for 30 days for AE monitoring (serious AEs will be collected for 90 days after the end of treatment or 30 days after the end of treatment if the subject initiates new anticancer therapy, whichever is earlier). Subjects who discontinue treatment for reasons other than disease progression will remain on study and continue to undergo study-related disease assessments until documented disease progression, initiation of a new non-study prostate cancer treatment, withdrawal of consent, or becoming lost to follow-up. All subjects will enter survival follow up, and will be contacted at their regularly scheduled clinic visit, or by telephone approximately every 6 months, until death or withdrawal of consent or end of study.

Type: Interventional

Start Date: Jan 2019

open study

PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry
BioMarin Pharmaceutical Phenylketonuria Hyperphenylalaninaemia
The objective of this study is to evaluate the safety of long-term treatment with Kuvan. expand

The objective of this study is to evaluate the safety of long-term treatment with Kuvan.

Type: Observational

Start Date: Sep 2008

open study

An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide...
Bristol-Myers Squibb Prostate Cancer
The purpose of this study is to assess the safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread. expand

The purpose of this study is to assess the safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread.

Type: Interventional

Start Date: Dec 2017

open study

Genomic Response Analysis of Heart Failure Therapy in African Americans
University of Pittsburgh Heart Failure
The response to therapy with a fixed dose combination of isosorbide dinitrate and hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction (HFrEF) when compared to similar white cohorts. This study will seek to confirm the previous... expand

The response to therapy with a fixed dose combination of isosorbide dinitrate and hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction (HFrEF) when compared to similar white cohorts. This study will seek to confirm the previous genetic sub-study from AHeFT which suggested a functional polymorphism of guanine nucleotide binding protein beta polypeptide 3 subunit (GNB3), C825T in exon 10, influences the therapeutic efficacy of FDC I/H. This study will initiate treatment with FDC I/H in 500 self designated African American subjects with systolic heart failure. They will be followed for up to two years on therapy. Clinical outcomes (survival, heart failure hospitalizations, and change in quality of life) on FDC I/H will be compared by GNB3 genotype subset. The hypothesis to be confirmed is that subjects homozygous for the T allele (those with the GNB3 TT genotype which is present in approximately 50% of black subjects) demonstrate enhanced therapeutic benefit from FDC I/H.

Type: Observational

Start Date: May 2015

open study

Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing...
AbbVie (prior sponsor, Abbott) Fibrosing Colonopathy
This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at... expand

This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at their regular clinical care visits over a 10-year period and approached if they develop symptoms of fibrosing colonopathy for collection and use of further detailed information.

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

Pulmonary Fibrosis Foundation Patient Registry
University of Michigan Interstitial Lung Disease (ILD) Idiopathic Pulmonary Fibrosis (IPF)
The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US. The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to have idiopathic... expand

The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US. The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to have idiopathic pulmonary fibrosis (IPF). The aim of the Registry is to create a cohort of well-characterized patients with interstitial lung disease (ILD) for participation in retrospective and prospective research

Type: Observational [Patient Registry]

Start Date: Mar 2016

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

Integrated Cancer Repository for Cancer Research
University of Nebraska Pancreatic Cancer Thyroid Cancer Lung Cancer Esophageal Cancer Thymus Cancer
The objectives of this project at UNMC and other IRB approved sites is to implement and maintain a comprehensive data and biospecimen bank known as the Integrated Cancer Repository for Cancer Research (iCaRe2). The data registry and biospecimen bank will provide core support... expand

The objectives of this project at UNMC and other IRB approved sites is to implement and maintain a comprehensive data and biospecimen bank known as the Integrated Cancer Repository for Cancer Research (iCaRe2). The data registry and biospecimen bank will provide core support services for future IRB approved multidisciplinary research on cancer and other chronic diseases carried out by members of the Fred and Pamela Buffett Cancer Center as well as internal and external research collaborators from different participating institutions/centers.

Type: Observational [Patient Registry]

Start Date: Nov 2013

open study

Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of...
Onconova Therapeutics, Inc. Myelodysplastic Syndrome MDS Refractory Anemia With Excess Blasts RAEB
The study's primary objective [in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)], is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician's Choice group, in all patients and in a subgroup... expand

The study's primary objective [in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)], is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician's Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk.

Type: Interventional

Start Date: Oct 2015

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

Inhibition of Urinary Angiotensinogen and the Reduction of Blood Pressure by SGLT2 Inhibition in Patients...
Tulane University Type 2 Diabetes Hypertension
To assess the effect of SGLT-2 inhibitors on blood pressure and urinary angiotensinogen. This is a cross over study design, where 40 subjects will receive Dapagliflozin for 6 weeks followed by placebo for 6 weeks, or placebo for 6 weeks followed by Dapagliflozin for 6 weeks.... expand

To assess the effect of SGLT-2 inhibitors on blood pressure and urinary angiotensinogen. This is a cross over study design, where 40 subjects will receive Dapagliflozin for 6 weeks followed by placebo for 6 weeks, or placebo for 6 weeks followed by Dapagliflozin for 6 weeks. In addition there will be an arm of 10 subjects who will receive sulfonylurea in an open label as a comparative to the cross over subjects to assess if the effect of Dapagliflozin may also be in part due to improved glycemic control.

Type: Interventional

Start Date: Mar 2016

open study

Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
Harvard School of Public Health HIV/AIDS
This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition into adulthood. A group of perinatally HIV-exposed, -uninfected (PHEU) young adults from a similar... expand

This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition into adulthood. A group of perinatally HIV-exposed, -uninfected (PHEU) young adults from a similar sociodemographic background and age distribution will be enrolled for comparison.

Type: Observational

Start Date: Apr 2014

open study

Check it: A New Approach to Controlling Chlamydia Transmission in Young People
Tulane University Chlamydia Trachomatis Infection Gonorrhea
This study, named "Check it," is a bundled program for African American (AA) men ages 15-24 that includes community testing for chlamydia and gonorrhea, expedited treatment for subjects who test positive and their female sexual contacts, and rescreening for these two sexually... expand

This study, named "Check it," is a bundled program for African American (AA) men ages 15-24 that includes community testing for chlamydia and gonorrhea, expedited treatment for subjects who test positive and their female sexual contacts, and rescreening for these two sexually transmitted infections.

Type: Interventional

Start Date: May 2017

open study

INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
Brigham and Women's Hospital Heart Failure Myocardial Infarction
INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure.... expand

INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three additional influenza seasons. The primary endpoint will be a composite of all-cause mortality or cardiopulmonary hospitalization.

Type: Interventional

Start Date: Aug 2016

open study