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About Advance Research Intitute of Miami FL

February 2015 – Current

Dipexium Pharmaceuticals Inc. A Randomized, Double-Blind, Multicenter, Superiority, Placebo-Controlled Phase 3 Study of Pexiganan Cream 0.8% Applied Twice Daily for 14 Days in the Treatment of Adults with Mild Infections of Diabetic Foot Ulcers

November 2014 – Current

Derma Sciences Inc. DSC 127-2012-01 A Randomized, Double-Blind, Parallel-group, Vehicle-controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DSC127 in Treating Non-healing Foot Ulcers in Subjects with Diabetes Mellitus.

November 2014 – Current

TEI Biosciences Inc. TEI-007v02 Multi-center, Prospective, Randomized Study with Primatrix Dermal Repair scaffold Moist Wound Therapy and Standard of Care Moist Wound Therapy for the Treatment of Chronic Diabetic Foot Ulcers

May 2014 – Dec 2014

Acell Inc. ACL2011-002-I

An Evaluation of Tissue Engineering Approaches for Treatment of Neuropathic Diabetic Foot Ulcers Resistant to Standard of Care:  Prospective, Randomized Controlled Trial

May 2014 – Nov 2014

Merck & Pfizer MK-8835-P005/P006

Study Drug:   Ertugliflozin     Protocol Title: A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Ertugliflozin (MK-8835/PF-04971729) with Sitagliptin Compared with Ertugliflozin Alone and Sitagliptin Alone, inthe Treatment of Subjects with T2DM With Inadequate Glycemic Control on Metformin Monotherapy. MK8835-005

Aug 2013 - Jan 2014

Sanuwave - SAN12-DERM02:

A Double-Blind, Multi-center, Randomized, Sham-Controlled, Parallel Group Comparison of the dermaPACE® (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care Versus Standard of Care Alone in the Treatment of Diabetic Foot Ulcers. Phase III

Aug 2011 - Feb 2013

A Long-term, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia. Phase III.

Feb 2011- 2013

GSK-Summit HZC113782

A Clinical Outcomes Study to compare the effects of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease. Phase II

Nov 2010 – Jun 2013

Boehringer Ingelheim COPD 205.452

A Randomized , active-controlled, double-blind, double-dummy, parallel group design, multi-center trial to compare the efficacy and safety of 2.5 ug and 5 ug Tiotropium Inhalation Solution delivered by the Respimat In haler with Tiotropium inhalation capsules

18 ug delivered by the HandiHaler . Phase III

Aug 2010 – Jan 2013

Otsuka- 331-08-212

Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adult Patients With Major Depressive Disorder. Phase II

Jun 2010

GSK- Pallas  EFC11319

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome. Phase III

Mar 2010- Nov 2012

Otsuka- Aspire 31-08-246 roll-over to31-08-248 roll-over to 31-10-270

A 52-week, multicenter, Open-label study to evaluate the effectiveness of Aripiprazole Intramuscular  Depot  as maintenance treatment in patients schizophrenia.

Phase IV.

Mar 2010- Apr 2014

Pfizer-Precision A3191172

A Randomized, Double Blind, Parallel-Group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen. Phase IV.

Feb 2010

GSK- Pallas EFC1140

A Randomized, Double Blind, Placebo Controlled, Parallel Group Trial for Assessing the Clinical Benefit of Dronedarone 400mg BID on Top of Standard Therapy in Patients With Permanent Atrial Fibrillation and Additional Risk Factors. Phase III

Jun 2009

Otsuka – Aripiprazole 31-07-246

A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia. Phase III

Jan 2009

GlaxoSmithKline A2-8397000 Assessment Test Prospective Validation Study of the Chronic Obstructive Pulmonary Disease.

Jun 2008

Gastrointestinal (GI) Randomized Event and Safety Open-label NSAIDS Study (GI-reasons): A Randomized, Open-label, Blinded-Endpoint, Parallel-Group Trial of GI Safety of Celecoxib compared with Non-Selective NSAIDS  in Osteoarthritis  Patients. 24 week Trial, Phase IV

Jun 2008

AstraZeneca- Symbicort

A 12 week, Randomized, Double-Blinded, Double dummy , Multicenter study comparing the efficacy ans safety of Symbicort  pMdi 160/4.5 ug x 2 actuations twice daily vs. Dudesonide inhalation power DPI 180 ux2 inhalation twice daily, in adult and adolescent (≥ 12years) African American subjects with asthma. Phase IV.

Dec 2007

AstraZeneca- Quetiapie Fumarate Extented-Release  (Seroquel XR) Generalized Anxiety Disorder Adjunct study: A multicenter, Randomized, Double-Blinded, Paraallel-Group, Placebo-controlled study of efficacy and safety of Quetipine Fumarate Extended –Release (SeroqueL XR) compared with placebo as an Adjunct for treatment in patients with Generalized Anxiety  Disorder who demonstrate partial or no response to a selective Serotonin Reuptake inhibitor or Serotonin-Norepinephrine Reutake Inhibitor alone or in combination with a Benzodiazepine , Phase III.

Jul 2007

Johnson-Johnson PAL-OUT-003

The Paliperidone ER Outcomes Study of Schizophrenia Patients in Typical Clinical Practice. Phase IV.

Jun 2007

Bifeprunox to Quetiapine on Weight Changes in stable Schizophrenic Patients. Phase IV

Apr 2007

AstraZeneca – Gold Study

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-controlled, Active-controlled Study of the efficacy and safety of Sustained-release Quetiapine Fumarate (Seroquel ) compared with Placebo in the treatment of Generalized Anxiety Disorder. Phase III

Feb 2007

A Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Dose-Response Study to evaluate the efficacy and safety of 3 fixed doses (25mg eq., 100mg eq., and 150mg eq.) of Paliperidone Palmitate in subjects with Schizophrenia. Phase II

Oct 2006

AstraZeneca- Pearl Study

A Multi-Center, Double-Blind, Randomized, Parallel Group Placebo Control to study the efficacy and safety of Qurtiapine Fumarete Sustained Release (Seroquel ER) in Combination with an Antidepressant in the Treatment of patients with Major Depressive Disorder with Inadequate Response to an Antidepressant Treatment. Phase III.

May 2006

Pfizer

Source Study, A Randomized, Parallel Group, Multiple Dose, 6 week study to Evaluate Safety, Tolerability, and Pharmacokinetics of Asenapine in Elderly subjects with Psychosis. Phase I.

Mar 2006

Sunovion- AC-3933

Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Assessing the Efficacy and Safety of AC-3933 Tablets Twice Daily in Adults With Mild to Moderate Alzheimer's Disease.

Jan 2006

AstraZeneca

Source Study, Efficacy and Safety of Quetiapine Fumerate Sustained Release (Seroquel SR) as Monotherapy in the Maintenance Treatment of patients with Major Depressive Disorder. Phase III

Jan 2006

Eli Lilly

Source Study, Cardiovascular Safety of Ziprasidone and Olanzapine. Open-Label, Observation Phase IV.

May 2004

Johnson-Johnson

Source Study, Schizophrenia Outcomes-Utilization Relapse, and Clinical Evaluation, Risperdal ConstaPhase IV.

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