Clinical Research Studies @ Florida Medical Clinic Specialties and Physicians

Clinical Research Division Studies
Current studies being conducted at Florida Medical Clinic, P.A.
All studies are grouped by field. Select sutdy title to learn more about the study.

Cardiology

Study Title Trial To Assess Chelation Therapy
Description A randomized, double-blind, placebo-controlled trial to assess chelation versus placbo. 30 weekly infusions followed by 10 bi-monthly infusions.
Eligibility Subjects that have had a heart attack in the past.

Cardiology

Study Title The IMPACT of Biotronik Home Monitoring Guided Anticoagulation on Stroke risk in Patients with Implaced ICD and CRT-D Devices.
Description The IMPACT Study will investigate the clinical benefit of the combined use of Biotronik Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and physician-directed anticoagulation in patients with implaced dual-chamber defibrillators or cardiac resynchronization therapy devices.
Eligibility 18 Years and Older Males & Females

Cardiology

Study Title The purpose of this study is to determine wheather periodic therapy programming reports illustrating physician usage of shock reduction programming can increase utilization of recommendation programming guidelines for debifrillators.
Description Shocks delivered to pts by defibrillators, while life-saving can create anxiety, pain and decrease quality of life. Previous Studies have shown that device programming & features can safetly reduce the number of shocks pts receive. This study will explore the extent to which Physicians use these programming and features. It will determine whether repeat and frequent awareness to how they program their own subjects & the programming trends of all enrolled subjects will change their programming patterns. This will be accomplished by understanding physicians device programming behaviors and providing reports as a tool to help physicians manage their subjects and provide shock reduction programming recommended by previous publications.
Eligibility Males & Females Subjects implated with Medtronic market released single, dual, or triple chamber debifrillator within the past 30 days are eligible for participation in the study.

Gastroenterology

Study Title Double-blind, Dose-response, Randomised, Placebo-controlled, Parallel Group, Muli-center Phase III Clinical Study on the Efficacy & Tolerability of Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis
Description The purpose of this study is to determine which dose of mesalazine granules compared to placebo is more effective in the prevention of recurrence of disease.
Eligibility 30 to 80 years old Male & Females Diagnosis of Left-Sided uncomplicated diverticular disease confirmed by computed tomography (CT).

Gastroenterology

Study Title A Double-Blind, Double-Dummy, Randomized, Active-Comparator, Non-Inferiority Study of LT-NS001 Versus Naproxyn for 12 Weeks in Ostoarthritis patients to compare Endoscopic Gastric Ulcer rates
Description LT-NS001 is a prodrug Naproxen, which is inactive as a cox inhibitor while intact and is rapidly metabolized to Naproxen once absorbed. This tiral will compare the rate of gastric ulcer by endoscopy over 3 months in patients with knee osteoarthritis, with patients receivign either LT-NS001 at a dose which provides comparable dose levels of Naproxen, or Naproxyn 500mg (an already approved treatment for OA).
Eligibility 45-80 years old Male or Female

Gastroenterology

Study Title A Phase 2-3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severly Active Ulcerative Colitis
Description The purpose of this study is to assess the effects (good & bad) of CNTO148 (golimumab)therapy in patients with Ulcerative Colitis.
Eligibility 18 Years and Older. Male and Female Active Ulcerative Colitis by endoscopy.

Gastroenterology

Study Title A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter study to assess the Efficacy and Safety of Budesonide Foram Versus Placebo in subjects with Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis.
Description This study is to assess the efficacy & safety of budesonide foam in subjects with active mild to moderate proctitis or proctosigmoiditis.
Eligibility 18 to 75 Years old. Male or Female. Diagnosis of Active, Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis.

Hematology

Study Title Iron Deficiency Anemia - Intravenous Ferumoxytol
Description A Phase III, Randomized, Double-Blind, Placebo Controlled Trial of Intravenous Ferumoxytol for the Treatment of Iron Deficiency Anemia.
Eligibility Male or Female 18 Years and Older Iron Deficiency Anemia

Hematology

Study Title Randomized Evaluation of Efficacy & Safety of Ferric Carboxymaltose in Patients with Iron Deficiency Anemia and Impaired Renal Function
Description The primary objective of this study is to examine the efficacy & safety (cardiovascular) of an investigational intravenous (IV) iron, Ferric Carboxymaltose (FCM), compared to IV Iron Sucrose (Venofer) in sujects who have Iron Deficiency Anemia (IDA) and impaired renal function.
Eligibility 18 years and older Male or Female

Oncology

Study Title Randomized Double-Blind, Placebo-Controlled Study of Everolimus in Combination with Exemestane in the Treatment of Postmenopausal Women with Extrogen Receptor Positive Locally Advanced or Metastatic Breast CA who are Refractory to Letrozole or Anastrozole
Description There are no treatments specifically approved after recurrence or progression on a NSAI. In light of the need for new treatment options for postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane+everolimus to exemestane+placebo in postmenopausal women with extrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI.
Eligibility 18 Years and Older Postmenopausal Females Diagnosis of Metastatic or locally advanced breast cancer not amendable to curative treatment by surgery or radiotherapy.

Oncology

Study Title A Randomized Double-blind, Placebo-Controlled trial of Neratinib (HKI-272) after Trastuzumab in women with Early-Stage HER-2/Neu Overexpresed/Amplified Breast Cancer.
Description The purpose of this study is to investigate wheather Neratinib can reduce the risk of perviously diagnosed HER-2 positive breast cancer from returning after treatment with Trastuzumab (Herceptin).
Eligibility 18 Years and Older Females with Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.

Oncology

Study Title A Phase 3, Randomized, Open-Label, Two-Arm Study of Neratinib + Paclitaxel (Taxol) versus Trastuzumab (Herceptin) + Paclitaxel (Taxol) as first-line treatment for ErbB-2 Positive locally recurrent or Metastatic Breast Cancer.
Description This study is investigating the effects of an experimental drug (Neratinib) in combination with Paclitaxel (Taxol) versus Trastuzumab (Herceptin) in combination with Paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects recieivng either regimen.
Eligibility 18 Years and Older Females with Advanced Breast Cancer

Rheumatology

Study Title A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy & Safety of Subcutaneous Abatacept (Orencia) versus Subcutaneous Adalimumb (Humira), both with background Methotrexate, in Biologic-Naive Subjects with Rheumatoid Arthritis
Description The purpose of this study is to demonstrate that subcutaneous Abatacept (Orencia) is non-inferior (nor worse than) to subcutaneous Adalimumab (Humira) in the treatment of subjects with Rheumatoid Arthritis who are biologic naive.
Eligibility 18 years and older. Male or Female Rheumatoid Arthritis

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