CLINIC
TITLE
DESCRIPTION
Cancer & Blood Disorders
Amgen 20070782
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy.
Cancer & Blood Disorders
Breast Cancer - ECOG 5103
A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer.
Cancer & Blood Disorders
IBCSG 25-02 (TEXT)
A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer.
Cancer & Blood Disorders
LYM. MANTLE C - 1) Cephalon C1803/2039/NL/US-CA
An Open-Label Study of Bendamustine Hydrochloride in Combination with Rituximab in the treatment of Patients With Relapsed/Refractory Mantle Cell Lymphoma.
Cancer & Blood Disorders
LYMPHOMA - Pharmatech PI-08904
Bendamustine Combined with Rituximab for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
Cancer & Blood Disorders
MULTIPLE MYELOMA - Cephalon C18083/1063/MM/US
An Open-Label Study of Bendamustine Combined with Bortezomib for Patients with Relapsed/Refractory Multiple Myeloma.
Cancer & Blood Disorders
MYELO DYSPLASTIC SYNDROME - Amgen 197
An Open Label Extension Study Evaluating the Safety in Long Term Dosing of AMG 531 in Thrombocytopenic Subjects with Myelodysplastic Syndrome (MDS).
Cancer & Blood Disorders
MYELO DYSPLASTIC SYNDROME - Amgen 198
A Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim Treatment of Thrombocytopenia in Subjects with Low or Intermediate-1 Risk Myelodyplastic syndrome (MDS).
Cancer & Blood Disorders
Pilot project to determine the role of Circulating Tumor Cells (CTC) in patients with prostate specific antigen (PSA) only recurrence and its association with PSA doubling time
Pilot project to determine the role of Circulating Tumor Cells (CTC) in patients with prostate specific antigen (PSA) only recurrence and its association with PSA doubling time.
Cancer & Blood Disorders
PROSTATE CANCER - CALGB 90203
Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer.
Cancer & Blood Disorders
PROSTATE CANCER - Medivation Protocol No. CRPC2
A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Patients with Progressive Castration-Resistant Prostate Cancer Previously Treated with Docetaxel-Based Chemotherapy.
Cardiology
ASTRONAUT
A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the 6 months efficacy and safety of aliskiren therapy on top of standard therapy, on morbidity and mortality when initiated early after hospitalization for acute decompensated heart failure.
Cardiology
CABANA
Pulmonary Vein Ablation compared to Medical Therapy in Management of A-Fib CABANA is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy (rate control or anti arrhythmic drugs) in patients with untreated or incompletely treated AF warranting therapy.
Cardiology
Dal-Heart Study
For patients with recent acute coronary syndrome. Oral CETP (cholesteryl ester transfer protein) “dalcetrapib = DAL”or placebo added to current therapy (Raising HDL through CETP inhibition).
Cardiology
RESPECT
The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.
Cardiology
RIVAL
This study compares a trans-radial approach during cardiac catheterization for patients with acute coronary syndromes to a trans-femoral approach. The hypothesis is that radial access site PCI will be associated with significantly less major bleeding and access site complications compared with a femoral approach, without increasing the risk of ischemic events. The overall benefit-risk profile will favor a trans-radial approach.
Dermatology
Discoid Lupus Erythematosus
A Phase 2, pilot, multicenter, randomized, placebo-controlled sequential, ascending dose study tocharacterize the safety, tolerability, pharmacokinetic and pharmacodynamic activity of CC-930 in subjects with recalcitrant Discoid Lupus Erythematosus (DLE). The purpose of the study is to assess if CC-930 is safe and tolerable in treating subjects withDiscoid Lupus Erythematosus. Pharmacokinetic and pharmacodynamics will also be evaluated.
Dermatology
Eczema: Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema (HANDEL)
The purpose of this study is to investigate the safety and efficacy of alitretinoin in the treatment of severe chronic hand eczema that does not respond to treatment with potent topical steroids.
Dermatology
Psoriasis: ESPRIT: Post-marketing, Observational Study of Humira® (adalimumab) in Patients With Chronic Plaque Psoriasis
The purpose of this 10-year observationaltion trial is to evaluate the long-term safety of Humira® in psoriasis patients. Patients seen in the MFA Psoriasis Clinic may be eligible to participate in this study.
Dermatology
Psoriasis: Prevalence of Non-Alcoholic Fatty Liver Disease Among Patients With Psoriasis
The purpose of this study is to determine the prevalence of non alcoholic fatty liver disease (NAFLD) in subjects with psoriasis compared to the non-psoriatic population by performing a limited right upper quadrant abdominal ultrasonography. Patients seen in the MFA Psoriasis Clinic may be eligible to participate in this study.
Dermatology
Psoriasis: PSOLAR: A Multicenter, Open Registry of Patients With Plaque Psoriasis Who Are Candidates for Systemic Therapy Including Biologics
The purpose of this study is to further evaluate the safety of infliximab (Remicade) and ustekinumab (Stelara) in patients with plaque psoriasis and co-morbidities, such as plaque psoriasis and psoriatic arthritis occurring together. The registry study will track the behavior of the disease in response to other therapies, such as other biologic drugs. The registry will also evaluate clinical outcomes, quality of life, and potential risks for patients who may receive standard therapies for psoriasis. Patients who are eligible for systemic treatment and are seen in the MFA Psoriasis Clinic may participate in this study.
Dermatology
Psoriasis: Serum Lipid Levels and Other Biomarkers of Cardiovascular Disease in Patients With Psoria
The purpose of this study is to measure serum lipid levels in subjects with and without psoriasis by using a detailed cholesterol test that gives a more accurate determination of LDL (bad cholesterol) and a better assessment of lipid-contribution to cardiovascular risk compared to standard lipid profiles. Markers of inflammation that contribute to cardiovascular disease will also be measured. Patients seen in the MFA Psoriasis Clinic may be eligible to participate in this study.
Endocrinology
Type 1 Diabetes: ANDROMEDA 1001: Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults (DIA-AID2)
This study will look at the effectiveness and safety of DiaPep277 for preservation of insulin secretion in adults with newly diagnosed type 1 diabetes. DiaPep277 is a peptide that alters the body's immune system attack on insulin-producing beta-cells that occurs during the development of type 1 diabetes. Adults (ages 20-45 years) with newly diagnosed (< 6 months) type 1 diabetes will be treated with 10 injections of DiaPep277 or placebo approximately every three months over a 24-month treatment and follow-up period.
Endocrinology
Type 1 Diabetes: DEFEND-2: Trial of Otelixizumab for Adolescents and Adults with Newly Diagnosed Type 1 Diabetes
DEFEND-2 is a confirmatory, 24-month study investigating a potential new medication, otelixizumab, in young adults (1245 years old) with newly diagnosed (< 90 days) type 1 diabetes. Preliminary results indicate that otelixizumab – an anti-CD3 monoclonal antibody – may reduce the body’s destruction of beta cells and help preserve insulin production. Participants will receive otelixizumab or placebo by intravenous infusion once daily over 30 minutes for eight consecutive days. Participant health and diabetes are closely monitored through physical examinations, blood and urine tests, and questionnaires.
Infectious Diseases
EPZ113734 ASSURE
This study is for HIV + individuals with undetectable viral loads on a regimen of Reyataz + Norvir + Truvada. The study is designed to compare the efficacy and safety of simplifying therapy from a regimen of Reyataz + Norvir + Truvada to a regimen of Reyataz + Epzicom without RTV over 48 weeks.
Infectious Diseases
FLU003: An International Observational Study to Characterize Adults Who Are Hospitalized With Complications of Influenza A - Pandemic H1N1 (H1N1v)
The purpose of this observational study is to describe the characteristics and outcomes over a 60-day follow-up period of participants with influenza A – pandemic H1N1 (H1N1v) who are hospitalized with severe and/or complicated influenza A. This information will be used to guide policymakers and to advise on the management of patients who are hospitalized with the flu. Over 1,000 individuals will be enrolled worldwide.
Infectious Diseases
HIV VALIDATION STUDY: Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection
The objective of this study is to develop a rapid, highly sensitive and specific, one-stage test for the diagnosis of HIV infection. A single blood draw from adult patients with a detectable viral load will be evaluated using an investigational HIV test. Patients seen in the MFA Infectious Diseases Clinic may be eligible to participate in this study.
Infectious Diseases
Influenze: FLU002: An International Observational Study to Characterize Adults with Influenza A - Pandemic H1N1 (H1N1v)
The purpose of this study is to better understand the course of illness for those who have H1N1v and the characteristics of people who do not do well. Investigators will also try to learn more about how different treatments and prior vaccination for the flu affect the course of the illness. Eligible participants with suspected influenza must be seeking treatment prior to enrollment in the study. Approximately 5,000 individuals with the flu will be enrolled in several countries around the world.
Infectious Diseases
POEM: Prospective Observational Epidemiologic Study of Maraviroc's Safety
The study will assess if the use of maraviroc (Selzentry) along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs in treatment-experienced HIV-1 infected patients. Patients seen in the MFA Infectious Diseases Clinic may be eligible to participate in this study.
Joint Health & Autoimmune Diseases
Environmental Exposure and Disease Flare in Adult and Juvenile Dermatomyositis and Polymyositis
The study examines environmental exposures in adult and juvenile dermatomyositis and polymyositis and whether the environmental exposures contribute to a disease flare.
Joint Health & Autoimmune Diseases
Speech and Voice assessments in Adult and Children with Myositis Disorders
The study examines the incidence of speech and voice abnormalities in children and adults with idiopathic inflammatory myopathies (myositis disorders), and assesses strength of muscles involved in speech, respiration and articulation, and functionality of respiratory, phonatory, articulatory and resonance systems in perception and production of speech in patients with myositis disorders.
Kidney Disease & Hypertension
Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes: The Occurrence of Renal Events (BEACON)
This study assesses the efficacy of bardoxolone methyl relative to placebo in delaying progression to end-stage renal disease (ESRD) and cardiovascular deaths in patients with Stage 4 Chronic Kidney Disease (CKD) and type 2 diabetes receiving standard of care.
Kidney Disease & Hypertension
SPRINT (Systolic Blood Pressure Intervention Trial)
The Systolic Blood Pressure Intervention Trial (SPRINT) is a National Institute of Health funded 2-arm, multicenter, randomized clinical trial designed to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal than currently recommended will reduce cardiovascular disease (CVD) risk, memory decline, or worsening kidney disease. Participants diagnosed with hypertension and other CVD events will be closely monitored through monthly blood pressure readings, physical examinations, blood and urine tests, and questionnaires.
Neurology
ALS
Clinical Trial of Ceftriaxone in Subjects with Amyotrophic Lateral Sclerosis
Neurology
Cervical Dystonia
CD PROBE - Cervical Dystonia - Patient Registry for Observation of BOTOX® Efficacy: A Multi-center, Prospective, Naturalistic, Observational Study of Cervical Dystonia and Therapy with BOTOX®.
Neurology
MS
An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis.
Pain & Non-Operative Spine Service
Discogenic Lumbar Back Pain- TransDiscal System
A prospective, randomized, multi-center, open-label clinical trial comparing disc biacuplasty with medical management for discogenic lumbar back pain.
Pain & Non-Operative Spine Service
mild® Decompression vs. Epidural Steroid Injection
mild® decompression alternative to open surgery epidural steroid injection comparative outcomes study (MiDAS ECO) in patients diagnosed with moderate to severe lumbar spinal stenosis exhibiting neurogenic claudication.
Radiology
ABUS (somo•InSIGHT)
A higher sensitivity to breast cancer detection can be achieved in women with dense breast tissue by performing and reviewing results of Automated Breast Ultrasound (ABUS) and Digital X-Ray Mammography (XRM) together as part of routine screening compared to performing and reviewing results of XRM alone.
Radiology
Accuracy of Philips MammoDiagnost DR versus Screen Film in the Detection of Breast Cancer
Eligible patient undergo both screen film and the FFDM mammography. The images then undergo a reader study to evaluate the performance of the FFDM mammogram. This study is only recruiting women who are scheduled for a breast biopsy.
Vascular Surgery
VARICOSE VEINS: Vanish-1/VAP.VV015 -- ClinicalTrials.gov ID # NCT01072877
A Phase III, Multi-center, randomized, parallel-group study to evaluate the efficacy and safety of Varisolve™ Polidocanol Endovenous Microfoam (PEM) 0.5%, 1.0% and 2.0% compared to vehicle for the treatment of saphenofemoral junction (SFJ) incompetence due to reflux of the great saphenous vein (GSV) or major accessory veins, with venous disease manifested by both symptoms and visible varicosities.
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