Charcot Arthropathy

Diabetes Complications

Zoledronic acid 5mg intravenous once a month for 3 months

Zoledronic Acid

Methylprednisolone 1gm intravenous once a month for 3 months

Methylprednisolone

Normal saline intravenous once a month for 3 months

Placebos

Department of Endocrinology, PGIMER

Zoledronic Acid or Methylprednisolone for Active Charcot's Neuroarthropathy of Foot in Patients With Diabetes Mellitus

Zoledronic Acid or Methylprednisolone in the Management of Active Charcot's Neuroarthropathy of Foot in Patients With Diabetes Mellitus: A Randomized, Double-blind, Placebo Controlled Trial

Ashu Rastogi

Assistant Professor

Postgraduate Institute of Medical Education and Research

Postpartum Hemorrhage

Recruiting only pregnant women prior to child-birth delivery.

misoprostol

Queens Hospital Center

Effect of Adjunctive Misoprostol Treatment on Blood Loss at Vaginal Delivery

Effect of Adjunctive Misoprostol on Blood Loss at Vaginal Delivery

Aleksandr Fuks

Directore, Department OB / GYN , Queens Hospital Center

New York City Health and Hospitals Corporation

flecainide x 6 months, then crossover to sotalol x 6 months

sotalol x 6 months, then crossover to flecainide x 6 months

Atrial Fibrillation

flecainide up to 150mg twice daily for the control of atrial fibrillation

Flecainide

sotalol up to 120mg twice daily for the control of atrial fibrillation

Sotalol

Jesse Brown VA Medical Center

Rush University Medical Center

University of Illinois at Chicago

Advocate Christ Medical Center

Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

A Prospective, Multi-Center, Randomized, Open Label Trial to Determine if a Common Atrial Fibrillation Risk Locus Modulates Differential Response to Antiarrhythmic Drugs

Subjects will be monitored with the Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM) system to assess AF burden. The device will be programmed to optimize the memory for storing AF episode..

Quality of life assessment: Patients will be asked to fill out the AFEQT quality of life questionnaire baseline (study randomization), two, four, six, eight, ten, and 12 months (completion of the study). The questionnaire at the end of the 6rd month will be administered just prior to stopping the first study drug. The validated questionnaire is comprised of 20 questions about AF symptoms with answers given on a Likert scale. The questionnaire will be provided to the patients in paper format either in person or by mail, as applicable. A follow-up phone call will be made to each patient to ensure that the questionnaire is completed and returned.

Dawood Darbar, MD

Professor of Medicine

Medtronic

To analyze the effect of urate-lowering therapy (specifically with febuxostat [Uloric]) on the synovial pannus in the "index joint" of a subgroup of patients. Subjects not currently on any urate-lowering therapy, or on a serum urate lowering drug other than febuxostat (Uloric) and who have a serum urate level of > or = to 9.0, will be treated with febuxostat (Uloric) and their serum urate level will be followed at months 1, 3, 6, and 9. Magnetic Resonance Imaging (with and without gadolinium) of the same "index joint" will be repeated at month 9 to assess for the presence and degree of synovial pannus. Because initiation of urate-lowering therapy can induce acute attacks of gout, these subjects will also be started on colchicine as a prophylactic (and remain on colchicine for 6 months).

To analyze synovial pannus in the Magnetic Resonance Imaging (with and without gadolinium) of the "index joint" on Subjects not currently on any urate-lowering therapy, or on a serum urate lowering drug other than febuxostat (Uloric).

All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their "index joint" determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the "index joint" will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.
Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)

MRI of Index Joint

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

The primary aim of this study will be to determine the percentage of patients with known gout who have evidence of chronic ongoing synovial-based inflammatory disease, i.e. synovial pannus, in their "index joint", and determine if there is a correlation of the prevalence and severity of synovial pannus in the "index joint" with the patients' serum urate levels on the day of their MRI.

Number and Percentage of Participants With Evidence of Chronic Ongoing Synovial-Based Inflammatory Disease at Baseline.

A sub-study in a subgroup of patients will analyze the Number and Percentage of Substudy Participants for whom the Severity of Synovial Pannus was Significantly Reduced After 9 Months of Treatment with Febuxostat (Uloric) in the "index joint" by comparing the baseline MRI with a repeat MRI of the same joint.

The primary endpoint of this sub-study was to determine if a nine month course of aggressive serum ULT in patients with gout significantly affects the severity of synovial pannus in the index joint as determined by comparing the baseline and month 9 MRI's using the aforementioned grading scale. Secondary endpoints included an assessment of significant change of the subjects' serum CRP and estimated Glomerular Filtration Rate (eGFR) from baseline to month 9. Other endpoints included assessing for significant change of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema/lesions, and soft tissue edema on the MRI from baseline to month 9.

Febuxostat Sub-Study

Number and Percentage of Substudy Participants for Whom the Severity of Synovial Pannus Was Significantly Reduced After 9 Months of Treatment With Febuxostat (Uloric).

Number of Participants with Other Characteristic Findings of Gout on these MRI's. These include erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema, and soft tissue edema. These secondary endpoints will also be summed with patients' serum urate levels.

Number of Participants With Other Characteristic Findings of Gout on MRI's Correlated With Serum Urate Levels.

Determine if there is a correlation between the prevalence and severity of synovial pannus in the "index joint" with the patients' mean serum urate level from the previous 2 years at baseline.

To analyze synovial pannus in the Magnetic Resonance Imaging (with and without gadolinium) of the "index joint" on Subjects not currently on any urate-lowering therapy, or on a serum urate lowering drug.
Magnetic Resonance Imaging: An Magnetic Resonance Imaging (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).

Mean Serum Urate Levels for Previous 2 Years at Baseline.

Determine if the Number of Participants Prevalence and Severity of Synovial Pannus in the "Index Joint" with the patient's serum high-sensitivity C-Reactive Protein on the same day as the Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be assessed for the severity of synovial pannus, which is graded on a scale of 1 to 6 (with 6 being the most severe).

The Severity of Synovial Pannus the Day of Serum High-sensitivity C-Reactive Protein and Magnetic Resonance Imaging

Baseline radiographs of the "index" joint will also be obtained on the same day as their MRI and assessed for the presence or absence of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema, or soft tissue edema. This will be correlated with the presence and severity of synovial pannus in that same joint. The analysis will also be performed to see if there is a correlation with serum urate levels and the presence of erosions on their plain radiograph.

Presence or Absence of Erosive Changes on Baseline Radiographs of the "Index" Joint Correlated With the Presence and Severity of Synovial Pannus Correlation With Serum Urate Levels and the Presence of Erosions on Their Plain Radiograph.

The concentration of serum high-sensitivity C-Reactive Protein at enrollment.

High-sensitivity C-Reactive Protein Concentrations

Overall Study

John Carter, M.D

Gout

An Magnetic Resonance Imaging (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).

Magnetic Resonance Imaging

All subjects in the sub-study will be started on febuxostat 40mg daily at baseline. If their serum urate level is > 6.0 at months 1 or 3, then the febuxostat dose will be increased to 80mg daily.

Febuxostat

Colchicine will be dosed at 0.6mg by mouth BID for the first three months then 0.6mg daily from months 3 to 6, and then discontinued at month 6.

Colchicine

University of South Florida Medical Clinics

An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.

Shifting the Paradigm of Gout: An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.

University of South Florida

Takeda Pharmaceuticals North America, Inc.

All patients (with no structural damage on the plain x-ray) will receive a MRI and Ultrasound (US) of their most involved joint and an asymptomatic joint.

MRI and Ultrasound

MRI and Ultrasound Findings in Patients With Gout and Normal Plain Radiographs

John D. Carter, M.D.

Sprains and Strains

Contusions

each patient in this group will receive 90mg once daily, for the 14 days treatment.

etoricoxib 90mg 14 days

Patients in this group will receive 60mg of the drug, daily

etoricoxib 60mg daily for 14 days

Efficacy and Safety of Etoricoxib in Acute Ankle Sprain: A Double-Blind Comparative Study Among 2 Treatments Protocols

Efficacy and Safety of the Non-Steroidal Anti-Inflammatory Drug Etoricoxib in the Treatment of Acute Ankle Sprain in Sports: A Randomized Double-Blind Comparative Study Among 2 Treatments in the Acute Phase