Disorder Related to Renal Transplantation

Elderly patients (age 60 or older) on tacrolimus experiencing neurological AEs (tremor, insomnia, vertigo, photophobia, mood disturbances, or headache) presumably from tacrolimus immediate-release or tacrolimus XL will be converted to Envarsus. This conversion will be based on the Envarsus package insert which is a 20% reduction in total daily dose and is taken once a day. The conversion from Astagraf to Envarsus will be a 36% reduction.

Tacrolimus XR (Envarsus)

University of Illinois at Chicago

Converting Elderly Kidney Transplant Recipients From Tacrolimus to Envarsus to Limit Neurological AE and Improve QOL

An Evaluation of Converting Elderly Kidney Transplant Recipients From Tacrolimus to Envarsus to Limit Neurological Adverse Events and Improve Quality of Life

Mean change in QOL scores from baseline to day 14 and day 28 after conversion from tacrolimus to Envarsus.

Mean change in neurological scores (including insomnia, vertigo, photophobia, mood, headache, and tremor) from baseline to day 14 and day 28 after conversion from tacrolimus to Envarsus.

Proportion of patients preferring Envarsus compared with their previous tacrolimus formulation after 28 days of treatment

Percent of patients reporting non-adherence from baseline to day 14 and 28 after conversion from tacrolimus to Envarsus.

Mean incremental costs from baseline to day 28 following conversion to Envarsus.

Patricia West-Thielke

Director of Clinical Research

Veloxis Pharmaceuticals

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

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

Diet modification - nortriptyline and then if necessary topiramate

Diet Modification topiramate and then nortriptyline if necessary

Migraine Disorders

The nortriptyline will be given in an escalating fashion, starting at 25 mg PO qhs for 2 weeks, followed by 50 mg PO qhs for 2 weeks, and finally 75 mg PO qhs. Patients will be encouraged to use the lowest effective dose and to self-titrate their medication.

nortriptyline

Topiramate dosing will be 25 mg PO qhs for 1 week, followed by 25 mg BID for 1 week, followed by 25 mg in the morning and 50 mg qhs for 1 week, and finally 50 mg BID

Topiramate

Saint Louis University

Trial of Nortriptyline and Topiramate in the Initial Treatment of Vestibular Migraine

A Prospective Randomized Cross-over Trial of Nortryptyline and Topiramate in the Initial Treatment of Vestibular Migraine.

Changes in Migraine Specific Quality of LIfe (MSQ) and Dizziness Handicap Inventory (DHI) between groups

Anthony A. Mikulec, MD

Associate Professor

St. Louis University

Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7 days (D 1-7) plus Idarubicin 12 mg/m2/day iv daily for 3 days (D 1-3)

Acute Myelogenous Leukemia

Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7 days (D 1-7) plus Daunorubicin 90 mg/m2/day iv daily for 3 days (D 1-3)

Cytarabine plus Daunorubicin [Arm II (AD regimen)]

A prospective randomized comparison of idarubicin and high-dose daunorubicin in combination with cytarabine in the induction chemotherapy for acute myeloid leukemia

Asan Medical Center

Idarubicin Versus High Dose Daunorubicin in Acute Myelogenous Leukemia (AML)

A Prospective Randomized Comparison of Idarubicin and High-dose Daunorubicin in Combination With Cytarabine in the Induction Chemotherapy for Acute Myeloid Leukemia

A complete remission will be defined as blasts of 5% or less in a normocellular bone marrow with neutrophils of 1,000/mcL or more and platelets of 100,000/mcL or more in the peripheral blood, the disappearance of all blasts in the peripheral blood, and no evidence of extramedullary leukemic cell infiltration

This study will evaluate the impacts of induction chemotherapy regimen on duration of CR, relapse-free survival (RFS), event-free survival (EFS), and overall survival (OS).
This study will also evaluate the clinical significance of genetic polymorphisms of drug-metabolizing enzymes and mutations of leukemia-related genes.

photophobia/diarré

Converting Elderly Kidney Transplant Recipients From Tacrolimus to Envarsus to Limit Neurological AE and Improve QOL

Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

Trial of Nortriptyline and Topiramate in the Initial Treatment of Vestibular Migraine

Idarubicin Versus High Dose Daunorubicin in Acute Myelogenous Leukemia (AML)

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