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Confidential internal document pursuant to ors 4

CONFIDENTIAL INTERNAL DOCUMENT PURSUANT TO ORS 41.675 This document, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized review, use, disclosure, or distribution is prohibited. If you are not the intended recipient, please contact the sender by e-mail or telephone and destroy all copies of the document and attachments. Thank you. PLEASE BRING THIS PACKET WITH YOU TO THE MEETING
IMPORTANT NOTICE TO IRB MEMBERS
If unable to attend, please notify Lyn Walford (706-2900 Ext. 7878) as soon as possible.
Reviewers of non-expedited agenda items must attend, either in person or via teleconference.
Expedited reviews may be submitted to the IRB Office prior to the meeting. ST. CHARLES HEALTH SYSTEM
INSTITUTIONAL REVIEW BOARD
Monday, May 17, 2010
0630-0800; Classroom E
1st Floor, behind from Reception Desk
Abbreviations:
♫ - Study appears in more than one section CALL TO ORDER
Dr. Archie Bleyer
Welcome Michael Gibson, Community Member, Non-Scientist REVIEW/APPROVE MINUTES – April 19, 2010
Dr. Bleyer
PREVIOUS/OLD BUSINESS (0)
Dr. Bleyer
A. Hip1 [3100NO-2213-WW]: A Phase 2, Multicenter, Randomized, Active-Controlled,
Parallel Group, Dose-Finding and Safety Study of Recombinant Human Bone Morphogenetic
Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) in Subjects with Decreased Bone
Mineral Density PI: Karen L. Oppenheimer, MD
Accrual Suspension
B. PRIMA: Prevention of Radiation-Induced Mucositis/Xerostomia with Acupuncture in
Patients with Head/Neck Cancer PI: Russ Omizo, MD
Contingencies
C. RTOG-0825: Phase III Double-Blind Placebo-Controlled Trial Of Conventional Concurrent
Chemoradiation And Adjuvant Temozolomide Plus Bevacizumab Versus Conventional
Concurrent Chemoradiation And Adjuvant Temozolomide In Patients With Newly
Diagnosed Glioblastoma PI: Russ Omizo, MD
Contingencies
D. ASCERT, ACCF-STS Database Collaboration on the Comparative Effectiveness of PCI and
CABG PI: Bruce McLellan, MD
Contingencies
E. National Cancer Institute Central IRB
NEW BUSINESS
A. NEW PROTOCOLS (2)
1. CP-MGAWN1-02: A Phase 2, Stratified, Randomized, Double-Blind Placebo-
Controlled Study to Evaluate the Safety and Efficacy of MGAWN1 in Subjects with
Laboratory-documented West Nile Fever or Suspected Central Nervous System Infection
Due to West Nile Virus PI: Jon E. Lutz
Primary Reviewer: Dr. Richards
a. Protocol
b. ICF
c. HIPAA
d. IB
e. Scales (Fatigue Severity, Glasgow Coma, Modified Rankin)
Objective: The primary safety objective will be to evaluate the safety and tolerability of
MGAWN1 in allsubjects (WNV+ and WNV−) as assessed by:
• Incidence and severity of AEs • Incidence of serious AEs (SAEs) • Laboratory abnormalities • Vital signs • Electrocardiogram (ECG) abnormalities • Physical examination abnormalities The primary efficacy objectives will be differences between treatment groups in the following measures: 1. The percentage of subjects with confirmed WNF who have ≥20% improvement from baseline in overall SF-12 score at Study Day 28, or 2. The percentage of subjects with confirmed WNND who show improvement in the Modified Rankin Scale (MRS) (≥1 improvement in score) at Study Day 14 as compared with baseline. Risk/Benefit: Page 5 of the ICF.
Privacy & Confidentiality: Governed by HIPAA
Consent documents: ICF and HIPAA
Subjects: Persons 18 years of age or older whose physician believes symptoms indicate
2. JUMP TEST: Comparison of Single Let Squat Test to Jump Test as a predictor for risk
of lower extremity in children.
PI: Viviane Ugalde, MD
Primary Reviewer: Mr. Danaher
a. Protocol – contained within ICF b. ICF c. HIPAA Note: This is an investigator-initiated trial
Objective:
Risk/Benefit: There is no additional risk or discomfort beyond what one would expect
from a jump or a squat. Benefits include decreased risk of injury while participating in
sports activities.
Privacy & Confidentiality: Governed by HIPAA.
Subjects: Children between the ages of 7 and 18 years old.
ICF: Combined with HIPAA
Grade Level: Requested of P.I.
Assent Form: None provided
B. CONTINUING REVIEWS – (3)
1. COFLEX: A multi-center, prospective, randomized, clinical trial comparing
stabilization with Coflex vs. pedicle screw fixation and fusion after decompression for at least moderate lumbar spinal stenosis. PI: Raymond Tien, MD
Primary Reviewer: Dr. Lyon

2. E2805
: ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
PI: Robert F. Boone, MD
Primary Reviewer: Dr. Brundage
Addendum #9
ICF

3. TOPCAT: Treatment of preserved cardiac function heart failure with an aldosterone
antagonist. PI: Michael C. Widmer, MD
Primary Reviewer: Dr. Rizenthaler
DSMB Memo
C. AMENDMENTS/REVISIONS (4)
1. ARISTOTLE, protocol # CV185030: “A Phase 3 Active (Warfarin) Controlled,
Randomized Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects with Nonvalvular Atrial Fibrillation” PI: Gavin L. Noble, M.D.
Administrative Letter
ICF Addendum
Primary Reviewer: Mr. Danaher
2. ♫ ENGAGE study, Protocol #: DU176b-C-U301, “A Phase 3, Randomized, Double-
Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for
Evaluation of Efficacy and Safety of DU-176b Versus Warfarin In Subjects with Atrial
Fibrillation – Effective Anticoagulation with Factor Xa Next Generation in Atrial
Fibrillation (ENGAGE – AF TIMI - 48)” Protocol Version #3
PI: James Laughlin, MD
Protocol Amendment #3
Increased Transportation Funding
Primary Reviewer: Dr. Richards
3. NSABP R-04: Trial Comparing Pre-Op RT & Capecitabine w/without Oxaliplatin
w/Pre-Op RT & Continuous IVI 5-FU w/without Oxaliplatin in Operable Rectal CAICF
PI: Stephen Kornfeld

Addendum #1 to Investigator’s Brochure (IB) for capecitabine (Xeloda®) –
dated February 2010. This version of the IB is Version 11, dated August 2009.  Addendum #2 IB for capecitabine (Xeloda®) – dated April, 2010. The current
Primary Reviewer: Dr. Brundage
4. S0819 “A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or
Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients
with Advanced Non-Small Cell Lung Cancer (NSCLC)." PI: William Martin, MD
Revision #2 Effective May 1, 2010, registrations to the above-referenced study
will only be accepted via the OPEN registration system. This amendment has been approved by the NCI's Central IRB. Primary Reviewer: Dr. Brundage
D. STUDY and/or ACCRUAL CLOSURES- (1)
1. AQUARIUS study, Protocol #: CSPP100A2366, “A 104 week, randomized, double-
blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy of
aliskiren on the progression of atherosclerosis in patients with coronary artery disease
when added to optimal background therapy” PI: Jason R. Wollmuth, MD
 The site has been unable to identify subjects that qualify for this study. Also, the Heart Institute of the Cascades is undergoing a reorganization that will allow it to have the resources needed to continue participation. No subjects have been screened. The Sponsor closure visit is currently scheduled for 29-Apr-2010 Primary Reviewer: Dr. Lyon
E. MISCELLANEOUS (0)
EXPEDITED REVIEWS: These items were reviewed separately by a specific Expedited
Reviewer; they will not have be in your packet unless you are an Expedited Reviewer

A. ADVERSE EVENT REPORTS ONSITE (4)
:
Reviewer: Dr. Cutter
1. ♫ ARISTOTLE, PI: Gavin Noble, MD
2. CHOICE PI: Raymond Tien, MD

3. S0727 PI: William Martin, MD
4. TRIATHLON CR PI: Knute Buehler, MD


B. AMENDMENTS/REVISIONS (11)

1. The Heart Institute of the Cascades, will be transferring the responsibilities and accountability of all study activities going forward as of 03-May-2010 to St. Charles Health System, Inc. – Cardiovascular Services Department. a. ♫ ROCHE Reviewer: Dr. Rizenthaler
C. CONTINUING REVIEWS (1)
1. NSABP B-33: Treatment w/without exemestane for breast cancer patients who are
disease free after completing tamoxifen therapy
PI: Robert F. Boone, MD
Reviewer: Dr. Rizenthaler
D. ACCRUAL/PERMANENT CLOSURES: (1)
1. ♫ ROCHE-ACS / NC20971: dal-OUTCOMES study “A phase III, double-blind,
randomized placebo-controlled study, to evaluate the effects of RO4607381 on cardiovascular (CV) risk in stable CHD patients, with a documented recent Acute Coronary Syndrome (ACS)”Temporary Accrual Closure PI: Bruce A. McLellan, MD
Reviewer: Dr. Lyon
E. MISCELLANEOUS (5)


1.
ARISTOTLE, protocol # CV185030: “A Phase 3 Active (Warfarin) Controlled,
Randomized Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of
Apixaban in Preventing Stroke and Systemic Embolism in Subjects with Nonvalvular
Atrial Fibrillation” PI: Gavin L. Noble, M.D.
Subject Transfer
Reviewer: Mr. Danaher
2. ♫ ENGAGE: A phase 3, randomized, double-blind, double-dummy, parallel group,
multi-center, multi-national study for evaluation of efficacy and safety of DU-176b
versus warfarin in subjects with atrial-fibrillation – effective anticoagulation with factor
Xa next generation with atrial-fibrillation PI: James C. Laughlin
DMC Memo #49
Reviewer: Dr. Richards
3. ♫ ROCHE-ACS / NC20971: dalOUTCOMES: A phase III, double-blind, randomized
placebo-controlled study, to evaluate the effects of RO4607381 on cardiovascular (CV)
risk in stable CHD patients, with a documented recent Acute Coronary Syndrome
(ACS)PI: Bruce McLellan, MD
Protocol Violation
Six-monthly SUSAR report
Patient Retention Items
Reviewer: Dr. Lyon
4. STAR—P-2: Study of tamoxifen and raloxifene for the prevention of breast cancer
Medical Release
Reviewer: Dr. Brundage
F. INVESTIGATOR BROCHURES (0)
NEXT MEETING: Monday, June 21, 2010 @ 6:30am
Dr. Bleyer
Archie Bleyer, MD, Chair, Scientist Member Katie B. Richards, MD, Chair Alternate, Community Representative, Scientist Member Bruce Brundage, MD, Community Representative, Scientist Member Peggy Carey, BSN, MPA, Non-Scientist Member Bill Danaher, Non-Scientist Member David Lyon, PhD, Community Representative, Scientist Member James Ritzenthaler, MD, Community Representative, Scientist Member Bob Cutter, PharmD, RPh, Scientist Member Michael Gibson, Community Representative, Non-Scientist Member cc: (meeting packet) Ken House, Director, Quality Management Jim Diegel, President Jay Henry, CEO Pam Steinke, VP Quality Management

Source: http://www.stcharlesresearch.org/images/IRB%20Agenda%20May%2017%202010_copy3.pdf

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Venice Summer School 2010 – EU Integration and HealthSystems, 28 July 2010Unit E.1, Antitrust – Pharma and Health ServicesMartin Dorazil,European Commission, DG Competition State aid / Public procurement and HealthMartin Dorazil,European Commission, DG Competition • " Competition policy is basically about making sure that companies compete with each other on an equal footing

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