Emmcclinicalresearch.org

IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
Cardiology
1) A Clinical Evaluation of the Medtronic Endeavor®
Resolute Zotarolimus-Eluting Coronary Stent System in
the Treatment of De Novo Lesions in Native Coronary
Arteries with a Reference Vessel Diameter of 2.25 mm to
4.2 mm (08-2-C-049)
Northeast Cardiology
2) A Multicenter, Double-blind, Randomized Study to
Establish the Clinical Benefit and Safety of Vytorin
(Ezetimibe/Simvastatin Tablet) vs Simvastatin
Monotherapy in High-Risk Subjects Presenting with
Acute Coronary Syndrome (Improved Reduction of
Outcomes: Vytorin Efficacy International Trial -
IMPROVE IT) (05-2-C-039)
Northeast Cardiology
3) Clopidogrel Optimal Loading Dose Usage to Reduce
Recurrent Events/Optimal Antiplatelet Strategy for
Interventions - CURRENTS, A Randomized Multinational,
Double-blind Study Comparing a High Loading Dose
Regimen of Clopidogrel Versus Standard Dose in
Patients with Unstable Angina or Non-ST Segment
Elevation Myocardial Infarction of STEMI Managed with
Early Invasive Strategy (06-2-C-042)
Northeast Cardiology
4) Enhancing Patient-Safety through Improved
Communication (EPIC): A Program to Reduce Healthcare
Acquired Infections and Medical Errors through
Improved Healthcare Staff Communication in Surgical
Units and Critical care.
The proposed study will implement and evaluate a 360 degree
evaluation tool for improving skills and communication in a
hospital setting. It is expected that communication between staff in the Surgical Unit will improve as a result of the program, and that improved communication and trust will lead to a reduction in medical errors and “near misses”.
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
5) Fractional Flow Reserve versus Angiographic Multivessel
Evaluation (F.A.M.E. Study)(06-2-C-040)
Northeast Cardiology
6) Implementation of Practice Standards for ECG
Monitoring PULSE (Practical Use of the Latest Standards
for Electrocardiography) Trial (08-2-C-044)
The long-term aim of the proposed multi-site clinical trial
(hereafter referred to as the Practical Use of the Latest
Standards for Electrocardiography or PULSE Trial) is to improve
nursing practices related to ECG monitoring in hospital settings
for better detection and diagnosis of cardiac arrhythmias, myocardial ischemia, and drug-induced prolonged QT syndrome.
7) JOSTENT Coronary Stent Graft, Humanitarian Device
Exemption (02-2-C-017)
Northeast Cardiology
8) PROMISE Trial: A Phase IV Pragmatic Randomized Trial
of Clinical Effectiveness of Imaging Strategies, Either
Anatomic (CTA) or Functional Testing Determined by The
Site (Exercise ECG, Stress Nuclear, Stress Echo).
9) The Association of BNP with Echocardiographic and
Electrocardiographic Parameters in Heart Failure
Patients: A Retrospective, Descriptive Study (08-2-M-
123)
This retrospective, descriptive study will investigate the
correlation of Brain Natriuretic Peptide (BNP) with electrocardiographic and echocardiographic parameters within a sample of heart failure patients (CHF) at EMMC. The goal is to compare clinical markers that distinguish two groups: Patients with 1) diastolic heart failure and 2) systolic heart failure.
Critical Care Medicine
10) Adult ICU Physician Bereavement Practices (09-2-M-
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
11) Preventing Failure to Rescue in Rural Hospitals
Pulse Oximeters and heart rate monitor use to detect patient deterioration, in lieu of Rapid Response Team at the time of cardiac arrest.
12) Promoting Culture Change for Patient Safety in Critical
Care Areas
This program seeks to implement a 360 degree evaluation
process within the ICU at EMMC. The goal of the project is to
create a "cultural change" in which patient safety is the primary
concern of all medical staff. By making each member of the
medical staff accountable to each other, it is believed that
13) Symbiq Data Portal Beta Test Study
Subtotal of (4) Critical Care Medicine projects Dementia
14) Assess the Prognostic Usefulness of Flutemetamol (18F)
Injection for Identifying Subjects With Amnestic Mild
Cognitive Impairment Who Will Convert to Clinically
Probable Alzheimers Disease
Emergency Medicine
15) Patients transported by EMS to an emergency
department that could be managed at a walk-in-care
center.
This is a retrospective study looking at patients coming to
EMMCs ED in 2007 by EMS. Of this patient population a
subpopulation will be identified, based on parameters defined by
emergency physicians, which could have been treated at an
alternate care site such as Walk-In Care.
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
16) Pediatric Emergency Preparedness
A partnership between EMHS, MHA, Maine ACEP, and Maine AAP proposes a statewide survey of essential pediatric equipment in Maine emergency departments in order to help hospitals meet preparedness guidelines for care of children in the emergency department as set forth by the National ACEP and AAP.
Subtotal of (2) Emergency Medicine projects Endocrinology
17) A Phase III, Randomized, Double-Blind, Placebo-
Controlled, Multicenter Study to Evaluate the Safety and
Efficacy of XXX in Patients with Type 2 Diabetes Mellitus
on Background Treatment with Glimepiride with or
without Metformin.
18) A Phase III, Randomized, Double-Blind, Placebo-
Controlled, Multicenter Study to Evaluate the Safety and
Efficacy of XXX in Patients with Type 2 Diabetes Mellitus
on Background Treatment with Pioglitazone.
19) Evaluation of the efficacy and safety of two approaches
to escalate insulin therapy in patients with type 2
diabetes mellitus not achieving adequate glycemic
control on basal insulin glargine with or without oral
20) Hyperglycemia Control for the Inpatient - PowerPoint
presentation for EMMC Grand Rounds, Feb 24, 2010
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
21) Improving Rural Maine's Critical Access to Emergency
and Chronic Disease Care through Telehealth and
Telehomecare - Adult Trauma and Outpatient
Consultations (Trauma (07-2-M-104) PICU (07-2-M-
103) Diabetes Homecare (07-1-M-099))
This project is composed of 3 programs: 1. Trauma emergency,
2. PICU, and 3. Telehomehealthcare. Each program looks at the impact of using televideo technology to improve patient service and outcomes. Trauma and PICU are evaluation programs examining the use of televideo technology for physician consultations between EMMC and 8 critical access hospitals. The trauma outpatient program is evaluating the use of televideo technology for follow-up consultations with patients recovering from recent emergency trauma. The telehomehealthcare program is a prospective study investigating the impact of diabetic patients having a telemedicine monitoring device in their home.
22) The Effect of LY2189265 on Blood Pressure and Heart
Rate, as Assessed by Ambulatory Blood Pressure
Monitoring, in Patients with Type 2 Diabetes Mellitus
23) The Impact of LY2189265 versus Insulin Glargine in
Combination with Insulin Lispro for the Treatment to
Target of Type 2 Diabetes Mellitus.
Family Medicine
24) 005-50 A Phase 3 open-label clinical trial to study the
immunogenicity and tolerability of V502 [a multivalent
human papillomavirus (HPV) L1 virus-like particle (VLP)
vaccine] given concomittantly with Menactra and Adacel
in preadolescents and adolescents (11 to 15 year olds)
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
25) A Phase III, Randomized, Double-Blind, Placebo-
Controlled, Multicenter Study to Evaluate the Safety and
Efficacy of XXX in Patients with Type 2 Diabetes Mellitus
on Background Treatment with Glimepiride with or
without Metformin.
26) Evaluating the Use of Health Information Technology to
Improve Outcomes for Rural Patients with Diabetes
Mellitus and COPD
This project seeks to improve self-management and care of
patients with chronic disease in rural Maine by providing patients
with access to a web-based patient portal in which they can view
medical information and their self-care plan; create an enhanced
EMR for provider use; and build a continuity of care record that
will facilitate inter-facility transfers.
27) Evaluating the Use of Health Information Technology to
Improve Outcomes for Rural Patients with Diabetes
Mellitus and COPD
This project seeks to improve self-management and care of
patients with chronic disease in rural Maine by providing patients
with access to a web-based patient portal in which they can view
medical information and their self-care plan; create an enhanced
EMR for provider use; and build a continuity of care record that
will facilitate inter-facility transfers.
28) Evaluation of the HIT self-management program for
severe chronic disease patients in rual areas
Evaluate the protential of the chronic disease management and
the quality of care for patients in five rural primary care
physician practices AHRQ
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
29) Evaluation of the Value and Use of Health Information
Technology (08-2-M-132) (a.k.a. Secured Messaging
Pilot Project)
The purpose of this study is to determine the consequences,
both positive and negative, of the adoption of health information
technology (HIT). More specifically, the collaborators (Abt.
Associates, Masspro, Massachusetts General Hospital) hope to accomplish the following:1)Develop measurement methodologies that, both qualitatively and quantitatively, can be used to evaluate the benefits of the adoption and appropriate use of HIT as they accrue to multiple stakeholders.
2)Use these measures in evaluating the adoption and use of secure messaging in three health care organizations (to be determined by the Office of the National Coordinator for Health Information Technology at the U.S. Department of Health and Human Services).
30) Integrating Behavioral Healthcare and Primary Care
Services for Substance Abuse Affected Families: A
Planning Project
This project, now in the planning phase, seeks to integrate
behavioral healthcare within primary care. The specific focus is
on substance abuse screening and treatment. The model for the
project is based on Screening, Brief Intervention and Referral for
Treatment (SBIRT). All patients in the Center for Family Medicine
(CFM) will be screened for possible substance abuse. Those with
a positive screen wil receive further services on site, or (if
needed) be referred to more intense treatment off-site. A
licensed social worker and substance abuse counselor will be co-located within the CFM, resulting in more integrated, patient-centered care.
31) Planning a State-Wide Rural Telemedicine Network for
Follow-up Care
To define a sustainable state-wide telemedicine network that will
facilitate remote follow-up care visits for rural patients who have
been treated and released from a specialty care hospital.
Gastroenterology
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
32) Chemoprevention of Colorectal Adenomas
33) Polyps distribution and BMI
Subtotal of (2) Gastroenterology projects General Surgery
34) The Efficacy of Vitamin D3 Supplementation in the
Prevention of Hypovitaminosis D After the Roux-en-Y
Gastric Bypass Procedure (06-2-M-084)
Geriatrics
35) Northeast Integrated Geriatrics Care: Improving
Transition of Elderly Patients with Mental Health and
Behavioral Needs from Acute (hospital based) to Long-
Term Care Through Improved Capacity for Integrated
Care at Nursing Homes (09-2-M-162)
Hematology/Oncology
36) Initial Results of a Cognitive Behavioral Intervention for
Patients with Chemotherapy-Related Cognitive
Complaints
This project is a report on the results of Dr. Robert J. Ferguson's
Randomized Control Wait-List Trial and Single Group design
testing his MAAT treatment. The intention is to develop two
separate manuscripts a) comparing the results from the two
studies, and b) to examine the impact of MAAT on Quality of Life. Manuscript a) in progress.
37) Validation of Meta-Memory Questionnaire with Breast
Cancer Sample
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
Subtotal of (2) Hematology/Oncology projects Infectious Disease
38) Investigational New Drug: Stibogluconate Sodium
(Pentostam) (08-2-M-144)
39) Validating Nosocomial Infection Definitions in
Behavioral Healthcare Settings
This multi-center, international trial, will seek to implement a
series of modified nosocomial infection definitions, modified for
behavioral healthcare settings. These definitions were developed
by a panel of experts from 2005 to 2007. The project will a)
describe the ease with which the definitions translate to
behavioral healthcare settings and b) validate or modify the
defintions based on the experience of 20-30 behavioral healthcare facilities located across the US and Canada.
40) VZ-009, Safety and Efficacy of Varicella Zoster Immune
Globulin (Human) (VariZIGTM) in Patients At Risk of
Varicella Infection - Investigational New Drug
Application Expanded Access Protocol (07-2-M-102)
Expanded access program to make VariZIG™ available to
patients who require varicella zoster immune globulin.
Subtotal of (3) Infectious Disease projects Inpatient Care
41) Case Report on Paralytic Shellfish Poisoning
Preparing for submission to the EMMC Privacy Describes the clinical pathology and toxicology associated with paralytic shellfish poisoning (PSP). Study is a case series focusing on three patients diagnosed with PSP at Eastern Maine Medical Center during the summer of 2007.
42) Creating a Culture of Patient Safety for Rural Hospitals
(BSP)
The goals of this Implementation project are to:
1.Create a shared behavior-based vision of patient safety for all
the hospitals in the organization
2.Provide leadership development on the importance of patient
safety for each hospital within the organization
3.Eliminate the barriers of near-miss and incident reporting
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
43) Evaluation of the C.A.R.E. Programme
Data analysis of the CROSSROADS AFTERCARE AND RECOVERY EVALUATION PROGRAMME, which took place in Antigua. The program was designed to offer treatment for substance abuse. Follow up data is available for two years after discharge.
44) Medication Reconciliation
45) Randomized Clinical Trial of Subcutaneous Analog Basal
Bolus Therapy Compared with Sliding Scale Human
Insulin in the Hospital Management of Hyperglycemia in
Non-Critically Ill Patients without Known History of
Diabetes: The HMH Trial.
Internal Medicine
46) (00-2-M-016) Mogadon(Nitrazepam) in convulsive
Disorders
This is an open uncontrolled study of the use of nitrazepam for
the treatment of patients refractory to other anticonvulsant
therapy, or to maintain a treatment response to nitrazepam which was started in other countries.
47) Evaluation of the HIT self-management program for
severe chronic disease patients in rual areas
Evaluate the protential of the chronic disease management and
the quality of care for patients in five rural primary care
physician practices AHRQ
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
48) Evaluation of the Value and Use of Health Information
Technology (08-2-M-132) (a.k.a. Secured Messaging
Pilot Project)
The purpose of this study is to determine the consequences,
both positive and negative, of the adoption of health information
technology (HIT). More specifically, the collaborators (Abt.
Associates, Masspro, Massachusetts General Hospital) hope to accomplish the following:1)Develop measurement methodologies that, both qualitatively and quantitatively, can be used to evaluate the benefits of the adoption and appropriate use of HIT as they accrue to multiple stakeholders.
2)Use these measures in evaluating the adoption and use of secure messaging in three health care organizations (to be determined by the Office of the National Coordinator for Health Information Technology at the U.S. Department of Health and Human Services).
49) Planning a State-Wide Rural Telemedicine Network for
Follow-up Care
To define a sustainable state-wide telemedicine network that will
facilitate remote follow-up care visits for rural patients who have been treated and released from a specialty care hospital.
Subtotal of (4) Internal Medicine projects Jackson Laboratory
50) “Development of a Molecular Diagnostic/Prognostic Test
to Aid in Clinical Management of Leukemia or
Lymphoma.
PI: Kevin Mills, PhD, Assistant Professor
Purpose of study: To develop a simple and inexpensive PCR-
based diagnostic test, based on a unique gene expression
signature identified in the PI’s lab, which will more accurately stratify patients at risk for B-cell leukemia or lymphoma.
51) OncoCL: A Cancer Cell Ontology
PI: Mary Dolan, PhD, Mouse Genome Informatics
Consortium
Purpose of study: To develop a new biomedical ontology,
OncoCL, that will provide a framework for standardization of
cancer-associated genetic and genomic data.
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
52) The JAX Genomics Physicians Portal
Team (TBD): JAX scientists, EMMC physicians, and the Personalized Medicine Coalition (PMC)Purpose of study: To create the JAX Genomics Physician Portal, a definitive web portal to educate physicians and their patients on the topic of personalized medicine.
Subtotal of (3) Jackson Laboratory projects Neonatology
53) Treatment of Neonatal Abstinence Syndrome: Evaluation
of Efficacy of Phenobarbital in Combination with Either
Methadone or Diluted Deodorized Tincture of Opium as
Stabilizing and Tapering Regimens (HOME NOW) (07-2-
M-107)
HOMENOW Randomized trial evaluating two treatment regimens
for Neonatal Abstinence Syndrome known as (NAS).
54) Treatment of Neonatal Abstinence Syndrome: Evaluation
of Efficacy of Phenobarbitol-First Versus Methadone-
First for Treatment of Neonatal Abstinence Syndrome
(NAS) (09-2-M-160)
Neurology
55) Video EEG Monitoring in Northern Maine: Impact on
Diagnosis and Patient Management
To review col ected video EEG data from EMMC and compare
patients pre-monitoring diagnosis and treatment with the post-
monitoring diagnosis and management to determine the impact
of video EEG monitoring on patient diagnosis and ongoing
treatment.
Ophthalmology
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
56) A Five Year, Multicenter, Commercial Label Safety Study
of XXX in subjects with XXX induced Iris Pigmentation
Changes
57) A Randomized, Multi-Center, Double-Masked, Placebo-
Controlled, Parallel-Group Safety and Efficacy Study of
Azithromycin Ophthalmic Solution, 1% Versus Placebo
for Four Weeks in Subjects with Blepharitis (09-2-M-156)
58) C-08-077 A randomized double masked study of fid
115038 and fid 115037 versus fid 115039 in the
treatment of dry eye
59) Factor Structure and Concurrent Validity of a Test of
Visuospatial Perception
The present study involves first an item factor analysis of the
item data from the Motor-Free Visual Perceptual Test, using the general method of Thurstone (Mutiple Groups Factor Analysis), but the corrections for attenuation, to assess factorial complexity. Then the simplified factors are to be correlated with external measures of visuospatial and language ability and attention to deter their concurrent validity.
Orthopedics
60) An Evaluation of Neurological Outcomes of Patients
Transported with External Pelvic Stabilization Devices in
a Rural State: A Ten-Year Review
Describes outcomes for patients transported by LifeFlight of
Maine with external pelvic stabilization devices (e.g., the MAST
or Pelvic Binder). The study will compare patients transported
with the MAST device versus the Pelvic Binder device and those
transported with any device versus those not receiving a device, focusing on neurological complications. This wil be a ten-year retrospective review.
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
61) Investigating the Use of a Cryopneumatic Therapy
Device in Primary TKA Patients (08-1-M-143)
This study will assess the clinical effectiveness of the application
of cold and intermittent compression for an orthopedic
postoperative patient with the Game Ready Professional Therapy
System (the “Device”) according to the clinical protocol dated
November 2007, attached hereto as Exhibit A and incorporated herein by reference (as amended by Sponsor from time to time, the "Clinical Protocol (Game Ready)(Cool systems) 62) Outcomes in Rotator Cuff Repair Using Graft
Reinforcement
63) Overview and Analysis of Autogenous Bone Grafts using
RIA for Non Union Diaphyseal Fractures
The proposed descriptive study will provide data on which to
base hypothesis articulation on nonunion diaphyseal fracture
treatment with use of a Reamer Irrigator Aspirator (RIA) for
autogenous intramedullary reaming of long bone to provide bone
graft. Specifically, a chart review of patients on whom RIA
procedure was performed will be completed to assess surgical
techniques and outcomes.
Pain Medicine
64) Fibromyalgia
65) NUCYNTA (Tapentadol Immediate Release) Versus
Oxycodone Immediate Release in the Treatment of
Acute Low Back Pain
Palliative Care
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
66) Does a Specialized Inpatient Unit Improve Care? An
Evaluation of Eastern Maine Medical Center's West-Side
Court (09-2-M-154)
This project will evaluate the effectiveness of a new unit in
EMMC that will be devoted to patients presenting with behavioral
or psychiatric issues. The unit will be located on Grant 5 and
open in January. The project will retrospectively review all patients referred to the unit, assess the profile of these patients, and compile a control group (one year before opening of West-Side Court) matched on age, gender, and admitting dx.
Pediatric Critical Care
67) Improving Rural Maine's Critical Access to Emergency
and Chronic Disease Care through Telehealth and
Telehomecare - Adult Trauma and Outpatient
Consultations (Trauma (07-2-M-104) PICU (07-2-M-
103) Diabetes Homecare (07-1-M-099))
This project is composed of 3 programs: 1. Trauma emergency,
2. PICU, and 3. Telehomehealthcare. Each program looks at the
impact of using televideo technology to improve patient service
and outcomes. Trauma and PICU are evaluation programs
examining the use of televideo technology for physician
consultations between EMMC and 8 critical access hospitals. The trauma outpatient program is evaluating the use of televideo technology for follow-up consultations with patients recovering from recent emergency trauma. The telehomehealthcare program is a prospective study investigating the impact of diabetic patients having a telemedicine monitoring device in their home.
Subtotal of (1) Pediatric Critical Care project Pediatric Hematology/Oncology
68) AALL0232, High Risk B-Precurser Acute Lymphoblastic
Leukemia
COG Group-wide phase III study designed for NCI high risk
patients with acute lymphoblastic leukemia (ALL) from 1-30
years of age
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
69) AALL0331 Standard Risk B-precursor Acute
Lymphoblastic Leukemia
COG Group Wide Phase III study designed for NCI standard risk
acute lymphoblastic leukemia
70) AALL03B1 Classification of Acute Lymphoblastic
Leukemia
Laboratory classification protocol for patients with acute
lymphoblastgic leukemia
71) AALL03N1 Understanding the Ethnic and Racial
Differences in Survival in Children with Acute
Lymphoblastic Leukemia
72) AALL0433 Intensive Treatment for Intermediate-Risk
Relapse of Childhood B-Precursor Acute Lymphoblastic
Leukemia (ALL): A Randomized Trial of Vincristine
Strategies
73) AALL0434 Intensified Methotrexate, Nelarabine
(Compound 506U78; IND# 52611) and Augmented BFM
Therapy for Children and Young Adults with Newly
Diagnosed T-cell Acute Lymphoblastic Leukemia
74) AAML0431 The Treatment of Down Syndrome Children
with Acute Myeloid Leukemia (AML) and Myelodysplastic
Syndrome (MDS) Under the Age of 4 Years
75) ACCRN07 Protocol for the Enrollment on the Official COG
Registry, The Childhood Cancer Research Network
(CCRN)
76) ACNS0232 Radiotherapy Alone Versus Chemotherapy
Followed by Response Based Radiotherapy for Newly
Diagnosed Primary CNS Germinima
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
77) ACNS0331 A Study Evaluating Limited Target Volume
Boost Irradiation and Reduced Dose Craniospinal
Radiotherapy 18.00 Gy and Chemotherapy in Children
with Newly Diagnosed Standard Risk Medulloblastoma.
A Phase III double randomized trial
78) AEWS0031 Trial of Chemotherapy Intensification
through Interval Compressionin Ewing Sarcoma and
Related Tumors
79) AHOD0031, A Phase III Study of Dose-Intensive,
Response-Based Chemotherapy and Radiation Therapy
for Children and Adolescents with Newly Diagnosed
Intermediate Risk Hodgkin Disease
80) AHOD03P1 - Treatment of Children with Newly-
Diagnosed Low Stage Lymphocyte Predominant Hodgkin
Disease (LPHD)
81) AHOD04B1 Tissue Banking in Hodgkin's Disease
82) ALTE03N1 - Key Adverse Events after Childhood Cancer
83) ANBL00B1 Neuroblastoma Biology Studies
84) ANHL01P1 A Pilot Study to Determine Toxicity of the
Addition of Rituximab to the Induction and
Consolidation Phases and the Addition of Rasburicase to
the Reduction Phase in Children with Newly Diagnosed
Advanced B-Cell Leukemia/Lymphoma Treated with
LMB/FAB Therapy - Initial Treatment with Rasburicase
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
85) ANHL04B1 Rare and Cutaneous Non-Hodgkin Lymphoma
Registry
86) AOST06B1 A Children's Oncology Group Protocol for
Collecting and Banking Osteosarcoma Specimens
87) POG 9440 National Wilms Tumor Study
88) POG 9641 Primary Surgical Therapy for Biologically
Defined Low-Risk Neuroblastoma
89) POG 9851 Osteosarcoma Biology Protocol: Companion to
Group-Wide Therapeutic Studies
90) POG 9904 ALinC17: Protocol for Patients with Low Risk
Acute Lymphoblastic Leukemia: A POG Phase III study
91) POG 9905 ALinC 17: Protocol for Patients with Standard
Risk Acuted Lymphoblastic Leukemia (ALL) A Pediatric
Oncology Group Phase III Study
Subtotal of (24) Pediatric Hematology/Oncology projects Pediatric Medicine
92) (08-2-M-133) Adverse events during propofol
procedural sedation in children: does the type of
procedure make a difference?
Retrospective analysis of cases submitted to the Pediatric
Sedation Research Consortium database. Analysis will compare
the use of propofol between different procedures (e.g., MRI,
Bronchoscopy, Endoscopy) with respect to complications.
93) Autism screening test
To be funded by the CDC. Need more information IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
94) Pediatric Trauma Stress Project (CHOP)
95) Way to Optimal Weight (WOW) Program
The WOW Program offers an age-specific, multidisciplinary, tiered approach to positively affecting the present epidemic of childhood obesity. This will be a three-phase program involving a physician, nurse, dietician, clinical psychologist and physical trainer all at one site.
Subtotal of (4) Pediatric Medicine projects Pediatric Oncology
96) AALL02P2 - Treatment of Late Isolated Extramedullary
Relapse from Acute Lymphoblastic Leukemia
(ALL)(Initial CR1 >/= 18 months) (09-2-P-173)
97) AALL07P1, A Phase II Pilot Trial of Bortezomib (PS-341,
Velcade®, IND# 58,443) in Combination with Intensive
Re-Induction Therapy for Children with Relapsed Acute
Lymphoblastic Leukemia (ALL) and Lymphoblastic
Lymphoma (LL)(09-2-P-174)
98) AAML0531 A Phase III Randomized Trial of
Gemtuzumab Ozogamicin (Mylotarg) Combined with
Conventional Chemotherapy for De Novo Acute Myeloid
Leukemia (AML) in Children, Adolescents, and Young
Adults
99) AAML0631 Risk Adapted Treatment of Newly Diagnosed
Childhood Acute Promyelocytic Leukemia (APL) using
Arsenic Trioxide (Trisenox® IND# 103,331) during
Consolidation
100) ACNS02B3, A Children's Oncology Group Protocol for
Collecting and Banking Pediatric Brain Tumor Research
Specimens (09-2-P-175)
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
101) ACNS0332 Efficacy of Carboplatin Administered
Concomittantly with Radiation and Isotretinoin as a Pro
Apoptotic Agent in other than Average-Risk
Medulloblastoma/PNET Patients
102) ACNS0334 Phase III Randomized Trial for the Treatment
of Newly Diagnosed Supratentorial PNET and High-Risk
Medulloblastoma in Children Less than 36 Months old
with Intensive Induction Chemotherapy with
Methotrexate Folowed by Consolidation with Stem Cell
Rescue vs. the Same Therapy without Methotrexate
103) ADVL04P2 A Feasibility Pilot and Phase 2 Study of
Chemoimmunotherapy with Epratuzumab for Children
with Relapsed CD22 Positive Acute Lymphoblastic
Leukemia
104) ANBL0032 Phase 2, Randomized Study of Chimeric
Antibody 14.18 (Ch14.18) in High-Risk Neuroblastoma
Following Myeloablative Therapy and Autologous Stem
Cell Rescue
105) ANBL0532, Phase III Randomized Trial of Single v.
Tandem Myeloablative Consolidation Therapy for High-
Risk Neuroblastoma (09-1-P-167)
106) AOST0331 A randomized trial of the European and
American steosarcoma Study Group to Optimize
treatment strategies for resectable osteosarcoma based
on histologic response to pre-operative chemotherapy
(EUAMOS)
107) AREN0321 Treatment of High-Risk Renal Tumors. A
COG Group-Wide Phase II Study
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
108) AREN03B2 Renal Tumors Classification, Biology and
Banking Study
109) AREN0532 Treatment for Very Low and Standard Risk
Favorable Histology Wilms Tumor
110) AREN0533 Treatment of Newly Diagnosed Higher Risk
Favorable Histology Wilms Tumors
111) AREN0534 Treatment for Patients with Bilateral,
Multicentric or Bilaterally Predisposed Unilateral Wilms
Tumor
112) ARST0331, Vincristine, Dactinomycin, and Lower Doses
of Cyclophosphamide With or Without Radiation Therapy
for Patients with Newly Diagnosed Low-Risk
Embryonal/Botryoid Rhabdomyosarcoma
113) ARST0531 Randomized Study of Vincristine,
Dactinomycin and Cyclophosphamide (VAC) versus VAC
Alternating with Vincristine and Irinotecan (VI) for
Patients with Intermediate-Risk Rhabdomyosarcoma
(RMS)
Subtotal of (18) Pediatric Oncology projects Performance Improvement
114) Reaching a Zero Defect Level for CMS Performance
Improvement Indicators within Not-for-Profit
Healthcare Organizations Using a Traffic Control Model
(Patient Bunker)
To create a system to help reach "zero-defects" for CMS
Performance Improvement Indicators in Not-for-Profit Healthcare
Organizations. A quality control individual will monitor patient
care for compliance with CMS Performance Indicators.
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
Subtotal of (1) Performance Improvement project Pharmacy
115) Proposal for Standardized Vancomycin Dosing and
Monitoring for Patients Receiving High-flux Hemodialysis
Physical Therapy
116) A Continuing Mobilization Program for Elderly Patients
(08-2-M-125)
This study will create a program to educate and assist elderly in-
patients who are at low to medium risk of falling. The study will
evaluate the program by randomly assigning patients who have
an acute medical condition to either the continuing mobilization
program or usual care.
psychology
117) Does a Specialized Inpatient Unit Improve Care? An
Evaluation of Eastern Maine Medical Center's West-Side
Court (09-2-M-154)
This project will evaluate the effectiveness of a new unit in
EMMC that will be devoted to patients presenting with behavioral
or psychiatric issues. The unit will be located on Grant 5 and open in January. The project will retrospectively review all patients referred to the unit, assess the profile of these patients, and compile a control group (one year before opening of West-Side Court) matched on age, gender, and admitting dx.
118) Videoconference CBT for rural breast cancer survivors
with cognitive compliants
Uses videoconference and cognitive behavioral therapy to
provide breast cancer survivors in rural Maine with skills to
improve their cognitive function.
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
Rehabilitation
119) Cognitive Impairment After Chemotherapy Dartmouth
Grant
This project will assess the ability of a targeted
psychopharmacological intervention to augment the efficacy of a
standardized cognitive remediation intervention in individuals
who have persistent cognitive deficits following mild to moderate
TBI (MTBI) and use functional MRI (fMRI) to clarify the neural mechanisms underlying these interventions.
Respiratory Medicine
120) A Long-Term, Open-Label, Safety Study of Eszopiclone in
Children (6 to 11 years) and Adolescents (12 to 17
years) with Attention-Deficit/Hyperactivity Disorder-
Associated Insomnia
121) A Randomized, Placebo-Controlled, Double-Blind, Fixed-
Dose, Study of the Efficacy and Safety of Eszopiclone in
Children (6 to 11 years) and Adolescents (12 to 17
years) with Attention-Deficit/Hyperactivity Dosorder-
Associated Insomnia
Subtotal of (2) Respiratory Medicine projects Trauma - Orthopedics
122) Assess Content Validity for External Fixator Placement
within a Fractured Femur Simulator (07-2-M-120)
Assess whether a femur fracture simulator is realistic
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
123) Attitudes of Critical Care Physicians Towards
Documenting Absence of Drug Intoxication When
Performing Brain Death Examinations.
objective: To assess physician documentation regarding the
absence of intoxication in patients prior to brain death (BD)
examinations. Method: A survey will be sent to the Society of
Critical Care Medicine (SCCM) and a request will be made that it be sent to their membership via email for completion. No patients will be involved or invited. Only medical personnel will be invited to complete the survey. The SCCM has a very large international membership. If even 1-2% respond, there will be several hundred responses. This will be enough to answer our questions.
124) Evaluating the Use of Image-Guided Navigation for
Femoral Fracture Reduction and Fixation: A Clinical Pilot
Study (06-2-M-089)
This is a prospective, randomized pilot study evaluating the use
of VectorVision Trauma technology (computer assisted
fluoroscopic navigation) versus standard methods (C-arm
fluoroscopy) for the reduction and fixation of femoral fractures.
Study will target 40 patients over one and one half years and will
randomly assign one half to the control group (standard
procedures) and one half to computer assisted flouroscopic
125) Trial to Evaluate Ultrasound in the Treatment of Tibial
Fractures (TRUST)(08-2-M-130)
Evaluate the impact of low-intensity, pulsed ultrasound applied
to tibial fractures treated with intramedullary nailing on
functional status and time to radiographic healing of tibial
fractures.
Will also assesss the impact of therapeutic ultrasound vs. placebo-treatment on functional status and rates of nonunion of tibial fractures 126) Tritanium Primary Acetabular Shell Study
Subtotal of (5) Trauma - Orthopedics projects Trauma - Surgery
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
127) (06-1-M-092) Evaluation of Second Non-Contiguous
Spine Fractures in Blunt Trauma Patients with Cervical
Spine Fractures
This study primarily estimates the incidence of second
noncontiguous spine fractures in patients presented with a
cervical spine fracture, and asks whether the rate of detecting
these injuries was different prior to utilizing CT scan to examine the whole spine. It also examines mechanisms of injury, patient demographics, and injury characteristics as associates of noncontiguous spine fractures in patients with a cervical spine fracture.
128) A Randomized, Double-Blind, Placebo-Controlled Study
to Investigate the Efficacy and Safety of XXX in Patients
with Severe Traumatic Brain Injury.
129) Clinical Investigation on the Effects of Light-Emitting
Diode (L.E.D.) Light on Surgical Wound Healing (08-1-M-
147)
Investigating whether LED light can improve wound healing in a
post-operative clinical setting. This will be a prospective
randomized design.
130) Identifying prolonged exposure and utilization of the
Long Spine Board in trauma patients leads to
predisposition of skin breakdown with possible
progression to ulceration.
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
131) Improving Rural Maine's Critical Access to Emergency
and Chronic Disease Care through Telehealth and
Telehomecare - Adult Trauma and Outpatient
Consultations (Trauma (07-2-M-104) PICU (07-2-M-
103) Diabetes Homecare (07-1-M-099))
This project is composed of 3 programs: 1. Trauma emergency,
2. PICU, and 3. Telehomehealthcare. Each program looks at the impact of using televideo technology to improve patient service and outcomes. Trauma and PICU are evaluation programs examining the use of televideo technology for physician consultations between EMMC and 8 critical access hospitals. The trauma outpatient program is evaluating the use of televideo technology for follow-up consultations with patients recovering from recent emergency trauma. The telehomehealthcare program is a prospective study investigating the impact of diabetic patients having a telemedicine monitoring device in their home.
Subtotal of (5) Trauma - Surgery projects 132) Study of Bladder Wash Specimens with the UroVysion
Test (08-1-M-129)
Vascular Surgery
133) (06-1-M-082) Carotid RX ACCULINK/RX ACCUNET Post-
Approval Trial to Uncover Unanticipated or Rare Events -
CAPTURE 2
Post-approval registry with ability to collect more real world data
from RX ACCULINK and RX ACCUNET Systems. Provides
additional information that the RX ACCULINK Carotid Stent
System and RX ACCUNET Embolic Protection System (EPS) can
be used safely by a wide range of physicians under commercial use conditions.
134) Carotid Stenting for High Surgical Risk Patients:
Evaluating Outcomes Through the Collection of Clinical
Evidence (CHOICE)(10-1-M-173)
IRB Activity for Active Projects by Therapeutic Area Project Title
Department
IRB Activity
Subtotal of (2) Vascular Surgery projects Grand Total of (134 projects)

Source: http://www.emmcclinicalresearch.org/assets/0/274/306/376/382/f1bdff82-47ce-4ef0-ad84-577406b5c310.pdf