International Clinical Trials Registry Platform (ICTRP)

What is a clinical trial?

For the purposes of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products,surgical procedures, radiologic procedures, devices,behavioural treatments, process-of-care changes,preventive care, etc. Biomedical clinical trials of experimental drug, treatment, device or behavioral intervention may proceed through four phases:

· Clinical trials test a new biomedical intervention in a small group of people (e.g., 20-80) for the first time to evaluate safety (e.g., to determine a safe dosage range and to identify side effects).

· Clinical trials study the biomedical or behavioral intervention in a larger group of people (several hundred)to determine efficacy and to further evaluate its safety.

· Studies investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects(from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the intervention to be used safely.

· Studies are conducted after the intervention has been marketed. These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.

What is trial registration?

WHO regards trial registration as the publication of an internationally-agreed set of information about the design,conduct and administration of clinical trials. These details are published on a publicly-accessible website managed by a registry conforming to WHO standards.

1．WHO Trial Registration Data Set (Version 1.2.1)

The minimum amount of trial information that must appear in a register in order for a given trial to be considered fully registered. There are currently 20 items in the WHO Trial Registration Data Set. It is sometimes referred to as the TRDS.

- Primary Registry and Trial Identifying Number

Name of Primary Registry, and the unique ID number assigned by the Primary Registry to this trial.

- Date of Registration in Primary Registry

Date when trial was officially registered in the Primary Registry.

- Secondary Identifying Numbers

Other identifiers besides the Trial Identifying Number allocated by the Primary Registry, if any. These include:

o The Universal Trial Number (UTN)

o Identifiers assigned by the sponsor (record Sponsor name and Sponsor-issued trial number (e.g. protocol number))

o Other trial registration numbers issued by other Registries (both Primary and Partner Registries in the WHO Registry Network, and other registries)

o Identifiers issued by funding bodies, collaborative research groups, regulatory authorities, ethics committees / institutional review boards, etc.

All secondary identifiers will have 2 elements: an identifier for the issuing authority (e.g. NCT, ISRCTN,ACTRN) plus a number.

There is no limit to the number of secondary identifiers that can be provided.

- Source(s) of Monetary or Material Support

Major source(s) of monetary or material support for the trial (e.g. funding agency, foundation, company,institution).

- Primary Sponsor

The individual, organization, group or other legal entity which takes responsibility for initiating, managing and/or financing a study. The Primary Sponsor is responsible for ensuring that the trial is properly registered. The Primary Sponsor may or may not be the main funder.

- Secondary Sponsor(s)

Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship.

A secondary sponsor may have agreed to:

o take on all the responsibilities of sponsorship jointly with the primary sponsor; or

o form a group with the Primary Sponsor in which the responsibilities of sponsorship are allocated among the members of the group; or

o act as the Primary Sponsor’s legal representative in relation to some or all of the trial sites.

- Contact for Public Queries

Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status.

- Contact for Scientific Queries

There must be clearly assigned responsibility for scientific leadership to a named Principal Investigator.The PI may delegate responsibility for dealing with scientific enquiries to a scientific contact for the trial. This scientific contact will be listed in addition to the PI.The contact for scientific queries must therefore include:

o Name and title, email address, telephone number,postal address and affiliation of the Principal Investigator, and;

o Email address, telephone number, postal address and affiliation of the contact for scientific queries about the trial (if applicable). The details for the scientific contact may be generic (that is, there does not need to be a named individual): e.g. a generic email address for research team members qualified to answer scientific queries.

- Public Title

Title intended for the lay public in easily understood language.

- Scientific Title

Scientific title of the study as it appears in the protocol submitted for funding and ethical review. Include trial acronym if available.

- Countries of Recruitment

The countries from which participants will be, are intended to be, or have been recruited at the time of registration.

- Health Condition(s) or Problem(s) Studied

Primary health condition(s) or problem(s) studied (e.g.,depression, breast cancer, medication error).

If the study is conducted in healthy human volunteers belonging to the target population of the intervention (e.g.preventive or screening interventions), enter the particular health condition(s) or problem(s) being prevented.

- Intervention(s)

For each arm of the trial record a brief intervention name plus an intervention description.

Intervention Name: For drugs use generic name; for other types of interventions provide a brief descriptive name.

o For investigational new drugs that do not yet have a generic name, a chemical name, company code or serial number may be used on a temporary basis. As soon as the generic name has been established,update the associated registered records accordingly.

o For non-drug intervention types, provide an intervention name with sufficient detail so that it can be distinguished from other similar interventions.

Intervention Description: Must be sufficiently detailed for it to be possible to distinguish between the arms of a study (e.g. comparison of different dosages of drug)and/or among similar interventions (e.g. comparison of multiple implantable cardiac defibrillators). For example,interventions involving drugs may include dosage form,dosage, frequency and duration.

If the intervention is one or more drugs then use the International Non-Proprietary Name for each drug if possible (not brand/trade names). For an unregistered drug, the generic name, chemical name, or company serial number is acceptable.

If the intervention consists of several separate treatments,list them all in one line separated by commas (e.g.＂low-fat diet, exercise＂).

For controlled trials, the identity of the control arm should be clear. The control intervention(s) is/are the interventions against which the study intervention is evaluated (e.g. placebo, no treatment, active control). If an active control is used, be sure to enter in the name(s)of that intervention, or enter ＂placebo＂ or ＂no treatment＂as applicable. For each intervention, describe other intervention details as applicable (dose, duration, mode of administration, etc).

- Key Inclusion and Exclusion Criteria

Inclusion and exclusion criteria for participant selection,including age and sex. Other selection criteria may relate to clinical diagnosis and co-morbid conditions; exclusion criteria are often used to ensure patient safety.

If the study is conducted in healthy human volunteers not belonging to the target population (e.g. a preliminary safety study), enter ＂healthy human volunteer＂.

- Study Type

Study type consists of:

o Type of study (interventional or observational)

o Study design including:

Method of allocation

(randomized/non-randomized)

Masking (is masking used and, if so, who is masked)

Assignment (single arm, parallel, crossover or factorial)

Purpose

o Phase (if applicable)

For randomized trials: the allocation concealment mechanism and sequence generation will be documented.

- Date of First Enrollment

Anticipated or actual date of enrolment of the first participant.

- Target Sample Size

Number of participants that this trial plans to enrol in total.

- Recruitment Status

Recruitment status of this trial:

o Pending: participants are not yet being recruited or enrolled at any site

o Recruiting: participants are currently being recruited and enrolled

o Suspended: there is a temporary halt in recruitment and enrolment

o Complete: participants are no longer being recruited or enrolled

o Other

- Primary Outcome(s)

o Outcomes are events, variables, or experiences that are measured because it is believed that they may be influenced by the intervention.

The Primary Outcome should be the outcome used in sample size calculations, or the main outcome(s) used to determine the effects of the intervention(s). Most trials should have only one primary outcome.For each primary outcome provide:

o The name of the outcome (do not use abbreviations)

o The metric or method of measurement used (be as specific as possible)

o The timepoint(s) of primary interest

Example:

Outcome Name: Depression

Metric/method of measurement: Beck Depression Score

Timepoint: 18 weeks following end of treatment

- Key Secondary Outcomes

Secondary outcomes are outcomes which are of secondary interest or that are measured at timepoints of secondary interest. A secondary outcome may involve the same event, variable, or experience as the primary outcome, but measured at timepoints other than those of primary interest.

As for primary outcomes, for each secondary outcome provide:

o The name of the outcome (do not use abbreviations)

o The metric or method of measurement used (be as specific as possible)

o The timepoint(s) of interest

2. WHO Registry Criteria (Version 2.1, April 2009)

Primary Registries in the WHO Registry Network as well as Partner Registries need to meet certain criteria so WHO can be sure that the data collected meets the standards of the ICTRP. These criteria can be categorized into 6 main areas:

· Content

· Quality and Validity

· Accessibility

· Unambiguous Identification

· Technical Capacity

· Administration and Governance

2.1 Contents

Primary Registries in the WHO Registry Network will:

o Accept prospective registration of interventional clinical trials submitted by Responsible Registrants

o Be open to all prospective registrants (ICMJE)

o Be able to collect and publicly display the WHO Trial Registration Data Set (ICMJE)

o Endeavour to keep registered information up-to-date

o Never remove a trial once it has been registered

2.2 Quality and Validity

Primary Registries in the WHO Registry Network will:

o Have a mechanism in place to ensure the validity of the registered data (ICMJE)

o Registries must have processes in place to maximize the possibility that the data registered is complete and accurate. These processes should be documented as Standard Operating Procedures(SOPs)

o This will include processes to make certain that:

o the person registering the trial exists and is the appropriate Responsible Registrant

o the trial exists

o the data submitted is complete

o It is the responsibility of the Responsible Registrant to make sure that the data provided to the Registry is complete and accurate

o Maintain a publicly accessible audit trail so changes made to the WHO Trial Registration Data Set for an individual trial can be tracked

o Participate in the development of WHO Best Practice Guidelines for Clinical Trial Registries

2.3 Accessibility

Primary Registries in the WHO Registry Network will:

o Ensure that the WHO Trial Registration Data Set for all registered trials will be:

o Accessible to the public at no charge (ICMJE)

o Electronically searchable (ICMJE)

o Made available to the ICTRP in English

o Allow registrants to submit a trial for registration at any time of day on any day of the week (24 hours a day,seven days a week)

o Allow the register to be searched at any time of day on any day of the week (24 hours a day, seven days a week)

It is desirable that Primary Registries in the WHO Registry Network also make the WHO Trial Registration Data Set available in the language(s) of the country or countries served by the registry.

2.4 Unambiguous Identification

Primary Registries in the WHO Registry Network will:

o Have in place processes to prevent the registration of a single trial more than once on their database

o Facilitate the retrospective linking (or bridging) on the WHO Search Portal of a single trial registered with more than one registry by entering secondary identifiers. This includes the UTN, and the unique identifiers allocated by other Primary Registries in the WHO Registry Network

It is desirable that Primary Registries in the WHO Registry Network as part of the registration process,search the ICTRP Search Portal and attempt to determine if the trial has already been registered by another Primary Registry or an ICMJE approved registry.

2.5 Technical Capacity

Primary Registries in the WHO Registry Network will:

o Submit the WHO Trial Registration Data Set for all records on their registry, in English, to the Central Repository

o Have access to a database that is used to store and manage the submitted data

o Be able to demonstrate that they have access to adequate information technology support

o Have adequate security and other provisions against data corruption and loss

2.6 Administration and Governance

Primary Registries in the WHO Registry Network will:

o Have at least a national remit, and the support of government within the country (or region) to act as the WHO Primary Registry for that country (or region)

o Publicly disclose ownership, governance structure and not/for-profit status

o Be managed by a not-for-profit agency (ICMJE)

o Should a registry cease to function the registry agrees that at least the WHO Trial Registration Data Set (original and updated) for all trial records will be transferred to a Primary Registries in the WHO Registry Network or appropriate alternative

It is desirable that Primary Registries in the WHO Registry Network have a strategy in place addressing the medium to long term sustainability of the registry.

Trial Registration

· Why is trial registration important?

· How to register a trial

· Organizations with policies on clinical trial registration

· What is the difference between a clinical trials register and registry?

· The Universal Trial Number (UTN)

1. Why is Trial Registration Important?

The registration of all interventional trials is considered to be a scientific, ethical and moral responsibility because:

· There is a need to ensure that decisions about health care are informed by all of the available evidence

· It is difficult to make informed decisions if publication bias and selective reporting are present

· The Declaration of Helsinki states that ＂Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject＂.

· Improving awareness of similar or identical trials will make it possible for researchers and funding agencies to avoid unnecessary duplication

· Describing clinical trials in progress can make it easier to identify gaps in clinical trials research

· Making researchers and potential participants aware of recruiting trials may facilitate recruitment

· Enabling researchers and health care practitioners to identify trials in which they may have an interest could result in more effective collaboration among researchers.The type of collaboration may include prospective meta-analysis

· Registries checking data as part of the registration process may lead to improvements in the quality of clinical trials by making it possible to identify potential problems (such as problematic randomization methods)early in the research process

2. How to Register a Trial

You cannot register a trial with WHO. The WHO ICTRP is not a clinical trials registry.

To register a trial, submit the details directly to any one of the Primary Registries in the WHO Registry Network or an ICMJE approved registry.

To meet the requirements of the International Committee of Medical Journal Editors (ICMJE) you can register your trial with any Primary Registry in the WHO Registry Network or an ICMJE approved registry.

To meet WHO requirements for transparency and publication, it is only necessary for your trial to be registered once, in either a Primary Registry in the WHO Registry Network or an ICMJE approved registry.

NOTE: Regulatory, legal, ethical, funding and other requirements for oversight and conduct of clinical trials differ from country to country. It is recommended that those responsible for conducting a clinical trial check to make sure they are complying with the specific requirements of each country.

2.1 Organizations with policies on clinical trial registration

The WHO Registry Network provides prospective trial registries with a forum to exchange information and work together to establish best practice for clinical trial registration.

The organizations listed below have policies on clinical trial registration. If you know of an organization that could be added to this list, please contact us.

2.2 Codes of Research Practice

Guidelines for the Conduct of Research in the Intramural Research Program at NIH

NHMRC, Australian Code for the Responsible Conduct of Research

UK Research Integrity Office, Code of Practice for Research (3.7.13)

2.3 Funders

Canadian Institutes of Health Research (CIHR)

National Institute of Allergy and Infectious Diseases

National Institutes of Health (NIH), United States of America

Wellcome Trust

2.4 Ethics Committees

Mc Master University

National Research Ethics Service, UK (2 links below)

The Royal Children's Hospital Melbourne

2.5 Legal Requirement

Drugs Controller General, India

European Commission

Food and Drug Administration (FDA) Amendment Act 2007

Ministerio de Salud, Argentina

Ministry of Health, Israel: Guidelines for Clinical

Trials In Human Subjects

Agência Nacional de Vigilancia Sanitária (ANVISA),Brazil

Department of Health, South Africa (2 links below)

2.6 National Research Ethics Oversight Agencies

National Statement on Ethical Conduct in Human Research (2007), Australia

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS), Canada

2.7 Professional Organizations

American Medical Assocation

European Medical Research Councils / European Science Foundation

FairDrugs.org: Call for Ethical Clinical Trials in Developing Countries

National Health and Medical Research Council:Australian Code for the Responsible Conduct of Research

Pan American Health Organization

Red Latinoamericana de ética y Medicamentos

(RELEM): The Buenos Aires Declaration on the

Ethics of Clinical Trials

The Association for Research in Vision and Ophthalmology

The Society for Clinical Trials

World Medical Association: Declaration of Helsinki

2.8 Publishers

British Medical Journal (BMJ)

Council of Science Editors (CSE)

Pan American Journal of Public Health

International Committee of Medical Journal Editors(ICMJE)

SciELO (Scientific Electronic Library Online)

Statement on Publishing Clinical Trials in Indian

Biomedical Journals. Indian J Med Res 127,

February 2008, pp 104-105

Joint Statement of Establishing Chinese Clinical Trial

Registration and Publication System. Chinese

Clinical Trial Registration and Publication

Collaboration

World Association of Medical Journal Editors(WAME)

2.9 Universities

Boston University Medical Campus

Imperial College London

University of Oxford

3. Which Clinical Trial Registries can be part of The WHO Registry Network?

Any registry that enters clinical trials into its database prospectively (that is, before the first participant is recruited), and meets the WHO Registry Criteria or that is working with ICTRP towards becoming a Primary Registry can be part of the WHO Registry Network.

The WHO Registry Network is composed of:

o Primary Registries

o Partner Registries

o Registries working with the ICTRP towards becoming Primary Registries

3.1 Primary Registries in the WHO Registry Network

Primary Registries in the WHO Registry Network meet specific criteria for content, quality and validity,accessibility, unique identification, technical capacity and administration. Primary Registries meet the requirements of the ICMJE.

The registries that currently meet these criteria are shown in Table 1.

3.2 Partner Registries

Partner Registries meet the same criteria as Primary Registries in the WHO Registry Network (i.e. for content,quality and validity, etc) except they do not need to:

o Have a national or regional remit or the support of government

o Be managed by a not-for-profit agency

o Be open to all prospective registrants

From 1 October 2008, all Partner Registries must also be affiliated with either a Primary Registry in the WHO Registry Network or an ICMJE approved registry.

It is the responsibility of Primary Registries in the WHO Registry Network to ensure that their Partner Registries meet WHO Registry Criteria.

Current Partner Registries are shown in Table 2.

Table 1 Registries that currently meet WHO registry criteria

Table 2 Partner registries that currently meet WHO registry criteria

4. What is the difference between a clinical trials register and a clinical trials registry?

A clinical trials register is the formal record of an internationally agreed minimum amount of information about a clinical trial. This record is usually stored in and managed using a database. A clinical trials registry is the entity that houses the register, and is responsible for ensuring the completeness and accuracy of the information it contains, and that the registered information is used to inform health care decision making. A clinical trials registry is more than its database.

5. The Universal Trial Number (UTN)

The aim of the Universal Trial Number (UTN) is to facilitate the unambiguous identification of clinical trials.

The UTN is not a registration number.

The UTN is a number that should be obtained early in the history of the trial. The UTN should:

· become permanently attached to the trial

· be used whenever information about the trial is communicated

· become part of the trial's identity

· be documented in the trial protocol

· be submitted every time the trial is registered

It is recognized that some UTNs will be attached to trials that do not progress; that is, trials that never become fully developed protocols and that never recruit participants.Some UTNs will therefore never appear attached to a registered trial.

Questions about Clinical Trials Registration in ICMJE

1. Will the ICMJE consider clinical trial resultsposted at ClinicalTrials.gov in compliance with the Food and Drug Administration Amendments Act of 2007 to be prior publication?

It is important to note that the ICMJE clinical trial registration policy requires prospective registration of all interventional clinical studies, but does not require results reporting for registered trials. While the ICMJE recognizes the potential problems associated with posting preliminary research results that have not yet undergone an independent peer-review process, it acknowledges that the Food and Drug Administration Amendments Act of 2007 (FDAAA; U.S. Public Law 110-85, Title VIII), mandates the posting of summary results data for certain trials in ClinicalTrials.gov. Thus,the ICMJE will not consider results data posted in the tabular format required by ClinicalTrials.gov to be prior publication. However, editors of journals that follow the ICMJE recommendations may consider posting of more detailed descriptions of trial results beyond those included in ClinicalTrials.gov to be prior publication. The ICMJE anticipates that the climate for reporting results for registered trials will change dramatically over coming years and the ICMJE may need to amend these recommendations as additional agencies institute other mandates related to results reporting.

2. Does the ICMJE require registration of clinical trials of devices?

What if I register my device trial in ClinicalTrials.gov and it is covered by the delayed posting (“l(fā)ock box”) provision of Food and Drug Administration Amendments Act of 2007 (FDAAA), meaning that the registered information is not publicly accessible immediately following registration?

The ICMJE does require public, prospective registration of clinical trials of all interventions, including devices.

Two options are available to investigators who are conducting trials covered by the FDAAA lock box provision and seeking consideration for publication in ICMJE journals:

If you wish for the information to be made available to the public in accordance with the ICMJE clinical trials registration policy, do not answer the optional question,“Delayed Posting? (Y/N),” during the registration process that results in the placement of device trial registration in the lock box.

Alternatively, you may wish to register the trial in another acceptable registry, in addition to ClinicalTrials.gov.

Although the ICMJE believes that dual registration should be avoided in most situations, it is, however,another mechanism around the ClinicalTrials.gov device trial lock box problem. Note that each registration should cross-reference the unique registration identification number (e.g., NCT number for ClinicalTrials.gov) issued by the other registry to ensure recognition that both registrations present information about a single device trial.)

3. Do trials that began before July 1, 2005 need to be enrolled before September 13, 2005 in order to be eligible for consideration at an ICMJE journal?

Trials that began before July 1, 2005:Investigators should register trials that began enrolling patients any time before July 1, 2005 as soon as possible if they wish to submit them to a journal that follows the ICMJE policy. While the ICMJE hoped that all such trials would be registered by September 13, 2005, the committee understands that the policy statement was not entirely clear. Thus, ICMJE journals will consider trials that began before July 1, 2005 that were not registered prior to September 13, 2005. However, beginning on September 13, 2005, ICMJE journals will consider such trials only if they were adequately registered before journal submission. The ICMJE journals will accept＂retrospective registration＂ of trials that began before July 1, 2005 (retrospective meaning registration occurs after patient enrollment begins).

Trials that began after July 1, 2005:ICMJE journals will consider trials beginning on or after July 1, 2005 only if registration occurred before the first patient was enrolled (“prospective registration”).

4. What is the ICMJE definition of an “ongoing”trial?

The ICMJE considers trials that began enrollment before July 1, 2005 to be “ongoing” if the investigators were still collecting, cleaning, or analyzing data as of July 1, 2005.

Ongoing trials require registration before submission to a journal.

5. What is the ICMJE definition of a clinical trial?

The most recent editorial on trails registration at www.icmje.org discusses the evolution of the ICMJE definition of clinical trials. In June 2007 the ICMJE adopted the WHO’s definition of clinical trial: “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration. The ICMJE member journals will start to implement the expanded definition of clinically directive trials for all trials that begin enrollment on or after 1 July 2008. Those who are uncertain whether their trial meets the expanded ICMJE definition should err on the side of registration if they wish to seek publication in an ICMJE journal. The ICMJE secretariat office is unable to review specific studies to determine whether registration is necessary. If researchers or others have questions about the need to register a specific study, they should err on the side of registration or consult the editorial office of the journal they wish to publish the study in.

6. What is the relationship between the ICMJEtrials registration policy and the ongoing WHO trials registry effort?

In September 2005, the ICMJE implemented a policy that requires registration of clinically directive trials. The WHO is also working towards the implementation of an international trials registration process. Although several editors of ICMJE journals are independently involved as advisors to the WHO process, the two efforts are separate. The ICMJE welcomes the WHO initiative and is following its progress closely. When the final WHO policy is available, the ICMJE will determine whether to revise the ICMJE requirements to correspond to the WHO requirements. At present, the ICMJE expects investigators who wish to publish in ICMJE journals to adhere to the current ICMJE trials registry policy as documented on this web site (see May 2005 editorial and Frequently Asked Questions for details of the current ICMJE policy including the definition of applicable trials,acceptable registries, timing of registration, and required data items).

7. Which trials registries are acceptable to the ICMJE?

The ICMJE accepts registration in the following registries:

www.anzctr.org.au

www.clinicaltrials.gov

www.ISRCTN.org

www.umin.ac.jp/ctr/index/htm

www.trialregister.nl

In addition to the above registries, starting in June 2007 the ICMJE will also accept registration in any of the primary registries that participate in the WHO International Clinical Trials Portal (see http://www.who.int/ictrp/network/primary/en/index.html).Because it is critical that trial registries are independent of for-profit interests, the ICMJE policy requires registration in a WHO primary registry rather than solely in an associate registry, since for-profit entities manage some associate registries. Trial registration with missing or uninformative fields for the minimum data elements is inadequate even if the registration is in an acceptable registry.

8. What should trial registries that wish to be ICMJE-acceptable registries do?

The ICMJE is no longer the entity that reviews registries for acceptability. Registries should consult the WHO International Clinical Trials Registry Platform. Registries that the WHO designates as primary registries will be acceptable to the ICMJE.

9. Where can I get information about how to register a trial?

Please refer to the registry that you choose to register in for instructions about the registration process for that specific registry.

10. I'm having trouble registering my trial in ClinicalTrials.gov or believe that my trial is not eligible for registration in that registry... What now?

Send an email to register@clinicaltrials.gov with your question or explaining the problems you are encountering.

11. Are clinical trials registries in languages other than English acceptable to meet the ICMJE’s trials registration policy?

The ICMJE is cooperating with the WHO effort and will adopt WHO policy with respect to registry language.

However, until the WHO has a mechanism in place to solve the problems of searching across registries in different languages, the ICMJE feels that the minimal data items need to be registered in English as well as in the native language of the registry.

12. Do I need to register a trial if the subjects were health care providers and not patients?

Some trials assign health care providers, rather than patients, to intervention and comparison/control groups.

If the purpose of the trial is to examine the effect of the provider intervention on the health outcomes of the providers’ patients, then investigators should register the trial. If the purpose if to examine the effect only on the providers (for example, provider knowledge or attitudes),then registration is not necessary.

The studies addressing alzheimer disease and brain injuries in the ClinicalTrials from 2008 to 2010 are listed in Tables 3-4.Table 3 Studies addressing alzheimer disease in the ClinicalTrials

Alzheimer Disease Truncated and Extended Forms of Amyloid Beta Peptides in Centre Hospitalier Universitaire Philippe ROBERT,Alzheimer's Disease: Genesis, Toxicity and Identification as de Nice Ph.D.Biological Markers Alzheimer Disease Efficacy and Safety of Tamibarotene (OAM80) for Alzheimer's Osaka City University Takami Miki, M.D.Disease Alzheimer Disease Inappropriate Medications Associated With Anticholinesterase University Hospital, Limoges Marie - Laure and/or Memantine Treatment in the Elderly (MIDA)LAROCHE Alzheimer Disease Effect of Different Doses of SAR110 894D on Cognition in Sanofi-Aventis Patients With Mild to Moderate Alzheimer's Disease on Donepezil Alzheimer Disease Cognitive-Behavioral Treatment for Mild Alzheimer's Patients University of Zurich Simon Forstmeier,and Their Caregivers (CBTAC)Ph.D Alzheimer Disease AC-1 204 Long-term Efficacy Response Trial (ALERT Protocol)Accera, Inc.Samuel T Henderson, Ph.D.Alzheimer Disease Zolpidem CR and Hospitalized Patients With Deme Massachusetts General Hospital Kaloyan S Tanev,M.D.Alzheimer Disease Predictors of Cognitive Decline in Normal Aging National Institute on Aging (NIA)Kenneth E. Rich Alzheimer Disease TMS Stimulation and Cognitive Training in Alzheimer Patients Neuronix Ltd Martin Rabey, Prof.Alzheimer Disease Semantic Memory, Financial Capacity, and Brain Perfusion in Department of Veterans Affairs David G Clark, M.D.Mild Cognitive Impairment (MCI)Alzheimer Disease Low-Dose Opiate Therapy for Discomfort in Dementia (L-DOT)Department of Veterans Affairs Jennifer A Biladeau Alzheimer Disease Study of Escitalopram Versus Placebo in the Treatment of Sheba Medical Center Anna Sverdlik, M.D.Depressive Syndrome in Alzheimer’s Disease, Vascular Dementia, and Mixed Vascular and Alzheimer’s Dementia Alzheimer Disease Alzheimer's Disease and Related Disorders (MERE)University Hospital, Angers Cedric ANNWEILER, DM Alzheimer Disease Evaluation of Alteration by Magnetic Resonance Imaging (MRI)University Hospital, Bordeaux Michèle ALLARD in Dementia Among Elderly Subjects (AMIMAGE)Alzheimer Disease Statin Effects on Beta-Amyloid and Cerebral Perfusion in University of Wisconsin, Madison Laura E. Jacobson Adults at Risk for Alzheimer's Disease (SHARP)Alzheimer Disease Efficacy and Safety Study of ABT-384 in Subjects With Abbott Alison Torres Mild-to-Moderate Alzheimer's Disease Alzheimer Disease Efficacy and Safety Study of ABT-288 in Subjects With Abbott Lindsey Bensman Mild-to-Moderate Alzheimer's Disease Alzheimer Disease Alzheimer and Sleep University Hospital,Lacarin Patrick Clermont-Ferrand Alzheimer Disease Non Pharmacological Treatment in Alzheimer's Disease and Centre Hospitalier Universitaire Philippe Ph Associated Disorders de Nice ROBERT, M.D.Alzheimer Disease Predictive Value of Cognitive Tests Performed in CES for the University Hospital, Angers Bruno Fantino Diagnosis of Alzheimer's Disease and Related Disorders(EVATEM)Alzheimer Disease The Serotonergic Transmitter System in Dementia and Rigshospitalet, Denmark Vibe G. Frokjaer,Affective Disorders M.D.Alzheimer Disease Functional Magnetic Resonance Imaging (fMRI) of University of Wisconsin, Madison Amy Hawley Anosognosia in Amnestic Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD)Alzheimer Disease Safety and Tolerability of AFFITOPE AD03 (MimoVax)Affiris AG Siegfried Kasper Alzheimer Disease Donepezil Treatment of Psychotic Symptoms in Dementia Beersheva Mental Health Center Vladimir Lerner,Patients M.D., Ph.D.Alzheimer Disease Sensory-cognitive and Physical Fitness Training in Mild University of Konstanz Franka Gl?ckner,Cognitive Impairment Dipl.-Psych.Alzheimer Disease Brain Study of Patients With Frontal Lobe Dementia and National Institute of Neurological Patient Recruitment Parkinsonian Disorders Disorders and Stroke (NINDS)and Public Liaison Office Alzheimer Disease Dominantly Inherited Alzheimer Network (DIAN)Washington University School of Ana Isabel Alvarez-Medicine Retuerto, Ph.D.Alzheimer Disease Modafinil Treatment for Sleep/Wake Disturbances in Older VA Palo Alto Health Care System Ban Ku, BA Adults

Alzheimer Disease Gait and Alzheimer Interaction Tracking (GAIT) Study University Hospital, Angers BEAUCHET Olivier Alzheimer Disease Evaluation of [18F]FMH3 and PET as a Marker of Histamine-3 Institute for Neurodegenerative Laura Leary Receptor Activity in Subjects With AD Compared w/ HC Disorders Alzheimer Disease Study of Adherence and Effects of Balance Exercices (SIEL University Hospital, Angers Cédric ANNWEILER BLEU Associatio) (SIELBLEU)Alzheimer Disease Enhancing Consent for Alzheimer's Research (BWP-AD)National Institute on Aging (NIA)Tia Thrasher Alzheimer Disease Telephone Call From Acute Care Physicians to Long Term Maimonides Medical Center Sergey I Genkin Care Physicians: Impact on Transitional Care of Elderly Patients Alzheimer Disease Alzheimer's in Long-Term Care--Treatment for Agitation University of Washington Lucy Wang, M.D.Alzheimer Disease Evaluation of Apathy Using Attentional Reaction Test in Centre Hospitalier Universitaire Philippe ROBERT Neurodegenerative Diseases de Nice Alzheimer Disease Supporting Caregivers of Persons With Dementia: A Pilot Hamilton Health Sciences Lori Letts Study Corporation Alzheimer Disease Rajavtihi Neuronal Adult Stem Cells Project (RNASc)Rajavithi Hospital Subsai Kongsaengdao Alzheimer Disease Effects of Strengthening Exercise on the Brain for Early Union College, New York Cay Dementia and Normative Older Adults Anderson-Hanley Alzheimer Disease To Compare Positron Emission Tomography (PET)AstraZeneca AstraZeneca Clinica l Measurements of Fibrillar Amyloid Burden Study Information Alzheimer Disease Escitalopram Treatment of Patients With Agitated Dementia University of Rochester Carol Basener, BSN Alzheimer Disease Effects of Simvastatin on Biomarkers (SimBio University of Washington Dan Morelli Alzheimer Disease Improving Function, Quality of Life, Glycemia in Diabetics With University of Nebraska Daniel A Ramirez Dementia Alzheimer Disease Behavioral and Neuroimaging Changes After Cognitive Rehab Department of Veterans Affairs Jessica in Traumatic Brain Injuries (TBI) and Mild Cognitive Impairmen t Tedjopranoto(MCI)Alzheimer Disease UW/VA Madison Brain Bank University of Wisconsin, Madison Bridget Gregory Alzheimer Disease Clinical and Genetic Study of Neurodegenerative Disorders Institut National de la Santé Et de Alexis Brice With Cognitive Impairment la Recherche Médicale, France Alzheimer Disease Apathy in Dementia Methylphenidate Trial (ADMET Johns Hopkins Bloomberg Anne Casper School of Public Health Alzheimer Disease Studying the Effects of Antihypertensives on Individuals at Risk University of Wisconsin, Madison Jane F Sachs for Alzheimer's (SEAIRA)Alzheimer Disease Practice Effects and Amyloid Imaging Using 18F-PIB or University of Utah Kevin Duff Flutemetamol PET and FDG-PET Alzheimer Disease The Effect of JNJ-39393406 on Event Related Potentials in Janssen Pharmaceutica N.V.,Stable Schizophrenic Patients Belgium Alzheimer Disease Wii-fit for Activity, Balance and Gait in Assisted Living University of Nebraska Kalpana P Padala Alzheimer Disease Effectiveness of Care Management in Alzheimer Patients Institut de Sante Publique,Catherine HELMER(AIDALZ)d'Epidemiologie et de Developpement Alzheimer Disease Efficacy and Safety Study of DCB-AD1 in Patients With Mild to National Taiwan University Ming-Jang Chiu Moderate Alzheimer’s Disease Hospital Alzheimer Disease An Open Positron Emission Tomography Study to Assess the AstraZeneca Malin Sydvander Effects of Varying Mass of AZD4 694 on Radioligand Binding Parameters in Healthy Volunteers and Patients With Alzheimer's Disease Alzheimer Disease Study of Social Behavior and Emotion in Frontotemporal University of California, Los Jill Shapira Dementia, Alzheimer's Disease and Controls Angeles Alzheimer Disease Evaluation of the Diagnostic Potential of BAY1006578 in Bayer Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1 006 578 in Healthy Volunteers Alzheimer Disease Meditation or Education for Alzheimer Caregivers Oregon Health and Science Alexandra Amen University Alzheimer Disease Hormone and Information Processing Study (HIP)University of Washington Ashley Holder

Alzheimer Disease Side Effects of Newer Antipsychotics in Older Adults Veterans Medical Research Danielle K. Glorioso Foundation Alzheimer Disease Study of the Pharmacokinetics and Pharmacodynamics of QR Pharma Inc.Mark T Leibowitz POSIPHEN? in Subjects With Amnestic Mild Cognitive Impairment Alzheimer Disease Imaging of Cognition, Learning, and Memory in Aging Columbia University Daniel J Barulli Alzheimer Disease Dose Response Study of Aerobic Exercise in Older Adults University of Kansas Pat Laubinger Alzheimer Disease Glucose Metabolic, Amyloid, and Tau Brain Imaging in Down National Institute on Aging (NIA)Andrea Kaplan Syndrome and Dementia Alzheimer Disease Evaluating the Effects of Music Interventions on Hospitalised National Ageing Research Jonathan B Barber People With Dementia Institute, Australia Alzheimer Disease Dopaminergic Enhancement of Learning and Memory in University Hospital Muenster Bernward Winter Healthy Adults and Patients With Dementia/Mild Cognitive Impairment Alzheimer Disease Clinical Trial of Donepezil Between the Naive Group and the Samsung Medical Center Doh Kwan Kim Switching Group Alzheimer Disease Effects of Exercise and Cognitive Training on Cognitive The Cleveland Clinic Emily Newman Function in Older Adults Alzheimer Disease Use of Autobiographical and Interest Assessment for a Better Association Recherche Philippe ROBERT Stimulation of Patients in Nursing Home Méthodologie Evaluation Psychiatrique Alzheimer Disease Evaluation of the Safety, Tolerability, Pharmacokinetics, and Eisai Inc.Susan Nava Pharmacodynamics of E2609 in Healthy Subjects and an Elderly Cohort Alzheimer Disease Genes, Exercise, Memory and Neurodegeneration National Institute on Aging (NIA)Thomas O.Obisesan Alzheimer Disease A Study of Acupuncture for Patients With Behavioural and Chengdu University of Traditiona l Yong Tang Psychological Symptoms of Dementia Chinese Medicine Alzheimer Disease Memory Disorders Registry Cedars-Sinai Medical Center Andrew Berg Alzheimer Disease Implications of Amyloid Pathology National Institute on Aging (NIA)Kelly O'Keefe Alzheimer Disease Online Caregiver Psychoeducation and Support for Department of Veterans Affairs Theodore J Hahn Alzheimer's Alzheimer Disease Amyloid Plaque and Tangle Imaging in Aging and Dementia National Institute on Aging (NIA)Andrea Kaplan Alzheimer Disease Evolution of Memory Related Activity National Institute on Aging (NIA)Caroline Sullivan Alzheimer Disease Tracking Technologies for the Analysis of Mobility in Tel-Aviv Sourasky Medical Jeremia Heinik Alzheimer's Disease (SenTra)Center Alzheimer Disease Bupropion for the Treatment of Apathy in Alzheimer's University Hospital, Bonn Annika Spottke Dementia (APA-AD)

Table 4 Studies addressing brain injury in the ClinicalTrials

Brain Injury Effect of Passive Gait Training on the Cortical Activity in Patients University of Aarhus Natallia Lapitskaya,With Severe Brain Injury.M.D.Brain Injury Cortical Excitability in Patients With Severe Brain Injury University of Aarhus Natallia Lapitskaya,M.D.Brain Injury Efficacy of Pharmacological Treatment of Working Memory Kessler Foundation Elie P Elovic, M.D.Impairment After Traumatic Brain Injury: Evaluation With fMRI Brain Injury Evaluation of an Intervention Model for Family Crisis and Support Virginia Commonwealth Jeffrey S. Kreutzer University Brain Injury The Study of Cognitive Rehabilitation Effectiveness for Mild Brooke Army Medical Center Douglas B. Cooper,Traumatic Brain Injury (SCORE)Ph.D.Brain Injury Functional and Anatomical Magnetic Resonance Imaging (MRI) of Intermountain Health Care, Inc.Susan K. Churchill Chronic Brain Injury and Hyperbaric Oxygen (HBO2) Study Subjects (HYBOBI-MRI)Brain Injury Efficacy Study of NH001 in Vegetative State & Minimally NeuroHealing Pharmaceuticals Elkan Gamzu Conscious State Following a Traumatic Brain Injury (NH001-2)Inc.Brain Injury Efficacy of Botulinum Toxin Injections in the Rectus Femoris to Mary Free Bed Rehabilitation Krisanne B. Chapin.Treat Stiff Knee Gait Following Acquired Brain Injury Hospital Ph.D.Brain Injury Behavioral Trial Studying Programmed Training to Improve Mayo Clinic Allen W. Brown M.D.Advocacy Skills for Individuals With Traumatic Brain Injury (MAP)Brain Injury Telephone Intervention After Traumatic Brain Injury University of Washington Kathleen R. Bell Brain Injury Magnesium Sulfate to Prevent Brain Injury in Premature Infants Eunice Kennedy Shriver National Thomas E. Wiswell,Institute of Child Health and M.D.Human Development (NICHD)Brain Injury Treatment of Traumatic Brain Injury With Hyperbaric Oxygen San Antonio Military Medical E. George Wolf, M.D.Therapy Center Brain Injury Telephone Intervention for Caregivers of Persons With Traumatic University of Washington Janet M. Powell, Ph.D.Brain Injury Brain Injury Hypothermia to Treat Severe Brain Injury National Institute of Neurological Guy L. Clifton,M.D.Disorders and Stroke (NINDS)Brain Injury Efficacy and Safety Study of Intravenous Progesterone in Patients BHR Pharma, LLC Vadim Paluy, M.D.With Severe Traumatic Brain Injury (SyNAPSe)Brain Injury Treatment of Adult Growth Hormone Deficiency After Traumatic Pfizer Pfizer Brain Injury Brain Injury Tranexamic Acid for Preventing Progressive Intracranial Khon Kaen University Warawut -Haemorrhage in Traumatic Brain Injury Kittiwattanagul, M.D.Brain Injury Invasive and Non-Invasive Assessment of Cerebral Oxygenation Hospitales Universitarios Virgen Santiago R Leal-Noval,in Patients With Severe Traumatic Brain Injury (TBI)del Rocío M.D., Ph.D.Brain Injury Improving Psychological Wellness After Acquired Brain Injury Toronto Rehabilitation Institute Robin E Green, Ph.D Brain Injury Pharmacological Intervention in Depression After Traumatic Brain Virginia Commonwealth Jeffrey S. Kreutzer,Injury University Ph.D.Brain Injury Progesterone for the Treatment of Traumatic Brain Injury Emory University David W. Wright, M.D.(ProTECT III)Brain Injury Hypertonic Resuscitation Following Severe Traumatic Brain Injury University of Washington Gerald Van Belle, Ph.D.(TBI)Brain Injury Age of Blood in Brain Injury University of British Columbia Dean Chittock, M.D.Brain Injury Proteomics of Brain Trauma-associated Elevated Intracranial The University of Texas Health Pramod Dash, Ph.D.Pressure (ICP)Science Center, Houston Brain Injury Life Improvement Following Traumatic Brain Injury (LIFT)University of Washington Jesse R Fann, M.D.Brain Injury Evaluation of Outcome Measures for Patients Diagnosed With National Institutes of Health Patient Recruitment and Traumatic Brain Injury Clinical Center (CC)Public Liaison Office Brain Injury Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Craig Hospital David L. Ripley, M.D.Testosterone Therapy Brain Injury Multidisciplinary Treatment in Patients With Mild Traumatic Brain Haukeland University Hospital Jan Sture Skouen,Injury M.D., Ph.D.Brain Injury Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Assistance Publique - H?pitaux de Jacques DURANTEAU,Injury Patients (SEPIA)Paris M.D.,Ph.D.Brain Injury Evaluation, Pathogenesis, and Outcome of Subjects With or National Institute of Neurological Martin R. Cota, CCRC Suspected Traumatic Brain Injury Disorders and Stroke (NINDS)

Brain Injury The DECRA Trial: Early Decompressive Craniectomy in Patients National Trauma Research D. J. Cooper With Severe Traumatic Brain Injury Institute Brain Injury Study of Bedside EEG to Evaluate Brain Injury in Premature Brigham and Women's Hospital Linda J Van Marter,Newborns (BrainZ)M.D.Brain Injury Study of NNZ-2566 in Patients With Traumatic Brain Injury Neuren Pharmaceuticals Limited Ross R Bullock, M.D.(INTREPID2566)Brain Injury Neural Bases of Cognitive Rehabilitation for Brain Injury Department of Veterans Affairs Mark D'Esposito, M.D.Brain Injury Does Cognitive Rehabilitation Demonstrate Benefits in the Group Mayo Clinic Merri L Vitse Setting With People Whom Have Experienced Brain Injury?Brain Injury Genotype Influence on Recovery After Traumatic Brain Injury Department of Veterans Affairs Fiona Crawford, Ph.D.Brain Injury Treatment Of Adult Growth Hormone Deficiency After Traumatic Pfizer Pfizer CT.gov Call Brain Injury.Center Brain Injury Hyperbaric Oxygen Therapy in Chronic Stable Brain Injury Intermountain Health Care, Inc.Susan K. Churchill,(HYBOBI)APRN-NP Brain Injury Expressive Arts as a Social and Community Integration Tool for University of Toronto Michelle Keightley Youth Recovering From Brain Injury Brain Injury Effect of Rozerem on Sleep Among People With Traumatic Brain Kessler Foundation Anthony Lequerica,Injury Ph.D.Brain Injury Alveolar Recruitment in Brain Injury Hospital Clinic of Barcelona Elizabeth Zavala, M.D.,Ph.D.Brain Injury Influence of Physical Exercise on Cognitive Functioning of Federal University of S?o Paulo Marco T De Mello,Traumatic Brain Injury Patients Ph.D.Brain Injury Delayed Versus Early Enoxaparin Prophylaxis After Traumatic University of Texas Southwestern Herb A Phelan, M.D.Brain Injury (TBI) (DEEP)Medical Center Brain Injury Neuropsychological Cognitive Behavioral Therapy for Patients Philipps University Marburg Cornelia Exner, Dr.With Acquired Brain Injury Medical Center (Ph.D.)Brain Injury Ante-hypophyseal Dysfunctions in Children Following Moderate to Hospices Civils de Lyon Etienne JAVOUHEY,Severe Traumatic Brain Injuries (Endoc-TC)M.D., Ph.D.Brain Injury Study of NNZ-2 566 in Patients With Traumatic Brain Injury Under Neuren Pharmaceuticals Limited Ross R Bullock, M.D.,EFIC (INTREPID-2 566)Ph.D.Brain Injury Carbamazepine for the Treatment of Chronic Post-Traumatic Brain Carolinas Healthcare System Marybeth Whiney, R.N.Injury Irritability and Aggression Brain Injury OSCAR - An Internet-based Supportive Coaching for Informal University of Bern Hansjoerg Znoj, Prof.Caregivers of Adult Individuals With an Acquired Brain Injury Dr. phil.Brain Injury Depression and Traumatic Brain Injury Sunnybrook Health Sciences Krista L Lanctot, Ph.D.Centre Brain Injury Anterior Pituitary Hormone Replacement in Traumatic Brain Injury The University of Texas,Randall J Urban, M.D.Galveston Brain Injury Safety of Dexmedetomidine in Severe Traumatic Brain Injury University of Maryland Deborah Stein, M.D.Brain Injury Effects of Transport on Patients With Traumatic Brain Injury University of Cincinnati Warren A Dorlac, M.D.Brain Injury Deep Brain Stimulation for Traumatic Brain Injury Ohio State University Ali Rezai, M.D.Brain Injury Problem Solving for Caregivers of Persons With Brain Injury Centers for Disease Control and Timothy R Elliot, Ph.D.,Prevention ABPP Brain Injury Comparison Between Different Types of Oxygen Treatment Minneapolis Medical Research Gaylan L Rockswold,Following Traumatic Brain Injury Foundation M.D., Ph.D.Brain Injury The Effect of Exercise on Mood After Traumatic Brain Injury University of Washington Kathleen R Bell, M.D.Brain Injury Treatment Strategy to Prevent Mood Disorders Following University of Iowa Ricardo E. Jorge, M.D.Traumatic Brain Injury Brain Injury Assessing Special Features of Impaired Gait After Acquired Brain Sheba Medical Center Manuel Zwecker, M.D.Injury With an Instrumented Treadmill Brain Injury Eye Movement Recordings in the Diagnosis of Traumatic Brain Department of Veterans Affairs Jonathan Jacobs, Ph.D.Injury Brain Injury Discrete Hypothermia in the Management of Traumatic Brain Emory University Odette A Harris, M.D.Injury Brain Injury Corticosteroid Therapy for Glucocorticoid Insufficiency Related to Nantes University Hospital Karim ASEHNOUNE Traumatic Brain Injury (Corti-TC)Brain Injury Effects of Erythropoietin on Cerebral Vascular Dysfunction and Baylor College of Medicine Claudia Robertson,Anemia in Traumatic Brain Injury M.D.

Brain Injury Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Louisiana State University Health Paul G Harch, M.D.Traumatic Brain Injury Sciences Center in New Orleans Brain Injury Advanced Imaging Tools in the Study of Mild Traumatic Brain Kettering Health Network Jason Parker, Ph.D.Injury (mTBI)Brain Injury Effect of Aerobic Exercise Training on Cardiorespiratory Function National Institutes of Health Patient Recruitment and in Patients With Traumatic Brain Injury Clinical Center (CC)Public Liaison Office Brain Injury Outcome Predictors in Acute Brain Injury Bayside Health Warwick Butt, FRACP Brain Injury Rehabilitation Research and Training Center for Traumatic Brain Children's Hospital Medical Sharil L Wade, Ph.D.Injury Interventions--Teen Online Problem Solving Study Center, Cincinnati(RRTC--TOPS)Brain Injury MEG and DTI of Neural Function and Connectivity in Traumatic University of California, San Pratik Mukherjee, M.D.,Brain Injury (Dana-REAC)Francisco Ph.D.Brain Injury Imaging of Traumatic Brain Injury (Imaging of TBI)University of Maryland Rao P Gullapalli, Ph.D.Brain Injury Effects of Hypothermia Upon Outcomes After Acute Traumatic The University of Texas Health Guy L Clifton, M.D.Brain Injury (NABIS:HIIR)Science Center, Houston Brain Injury Rehabilitation of Traumatic Brain Injury in Active Duty Military The Defense and Veterans Brain Deborah L. Warden,Personnel and Veterans Injury Center M.D.Brain Injury The Predictive Value of Clinical and Immunological Factors in the Royal Alexandra Hospital Demetrios Development of Pneumonia After Traumatic Brain Injury Kutsogiannis, M.D.Brain Injury Erythropoietin Effects After Traumatic Brain Injury Medical College of Wisconsin Ram Nirula, M.D., MPH Brain Injury Improving New Learning and Memory in Traumatic Brain Injury Kessler Foundation Nancy D Chiaravalloti,Ph.D.Brain Injury Treatment of Citalopram for Anxiety Disorders Following a Walter Reed Army Medical Center Michael Jaffee, M.D.Traumatic Brain Injury Brain Injury Amantadine for the Treatment of Traumatic Brain Injury Irritability Carolinas Healthcare System Flora M Hammond,and Aggression: A Multi-site Study M.D.Brain Injury Effects of Intranasal Nerve Growth Factor for Traumatic Brain Jinling Hospital, China Xinfeng Liu, M.D.Injury Brain Injury Evaluation and Diagnosis of Potential Research Subjects With National Institute of Nursing Melaine F. Bertrand Traumatic Brain Injury Research (NINR)Brain Injury A Prospective, Randomized Trial of Early Versus Late Memorial Medical Center Russell D Dumire, M.D.Tracheostomy in Trauma Patients With Severe Brain Injury Brain Injury The Paracetamol AfteR Traumatic Brain InjurY Study (PARITY)South East Sydney and Illawarra Manoj Saxena Area Health Service Brain Injury Study on the Effect of Prostacyclin Compared to Placebo in Ume? University Lars-Owe Koskinen,Traumatic Brain Injury Professor Brain Injury Traumatic Brain Injury Among Homeless Veterans VA Eastern Colorado Health Care Lisa A. Brenner, Ph. D.System Brain Injury A Health & Wellness Intervention for Individuals With Traumatic VA Eastern Colorado Health Care Lisa Brenner, Ph.D.Brain Injury (TBI)System Brain Injury Efficacy of Ketamine in Children With Severe Brain Injury for Brain University of Arkansas Muayyad Tailounie,Cell Protection M.D.Brain Injury Affect Recognition: Enhancing Performance of Persons With University at Buffalo Barry Willer, Ph.D.Traumatic Brain Injury (TBI)Brain Injury S-100B as Pre-Head CT Scan Screening Test After Mild University of Rochester Jeffrey J Bazarian,Traumatic Brain Injury M.D., MPH Brain Injury Electrolyte and Fluid Disturbances in Subarachnoid Hemorrhage University Hospital Inselspital,Jan Wiegand, M.D.and Traumatic Brain Injury Berne Brain Injury Efficacy Study of Strattera for Treating Attention Disorders in Craig Hospital David L Ripley, M.D.Traumatic Brain Injury (TBI)Brain Injury Study of Citicoline for the Treatment of Traumatic Brain Injury Columbia University Sherry Melton, M.D.(COBRIT)Brain Injury Osmotic Therapy for Treatment of Intracranial Hypertension for Indiana University Richard B. Rodgers,Traumatic Brain Injury M.D.Brain Injury Study of the Safety and Efficacy of Conivaptan (Vaprisol?) to University of Washington Miriam Treggiari, M.D.Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury Brain Injury Amantadine and Temporal Discrimination in Patients With Carolinas Healthcare System Oleg V. Tcheremissine,Traumatic Brain Injury (TBI)M.D.

Brain Injury Effectiveness of Amantadine Hydrochloride for Treatment of JFK Medical Center Joseph T. Giacino,Severe Traumatic Brain Injury (TBI)Ph.D.Brain Injury The Effect of Mild Traumatic Brain Injury on Recovery From Injury University of Pittsburgh Brian G Harbrecht, M.D.Brain Injury Mindfulness-Based Cognitive Therapy Intervention to Treat Lakehead University Michel Bédard, Ph.D.Depression in Individuals With a Traumatic Brain Injury Brain Injury Hypothermia in Traumatic Brain Injury in Children (HiTBIC)Australia and New Zealand John Beca, FJFICM Intensive Care Society Brain Injury Safety of Autologous Stem Cell Treatment for Traumatic Brain The University of Texas Health Charles S. Cox, Jr.,Injury in Children Science Center, Houston M.D.Brain Injury A Phase 2a Dose Escalation Study With SLV334 in Patients With Abbott Products Alicia Batchelor Traumatic Brain Injury.Brain Injury Safety and Tolerability of Oxycyte in Patients With Traumatic Brain Oxygen Biotherapeutics, Inc.Michael Reinert, M.D.Injury (TBI) (STOP-TBI)Brain Injury Effect of Namenda on Short Term Memory and Attention in University of Missouri-Columbia S. Jon Rupright, D.O.Patients With Mild to Moderate Traumatic Brain Injury Brain Injury Diffusion-Tensor Magnetic Resonance Imaging (MRI) and the Johns Hopkins University Ernest M Graham, M.D.Evaluation of Perinatal Brain Injury Brain Injury Preventing Epilepsy After Traumatic Brain Injury With Topiramate University of Pennsylvania Marc A Dichter, M.D.,(PEPTO)Ph.D.Brain Injury Neurocognitive Evaluation of Mild Traumatic Brain Injury in the Children's Hospital of Philadelphia Michael L. Nance, M.D.Hospitalized Pediatric Population Brain Injury S100 Protein in Minor/Mild Traumatic Brain Injury Assistance Publique - H?pitaux de Jean-Louis Beaudeux,Paris M.D., Ph.D.Brain Injury Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children Teva GTC Ido Yatsiv, M.D.With Chronic Traumatic Brain Injury (TBI)Brain Injury Normothermia in Patients With Acute Cerebral Damage Fondazione IRCCS Ca' Granda,Nino Stocchetti, M.D.Ospedale Maggiore Policlinico Brain Injury Efficacy and Safety of Rivastigmine in Patients With Traumatic Novartis Novartis Pharma Brain Injury and Cognitive Impairment Brain Injury Multimodal Neurodiagnostic Imaging of Traumatic Brain Injury and St. Louis University Richard Bucholz, M.D.Post-Traumatic Stress Disorder (SANIC)Brain Injury Proteomics of Severe Traumatic Brain Injury: A Feasibility Study University of Calgary Zygun A David, M.D.Brain Injury Effect of Passive Gait Training on the Cortical Activity in Patients University of Aarhus Karsten Koch-Jensen,With Severe Traumatic Brain Injury.M.D.Brain Injury Feasibility Study of Duloxetine in the Treatment of Depression in Rehabilitation Hospital of Indiana Lance Trexler, Ph.D.Patients With Traumatic Brain Injury (TBI)Brain Injury Heart Rate Variability (HRV) Among Children With Brain Damage Alyn Pediatric & Adolecent HeM.D.a Rotem Rehabilitation Center Brain Injury A TMU/NIH Integrated Research Project Translation of Basic Taipei Medical University Wen-Ta Chiu Research to Clinical Diagnosis and Treatment of Mild Traumatic WanFang Hospital Brain Injury (mTBI)Brain Injury Growth Hormone and Insulin Growth Factor 1 Deficiencies in University of Virginia Peter D Patrick, Ph.D.Children/Adolescents Following Traumatic Brain Injury: The Impact on Growth and Neuropsychological Development Brain Injury Mannitol Versus Hypertonic Saline to Treat Intracranial Direction Centrale du Service de Henry BORET, M.D.Hypertension (ICHT) After Severe Traumatic Brain Injury (TBI) :Santé des Armées Comparative Effects on PtiO2 and Microdialysis Values Brain Injury Excitatory Amino Acids and Activated Microglia After Traumatic VU University Medical Center Bart van Berckel, M.D.;Brain Injury: a (R)-[11C]PK11195 PET Study Ph.D.Brain Injury ＂Interactive Metronome Technology for Blast-Related Traumatic Foundation for the Advancement Henry M. Jackson Brain Injury＂of Military Medicine Brain Injury Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Virginia Commonwealth David X Cifu, M.D.Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI) (HBOT)University Brain Injury Clinical Trial of a Rehabilitation Game - SuperBetter Ohio State University W Mysiw, M.D.Brain Injury Magnesium Sulfate For Brain Injury National Institute of Neurological Nancy Temkin, Ph.D.Disorders and Stroke (NINDS)

Brain Injury Therapy for Reading Problems in Adults After Brain Injury Eunice Kennedy Shriver National Rhonda B. Friedman,Institute of Child Health and Ph.D.Human Development (NICHD)Brain Injury Pilot Study of Hyperbaric Oxygen Therapy (HBOT) in Chronic Louisiana State University Health Paul G Harch, M.D.Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS)Sciences Center in New Orleans and TBI/Post-Traumatic Stress Disorder (PTSD)Brain Injury Brain Computer Interfaces for Functional Recovery From Brain University of Washington Jeffrey G Ojemann,Injury (BCI)M.D.Brain Injury Internet-Based Treatment for Children With Traumatic Brain Children's Hospital Medical Shari L. Wade, Ph.D.Injuries & Their Families: Counselor Assisted Problem Solving Center, Cincinnati(CAPS)Brain Injury The Use of Low Molecular Weight Heparin in Traumatic Brain Minneapolis Medical Research John K. Cumming, M.D.Injury Foundation Brain Injury Supporting Traumatic Brain Injury (TBI) Caregivers Eunice Kennedy Shriver National Armando James Institute of Child Health and Rotondi Human Development (NICHD)Brain Injury Vestibular Consequences of Blast-related Mild Traumatic Brain Department of Veterans Affairs Faith Akin, Ph.D.Injury (TBI)Brain Injury Physical Work Capacity After Traumatic Brain Injury The University of Texas,Kurt A. Mossberg, PT,Galveston Ph.D.Brain Injury Awareness of Deficit After Combat-related Brain Injury University of Wisconsin, Madison Sterling C Johnson,Ph.D.Brain Injury Improving Work Outcomes for Veterans With Traumatic Brain Department of Defense Elizabeth W Twamley,Injury Ph.D.Brain Injury Dexanabinol in Severe Traumatic Brain Injury Pharmos Andrew Maas, M.D.Brain Injury Methylphenidate (Ritalin) and Memory/Attention in Traumatic Brain Dartmouth-Hitchcock Medical Thomas W McAllister,Injury (TBI)Center M.D.Brain Injury Normoglycemia and Neurological Outcome University of Louisville Rainer Lenhardt, M.D.Brain Injury A Trial of Two On-Line Interventions for Child Brain Injury University of Pittsburgh Armando J Rotondi,Ph.D.Brain Injury Sertraline vs. Placebo for Symptoms Following Traumatic Brain Walter Reed Army Medical Center Michael Jaffee, M.D.Injury Brain Injury Checking the Usability of a Virtual Reality System in Children With Sheba Medical Center Amichay Brezner, Ph.D.Brain Injury Brain Injury Safety of Darbepoetin Alfa Treatment in Patients With Severe Royal Alexandra Hospital Demetrios J.Traumatic Brain Injury Kutsogiannis, M.D.MHS FRCPC Brain Injury Therapeutic Hypothermia for Severe Traumatic Brain Injury in Yamaguchi University Hospital Tsuyoshi Maekawa,Japan M.D., Ph.D.Brain Injury Effects of Rapid-Resisted Exercise and Bright Light Therapy on National Institutes of Health Patient Recruitment and Ambulatory Adults With Traumatic Brain Injury Clinical Center (CC)Public Liaison Office Brain Injury Resuscitative Endocrinology: Single-dose Clinical Uses for University of Texas Southwestern Jane G Wigginton, M.D.Estrogen - Traumatic Brain Injury (RESCUE - TBI)Medical Center Brain Injury Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI)Department of Veterans Affairs Yelena Bogdanova,(CRbTBI)Ph.D.Brain Injury Telerehabilitation for Operation Iraqi Freedom/Operation Enduring Department of Veterans Affairs Kris Siddharthan, Ph.D.Freedom (OIF/OEF) Returnees With Combat-Related Telerehab MS for Traumatic Brain Injury Brain Injury An Exploratory Study to Evaluate Two Acupuncture Methods for Samueli Institute for Information Louis M French, PsyD the Treatment of Headaches Associated With Traumatic Brain Biology Injury Brain Injury Impact of Inspired Oxygen Fraction on Outcome in Patients With Kuopio University Hospital Esko Ruokonen,Traumatic Brain Injury (BRAINOXY)Professor Brain Injury Monitoring Brain Activity in Human Brain Injury Soroka University Medical Center Alon Friedman,M.D./Ph.D.Brain Injury The Use of Transcranial Direct Current Stimulation (tDCS) to National Taiwan University Wen-Shiang Chen,Study Implicit Motor Learning on Patients With Brain Injury Hospital M.D., Ph.D.Brain Injury ng Devices That Involve the Sense of Touch in Subjects With National Institutes of Health Patient Recruitment and Traumatic Brain Injury Clinical Center (CC)Public Liaison Office Brain Injury Pain in Traumatic Brain Injury - Basile, M.D.Staten Island University Hospital Rosemarie Basile, M.D.

Brain Injury Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Department of Veterans Affairs Christine Marx, M.D.Veterans MA Brain Injury Erythropoietin in Traumatic Brain Injury (EPO-TBI)Australian and New Zealand Rinaldo Bellomo, M.D.Intensive Care Research Centre Brain Injury Incidence/Magnitude-Haemorrhagic Progression-Cerebral Novo Nordisk Brett Skolnick, Ph.D.Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury Brain Injury Normothermia Protocol for Traumatic Brain Injury Patients Medivance, Inc.Farid Sadaka, M.D.Brain Injury The Prophylactic Hypothermia Trial to Lessen Traumatic Brain Australian and New Zealand Jamie Cooper, BMBS,Injury (POLAR-RCT)Intensive Care Research Centre M.D.Brain Injury AcuSleep in Mild Traumatic Brain Injury (TBI) (AcuTBI)Department of Veterans Affairs Wei Huang, M.D. Ph.D.Brain Injury Study to Evaluate the Safety, Tolerability, and Efficacy of Cephalon Sponsor's Medical Armodafinil as Treatment for Patients With Excessive Sleepiness Expert, M.D.Associated With Mild or Moderate Closed Traumatic Brain Injury Brain Injury Study to Evaluate the Efficacy and Safety of Armodafinil as Cephalon Sponsor's Medical Treatment for Patients With Excessive Sleepiness Associated Expert, M.D.With Mild or Moderate Closed Traumatic Brain Injury Brain Injury Recombinant Human Growth Hormone During Rehabilitation From University of Texas Southwestern Ramon R.Traumatic Brain Injury. (Growth-TBI)Medical Center Diaz-Arrastia, M.D.,Ph.D.Brain Injury Brain Tissue Oxygen Monitoring in Traumatic Brain Injury (TBI)University of Texas Southwestern Ramon R.(BOOST 2)Medical Center Diaz-Arrastia, M.D.,Ph.D.Brain Injury Cerebral Blood Flow (CBF) Disturbances Following Traumatic Azienda Ospedaliera San Giuseppe Citerio, DM Brain Injury (TBI) and Subarachnoid Hemorrhage (SAH)Gerardo di Monza Brain Injury Mild Hypothermia and Supplemental Magnesium Sulfate Infusion U.S. Army Medical Research and Greg Zorman, M.D.in Severe Traumatic Brain Injury (TBI) Subjects Materiel Command Brain Injury Hyperbaric Oxygen Therapy in Chronic Traumatic Brain Injury or International Hyperbaric Medical Paul G Harch, M.D.Post-Traumatic Stress Disorder (NBIRR-1)Foundation Brain Injury Executive Dysfunction and Self-Harm Behavior: An Examination o f Colorado Traumatic Brain Injury Lisa Brenner, Ph.D.Veterans With Traumatic Brain Injury, Post Traumatic Stress Trust Fund Disorder, or Both Brain Injury Biomarkers of the Mild and Moderate Traumatic Brain Injury Banyan Biomarkers, Inc Jackson Streeter, M.D.(MMTBI)Brain Injury Safety Study of Human Chorionic Gonadotropin (hCG) and University of Calgary David A Zygun, M.D.,Epoetin Alfa (EPO) in Traumatic Brain Injury: Dosing Tier 1 MSc Brain Injury Efficacy of Modified Constraint-induced Movement Therapy in Chang Gung Memorial Hospital Chia-Ling chen,Children With Brain Damage M.D.,Ph.D.Brain Injury Home Based Exercise Program for Brain Injury Children Alyn Pediatric & Adolecent Michal Katz-Leurer,Rehabilitation Center Ph.D.Brain Injury Examination of Virtual Supermarket (Vmall) as an Assessment of Sheba Medical Center Amichai Brezner, M.D.Executive Functions in Children and Adolescents With Acquired Brain Injury Brain Injury Hypopituitarism Following Traumatic Brain Injury or Spontaneous Rigshospitalet, Denmark Marianne C Klose, M.D.Subarachnoidal Haemorrhages Brain Injury Improving Executive Functions After Traumatic Brain Injury (TBI):Mount Sinai School of Medicine Wayne A Gordon, Ph.D.A Clinical Trial of the ＂Executive Plus＂ Program Brain Injury Improving Executive Functions After Traumatic Brain Injury (TBI):Mount Sinai School of Medicine Wayne A Gordon, Ph.D.A Clinical Trial of the ＂Executive Plus＂ Program Brain Injury Building Better Caregivers Online: An Online Workshop for Stanford University Kate R Lorig Caregivers of Those With Traumatic Brain Injury, Post Traumatic Stress Disorder, or Alzheimer's or Other Dementia Brain Injury Behavioral and Neuroimaging Changes After Cognitive Rehab in Department of Veterans Affairs Benjamin M.Traumatic Brain Injuries (TBI) and Mild Cognitive Impairment Hampstead, Ph.D.(MCI)Brain Injury Traumatic Brain Injury (TBI) Screening Instruments Department of Veterans Affairs Rodney D.Vanderploeg, Ph.D.Brain Injury Precedex Versus Propofol-Awakening for Reducing Brain Injury Duke University Carmelo Graffagnino,Expansion (PrePARE)M.D.Brain Injury Interacting Together Everyday: Recovery After Childhood Children's Hospital Medical Shari L. Wade, Ph.D.Traumatic Brain Injury (TBI) ＂I-InTERACT Center, Cincinnati

Brain Injury A Pilot Study to Identify Biomarkers Associated With Chronic The University of Texas Health Georgene Traumatic Brain Injury (Chronic TBI)Science Center, Houston Hergenroeder, MHA,RN Brain Injury Improving Executive Functioning After Traumatic Brain Injury Mount Sinai School of Medicine Wayne Gordon, Ph.D.(TBI): A Trial of the ＂Short Term Executive Plus＂ Program (STEP)Brain Injury Long-term Clinical Correlates of Traumatic Brain Injury National Institutes of Health Patient Recruitment and Clinical Center (CC)Public Liaison Office Brain Injury The Effect of Aerobic Exercise on Mild Traumatic Brain Injury Department of Veterans Affairs David E Cox, Ph.D.Brain Injury Sodium-Lactate and Traumatic Brain Injury Institut d'Anesthesiologie des Carole R ICHAI,Alpes Maritimes M.D.-Ph.D.Brain Injury Telerehabilitation for the Hand and Arm After Stroke and Ono Academic College Heidi Sugarman, Ph.D.Traumatic Brain Injury Brain Injury Approaches to Auditory Rehabilitation for Mild Traumatic Brain Department of Veterans Affairs Gabrielle Saunders Injury (mTBI)Brain Injury Transcranial Doppler on Admission of Patients With Mild to University Hospital, Grenoble Jean Francois Payen,Moderate Traumatic Brain Injury (TCD)M.D.Brain Injury Overcoming Membrane Transporters to Improve CNS Drug University of Pittsburgh Michael J Bell, M.D.Delivery - Improving Brain Antioxidants After Traumatic Brain Injury (Pro-NAC)Brain Injury The Effect of Hyperbaric Oxygen Therapy on Patients Suffering Assaf-Harofeh Medical Center Shai Efrati, M.D.From Neurologic Deficiency Due Traumatic Brain Injury Brain Injury A Study to Evaluate the Efficacy of Somatropin in Adults With Pfizer Pfizer CT.gov Call Growth Hormone Deficiency Caused by Trauma and/or Head Center Injury (GHD)Brain Injury Psychological Treatment for Children Suffering From Post Rabin Medical Center Maayans Shorer, Ph.D.Traumatic Stress Symptoms and Mild Traumatic Brain Injury (TBI)Brain Injury The EPIC Project: Impact of Implementing the EMS Traumatic University of Arizona Daniel W Spaite, M.D.Brain Injury Treatment Guidelines Brain Injury Treatment of Traumatic Brain Injury (TBI)-Related Attention Vanderbilt University Michael G Tramontana,Deficits Ph.D.Brain Injury Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Durham VA Medical Center Christine E. Marx,Veterans M.D.,MA Brain Injury Safety and Feasibility of Minocycline in the Treatment of Traumatic Wayne State University Jay M Meythaler, M.D.Brain Injury (TBI)Brain Injury The Efficacy of Familiar Voice Stimulation During Coma Recovery Department of Veterans Affairs Theresa Pape, BS MA DrPH Brain Injury Pituitary Functions After Traumatic Brain Injury (TBI) and/or University of Erlangen-Nürnberg Michael Buchfelder,Subarachnoid Hemorrhage (SAH)Medical School M.D., Ph.D.Brain Injury Mission Connect Mild Traumatic Brain Injury (TBI) Integrated Baylor College of Medicine Claudia S Robertson,Clinical Protocol M.D.Brain Injury The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Hadassah Medical Organization Guy Rosenthal, M.D.Moderate Traumatic Brain Injury (TBI) Patients (DCS)Brain Injury Evaluation of VA's Traumatic Brain Injury (TBI) Clinical Reminder Department of Veterans Affairs Judi L and Comprehensive TBI Evaluation Babcock-Parziale,Ph.D.Brain Injury Pilot of Acupuncture to Improve Quality of Life in Veterans With Department of Veterans Affairs Thomas W. Findley,Traumatic Brain Injury (TBI) and Post-Traumatic Stress Disorder M.D. Ph.D.(PTSD)Brain Injury The Use of Anti-oxidants to Reduce Sequela of Mild Traumatic Brooke Army Medical Center Michael E. Hoffer, M.D.Brain Injury (mTBI) After Blast Exposure Brain Injury Neonatal Estimation Of Brain Damage Risk And Identification of Hannover Medical School Olaf Dammann Neuroprotectants (NEOBRAIN)Brain Injury Consistency of Automated Neuropsychological Assessment VA Eastern Colorado Health Care Lisa A Brenner, Ph.D.Metrics (ANAM) Performance in Those With Deployment Acquired System Mild Traumatic Brain Injury (TBI)Brain Injury Internet-based Interacting Together Everyday, Recovery After Children's Hospital Medical Shari L Wade, Ph.D.Childhood TBI (I-InTERACT)--RRTC Center, Cincinnati Brain Injury Telepharmacy Robotic Medicine Delivery Unit ＂TRM.D.U＂University of Illinois Daniel R Touchette, MA Assessment

Brain Injury Clinical Randomisation of an Antifibrinolytic in Significant Head London School of Hygiene and Haleema Shakur, BSc,Injury (CRASH-3)Tropical Medicine MSc, RGN Brain Injury Vietnam Head Injury Study - Phase III U.S. Army Medical Research and Jordan Grafman, Ph.D.Materiel Command Brain Injury Hyperbaric Oxygen Therapy for Persistent Post-concussive U.S. Army Medical Research and Scott Miller, M.D., COL Symptoms After Mild TBI (HOPPS)Materiel Command Brain Injury Acute Cognitive and Neurobehavioral Intervention: Efficacy Virginia Commonwealth Jeffrey S Kreutzer,Evaluation University Ph.D.Brain Injury Top-Down Executive Control in Traumatic Brain Injury (TBI), PTSD Department of Veterans Affairs Michael A. Cole, Ph.D.and Combined Brain Injury The LETS Study: A Longitudinal Evaluation of Transition Services Bloorview Kids Rehab Colin Macarthur, Ph.D.Brain Injury Comparative Efficacy of Three Preparations of Botox-A in Treating The University of Texas Health Gerard E Francisco,Spasticity Science Center, Houston M.D.Brain Injury ACT-ICU Study: Activity and Cognitive Therapy in the Intensive Vanderbilt University Nathan E. Brummel,Care Unit M.D.Brain Injury Factors Affecting Return to Work Among OEF/OIF Veterans With Department of Veterans Affairs Elizabeth M. Hannold,Polytrauma Ph.D. MS BS Brain Injury Cerebral Antibiotics Distribution After Acute Brain Injury Poitiers University Hospital Claire DAHYOT, M.D.Brain Injury Training in Goal-directed Attention Regulation for Individuals With Department of Veterans Affairs Mark D'Esposito, M.D.Brain Injury Brain Injury CDP-Choline and Working Memory After TBI: A Neuroimaging University of Pittsburgh Patricia M. Arenth,Study Ph.D.Brain Injury A Study Comparing Modified Lund Concept and Cerebral University of Sarajevo Kemal Dizdarevic, M.D.,Perfusion Pressure-targeted Therapy in Secondary Brain MSc, Ph.D.Ischaemia.Brain Injury Measuring Head Impacts in Sports Eunice Kennedy Shriver National Rick Greenwald, Ph.D.Institute of Child Health and Human Development (NICHD)Brain Injury Oxygen Toxicity of HBOT in Chronic Brain Injury Louisiana State University Health Paul G Harch, M.D.Sciences Center in New Orleans Brain Injury Progesterone Treatment of Blunt Traumatic Brain Injury Emory University Arthur L Kellermann,M.D., MPH Brain Injury Quantitative Automated Lesion Detection of Traumatic Brain Injury Department of Veterans Affairs David L. Woods, Ph.D.(QALD)Brain Injury Prospective Memory in Children With Traumatic Brain Injury Eunice Kennedy Shriver National Stephen R. McCauley,Institute of Child Health and Ph.D.Human Development (NICHD)Brain Injury Respiratory Mechanics in Brain Injured Patients Università degli Studi dell'Insubria Paolo Pelosi, M.D.Brain Injury PC-Based Cognitive Rehabilitation for Traumatic Brain Injury (TBI)Department of Veterans Affairs David L. Woods, Ph.D.Brain Injury Neuroendocrine Dysfunction in Traumatic Brain Injury: Correlation Denver Research Institute Margaret E Wierman,With Cognitive Dysfunction and Repair M.D.Brain Injury Neural Markers and Rehabilitation of Executive Functioning in University of North Carolina,Eric B. Elbogen, Ph.D.Veterans With Traumatic Brain Injury and Posttraumatic Stress Chapel Hill Disorder Brain Injury Restoration of Life Role Participation Through Integrated Cognitive Louis Stokes VA Medical Center Janis Daly, Ph.D., M.S.and Motor Training for Individuals With Traumatic Brain Injury (TBI)Brain Injury Rural Veterans With Post-traumatic Stress Disorder (PTSD) And Michael Debakey Veterans Affairs Mary R Newsome,Comorbid Mild Traumatic Brain Injury (TBI): A Feasibility Study Medical Center Ph.D.Brain Injury Fatigue, Sleep Disorders and Endocrine Abnormalities in TBI Kessler Foundation Anthony Lequerica,Patients Ph.D.Brain Injury Divalproex Sodium for Mood Swings and Alcohol Use Following Denver Research Institute Brandon Schmidt, MA Head Injury.Brain Injury Hypothermia in Children After Trauma Phoenix Children's Hospital P. David Adelson, M.D.Brain Injury Use of Biperiden for the Prevention of Post-traumatic Epilepsy Federal University of S?o Paulo Julieta G Silva Brain Injury Near Infrared Spectroscopy (NIRS) as Transfusion Indicator in Hospitales Universitarios Virgen Santiago R Leal-Noval,Neurocritical Patients del Rocío M.D., Ph.D.Brain Injury Cognitive REmediation After Trauma Exposure Trial = CREATE INTRuST, Post-Traumatic Stress Thomas W McAllister,Trial Disorder - Traumatic Brain Injury M.D.Clinical Consortium

Brain Injury Amantadine for Treatment of Symptoms of the Post-Traumatic Methodist Rehabilitation Center Stuart A Yablon, M.D.Confusional State Brain Injury Clinical Proteomic Research for the Brain (＂CPR Brain＂)Massachusetts General Hospital MingMing Ning, M.D.Brain Injury Structural and Functional Neuroimaging Studies of Combat National Institute of Neurological Patient Recruitment and Veterans Disorders and Stroke (NINDS)Public Liaison Office Brain Injury Development of Quality of Life Tool for TBI (TBI QOL)Department of Veterans Affairs Shirley Groer, Ph.D. MS Brain Injury Cerebral Hemodynamic Effects of Hypertonic Solutions in The University of Texas Health Roman Hlatky, M.D.Severely Head-Injured Patients Science Center at San Antonio Brain Injury Clinical Proteomic Research for the Brain (CPR)Massachusetts General Hospital MingMing Ning, M.D.Brain Injury Executive Dysfunction and Suicide in Psychiatric Outpatients and Department of Veterans Affairs Lisa Anne Brenner,Inpatients Ph.D.Brain Injury Treatment of Post-TBI Depression Mount Sinai School of Medicine Wayne Gordon, Ph.D.Brain Injury Assess the Safety and Efficacy of a Seizure Mayfield Clinic & Spine Institute Lori Shutter, M.D.Medication,Levetiracetam(LEV;Keppra),in Neuroscience Intensive Care Unit Patients Brain Injury The Effects of Explosive Blast as Compared to Post-Traumatic Minnesota Veterans Research Scott R Sponheim,Stress Disorder on Brain Function and Structure Institute Ph.D.Brain Injury Observational Study of Cortical Spreading Depression in Human University of Cincinnati Jed A. Hartings, Ph.D.Brain Trauma (COSBID-TBI)Brain Injury The Effect of Transcranial Magnetic Stimulation on Learning With National Institute of Neurological Patient Recruitment and Reward in Healthy Humans Disorders and Stroke (NINDS)Public Liaison Office Brain Injury The Use of Tissue Oxygen Monitoring in Critically Injured Patients University of California, San Geoffrey T Manley,Francisco M.D., Ph.D.Brain Injury Posttraumatic Hypopituitarism - Incidence, Predictors and Rigshospitalet, Denmark Ulla Feldt-Rasmussen,Testvalidity M.D.Brain Injury Effects of Aerobic Exercise on Cognition, Mood and Fatigue Mount Sinai School of Medicine Wayne Gordon, Ph.D.Following TBI Brain Injury Hypertonic Saline vs. Mannitol for Elevated Intercranial Pressure University of Cincinnati Lori Shutter, M.D.Brain Injury A Pilot Study of NSICU Assessment of Seizure Prophylaxis With University of Cincinnati Jerzy P Szaflarski,Lacosamide M.D., Ph.D.Brain Injury Intrathecal Baclofen Therapy and Paroxysmal Dysautonomia in University Hospital, Bordeaux Emmanuel Cuny,Severe Brain-Injured Patients Professor Brain Injury Risk Factors of Minor Head Injury Medical University of Vienna Wolfgang Machold,M.D.Brain Injury CONcussion Treatment After Combat Trauma (CONTACT)INTRuST, Post-Traumatic Stress Kathleen R Bell, M.D.Disorder - Traumatic Brain Injury Clinical Consortium Brain Injury Anaesthesia With Propofol Versus Midazolam: Effect on Oxidative Rennes University Hospital Yannick Mallédant,Stress in the Brain of Head Trauma Patients (PROMIS)M.D., Ph.D.Brain Injury Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients University of California, Irvine Joseph C Wu, M.D.

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