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ResearchMatch

ResearchMatch has a simple goal – to bring together two groups of people who are looking for one another: (1) people who are trying to find research studies, and (2) researchers who are looking for people to participate in their studies. It is a free and secure registry that has been developed by major academic institutions across the country who want to involve you in the mission of helping today’s studies make a real difference for everyone’s health in the future.

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How do Personality Traits Effect Adjustment to Stroke?

What is the study about?
I am researching how personality traits affect people’s adjustment to having had a stroke.

After having a stroke some people do well but others get very depressed. So far research into why this happens hasn’t found exactly why this is. In people who have not had a stroke particular personality traits have been associated with depression. For example, having high standards for yourself and being critical of yourself have been linked to becoming depressed. I would like to find out how these personality traits influence how a person adjusts to life after a stroke.

I hope that by carrying out this research, we will find out more about how people adjust to the change. We may be able to understand post-stroke mood difficulties better. A greater understanding will hopefully help professionals help people who have had a stroke.

Research being conducted by:
Leah Bousie
Trainee Clinical Psychologist
Department of Psychology
University of Surrey
Guildford
GU2 7XH
EMAIL: l.bousie@surrey.ac.uk

Original posting: University of Surrey .

1. WHAT ARE CLINICAL TRIALS AND WHY DO PEOPLE PARTICIPATE?

Clinical are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.

People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.

2. WHAT IS CLINICAL RESEARCH?

Clinical research is medical research that involves people like you. People volunteer to participate in carefully conducted investigations that ultimately uncover better ways to treat, prevent, diagnose, and understand human disease. Clinical research includes trials that test new treatments and therapies as well as long–term natural history studies, which provide valuable information about how disease and health progress.

The idea for a clinical research study—also known as a clinical trial—often originates in the laboratory. After researchers test new therapies or procedures in the laboratory and in animal studies, the most promising experimental treatments are moved into clinical trials, which are conducted in phases. During a trial, more information is gained about an experimental treatment, its risks, and its effectiveness.

The protocol of Clinical research is conducted according to a plan known as a protocol. The protocol is carefully designed to safeguard the participants’ health and answer specific research questions. A protocol describes the following:

Who is eligible to participate in the trial
Details about tests, procedures, medications, and dosages
The length of the study and what information will be gathered
A clinical study is led by a principal investigator (PI), who is often a doctor. Members of the research team regularly monitor the participants’ health to determine the study’s safety and effectiveness.

Protocol review: Each clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are minimal and are worth any potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected. Federal regulation requires all institutions in the United States that conduct or support biomedical research involving people to have an IRB initially approve and periodically review the research.

3. WHO PARTICIPATES IN CLINICAL TRIALS?

Many different types of people participate in clinical trials. Some are healthy, while others may have illnesses. A healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention. Research procedures with healthy volunteers are designed to develop new knowledge, not to provide direct benefit to study participants. Healthy volunteers have always played an important role in research.

Healthy volunteers are needed for several reasons. When developing a new technique, such as a blood test or imaging device, healthy volunteers (formerly called “normal volunteers”) help define the limits of “normal.” These volunteers serve as controls for patient groups and are often matched to patients on characteristics such as age, gender, or family relationship. They receive the same test, procedure, or drug the patient group receives. Investigators learn about the disease process by comparing the patient group to the healthy volunteers.

Factors like how much of your time is needed, discomfort you may feel, or risk involved depends on the trial. While some require minimal amounts of time and effort, other studies may require a major commitment in time and effort on behalf of the volunteer, and may involve some discomfort. The research procedure may also carry some risk. The consent process for healthy volunteers includes a detailed discussion of the study’s procedures and tests.

A patient volunteer has a known health problem and participates in research to better understand, diagnose, treat, or cure that disease or condition. Research procedures with a patient volunteer help develop new knowledge. These procedures may or may not benefit the study participants.

Patient volunteers may be involved in studies similar to those in which healthy volunteers participate. These studies involve drugs, devices, or interventions designed to prevent, treat, or cure disease. Although these studies may provide direct benefit to patient volunteers, the main aim is to prove, by scientific means, the effects and limitations of the experimental treatment. Consequently, some patients serve as controls by not taking the test drug, or by receiving test doses of the drug large enough only to show that it is present, but not at a level that can treat the condition. A study’s benefits may be indirect for the volunteers but may help others.

All clinical trials have guidelines about who can participate, called Inclusion/Exclusion Criteria. Factors that allow someone to participate in a clinical trial are “inclusion criteria.” Those that exclude or not allow participation are “exclusion criteria.” These criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers.

Some studies need both types. Inclusion and exclusion criteria are not used to reject people personally; rather, the criteria are used to identify appropriate participants and keep them safe, and to help ensure that researchers can find new information they need.

Read more on NIH Clinical Trials.

Continued research into the diagnosis, causes and treatment of aphasia and related disorders is conducted by the Harold Goodglass Aphasia Research Center (located at the Boston V.A.Medical Center), Boston University School of Medicine. The contribution of aphasic patients serving as subjects in this research is invaluable, as without them this work would not be possible.

If you have impaired speech or language due to a stroke or other event affecting neurological functioning, your participation in this research would be welcomed. Various aspects of language and thinking ability are tested, and patients typically find testing interesting and informative. Testing could be done at your home if that would be easiest for you.

As a basis for understanding changes in speech and language functions that occur after brain injury, it is important to understand language functioning in normal adults. Thus, the HaroldGoodglass Aphasia Research Center also welcomes normally functioning (non brain injured) adults for participation in our research programs.

If you would like to become a test subject, or would like additional information, you may call 857-364- 4774, or send e-mail to aphasia@bu.edu. .

Augmenting Language Therapy for Aphasia: A Randomized Double-Blind Placebo-Controlled Trial of Levodopa in Combination with Speech-Language Therapy.

Objective
There is preliminary evidence that increased levels of dopamine may improve learning following stroke. This study
evaluates whether a pharmacologic agent, levodopa, can help increase the amount of improvement that may be achieved during speech and language therapy for individuals with non-fluent aphasia. The speech-language treatment is done on a computer program that allows individuals with aphasia to practice reading aloud sentences together with an animated “therapist” on the computer.

Principal Investigator(s): Leora Cherney

Sponsor(s): The National Institute on Disability and Rehabilitation Research (NIDRR)
Contact: Center for Aphasia Research at 312-238-6163

How to Participate: Individuals with non-fluent aphasia following a stroke
Must be at least 6 months since stroke onset

Location
Rehabilitation Institute of Chicago (RIC)
345 East Superior Street
Chicago, IL 60611
Main: 312-238-1000

Get more information by clicking on RIC.

RESEARCH STUDIES & CLINICAL TRIALS
Research is an essential part of the Rehabilitation Institute of Chicago’s (RIC) mission: to help people with disabilities gain as independent and fulfilling lives as possible. Every day, research at RIC is taking place, providing practical solutions for today and the promise of hope for tomorrow. We invite you to explore the active research projects underway at RIC for aphasia .

Research at uPENN

Has a stroke left you or a loved one speechless?

Aphasia is a condition characterized by impairment of the ability to communicate, and occurs frequently after stroke.

Please contact University of Pennsylvania to see what research studies are ongoing. Click on UPENN Research.

The Internet Stroke Center

The Internet Stroke Center exists to advance understanding of stroke research and clinical care. Their goal is to provide current, professional, un-biased information about stroke. The information on this site is obtained from published accounts, meeting presentations, internet searches, and direct correspondence.

To view their site and see what research programs are going on, click on Stroke Center and search for “aphasia”.

The purpose of this study is to evaluate the effectiveness of small amounts of electrical current, applied without surgery to the brain, in combination with speech-language treatment, on the language outcome of study subjects with nonfluent aphasia (i.e. difficulty with the comprehension and expression of spoken and written language) following a stroke. Find out more.
Contact: Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486654

Contacts
Contact: Leora R Cherney, Ph.D. 312-238-1117 lcherney@ric.org

RECRUITING: CLINICAL TRIAL

H. Lundbeck A/S, a Danish pharmaceutical company, is conducting two phase III trials of desmoteplase, a new thrombolytic for treating acute ischemic stroke.

Desmoteplase is intended to be injected within three to nine hours after the onset of ischemic stroke symptoms.

The trial is ongoing in more than 200 sites worldwide, including more than 72 sites across the U.S. The 2 trials will enroll a total of 880 patients (worldwide) between the ages of 18 and 85.

Desmoteplase is being studied in two clinical trials named DIAS-3 and DIAS-4 (Desmoteplase in Acute Ischemic Stroke). In the program conducted so far, the safety of desmoteplase was investigated in the Dose Escalation of Desmoteplase for Acute Ischaemic Stroke (DEDAS) and Desmoteplase in Acute Ischaemic Stroke (DIAS) Phase II trials and the DIAS-2 Phase III trial. DIAS-3 and DIAS-4 are aimed at examining the efficacy of the treatment in patients with ischemic stroke with an occlusion or severe stenosis in the affected cerebral blood vessel.

In 2009, DIAS-3 and DIAS-4 were started, and the results of these trials will determine whether desmoteplase will gain marketing authorization as a safe and effective treatment for patients with AIS. Patient inclusion in DIAS-3 is mainly focused in Asia and Europe; while in DIAS-4 most sites are located in the U.S., with six more sites in process of being activated. Patient safety is continuously monitored.

The important milestone of enrolling more than 50 percent of the required number of patients in DIAS-3 was passed at the end of 2011.

For study locations and inclusion/exclusion criteria, visit the trial registration page (NCT00856661) at www.clinicaltrials.gov .

To get more information on this trial, please email LundbeckClinicalTrials@lundbeck.com.