B4 Clinic Research Study: Mobilizing Evidence into Action to Improve Outcomes of Vulnerable Seniors
Who is the principal investigator for this study?
Dr. Maureen Ashe
Additional Information: Inclusion Criteria
We will include men and women aged 65 years+ who are community-dwelling residents of Metro Vancouver with a recent history (within 12 months) of hip fracture.
Additional Information: Exclusion Criteria
We will exclude seniors who prior to the fracture were: unable to walk 10 metres (with or without mobility aid); diagnosed with any type of dementia (Alzheimer's, vascular, etc.); and/or were discharged to a residential care facility following the hip fracture repair.
Additional Information: Study Participation
Time commitment required (e.g., # visits,) : one year follow-up from time of enrolment, 3 measurement sessions of 1.5 hours in length (beginning, middle, and end of study) plus monthly telephone calls (15-30 minutes). The intervention group will be asked to attend a B4 Clinic assessment for 1-2 hours and outpatient physiotherapy as determined by a geriatrician.
Strategies to improve function and recovery after spinal cord injury
Who is the principal investigator for this study?
Dr. Tania Lam
Additional Information: Inclusion Criteria
Individuals with motor-incomplete SCI (>12 months post-injury) due to non-progressive lesion with controlled spasticity and no previous musculoskeletal or neurological disease affecting their balance or mobility.
Two age-matched groups of able-bodied control subjects with no previous musculoskeletal or neurological disease affecting their balance or mobility.
Additional Information: Exclusion Criteria
medical condition that precludes exercise
weight is >300 lbs or height is >6'1"
under 19 years of age
Additional Information: Study Participation
Time commitment required (e.g., # visits,): 4 or 6 visits, each 1.5 - 2 hours
A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events with Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients with History of Myocardial Infarction (PEGASUS)
Who is the principal investigator for this study?
Dr. J. Saw
Additional Information: Inclusion Criteria
Eligible participants will also be either older than 65, diabetic, have a previous history of MI, have confirmed multi-vessel coronary artery disease, or chronic non-end stage renal dysfunction.
Additional Information: Exclusion Criteria
Any history of stroke or intracranial bleeding, recent surgery, gastric bleeding within the last 6 months, spinal surgery within the last 5 years.
Additional Information: Study Participation
Time commitment required (e.g., # visits,): 10-15 hours over four years for visits which occur every 4-6 months.
Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active Control Study to determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) vs. Avonex(r) (Interferon β-1a) in Patients with Relapsing-Remitting Multiple Sclerosis
Who is the principal investigator for this study?
Dr. Anthony Traboulsee
Additional Information: Inclusion Criteria
Must be 18 to 55 years of age, inclusive, at the time of consent
Must have a confirmed diagnosis of Relapsing Remitting MS (RRMS) and a cranial MRI demonstrating lesion(s) consistent with MS
Must have a baseline EDSS between 0.0 and 5.0, inclusive
Male subject and female subjects of childbearing potential must be willing and able to continue contraception for 4 months after their last dose of study treatment
Additional Information: Exclusion Criteria
Known intolerance, contraindication to, or history of non compliance with Avonex 30 mcg
History of treatment with DAC-HYP
History of malignancy
History of severe allergic or anaphylactic reactions
Known hypersensitivity to study drugs or their excipients
History of abnormal laboratory results indicative of any significant disease
An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization
Additional exclusion criteria are listed in the study Information and Informed Consent Form.
Questionnaires, a bone density scan, height, weight, waist circumference and blood and urine samples will be taken. A nutritional supplement N-Acetyl Cycteine (NAC) in the form of a pill will be taken daily for the second 3 months of the study.
Who can I contact for more information?
Name: Sarah Charlesworth
Telephone: 604-875-5232
e-mail: (not registered with ClinicalTrials.gov)
Study Title:
Fathers with Arthritis
Who is the principal investigator for this study?
Dr. Catherine Backman
Additional Information: Inclusion Criteria
N/A
Additional Information: Exclusion Criteria
N/A
Additional Information: Study Participation
Questionnaire to be completed at home and mailed in
Who can I contact for more information?
Name:
Dr. Catherine Backman & Alana Longson
Telephone:
604.871.4564 or 604.822.7409
e-mail:
or
Study Title:
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled trial of Ustekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis and Previously Treated with Biologic Anti-TNFα Agent(s) (CNTO1275PsA3002)
Who is the principal investigator for this study?
Dr. Jan Dutz
Additional Information: Exclusion Criteria
Subjects with rheumatoid arthritis, ankylosing spondylitis, lupus, or Lyme disease
Additional Information: Study Participation
Time commitment required (eg., # of visits): Up to 12 visits. Visit times will vary between 1 and 3 hours, depending on the visit.
Tests involved (eg., quesionnaires, blood tests, etc.): Blood tests, chest x-ray, x-rays of the hands and feet, psoriatic arthritis evaluations, study drug injections, questionnaires.
Who can I contact for more information?
Name:
Study Co-ordinator
Telephone:
604.875.5296
e-mail:
Study Title:
The Use of a Home-based Walking Program to Treat Orthostatic Hypotension in Older Adults with Type 2 Diabetes
Who is the principal investigator for this study?
Dr. Kenneth Madden
Additional Information: Inclusion Criteria
Type 2 diabetes for at least 5 years treated with diet alone or oral agents
Nonsmoker for at least 5 years
Subjects must be sedentary
BMI between 24 and 35
All subjects will have a fasting glucose of <12 mM and a hemoglobin A1c < 8.5%
All subjects must have developed hypertension CDA guidelines (systolic greater than 130 or diastolic greater than 80)
Orthostatic hypotension defined as a decrease in systolic blood pressure of at least 20 mm Hg or diastolic blood pressure of at least 10 mm Hg within 3 minutes of assuming an upright posture on the initial screening visit as per current American Academy of Neurology guidelines.
Additional Information: Exclusion Criteria
Abnormalities on complete blood count, electrolytes or creatinine, on resting ECG, treadmill exercise stress test
Significant pulmonary, exercise-limiting orthopedic or neurological impairment
Evidence of valvular disease, exercise-induced syncope, angina, arrhythmias or peripheral vascular disease
Poor blood pressure control as defined as systolic blood pressure greater than or equal to 160 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg
Total cholesterol/HDL cholesterol greater than or equal to 5.0 or LDL cholesterol greater than or equal to 4.21 mmol/L
Peripheral neuropathy severe enough to cause discomfort (for safety reasons)
Overt diabetic nephropathy excluding subjects with a urine albumin to creatinine ratio of greater than 2.0 in men or 2.8 in women
On November 21st the Globe and Mail and CTV W5 featured the story of an experimental diagnostic and surgical procedure for Multiple Sclerosis called chronic cerebrospinal venous insufficiency (CCSVI). Multiple Sclerosis is the leading cause of disability in Canada. Over 60,000 Canadians are affected by this disease and many are now wondering about the validity of this research. Many of us in the MS clinical and research community watched this story with great interest, but also with some natural skepticism as we have seen similar claims of potential causes and cures in the past.
As MS clinicians and researchers at the University of British Columbia and Vancouver Coastal Health, our goal is to provide the best treatment that is safely available to our patients and to pursue research that could lead to improvements in their lives. With respect to the validity of CCSVI, the work recently published by Dr. Zamboni on the narrowing of the veins in the neck does suggest that this may be common in people with MS.
We had been aware of this story in the MS research community prior to the news report and had been developing plans in collaboration with radiology (including interventional vascular specialists) and physics experts at the University of British Columbia and Vancouver Coastal Health to try and confirm the findings independently using a variety of imaging techniques. We need to determine how common this abnormality is and how easily it can be detected with routine tests available throughout our region. With the support of the MS Society of Canada we will investigate this as rapidly as possible. However, all research activities must go through a careful process of review by the Clinical Research Ethics Board at UBC as well as Vancouver Coastal Health before anyone with MS can participate. This process can take several months.
The news report also discussed an experimental treatment for correcting the narrowing of the veins using a catheter (a tube that goes into a blood vessel with a balloon attached to it). The people who were interviewed expressed that they dramatically improved after they were treated, and it is their enthusiasm that has really caused much of the excitement about this treatment. We must urge caution when reading these results as we believe that this part of Dr. Zamboni's experiment is not well controlled. By this we mean that all patients in his study were treated with the procedure. There was no group of patients who acted as control or untreated subjects. The reason for designing a study with a control group is to avoid bias and the placebo effect. Therefore, we believe that it is important to test the validity of this experimental treatment within a well designed study that avoids the potential influence of bias. Dr. Zamboni also agrees with this approach. We hope to work with other MS centers within Canada and worldwide. This type of study takes many months to organize, fund, and get underway, but it is the safest and only way to move forward and determine independently the value of treating CCSVI.
Many questions remain unanswered. We hope the following list of questions and answers will help those of you with MS who want immediate information on this; however, some questions can only be answered with further testing, which we hope to get underway as soon as possible.
Frequently Asked Questions about CCSVI and MS
Q: Do these reports of a possible association between insufficient vein drainage and MS mean that MS is caused by venous insufficiency? A: No. Based on results published about these findings to date, there is not enough evidence to say that obstruction of veins causes MS, or to determine when this obstruction may occur in the course of disease.
Q: If CCSVI turns out to be important in MS, can it be treated?
A: No one knows yet. Dr. Zamboni's work suggests that not all patients benefit from the surgery, and for those that do, the benefit may only be short term. Surgical procedures for CCSVI in MS are still experimental and should be undertaken only as part of formal clinical trials that include all of the standard safeguards that are followed in such trials.
Q: I have MS. Should I be tested for signs of CCSVI? A: No, unless you are involved in a research study exploring this phenomenon. At this time there is no proven therapy to resolve any abnormalities that might be observed, and it is still not clear whether relieving venous obstructions would be beneficial. We are applying for funding from the MS Society of Canada to determine the most practical and reliable test for CCSVI. Patients interested in participating in these studies can leave their name and contact details with their neurologist or clinic.
Q: Should I get my veins tested at a private diagnostic facility? A: No. The validity of this testing is not proven as yet. Furthermore, treatment of any abnormality is experimental and would not occur at a hospital in Canada unless it was part of a study approved by the hospital and ethics committees.
Q: Can my MRI be checked for CCSVI? A: No. A routine MRI would not include the required detail of the veins to check for CCSVI.
Q: Does CCSVI make the standard treatments of MS meaningless? A: No. There is ample evidence proving that the Health Canada approved therapies for MS provide benefit for people with most forms of MS.
Q: Are other Canadian centres performing routine testing or surgery for CCSVI? A: No. The UBC MS Clinic is a member of the Canadian Network of MS Clinics. A consensus statement from this network recommends that further research is required to test Dr. Zamboni's findings. Discussions are underway through this network looking at the possibility of doing a Canada wide study.
Q: Will the MS Society of Canada fund research into CCSVI in MS? A: The MS Society welcomes research proposals from any qualified investigators whose research questions are relevant to multiple sclerosis. All proposals received are thoroughly evaluated for their relevance and excellence by our volunteer scientific peer review panels.
Q: How can I support this work? A: Funding to support this important research will be critical. Donations can be made through the MS Society of Canada (www.mssociety.ca), the VGH and UBC Hospital Foundation (www.worldclasshealthcare.ca), or the UBC Faculty of Medicine (www.med.ubc.ca/giving).
Anthony Traboulsee, MD
Assistant Professor (Medicine)
Medical Director, UBC MS Clinic and Clinical Trials Group
V. Devonshire, MD
S.A. Hashimoto, MD
J. Hooge, MD
L. Kastrukoff, MD
J. Oger, MD
Department of Medicine
Division of Neurology
S199, 2211 Wesbrook Mall
Vancouver, BC Canada V6T 2B5
Tel: 604-822-0788
Fax: 604-822-7703
Study Title:
Stone Centre Urine and Serum Bank
Who is the principal investigator for this study?
Dr. Ben H. Chew
Additional Information: Inclusion Criteria
CONTROLS
No history of kidney stone disease
STUDY (Stone Patient)
Radiological evidence indicating presence of a current renal or ureteric stone
Additional Information: Exclusion Criteria
Pregnancy
Positive Urine Culture
Active cancer
Recurrent urinary infections
Gross hematuria
Inability to provide informed consent
Investigator's refusal to include
CONTROLS ONLY
Family history of stones
History of stones
Additional Information: Study Participation
Time commitment required (eg, # visits)
if patients are not followed for their stone disease, or do not have stone disease and are in the control group, a total of no more than 30 minutes will be recuired of their time to collect blood and urine. The patients who are followed for their stone disease, collectons can be done on the day of one of their hospital visits.
