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NCT ID: NCT01654445 Completed - Ischemic Stroke Clinical Trials

TNK-tPA Evaluation for Minor Ischemic Stroke With Proven Occlusion

TEMPO-1
Start date: July 2012
Phase: Phase 2
Study type: Interventional

This trial will enroll patients that have been diagnosed with a transient ischemic attack (TIA) or minor stroke that has occurred within the past 12 hours. Anyone diagnosed with a minor stroke faces the possibility of long-term disability and even death, regardless of treatment. Stroke symptoms such as weakness, difficulty speaking and paralysis may improve or worsen over the hours or days immediately following a stroke. The purpose of this research trial is to study the effects of a clot-dissolving drug, tenecteplase (TNK-tPA), as a treatment for patients who arrive within twelve hours from stroke onset. This study is attempting to see if TNK-tPA given through a vein in the arm (intravenous) to patients is a safe treatment for stroke patients. Neither the safety nor the effectiveness of this treatment has been proven yet. This trial will be conducted at several site in Canada. Dr Michael Hill and Dr. Shelagh Coutts are the Principal Investigators of this trial, coordinated at the University of Calgary, Foothills Medical Centre.

NCT ID: NCT01654029 Completed - Stroke Clinical Trials

Patient Centred Communication Intervention

PCCI
Start date: September 2010
Phase: N/A
Study type: Interventional

The most frequent consequence of a stroke is a communication impairment. When patients cannot articulate their needs, frustration and agitation are frequent responses, often resulting in poor optimization of post-stroke function. Staff's lack of knowledge of communication strategies exacerbates the problem. A key component of patient-centred care is the ability of staff to communicate in such a way that allows them to understand the patient's needs. Members of our team developed the patient-centred communication intervention (PCCI) targeting registered and unregulated staff caring for complex continuing care (CCC) patients with communication impairments post stroke. The purpose of the study is to examine if the PCCI results in improved patients' quality of life and in improved staff attitudes and skills in caring for patients with communication impairments.

NCT ID: NCT01653899 Completed - Diabetes Clinical Trials

Caspase Inhibition in Islet Transplantation

Start date: June 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This is an Investigator Initiated, Phase I/II study, where Type 1 diabetic participants will receive a 14 day oral treatment of the investigational caspase inhibitor drug IDN-6556 following their first islet transplant. Two pilot studies are proposed to establish the optimal safety and efficacy dose of IDN-6556 (25 mg twice daily (Pilot 1) or a loading dose of 100 mg two hours prior to transplantation, then two 50 mg doses following transplant (Day 0) (Pilot 2). This will be followed by 50 mg three times daily). Participants of both pilot studies will receive islet cell transplants under the University of Alberta's standard-of-care therapy. Secondary objectives include: 1. To determine the proportion of subjects treated with IDN-6556 who achieve and maintain insulin independence after the first or subsequent islet transplant. 2. To obtain preliminary data on the efficacy of IDN-6556 to maintain adequate immunological protection against both allo- and autoimmunity of islet transplant recipients.

NCT ID: NCT01653730 Completed - Pulmonary Fibrosis Clinical Trials

Comparative Study of 3 Portable Oxygen Concentrators During a 6-minute Walk Test in Patients With Chronic Lung Disease

Start date: February 2010
Phase: N/A
Study type: Interventional

Background: Portable oxygen concentrators (POCs) featuring the latest integrated oxygen conserving devices (OCDs) provide greater patient accessibility and mobility during ambulation and travel. Recent POCs are compact, lightweight, battery-operated, and require no refill-time, thus meeting patients' clinical and lifestyle needs. There is, however, a lack of research on the clinical performance of the latest POCs that could help to determine their ability to maintain patients' oxygen saturations ≥ 90 % during exercise. Aim: The purpose of this study is to compare the ability of three POCs, with maximum oxygen production capabilities of 950 to 3000 ml per minute, to maintain oxygen saturations ≥ 90 % in patients with chronic lung disease during exercise. Method: Six minute walk tests (6-MWTs) will be administered in order to measure oxygen saturations by pulse oximetry (SpO2) in up to 20 patients with a diagnosis of either Chronic Obstructive Pulmonary Disease (COPD), or Pulmonary Fibrosis (PF) with documented exertional oxygen desaturations of ≤ 85% on room air. All participants will participate in 4 different 6-minute walk tests: the first will be a control walk performed with the participants' current oxygen system set at their prescribed exertional flow rate. Then, the participants will perform a walk test with each of the three POCs set at the units' maximum pulse dose setting. The order in which the participants use the POCs will be randomly assigned using a sequence generator. Hypothesis: It is hypothesized that all three POCs will provide oxygen saturations ≥ 90 % during exercise in patients with chronic lung disease with moderate to severe exertional oxygen desaturation.

NCT ID: NCT01653704 Completed - Clinical trials for Focus of Study is Teaching Crisis Resource Management

Learning Crisis Resource Management: Practicing Versus Observational Role in Simulation Training

Start date: March 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effectiveness in learning crisis resource management (CRM) principles when being an active participant in simulation-based education versus being an observer participant. The investigators hypothesize that active participants will improve their CRM skills more than observer participants.

NCT ID: NCT01653470 Completed - Cancer Clinical Trials

Study to Evaluate Safety & Tolerability of BMS-906024 in Combination With Chemotherapy & to Define DLTs & MTD of BMS-906024 in Combination With One of the Following Chemotherapy Regimens; Weekly Paclitaxel, 5FU+Irinotecan or Carboplatin+Paclitaxel in Subjects With Advanced / Metastatic Solid Tumors

Start date: October 12, 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in combination with each of the following three chemotherapy regimens: Paclitaxel, 5FU plus Irinotecan (FOLFIRI), or Carboplatin plus Paclitaxel in subjects with advanced or metastatic solid tumors

NCT ID: NCT01653015 Completed - Influenza Clinical Trials

Live Versus Inactivated Influenza Vaccine Study in Hutterite Children

Start date: November 2012
Phase: Phase 4
Study type: Interventional

There is uncertainty about whether a live attenuated vaccine (LAIV) offers additional benefit over inactivated trivalent influenza vaccine (TIV) in providing indirect benefit to those who are unvaccinated through herd immunity. The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with LAIV can provide increased community-wide protection over TIV. Children aged 3 to 15 years in Hutterite colonies from Alberta and Saskatchewan will be randomized to one of two regimens: TIV or LAIV. The primary outcome of this study will be laboratory-confirmed influenza as detected by PCR in all participants (i.e vaccine recipients and nonrecipients). Secondary outcomes will include influenza-like illness, hospitalization, pneumonia, death, antibiotic use, absenteeism.

NCT ID: NCT01652144 Completed - Clinical trials for Mantle Cell Lymphoma

A Phase II Study of AT7519M, a CDK Inhibitor, in Patients With Relapsed Mantle Cell Lymphoma

Start date: September 14, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out what effects a new drug AT7519M has on mantle cell lymphoma.

NCT ID: NCT01651780 Completed - Clinical trials for Aortic Valve Insufficiency

Open-label, Randomized Trial in Patients Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH

BRAVO-2/3
Start date: October 2012
Phase: Phase 3
Study type: Interventional

This is an international, multicenter, open-label, randomized controlled trial. All patients undergoing transfemoral TAVR at the participating centers will be eligible. All sites will initiate enrolment with 2 feasibility roll-in bivalirudin treated patients and thereafter patients will be randomly assigned to either standard dosing of bivalirudin or UFH as control. The 2 roll-in cases per site will constitute the feasibility cohort that will be followed and analyzed separately. Patients will undergo TAVR according to current standard of care practices at the treating centers. Use of antiplatelet agents pre, during, and post procedure, and possibly oral anticoagulants post procedure, will be according to the sites' standard practice. ALL available data will be collected in the eCRF prospectively

NCT ID: NCT01651442 Completed - Primary Insomnia Clinical Trials

Sequenced Therapies for Comorbid and Primary Insomnias

Start date: August 1, 2012
Phase: N/A
Study type: Interventional

Chronic insomnia is a prevalent disorder associated with increased health care costs, impaired functioning, and an increased risk for developing serious psychiatric disorders. Cognitive-behavioral therapies (CBTs) and benzodiazepine receptor agonist (BzRA) medications are the most widely supported approaches for insomnia management. Unfortunately, few studies have compared the psychological/behavioral therapies and BzRAs for insomnia treatment. Moreover, insomnia treatment studies have been limited by small, highly screened study samples, fixed-dose and fixed-agent pharmacotherapy strategies that do not represent usual adjustable dosing practices, relatively short follow-up intervals, and reliance on self-report or polysomnographic (PSG) sleep parameters as outcomes, rather than on more clinically relevant indicators of remission. Finally, studies have yet to test the benefits of treatment sequencing for those who do not respond to initial their insomnia therapy. This multi-site project will address these limitations. Two study sites will enroll a total of 224 participants who meet broad criteria for a chronic insomnia disorder, and a sizeable portion (60%) of this sample will have insomnia occurring comorbid to a psychiatric disorder. Participants will be evaluated with clinical assessments and PSG, and then will be randomly assigned to first-stage therapy with an easy-to-administer behavioral insomnia therapy (BT) or zolpidem (most widely prescribed BzRA). Centrally trained therapists will administer therapies according to manualized, albeit flexible, treatment algorithms. Initial outcomes will be assessed after 6 weeks, and treatment remitters will be followed for the next 12 months on maintenance therapy. Those not achieving remission will be offered re-randomization to a second, 6-week treatment involving pharmacotherapy (zolpidem or trazodone) or psychological therapy (BT or cognitive therapy-CT). All participants will be re-evaluated 12 weeks after protocol initiation, and at 3-, 6-, 9-, and 12-month follow-ups while continuing their final treatment. Insomnia remission, defined categorically as a score < 8 on the Insomnia Severity Index, will serve as the primary outcome for treatment comparisons. Secondary outcomes will include sleep diary and PSG sleep measures; subjective ratings of sleep and daytime function; adverse events; dropout rates; and treatment acceptability. Our over-arching goal is to obtain new information that aids in the development of clinical guidelines for managing insomnia sufferers with and without comorbid psychiatric conditions.