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NCT ID: NCT02240199 Completed - Clinical trials for Post-mastectomy Pain Syndrome

Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain

PLAN
Start date: November 2014
Phase: Phase 3
Study type: Interventional

Breast tissue and the areas surrounding the breast contain many small to medium-sized nerves. During surgery on the breast, these nerves can be inadvertently cut or damaged. Chemotherapy and radiotherapy after surgery worsen the injury experienced by these nerves. These nerves eventually become abnormal and provide pain signals to the brain well beyond the healing period after surgery. Patients with these abnormal nerves suffer from chronic pain in the breast area that persists for several years after surgery. Chronic pain is associated with a reduced quality of life, daily functioning, psychological distress, and contributes to excessive health care expenditures. There is encouraging data suggesting that an infusion of Lidocaine during surgery and Pregabalin given around the time of surgery can prevent the development of chronic pain after breast cancer surgery. A large randomized controlled trial is needed to determine the efficacy of these two interventions on reducing chronic pain after breast cancer surgery (e.g. within 3 months of surgery). A pilot trial is first needed to determine the feasibility of undertaking such a trial.

NCT ID: NCT02240095 Completed - Clinical trials for Medical and Nursing Students' Evidence Retrieval Skills

Increasing Medical and Nursing Students Searching of Current Best Evidence to Answer Clinical Questions

MPFS-2
Start date: September 2014
Phase: N/A
Study type: Interventional

Translation of new knowledge from research into evidence-informed health care is a shared obligation of the clinical and the scientific communities. Unfortunately, studies of quality of care continue to show that this goal is substantially unrealized. One main barrier is lack of quick and easy identification, appraisal and synthesis of current best evidence. This start with medical and nursing students, which have numerous clinical-related questions daily, but face a large volume of 3000 articles published every day, accessible in many scattered resources. To address theses problems, McMaster's Health Information Research Unit (Hamilton, Ontario, Canada) has developed and implemented "McMaster Premium LiteratUre Service Federated Search" (MPFS), an online search engine that provides a unique 1-stop search and organized access to current best evidence in daily practice. However additional barriers need to be overcome for students to actually search and use this evidence in their learning and practice. Theses include logistical barriers (time constraints, forgotten questions), as well as educational barriers (eg, lack of awareness of the "architecture" of evidence, limited searching skills, and lack of reference standards among peers for finding best evidence). In a previous trial, the investigators tested 3 innovative online interventions among clinicians registered to MPFS to overcome these barriers and increase the quantity and quality of searching for current best evidence to answer clinical questions (NCT02038439). The investigators seek to conduct a second randomized trial testing the same 3 interventions, this time among medical and nursing students registered in MPFS.

NCT ID: NCT02240030 Completed - Clinical trials for Idiopathic Parkinson's Disease

Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes

SPAN-PD™
Start date: November 2014
Phase: Phase 3
Study type: Interventional

This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic. Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.

NCT ID: NCT02239601 Completed - Breast Cancer Clinical Trials

Chemotherapy Induced Peripheral Neuropathy. Could Physical Therapy Help Treat Symptoms?

Start date: December 1, 2014
Phase: N/A
Study type: Interventional

The cause of Chemotherapy-Induced Peripheral Neuropathy (CIPN) is still unknown. An estimated 55-60% of patients will experience lasting symptoms affecting function for years post-treatment. Physical therapy is an established, effective treatment for entrapped nerves and neuropathic pain. This study sought to identify additional risk factors and provide evidence for the role of physical therapy in the treatment of CIPN.

NCT ID: NCT02239393 Completed - Multiple Sclerosis Clinical Trials

Safety and Efficacy of Intravenous Autologous Mesenchymal Stem Cells for MS: a Phase 2 Proof of Concept Study

MESCAMS
Start date: June 2015
Phase: Phase 2
Study type: Interventional

The mechanism of action of MSC relies on their ability to modulate pathogenic immune responses and provide neuroprotection through the release of anti-apoptotic, anti-oxidant and trophic factors as demonstrated by in-vitro and in-vivo preclinical studies. Patients will be randomized to receive immediate vs. delayed treatment with either a dose equal to 1-2 millions/kg of body weight of autologous MSC, or equivalent volume of suspension media at baseline. At week 24 treatments will be reversed. The primary outcome of this study is to evaluate: - Treatment's safety within one year from MSC administration by measuring the number, time-frame and severity of adverse events and - Treatment's activity in terms of reduction in total number of gadolinium-enhancing lesions (GEL) by magnetic resonance imaging (MRI) scans. Secondary outcomes are to gain preliminary information on the efficacy of the experimental treatment in terms of combined MRI activity and clinical efficacy (incidence of relapses and disability progression).

NCT ID: NCT02239341 Completed - High-Risk Pregnancy Clinical Trials

Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.

Start date: October 30, 2014
Phase: N/A
Study type: Interventional

The current standard of care for pregnant women deemed to be high-risk often involves recommending varying levels of activity-restriction, up to and including hospitalization. High levels of activity-restriction can lead to physical deconditioning of the mother, which can be difficult to recover from after birth. The proposed study will investigate whether a mild muscular conditioning program conducted in bed and given to hospitalized activity-restricted high-risk pregnant women will improve functional ability, cardiovascular deconditioning and overall quality of life in the postpartum period compared to a control group with no in hospital bed-rest exercise program. We hypothesize that women with a in-hospital muscle conditioning program will be better able to perform functional ability tasks and activities of daily living than a control group with no exercise program.

NCT ID: NCT02239289 Completed - Clinical trials for Chronic Low Back Pain

Use of Biofeedback Training to Correct Abnormal Neuromechanical Pattern in Chronic Low Back Pain Patients

Start date: March 2014
Phase: N/A
Study type: Interventional

The purpose of the present study is to evaluate the benefit of biofeedback training on the capacity of chronic low back pain patients to decrease their lumbar paraspinal muscles activity during trunk full flexion and its relationship with changes in clinical outcomes. To do so, twenty patients with nonspecific mechanical low back pain will be recruited and all participants will take part in four sessions of supervised biofeedback training, consisting of 5 blocks with at least 12 trunk flexion-extension tasks. It is hypothesized that participants will have improved neuromechanical parameters with the biofeedback training and that this improvement will be positively associated to changes in clinical outcomes. This study will also allow for generation of preliminary data, in order to plan for a larger randomized control trial.

NCT ID: NCT02239146 Completed - Clinical trials for Acquired Bleeding Disorder

Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass

Start date: October 2005
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial revascularization requiring cardiopulmonary bypass (CPB).

NCT ID: NCT02239120 Completed - Stroke Clinical Trials

Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)

Start date: November 27, 2014
Phase: Phase 3
Study type: Interventional

This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).

NCT ID: NCT02238847 Completed - Pancreatic Cancer Clinical Trials

Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy

Start date: March 24, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.