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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Vohra, Sunita;

    Study Objective: To determine if a pediatric integrative medicine (PIM) service is effective in reducing overall symptoms of pain, nausea/vomiting, and/or anxiety (PNVA), length of stay, and costs, in hospitalized children when compared to conventional care. In this context, "integrative" refers to a combined approach of complementary and conventional medical therapies in an evidence-based fashion. Design: cluster trial; 2-arm controlled evaluation study in pediatric oncology, general pediatrics and pediatric cardiology. Intervention will be offered during a 6-month PIM period following a 6 month control period. Population: Inclusion criteria: (i) In-patients in participating division and (ii) informed consent/assent. Exclusion criteria: (i) lack of parent participation, fluency in English, or informed consent Intervention: Recommendations for specific CAM therapies will be determined by a staff PIM pediatrician. Any combination of the following CAM therapies (dose, duration, amount to be based on patient need as assessed by CAM provider, patient, and parent): acupuncture/acupressure, massage, Reiki; all are to be offered in addition to usual care. Control: Usual care. Outcomes: Primary outcome: feasibility (i.e enrollment); Secondary outcomes: (i) PNVA symptom management, (ii) need for conventional pharmacotherapy, (iii) adverse events; (iv) parent and health care provider satisfaction with care provided, v) length of stay; and vi) cost-effectiveness (analysis of this outcome to be limited to patients admitted for at least 2 days and for not more than 30 days). Significance: To our knowledge, this study will be the first comparative effectiveness trial to assess the impact of PIM for hospitalized children with cancer. This study will investigate if adding complementary therapies such as acupuncture, massage and reiki to inpatient pediatric care is feasible and what the effects are on outcomes such as patient symptoms, cost, safety, satisfaction and length of stay.

    image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/ Federated Research D...arrow_drop_down
    image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    OpenTrials
    Clinical Trial . 2013
    Data sources: OpenTrials
    Borealis
    Dataset . 2016
    Data sources: Datacite
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      image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/ Federated Research D...arrow_drop_down
      image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
      image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
      OpenTrials
      Clinical Trial . 2013
      Data sources: OpenTrials
      Borealis
      Dataset . 2016
      Data sources: Datacite
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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Ball, Geoff;

    Portion size measurement aids (PSMAs) are tools that facilitate the estimation of food servings. The objectives of this study are to determine (a) if food portion size estimation accuracy differs when using a two dimensional (2D) PSMA (actual-size photos called Portion Size Cards) compared to a 3D PSMA (Portion Size Kit) and (b) whether differences exist in the short-term usefulness of and satisfaction with these PSMAs in a sample of parents of overweight children and youth. We hypothesize that the group that receives the 3D PSMAs will be more accurate in food portion size estimation and will be more satisfied with the tool compared to the group that receives the 2D PSMAs. Forty primary caregivers of overweight children and youth attending the Pediatric Centre for Weight and Health (Edmonton, AB) will be recruited. Participants will be randomly assigned to one of the two groups (2D PSMAs versus 3D PSMAs). After a brief explanation of the respective tool, participants will estimate the volumes of pre-measured rubber food portion models on a test plate. Participants will then be given the 2D or 3D PSMAs to take home with them to use in the real-world. After 2-4 weeks, participants will be telephoned by the research team to complete a brief survey to evaluate their usefulness of and satisfaction with the 2D or 3D PSMAs at home.

    image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/ OpenTrialsarrow_drop_down
    image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    OpenTrials
    Clinical Trial . 2010
    Data sources: OpenTrials
    image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Borealis
    Dataset . 2016
    Data sources: Datacite
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      image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/ OpenTrialsarrow_drop_down
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      OpenTrials
      Clinical Trial . 2010
      Data sources: OpenTrials
      image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
      Borealis
      Dataset . 2016
      Data sources: Datacite
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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Vohra, Sunita;

    This study will be a 2 arm controlled clinical trial (CCT) comparing usual care to usual care plus MBSR. Participants will be residents of a local inpatient treatment facility for adolescents with serious mental health issues. Outcomes the investigators will measure include mental health status as well as mindfulness. The investigators will also conduct qualitative interviews to assess the personal impact of the intervention on the patients and their families. In order to map and measure cognitive changes during MBSR the investigators will conduct brain imaging using functional magnetic resonance imaging (fMRI) and Event-Related Potential (ERP) recordings. Through this study the investigators will determine if MBSR is helpful to our population. Mindfulness-based stress reduction (MBSR) is a group program in which participants are taught to be mindful or present-focused. MBSR programs consist of instruction in a variety of mindfulness meditations including body scan, sitting meditation, mindful yoga, and discussion of these practices. Our study purpose is to develop and conduct a pilot mixed-methods randomized controlled trial (RCT), combining clinical outcomes, qualitative interviews, and brain imaging to assess the impact of the intervention on children with mental health challenges.

    image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/ Federated Research D...arrow_drop_down
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    image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    OpenTrials
    Clinical Trial . 2011
    Data sources: OpenTrials
    Borealis
    Dataset . 2016
    Data sources: Datacite
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      image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/ Federated Research D...arrow_drop_down
      image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
      image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
      OpenTrials
      Clinical Trial . 2011
      Data sources: OpenTrials
      Borealis
      Dataset . 2016
      Data sources: Datacite
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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Magee, Laura A;

    Primary research question: For pregnant women with non-severe, non-proteinuric maternal hypertension at 14-33 weeks, will 'less tight' control (target diastolic blood pressure [dBP] of 100 mmHg) versus 'tight' control (target dBP of 85 mmHg) increase (or decrease) the likelihood of pregnancy loss or Neonatal Intensive Care Unit (NICU) admission for greater than 48 hours? Secondary research question: Will 'less tight' versus 'tight' control increase (or decrease) the likelihood of serious maternal complications? Other research questions: Will 'less tight' versus 'tight' control: 1. Increase (or decrease) the likelihood of serious perinatal complications? 2. Increase (or decrease) the likelihood of severe hypertension and pre-eclampsia? 3. Increase (or decrease) the likelihood of maternal satisfaction with care? 4. Result in significant changes in dBP or health care costs? Treatment Allocation: Eligible women will be randomised centrally to either 'less tight' control (aiming for dBP of 100mmHg) or 'tight' control (aiming for dBP of 85mmHg) of their hypertension. Randomisation will be stratified by centre and type of hypertension (pre-existing or gestational). - In the 'less tight' control group, if dBP is ≥105mmHg, then antihypertensive medication must be started or increased in dose. - In the 'tight' control group, if dBP is ≤80mmHg, then antihypertensive medication must be decreased in dose or discontinued. - In both groups, centres will provide their usual care. Data will be collected on potential co-interventions (e.g., hospitalisation, bedrest). Outcomes: Primary: Pregnancy loss (miscarriage or ectopic pregnancy, pregnancy termination, stillbirth, or neonatal death) or high level neonatal care for >48 hours in the first 28 days of life or prior to primary hospital discharge, whichever is later. Secondary: One/more serious maternal complication(s) until six weeks postpartum. Follow-up: Compliance (dBP and antihypertensive dose) will be assessed within 4 weeks of randomisation. Outcome data will be collected during the woman's (and baby's) hospital stay for birth (or loss). Women will be contacted 6 to 12 weeks after delivery (or loss) and, for preterm babies, when the baby is at 36 weeks corrected gestational age to enquire about satisfaction with care and any major maternal/neonatal morbidity following hospital discharge. The investigators do not know which approach to treatment of non-severe high blood pressure in pregnancy is better for women and babies. In the CHIPS Trial, the investigators seek to determine whether 'less tight' control (aiming for a diastolic blood pressure [dBP] of 100 mmHg), compared with 'tight' control (aiming for a diastolic blood pressure [dBP] of 85 mmHg) can decrease the risks of adverse baby outcomes without increasing the risk of problems for the mother.

    image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/ OpenTrialsarrow_drop_down
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    OpenTrials
    Clinical Trial . 2010
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2010
      Data sources: OpenTrials
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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Richer, Lawrence;

    Migraine headache is a painful condition of recurrent moderate to severe head pain associated with nausea, vomiting, photophobia, and phonophobia. The condition is highly prevalent and a significant community health problem with considerable impact on the health care system. To alleviate the pain and morbidity associated with a migraine attack, drug therapies are often employed including simple analgesics like ibuprofen and migraine-specific medications like sumatriptan. When these treatments fail or in severe, intractable cases, patients and families may present to the Emergency Department (ED). Ketorolac in combination with metoclopramide or prochlorperazine was the most common multi-drug combination used in 36% of ED presentations for migraine across Canada in our national practice variation study. The scientific rationale for combining a non-selective non-steroidal anti-inflammatory drug (NSAID) with inhibition of both the cyclooxygenase (COX) 1 and 2 isoenzymes with other migraine therapies is enticing; however, no studies have specifically examined the relative efficacy of the practice. Why would the combination of a non-selective NSAID like ketorolac with other migraine therapies improve treatment outcomes? The benefit of multi-target combinations may be relate to the duration of the migraine and the multiple brain areas involved in sustained pain. It has long been recognized that patients who treat their migraine headaches early at the onset have a better response. The underlying mechanism for this phenomenon has now been identified. The initiation of migraine pain requires activation of the trigeminal (5th cranial nerve) nociceptive (pain) system. Activation of these sensory fibers within the arachnoid membrane on the surface of the brain produces the first and most common painful manifestation of migraine - the pulsatile headache. With each heartbeat, minor dilation of the cerebral blood vessels produces stretch and a painful activation of the trigeminal fibers known as peripheral sensitization. The second phase in the maintenance of a migraine attack over several hours is the sensitization of trigeminal pain pathways leading to higher brain centers known as central sensitization. The efficacy of medications like the triptans is greater early in the course of a migraine attack when there is only peripheral sensitization and before the onset of central sensitization. Non-selective NSAIDs like naproxen sodium and ketorolac may be uniquely effective in the reduction of central sensitization in the animal model of migraine and the reduction of migraine pain in adult patients late in the course of a migraine headache. The population of patients in the ED is uniquely different from outpatients in that most have developed their migraine headache hours or days before presenting. In our practice variation study, the mean duration of the migraine prior to presenting to the ED was 2 days. Including an NSAID when treating a prolonged migraine in the ED may thus increase the therapeutic window and improve outcomes. While many Canadian ED physicians have adopted the practice of combining ketorolac with other migraine therapies, the gold standard assessment of efficacy and safety in a randomized clinical trial has not been applied. Migraine headaches are a common problem for children. When treatment at home fails, children may benefit from intravenous treatment administered in a hospital setting like the Emergency Department. Most treatments used however have only been tested in adults and the best treatment strategy for children is not always clear. The combination of more than one medication is frequently prescribed in Canadian Emergency Departments. The purpose of this study is to investigate whether the combination of ketorolac (an anti-inflammatory pain medication) and metoclopramide (an anti-nauseant that may also relieve migraine headaches) is better than metoclopramide by itself.

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    OpenTrials
    Clinical Trial . 2012
    Data sources: OpenTrials
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    Borealis
    Dataset . 2016
    Data sources: Datacite
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      OpenTrials
      Clinical Trial . 2012
      Data sources: OpenTrials
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      Borealis
      Dataset . 2016
      Data sources: Datacite
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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Vohra, Sunita;

    Study Objective: To determine if a pediatric integrative medicine (PIM) service is effective in reducing overall symptoms of pain, nausea/vomiting, and/or anxiety (PNVA), length of stay, and costs, in hospitalized children when compared to conventional care. In this context, "integrative" refers to a combined approach of complementary and conventional medical therapies in an evidence-based fashion. Design: cluster trial; 2-arm controlled evaluation study in pediatric oncology, general pediatrics and pediatric cardiology. Intervention will be offered during a 6-month PIM period following a 6 month control period. Population: Inclusion criteria: (i) In-patients in participating division and (ii) informed consent/assent. Exclusion criteria: (i) lack of parent participation, fluency in English, or informed consent Intervention: Recommendations for specific CAM therapies will be determined by a staff PIM pediatrician. Any combination of the following CAM therapies (dose, duration, amount to be based on patient need as assessed by CAM provider, patient, and parent): acupuncture/acupressure, massage, Reiki; all are to be offered in addition to usual care. Control: Usual care. Outcomes: Primary outcome: feasibility (i.e enrollment); Secondary outcomes: (i) PNVA symptom management, (ii) need for conventional pharmacotherapy, (iii) adverse events; (iv) parent and health care provider satisfaction with care provided, v) length of stay; and vi) cost-effectiveness (analysis of this outcome to be limited to patients admitted for at least 2 days and for not more than 30 days). Significance: To our knowledge, this study will be the first comparative effectiveness trial to assess the impact of PIM for hospitalized children with cancer. This study will investigate if adding complementary therapies such as acupuncture, massage and reiki to inpatient pediatric care is feasible and what the effects are on outcomes such as patient symptoms, cost, safety, satisfaction and length of stay.

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    OpenTrials
    Clinical Trial . 2013
    Data sources: OpenTrials
    Borealis
    Dataset . 2016
    Data sources: Datacite
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      OpenTrials
      Clinical Trial . 2013
      Data sources: OpenTrials
      Borealis
      Dataset . 2016
      Data sources: Datacite
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    Authors: Ball, Geoff;

    Portion size measurement aids (PSMAs) are tools that facilitate the estimation of food servings. The objectives of this study are to determine (a) if food portion size estimation accuracy differs when using a two dimensional (2D) PSMA (actual-size photos called Portion Size Cards) compared to a 3D PSMA (Portion Size Kit) and (b) whether differences exist in the short-term usefulness of and satisfaction with these PSMAs in a sample of parents of overweight children and youth. We hypothesize that the group that receives the 3D PSMAs will be more accurate in food portion size estimation and will be more satisfied with the tool compared to the group that receives the 2D PSMAs. Forty primary caregivers of overweight children and youth attending the Pediatric Centre for Weight and Health (Edmonton, AB) will be recruited. Participants will be randomly assigned to one of the two groups (2D PSMAs versus 3D PSMAs). After a brief explanation of the respective tool, participants will estimate the volumes of pre-measured rubber food portion models on a test plate. Participants will then be given the 2D or 3D PSMAs to take home with them to use in the real-world. After 2-4 weeks, participants will be telephoned by the research team to complete a brief survey to evaluate their usefulness of and satisfaction with the 2D or 3D PSMAs at home.

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    OpenTrials
    Clinical Trial . 2010
    Data sources: OpenTrials
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    Borealis
    Dataset . 2016
    Data sources: Datacite
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      OpenTrials
      Clinical Trial . 2010
      Data sources: OpenTrials
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      Borealis
      Dataset . 2016
      Data sources: Datacite
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    Authors: Vohra, Sunita;

    This study will be a 2 arm controlled clinical trial (CCT) comparing usual care to usual care plus MBSR. Participants will be residents of a local inpatient treatment facility for adolescents with serious mental health issues. Outcomes the investigators will measure include mental health status as well as mindfulness. The investigators will also conduct qualitative interviews to assess the personal impact of the intervention on the patients and their families. In order to map and measure cognitive changes during MBSR the investigators will conduct brain imaging using functional magnetic resonance imaging (fMRI) and Event-Related Potential (ERP) recordings. Through this study the investigators will determine if MBSR is helpful to our population. Mindfulness-based stress reduction (MBSR) is a group program in which participants are taught to be mindful or present-focused. MBSR programs consist of instruction in a variety of mindfulness meditations including body scan, sitting meditation, mindful yoga, and discussion of these practices. Our study purpose is to develop and conduct a pilot mixed-methods randomized controlled trial (RCT), combining clinical outcomes, qualitative interviews, and brain imaging to assess the impact of the intervention on children with mental health challenges.

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    OpenTrials
    Clinical Trial . 2011
    Data sources: OpenTrials
    Borealis
    Dataset . 2016
    Data sources: Datacite
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      OpenTrials
      Clinical Trial . 2011
      Data sources: OpenTrials
      Borealis
      Dataset . 2016
      Data sources: Datacite
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    Authors: Magee, Laura A;

    Primary research question: For pregnant women with non-severe, non-proteinuric maternal hypertension at 14-33 weeks, will 'less tight' control (target diastolic blood pressure [dBP] of 100 mmHg) versus 'tight' control (target dBP of 85 mmHg) increase (or decrease) the likelihood of pregnancy loss or Neonatal Intensive Care Unit (NICU) admission for greater than 48 hours? Secondary research question: Will 'less tight' versus 'tight' control increase (or decrease) the likelihood of serious maternal complications? Other research questions: Will 'less tight' versus 'tight' control: 1. Increase (or decrease) the likelihood of serious perinatal complications? 2. Increase (or decrease) the likelihood of severe hypertension and pre-eclampsia? 3. Increase (or decrease) the likelihood of maternal satisfaction with care? 4. Result in significant changes in dBP or health care costs? Treatment Allocation: Eligible women will be randomised centrally to either 'less tight' control (aiming for dBP of 100mmHg) or 'tight' control (aiming for dBP of 85mmHg) of their hypertension. Randomisation will be stratified by centre and type of hypertension (pre-existing or gestational). - In the 'less tight' control group, if dBP is ≥105mmHg, then antihypertensive medication must be started or increased in dose. - In the 'tight' control group, if dBP is ≤80mmHg, then antihypertensive medication must be decreased in dose or discontinued. - In both groups, centres will provide their usual care. Data will be collected on potential co-interventions (e.g., hospitalisation, bedrest). Outcomes: Primary: Pregnancy loss (miscarriage or ectopic pregnancy, pregnancy termination, stillbirth, or neonatal death) or high level neonatal care for >48 hours in the first 28 days of life or prior to primary hospital discharge, whichever is later. Secondary: One/more serious maternal complication(s) until six weeks postpartum. Follow-up: Compliance (dBP and antihypertensive dose) will be assessed within 4 weeks of randomisation. Outcome data will be collected during the woman's (and baby's) hospital stay for birth (or loss). Women will be contacted 6 to 12 weeks after delivery (or loss) and, for preterm babies, when the baby is at 36 weeks corrected gestational age to enquire about satisfaction with care and any major maternal/neonatal morbidity following hospital discharge. The investigators do not know which approach to treatment of non-severe high blood pressure in pregnancy is better for women and babies. In the CHIPS Trial, the investigators seek to determine whether 'less tight' control (aiming for a diastolic blood pressure [dBP] of 100 mmHg), compared with 'tight' control (aiming for a diastolic blood pressure [dBP] of 85 mmHg) can decrease the risks of adverse baby outcomes without increasing the risk of problems for the mother.

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    OpenTrials
    Clinical Trial . 2010
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2010
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    Authors: Richer, Lawrence;

    Migraine headache is a painful condition of recurrent moderate to severe head pain associated with nausea, vomiting, photophobia, and phonophobia. The condition is highly prevalent and a significant community health problem with considerable impact on the health care system. To alleviate the pain and morbidity associated with a migraine attack, drug therapies are often employed including simple analgesics like ibuprofen and migraine-specific medications like sumatriptan. When these treatments fail or in severe, intractable cases, patients and families may present to the Emergency Department (ED). Ketorolac in combination with metoclopramide or prochlorperazine was the most common multi-drug combination used in 36% of ED presentations for migraine across Canada in our national practice variation study. The scientific rationale for combining a non-selective non-steroidal anti-inflammatory drug (NSAID) with inhibition of both the cyclooxygenase (COX) 1 and 2 isoenzymes with other migraine therapies is enticing; however, no studies have specifically examined the relative efficacy of the practice. Why would the combination of a non-selective NSAID like ketorolac with other migraine therapies improve treatment outcomes? The benefit of multi-target combinations may be relate to the duration of the migraine and the multiple brain areas involved in sustained pain. It has long been recognized that patients who treat their migraine headaches early at the onset have a better response. The underlying mechanism for this phenomenon has now been identified. The initiation of migraine pain requires activation of the trigeminal (5th cranial nerve) nociceptive (pain) system. Activation of these sensory fibers within the arachnoid membrane on the surface of the brain produces the first and most common painful manifestation of migraine - the pulsatile headache. With each heartbeat, minor dilation of the cerebral blood vessels produces stretch and a painful activation of the trigeminal fibers known as peripheral sensitization. The second phase in the maintenance of a migraine attack over several hours is the sensitization of trigeminal pain pathways leading to higher brain centers known as central sensitization. The efficacy of medications like the triptans is greater early in the course of a migraine attack when there is only peripheral sensitization and before the onset of central sensitization. Non-selective NSAIDs like naproxen sodium and ketorolac may be uniquely effective in the reduction of central sensitization in the animal model of migraine and the reduction of migraine pain in adult patients late in the course of a migraine headache. The population of patients in the ED is uniquely different from outpatients in that most have developed their migraine headache hours or days before presenting. In our practice variation study, the mean duration of the migraine prior to presenting to the ED was 2 days. Including an NSAID when treating a prolonged migraine in the ED may thus increase the therapeutic window and improve outcomes. While many Canadian ED physicians have adopted the practice of combining ketorolac with other migraine therapies, the gold standard assessment of efficacy and safety in a randomized clinical trial has not been applied. Migraine headaches are a common problem for children. When treatment at home fails, children may benefit from intravenous treatment administered in a hospital setting like the Emergency Department. Most treatments used however have only been tested in adults and the best treatment strategy for children is not always clear. The combination of more than one medication is frequently prescribed in Canadian Emergency Departments. The purpose of this study is to investigate whether the combination of ketorolac (an anti-inflammatory pain medication) and metoclopramide (an anti-nauseant that may also relieve migraine headaches) is better than metoclopramide by itself.

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    OpenTrials
    Clinical Trial . 2012
    Data sources: OpenTrials
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    Borealis
    Dataset . 2016
    Data sources: Datacite
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      Clinical Trial . 2012
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      Borealis
      Dataset . 2016
      Data sources: Datacite
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