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  1. Article ; Online: Sleep and quality of life of patients with glycogen storage disease on standard and modified uncooked cornstarch.

    Rousseau-Nepton, Isabelle / Huot, Céline / Laforte, Diane / Mok, Elise / Fenyves, Daphna / Constantin, Evelyn / Mitchell, John

    Molecular genetics and metabolism

    2017  Volume 123, Issue 3, Page(s) 326–330

    Abstract: Background: Glycemic control in hepatic glycogen storage diseases (GSDs) relies on specific nutritional recommendations, including strict avoidance of a fasting period. Uncooked cornstarch (UCCS) is an important therapeutic component. A new modified ... ...

    Abstract Background: Glycemic control in hepatic glycogen storage diseases (GSDs) relies on specific nutritional recommendations, including strict avoidance of a fasting period. Uncooked cornstarch (UCCS) is an important therapeutic component. A new modified UCCS, Glycosade™, was created with the objective of prolonging euglycemia. We aimed to determine the length of euglycemia on Glycosade™ using a continuous glucose monitor (CGM) and to evaluate whether longer euglycemia and thus less nighttime interruptions would improve sleep and quality of life (QoL) after the introduction of the modified cornstarch.
    Methods: We conducted a prospective cohort study to assess quality and quantity of sleep and quality of life (QoL) in patients with GSDs on standard UCCS and after the introduction of Glycosade™. Sleep and QoL evaluation was done for patients using validated questionnaires, a standardized sleep diary and actigraphy. Length of fast and glucose variability were determined with CGM.
    Results: Nine adults with GSD Ia took part in the study. Glycosade™ introduction was done under close supervision during a hospital admission. Comparison of sleep in 9 patients showed sleep disturbances on standard UCCS that were improved with Glycosade™. QoL was normal both pre and post Glycosade™. The CGM confirmed maintenance of a longer fasting period with Glycosade™ at home.
    Conclusion: Glycosade™ represents an alternative option for GSD patients. We showed possible benefits in terms of sleep quality. We also confirmed the longer length of fast on Glycosade™.
    Synopsis: A new modified form of uncooked starch for patients with glycogen storage disease represents an alternative option as it showed a longer length of fast and improvements in sleep quality.
    MeSH term(s) Actigraphy ; Adult ; Blood Glucose/physiology ; Fasting/physiology ; Female ; Glucose/administration & dosage ; Glycogen Storage Disease/blood ; Glycogen Storage Disease/physiopathology ; Humans ; Hypoglycemia/blood ; Hypoglycemia/diet therapy ; Hypoglycemia/drug therapy ; Hypoglycemia/physiopathology ; Male ; Middle Aged ; Prospective Studies ; Quality of Life ; Sleep/physiology ; Starch ; Treatment Outcome ; Young Adult
    Chemical Substances Blood Glucose ; Starch (9005-25-8) ; Glucose (IY9XDZ35W2)
    Language English
    Publishing date 2017-09-11
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1418518-0
    ISSN 1096-7206 ; 1096-7192
    ISSN (online) 1096-7206
    ISSN 1096-7192
    DOI 10.1016/j.ymgme.2017.09.003
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    In stock of ZB MED Cologne/Königswinter

    Zs.A 617: Show issues Location:
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  2. Article ; Online: A randomized controlled trial of isotonic versus hypotonic maintenance intravenous fluids in hospitalized children

    Laforte Diane / Houghton Fiona / Fairbairn James / Saba Thomas G / Foster Bethany J

    BMC Pediatrics, Vol 11, Iss 1, p

    2011  Volume 82

    Abstract: Abstract Background Isotonic saline has been proposed as a safer alternative to traditional hypotonic solutions for intravenous (IV) maintenance fluids to prevent hyponatremia. However, the optimal tonicity of maintenance intravenous fluids in ... ...

    Abstract Abstract Background Isotonic saline has been proposed as a safer alternative to traditional hypotonic solutions for intravenous (IV) maintenance fluids to prevent hyponatremia. However, the optimal tonicity of maintenance intravenous fluids in hospitalized children has not been determined. The objective of this study was to estimate and compare the rates of change in serum sodium ([Na]) for patients administered either hypotonic or isotonic IV fluids for maintenance needs. Methods This was a masked controlled trial. Randomization was stratified by admission type: medical patients and post-operative surgical patients, aged 3 months to 18 years, who required IV fluids for at least 8 hours. Patients were randomized to receive either 0.45% or 0.9% saline in 5.0% dextrose. Treating physicians used the study fluid for maintenance; infusion rate and the use of additional fluids were left to their discretion. Results Sixteen children were randomized to 0.9% saline and 21 to 0.45% saline. Baseline characteristics, duration (average of 12 hours) and rate of study fluid infusion, and the volume of additional isotonic fluids given were similar for the two groups. [Na] increased significantly in the 0.9% group (+0.20 mmol/L/h [IQR +0.03, +0.4]; P = 0.02) and increased, but not significantly, in the 0.45% group (+0.08 mmol/L/h [IQR -0.15, +0.16]; P = 0.07). The rate of change and absolute change in serum [Na] did not differ significantly between groups. Conclusions When administered at the appropriate maintenance rate and accompanied by adequate volume expansion with isotonic fluids, 0.45% saline did not result in a drop in serum sodium during the first 12 hours of fluid therapy in children without severe baseline hyponatremia. Confirmation in a larger study is strongly recommended. Clinical Trial Registration Number NCT00457873 ( http://www.clinicaltrials.gov/ )
    Keywords hyponatremia ; sodium ; intravenous fluids ; isotonic fluid ; Pediatrics ; RJ1-570 ; Medicine ; R ; DOAJ:Pediatrics ; DOAJ:Medicine (General) ; DOAJ:Health Sciences
    Subject code 610
    Language English
    Publishing date 2011-09-01T00:00:00Z
    Publisher BioMed Central
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: A randomized controlled trial of isotonic versus hypotonic maintenance intravenous fluids in hospitalized children.

    Saba, Thomas G / Fairbairn, James / Houghton, Fiona / Laforte, Diane / Foster, Bethany J

    BMC pediatrics

    2011  Volume 11, Page(s) 82

    Abstract: Background: Isotonic saline has been proposed as a safer alternative to traditional hypotonic solutions for intravenous (IV) maintenance fluids to prevent hyponatremia. However, the optimal tonicity of maintenance intravenous fluids in hospitalized ... ...

    Abstract Background: Isotonic saline has been proposed as a safer alternative to traditional hypotonic solutions for intravenous (IV) maintenance fluids to prevent hyponatremia. However, the optimal tonicity of maintenance intravenous fluids in hospitalized children has not been determined. The objective of this study was to estimate and compare the rates of change in serum sodium ([Na]) for patients administered either hypotonic or isotonic IV fluids for maintenance needs.
    Methods: This was a masked controlled trial. Randomization was stratified by admission type: medical patients and post-operative surgical patients, aged 3 months to 18 years, who required IV fluids for at least 8 hours. Patients were randomized to receive either 0.45% or 0.9% saline in 5.0% dextrose. Treating physicians used the study fluid for maintenance; infusion rate and the use of additional fluids were left to their discretion.
    Results: Sixteen children were randomized to 0.9% saline and 21 to 0.45% saline. Baseline characteristics, duration (average of 12 hours) and rate of study fluid infusion, and the volume of additional isotonic fluids given were similar for the two groups. [Na] increased significantly in the 0.9% group (+0.20 mmol/L/h [IQR +0.03, +0.4]; P = 0.02) and increased, but not significantly, in the 0.45% group (+0.08 mmol/L/h [IQR -0.15, +0.16]; P = 0.07). The rate of change and absolute change in serum [Na] did not differ significantly between groups.
    Conclusions: When administered at the appropriate maintenance rate and accompanied by adequate volume expansion with isotonic fluids, 0.45% saline did not result in a drop in serum sodium during the first 12 hours of fluid therapy in children without severe baseline hyponatremia. Confirmation in a larger study is strongly recommended.
    Clinical trial registration number: NCT00457873 (http://www.clinicaltrials.gov/).
    MeSH term(s) Adolescent ; Child ; Child, Preschool ; Double-Blind Method ; Female ; Fluid Therapy/methods ; Hospitalization ; Humans ; Hyponatremia/prevention & control ; Hypotonic Solutions/administration & dosage ; Infant ; Isotonic Solutions/administration & dosage ; Male ; Prospective Studies ; Sodium/blood ; Sodium Chloride/administration & dosage
    Chemical Substances Hypotonic Solutions ; Isotonic Solutions ; Sodium Chloride (451W47IQ8X) ; Sodium (9NEZ333N27)
    Language English
    Publishing date 2011-09-23
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2041342-7
    ISSN 1471-2431 ; 1471-2431
    ISSN (online) 1471-2431
    ISSN 1471-2431
    DOI 10.1186/1471-2431-11-82
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  4. Article ; Online: Zoledronic acid for the treatment of osteopenia in pediatric Crohn's disease.

    Sbrocchi, Anne Marie / Forget, Sylviane / Laforte, Diane / Azouz, E Michel / Rodd, Celia

    Pediatrics international : official journal of the Japan Pediatric Society

    2010  Volume 52, Issue 5, Page(s) 754–761

    Abstract: Background: Pediatric patients with Crohn's disease often have low bone mass (osteopenia) for age. No randomized, placebo-controlled trials using zoledronic acid have ever been performed in this population. The objective of this study was to assess the ... ...

    Abstract Background: Pediatric patients with Crohn's disease often have low bone mass (osteopenia) for age. No randomized, placebo-controlled trials using zoledronic acid have ever been performed in this population. The objective of this study was to assess the efficacy of zoledronic acid in children with Crohn's disease and osteopenia.
    Methods: A double-blind, randomized, placebo-controlled design was used. Thirteen adolescents received either a single intravenous dose of zoledronic acid (0.066 mg/kg, max 4 mg, n= 7) or saline placebo (n= 6). The primary outcome was change in lumbar spine bone mineral density (LSBMD) z-score at 6 months. Secondary outcomes included bone markers and adverse events.
    Results: At 6 months, the change in LSBMD z-score was significantly higher in the zoledronic acid group compared to placebo (0.7 vs 0.1, P < 0.001). Volumetrically adjusted LSBMD z-score also significantly increased in the treated group. This significant difference persisted until 12 months. With zoledronic acid, urinary C-telopeptide excretion decreased by 50% at 6 months and remained suppressed at 12 months (P= 0.02), but no changes were observed with placebo. Both groups had similar adverse events which included transient fever, arthralgias, and nausea (3/7 treated, 2/6 placebo, P= NS).
    Conclusions: In this study, zoledronic acid demonstrated a significant increase in LSBMD at 6 and 12 months following a well-tolerated infusion.
    MeSH term(s) Adolescent ; Analysis of Variance ; Bone Density/physiology ; Bone Diseases, Metabolic/drug therapy ; Bone Diseases, Metabolic/etiology ; Bone Diseases, Metabolic/physiopathology ; Child ; Crohn Disease/complications ; Crohn Disease/diagnosis ; Crohn Disease/drug therapy ; Diphosphonates/administration & dosage ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Female ; Follow-Up Studies ; Humans ; Imidazoles/administration & dosage ; Injections, Intravenous ; Male ; Prospective Studies ; Reference Values ; Statistics, Nonparametric ; Time Factors ; Treatment Outcome
    Chemical Substances Diphosphonates ; Imidazoles ; zoledronic acid (6XC1PAD3KF)
    Language English
    Publishing date 2010-10
    Publishing country Australia
    Document type Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1470376-2
    ISSN 1442-200X ; 1328-8067
    ISSN (online) 1442-200X
    ISSN 1328-8067
    DOI 10.1111/j.1442-200X.2010.03174.x
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    In stock of ZB MED Cologne/Königswinter

    Zs.A 848: Show issues Location:
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  5. Article ; Online: Recruitment and retention of participants for an international type 1 diabetes prevention trial: a coordinators' perspective.

    Franciscus, Margaret / Nucci, Anita / Bradley, Brenda / Suomalainen, Heli / Greenberg, Ellen / Laforte, Diane / Kleemola, Paivi / Hyytinen, Mila / Salonen, Marja / Martin, Mary Jean / Catte, Daniel / Catteau, Jacki

    Clinical trials (London, England)

    2013  Volume 11, Issue 2, Page(s) 150–158

    Abstract: Background: The Trial to Reduce Insulin Dependent Diabetes Mellitus in the Genetically at Risk (TRIGR) is the first multicenter international type 1 diabetes (T1D) prevention trial to be undertaken. A unique feature of TRIGR has been recruitment of ... ...

    Abstract Background: The Trial to Reduce Insulin Dependent Diabetes Mellitus in the Genetically at Risk (TRIGR) is the first multicenter international type 1 diabetes (T1D) prevention trial to be undertaken. A unique feature of TRIGR has been recruitment of eligible pregnant women and enrollment of newborns for long-term follow-up assessments.
    Purpose: Our purpose is to summarize the recruitment and retention strategies used to conduct TRIGR from the perspective of the study coordinators.
    Methods: TRIGR was designed to test whether weaning to formula containing hydrolyzed versus intact cow's milk protein would be efficacious in decreasing risk for development of T1D-associated autoantibodies and T1D among infants identified to be at increased risk for T1D based on their human leukocyte antigen (HLA) profile and family history. Multiple strategies tailored to local issues were required to enroll and follow the target number of infants.
    Results: This study was conducted in the United States, Canada, Australia, and 12 countries in Europe. Of the 5606 mothers registered worldwide, 5000 of their infants were randomized. Of these, 2159 were HLA eligible and enrolled in the 8-month intervention and 10-year follow-up phases of this study. The TRIGR study met the accrual goal after 4.7 years of recruitment, 2.7 years longer than projected initially. Challenges included difficulty in finding fathers with T1D, a higher than expected rate of premature delivery among T1D mothers, and implementation of new privacy regulations mid-trial. The majority of participants were recruited from primary care antenatal clinics located near the study centers and from a general hospital or pediatric center that was affiliated with a TRIGR Study center. Internet and magazine advertisements were found to be useful for recruitment of families. Alternative follow-up strategies are offered to families who wish to reduce or discontinue participation.
    Limitations: Our experience is limited to a single international multicenter trial.
    Conclusions: TRIGR coordinators played key roles in the recruitment and intervention periods and continue to be instrumental in retaining families and children during the 10-year follow-up period for each child.
    MeSH term(s) Adult ; Australia ; Canada ; Diabetes Mellitus, Type 1/genetics ; Diabetes Mellitus, Type 1/prevention & control ; Diet Therapy/methods ; Double-Blind Method ; Europe ; Female ; HLA Antigens/genetics ; Humans ; Infant, Newborn ; International Cooperation ; Male ; Multicenter Studies as Topic/methods ; Patient Selection ; Pregnancy ; Randomized Controlled Trials as Topic/methods ; Research Personnel ; United States
    Chemical Substances HLA Antigens
    Language English
    Publishing date 2013-11-11
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2138796-5
    ISSN 1740-7753 ; 1740-7745
    ISSN (online) 1740-7753
    ISSN 1740-7745
    DOI 10.1177/1740774513510070
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    In stock of ZB MED Cologne/Königswinter

    Zs.A 5831: Show issues Location:
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  6. Article: Effects of maternal vitamin A status on kidney development: a pilot study.

    Goodyer, Paul / Kurpad, Anura / Rekha, Swarna / Muthayya, Sumitra / Dwarkanath, Pratibha / Iyengar, Arpana / Philip, Babu / Mhaskar, Arun / Benjamin, Alice / Maharaj, Suran / Laforte, Diane / Raju, Chandhana / Phadke, Kishore

    Pediatric nephrology (Berlin, Germany)

    2007  Volume 22, Issue 2, Page(s) 209–214

    Abstract: Nephron endowment ranges widely in normal human populations. Recent autopsy studies have drawn attention to the possibility that subtle congenital nephron deficits may be associated with increased risk of developing hypertension later in life. Since ... ...

    Abstract Nephron endowment ranges widely in normal human populations. Recent autopsy studies have drawn attention to the possibility that subtle congenital nephron deficits may be associated with increased risk of developing hypertension later in life. Since modest maternal vitamin A deficiency reduces nephron number in rats, we designed a pilot study to determine the prevalence of maternal vitamin A deficiency in Montreal (Canada) and Bangalore (India) and the usefulness of newborn renal volume as a surrogate for nephron endowment. Among 48 pregnant Montreal women, two (4%) had one isolated mid-gestation retinol level slightly below the accepted limit of normal (0.9 mumol/L), whereas 25 (55%) of 46 pregnant women in Bangalore had at least one sample below this limit. Average estimated retinoid intake was correlated with mean serum retinol in pregnant women from Bangalore. In Montreal where maternal vitamin A deficiency was negligible, we found that newborn renal volume (estimated by renal ultrasonography at 2-6 weeks of age) was correlated with surface area at birth and was inversely correlated with serum creatinine at 1 month. Interestingly, renal volume adjusted for body surface area in Montreal (184+/-44 ml/m(2)) was significantly greater than in Bangalore (114+/-33 ml/m(2)) (p<0.01). Definitive studies are needed to establish whether maternal vitamin A deficiency accounts for subtle renal hypoplasia in Indian newborns. If so, there may be important public health implications for regions of the world where maternal vitamin A deficiency is prevalent.
    MeSH term(s) Canada/epidemiology ; Creatinine/blood ; Cystatin C ; Cystatins/blood ; Female ; Fetal Development/physiology ; Humans ; Hypertension/etiology ; India/epidemiology ; Infant, Newborn ; Kidney/diagnostic imaging ; Kidney/embryology ; Kidney Diseases/complications ; Kidney Diseases/congenital ; Maternal-Fetal Exchange ; Nephrons/embryology ; Nephrons/pathology ; Pilot Projects ; Pregnancy ; Prenatal Exposure Delayed Effects/etiology ; Prenatal Exposure Delayed Effects/pathology ; Prevalence ; Ultrasonography ; Vitamin A/blood ; Vitamin A Deficiency/complications ; Vitamin A Deficiency/epidemiology
    Chemical Substances CST3 protein, human ; Cst3 protein, rat ; Cystatin C ; Cystatins ; Vitamin A (11103-57-4) ; Creatinine (AYI8EX34EU)
    Language English
    Publishing date 2007-02
    Publishing country Germany
    Document type Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 631932-4
    ISSN 1432-198X ; 0931-041X
    ISSN (online) 1432-198X
    ISSN 0931-041X
    DOI 10.1007/s00467-006-0213-4
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    In stock of ZB MED Cologne/Königswinter

    Zs.A 2196: Show issues Location:
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