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  • 1
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    Online Resource
    A new approach to model the spatiotemporal development of biofilm phase in porous media : Modelling biofilm growth in porous medium
    Wiley ; 2011
    In:  Environmental Microbiology Vol. 13, No. 11 ( 2011-11), p. 3010-3023
    Details
    In: Environmental Microbiology, Wiley, Vol. 13, No. 11 ( 2011-11), p. 3010-3023
    Type of Medium: Online Resource
    ISSN: 1462-2912
    URL: Article
    DOI: 10.1111/j.1462-2920.2011.02578.x
    Language: English
    Publisher: Wiley
    Publication Date: 2011
    detail.hit.zdb_id: 2020213-1
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  • 2
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    Safety and tolerability of short‐term infusions of intravenous lacosamide in pediatric patients with epilepsy: An open‐label, phase 2/3 trial
    Wiley ; 2023
    In:  Epilepsia Open Vol. 8, No. 1 ( 2023-03), p. 146-153
    Details
    In: Epilepsia Open, Wiley, Vol. 8, No. 1 ( 2023-03), p. 146-153
    Abstract: The objective of this study is to evaluate the safety and tolerability of intravenous (IV) lacosamide infusion in patients aged ≥1 month to 〈 17 years with epilepsy. Methods This Phase 2/3 open‐label trial (EP0060; NCT02710890) enrolled patients in two age cohorts (cohort 1: ≥8 to 〈 17 years; cohort 2: ≥1 month to 〈 8 years). Eligible patients were receiving oral lacosamide as adjunctive treatment or monotherapy (in an open‐label long‐term trial or by prescription) or were not receiving lacosamide before enrolment. Patients initiated IV lacosamide (2‐12 mg/kg/day or 100‐600 mg/day; 15‐60 minutes infusion) as a replacement for oral lacosamide or as adjunctive treatment. The primary outcomes were treatment‐emergent adverse events (TEAEs) and discontinuations due to TEAEs. Results In total, 103 patients were enrolled and completed the trial; 55 patients were included in cohort 1 (≥8 to 〈 17 years), 48 in cohort 2 (≥1 month to 〈 8 years). During the 4 weeks before screening, 74 (71.8%) patients had focal seizures, 12 (11.7%) had generalized seizures, and two (1.9%) had unclassified seizures. Most patients (74 [71.8%]) initiated lacosamide as adjunctive IV treatment. The mean overall duration of exposure to IV lacosamide was 1.18 days. Seventy‐nine (76.7%) patients had one IV lacosamide infusion, 20 (19.4%) had two, one (1.0%) had three, and three (2.9%) had 10 infusions. Overall, five (4.9%) patients had a total of seven TEAEs. The only TEAEs reported in two or more patients were increased blood triglycerides (two [1.9%] ). No serious or severe TEAEs were reported, and no patients discontinued due to TEAEs. No TEAEs were considered drug‐related by the investigator. No consistent or clinically relevant treatment‐related changes from baseline were observed for hematology, clinical chemistry parameters, vital signs, or 12‐lead electrocardiograms. Significance IV lacosamide was generally well tolerated in pediatric patients (≥1 month to 〈 17 years) with epilepsy, and no new safety concerns were identified.
    Type of Medium: Online Resource
    ISSN: 2470-9239 , 2470-9239
    URL: Issue
    URL: Article
    DOI: 10.1002/epi4.v8.1
    DOI: 10.1002/epi4.12682
    Language: English
    Publisher: Wiley
    Publication Date: 2023
    detail.hit.zdb_id: 2863427-5
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  • 3
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    Synthesis of Meso/Macroporous γ‐Alumina via Aluminum Pellet with Controllable Porosity: Ammonium Bicarbonate Influences through Drying and Calcination Steps
    Wiley ; 2019
    In:  ChemistrySelect Vol. 4, No. 19 ( 2019-05-24), p. 5872-5879
    Details
    In: ChemistrySelect, Wiley, Vol. 4, No. 19 ( 2019-05-24), p. 5872-5879
    Abstract: Mesoporous and macroporous γ‐alumina have been synthesized using the economic source of aluminum pellets. To manipulate the porosity and overall porous characteristics, ammonium bicarbonate was incorporated into the gel and studied to determine its influence on the porous structure of the obtained γ‐alumina. The nanostructure of the synthesized γ‐alumina, characterized by the N 2 sorption isotherms and FESEM analysis, indicated that the γ‐alumina of desired pore size distribution could be achieved using such economical source of aluminum when ammonium bicarbonate was considered to tailor its porous structure. The formation of macropores in synthesized γ‐alumina was confirmed by the FESEM images and the crystalline structure of the γ‐alumina of optimal porous structure was revealed via X‐ray diffraction pattern. Before and after being calcinated at 500 °C, TG‐DTA and FT‐IR analyses were also conducted to better assess the impact that thermal processes could have on ultimate γ‐alumina porous characteristics. Considering the embedded ammonium bicarbonate expander, a two‐step mechanism was finally proposed to explain the observed porosity developed through heating stages. Different porosity patterns developed through drying and calcination steps were then contributed to the reactions taking place at each, and N 2 sorption isotherms, as well as the FESEM images, were used to evaluate the introduced pore forming mechanisms.
    Type of Medium: Online Resource
    ISSN: 2365-6549 , 2365-6549
    URL: Issue
    URL: Article
    DOI: 10.1002/slct.v4.19
    DOI: 10.1002/slct.201900523
    Language: English
    Publisher: Wiley
    Publication Date: 2019
    detail.hit.zdb_id: 2844262-3
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  • 4
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    Analyses of seizure responses supportive of a novel trial design to assess efficacy of antiepileptic drugs in infants and young children with epilepsy: Post hoc analyses of pediatric levetiracetam and lacosamide trials
    Wiley ; 2021
    In:  Epilepsia Open Vol. 6, No. 2 ( 2021-06), p. 359-368
    Details
    In: Epilepsia Open, Wiley, Vol. 6, No. 2 ( 2021-06), p. 359-368
    Abstract: Recently, a novel trial design has been proposed to overcome challenges with traditional placebo‐controlled trials of antiepileptic drugs in infants and young children (≥1 month of age) (Auvin S, et al. Epilepsia Open 2019;4:537‐43). The proposed time‐to‐event trial design involves seizure counting by caregivers and allows adjustment of the duration of the baseline period and duration of exposure to placebo or potentially ineffective treatment based on the patient's seizure burden and response. We performed post hoc analyses to mimic this trial design and evaluate its viability. As these analyses required trials with prolonged baseline and treatment periods and diary data, which is not a typical design of trials in infants and young children (1 month to 〈 4 years of age), data from two trials in pediatric patients (4‐16 years of age) were used. Methods We performed post hoc analyses of two randomized, double‐blind, placebo‐controlled trials of adjunctive levetiracetam (N159; NCT00615615) and lacosamide (SP0969; NCT01921205) in children and adolescents (4‐16 years of age) with focal‐onset seizures. In these analyses, patients were followed until they completed the 10‐week maintenance period, discontinued during the maintenance period, or reached their “nth” seizure (n = number of seizures patient had during baseline). Efficacy was assessed by determining time to nth seizure. Results In the analyses of both trials, patients on levetiracetam or lacosamide had a 34% lower risk of reaching their baseline seizure count during their 10‐week maintenance period than patients on placebo. The previously published primary results of these trials also demonstrated efficacy of adjunctive levetiracetam and lacosamide. Significance Although these were post hoc analyses of trials in older children (4‐16 years of age), our results provide supportive evidence for the utility of the novel time‐to‐event trial design for future trials in infants and young children (1 month to 〈 4 years of age).
    Type of Medium: Online Resource
    ISSN: 2470-9239 , 2470-9239
    URL: Issue
    URL: Article
    DOI: 10.1002/epi4.v6.2
    DOI: 10.1002/epi4.12482
    Language: English
    Publisher: Wiley
    Publication Date: 2021
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  • 5
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    Pharmacokinetics, safety, and tolerability of intravenous brivaracetam in pediatric patients with epilepsy: An open‐label trial
    Wiley ; 2022
    In:  Epilepsia Vol. 63, No. 4 ( 2022-04), p. 855-864
    Details
    In: Epilepsia, Wiley, Vol. 63, No. 4 ( 2022-04), p. 855-864
    Abstract: To evaluate the pharmacokinetics, safety, and tolerability of brivaracetam (BRV) as 15‐min intravenous (IV) infusion and bolus (≤2‐min injection). Methods EP0065 (ClinicalTrials.gov: NCT03405714) was a Phase 2, multicenter, open‐label trial in patients ≥1 month to 〈 16 years of age with epilepsy. Patients received up to 5 mg/kg/day BRV (not exceeding 200 mg/day). Enrollment was sequential by descending age, depending on safety review. Outcomes included BRV plasma concentrations before and after IV administration, treatment‐emergent adverse events (TEAEs), and discontinuations due to TEAEs. Results Fifty patients were enrolled, received BRV, and completed the trial. Twenty‐six patients (52.0%) received 15‐min infusions and 24 (48.0%) received bolus injections. Most patients (80.0%) received one IV dose. In the 15‐min infusion group, geometric mean (GeoMean) BRV concentrations 15 (±2) min ( n  = 21) and 3 h (±15 min) ( n  = 21) post dose were 1903.0 ng/mL (geometric coefficient of variation [GeoCV]: 60.7%) and 1130.3 ng/mL (58.8%), respectively. In the bolus group, GeoMean BRV concentrations 15 (±2) min ( n  = 19) and 3 h (±15 min) ( n  = 21) post dose were 1704.8 ng/mL (GeoCV: 74.5%) and 1383.9 ng/mL (85.0%), respectively. Overall, 14 patients (28.0%) had TEAEs (15‐min infusion: 8 [30.8%]; bolus: 6 [25.0%] ), most commonly (≥5% of patients) somnolence (3 [6.0%]). Ten patients (20.0%) had drug‐related TEAEs (15‐min infusion: 6 [23.1%] ; bolus: 4 [16.7%]). No patients discontinued due to TEAEs, and no deaths occurred. Significance IV BRV (up to 200 mg/day) was well tolerated in patients ≥1 month to 〈 16 years of age, regardless of whether BRV was administered as 15‐min infusion or bolus. No unexpected safety or pharmacokinetic differences were observed between patients receiving 15‐min infusions or bolus, and plasma concentrations were in the expected range. Safety results were consistent with the known safety profile of oral BRV, with no new safety concerns identified.
    Type of Medium: Online Resource
    ISSN: 0013-9580 , 1528-1167
    URL: Issue
    URL: Article
    DOI: 10.1111/epi.v63.4
    DOI: 10.1111/epi.17187
    RVK:
    XA 10000
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 2002194-X
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  • 6
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    Treatment patterns in myasthenia gravis: A United States health claims analysis
    Wiley ; 2023
    In:  Muscle & Nerve Vol. 67, No. 4 ( 2023-04), p. 297-305
    Details
    In: Muscle & Nerve, Wiley, Vol. 67, No. 4 ( 2023-04), p. 297-305
    Abstract: Limited knowledge exists on treatment patterns in clinical practice in patients with myasthenia gravis (MG). In this study we examined MG treatment patterns in the United States. Methods Adult patients newly diagnosed with MG were identified from the IBM MarketScan insurance claims database. Patients with ≥2 MG International Classification of Disease diagnosis codes ≥3 months apart were retrospectively followed from the date of their first MG diagnosis record or start of treatment with acetylcholinesterase inhibitors (AChEI), intravenous (IV) or subcutaneous (SC) immunoglobulin (Ig), or plasma exchange (PLEx) therapy. Based on treatment received at any time during the follow‐up period, patients were segmented into six main treatment cohorts. Exacerbations and use of IVIg, SCIg, or PLEx after the index date were identified. Results During 2010 to 2019, 7,194 patients were followed for up to 10 (median, 2.3) years. Of 6,539 treated patients, 6,462 (99%) were ever treated with AChEI and/or corticosteroids (CS); 95% were first treated with AChEI and/or CS only; 33% received ≥1 nonsteroid immunosuppressive treatment (IST) and 2% received a biologic. During treatment with first IST (n = 2,166), patients experienced 42% and 94% higher incidence rates of exacerbations and IVIg, respectively, compared with AChEI and/or CS (n = 6,242), and 33% and 23% higher, respectively, compared with a second IST (n = 353). Discussion Many patients experienced exacerbations and received rescue therapy despite treatment, suggesting current treatments may not provide adequate disease control for some patients and that additional treatment options should be explored.
    Type of Medium: Online Resource
    ISSN: 0148-639X , 1097-4598
    URL: Issue
    URL: Article
    DOI: 10.1002/mus.v67.4
    DOI: 10.1002/mus.27791
    RVK:
    XA 10000
    Language: English
    Publisher: Wiley
    Publication Date: 2023
    detail.hit.zdb_id: 1476641-3
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  • 7
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    Immunogenicity of HPV and HBV vaccines: adjuvanticity of synthetic analogs of monophosphoryl lipid A combined with aluminum hydroxide
    Wiley ; 2019
    In:  APMIS Vol. 127, No. 3 ( 2019-03), p. 150-157
    Details
    In: APMIS, Wiley, Vol. 127, No. 3 ( 2019-03), p. 150-157
    Abstract: Monophosphoryl lipid A (MPL), a purified and detoxified product of lipopolysaccharide (LPS) of Salmonella minnesota R595, has been used as an adjuvant in different vaccines. In this study, the efficacy of human papillomaviruses (HPV) and hepatitis B virus (HBV) vaccines formulated with aluminum hydroxide combined with two different synthetic MPLs, 3D‐(6‐acyl)‐PHAD or 3D‐PHAD, or aluminum hydroxide combined with the mixtures of such MPLs, has been assessed. The immunogenicity in female BALB/c mice was verified by two intramuscular injections of differently formulated HPV and HBV vaccines and the total immunoglobulin G (IgG) antibody response was considered to compare the employed adjuvants. As verified experimentally, a mixture of 3D‐(6‐acyl)‐PHAD and 3D‐PHAD was able to induce significantly higher antibody titer than that of either 3D‐(6‐acyl)‐PHAD or 3D‐PHAD, when used individually. Interestingly, based on the responses achieved in terms of the total antibody levels, such mixture of synthetic MPLs was found to be even more effective than the bacterially derived MPL. Accordingly, the obtained results indicated that, if designed appropriately, synthetic MPL molecules could provide improved adjuvanticity with high level of consistency.
    Type of Medium: Online Resource
    ISSN: 0903-4641 , 1600-0463
    URL: Issue
    URL: Article
    DOI: 10.1111/apm.2019.127.issue-3
    DOI: 10.1111/apm.12927
    RVK:
    XA 13160
    Language: English
    Publisher: Wiley
    Publication Date: 2019
    detail.hit.zdb_id: 2098213-6
    SSG: 12
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  • 8
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    Safety, tolerability, and efficacy of adjunctive lacosamide in pediatric patients with epilepsy syndromes associated with generalized seizures: Phase 2, open‐label exploratory trial
    Wiley ; 2023
    In:  Epilepsia
    Details
    In: Epilepsia, Wiley
    Abstract: To evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of lacosamide (LCM) (up to 12 mg/kg/day or 600 mg/day) as adjunctive therapy in pediatric patients with epilepsy syndromes associated with generalized seizures. Methods Phase 2, multicenter, open‐label exploratory trial (SP0966; NCT01969851; 2012‐001446‐18) of oral LCM for epilepsy syndromes associated with generalized seizures in pediatric patients ≥1 month to 〈 18 years of age taking one to three concomitant antiseizure medications. The trial comprised a 6‐week prospective baseline period, 6‐week flexible titration period, and 12‐week maintenance period. Results Fifty‐five patients (mean age: 9.2 years; 56.4% male) took at least one dose of LCM and had at least one post‐baseline efficacy‐related assessment. The median treatment duration was 127.0 days. There were no clinically significant mean or median changes or worsening from baseline to end of the titration period in the count of generalized spike–wave discharges per interpretable hour on 24‐h ambulatory electroencephalogram recordings, or from baseline to the maintenance period in mean and median days with any generalized or focal to bilateral tonic–clonic seizures per 28 days. Treatment‐emergent adverse events (TEAEs) were reported by 49 patients (89.1%), and three patients (5.5%) discontinued due to TEAEs. The median change and median percentage change in days with any generalized or focal to bilateral tonic–clonic seizures per 28 days from baseline to the maintenance period were both 0. Trends toward improvement (decrease) were observed in median change and median percentage change in days with each individual seizure type (absence, myoclonic, clonic, tonic, tonic–clonic, atonic, and focal to bilateral tonic–clonic) per 28 days. Significance Safety findings were consistent with the known safety profile of LCM and were as expected for the pediatric population. There was no worsening of generalized seizures with LCM. Limitations include the inability to correlate spike and wave data with clinical outcomes, and the lack of similar studies against which the results can be compared.
    Type of Medium: Online Resource
    ISSN: 0013-9580 , 1528-1167
    URL: Article
    DOI: 10.1111/epi.17741
    RVK:
    XA 10000
    Language: English
    Publisher: Wiley
    Publication Date: 2023
    detail.hit.zdb_id: 2002194-X
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  • 9
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    WATER ALLOCATION OPTIMIZATION FOR SUPPLEMENTARY IRRIGATION IN RAINFED LANDS TO INCREASE TOTAL INCOME CASE STUDY: UPSTREAM KARKHEH RIVER BASIN : WATER ALLOCATION OPTIMIZATION FOR SUPPLEMENTARY IRRIGATION IN RAINFED
    Wiley ; 2013
    In:  Irrigation and Drainage Vol. 62, No. 1 ( 2013-02), p. 74-83
    Details
    In: Irrigation and Drainage, Wiley, Vol. 62, No. 1 ( 2013-02), p. 74-83
    Type of Medium: Online Resource
    ISSN: 1531-0353
    URL: Issue
    URL: Article
    DOI: 10.1002/ird.v62.1
    DOI: 10.1002/ird.1700
    Language: English
    Publisher: Wiley
    Publication Date: 2013
    detail.hit.zdb_id: 2045607-4
    SSG: 21
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  • 10
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    Kinetic models to describe Nannochloropsis salina cultivation under different illumination conditions
    Wiley ; 2022
    In:  Environmental Progress & Sustainable Energy Vol. 41, No. 4 ( 2022-07)
    Details
    In: Environmental Progress & Sustainable Energy, Wiley, Vol. 41, No. 4 ( 2022-07)
    Abstract: Nannochloropsis salina ( N . salina ) has recently received growing interests as a sustainable source of high‐value bioproducts. As the illumination condition could be manipulated to affect the microalgae activities in indoor cultivation, in this study, kinetic models were developed to describe the growth and bioproduct formation in N. salina under different illumination conditions. Being continuously exposed to white (380–760 nm), blue (430 nm), red (680 nm), and mixed blue/red light, the growth of N. salina was assessed over the course of 12 days incubation and the evolving cell densities, lipid, and carbohydrate concentrations were recorded. Kinetic models were then used to fit the experimental results and describe microalgae behaviors with respect to illumination conditions. The highest growth rates were recorded when the microalgae were exposed to the blue/red light, leading to 0.8 g/L standing dry biomass. Also, although lipid and carbohydrate productions were stimulated under other illumination conditions, the advanced biomass production achieved by blue/red light resulted in the highest lipid and carbohydrate productions. As confirmed by the kinetic models, the results obtained in this study revealed that the light absorbed by the photosynthetic pigments of N. salina could be manipulated to not only control the microalgae growth, but also its biological activities, including carbohydrate and lipid productions. Therefore, a two‐stage process would be recommended for lipid and carbohydrate production by N. salina .
    Type of Medium: Online Resource
    ISSN: 1944-7442 , 1944-7450
    URL: Issue
    URL: Article
    DOI: 10.1002/ep.v41.4
    DOI: 10.1002/ep.13833
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 2462324-6
    SSG: 21
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