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  • 1
    Online Resource
    Online Resource
    Guidelines of the International Headache Society for Controlled Clinical Trials in Cluster Headache
    SAGE Publications ; 2022
    In:  Cephalalgia Vol. 42, No. 14 ( 2022-12), p. 1450-1466
    Details
    In: Cephalalgia, SAGE Publications, Vol. 42, No. 14 ( 2022-12), p. 1450-1466
    Abstract: In 1995, a committee of the International Headache Society developed and published the first edition of the Guidelines for Controlled Trials of Drugs in Cluster Headache. These have not been revised. With the emergence of new medications, neuromodulation devices and trial designs, an updated version of the International Headache Society Guidelines for Controlled Clinical Trials in Cluster Headache is warranted. Given the scarcity of evidence-based data for cluster headache therapies, the update is largely consensus-based, but takes into account lessons learned from recent trials and demands by patients. It is intended to apply to both drug and neuromodulation treatments, with specific proposals for the latter when needed. The primary objective is to propose a template for designing high quality, state-of-the-art, controlled clinical trials of acute and preventive treatments in episodic and chronic cluster headache. The recommendations should not be regarded as dogma and alternative solutions to particular methodological problems should be explored in the future and scientifically validated.
    Type of Medium: Online Resource
    ISSN: 0333-1024 , 1468-2982
    URL: Article
    DOI: 10.1177/03331024221120266
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
    detail.hit.zdb_id: 2019999-5
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  • 2
    Online Resource
    Online Resource
    Relationship Between Anti-DFS70 Autoantibodies and Oxidative Stress
    SAGE Publications ; 2022
    In:  Biomarker Insights Vol. 17 ( 2022-01), p. 117727192110667-
    Details
    In: Biomarker Insights, SAGE Publications, Vol. 17 ( 2022-01), p. 117727192110667-
    Abstract: The anti-DFS70 autoantibodies are one of the most commonly and widely described agent of unknown clinical significance, frequently detected in healthy individuals. It is not known whether the DFS70 autoantibodies are protective or pathogenic. One of the factors suspected of inducing the formation of anti-DFS70 antibodies is increased oxidative stress. We evaluated the coexistence of anti-DFS70 antibodies with selected markers of oxidative stress and investigated whether these antibodies could be considered as indirect markers of oxidative stress. Methods: The intensity of oxidative stress was measured in all samples via indices of free-radical damage to lipids and proteins such as total oxidant status (TOS), concentrations of lipid hydroperoxides (LPH), lipofuscin (LPS), and malondialdehyde (MDA). The parameters of the non-enzymatic antioxidant system, such as total antioxidant status (TAS) and uric acid concentration (UA), were also measured, as well as the activity of superoxide dismutase (SOD). Based on TOS and TAS values, the oxidative stress index (OSI) was calculated. All samples were also tested with indirect immunofluorescence assay (IFA) and 357 samples were selected for direct monospecific anti DFS70 enzyme-linked immunosorbent assay (ELISA) testing. Results: The anti-DFS70 antibodies were confirmed by ELISA test in 21.29% of samples. Compared with anti-DFS70 negative samples we observed 23% lower concentration of LPH ( P = .038) and 11% lower concentration of UA ( P = .005). TOS was 20% lower ( P = .014). The activity of SOD was up to 5% higher ( P = .037). The Pearson correlation showed weak negative correlation for LPH, UA, and TOS and a weak positive correlation for SOD activity. Conclusion: In samples positive for the anti-DFS70 antibody a decreased level of oxidative stress was observed, especially in the case of samples with a high antibody titer. Anti-DFS70 antibodies can be considered as an indirect marker of reduced oxidative stress or a marker indicating the recent intensification of antioxidant processes.
    Type of Medium: Online Resource
    ISSN: 1177-2719 , 1177-2719
    URL: Article
    DOI: 10.1177/11772719211066791
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
    detail.hit.zdb_id: 2256754-9
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  • 3
    Online Resource
    Online Resource
    Intravenous drug abuse in young men : Risk factors assessed in a longitudinal perspective
    SAGE Publications ; 1992
    In:  Scandinavian Journal of Social Medicine Vol. 20, No. 2 ( 1992-06), p. 94-101
    Details
    In: Scandinavian Journal of Social Medicine, SAGE Publications, Vol. 20, No. 2 ( 1992-06), p. 94-101
    Abstract: Intravenous drug abuse in young men: Risk factors assessed in a longitudinal perspective. Stenbacka, M. (Department of Social Medicine, Kronan Health Centre, S-172 83 Sundbyberg, Sweden). The role of family background as well as behavioural and psychological factors as risk factors for intravenous drug abuse was analysed in a longitudinal study of 8168 Swedish men conscripted for military service in 1969-70. Information about risk factors was obtained from a survey of all Swedish conscripts. Records on intravenous drug abuse, during a followup ending in 1986, were obtained from a survey of intravenous drug abusers among persons brought to the Central police arrest in Stockholm. Strong predictors of intravenous drug abuse were contact with the police or juvenile authorities (RR = 22.3 95% CI 15.1-33.0), high alcohol consumption (RR = 9.2 95% CI 6.7-12.7) and psychiatric diagnosis at conscription (RR = 6.0 95% CI 4.5-8.1) and low social class (RR = 3.6 95% CI 2.2-5.9). In multivariate analyses, these factors and indicators of deviant behaviour still carried significantly increased relative risk for intravenous drug abuse, although several of them are interrelated. Low emotional control, nervousness, sleeping problems and other nervous problems were associated with an increased relative risk in univariate but not in multivariate analyses.
    Type of Medium: Online Resource
    ISSN: 0300-8037
    URL: Article
    DOI: 10.1177/140349489202000206
    Language: English
    Publisher: SAGE Publications
    Publication Date: 1992
    detail.hit.zdb_id: 2027122-0
    detail.hit.zdb_id: 2253902-5
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  • 4
    Online Resource
    Online Resource
    Clinical Results and Mechanical Properties of the Carotid CGUARD Double-Layered Embolic Prevention Stent
    SAGE Publications ; 2017
    In:  Journal of Endovascular Therapy Vol. 24, No. 1 ( 2017-02), p. 130-137
    Details
    In: Journal of Endovascular Therapy, SAGE Publications, Vol. 24, No. 1 ( 2017-02), p. 130-137
    Abstract: Purpose: To report early clinical outcomes with a novel double-layer stent for the internal carotid artery (ICA) and the in vitro investigation of the stent’s mechanical properties. Methods: A prospective single-center study enrolled 30 consecutive patients (mean age 73.1±6.3 years; 21 men) with symptomatic (n=25) or high-grade (n=5) ICA stenosis treated with the new double-layer carotid CGUARD Embolic Prevention System (EPS) stent, which has an inner open-cell nitinol design with an outer closed-cell polyethylene terephthalate layer. The average stenosis of the treated arteries was 84.1%±7.9% with a mean lesion length of 16.6±2.1 mm. In the laboratory, 8×40-mm stents where tested in vitro with respect to their radial force during expansion, the bending stiffness of the stent system and the expanded stent, as well as the collapse pressure in a thin and flexible sheath. The wall adaptation was assessed using fluoroscopy after stent release in step and curved vessel models. Results: The stent was successfully implanted in all patients. No peri- or postprocedural complications occurred; no minor or major stroke was observed in the 6-month follow-up. The bending stiffness of the expanded stent was 63.1 N·mm 2 and (not unexpectedly) was clearly lower than that of the stent system (601.5 N·mm 2 ). The normalized radial force during expansion of the stent to 7.0 mm, consistent with in vivo sizing, was relatively high (0.056 N/mm), which correlates well with the collapse pressure of 0.17 bars. Vessel wall adaptation was harmonic and caused no straightening of the vessel after clinical application. Conclusion: Because of its structure, the novel CGUARD EPS stent is characterized by a high flexibility combined with a high radial force and very good plaque coverage. These first clinical results demonstrate a very safe implantation behavior without any stroke up to 6 months after the procedure.
    Type of Medium: Online Resource
    ISSN: 1526-6028 , 1545-1550
    URL: Article
    DOI: 10.1177/1526602816671134
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2017
    detail.hit.zdb_id: 2049858-5
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  • 5
    Online Resource
    Online Resource
    Correlation of self-assessed fatigue and alertness in multiple sclerosis
    SAGE Publications ; 2010
    In:  Multiple Sclerosis Journal Vol. 16, No. 9 ( 2010-09), p. 1134-1140
    Details
    In: Multiple Sclerosis Journal, SAGE Publications, Vol. 16, No. 9 ( 2010-09), p. 1134-1140
    Abstract: Background: Fatigue is the most common symptom in multiple sclerosis patients, but is difficult to measure; quantification thus relies on self-assessed questionnaires. Objective: To evaluate a battery of neuropsychological tests regarding their capacity to objectify self-reported fatigue. Methods: We assessed the correlation between age, gender, education, Kurtzke’s Expanded Disability Status Scale, depression, fatigue and neuropsychological testing using a cross-sectional approach in 110 multiple sclerosis patients. Fatigue was measured with the Fatigue Severity Scale. Cognition was measured using a series of neuropsychological tests including three subtests of the Test of Attentional Performance, the Brief Repeatable Battery of Neuropsychological Tests and the Faces Symbol Test. Results: According to the Fatigue Severity Scale 51.4% of the cohort were fatigued (scores ≥4). Age, education and depression showed a significant correlation with the Fatigue Severity Scale. Only 5.5% of the cohort exhibited cognitive impairment in the Brief Repeatable Battery of Neuropsychological Tests scores. After correction for age, education, Expanded Disability Status Scale and depression, Fatigue Severity Scale scores were an independent predictor of performance in the alertness subtest of the Test of Attentional Performance (standardized coefficient beta = 0.298, p = 0.014). Conclusion: The alertness subtest of the Test of Attentional Performance may offer an objective method of evaluating self-reported fatigue, and may therefore — in addition to the Fatigue Severity Scale — be a suitable tool for the assessment of multiple sclerosis patients complaining of fatigue.
    Type of Medium: Online Resource
    ISSN: 1352-4585 , 1477-0970
    URL: Article
    DOI: 10.1177/1352458510374202
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2010
    detail.hit.zdb_id: 2008225-3
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  • 6
    Online Resource
    Online Resource
    Surveillance for Hemodialysis Access Stenosis: Usefulness of Ultrasound Vector Volume Flow
    SAGE Publications ; 2016
    In:  The Journal of Vascular Access Vol. 17, No. 6 ( 2016-11), p. 483-488
    Details
    In: The Journal of Vascular Access, SAGE Publications, Vol. 17, No. 6 ( 2016-11), p. 483-488
    Abstract: To investigate if ultrasound vector-flow imaging (VFI) is equal to the reference method ultrasound dilution technique (UDT) in estimating volume flow and changes over time in arteriovenous fistulas (AVFs) for hemodialysis. Materials and methods From January 2014 to January 2015, patients with end-stage renal disease and matured functional AVFs were consecutively solicited to participate in this prospective study. All patients were included after written informed consent and approval by the National Committee on Biomedical Research Ethics and the local Ethics Committee (journal no. H-4-2014-FSP). VFI and UDT measurements were performed monthly over a six-month period. Nineteen patients were included in the study. VFI measurements were performed before dialysis, and UDT measurements after. Statistical analyses were performed with Bland-Altman plot, Student's t-test, four-quadrant plot, and regression analysis. Repeated measurements and precision analysis were used for reproducibility determination. Results Precision measurements for UDT and VFI were 32% and 20%, respectively (p = 0.33). Average volume flow measured with UDT and VFI were 1161 mL/min (±778 mL/min) and 1213 mL/min (±980 mL/(min), respectively (p = 0.3). The mean difference was -51 mL/min (CI: -150 mL/min to 46 mL/min) with limits of agreement from -35% to 54%, with a strong correlation (r 2 = 0.87). A large change in volume flow between dialysis sessions detected by UDT was confirmed by VFI (p = 0.0001), but the concordance rate was poor (0.72). Conclusions VFI is an acceptable method for volume flow estimation and volume flow changes over time in AVFs.
    Type of Medium: Online Resource
    ISSN: 1129-7298 , 1724-6032
    URL: Article
    DOI: 10.5301/jva.5000589
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2016
    detail.hit.zdb_id: 2079292-X
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  • 7
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    Combined Lysis of Thrombus with Ultrasound and Systemic Tissue Plasminogen Activator for Emergent Revascularization in Acute Ischemic Stroke (Clotbust-ER): Design and Methodology of a Multinational Phase 3 Trial
    SAGE Publications ; 2015
    In:  International Journal of Stroke Vol. 10, No. 7 ( 2015-10), p. 1141-1148
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 10, No. 7 ( 2015-10), p. 1141-1148
    Abstract: We designed a Phase 3 clinical trial to determine the safety and efficacy of adding transcranial ultrasound using an operator-independent headframe to recombinant tissue-plasminogen-activator for the treatment of acute ischemic stroke. Methods Combined lysis of thrombus with ultrasound and systemic tissue-plasminogen-activator for emergent revascularization in acute ischemic stroke is a randomized, double-blind, placebo-controlled clinical trial that will enroll subjects with the following main inclusion criteria: less than 4·5 hours from symptom onset (three-hours in US and Canada), age 18–80 years, baseline National Institutes of Health Stroke Scale score ≥ 10, and premorbid modified-Rankin-score of 0–1, eligibility for full dose recombinant tissue-plasminogen-activator. Subjects will receive two-hours of 2-MHz pulsed wave transcranial ultrasound (target group) or sham ultrasound (control group). The projected sample size is approximately 824 subjects. Results The primary endpoint, based on intention-to-treat criteria of patients enrolled within three-hours of symptom onset is the comparison between target and control groups of modified-Rankin-score scores at day 90 poststroke assessed using the proportional odds method. The study will have two planned interim analyses after approximately one-third and two-thirds of subjects have reached the 90-day modified-Rankin-score evaluation. Safety outcomes are symptomatic intracranial hemorrhage within 24 h and an overall analysis of adverse events. Conclusions Since intravenous recombinant tissue-plasminogen-activator remains the only medical therapy to reverse ischemic stroke applicable in the emergency department, our trial will determine if the additional use of transcranial ultrasound improves functional outcomes in patients with severe acute ischemic stroke (NCT#01098981).
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/ijs.12536
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2015
    detail.hit.zdb_id: 2211666-7
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  • 8
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    Online Resource
    PIK3CA Mutational Analysis in Patients With Macrodactyly
    SAGE Publications ; 2022
    In:  Pediatric and Developmental Pathology Vol. 25, No. 6 ( 2022-11), p. 624-634
    Details
    In: Pediatric and Developmental Pathology, SAGE Publications, Vol. 25, No. 6 ( 2022-11), p. 624-634
    Abstract: Somatic mosaicism for PIK3CA mutations causes various types of growth disorders, which have been summarized under the term PROS ( PIK3CA related overgrowth spectrum). Targeted therapy with PI3K inhibitors seems to be a promising alternative for severe PROS cases. Therefore, PIK3CA testing may become more relevant in the future. Methods We report on 14 PROS patients, who had surgery for macrodactyly in the majority of cases. Clinical data were retrieved from the patient’s records. Macroscopic and microscopic findings were retrospectively reviewed. Mutational analysis was performed on formalin-fixed paraffin-embedded (FFPE) material. Results Patient age ranged from 7 months to 35 years. Five patients showed additional anomalies. One patient had CLOVES syndrome. The majority of the specimens were ray resections characterized by hypertrophic fat tissue. Overall, microscopy was subtle. The abnormal adipose tissue showed lobules exhibiting at least focally fibrous septa. In each case, we could detect a PIK3CA mutation. Conclusion Histology of affected fat tissue in PROS patients is overall nonspecific. Therefore, mutational analysis represents the key to the diagnosis, especially in unclear clinical cases. We demonstrated that FFPE material is suitable for PIK3CA testing, which can be considered as basis for targeted therapy with PI3K inhibitors.
    Type of Medium: Online Resource
    ISSN: 1093-5266 , 1615-5742
    URL: Article
    DOI: 10.1177/10935266221080155
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
    detail.hit.zdb_id: 1480654-X
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  • 9
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    “I miss the care even though I know it’s just a machine”: An explorative study of the relationship between an Internet-based smoking cessation intervention and its participants
    SAGE Publications ; 2013
    In:  Health Informatics Journal Vol. 19, No. 3 ( 2013-09), p. 233-243
    Details
    In: Health Informatics Journal, SAGE Publications, Vol. 19, No. 3 ( 2013-09), p. 233-243
    Abstract: This study aimed to investigate how users perceive the different elements of an internet based smoking cessation intervention and to see if the program meet needs and expectations of people in a smoking cessation process. Nine semi-structured interviews were conducted in February 2010. Participants were recruited via the homepage of the smoking cessation program Dit Digitale Stopprogram (Your Digital Quit Program) operated by the Danish Cancer Society. The main result was that participants established a relationship to the program which influenced their smoking cessation process. Participants perceived the program as caring and found it supportive. However, the program also created feelings of frustration, disappointment and anger. Some participants in the last phase of cessation experienced text messages from the program as smoking cues. The study concluded that individual interpretations of the different elements in an Internet-based smoking cessation intervention can have both positive and negative impact on the smoking cessation process of participants.
    Type of Medium: Online Resource
    ISSN: 1460-4582 , 1741-2811
    URL: Article
    DOI: 10.1177/1460458212470572
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2013
    detail.hit.zdb_id: 2070802-6
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  • 10
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    The Systematic Development of an Internet-Based Smoking Cessation Intervention for Adults
    SAGE Publications ; 2016
    In:  Health Promotion Practice Vol. 17, No. 4 ( 2016-07), p. 490-500
    Details
    In: Health Promotion Practice, SAGE Publications, Vol. 17, No. 4 ( 2016-07), p. 490-500
    Abstract: Objectives. The objective of this project was to determine whether intervention mapping is a suitable strategy for developing an Internet- and text message–based smoking cessation intervention. Method. We used the Intervention Mapping framework for planning health promotion programs. After a needs assessment, we identified important changeable determinants of cessation behavior, specified objectives for the intervention, selected theoretical methods for meeting our objectives, and operationalized change methods into practical intervention strategies. Results. We found that “social cognitive theory,” the “transtheoretical model/stages of change,” “self-regulation theory,” and “appreciative inquiry” were relevant theories for smoking cessation interventions. From these theories, we selected modeling/behavioral journalism, feedback, planning coping responses/if-then statements, gain frame/positive imaging, consciousness-raising, helping relationships, stimulus control, and goal-setting as suitable methods for an Internet- and text-based adult smoking cessation program. Furthermore, we identified computer tailoring as a useful strategy for adapting the intervention to individual users. Conclusion. The Intervention Mapping method, with a clear link between behavioral goals, theoretical methods, and practical strategies and materials, proved useful for systematic development of a digital smoking cessation intervention for adults.
    Type of Medium: Online Resource
    ISSN: 1524-8399 , 1552-6372
    URL: Article
    DOI: 10.1177/1524839916631536
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2016
    detail.hit.zdb_id: 2036801-X
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