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1.
  • Allen, D. B., et al. (författare)
  • GH safety workshop position paper: a critical appraisal of recombinant human GH therapy in children and adults
  • 2016
  • Ingår i: European Journal of Endocrinology. - 0804-4643. ; 174:2, s. P1-P9
  • Tidskriftsartikel (refereegranskat)abstract
    • Recombinant human GH (rhGH) has been in use for 30 years, and over that time its safety and efficacy in children and adults has been subject to considerable scrutiny. In 2001, a statement from the GH Research Society (GRS) concluded that 'for approved indications, GH is safe'; however, the statement highlighted a number of areas for on-going surveillance of long-term safety, including cancer risk, impact on glucose homeostasis, and use of high dose pharmacological rhGH treatment. Over the intervening years, there have been a number of publications addressing the safety of rhGH with regard to mortality, cancer and cardiovascular risk, and the need for long-term surveillance of the increasing number of adults who were treated with rhGH in childhood. Against this backdrop of interest in safety, the European Society of Paediatric Endocrinology (ESPE), the GRS, and the Pediatric Endocrine Society (PES) convened a meeting to reappraise the safety of rhGH. The ouput of the meeting is a concise position statement.
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2.
  • Boguszewski, Margaret C S, 1964-, et al. (författare)
  • Low birth size and final height predict high sympathetic nerve activity in adulthood.
  • 2004
  • Ingår i: Journal of hypertension. - 0263-6352. ; 22:6, s. 1157-63
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVE: Being born small for gestational age (SGA) is associated with insulin resistance, hypertension and increased cardiovascular morbidity/mortality in adulthood. Sympathetic nerve hyperactivity is a well-known risk factor for cardiovascular disease mortality and is proposed to link insulin resistance with hypertension. The objective of this study was to test the hypothesis that sympathetic nerve activity is altered in individuals born SGA. DESIGN: A cross-sectional, comparative study of 20 healthy adults (21-25 years old) born SGA (birth weight < -2SD score for healthy newborns) with normal and short stature, and 12 age, gender and body mass index matched individuals, born appropriate for gestational age (AGA) with normal stature. METHODS: Direct recordings of resting sympathetic nerve activity to the muscle vascular bed (MSA) were obtained from the peroneal nerve posterior to the fibular head. Heart rate, respiration and blood pressure were recorded during the microneurographic session. RESULTS: MSA was increased in both groups of young adults born SGA as compared to those born AGA (P < 0.05 and P < 0.005, respectively). In the combined study group MSA was inversely correlated to birth weight, length (r = -0.59, P < 0.001 and r = -0.69, P < 0.0005, respectively) and final adult height (r = -0.58; P < 0.001). CONCLUSIONS: Being born SGA and achieving a short final height is associated with increased sympathetic nerve traffic. We suggest that the increase in sympathetic nerve traffic in young adults born SGA with normal and short stature may be the link between low birth size, hypertension and cardiovascular morbidity later in life.
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3.
  • Bridel, Claire, et al. (författare)
  • Diagnostic Value of Cerebrospinal Fluid Neurofilament Light Protein in Neurology: A Systematic Review and Meta-analysis.
  • 2019
  • Ingår i: JAMA neurology. - 2168-6157. ; 76:9, s. 1035-1048
  • Tidskriftsartikel (refereegranskat)abstract
    • Neurofilament light protein (NfL) is elevated in cerebrospinal fluid (CSF) of a number of neurological conditions compared with healthy controls (HC) and is a candidate biomarker for neuroaxonal damage. The influence of age and sex is largely unknown, and levels across neurological disorders have not been compared systematically to date.To assess the associations of age, sex, and diagnosis with NfL in CSF (cNfL) and to evaluate its potential in discriminating clinically similar conditions.PubMed was searched for studies published between January 1, 2006, and January 1, 2016, reporting cNfL levels (using the search terms neurofilament light and cerebrospinal fluid) in neurological or psychiatric conditions and/or in HC.Studies reporting NfL levels measured in lumbar CSF using a commercially available immunoassay, as well as age and sex.Individual-level data were requested from study authors. Generalized linear mixed-effects models were used to estimate the fixed effects of age, sex, and diagnosis on log-transformed NfL levels, with cohort of origin modeled as a random intercept.The cNfL levels adjusted for age and sex across diagnoses.Data were collected for 10 059 individuals (mean [SD] age, 59.7 [18.8] years; 54.1% female). Thirty-five diagnoses were identified, including inflammatory diseases of the central nervous system (n = 2795), dementias and predementia stages (n = 4284), parkinsonian disorders (n = 984), and HC (n = 1332). The cNfL was elevated compared with HC in a majority of neurological conditions studied. Highest levels were observed in cognitively impaired HIV-positive individuals (iHIV), amyotrophic lateral sclerosis, frontotemporal dementia (FTD), and Huntington disease. In 33.3% of diagnoses, including HC, multiple sclerosis, Alzheimer disease (AD), and Parkinson disease (PD), cNfL was higher in men than women. The cNfL increased with age in HC and a majority of neurological conditions, although the association was strongest in HC. The cNfL overlapped in most clinically similar diagnoses except for FTD and iHIV, which segregated from other dementias, and PD, which segregated from atypical parkinsonian syndromes.These data support the use of cNfL as a biomarker of neuroaxonal damage and indicate that age-specific and sex-specific (and in some cases disease-specific) reference values may be needed. The cNfL has potential to assist the differentiation of FTD from AD and PD from atypical parkinsonian syndromes.
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4.
  • Buendia, Ruben, 1982-, et al. (författare)
  • Estimation of body fluids with bioimpedance spectroscopy: state of the art methods and proposal of novel methods
  • 2015
  • Ingår i: Physiological Measurement. - 0967-3334. ; 36:10, s. 93
  • Tidskriftsartikel (refereegranskat)abstract
    • Determination of body fluids is a useful common practice in determination of disease mechanisms and treatments. Bioimpedance spectroscopy (BIS) methods are non-invasive, inexpensive and rapid alternatives to reference methods such as tracer dilution. However, they are indirect and their robustness and validity are unclear. In this article, state of the art methods are reviewed, their drawbacks identified and new methods are proposed. All methods were tested on a clinical database of patients receiving growth hormone replacement therapy. Results indicated that most BIS methods are similarly accurate (e.g.
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5.
  • Buendia, R, et al. (författare)
  • Robustness study of the different immittance spectra and frequency ranges in bioimpedance spectroscopy analysis for assessment of total body composition.
  • 2014
  • Ingår i: Physiological measurement. - 1361-6579. ; 35:7, s. 1373-95
  • Tidskriftsartikel (refereegranskat)abstract
    • The estimation of body fluids is a useful and common practice for assessment of disease status and therapy outcomes. Electrical bioimpedance spectroscopy (EBIS) methods are noninvasive, inexpensive and efficient alternatives for determination of body fluids. One of the main source of errors in EBIS measurements in the estimation of body fluids is capacitive coupling. In this paper an analysis of capacitive coupling in EBIS measurements was performed and the robustness of the different immittance spectra against it tested. On simulations the conductance (G) spectrum presented the smallest overall error, among all immittance spectra, in the estimation of the impedance parameters used to estimate body fluids. Afterwards the frequency range of 10-500 kHz showed to be the most robust band of the G spectrum. The accuracy of body fluid estimations from the resulting parameters that utilized G spectrum and parameters provided by the measuring device were tested on EBIS clinical measurements from growth hormone replacement therapy patients against estimations performed with dilution methods. Regarding extracellular fluid, the correlation between each EBIS method and dilution was 0.93 with limits of agreement of 1.06 ± 2.95 l for the device, 1.10 ± 2.94 l for G [10-500 kHz] and 1.04 ± 2.94 l for G [5-1000 kHz]. Regarding intracellular fluid, the correlation between dilution and the device was 0.91, same as for G [10-500 kHz] and 0.92 for G [5-1000 kHz]. Limits of agreement were 0.12 ± 4.46 l for the device, 0.09 ± 4.45 for G [10-500 kHz] and 0.04 ± 4.58 for G [5-1000 kHz]. Such close results between the EBIS methods validate the proposed approach of using G spectrum for initial Cole characterization and posterior clinical estimation of body fluids status.
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6.
  • Christiansen, J. S., et al. (författare)
  • Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations
  • 2016
  • Ingår i: European Journal of Endocrinology. - 0804-4643. ; 174:6, s. C1-C8
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective: The Growth Hormone (GH) Research Society (GRS) convened a workshop to address important issues regarding trial design, efficacy, and safety of long-acting growth hormone preparations (LAGH). Participants: A closed meeting of 55 international scientists with expertise in GH, including pediatric and adult endocrinologists, basic scientists, regulatory scientists, and participants from the pharmaceutical industry. Evidence: Current literature was reviewed for gaps in knowledge. Expert opinion was used to suggest studies required to address potential safety and efficacy issues. Consensus process: Following plenary presentations summarizing the literature, breakout groups discussed questions framed by the planning committee. Attendees reconvened after each breakout session to share group reports. A writing team compiled the breakout session reports into a draft document that was discussed and revised in an open forum on the concluding day. This was edited further and then circulated to attendees from academic institutions for review after the meeting. Participants from pharmaceutical companies did not participate in the planning, writing, or in the discussions and text revision on the final day of the workshop. Scientists from industry and regulatory agencies reviewed the manuscript to identify any factual errors. Conclusions: LAGH compounds may represent an advance over daily GH injections because of increased convenience and differing phamacodynamic properties, providing the potential for improved adherence and outcomes. Better methods to assess adherence must be developed and validated. Long-term surveillance registries that include assessment of efficacy, cost-benefit, disease burden, quality of life, and safety are essential for understanding the impact of sustained exposure to LAGH preparations.
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7.
  • Clayton, P E, et al. (författare)
  • Management of the child born small for gestational age through to adulthood: a consensus statement of the International Societies of Pediatric Endocrinology and the Growth Hormone Research Society.
  • 2007
  • Ingår i: The Journal of clinical endocrinology and metabolism. - 0021-972X. ; 92:3, s. 804-10
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVE: Low birth weight remains a major cause of morbidity and mortality in early infancy and childhood. It is associated with an increased risk of health problems later in life, particularly coronary heart disease and stroke. A meeting was convened to identify the key health issues facing a child born small for gestational age (SGA) and to propose management strategies. PARTICIPANTS: There were 42 participants chosen for their expertise in obstetrics, peri- and neonatal medicine, pediatrics, pediatric and adult endocrinology, epidemiology, and pharmacology. EVIDENCE: Written materials were exchanged, reviewed, revised, and then made available to all. This formed the basis for discussions at the meeting. Where published data were not available or adequate, discussion was based on expert clinical opinions. CONSENSUS PROCESS: Each set of questions was considered by all and then discussed in plenary sessions with consensus and unresolved issues identified. The consensus statement was prepared in plenary sessions and then edited by the group chairs and shared with all participants. CONCLUSIONS: The diagnosis of SGA should be based on accurate anthropometry at birth including weight, length, and head circumference. We recommend early surveillance in a growth clinic for those without catch-up. Early neurodevelopment evaluation and interventions are warranted in at-risk children. Endocrine and metabolic disturbances in the SGA child are recognized but infrequent. For the 10% who lack catch-up, GH treatment can increase linear growth. Early intervention with GH for those with severe growth retardation (height sd score, <-2.5; age, 2-4 yr) should be considered at a dose of 35-70 microg/kg x d. Long-term surveillance of treated patients is essential. The associations at a population level between low birth weight, including SGA, and coronary heart disease and stroke in later life are recognized, but there is inadequate evidence to recommend routine health surveillance of all adults born SGA outside of normal clinical practice.
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8.
  • Dellenborg, Liselott (Lisen), 1966-, et al. (författare)
  • Perspectives on Sexuality Among Patients with Hypopituitarism: Broadening the Medical Focus on Sexual Function to Include Sexual Wellbeing
  • 2020
  • Ingår i: Sexuality and Disability. - 0146-1044.
  • Tidskriftsartikel (refereegranskat)abstract
    • Hypopituitarism means a partial or complete inability to produce pituitary hormones, including those regulating gonadal function. The condition therefore leads to hormone deficiencies that may affect sexuality in various ways. This study aimed to explore patients' own experiences of hypopituitarism in relation to sexuality, and it is based on interviews with 19 men and women. A qualitative methodology inspired by Gadamer's philosophical hermeneutics was used. Analysis revealed that current healthcare practices, which focus primarily on sexual functioning, fail to address patients' existential concerns about loneliness, loving relationships and selfhood. Another important finding was that women felt that their sexual functioning and wellbeing tended to go unnoticed, while men said that healthcare professionals focused mainly on erectile function rather than problems with sexual wellbeing. Cultural and gender norms were apparent in these healthcare interactions, and proactive efforts to improve awareness is required in order to improve the quality of care provided to these patients. Healthcare professionals need time, space and support for reflection so that they may enhance their knowledge about the complexity of sexuality and discuss the results of research into hormone replacement in men and women. They also need support to develop critical awareness of how gendered norms about sexuality may negatively affect the care provided to persons with hypopituitarism.
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9.
  • Gil Berglund, E, et al. (författare)
  • Growth hormone replacement therapy induces codeine clearance.
  • 2002
  • Ingår i: European journal of clinical investigation. - 0014-2972. ; 32:7, s. 507-12
  • Tidskriftsartikel (refereegranskat)abstract
    • The increasing clinical use of growth hormone (GH) has raised questions about other than growth-related metabolic effects of this treatment. GH regulates the expression of several hepatic drug metabolising enzymes in the rat, but it is not known whether GH treatment alters the expression of such liver enzymes in man. We have investigated the effects of GH on codeine clearance and two enzymes of the cytochrome P450 (CYP) family, CYP3A and CYP2D6, and UDP-glucuronosyl transferase (UDPGT). These enzymes have a superior importance in hepatic biotransformation of numerous drugs. In addition, CYP3A and UDPGT are catalysts of many reactions with endobiotics such as steroid hormones.We used codeine as a probe drug for assessment of the enzyme activities. Codeine was administered as a single-dose prior to, and after 3 months of GH substitution in GH-deficient patients. Total clearance, and clearance along each of the three primary metabolic pathways of codeine, was assessed.Three months of GH substitution increased the total clearance of codeine (21%, P < 0.01) and clearance catalysed by UDPGT significantly (31%, P < 0.05). The treatment tended to increase the clearance via the CYP3A pathway (83%, P = 0.05).The effects of GH replacement therapy on drug metabolism may have clinical implications when combined with drugs that are substrates of UDPGT and CYP3A. Effects on steroid hormone metabolism with endocrine consequences can not be ruled out.
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10.
  • Gillberg, P, et al. (författare)
  • Commencing growth hormone replacement in adults with a fixed low dose. Effects on serum lipoproteins, glucose metabolism, body composition, and cardiovascular function.
  • 2001
  • Ingår i: Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society. - 1096-6374. ; 11:5, s. 273-81
  • Tidskriftsartikel (refereegranskat)abstract
    • The safety and effects of a fixed low dose of growth hormone (GH), 0.17 mg/day was evaluated for 3 months, on glucose metabolism, serum lipids, body composition and cardiac function in 53 GH deficient adults aged 18-78 years. Body composition was determined by dual energy X-ray absorptiometry and total body water was determined by bioelectrical impedance. Echocardiography was used to assess cardiac function and bicycle ergonometry was used to determine exercise capacity. All investigations were performed at baseline and after 3 months. At 3 months, serum levels of insulin-like growth factor (IGF)-I, IGF binding protein (IGFBP)-3 and lipoprotein (a) and lean body mass were increased (P<0.05). Total and low density lipoprotein cholesterol levels and fat mass were reduced (P<0.05). There was an increase in the serum glucose value at 120 min after an oral glucose tolerance test performed at 3 months (P<0.05), no other changes in glucose metabolism or in cardiac function were noted. Side-effects were few and mild. This fixed low-dose regime resulted in improvements in body composition and lipid profile, without causing serious side effects. This is therefore a valid method to institute GH replacement in adults.
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